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The Facet Screw Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of facet joints. The Facet Screw Fixation System is indicated for posterior surgical treatment with or without bone graft at single or multiple levels from C2 to S1 (inclusive). For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly 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 pedicle. The Facet Screw Fixation System is indicated for treatment for any or all of the following:
Spondylolisthesis
Spondylolysis
Pseudoarthrosis or failed previous fusions which are symptomatic
Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disk confirmed by history and radiographic studies and/or degenerative disease of the facets with instability
Trauma including spinal fractures and/or dislocations

The Facet Screw Fixation System is manufactured by U&I Corporation. The Facet Screw Fixation System is a set of screws used for translaminar or transfacet fixation in the spine as an adjunct for fusion. The Facet Screw Fixation System consists of screws and washer. The screws are provided in two diameters and each diameter screw is provided in multiple lengths to accommodate the various anatomy of the spine. The washer is provided to help compression for bone fusion. The screw is cannulated to aid in placement via K-WIRE. All implant components are made of titanium alloy in accordance with ASTM F 136. The Facet Screw Fixation System is intended to provide immobilization and stabilization of the facet articular process to support fusion with minimal invasion.

The provided document is a 510(k) premarket notification for a medical device called the "Facet Screw Fixation System." It focuses on demonstrating substantial equivalence to predicate devices through design, material, and mechanical performance testing, rather than presenting a clinical study where acceptance criteria are met by device performance in a human subject. As such, information regarding diagnostic performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test and training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies is not applicable or available in this document.

Here's an analysis based on the information provided, tailored to address your questions where possible:

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

The document describes performance testing based on industry standards, implying that the device's performance must meet or be comparable to that of the predicate devices as defined by these standards. Specific numerical acceptance criteria for each test are not explicitly detailed in the summary, nor are the precise quantitative results for the Facet Screw Fixation System. Instead, the conclusion states that the device's mechanical performance "demonstrated substantial equivalence to predicate devices."

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

The document describes non-clinical bench testing, not clinical trials with patient data. Therefore, the concept of a "test set" in the context of clinical data or AI algorithms is not applicable here. The "sample size" would refer to the number of facet screws or components tested in the bench studies. This specific number is not provided in the summary. Data provenance is also not applicable as it pertains to clinical data.

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

This information is not applicable as the study described is a non-clinical bench test, not a clinical study involving expert interpretation or ground truth establishment based on human assessors.

4. Adjudication method for the test set

This information is not applicable as the study described is a non-clinical bench test.

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 information is not applicable. The document describes a medical device (Facet Screw Fixation System) which is a physical implant, not an AI or imaging diagnostic tool that would typically undergo MRMC studies.

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)

For non-clinical bench testing, the "ground truth" is typically defined by the established ASTM standards and specified physical properties/performance metrics for the materials and design, which are objectively measured using testing equipment.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is a physical device undergoing mechanical testing, not a machine learning algorithm.

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

This information is not applicable.

In summary: The provided 510(k) summary focuses on demonstrating that a physical medical device (Facet Screw Fixation System) is substantially equivalent to existing predicate devices based on its design, materials, and mechanical performance in non-clinical bench testing, adhering to recognized ASTM standards. It does not contain information related to clinical performance, AI algorithm validation, or studies involving human readers or patient data that would typically require the detailed performance metrics, sample sizes, and expert review processes you inquired about.

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