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The SIRION Lateral Lumbar Interbody System Spacer, either used individually or assembled to the SIRION plate, is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). SIRION Spacers are to be used with autogenous bone graft and supplemental fixation. Approved supplemental fixation includes the Olympic Posterior Spinal Fixation System. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The SIRION Lateral Lumbar Interbody System Plate, in 2-hole and 4-hole configurations, is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The SIRION Lateral Lumbar Interbody System Plate, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications

Hyperlordotic interbody devices (>20° lordosis) must be used in conjunction with the SIRION plate for fixation.

The Sirion Lateral Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis). The Sirion cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.

Here's an analysis of the provided text regarding the SIRION Lateral Lumbar Interbody Fusion device:

The provided document is a 510(k) summary for the SIRION Lateral Lumbar Interbody Fusion device. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving the device meets specific acceptance criteria through clinical performance.

Based on the provided text, a table of acceptance criteria and reported device performance for a clinical study to prove performance against specific metrics is not available. The document explicitly states: "No clinical studies were performed."

Instead, the submission relies on non-clinical testing and a comparison to predicate devices to establish substantial equivalence.

Here's what can be extracted from the document regarding testing and comparisons:

1. Table of Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing and Equivalence):

Note: The document only states "The results of these evaluations indicate that the Sirion implants are equivalent to predicate devices." It does not provide specific numerical acceptance criteria or detailed results from these non-clinical tests.

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

• Test Set Sample Size: Not applicable. No clinical test set was used, as "No clinical studies were performed."
• Data Provenance: The non-clinical testing (FEA and Mechanical) was conducted internally or by a contracted lab for Astura Medical. The data provenance details (e.g., country of origin, retrospective/prospective) are not specified in the summary but would be part of the full 510(k) submission.

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

• Not applicable. No clinical test set was used, and therefore no ground truth established by experts for performance evaluation.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No MRMC comparative effectiveness study was done. The document explicitly states "No clinical studies were performed."

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

• Not applicable. This device is a physical medical implant, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" would be established by validated engineering standards (ASTM F2077, ASTM F2267, etc.) and direct physical measurements and observations during testing (e.g., expulsion force, deformation under load). This is a technical ground truth based on established engineering principles and standardized test methods.

8. The Sample Size for the Training Set:

• Not applicable. There is no mention of a "training set" in the context of an AI/ML algorithm, as this is a physical medical device. The "training" for this type of device development involves established engineering design principles, material science, and manufacturing processes.

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

• Not applicable, as no training set for an AI/ML algorithm is mentioned.

Summary of the K202495 Submission:

This 510(k) clearance for the SIRION Lateral Lumbar Interbody Fusion device is based on demonstrating substantial equivalence to previously cleared predicate devices (Sirion Lateral Lumbar Interbody Fusion K192006, Half Dome K152512, K163481, K172947, K182877, and ATEC ALIF and LLIF Spacer System K182746). The equivalence is supported by non-clinical testing (FEA for static/dynamic compression and shear, subsidence, and mechanical expulsion testing) which showed the new device to be comparable. No clinical studies were performed or required for this 510(k) clearance. The acceptance criteria are therefore implicit in the demonstrated equivalence to existing legally marketed devices and adherence to relevant ASTM standards for mechanical performance.

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The DOLOMITE Stand-Alone Cervical Interbody Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at disc levels (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six weeks of nonoperative treatment with intervertebral cages. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Dolomite Spacer is an interbody fusion device intended to be used with supplemental fixation for one or two levels of the cervical spine.

The DOLOMITE Spacer and Plate assembly are an integrated interbody fusion device intended for stand-alone use at one or two levels of the cervical spine (C2-T1) and used with titanium alloy screws. Multiple full plate assembly configurations can't be used in conjunction for two contiguous levels of the cervical spine. When used with anchors, the assembly is intended for use at one level of the cervical spine with additional supplemental fixation that has been cleared by the FDA for use in the cervical spine.

The DOLOMITE Anterior Cervical Stabilization System are implants developed for the stabilization of the cervical column. The spacers are a 2-piece modular design which allows for interchangeable plate and spacer components. The plate and spacer components contain interlocking features in addition to a locking mechanism which allows for intraoperative assembly prior to implantation. The spacer components are available in a range of footprints and heights in PEEK OPTIMA LT120HA or machined Titanium alloy. The plates are offered in multiple fixation types and sizes to suit the individual pathology and anatomical conditions of the patient in machined Titanium alloy. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates to allow bone growth.

