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The Innovasis Oryx Cervical Plate System is intended for use in anterior cervical fixation for the following indications: i. Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), ii. Spondylolisthesis, iii. Trauma (i.e., fracture or dislocation) iv. Spinal stenosis. v. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), vi. Tumor, vii. Pseudoarthrosis: and viii. Previous failed fusion. The Innovasis Oryx Cervical Plate System is indicated for stabilizing the cervical spine from C2 to C7.

The Oryx Cervical Plate System consists of a number of plates and screws of varying lengths. The plates feature lordotic curvature and a transverse plane curvature for an anatomical fit. The set contains ancillary products and instruments. All implant components are machined from implant grade titanium alloy, Ti6Al4V (ELI) per ASTM F136.

The provided text describes the 510(k) premarket notification for the Innovasis Oryx™ Cervical Plate System. It details the device, its intended use, indications for use, and a comparison to a predicate device. However, it does not contain information about acceptance criteria, a specific study proving device performance against such criteria, sample sizes for test/training sets, data provenance, expert involvement, adjudication methods, or MRMC/standalone studies as typically expected for software-based medical devices or diagnostic tools.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, the Synthes Anterior CSLP System (K030866), through non-clinical performance testing of the mechanical components.

Here's an analysis based on the provided text, highlighting what is present and what is missing based on your request:

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

The document mentions performance testing on plates per ASTM F1717 (Static and Dynamic Compression Bend and Static Torsion) and ASTM F543 (bone screw Axial Pull-Out, Insertion and Removal Torque and Torsional Yield Strength). It states that this testing indicates the Oryx Cervical Plate System is "substantially equivalent to the predicate device."

Missing: Specific quantitative acceptance criteria (e.g., "must withstand X N of force for Y cycles") and the precise reported performance values for the Oryx system are not explicitly detailed in a table format in this summary. The substantial equivalence claim implies that the performance met or exceeded the predicate's established performance, but the exact numbers are not given.

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

Missing: This information is not relevant or present because the testing described is mechanical, non-clinical performance testing of a physical implant, not a study evaluating a software algorithm or diagnostic tool. Therefore, there's no "test set" in the sense of clinical or image data, nor is there data provenance as one might expect for an AI product.

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)

Missing: Not applicable. This device is a physical implant, not a diagnostic tool requiring expert interpretation for ground truth.

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

Missing: Not applicable for mechanical performance 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

Missing: Not applicable. This is a physical implant, not an AI-assisted diagnostic tool.

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

Missing: Not applicable. This is a physical implant, not a software algorithm.

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

For mechanical testing: The "ground truth" is implicitly derived from the established performance standards of ASTM F1717 and F543, and the performance characteristics of the predicate device (Synthes Anterior CSLP System). These standards provide quantifiable metrics for material strength and mechanical behavior.

8. The sample size for the training set

Missing: Not applicable. This is a physical implant, not a software algorithm requiring a training set.

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

Missing: Not applicable.

Summary of what is present:

• Acceptance Criteria Mentioned: Performance testing per ASTM F1717 (Static and Dynamic Compression Bend, Static Torsion) and ASTM F543 (bone screw Axial Pull-Out, Insertion and Removal Torque, Torsional Yield Strength).
• Reported Device Performance: The device's performance "indicates that the Oryx Cervical Plate System is substantially equivalent to the predicate device." This implies the device met or exceeded the performance thresholds expected for the predicate under these standards.
• Predicate Device: Synthes Anterior CSLP System (K030866).
• Materials: Ti6Al4V (ELI) per ASTM F136 for implants.

Conclusion based on the provided text:

The document focuses on demonstrating that the Innovasis Oryx™ Cervical Plate System is substantially equivalent to a legally marketed predicate device (Synthes Anterior CSLP System) based on non-clinical mechanical performance testing and material characterization. It explicitly states: "Performance data and rationales submitted herein demonstrate that the subject Oryx Cervical Plate System is substantially equivalent to the predicate device with regard to design, technological characteristics, materials, performance, intended use and indications for use."

The device is a physical orthosis, not a software or AI-driven diagnostic tool, which is why much of the information typically requested for AI/software (like sample sizes for test/training sets derived from clinical data, expert involvement, adjudication, MRMC studies, etc.) is not present in this 510(k) summary.

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