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The Pro-Link® Stand-Alone Cervical Spacer System is intended to be used with the screws provided and requires no additional supplementary fixation.

The Pro-Link® Stand-Alone Cervical Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. It is to be used in patients who have had at least six weeks of nonoperative treatment. This device is intended to be used with autogenous bone graft.

The Pro-Link® Stand-Alone Cervical Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from either Titanium (Ti 6Al-4V ELI) or Polyetheretherketone (PEEK-OPTIMA LT1) with tantalum markers and titanium pins (Ti 6Al-4V ELI). The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration. The implant has two pockets to permit placement of titanium bone screws (Ti 6Al-4V ELI) through the interbody to provide internal fixation. The implant also has one central threaded hole to permit the insertion of a titanium lock plate (Ti 6Al-4V ELI) to prevent screw back out.

The provided text describes a medical device, the Pro-Link® Stand-Alone Cervical Spacer System, and its substantial equivalence to predicate devices, focusing on its design, materials, and intended use. However, it does not contain the detailed acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical study report or a more comprehensive FDA submission.

The "Performance Data" section briefly mentions "Mechanical testing" and "engineering rationale" conducted according to FDA guidance, but it does not provide specific acceptance criteria values, reported device performance metrics, or the actual study results. It only states that the testing was performed to demonstrate that no 'worst-case condition' was introduced.

Therefore, I cannot fulfill your request for the specific table and study details as they are not present in the provided text.

Here's what I can extract based on the information given, and where the requested information is missing:

Acceptance Criteria and Device Performance

Study Details:

1. Sample size used for the test set and the data provenance:

   • Test set sample size: Not specified.
   • Data provenance: Mechanical testing and engineering rationale were performed according to FDA guidance and specific ISO standards (though the full standard name is garbled in the text). This implies laboratory testing rather than human subject data.

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

   • Not applicable as the reported "Performance Data" refers to mechanical testing, not clinical data requiring expert ground truth.

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

   • Not applicable for mechanical testing.

4. 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 device is a physical intervertebral body fusion device, not an AI or imaging diagnostic device.

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

   • Not applicable. This is a physical medical device.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • For the mechanical performance, the "ground truth" would be established engineering principles and performance standards (e.g., ISO for intervertebral fusion devices).

7. The sample size for the training set:

   • Not applicable, as this is a physical device undergoing mechanical testing, not an AI algorithm requiring a training set.

8. How the ground truth for the training set was established:

   • Not applicable.

Summary of what the document does say about performance:

The document states:
"Mechanical testing and engineering rationale to compare compressive and static torsion conducted in accordance with '510(k) Guidance Document for Intervertebral Body Fusion Devices,' June 14, 2007, was presented to demonstrate that no 'worst-case condition' was introduced to the Pro-Link® Stand-Alone Cervical Spacer System."

This indicates that the "study" demonstrating performance was a series of mechanical tests (compressive and static torsion) and engineering analysis, rather than a clinical trial with human subjects. The purpose was to show that the new device did not introduce any "worst-case condition" compared to its predicate devices, thereby supporting the claim of substantial equivalence.

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