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The aprevo® anterior and lateral lumbar interbody fusion devices are intended for interbody fusion in skeletally mature patients and are to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches may include anterior lumbar interbody fusion or lateral lumbar interbody fusion.

The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® anterior and lateral lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® transforaminal lumbar interbody fusion device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® transforaminal lumbar interbody fusion device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® transforaminal lumbar interbody fusion device is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® transforaminal lumbar interbody fusion devices are to be filled with auto graft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for interbody fusion in skeletally mature patients. The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone and/or corticocancellous bone and is to be used with supplemental fixation cleared for use in the lumbar spine. The device may be implanted via an open or minimally invasive approach.

The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis, kyphosis, or sagittal), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for standalone use at one or two levels of the spine when used with the screws that accompany the implant and with implants less than or equal to 20° of lordosis. At more than two levels or with implants greater than 20° of lordosis, the aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended to be used with the screws that accompany the implant and with supplemental fixation. When used at more than one level in patients with degenerative scoliosis and/or sagittal deformity, the aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) must be used with the screws that accompany the implant and with supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine. These patients should be skeletally mature and have had at least six months of non-operative treatment. The device is to be filled with autograft bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. The device may be implanted via an open or minimally invasive approach.

The aprevo® TLIF-C Articulating System is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® TLIF-C Articulating System is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® TLIF-C Articulating System is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® TLIF-C Articulating System devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® Cervical ACDF lnterbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. The aprevo® Cervical ACDF lnterbody System must be used with supplemental fixation systems. For hyperlordotic corrections (≥20° lordosis), the system must be used with at least an anterior cervical plate as supplemental fixation.

The aprevo® Cervical ACDF-X lnterbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. When used as a standalone system, the aprevo® Cervical ACDF-X lnterbody implant with integrated screw fixation is intended for use at multiple contiguous levels, or up to two levels when used in trauma, deformity or failed previous fusions. Deformity procedures to correct coronal angulation or any use of hyperlordotic correction (≥20°) must include supplemental fixation such as posterior cervical screw fixation or anterior plating.

The aprevo® Lumbar Intervertebral Body Fusion Devices include ALIF, LLIF, TLIF, ALIF-X and TLIF-CA interbodies. The aprevo® lumbar interbody fusion devices are designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® device incorporates patient specific features to allow the surgeon to tailor the procedure to the individual needs of the patient and includes an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient CT scans. The aprevo® devices are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F3001, while the screws that accompany ALIF-X are machined from material per ASTM F136. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and instruments are provided as single use, sterile-packed product to the end user.

The aprevo® Cervical Intervertebral Body Fusion Devices include ACDF, ACDF-X and ACDF-X no cams. The aprevo® Cervical ACDF System, which includes the aprevo® Cervical ACDF Interbody, aprevo® Cervical ACDF-X Interbody, and the aprevo® Cervical ACDF-X (NO CAM) Interbody are designed to stabilize the cervical spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient-specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient and include an aperture for the packing of bone graft. The aprevo® Cervical ACDF System interbodies are additively manufactured from Ti-6Al-4V ELI titanium alloy per F3001, while the screws are machined from Ti alloy per ASTM F136. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and the instruments are provided to the end-user as single use, sterile-packed products.

The purpose of this 510(k) is to extend the expiration of imaging used to create 3D surgical plans. There have been no changes made to the software used in the surgical planning process.

The provided FDA 510(k) clearance letter (K250827) for Carlsmed, Inc.'s "aprevo®" interbody fusion devices primarily concerns the renewal of previously cleared devices and the extension of the imaging expiration dating used for 3D surgical planning. Therefore, the document does not contain details of a clinical study assessing the performance of an AI-based device meeting acceptance criteria in the way one might expect for a novel AI/ML medical device submission.

Instead, the performance testing summary indicates that "Clinical data was used to evaluate imaging expiration. Expiration dating was validated using statistical analysis (DICE score) with an acceptance criterion of >0.80. Additionally, the performance was evaluated across key cohorts." This suggests that the "device" being evaluated for performance in this context is likely related to the software's ability to accurately segment or generate 3D models from imaging data over time, rather than the interbody fusion implants themselves. The clearance is for the physical implants, which are considered substantially equivalent to previously cleared predicates. The "performance testing" here seems to be an update or validation related to the software component of the surgical planning.

