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The Huvex Interspinous Fixation System is a single-level, posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Huvex Interspinous Fixation System is intended for use at one level, in conjunction with autogenous bone graft, and not intended for stand-alone use.

The Huvex Interspinous Fixation System consists of a left plate, a right plate, pin, bolt, inner cap, center bar, and set screw. Each of these components is provided in several sizes to allow for the construction of five different Huvex Interspinous Fixation implant sizes. The left plate is provided assembled with the poly axial bar. The bar has a bone graft window to allow fusion between spinous process. Poly axial bar is also designed to fit the anatomical characteristics of the spinous process. The right plate is designed to be combined with left plate fixed to spinous process. Right plate contains a set screw to lock the right plate to the poly axial bar. The Huvex Interspinous Fixation System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. In addition to the implants a set of reusable surgical instruments are provided.

The provided document is a 510(k) summary for the Huvex Interspinous Fixation System. It describes the device, its intended use, and that performance testing was conducted to demonstrate substantial equivalence to predicate devices. However, the document does not describe acceptance criteria, the specific study design to prove acceptance criteria were met, or detailed performance results in the format requested.

It states general categories of tests performed but lacks the quantitative details needed to answer all parts of your request.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document states:

• "Static & Dynamic compression, Static torsion, and Static tension testing in accordance with a modified ASTM F1717 setup"
• "Static grip testing with a modified ASTM F1798 setup"
• "were conducted to demonstrate substantial equivalence to the predicate system(s)."

It does not provide specific acceptance criteria values (e.g., maximum deflection, fatigue cycles survived, ultimate load) or the quantitative performance results (e.g., "Device A survived X cycles," or "Device A withstood Y N of compression"). It only indicates that these tests were performed and deemed sufficient for substantial equivalence.

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

Not available in the provided document. The document does not specify the number of samples (implants) used for each mechanical test. Data provenance (country of origin, retrospective/prospective) is not relevant for mechanical bench testing of an implant; these tests are typically conducted in a lab environment.

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

Not applicable. This question pertains to clinical studies involving human interpretation or pathology. The provided document describes mechanical bench testing of a medical implant, not a diagnostic device or a clinical study that requires expert ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. This question relates to clinical studies and expert review for ground truth, not mechanical bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is relevant for diagnostic imaging devices where human readers interpret results, often with and without AI assistance. The Huvex Interspinous Fixation System is a surgical implant, and no MRMC study would be performed for its clearance.

6. Standalone Performance Study

The document describes standalone mechanical performance testing as part of its substantial equivalence claims. The tests mentioned (Static & Dynamic compression, Static torsion, Static tension, Static grip) are performed on the device itself (or device constructs) without a human in the loop. The "performance and SE determination" section says, "The Huvex Interspinous Fixation System has been demonstrated to be substantially equivalent to the predicate system(s) with respect to technical characteristics, performance, and intended use." This implies that the device's mechanical performance, in isolation, was evaluated against established standards or predicate device performance.

However, specific quantitative results from these standalone tests are not provided in this summary.

7. Type of Ground Truth Used

Not applicable in the sense of clinical ground truth. For mechanical testing, the "ground truth" or reference is typically defined by:

• ASTM standards: ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model) and ASTM F1798 (Standard Guide for Evaluation of Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Constructs) are mentioned, albeit as "modified" setups. These standards define the methodology for testing.
• Predicate device performance: The goal is to demonstrate "substantial equivalence" to predicate devices, meaning the device performs comparably mechanically. The performance of the predicate device acts as the benchmark.

8. Sample Size for the Training Set

Not applicable. Surgical implants undergo mechanical testing, not algorithm training using a "training set" of data in the AI sense.

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

Not applicable. As above, there is no "training set" for this type of device and evaluation.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence through mechanical bench testing. It lists the types of tests conducted and the standards referenced but does not provide the quantitative acceptance criteria or specific performance results that would directly answer your request in detail.

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