(197 days)
Intended for use in reconstruction (correction) of a hallux valgus deformity by providing for the reduction of 1st metatarsal-2nd metatarsal (IM) angle.
The KISSloc™ Suture System is a non-resorbable system consisting of a small Suture Plate, UHMWPE Suture Assembly and Arrow Plate for security. The suture is hooked around the Arrow Plate and passes through the two holes in the plate to form the entire assembly. This implant construct is intended to be used for realignment and stabilization of an underlying skeletal deformity. Ancillary instruments required to aid in insertion of the KISSloc™ Suture System will be provided separately in a sterile disposable package. All implant components will also be provided in a sterile package.
The provided document describes Arthrosurface Inc.'s KISSloc™ Suture System and its 510(k) premarket notification for substantial equivalence, focusing on engineering tests rather than clinical studies with explicit acceptance criteria for device performance.
Therefore, many of the requested fields regarding clinical study details, such as sample sizes, expert qualifications, and detailed ground truth establishment, are not applicable based on the information provided. The submission focuses on demonstrating substantial equivalence through non-clinical mechanical tests against predicate devices.
Here's an attempt to fill in the table and provide the requested information based on the available text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Metric) | Target Performance (Acceptance Threshold) | Reported Device Performance (KISSloc™ Suture System) |
|---|---|---|
| Peak load to failure (N) | Equivalent or superior to predicate | Equivalent or outperformed predicate |
| Number of cycles completed prior to failure | Equivalent or superior to predicate | Equivalent or outperformed predicate |
| Displacement slippage per cycle interval | Equivalent or superior to predicate | Equivalent or outperformed predicate |
Study Proving Device Meets Acceptance Criteria:
A non-clinical mechanical testing and engineering evaluation study was conducted to demonstrate the substantial equivalence of the KISSloc™ Suture System to its predicate devices.
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Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (number of devices/tests) used for the non-clinical mechanical tests.
- Data Provenance: The data was generated through laboratory mechanical testing and Finite Element Analysis (FEA). The country of origin for the data is not explicitly stated, but the company is based in Franklin, MA, USA, suggesting the testing likely occurred in the USA or through contracted labs. This was a retrospective comparison against established predicate device performance or specifications, as no new clinical data was provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a mechanical engineering study, not a clinical study involving expert assessment of medical images or patient outcomes. The "ground truth" for these tests would be the measured mechanical properties according to standard test methods.
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Adjudication method for the test set:
- Not applicable. Mechanical testing involves quantitative measurements, not subjective adjudication methods like those used in clinical image review.
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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 MRMC comparative effectiveness study was done. This device is a surgical implant, not an AI-powered diagnostic tool. The submission explicitly states, "No clinical data was provided in support of this substantial equivalency."
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical implant, not an algorithm or AI system. Its performance is intrinsic to its mechanical properties, not a standalone algorithmic output.
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The type of ground truth used:
- For the mechanical tests, the ground truth was the measured physical and mechanical properties (e.g., peak load, number of cycles, displacement slippage) determined through standardized laboratory testing protocols, compared against performance or specifications of the predicate devices. The Finite Element Analysis (FEA) provided simulated engineering data.
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The sample size for the training set:
- Not applicable. There was no "training set" in the context of machine learning or AI, as this was a physical device undergoing mechanical testing.
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How the ground truth for the training set was established:
- Not applicable for the same reasons as above.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.