Given this context, I will extract information relevant to the software's performance, as that is the only "acceptance criteria" and "study" mentioned, even if it's not a typical AI model performance study against clinical outcomes.

Here's an interpretation based on the limited information provided, assuming the "device performance" refers to the imaging processing capabilities of the aprevo® system's software, specifically regarding the "expiration" of imaging data for 3D surgical plans:

Acceptance Criteria and Device Performance Study for Imaging Expiration

The context of this FDA 510(k) submission (K250827) indicates that the performance study was specifically undertaken to extend the expiration of imaging used to create 3D surgical plans. This suggests the "device performance" being assessed relates to the consistency and accuracy of the software's ability to process imaging data for surgical planning over time, implying that "aging" of the input imaging data does not degrade the software's output beyond an acceptable threshold.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only specifies the acceptance criterion. The specific numerical performance result (e.g., the exact DICE score achieved) is not provided in this public clearance letter. However, the clearance implies that the criterion was met.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not specified in the provided text.
• Data Provenance: "Clinical data was used." No details on the country of origin or whether the data was retrospective or prospective are provided.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. (e.g., 2+1, 3+1, none).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done?: No, an MRMC study comparing human readers with and without AI assistance is not mentioned or implied by the description of this performance evaluation, which focuses on "imaging expiration" and DICE score.

6. Standalone (Algorithm Only) Performance

• Standalone Performance Done?: Yes, the use of a "DICE score" for "imaging expiration" strongly suggests an algorithm-only performance evaluation, likely comparing the software's segmentation or 3D reconstruction output against a form of ground truth derived from the clinical data. The phrase "There have been no changes made to the software used in the surgical planning process" further indicates an assessment of the software's intrinsic capabilities.

7. Type of Ground Truth Used

• Type of Ground Truth: The use of "DICE score" typically implies that the ground truth involves expert-annotated segmentations or regions of interest within the medical images. The DICE score measures the spatial overlap between the algorithm's output and the ground truth. While not explicitly stated, it's highly probable that this ground truth was derived from expert consensus or manual annotation of anatomical structures on the clinical imaging data.

8. Sample Size for the Training Set

• Training Set Sample Size: Not mentioned. This submission is for an extension/validation of existing software, not the initial clearance of a newly developed AI model, so details on original training are not typically included here.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not mentioned. As above, this document focuses on a validation study for imaging expiration, not the initial development or training of the AI algorithm.

Summary of Limitations Based on Provided Text:

The provided 510(k) summary (specifically the "Performance Testing Summary") is extremely concise regarding details of the study. It states that "Clinical data was used to evaluate imaging expiration" and that "Expiration dating was validated using statistical analysis (DICE score) with an acceptance criterion of >0.80. Additionally, the performance was evaluated across key cohorts."

Therefore, many typical details requested for robust AI/ML performance studies, such as specific sample sizes, expert qualifications, and adjudication methods, are not present in this public clearance letter. This is common for 510(k) summaries, which are often condensed versions of the full submission. The key takeaway is that the "performance testing" here addresses a specific aspect ("imaging expiration" for 3D surgical planning) of the software rather than a direct clinical efficacy study of the implant or a broad AI diagnostic/prognostic model.

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The aprevo® posterior/transforaminal lumbar interbody fusion device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® posterior/transforaminal lumbar interbody fusion device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone. The device may be implanted via an open or minimally invasive approach.

The aprevo® posterior/transforaminal lumbar interbody fusion device is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six months of non-operative treatment. The aprevo® transforaminal lumbar interbody fusion device is to be filled with autograft bone and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone. The device is intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). The device may be implanted via an open or minimally invasive approach.

The aprevo® posterior/transforaminal intervertebral body fusion device is designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® device incorporates patient specific features and includes an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient radiological images.

The aprevo® posterior/transforaminal lumbar interbody fusion device is additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and provided sterile. The associated instruments, which facilitate the placement, adjustment, and removal, if necessary, of the interbody device, are manufactured from stainless steel per ASTM A564 and provided sterile packaged for single use.

This FDA 510(k) clearance letter pertains to a physical medical device, specifically an intervertebral body fusion device, not a software-based AI device. Therefore, much of the information typically sought for AI/ML device acceptance criteria (e.g., ground truth establishment, training set details, multi-reader multi-case studies) is not applicable or present in this document.