The provided text is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) regarding the Astura Medical, LLC's "DOLOMITE Anterior Cervical Stabilization System." This document is a regulatory notice of substantial equivalence for a medical device and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML powered medical device, which is what the prompt is asking for.

The document explicitly states under "Clinical Test Summary" that "No clinical studies were performed." and under "Non-clinical Test Summary" that "The following analyses were conducted: Dynamic Compression Static Compression Dynamic Torsion Static Torsion. The results of these evaluations indicate that the Dolomite implants are equivalent to predicate devices."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets them, specifically in the context of an AI/ML powered medical device, based on the provided text. The text describes a conventional medical device (an intervertebral body fusion device) and its regulatory clearance process, which relies on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than performance against specific acceptance criteria in a clinical study of an AI/ML product.

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The EL CAPITAN Anterior Lumbar Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). EL CAPITAN System implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The EL CAPITAN Spacer and Plate assembly are an integrated interbody fusion device intended for stand-alone use when used with all titanium alloy screws. When used with anchors, the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.
Hyperlordotic interbody devices (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the Lumbar spine.

The EL CAPITAN Anterior Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). The Spacers are a 2-piece modular design which allows for interchangeable plate and spacer components. The plate and spacer components contain interlocking features in addition to a spring-loaded latch mechanism which allows for intraoperative assembly prior to implantation. The spacer components are available in a range of footprints and heights, and the plates are offered in multiple fixation types and sizes to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis)

This document is a 510(k) summary for the EL CAPITAN Anterior Lumbar Interbody System, a medical device for spinal fusion. This device is not an AI/ML-enabled device, and therefore, the requested information about acceptance criteria and studies demonstrating AI performance (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, etc.) is not applicable.

The document explicitly states: "No clinical studies were performed." This indicates that the device's substantial equivalence to predicate devices was based on non-clinical tests (mechanical and material properties), rather than clinical performance data. Therefore, there are no acceptance criteria related to AI/ML performance metrics, nor any studies proving such performance.

The non-clinical tests conducted establish the device's mechanical safety and performance, demonstrating equivalence to predicate devices. The acceptance criteria for these non-clinical tests would be the established ASTM standards mentioned (e.g., ASTM F2077, ASTM F1717, ASTM F2267).

To summarize why the specific points of your request cannot be answered from this document:

• Acceptance Criteria & Reported Device Performance (Table): Not applicable for AI/ML performance. The device's performance is shown through compliance with mechanical testing standards.
• Sample sizes & Data Provenance (Test/Training Sets): Not applicable as there is no AI/ML component. Mechanical tests have their own sample size requirements per ASTM standards.
• Number of experts & Qualifications: Not applicable as there is no AI/ML component and no clinical studies were performed requiring expert reading.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable.
• Standalone Performance: Not applicable.
• Type of ground truth: Not applicable for AI/ML. The "ground truth" for this device's safety and efficacy is derived from its mechanical properties, material biocompatibility, and demonstrated equivalence to previously cleared predicate devices through non-clinical testing.
• Sample size for training set & How ground truth established: Not applicable.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on:

1. Intended Use
2. Design
3. Materials Used (PEEK-OPTIMA LT120HA, Tantalum, Titanium Alloy, Nitinol)
4. Mechanical Safety and Performance (Non-clinical tests: Static/Dynamic Compression, Static/Dynamic Compression Shear, Subsidence, Expulsion per ASTM standards).

Therefore, this document does not contain the information required to answer your prompt, as it pertains to a traditional medical device, not an AI/ML-enabled one.

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The SIRION Lateral Lumbar Interbody System Spacer, either used individually or assembled to the SIRION plate, is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). SIRION Spacers are to be used with autogenous bone graft and supplemental fixation. Approved supplemental fixation includes the Olympic Posterior Spinal Fixation System. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The SIRION Lateral Lumbar Interbody System Plate, in 2-hole and 4-hole configurations, is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The SIRION Lateral Lumbar Interbody System Plate, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications

The Sirion Lateral Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis). The Sirion spacer may also be used with an integrated plate component. The Sirion cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.

