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The Facet-Link Stabilization Platform is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The system is indicated for use with bone graft, at single or multiple levels, from C2 to S1 (inclusive) for the Facet Screws and L3 to S1 (inclusive) for MINI and HEMI devices. The Platform is indicated for the treatment of any or all of the following:

1. Spondylolisthesis.
2. Degenerative disc disease (DDD) as defined as back pain of discogenic origin as confirmed by radiographic studies.
3. Degeneration of the facets with instability.

The Facet-Link Facet Screw System is indicated for treatment of any or all of the following:

1. Pseudoarthrosis and failed previous fusion;
2. Spondylolisthesis; and
3. Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies.

The Facet-Link Stabilization Platform consists of a series of devices designed to stabilize the spine. The Platform includes the MINI and HEMI devices. The devices are secured to the bone using Facet-Link trans-articular (facet) screws. The MINI device utilizes an adjustable monorail to crossconnect the Facet Screws, while the HEMI device uses a small, fixed plate as a cross-connector. The implants are fabricated from anodized titanium alloy (Ti-6AI-4V) and are supplied in various sizes. The devices are provided non-sterile and for single patient use.

The Facet-Link Stabilization Platform requires several purpose manual orthopedic instruments for implantation, including a variety of k-wires, gauges, inserters, drills, and drivers.

The provided text describes the Facet-Link Stabilization Platform, a medical device intended to stabilize the spine. However, the document does not contain the specific information required to complete the table and answer all questions regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop system. The document focuses on regulatory approval (510(k)) based on substantial equivalence to predicate devices, and the performance data presented is for mechanical and biocompatibility testing, not clinical performance or AI diagnostic accuracy.

Here's a breakdown of what can and cannot be answered based on the provided text:

Information Available:

• Acceptance Criteria (Implicit - based on predicate device testing): The document states that the device was evaluated to demonstrate substantial equivalence to predicate devices through various bench tests and functional cadaver tests. These tests are primarily focused on mechanical performance and biocompatibility.
  • Static Axial Compression Bending
  • Static Torsion
  • Dynamic Axial Compression Bending
  • Biocompatibility (ISO 10993)
  • MR Conditional (ASTM F2052-06)
• Reported Device Performance:
  • "Performance of the subject constructs was substantially equivalent to that of legally marketed screw constructs."
  • "Results demonstrated that repeatable and proper seating of the devices was achieved."
  • "The materials of the Stabilization Platform are biocompatible for the indicated use in accordance with ISO 10993."
  • "Testing demonstrated that the Stabilization Platform is MR Conditional, in accordance with ASTM F2052-06."

Information NOT Available (and thus cannot be filled in for your request):

• Specific numerical acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy).
• Detailed quantitative results of the bench tests (e.g., actual force values, displacement).
• Any information regarding an AI component, human-in-the-loop performance, diagnostic accuracy, or clinical outcomes that would typically be evaluated with a test set of patient data, experts, and ground truth.
• Sample sizes for test sets related to human or AI performance.
• Data provenance for clinical studies (country, retrospective/prospective).
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods.
• MRMC study details or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used for clinical validation (pathology, outcomes data, etc.).
• Sample size for training sets.
• How ground truth for training sets was established.

Based on the provided document, here's how the information would be organized, with unknowns explicitly stated:

Acceptance Criteria and Study Proving Device Meets Criteria

The Facet-Link Stabilization Platform underwent a series of bench tests and functional cadaver tests to demonstrate substantial equivalence to its predicate devices, as required for 510(k) clearance. The performance data primarily focused on mechanical stability, material biocompatibility, and MR compatibility. There is no information in the provided document about an AI component, clinical diagnostic performance metrics, or a study involving human readers or a test set with established ground truth related to diagnostic outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

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 for Test Set: Not applicable. The document describes bench tests and functional cadaver tests. No "test set" of patient data for diagnostic evaluation is mentioned.
• Data Provenance: Not applicable. The tests involved cadaveric specimens and laboratory equipment.

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. There is no mention of experts establishing ground truth for a diagnostic test set. The cadaver implantation testing assessed the ability of "users" to perform surgical techniques, but no specific number or qualifications are provided, and this is not establishing ground truth for a diagnostic outcome.

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

• Not applicable. No diagnostic test set or adjudication method is described.

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, an MRMC comparative effectiveness study was not done, and this device is not presented as an AI-assisted diagnostic tool.

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

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

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

• Not applicable. The "ground truth" for the performance described is based on established engineering standards (ASTM, ISO) for mechanical stability, biocompatibility, and MR compatibility, and the observable success of surgical implantation in cadavers, rather than clinical diagnostic outcomes.

8. The sample size for the training set

• Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

• 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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