However, I can extract the relevant information regarding acceptance criteria and the study that proves the device meets them based on the provided text.

Acceptance Criteria and Device Performance Study for aprevo® posterior/transforaminal lumbar interbody fusion device

This device is a physical implant designed for spinal fusion, and its acceptance criteria primarily revolve around mechanical performance and substantial equivalence to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not detail specific "test set" sample sizes in the context of clinical or evaluation studies as would be seen for AI/ML. For a physical device, testing is primarily non-clinical.

• Sample Sized for "Test Set": Not explicitly stated in terms of a population size. Non-clinical testing typically involves a sufficient number of device samples or test configurations to demonstrate mechanical performance according to the specified ASTM standards.
• Data Provenance: The mechanical testing references ASTM standards (e.g., ASTM F2077, ASTM F2267), indicating laboratory setting for mechanical performance evaluation. A "cadaveric validation" was also performed. Details on the number of cadavers are not provided. The data is thus derived from non-clinical (laboratory/engineering) studies and a cadaveric study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the clearance is for a physical medical device, not a diagnostic or prognostic AI/ML device requiring expert ground truth for interpretation. Mechanical testing and cadaveric validation do not typically involve human experts establishing a "ground truth" in the same way an AI model's output would be compared to a consensus reading.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or prognostic devices to assess the impact of AI on human reader performance. This device is a physical implant.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable. This device is a physical implant and does not involve an "algorithm only" performance. Its performance is assessed through its mechanical properties and successful fusion in conjunction with human surgical intervention and bone graft.

7. The Type of Ground Truth Used

For the mechanical performance, the "ground truth" is established by adherence to engineering standards (ASTM F2077, ASTM F2267) and the performance characteristics of predicate devices against which the new device is compared for substantial equivalence. For the cadaveric validation, the "ground truth" would be the observed physical behavior and performance within the cadaveric model. There is no clinical ground truth (like pathology or outcomes data from human patients) presented in this 510(k) summary, as "Clinical Testing" is explicitly stated as "Not applicable."

8. The Sample Size for the Training Set

This information is not applicable. This refers to a training set for an AI/ML model, which is not relevant to this physical medical device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

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aprevo® anterior and lateral lumbar interbody fusion device:

The aprevo® anterior and lateral lumbar interbody fusion devices are interbody fusion in skeletally mature patients and are to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches may include anterior lumbar interbody fusion or lateral lumbar interbody fusion.

The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) months of non-operative treatment. aprevo® anterior and lateral lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implanted via a variety of open or minimally invasive approaches.

aprevo® anterior lumbar interbody fusion device with interfixation:

The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for interbody fusion in skeletally mature patients and is to be used with supplementation cleared for use in the lumbar spine. The aprevo® anterior lumbar interbody fusion device with interfixation is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone and/or cortico-cancellous bone. These implants may be implanted via a variety of open or minimally invasive approaches. ALIF-X implants are intended for standalone use at one or two levels of the spine when used with the screws that accompany the implant and with implants less than or equal to 20° of lordosis. At more than two levels or with implants greater than 20° of lordosis, ALIF-X is intended to be used with the screws that accompany each implant and with supplemental fixation. When used at more than one level in patients with degenerative scoliosis and/or sagittal deformity, the aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

aprevo® anterior and lateral lumbar interbody fusion device:

The aprevo® anterior and lateral lumbar interbody fusion devices are designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient and include an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient radiological images.

The aprevo® anterior and lateral lumbar interbody fusion devices are additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and are provided sterile. The associated instruments, which facilitate the placement, adjustment, and removal, if necessary, of the interbody devices, are manufactured from stainless steel and provided sterile packaged for single use.

aprevo® anterior lumbar interbody fusion device with interfixation:

The aprevo® anterior lumbar interbody fusion device with interfixation is designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® device incorporates patient specific features to allow the surgeon to tailor the procedure to the individual needs of the patient and include an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient radiological images.

The aprevo® anterior lumbar interbody fusion device with interfixation is additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and is provided sterile. The device includes screws that are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and are offered in a range of lengths. The associated instruments, which facilitate the placement, adjustment, and removal, if necessary, of the device, are manufactured from stainless steel and provided sterile packaged for single use.

