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The Spartan S3 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 S 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. This submission ads a swivel washer and screw skirt to the 5mm diameter screw. 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) premarket notification for a medical device (Spartan S3 Facet System), not a study proving a device meets acceptance criteria related to an AI or diagnostic algorithm's performance. The information pertains to a physical implantable device used for spinal fusion.

Therefore, many of the requested categories in the prompt (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, how ground truth was established for training set) are not applicable to this type of device submission.

The "acceptance criteria" for a physical medical device like this are typically related to mechanical performance (e.g., strength, durability), biocompatibility, and manufacturing quality, demonstrated through pre-clinical testing, rather than diagnostic accuracy or algorithmic performance.

Here's the information that is extractable and relevant, framed within the context of a physical device's "acceptance criteria" and the study that proves it:

Acceptance Criteria and Device Performance for Spartan S3 Facet System

For a physical implantable device like the Spartan S3 Facet System, "acceptance criteria" are generally related to its physical performance characteristics, primarily mechanical integrity and equivalence to predicate devices, rather than diagnostic accuracy metrics. The "study" proving it meets these criteria is the pre-clinical testing performed.

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 in the provided summary. Performance testing was "following ASTM F2193-02," which specifies test methods but not the exact number of samples. Typically, these tests involve a statistically significant number of samples to ensure robust results.
• Data Provenance: The testing was "pre-clinical testing," implying laboratory-based mechanical and physical property testing. No geographic origin is specified, but it would have been conducted by the manufacturer or a contract testing lab. The testing is prospective in the sense that it's performed specifically to support the 510(k) submission prior to market.

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

• Not Applicable. This is a physical device, and "ground truth" for its performance is established through objective, standardized mechanical and material testing (e.g., tensile strength, fatigue life) against established ASTM standards and equivalence to predicate devices, not through expert consensus or clinical interpretation of data.

4. Adjudication Method for the Test Set

• Not Applicable. As above, "adjudication" (typically for subjective expert review) is not relevant for physical and mechanical performance testing. Test results are objective measurements.

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 a physical implantable device, not an AI or diagnostic algorithm, so MRMC studies are irrelevant.

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

• Not Applicable. This is a physical implantable device, not an AI or diagnostic algorithm.

7. The Type of Ground Truth Used

• For mechanical performance: The ground truth is established by objective, quantitative measurements of physical properties (e.g., force, displacement, cycles to failure) as defined by the ASTM F2193-02 standard and compared against the performance characteristics of legally marketed predicate devices. The "ground truth" is the device's ability to withstand specified loads for a required number of cycles without failure, demonstrating substantial equivalence.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device, not a machine learning model, so there is no "training set."

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

• Not Applicable. As above, there is no "training set" for a physical medical device.

Summary of the "Study" Proving Acceptance:

The "study" described is pre-clinical mechanical performance testing conducted according to the ASTM F2193-02 standard. This testing included:

• Static cantilever bend tests: Measures the device's strength under a constant, increasing load until failure.
• Dynamic cantilever bend tests: Measures the device's durability and resistance to fatigue under cyclic loading, simulating physiological stresses over time.

These tests were performed both with and without the added swivel washer and screw skirt to ensure the new components did not compromise the device's performance. The conclusion drawn from these tests was that the Spartan S3 Facet System is substantially equivalent to the predicate devices in terms of its mechanical performance, thereby demonstrating it meets the necessary safety and effectiveness criteria for its intended use and market clearance.

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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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