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The PMT Facet Screw is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The PMT Facet Screw is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1. The PMT Facet Screw is indicated for treatment of any or all of the following:

1. Pseudoarthrosis and failed previous fusion
2. Spondylolisthesis
3. Spondylolysis
4. Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies
5. Degeneration of the facets with instability; and
6. Fracture
   The PMT Facet Screw is intended for conventional or tissue-sparing surgical placement.

The PMT Facet Screw is available in fully threaded configurations with diameters of 3.5 mm, 3.75 mm and 4.0 mm and lengths of 13 mm to 25 mm (in 2 mm increments). The PMT Facet Screw is constructed of Titanium-6 Aluminum- 4 Vanadium ELI alloy (conforming to ASTM F136-13) and supplied sterile for single use only.

The provided text describes the 510(k) summary for the PMT Facet Screw and details the performance testing conducted to demonstrate its substantial equivalence to predicate devices. It does not describe an AI/ML powered device, but rather a medical implant. As such, information regarding AI/ML-specific acceptance criteria, the study proving the device meets those criteria, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable or available in this document.

However, based on the provided text, I can extract information relevant to the non-AI device's performance testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "In all instances, the PMT Facet Screw functioned as intended and met all pre-determined acceptance criteria and do not raise new issues of safety or effectiveness; thus demonstrating that the PMT Screw is substantially equivalent to the legally marketed predicate device."

While specific numerical acceptance criteria for each test (e.g., minimum bending strength, torque values) are not explicitly detailed in the provided text, the successful completion of the tests against established ASTM standards and FDA guidance implicitly defines these criteria.

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 does not specify the sample sizes used for each of the mechanical performance tests (e.g., number of screws tested for bending, torsion, pull-out, or drive torque). It also does not mention data provenance as these are laboratory-based physical tests, not clinical data.

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

Not applicable. The "ground truth" for the performance testing of this medical device is based on established engineering standards (ASTM) and regulatory guidance, not expert interpretation of clinical data in the traditional sense. These tests are objective measurements of physical properties.

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

Not applicable. This is not a study involving human adjudication of results, but rather objective mechanical and biological compatibility testing against predefined specifications.

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 an AI-powered diagnostic tool, and therefore MRMC studies are irrelevant here.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for the performance tests are the specifications and requirements defined by the referenced ASTM standards (F2193-14, F543-17) and FDA guidance documents for sterility and pyrogenicity. These are objective engineering and biological safety criteria.

8. The sample size for the training set:

Not applicable. There is no training set for a non-AI mechanical device.

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

Not applicable. There is no training set for a non-AI mechanical device.

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The VIPER® F2 Facet Fixation System is intended to stabilize the spine as an aid to fusion by the transfacet fixation method only:

Transfacet fixation: - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle.

This system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

The screws and washers that are the subject components of this submission are modified DISCOVERY® System screws and washers that are available in various geometries and sizes. Manufactured from ASTM F 136 implant grade titanium alloy.

The provided text describes the 510(k) summary for the VIPER® F2 Facet Fixation System. It focuses on demonstrating substantial equivalence to predicate devices through nonclinical mechanical testing, rather than device performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment cannot be extracted from this document in the typical sense of AI/medical device performance evaluation.

Here's an analysis based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the way a diagnostic AI device summary would. Instead, the "device performance" is demonstrated through nonclinical mechanical testing and comparison to predicate devices, implying that if the device performs comparably to legally marketed devices, it meets the unstated "acceptance criteria" for safety and effectiveness.

Nonclinical Test Summary and Implied Performance:

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

This information is not applicable as the study did not involve a test set of data points (e.g., medical images, patient records) for evaluation of the device's diagnostic or predictive performance. The "testing" involved mechanical benchmarks of the physical device.

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 information is not applicable. The device is an implantable medical device, not an AI or diagnostic tool requiring ground truth established by medical experts for performance evaluation. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1798).

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

This information is not applicable. There was no clinical test set or human interpretation involved that would require an 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

There was no MRMC comparative effectiveness study done. This device is a surgical implant, not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a physical implant, not an algorithm.

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

The "ground truth" for the nonclinical mechanical testing was based on engineering standards (ASTM F1798) for evaluating spinal arthrodesis implants.

8. The sample size for the training set

This information is not applicable. There was no training set involved as this is not an AI/machine learning device.

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

This information is not applicable. There was no training set.

