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The Kinamed SuperCable Iso-Elastic Cerclage System is intended to be used in the following: repair of long bone fractures due to trauma or reconstruction; reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy; sternotomy closure; and sublaminar and intrafacet wiring of the spinal column.

The Kinamed SuperCable® Iso-Elastic™ Cerclage System consists of an implantable cable and locking clasp (the locking clasp consists of a clip and a wedge). The cable is comprised of a monofilament core of nylon with a jacket of ultra-high molecular-weight-polyethylene (UHMWPE) fibers braided around the nylon core. Manual instrumentation is used for applying the cable. The subject of the present Special 510(k) submission is a line addition of a cable implant whose locking clasp is manufactured using a metal injection molding (MIM) process.

The provided document is a 510(k) summary for the Kinamed SuperCable® Iso-Elastic™ Cerclage System. It describes a line extension to an existing device, specifically a change in the manufacturing process for the locking clasp. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical efficacy studies typically found for novel devices.

Therefore, the document does not contain the detailed information requested for acceptance criteria, device performance studies, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies that would be present for an AI/ML-based medical device or a device requiring new clinical efficacy data.

Based on the information provided in the document:

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

The document mentions "Performance testing of the SuperCable Iso-Elastic Cerclage System includes ISO 10993 testing, Bacterial endotoxin levels (LAL), Static construct tensile testing, and Fatigue construct tensile testing." However, the specific acceptance criteria and the reported results for each of these tests are not provided in this 510(k) summary. The document only states that the device "meets the specifications of ASTM F2885 (Type 1, Densified)" for the locking clasp material. This implies the acceptance criteria for the material are the ASTM F2885 specifications.

2. Sample size used for the test set and the data provenance

Not applicable. This submission is for a modification to an existing device (change in manufacturing process for a component), not an AI/ML device that uses test sets or clinical data in the typical sense for performance evaluation. The performance testing mentioned (tensile, fatigue, etc.) would be conducted on a sample of manufactured devices, but the sample sizes are not reported.

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

Not applicable. Ground truth establishment by experts is not relevant for this type of device modification.

4. Adjudication method for the test set

Not applicable.

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 is not an AI-assisted device.

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

Not applicable. This is not an AI-based algorithm.

7. The type of ground truth used

Not applicable in the context of clinical "ground truth." The "ground truth" for this device would be defined by engineering specifications and material standards (e.g., ASTM F2885 for the material, and internal specifications for tensile strength and fatigue life).

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable.

Summary of what is presented in the document regarding acceptance criteria and study:

The submission focuses on demonstrating that a manufacturing change (Metal Injection Molding for the locking clasp) does not alter the safety or effectiveness of the device compared to the predicate. The basis of substantial equivalence is outlined by comparing properties such as:

• Same polymer cable
• Same intended use
• Same indications for use
• Same raw material alloy (Ti-6Al-4V) for locking clasp (though the manufacturing process changed)
• Same design
• Similar size and dimensions
• Same type of mating components
• Same shelf life
• Same biocompatibility
• Same sterilization and packaging methods

The performance testing mentioned (ISO 10993, LAL, Static construct tensile testing, Fatigue construct tensile testing) would serve as the "studies" to prove the device meets acceptance criteria, which would be the established specifications derived from the predicate device's performance and relevant standards. However, the specific data from these tests and the exact acceptance criteria are not included in this summary. The key statement regarding acceptance criteria is that the material "meets the specifications of ASTM F2885 (Type 1, Densified)."

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