The provided document is a 510(k) summary for a medical device called "aprevo® anterior and lateral lumbar interbody fusion device" and "aprevo® anterior lumbar interbody fusion device with interfixation." This document explicitly states that "Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data."

Therefore, no clinical study was conducted to prove the device meets acceptance criteria. The FDA's substantial equivalence determination was based on non-clinical testing.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

Since no clinical study was performed, there are no specific clinical acceptance criteria or reported device performance in this context. The non-clinical testing primarily demonstrates that the subject device has similar mechanical properties and performance as the predicate devices.

2. Sample size used for the test set and the data provenance

Not applicable, as no clinical test set was used for proving acceptance criteria in a comparative clinical study. The non-clinical testing would involve physical samples of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical test set requiring expert ground truth was utilized.

4. Adjudication method for the test set

Not applicable, as no clinical test set was utilized.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is an intervertebral body fusion device, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a physical implant, not a software algorithm.

7. The type of ground truth used

For the purpose of non-clinical testing, the "ground truth" would be the established engineering and material standards (e.g., ASTM F3001, ASTM F136) and the performance characteristics of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable, as this is a physical medical device and not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

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The aprevo® Digital Planning software is intended to be used by trained, medically knowledgeable design personnel to generate surgical plans for skeletally mature patients. The device processes a 3D spine model in conjunction with inputs from healthcare professionals to produce 3D models of spinal corrections and anatomical measurements.

The aprevo® Digital Planning, is a rules-based, semi-automated surgical planning software that, based on surgeon input, measures the 3D spine model and results in a spinal correction plan. The outputs consist of a surgical plan and 3D spinal correction assets, which are then reviewed by the surgeon. The device is operated by trained, medically knowledgeable Carlsmed design personnel.

The provided document is a 510(k) summary for the aprevo® Digital Planning software. While it describes the software and its intended use, it does not contain specific details on acceptance criteria or a comprehensive study report with quantitative performance metrics that would typically be found in a detailed validation study.

The relevant section for performance criteria and testing is under "Non-clinical Testing" (page 6). It states: "The surgical plans generated by aprevo® Digital Planning were shown to be substantially equivalent, with 90% confidence and reliability, to plans manually created by medically knowledgeable operators." This is a summary statement of a study result, but it lacks the detailed breakdown requested.

Therefore, many of the requested fields cannot be filled directly from the provided text. I will fill in what can be inferred or explicitly stated and highlight where information is missing.

Acceptance Criteria and Study for aprevo® Digital Planning Software

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific quantitative metrics for "substantial equivalence" (e.g., specific measurement tolerances for anatomical landmarks, angular measurements, or correctional values). The document states "90% confidence and reliability," which is a statistical measure of the comparison, not the quantitative metric itself.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the provided text.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study involved comparing software-generated plans to "plans manually created by medically knowledgeable operators," implying retrospective data processed by operators.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Described as "medically knowledgeable operators" and "Internal Carlsmed personnel only" (page 6). Specific qualifications like "radiologist with 10 years of experience" are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The comparison is between the automated software plans and "manually created plans," but how discrepancies, if any, were resolved for the ground truth is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done? Not explicitly mentioned as an MRMC study in the standard sense (human readers assisting with/without AI). The study described is a comparison between software-generated plans and manually created plans. It's not a study on how human readers improve with AI assistance, but rather a performance validation comparing the AI's output to human-generated output.
• Effect Size of Human Reader Improvement: Not applicable given the type of study described.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done? Yes, in a sense. The "Non-clinical Testing" section validates the performance of the software-generated surgical plans against manually created plans. While the software takes "inputs from healthcare professionals" and trained personnel operate it, the evaluation seems to focus on the output of the algorithms ("surgical plans generated by aprevo® Digital Planning") compared to a human-derived ground truth. The device is described as "rules-based, semi-automated."

7. Type of Ground Truth Used

• Ground Truth Type: "Plans manually created by medically knowledgeable operators" (page 6). This is a form of expert consensus or expert-derived ground truth.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not explicitly stated in the provided text. The document describes the software as "rules-based, semi-automated" and uses algorithms for landmark determination and surgical plan generation. This implies a rule-based system or potentially a machine learning model, but training set details are not provided.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not explicitly stated. Given the description of the device as "rules-based, semi-automated," it suggests that the "rules" and "algorithms" were likely developed based on medical knowledge and potentially expert-verified data, but the specific process for establishing ground truth for any potential training data is not detailed.