This document is focused on the regulatory clearance of a medical device, the SIRION Lateral Lumbar Interbody Fusion System, based on substantial equivalence to predicate devices. It does not contain information about a clinical study designed to test the device's performance against specific acceptance criteria for metrics like sensitivity, specificity, accuracy, or other performance characteristics typically associated with AI/software devices.

Therefore, many of the questions related to acceptance criteria, device performance tables, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, and MRMC studies are not applicable to the provided text.

Based on the provided text, here's what can be answered:

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

This document does not define acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, accuracy) for the device itself. Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical testing. The "performance" reported pertains to structural and mechanical integrity, rather than diagnostic or treatment efficacy metrics typically found in AI/software medical devices.

Note: The document states "The results of these evaluations indicate that the Sirion implants are equivalent to predicate devices," implying that passing these tests to a level comparable to predicate devices served as the acceptance criteria for these specific performance aspects.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical test set data is mentioned for performance evaluation in the context of an AI/software device. The tests mentioned are non-clinical (mechanical and structural).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment by experts for a test set is discussed in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is discussed.

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. No MRMC study was performed or discussed, as this is a physical medical device (interbody fusion system), not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The clearance is based on substantial equivalence to predicate devices and non-clinical mechanical testing, not on a ground truth related to clinical outcomes or expert labels.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not an AI/ML device.

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

Not applicable. No training set is mentioned.

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The ALTA Anterior Cervical Corpectomy Spacer is indicated for vertebral body replacement in the cervical spine (C3-C7) in skeletally mature patients. The Alta Anterior Cervical Corpectomy Spacer is intended to replace a diseased or damaged vertebral body caused by fracture, osteomyelitis, or tumor, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. The System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectance is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The ALTA Anterior Cervical Corpectomy Spacer is a vertebral body replacement system manufactured from PEEK-OPTIMA LT120HA (HA PEEK) or titanium alloy (Ti6Al4VELI). The devices have trapezoidal footprints and multiple sizes to accommodate patient anatomy and graft windows to help facilitate bony integration. The HA PEEK spacers have unidirectional teeth on both of their inferior and superior surfaces to prevent migration/expulsion and X-ray markers in the form of tantalum pins. The titanium alloy spacers have roughened superior and inferior surfaces to prevent migration/expulsion.

The provided text describes a 510(k) premarket notification for a medical device, the ALTA Anterior Cervical Corpectomy System. It is a submission for substantial equivalence to legally marketed predicate devices, not for a new AI/ML-based diagnostic or assistive technology requiring extensive clinical performance studies with human readers.

Therefore, many of the requested details, such as "acceptance criteria for device performance" in the context of an AI study, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or training set details, are not applicable to this specific submission as it pertains to a physical orthopedic implant device.

The relevant information from the document pertains to the device's physical and mechanical performance, not its diagnostic or interpretative accuracy.

Here's a breakdown of the applicable information based on the provided document, addressing the relevant parts of your request and noting what is not applicable:

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

Since this is a physical implant, the "acceptance criteria" are related to mechanical and material properties, and the "reported device performance" refers to the results of non-clinical (bench) testing.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: This is not applicable in the context of an AI/ML test set. For physical device testing, "samples" refer to the number of devices or test coupons subjected to mechanical testing. The document states "The following analyses were conducted," implying standard mechanical testing as per the ASTM standards. The exact number of test samples (e.g., number of implants tested per condition for compression, torsion, subsidence) is not explicitly provided in this summary but would be detailed in the full test reports referenced by the ASTM standards.
• Data Provenance: Not applicable in the context of clinical patient data as no clinical studies were performed. The "data" comes from bench testing of the physical devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This question is not applicable. The "ground truth" for a physical orthopedic implant is established by engineering specifications, material standards, and biomechanical testing standards (e.g., ASTM F2077, ASTM F2267). It does not involve human expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for establishing ground truth by reconciling discrepancies among human readers/experts. For a physical device's mechanical testing, there is no such adjudication process.

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

• This question is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic devices or AI algorithms that assist human interpretation. This submission is for a physical implant, not a diagnostic or AI-assisted system.

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

• This question is not applicable. This refers to the performance of an AI algorithm in isolation. The product is a physical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the non-clinical testing of this physical device, the "ground truth" is defined by engineering specifications, material properties, and relevant ASTM (American Society for Testing and Materials) standards (e.g., ASTM F2077 for compression/torsion and ASTM F2267 for subsidence) which dictate acceptable performance characteristics for spinal implants.

