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The Gemini-C Hybrid Cervical Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels within the cervical spine at disc levels from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. This device is intended for use with autogenous bone graft and/or allograft comprised of cancellous bone graft and supplemental fixation (i.e. anterior cervical plate such as the White Pearl Preferred Angle Anterior Cervical Plate). Patients should have had at least six weeks of non-operative treatment prior to treatment with intervertebral cages.

The Osseus Fusion Systems' Gemini-C Hybrid Cervical Interbody System is used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. This system includes three design configurations: 1) PEEK, 2) Titanium alloy (Ti-6Al-4V ELI), and 3) Hybrid PEEK/Titanium alloy. The implants are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of bone graft.

This document is a 510(k) premarket notification for a medical device and therefore describes a medical device (intervertebral body fusion device) rather than an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of mechanical and material performance standards and non-clinical testing, rather than AI/ML performance metrics, ground truth, or reader studies.

Here's an analysis based on the provided document, addressing the closest equivalents to your prompts for a traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to predicate devices through a series of standardized non-clinical mechanical tests. The performance is deemed acceptable if the device meets or exceeds the requirements of these ASTM standards, indicating similar mechanical safety and performance to the legally marketed predicate devices.

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: Not explicitly stated in terms of the number of device units tested. For mechanical testing, samples are typically device prototypes or finished products. ASTM standards dictate the number of samples required for each test.
• Data Provenance: The document does not specify the country of origin of the data beyond the fact that the testing was conducted for a device seeking approval in the United States. The testing is prospective in the sense that physical devices were manufactured and subjected to controlled laboratory tests, rather than analyzing historical patient data.

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

This question is not applicable to a non-AI/ML medical device. Ground truth, in the context of device performance, is established by adherence to engineering principles, material science, and the relevant ASTM (American Society for Testing and Materials) standards. The "experts" would be the engineers and technicians skilled in conducting the mechanical tests and interpreting the results according to the specified standards.

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

Not applicable. Mechanical testing involves quantitative measurements against defined standards, not subjective interpretations requiring adjudication among human observers.

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 traditional medical device, not an AI-powered diagnostic or assistive tool. No human reader studies were conducted or are relevant to its approval.

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

Not applicable. This is a physical intervertebral body fusion device, not an algorithm.

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

The "ground truth" for this device's performance is established by validated mechanical testing standards (ASTM standards). These standards define the expected physical properties and responses of materials and devices under simulated conditions relevant to their intended use. For example, the "ground truth" for compression strength is the maximum force the device can withstand before failure, measured according to ASTM F2077.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

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

Not applicable.

Summary of Relevant Information from the Document:

The provided document describes the Gemini-C Hybrid Cervical Interbody System, an intervertebral body fusion device.

• Acceptance Criteria for Device Type: Substantial equivalence to predicate devices regarding intended use, design, materials, mechanical safety, and performance, demonstrated through non-clinical testing.
• Study Proving Acceptance: A series of non-clinical, mechanical tests were conducted per established ASTM standards:
  • Static and dynamic compression (ASTM F2077)
  • Static and dynamic compression shear (ASTM F2077)
  • Static and dynamic torsion (ASTM F2077)
  • Subsidence (ASTM F2267)
  • Expulsion testing (ASTM Draft Standard F-04.25.02.02)
• Conclusion: The results of these evaluations indicated that the Gemini-C Hybrid Cervical Interbody System is equivalent to predicate devices, thus meeting the acceptance criteria for market clearance.
• Clinical Studies: "No clinical studies were performed." This is common for 510(k) devices when substantial equivalence can be demonstrated through non-clinical means.

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