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The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior lumbar interbody fusion device with interfixation is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone and/or cortico-cancellous bone. These implants may be implanted via a variety of open or minimally invasive approaches. ALIF-X implants are intended for standalone use at one or two levels of the spine when used with the screws that accompany the implant and with implants less than or equal to 20 degrees of lordosis. At more than two levels or with implants greater than 20 degrees of lordosis, ALIF-X is intended to be used with the screws that accompany each implant and with supplemental fixation. When used at more than one level in patients with degenerative scoliosis and/or sagittal deformity, the aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

The aprevo® anterior lumbar interbody fusion device with interfixation is designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® device incorporates patient specific features to allow the surgeon to tailor the procedure to the individual needs of the patient and includes an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient CT scans. The aprevo® devices are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F3001, while the screws are machined from material per ASTM F136. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and instrument are provided as single use, sterile-packed product to the end user. The purpose of this 510(k) is to modify the indications for use of the subject device to include standalone indications.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) clearance letter and a 510(k) Summary for a medical device called "aprevo® anterior lumbar interbody fusion device with interfixation."

This type of document primarily focuses on establishing substantial equivalence to previously cleared devices, rather than detailing specific performance acceptance criteria and studies demonstrating adherence to those criteria for software or AI/ML components. The text describes the device, its intended use, comparison to predicate devices, and regulatory classification. It does not mention any AI/ML components, software, or studies evaluating algorithm performance, human reader improvement with AI assistance, or related aspects.

Therefore, I cannot fulfill your request for information about acceptance criteria and a study that proves the device meets them based on the provided text.

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The aprevo® Cervical ACDF Interbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kvphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. The aprevo® Cervical ACDF Interbody System must be used with supplemental fixation systems. For hyperlordotic corrections (≥20 lordosis), the system must be used with at least an anterior cervical plate as supplemental fixation.

The aprevo® Cervical ACDF-X Interbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. When used as a standalone system, the aprevo® Cervical ACDF-X Interbody implant with integrated screw fixation is intended for use at multiple contiguous levels, or up to two levels when used in trauma, deformity or failed previous fusions. Deformity procedures to correct coronal anqulation or any use of hyperlordotic correction (>20°) must include supplemental fixation such as posterior cervical screw fixation or anterior plating.

The aprevo® Cervical ACDF System, which includes the aprevo® Cervical ACDF Interbody, aprevo® Cervical ACDF-X Interbody, and the aprevo® Cervical ACDF-X (no cam) Interbody are designed to stabilize the cervical spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient-specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient and include an aperture for the packing of bone graft.

The aprevo® Cervical ACDF System interbodies are additively manufactured from Ti-6AI-4V ELI titanium alloy per F3001, while the screw are machined from Ti alloy per ASTM F136. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and the instrument are provided to the end-user as single use, sterile-packed products.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device conformance. The text is a 510(k) summary for a medical device (aprevo® Cervical ACDF System) and primarily focuses on establishing substantial equivalence to predicate devices, rather than outlining specific acceptance criteria or an in-depth study with the requested details.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

1. Table of acceptance criteria and reported device performance: The document states that "All testing demonstrated substantial equivalence between the subject and predicate devices," but it does not specify what those acceptance criteria were (e.g., specific thresholds for static compression in N, or dynamic compression cycles) nor does it provide the reported performance values against those criteria. It only lists the types of tests performed (e.g., Static and Dynamic axial compression per ASTM F2077).

2. Sample sizes for test set and data provenance: This information is not present in the document.

3. Number of experts and qualifications for ground truth: This information is not present in the document. The testing described is bench testing, not clinical studies involving expert assessment of patient data.

4. Adjudication method for the test set: Not applicable as there's no mention of human-reviewed test sets for AI/software.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. The device described appears to be an implantable interbody fusion device, not an AI or imaging diagnostic software. Therefore, there would not be a study with human readers improving with AI assistance.

6. Standalone performance (algorithm only): Not applicable, as this is a physical medical device.

7. Type of ground truth used: For the bench testing, the "ground truth" would be the predetermined mechanical standards (e.g., ASTM standards) and measurements, not expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample size for the training set: Not applicable, as this is a physical medical device, not a machine learning model.

9. How ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided document is a regulatory submission for a physical medical device and discusses bench testing to demonstrate substantial equivalence, not a study of an AI/software device with the characteristics you've requested.