8. The sample size for the training set

• This question is not applicable. There is no "training set" as this is not an AI/ML device.

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

• This question is not applicable. There is no "training set."

Summary of Device Performance Study:

The study proving the device meets its acceptance criteria is a non-clinical bench testing program.

• Tests Conducted: Static and dynamic compression per ASTM F2077, Static and dynamic torsion per ASTM F2077, and Subsidence per ASTM F2267.
• Results: The results of these evaluations indicated that the ALTA Corpectomy implants are equivalent to predicate devices.
• Clinical Studies: No clinical studies were performed as substantial equivalence was demonstrated through non-clinical testing and comparison to legally marketed predicate devices.

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The HALF DOME POSTERIOR LUMBAR INTERBODY SYSTEM is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenc pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). HALF DOME SYSTEM implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Half Dome Posterior Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis). The Half Dome cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.

This document is a 510(k) Premarket Notification for a medical device called the "HALF DOME Posterior Lumbar Interbody System". This type of submission is for demonstrating substantial equivalence to a predicate device, rather than for proving safety and effectiveness through clinical trials with specific acceptance criteria related to device performance in generating data. Therefore, the information requested in your prompt regarding acceptance criteria for a study proving the device meets acceptance criteria is not applicable in the context of this 510(k) submission.

Here's why and what information is available:

• 510(k) Submissions are for Substantial Equivalence: A 510(k) seeks to demonstrate that the new device is as safe and effective as a legally marketed predicate device, often by showing similar technological characteristics and indications for use, and by performing non-clinical (bench) testing. They generally do not involve clinical studies with acceptance criteria for algorithm performance, expert ground truth, or MRMC studies.

• "Acceptance Criteria" in a 510(k) context: When the term "acceptance criteria" is used in a 510(k) non-clinical test summary, it refers to pre-defined thresholds for mechanical performance during bench testing (e.g., minimum load required to fail, maximum displacement under load). These tests are designed to show the device performs mechanically similar to or better than the predicate device.

Information provided in the document related to your prompt, adapted for a non-clinical device submission:

Here's a breakdown of the relevant sections from your request, with an explanation of why some are not applicable to this type of regulatory submission:

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

Since this is a mechanical interbody fusion device, the "acceptance criteria" and "reported device performance" are related to non-clinical (bench) testing methods to ensure the physical integrity and function of the implant. The document states:

Note: The document explicitly states "The results of these evaluations indicate that the Titanium Half Dome implants are equivalent to predicate devices." This implies that the device met the pre-defined criteria for equivalence to the predicate devices in these mechanical tests. Specific numerical acceptance criteria and performance values are typically detailed in the full test reports, which are not included in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated for each test in this summary. For mechanical bench testing, sample sizes are typically small (e.g., n=5 or n=10 per test condition) and determined by statistical considerations for materials testing.
• Data Provenance: The tests are non-clinical, controlled laboratory experiments. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply. The tests were performed by the manufacturer (Astura Medical) or a contracted lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This is a mechanical device, not an AI or diagnostic device that requires expert interpretation to establish ground truth for a test set. The "ground truth" for mechanical testing is derived from physical measurements and material properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As there's no expert interpretation for ground truth, there's no adjudication method.

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. This device is a surgical implant, not a diagnostic or AI-powered imaging tool that would involve human readers or AI assistance.

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

• Not Applicable. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Ground Truth: For non-clinical bench testing, the "ground truth" is established through physical measurement standards and engineering specifications. For example, the load at which a device deforms or fractures is a directly measurable physical property, not subject to expert consensus in the same way clinical diagnoses are. The "truth" is defined by the physical laws and material science.

8. The sample size for the training set

• Not Applicable. There is no "training set" for this type of mechanical device submission, as it does not involve machine learning algorithms.

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

• Not Applicable. As there is no training set, this question is irrelevant.

In summary, the provided document relates to a 510(k) submission for a physical medical device (interbody fusion system), not a diagnostic or AI-powered software device. Therefore, many of the questions asked in your prompt are not applicable to this context, as they pertain to the evaluation of algorithms or diagnostic performance with human interpretation. The "proof" for this device meeting acceptance criteria comes from its performance in standardized mechanical bench tests, demonstrating its equivalence to existing predicate devices.

