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The H-LINK™ Integrated Rod, when used with a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, the H-LINK™ Integrated Rod is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.

The H-LINK™ Integrated Rod is a unitary implant that combines a t-connector with two rods. The rod diameter is 5.5mm or 6.35mm and the t-connector feature adjusts laterally. The 5.5mm H-LINK™ Integrated Rod can be used with a 5.5mm rod titanium posterior pedicle screw system, such as the REVERE™ Stabilization System. The 6.35mm H-LINK™ Integrated Rod can be used with a 6.35mm rod titanium posterior pedicle screw system, or with the PROTEX Stabilization System, which utilizes 6.0mm or 6.5mm rods. These implants are available in a variety of sizes to accommodate individual patient anatomy. H-LINK™ is intended for posterior use only and is positioned and secured into bilateral pedicle screws.

H-LINK™ is composed of titanium alloy as specified in ASTM F136 and F1295. Due to the risk of galvanic corrosion following implantation, titanium alloy implants should not be connected to stainless steel implants.

The provided text is a 510(k) summary for the H-LINK™ Integrated Rod, a medical device. This document focuses on establishing substantial equivalence to existing predicate devices through technical characteristics and performance, specifically mechanical testing. It is not a study report for a diagnostic AI device, and therefore, much of the requested information (like acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models) is not applicable to this type of regulatory submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical testing performed to demonstrate that the H-LINK™ Integrated Rod is substantially equivalent to predicate devices based on established FDA guidance for spinal systems.

Here's a breakdown of the available information and why other points are not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented."

While specific numerical acceptance criteria (e.g., specific load endurance, displacement limits) and the detailed results of the mechanical tests are not explicitly tabulated within this summary document, the statement implies that:

• Acceptance Criteria: These would be derived from the "Guidance for Spinal System 510(k)s, May 3, 2004," which typically specifies various mechanical tests (e.g., static and dynamic axial compression, torsion, bending, fatigue testing) and performance requirements that the device must meet to be considered safe and effective, often by demonstrating equivalence or superiority to predicate devices under those conditions. The predicate devices themselves would have previously demonstrated acceptable performance under similar testing.
• Reported Device Performance: The document only states that the testing was "presented," indicating that the H-LINK™ Integrated Rod did meet the criteria outlined in the guidance and demonstrated performance substantially equivalent to the predicate devices (Globus Medical REVERE™ Stabilization System and PROTEX® Stabilization System). No specific performance values are given in this summary.

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

• Sample Size for Test Set: Not applicable in the context of mechanical testing. "Test set" for mechanical testing would refer to the number of physical device units subjected to the stress tests. This number is not specified in the summary.
• Data Provenance: The "data" refers to the results of mechanical tests performed on the physical device itself, not patient data. Therefore, country of origin or retrospective/prospective status is not relevant. These would be laboratory tests.

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

• Not applicable. This document is not about evaluating a diagnostic AI device or establishing ground truth from expert interpretation of data. The "ground truth" for mechanical testing is defined by engineering standards and test procedures specified in the FDA guidance and ASTM standards.

4. Adjudication Method for the Test Set

• Not applicable. This is not relevant for mechanical testing. Adjudication methods are typically for resolving discrepancies in expert interpretations of medical images or clinical outcomes, which is not the subject here.

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 not a study of a diagnostic AI device. MRMC studies are for evaluating the performance of diagnostic aids, often AI.

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

• No. This is not a diagnostic AI device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For mechanical testing, the "ground truth" is adherence to established mechanical engineering standards (e.g., ASTM F136, F1295, and the "Guidance for Spinal System 510(k)s"). The "truth" is whether the device can withstand specified loads and cycles without failure, as per the predefined criteria for substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable. There is no AI model being trained discussed in this document.

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

• Not applicable. There is no AI model being trained discussed in this document.

Summary of what is known from the 510(k) Summary:

The H-LINK™ Integrated Rod demonstrates substantial equivalence to predicate devices (Globus Medical REVERE™ Stabilization System and PROTEX® Stabilization System) through mechanical testing. The specific "acceptance criteria" and "study" are a conformance to the requirements outlined in the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004, and relevant ASTM standards (F136, F1295 for material composition). The summary indicates that these tests were performed and presented, implying that the device met the necessary mechanical performance benchmarks to achieve substantial equivalence.

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