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The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior lumbar interbody fusion device with interfixation is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an OD! >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone and/or cortico-cancellous bone. These implanted via a variety of open or minimally invasive approaches. The aprevo® anterior lumbar interbody fusion device with interfixation is intended to be used with the screws that accompany each implant and with supplemental fixation.

The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with mvelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches. The aprevo® anterior lumbar interbody fusion device with interfixation is intended to be used with the screws that accompany each implant and with supplemental fixation.

The aprevo® anterior lumbar interbody fusion device with fixation (ALIF-X is) designed to stabilize the lumbar spinal column and promote fusion. The personalized aprevo® interbodies incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient and include an aperture intended for the packing of bone graft. The aprevo® ALIF-X device is accompanied by three screws designed to be used to provide fixation.

The aprevo® ALIF-X interbodies are additively manufactured from Ti-6A1-4V ELI titanium alloy per ASTM F3001, while the screws are machined from material per ASTM F136. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and instrument are provided as single use, sterile-packed product to the end user.

The provided text is a 510(k) Summary for the aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X). It outlines the device, its intended use, and a summary of technological similarities and differences to a predicate device.

However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance, such as diagnostic accuracy, sensitivity, or specificity. The "Performance Testing Summary" section refers to mechanical testing standards (ASTM F2077 and ASTM F3001) for physical properties of the implant, not clinical or AI/ML performance.

Therefore, I cannot provide the requested information from the given text. The questions about test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not addressed in this filing, as they are not relevant to the type of device being described (a physical spinal implant, not an AI/ML-driven diagnostic or therapeutic tool).

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The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior lumbar interbody fusion device with interfixation is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone and/or cortico-cancellous bone. These implanted via a variety of open or minimally invasive approaches. The aprevo® anterior lumbar interbody fusion device with interfixation is intended to be used with the screws that accompany each implant and with supplemental fixation.

The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment, aprevo® lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches. The aprevo® anterior lumbar interbody fusion device with interfixation is intended to be used with the screws that accompany each implant and with supplemental fixation.

aprevo anterior and lateral lumbar interbody fusion devices (ALIF and LLIF):

The aprevo® anterior and lateral lumbar interbody fusion devices are intended for interbody fusion in skeletally mature patients and are to be used with supplementation cleared for use in the lumbar spine. The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI>40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches may include anterior lumbar interbody fusion or lateral lumbar interbody fusion.

The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non- operative treatment. aprevo anterior and lateral lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implanted via a variety of open or minimally invasive approaches.

aprevo® transforaminal lumbar interbody fusion devices (TLIF):

The aprevo® transforaminal lumbar interbody fusion device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® transforaminal lumbar interbody fusion device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® transforaminal lumbar interbody fusion device is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® transforaminal lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implanted via a variety of open or minimally invasive approaches.

The aprevo® Intervertebral Body Fusion Devices include ALIF-X, ALIF, LLIF, TLIF-O, and TLIF-C interbodies. The aprevo® interbody fusion devices are designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient.

The provided text describes a 510(k) premarket notification for a medical device called "aprevo® anterior and lateral lumbar interbody fusion device". It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, particularly regarding changes in a manufacturing process (addition of a new heat treatment).

Based on the document, this is not a study of a device that uses Artificial Intelligence (AI) or machine learning (ML), nor does it involve a multi-reader multi-case (MRMC) comparative effectiveness study, human readers, or ground truth establishment in the context of diagnostic or prognostic AI/ML applications. The device in question is an implantable interbody fusion device, and the "performance" described relates to mechanical properties and material characteristics, not diagnostic accuracy or expert interpretation.

Therefore, many of the requested elements for describing acceptance criteria and study that proves a device meets them (especially those related to AI/ML, human readers, sample sizes for test/training sets, ground truth establishment for interpretative tasks, and effect sizes of AI assistance) are not applicable or extractable from this document.

The document primarily focuses on non-clinical testing/performance data to demonstrate substantial equivalence following a manufacturing change.

Here's a breakdown of the relevant and non-relevant information based on your request:

Acceptance Criteria and Study for aprevo® Interbody Fusion Device

Study Type: Non-clinical (mechanical and material performance) to demonstrate substantial equivalence for a manufacturing process change. This is not a clinical study or a study involving AI/ML performance.