Summary of the Study:

The study proving the device meets acceptance criteria was a nonclinical mechanical testing program involving static and dynamic compression bending, and static and dynamic three-point bending, all conducted in accordance with ASTM F1798. The intent was to demonstrate that the modified components of the VIPER® F2 Facet Fixation System perform mechanically comparably to its predicate devices. No clinical tests were performed. The FDA's substantial equivalence determination was based on this nonclinical testing and comparison of intended use, design, materials, manufacturing methods, performance, sterility, biocompatibility, safety, and packaging design to legally marketed predicate devices.

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The Spartan S2 Facet System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:

1. Trauma, including spinal fractures and/or dislocations;

2. Spondylolisthesis;

3. Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity;

4. Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

The Spartan S2 Facet System will provide temporary stabilization as an adjunct to spinal fusion.

The Spartan S Facet System is a permanent implant device made from a titanium alloy TI 6AL4V-ELI. It is to be implanted from the posterior approach. The device is provided in two diameters and each diameter screw is provided in multiple lengths to accommodate the various anatomy of the spine. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved.

The provided text describes a 510(k) summary for the Spartan S2 Facet System, a medical device. This document focuses on establishing substantial equivalence for market clearance, rather than presenting a study demonstrating the device meets a predetermined set of acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.

Therefore, many of the requested sections (e.g., acceptance criteria table, sample size, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth types for test/training sets, training set size, ground truth establishment for training) cannot be answered from the provided text.

The document states: "The pre-clinical testing performed indicates that the Spartan S2 Facet System is substantially equivalent to the predicate devices and is adequate for the intended use." This implies that the 'acceptance criteria' for this clearance process was the demonstration of substantial equivalence through pre-clinical testing, likely mechanical or material testing as is common for implants. However, the specific details of these tests and their results are not provided.

Here is what can be inferred or explicitly stated from the provided text, recognizing the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable / Not Provided. The document refers to "pre-clinical testing," which typically involves mechanical and material testing, not human subject data or a "test set" in the context of AI performance evaluation. The type of data provenance would likely be laboratory test results, not country of origin for patient data.

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

• Not Applicable / Not Provided. Ground truth establishment by experts for a test set is relevant for diagnostic or AI-driven devices. This document refers to a physical implant.

4. Adjudication method for the test set:

• Not Applicable / Not Provided. Adjudication methods are typically used in clinical studies involving observer interpretation, not for mechanical device testing.

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. This is a 510(k) summary for a physical implant, not an AI-assisted diagnostic device. Therefore, an MRMC study related to AI assistance would not be performed.

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

• No. This is a physical implant, not an algorithm.

7. The type of ground truth used:

• Not Applicable / Not Provided for typical AI/diagnostic ground truth. For a physical implant, "ground truth" would relate to material properties and mechanical performance meeting engineering specifications, rather than expert consensus, pathology, or outcomes data in a clinical sense for diagnostic accuracy.

8. The sample size for the training set:

• Not Applicable / Not Provided. Training sets are relevant for machine learning algorithms.

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

• Not Applicable / Not Provided.

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The Facet Fixation System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

When properly used, facet screws will provide temporary stabilization as an adjunct to spinal bone grafting processes.

The US Spine Facet Fixation System consists of two implantable components, the screw in various lengths and an optional washer. Both components are made from implant grade wrought Titanium 6-Aluminum 4-Vanadium (Ti6Al4V) alloy.

The provided text describes a medical device, the "US Spine Facet Fixation System," and its 510(k) submission. However, it does not include information about a study based on AI/ML.

Here's a breakdown of the requested information based on the provided text, with "N/A" indicating information not present:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The specific quantitative acceptance criteria (e.g., "withstanding X N of force for Y cycles") and the actual quantitative results achieved by the device are not provided in this summary. It only states that testing was performed.

Study Details (Focusing on AI/ML, which is not present)

2. Sample size used for the test set and the data provenance
N/A - The document describes biomechanical testing, not a study involving a test set of data for an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - This is not an AI/ML study.

4. Adjudication method for the test set
N/A - This is not an AI/ML 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
N/A - This is not an AI/ML study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A - This is not an AI/ML study.

7. The type of ground truth used
N/A - The performance data is based on biomechanical testing of the physical device. For a physical device, the "ground truth" would be objective measurements from these tests and observation of the device's physical integrity and stability under load.

8. The sample size for the training set
N/A - This is not an AI/ML study.

9. How the ground truth for the training set was established
N/A - This is not an AI/ML study.

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