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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® 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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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 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 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 (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.

The aprevo® Interbody Fusion Devices include ALIF, LLIF, and TLIF 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 is a 510(k) summary for a medical device (aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device). It does not contain information about an AI/ML component, nor does it discuss acceptance criteria and studies related to AI/ML performance.

Instead, the document focuses on:

• Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.
• Device Description and Indications for Use: It describes the device and its intended uses.
• Technological Similarities and Differences: It explicitly states that the subject devices are identical to the predicate devices in terms of intended use, indications for use, dimensions, mechanical properties, raw materials, sterilization, and packaging. The only noted difference is the addition of a new Additive Manufacturing supplier.
• Non-Clinical Testing/Performance Data: The study described is mechanical performance testing (e.g., ASTM F2077, ASTM F3001) to validate that the new supplier's manufacturing processes result in devices that perform equivalently to the predicate devices. This is crucial for demonstrating that the change in supplier does not introduce new risks or alter performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies for an AI/ML device from this document. The questions you've asked are specific to AI/ML device validation (e.g., sample size for test/training sets, expert adjudication, MRMC studies, standalone performance, ground truth). This document is for a physical medical implant where "performance" is assessed through biomechanical testing, not AI/ML metrics.

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The aprevo® anterior and lateral lumbar interbody fusion devices are interbody fusion in skeletally mature patients and are to be used with supplemental fixation 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 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.

The aprevo® transforaminal lumbar interbody fusion device 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® 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 autogra:f 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 stenoiss, 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 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® 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 provided FDA 510(k) summary (K222082) for the aprevo® anterior and lateral lumbar interbody fusion devices and aprevo® transforaminal lumbar interbody fusion devices does not describe an AI software device or a study proving that the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.

Instead, this document is a regulatory submission for a physical medical device used for spinal fusion. The "Performance Data" section explicitly states: "No new performance data was necessary to evaluate the modifications to the indications for use." This indicates that the regulatory approval is based on substantial equivalence to predicate devices, rather than a new clinical or algorithmic performance study with acceptance criteria.

Therefore, the requested information cannot be extracted from this document as it relates to AI software performance studies, which are not present here.

However, based on the information that is available in the document, here's what can be provided:

Acceptance Criteria and Device Performance (Not Applicable - No AI/Software Performance Study)

This section is not applicable as the provided document is a 510(k) submission for a physical interbody fusion device, not an AI/software device that requires specific performance metrics like accuracy or sensitivity. The submission relies on demonstrating substantial equivalence to predicate devices rather than proving performance against acceptance criteria in a study as would be done for an AI device.

Sample Size and Ground Truth (Not Applicable - No AI/Software Performance Study)

2. Sample size used for the test set and the data provenance: Not applicable. No test set for AI performance is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
7. The type of ground truth used: Not applicable.

Comparative Effectiveness and Standalone Performance (Not Applicable - No AI/Software Performance Study)

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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

Training Set (Not Applicable - No AI/Software Performance Study)

8. The sample size for the training set: Not applicable. No training set for an AI algorithm is mentioned.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device and Regulatory Pathway:

• Device Name: aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices
• Regulatory Pathway: 510(k) Premarket Notification (K222082)
• Classification: Class II per 21 CFR §888.3080
• Product Code: MAX
• Nature of Device: Physical spinal interbody fusion devices, personalized with patient-specific features, manufactured from titanium alloy (Ti-6Al-4V).
• Indications for Use: Interbody fusion in skeletally mature patients for various lumbar spine conditions (e.g., severe symptomatic adult spinal deformity, degenerative disc disease, spondylolisthesis), to be used with supplemental fixation and bone graft.
• Key Regulatory Finding: Substantial Equivalence to legally marketed predicate devices (K202034, K210542 - aprevo™ Intervertebral Body Fusion Device; K191391 - HEDRON™ Lumbar Spacers). The submission explicitly states "No new performance data was necessary to evaluate the modifications to the indications for use," indicating the approval hinges on equivalence of design, materials, and intended use, not on a new performance study as one would see for an AI device.

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