Applicable Sections from Request:

• 1. A table of acceptance criteria and the reported device performance: This can be partially derived from the Discussion of Non-Clinical Testing/Performance Data section, as it outlines the tests performed to show equivalence.
• 2. Sample size used for the test set and the data provenance: For mechanical testing, this refers to the number of devices tested. Data provenance is not explicitly stated but is implied to be from internal testing by the manufacturer.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable in the context of an implantable device's performance, but if interpreted as device-only performance (without human input during its function), then yes, the mechanical tests are "standalone" in that sense.
• 7. The type of ground truth used: For mechanical properties, the "ground truth" would be established engineering standards (ASTM F2077-18, ASTM F3001-14) that define acceptable performance.

Non-Applicable Sections from Request (as per the provided document's content):

• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable for mechanical tests of an implantable device.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done... effect size: Not applicable. This is not an AI/ML diagnostic or image interpretation device.
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Detailed Response:

1. Table of Acceptance Criteria and Reported Device Performance

The document details that the "subject device underwent mechanical performance testing to validate that the performance of the worst-case subject devices is substantially equivalent to the previously cleared predicate devices." The acceptance criteria implicitly involve meeting the performance requirements of the cited ASTM standards, and the reported performance is that substantial equivalence was demonstrated.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the number of devices (samples) used for each mechanical test. Standard practice for such tests under ASTM typically involves a minimum number of samples (e.g., n=5 or n=6 per condition) to achieve statistical significance. However, the exact sample sizes are not provided in this summary.
• Data Provenance: The data provenance is implied to be from internal testing conducted by Carlsmed, Inc., as part of their premarket notification submission to the FDA. The country of origin for the data is not specified, but the company is based in Carlsbad, California, USA. The testing is prospective in the sense that it was conducted specifically to demonstrate equivalence for this submission, although the data itself is on device performance.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. This is a mechanical/material performance study of an implantable medical device, not a study involving human interpretation of medical images or data. "Ground truth" for these tests refers to the objective physical measurements against established engineering standards.

4. Adjudication Method for the Test Set:

• Not Applicable. No human adjudication process is involved as it's not an interpretive or diagnostic study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

• No. This type of study is typically performed for diagnostic or AI-assisted diagnostic devices. This device is an implantable interbody fusion device, and its performance is assessed via mechanical and material properties, not human reader accuracy with or without AI assistance.

6. If a Standalone Performance Study was done:

• Yes (in principle for mechanical device testing). The "Discussion of Non-Clinical Testing/Performance Data" describes tests performed on the device itself (e.g., static/dynamic compression, tensile testing) to evaluate its mechanical and material properties against established standards. These tests are performed on the device samples in a laboratory setting, independent of human clinical application for their evaluation of device performance in terms of strength, integrity, etc.

7. The Type of Ground Truth Used:

• The "ground truth" for this study is established by validated engineering standards and specifications (ASTM F2077-18 for mechanical properties and ASTM F3001-14 for material properties). The performance of the devices is measured against the requirements outlined in these standards and compared to the performance of predicate devices.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. As there is no training set for an AI/ML model, this question does not apply.

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aprevo® ALIF and LLIF:
The aprevo® anterior and lateral lumbar interbody fusion devices are interbody fusion in skeletally mature patients and are to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches may include anterior lumbar interbody fusion or lateral lumbar interbody fusion.

The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® anterior and lateral lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

aprevo® TLIF:
The aprevo® transforaminal lumbar interbody fusion device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® transforaminal lumbar interbody fusion device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® transforaminal lumbar interbody fusion device is indicated for use at one or more levels, of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® transforaminal lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

aprevo® ALIF-X:
The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior lumbar interbody fusion device with interfixation is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone and/or cortico-cancellous bone. These implanted via a variety of open or minimally invasive approaches. The aprevo® anterior lumbar interbody fusion device with interfixation is intended to be used with the screws that accompany each implant and with supplemental fixation.

The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches. The aprevo® anterior lumbar interbody fusion device with interfixation is intended to be used with the screws that accompany each implant and with supplemental fixation.

The aprevo® anterior, lateral and transforaminal lumbar interbody fusion devices are designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient and include an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient CT scans. The aprevo® devices are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F3001 and are provided sterile.

