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The Spinal USA Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment with or without bone graft, at single or multiple levels, of any or all of the following spinal levels L1 to S1 (inclusive): Spondylolisthesis, Spondylolysis, Pseudoarthrosis or failed previous which are symptomatic: Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

The Spinal USA Facet Screw System consists of a assortment of screws. Each are made of medical grade titanium alloy conforming to such standards as ASTM F-136 and/or ISO 5832-3. The screws will be provided non-sterile.

The provided text describes a medical device, the "Spinal USA Facet Screw System," and its mechanical testing to demonstrate substantial equivalence to a predicate device. It is a 510(k) premarket notification summary.

Here's a breakdown of the requested information based on the provided text, while noting that many of the requested items are not applicable to this type of device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a distinct "test set" sample size for mechanical testing in the way that would apply to clinical performance studies (e.g., number of patients or images). For mechanical testing, the "sample size" would refer to the number of individual screws and/or constructs tested for each mechanical test condition (Axial Pullout, Torque to Failure, Static 3-Point Bending, Dynamic 3-Point Bending). This specific number is not provided in the summary.
• Data Provenance: The mechanical testing was "performed per ASTM F1264." This indicates it was laboratory testing conducted according to a recognized standard, not data from human subjects or clinical trials. Therefore, concepts like "country of origin" or "retrospective/prospective" are not applicable here.

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

• N/A. This information is not relevant for a mechanical testing study of a medical implant and is not provided in the document. Ground truth as typically defined in AI/clinical studies (e.g., expert consensus on medical images or patient outcomes) does not apply to this type of engineering performance evaluation.

4. Adjudication Method for the Test Set

• N/A. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert opinions, typically in clinical studies or for establishing ground truth for AI model training/testing. This is not applicable to mechanical testing data.

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

• No. This was not a MRMC comparative effectiveness study. This type of study involves multiple human readers evaluating cases, often with and without AI assistance, to measure diagnostic performance. The submission describes mechanical testing of a surgical implant.

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

• N/A. This does not involve an algorithm or AI. It is a physical medical device (facet screw system) undergoing mechanical performance testing.

7. Type of Ground Truth Used

• The "ground truth" for this engineering study is defined by the measured mechanical properties of the device when subjected to standardized tests (ASTM F1264) and compared against pre-defined acceptance criteria, as well as against the mechanical performance of a predicate device. It's an objective measurement against engineering standards, not expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for the Training Set

• N/A. This device does not involve a "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by engineering principles and standards, not data training.

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

• N/A. As there is no training set for an AI model, this question is not applicable.

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The Facet-Link Facet Screw System is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The methods of fixation are:

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

Translaminar-facet fixation - The screws are inserted bilaterally through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet across the facet joint and into the inferior pedicle.

The Facet-Link Facet Screw System is indicated for facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1 (inclusive). The Facet-Link Facet Screw System is indicated for treatment of any or all of the following:

(a) pseudoarthrosis and failed previous fusion;

(b) spondylolisthesis: and

(c) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies.

The Facet-Link Facet Screw System is intended for conventional surgical placement.

The Facet-Link Facet Screw System consists of a conical and threaded head, partially threaded lag screws and fully threaded screws designed to compact or fixate juxtaposed facet articular processes to enhance spinal fusion and stability. The screws and washers are fabricated from anodized titanium alloy (Ti-6AI-4V) and are supplied in various sizes.

The Facet-Link Facet Screw System requires accessory general instruments for implantation. Instruments required for implantation may include a variety of k-wires, cannulae, drills, taps, and drivers.

The provided text describes a medical device, the Facet-Link Facet Screw System, and its performance testing to demonstrate substantial equivalence for 510(k) clearance. However, it does not include information about AI/algorithm performance, ground truth establishment for AI, expert consensus for AI, or multi-reader multi-case studies related to AI. The information provided is solely for the mechanical testing of a physical medical device.

Therefore, many of the requested sections related to AI/algorithm performance cannot be filled from the given text.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test, but it refers to "in vitro bench tests." This implies a set of physical samples of the device were tested.
• Data Provenance: In vitro bench tests. No country of origin is specified for the data itself as it's mechanical testing of a manufactured product. The manufacturing location is Facet-Link, Inc. in Rockaway, NJ, USA.
• Retrospective/Prospective: Not applicable, as this refers to physical device testing, not data analysis on patient outcomes.

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

• This question is not applicable as the study describes mechanical bench testing of a physical device, not an AI algorithm requiring expert ground truth.

4. Adjudication Method for the Test Set

• This question is not applicable for the same reasons as above.

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

• No. An MRMC study was not done. This type of study is relevant for evaluating human performance, often with AI assistance, which is not described here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No. This is not an algorithm; it is a physical medical device.

7. The Type of Ground Truth Used

• The "ground truth" for the mechanical tests would be the established engineering standards (ASTM F1717, ASTM F2193, and ASTM F543) and the performance of the predicate devices. The device's performance was compared against these standards and predicates to determine substantial equivalence.

8. The Sample Size for the Training Set

• This question is not applicable as there is no mention of a training set for an AI algorithm.

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

• This question is not applicable as there is no mention of a training set for an AI algorithm.

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The NuVasive® Facet Screw System is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The NuVasive Facet Screw System is indicated for facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1 (inclusive). The Facet Screw System is indicated for treatment of any or all of the following:

(a) pseudoarthrosis and failed previous fusion;
(b) spondylolisthesis;
(c) spondylolysis;
(d) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies;
(e) degeneration of the facets with instability; and
(g) fracture.

The NuVasive Facet Screw System is intended for conventional or percutaneous surgical placement.

The NuVasive Facet Screw System consists of fully threaded and partially threaded screws designed to compact juxtaposed facet articular processes to enhance spinal fusion and stability. The screws and washers are fabricated from anodized titanium alloy (Ti-6Al-4V) and are supplied in various sizes to accommodate the various anatomy of the spine.

The NuVasive Facet Screw System is a medical device intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document does not explicitly state a "test set" in the context of clinical trials with human subjects. The performance data is derived from nonclinical testing, specifically mechanical testing. Therefore, there is no information on human subject sample size, country of origin, or whether it was retrospective or prospective.

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

Not applicable. Ground truth for nonclinical mechanical testing is established by engineering standards and measurements, not expert clinical interpretation.

4. Adjudication method for the test set

Not applicable. This concept is relevant for clinical studies involving expert review, not for mechanical bench 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

Not applicable. This device is a surgical implant, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant to its evaluation.

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

Not applicable. This device is a surgical implant, not an algorithm.

7. The type of ground truth used

For the nonclinical performance testing, the "ground truth" was established by engineering standards and measurements as defined by the ASTM F1717-04 guideline for static and dynamic cantilever bending testing. The performance of the predicate device served as the benchmark for comparison.

8. The sample size for the training set

Not applicable. This device is a surgical implant; there is no "training set" in the context of machine learning or AI.

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

Not applicable. As there is no training set for this type of device, no ground truth was established for it.

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