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

The Pro-Link 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 non-operative treatment. This device is intended to be used with autogenous bone graft.

The PRO-LINK Cervical Spacer System is intended to serve as a stand-alone intervertebral body fusion device. The system is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. The implant is hollow to permit packing with autogenous bone graft to help promote fusion. It includes two pockets to permit placement of titanium bone screws (Ti 6Al-4V ELI) to provide internal fixation while a titanium lock plate (Ti 6Al-4V ELI) prevents screw back out.

The provided document is a 510(k) summary for the Pro-Link Cervical Spacer System, a medical device for spinal fusion. It focuses on demonstrating substantial equivalence to previously cleared devices rather than direct clinical performance studies against specific acceptance criteria. Therefore, several of the requested sections are not applicable or cannot be extracted directly from this type of regulatory submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria or reported device performance in the context of clinical outcomes or diagnostic accuracy. Instead, it demonstrates "substantial equivalence" to predicate devices through technical characteristics and a specific type of performance testing related to the device's physical properties.

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often done through performance testing (like the mechanical testing mentioned) that shows the new device meets established standards or performs comparably to the predicate, and by showing similar materials, design, and intended use. Specific quantitative clinical performance metrics with pre-defined thresholds (e.g., sensitivity/specificity for a diagnostic device) are typically not included in this type of submission for an intervertebral body fusion device unless a new indication or technology is being introduced that requires clinical trials.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable / Not mentioned. The document describes mechanical testing of the device itself, not a clinical study with a "test set" of patients or data. The testing mentioned (ASTM F2077) would involve a sample of the manufactured devices. The specific number of devices tested is not provided.
• Data Provenance: Not applicable. The "performance data" refers to in-vitro mechanical testing of the device. There is no mention of country of origin for clinical data, as no clinical data from patients is referenced. The testing type is in-vitro, not retrospective or prospective clinical data.

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

Not applicable. This device is an intervertebral body fusion system, not a diagnostic device requiring expert interpretation for ground truth establishment. The "performance data" section focuses on mechanical testing, which would be evaluated by engineers and regulatory bodies based on compliance with standards.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method is relevant to the mechanical testing described.

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 device is a surgical implant, not an AI-assisted diagnostic or decision support tool that would involve human readers or MRMC studies.

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

Not applicable. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

• For Mechanical Testing: The "ground truth" for the mechanical performance testing lies in the established ASTM standards (ASTM F2077, ASTM F2026, ASTM F560, ASTM F136). The device's performance is compared against these engineering standards and to the performance of predicate devices to establish substantial equivalence.
• For Substantial Equivalence: The ultimate "ground truth" for a 510(k) is the legal determination by the FDA that the new device is as safe and effective as a predicate device already on the market. This is a regulatory "truth" based on the submitted evidence.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-based device.

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

Not applicable. This device does not involve a training set.

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