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The HILINE™ Fixation System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

· Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;

· Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis;

· Spinal degenerative surgery, as an adjunct to spinal fusions;

· Use with a posterior spinal instrumentation construct when ligament augmentation is needed.

The HILINE™ Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.

The HILINE™ Fixation System is a sublaminar fixation system consisting of bands and clamps to mate with 3.5-6.5mm diameter rods, and associated manual surgical instruments. The bands have a titanium anchor attachment on one end that is detached after insertion and is not intended to be implanted. HILINE™ implants are manufactured from polyethylene terephthalate (PET), titanium alloy, commercially pure titanium, stainless steel, or cobalt chromium molybdenum alloy.

The provided text is a 510(k) summary for the HILINE™ Fixation System, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices based on mechanical testing and material characteristics. The summary explicitly states:

"Performance data demonstrate substantial equivalence to the predicate devices."

However, the provided text does not contain the detailed information required to fill out the table regarding acceptance criteria, specific device performance metrics, or study design details for clinical or AI-related performance evaluations. The "Performance Data" section solely mentions mechanical testing in accordance with ASTM F1798. There is no indication of a study involving human readers, ground truth establishment by experts, or any AI component.

Therefore, several sections of your request cannot be fulfilled based on the given information.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The document states that mechanical testing (static and dynamic tension, band pull-through, rod push-through, and static component torsion) was conducted in accordance with ASTM F1798, and that the performance data demonstrated substantial equivalence to the predicate devices. However, it does not specify the numerical acceptance criteria or the specific numerical results of these tests.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical or human-involved test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is 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: No, an MRMC study was not done. The device description and performance data section do not mention any AI component or human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone algorithm study was not done. The device description and performance data section do not mention any AI component.

7. The type of ground truth used: Not applicable. No ground truth for an AI algorithm or diagnostic performance study is mentioned. The "ground truth" relevant here pertains to the physical properties and performance of the device under mechanical stress, which are assessed through standardized mechanical testing (ASTM F1798).

8. The sample size for the training set: Not applicable. No training set for an AI algorithm is mentioned.

9. How the ground truth for the training set was established: Not applicable. No training set for an AI algorithm is mentioned.

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