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The HC Spinal System is intended for posterior noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients for the following indications: severe spondylolisthesis (i.e., Grades 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment), trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The HC Spinal System offers a comprehensive solution for immobilizing and stabilizing spinal deformities in patients as an adjunct to fusion. The HC Spinal System consists of monoaxial and polyaxial pedicle screws, set screw and rods. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants will be provided non-sterile and will be used for either posterior or anterolateral non cervical fixation.

The provided text is a 510(k) summary for the HC Spinal System, a medical device. It does not describe a study involving an AI algorithm or human-in-the-loop performance. Instead, it details the non-clinical testing performed on a physical spinal implant system to demonstrate its substantial equivalence to a predicate device.

Therefore, most of the requested information regarding AI performance, sample sizes for test/training sets in an AI context, expert ground truth, adjudication methods, and MRMC studies is not applicable to this document.

Here's the relevant information that can be extracted:

1. A table of acceptance criteria and the reported device performance

The document states that a series of non-clinical tests were performed. The "reported device performance" is a general statement that the device met the requirements. Specific numerical acceptance criteria and performance values are not provided in this summary.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample sizes for test set: Not specified in the document. The tests performed are engineering/materials tests on physical devices, not clinical studies with human participants.
• Data provenance: Taiwan (R.O.C.) (where the submitter is located), for the device manufacturing/testing.

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

Not applicable. The "ground truth" for this type of device (spinal implant) is established through engineering and material testing standards (e.g., ASTM F1717). No human expert consensus for a "test set" in the context of interpretation of medical data is described.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of interpretations.

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 document does not describe an AI device or an MRMC study.

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

Not applicable. This document does not describe an AI algorithm.

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

The "ground truth" or standard for evaluation is based on pre-defined acceptance criteria derived from established engineering and material testing standards, such as ASTM F1717 for mechanical performance, and general biological safety standards for cytotoxicity, irritation, etc. These are objective measures rather than expert consensus on medical image interpretation or pathology.

8. The sample size for the training set

Not applicable. There is no AI algorithm, so no training set.

9. How the ground truth for the training set was established

Not applicable. There is no AI algorithm, so no training set or associated ground truth establishment.

Summary of the study that proves the device meets the acceptance criteria:

The study described is a series of non-clinical tests performed on the HC Spinal System. These tests are outlined in Section 8 ("Non-clinical Testing") and include:

• Shelf Life Test
• In vitro Cytotoxicity Test
• Intracutaneous Irritation Study
• Skin Sensitization Study
• Pyrogen Test
• Acute Intravenous Systemic Toxicity Study
• Acute Intraperitoneal Systemic Toxicity Study
• Salmonella Reverse Mutation Test
• In Vitro Mammalian Chromosomal Aberration Test
• Rodent Micronucleus Test
• Bone Implantation Study
• Subchronic Intravenous Systemic Toxicity Study
• Static and Dynamic axial Compress Bending Testing
• Static Torsional Test

The document states that "All the test results demonstrate that HC Spinal system meets the requirements of its pre-defined acceptance criteria and intended uses." Specifically, for performance, it notes compliance with ASTM F1717. The purpose of these tests was to demonstrate the safety and performance of the device and to establish substantial equivalence to the predicate device (Xia® 4.5 Spinal System) under 510(k) regulations. No clinical test data was used to support this decision.

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