The aprevo® anterior lumbar interbody fusion device with interfixation, (ALIF-X), is designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient. The individualized surgical correction plan and device configurations are developed using patient CT scans. The aprevo® devices are manufactured from Titanium Alloy (Ti-6Al-4V) per ASTM F3001 and ASTM F136. The aprevo® ALIF-X device has a cavity intended for the packing of bone graft.

This document describes the regulatory clearance for the aprevo® family of devices (ALIF, LLIF, TLIF, ALIF-X). It is a 510(k) submission, which means the manufacturer is demonstrating that their device is "substantially equivalent" to already legally marketed predicate devices.

Therefore, the "acceptance criteria" for a 510(k) submission are typically based on demonstrating that the new device performs as safely and effectively as predicates, often through mechanical testing and equivalence to existing devices. There isn't an "AI-like" performance criteria table in this context because it's a physical medical device clearance, not an AI/ML software clearance.

However, based on the provided text, I can extract the information relevant to the performance testing and conclusions:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in the context of clinical data or patient-level data. The performance evaluations mentioned are related to mechanical testing and manufacturing processes. For mechanical testing (ASTM F2077), specific sample sizes of the device are tested. For manufacturing sensitivity and validation, these typically involve testing multiple batches or units during the manufacturing process. The document does not provide these specific numbers or the "provenance" of such samples (e.g., country of origin, retrospective/prospective). These details would typically be found in the actual test reports submitted to the FDA, not necessarily summarized in the 510(k) letter or summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable in the context of this 510(k) submission for a physical interbody fusion device. "Ground truth" established by experts is typically relevant for diagnostic or AI/ML-driven devices where human interpretation is being evaluated against an algorithm. Here, the "ground truth" for mechanical testing is established by technical standards (like ASTM F2077) and engineering principles.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts in evaluating diagnostic images or clinical scenarios, which is not the type of evaluation described for this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done and is not indicated for this type of physical medical device clearance (interbody fusion device). MRMC studies are primarily used for evaluating diagnostic imaging devices or AI tools where human readers are interpreting medical images. There is no mention of AI assistance in relation to human interpretation in this document.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a physical implant, not an algorithm or software that performs standalone diagnostic functions.

7. Type of Ground Truth Used:

For the mechanical performance testing, the "ground truth" is established by engineering standards and specifications, specifically ASTM F2077. This standard outlines the methodology and acceptance criteria for mechanical testing of intervertebral body fusion devices. For manufacturing processes, the "ground truth" involves validated process parameters and quality control metrics.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/ML-driven device that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As above, there is no "training set" for this device.

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The aprevo® TLIF-C Articulating System is interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® TLIF-C Articulating System is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® TLIF-C Articulating System is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® TLIF-C Articulating System devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® TLIF-C Articulating System devices are designed to stabilize the lumbar spinal column and promote fusion. The personalized aprevo® interbodies incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient and include an aperture intended for the packing of bone graft.

The aprevo® TLIF-C Articulating interbodies are additively manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F3001. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and instrument are provided as single use, sterile-packed product to the end user.

The provided text describes a medical device, the aprevo® TLIF-C Articulating System, and its substantial equivalence to predicate devices, supported by non-clinical testing. However, it does not contain the specific information required to answer the questions about acceptance criteria for a study demonstrating device performance for an AI/ML-enabled medical device. The information provided is primarily focused on the mechanical and physical performance of the interbody fusion device itself, not on the performance of any AI/ML component.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and study details for an AI/ML device based on the given input.

Here's a breakdown of why and what kind of information would be needed:

• No AI/ML Component Described: The text describes a physical interbody fusion device and its associated instruments. There is no mention of any AI or machine learning algorithms, software, or intelligent functions associated with the device. The "technological characteristics" mentioned refer to its mechanical properties and materials, not software performance.
• Non-Clinical Testing is for Physical Device: The "non-clinical testing" listed (Static and dynamic axial compression, Static and dynamic compression-shear, Subsidence, Cadaveric study) are standard tests for orthopedic implants to ensure their mechanical integrity and biocompatibility. These tests do not evaluate AI/ML performance.

To answer your questions, the input would need to describe an AI/ML-enabled medical device and its corresponding performance study, which would typically include metrics like sensitivity, specificity, accuracy, AUC, etc., along with details on the ground truth establishment, expert review, and dataset characteristics.

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