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The PASS LP Spinal System is a pedicle screw fixation system intended for immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatic patients diagnosed with the following conditions: spondylolistis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

A subset of PASS LP components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

The purpose of this submission is to extend to the PASS LP, with the addition of new components: 'Dominoes & Iliac Connectors'.

The provided document is a 510(k) premarket notification for the "OLYMPIC Posterior Spinal Fixation System" (K182239) and later references the "PASS LP Spinal System" (K182240). It appears that these are related or the K182240 is meant to be the direct subject of the 510(k) summary. I will answer based on the information provided for K182240, as that is where the performance data is detailed.

The document does not describe an acceptance criteria table with reported device performance for an AI/ML powered device. Instead, it details the substantial equivalence of a spinal fixation system to predicate devices based on biocompatibility and mechanical testing. The questions asked are typically relevant to the evaluation of AI/ML software.

However, I will extract the information that is present concerning performance testing for the spinal fixation system, even though it doesn't align with the AI/ML focus of the prompt's questions.

Here's the closest interpretation of the prompt's questions based on the provided text:

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

The document does not provide a formal "acceptance criteria" table with specific quantitative thresholds. Instead, it states that the performance data "indicate that the products are substantially equivalent as other devices commercially available."

Here's a table based on the types of tests performed and the general conclusions:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated for either biocompatibility or mechanical testing. Biocompatibility tests are typically performed on material samples, and mechanical tests on a set number of device samples according to the standard.
• Data Provenance: Not specified.

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

This question is not applicable. For a spinal fixation system, ground truth (e.g., successful fusion, mechanical integrity) is established through standardized testing (biocompatibility, mechanical tests) rather than expert consensus on a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically for subjective assessments, which are not described here.

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. This is not an AI-assisted device. The document explicitly states "No clinical studies were performed." and "No animal studies were performed."

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

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on:

• Standardized Material Properties: Conformance to ASTM F136 and ISO 5832-3 for titanium alloy.
• Standardized Biocompatibility Testing: Results of tests (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity) against recognized international standards (ISO 10993).
• Standardized Mechanical Testing: Performance against ASTM F1717-15 for static axial compression, static torsion, and dynamic axial compression. The implicit ground truth is that the device should meet or exceed the performance of predicate devices as outlined by these standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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The OLYMPIC Posterior Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine (T1-S2/Ilium): degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis). When used as an adjunct to fusion, the OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft/allograft.

In addition, the OLYMPIC Posterior Spinal Fixation System is intended for treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after the attainment of a solid fusion. Levels of pedicle and non-pedicle fixation for these patients are L3-sacrum/ilium.

When used for posterior non-cervical pedicle and non-pediatric patients, the OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft. Pediatric pediatric pedicle and non-pedicle fixation is limited to a posterior approach.

The OLYMPIC PSFS is a top loading thoracolumbar, sacral, and iliac fixation system implanted from the posterior approach and designed to provide fixation during the fusion process. The system is composed of preassembled uniplanar screws, hooks, rods, crosslinks, and rod connectors. The system is supported by a comprehensive set of instruments to install the implants within the system.

The provided text is a 510(k) summary for the OLYMPIC Posterior Spinal Fixation System. This document is a premarket notification for a medical device to demonstrate that it is substantially equivalent to a legally marketed predicate device.

Based on the content of the provided document, here's an analysis regarding acceptance criteria and supporting studies:

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

The document does not provide a table of acceptance criteria or specific numerical performance metrics for the device. Instead, it relies on demonstrating substantial equivalence to predicate devices through a non-clinical test.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes a non-clinical test (Dynamic Compression Bending – ASTM F1717) but does not specify a sample size for this test. It also does not mention data provenance as it's a mechanical test, not data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The study conducted was a non-clinical mechanical test, not a study requiring expert interpretation or ground truth establishment based on human observation or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. As explained above, the study was a mechanical test, not one involving human interpretation or adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a spinal fixation system (implants), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical medical implant, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not applicable. As it was a non-clinical mechanical test, the "ground truth" would be established by the physical properties and mechanical behavior of the materials and device in controlled laboratory settings, against established standards (ASTM F1717) and comparative predicate device performance.

8. The sample size for the training set

This is not applicable. There was no training set as this is a physical medical device and not an AI/ML or software device that undergoes a training phase.

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

This is not applicable, as there was no training set.

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