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The Synthes 3.5 mm LCP Distal Tibia T Plates are indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.

Synthes 3.5 mm LCP Distal Tibia T Plates are contoured to match the anatomy of the distal tibia. The plates have both combination and locking screw holes which accept various Synthes screws. They are available in stainless steel and titanium, in a variety of lengths.

This 510(k) summary is for the Synthes 3.5 mm LCP Distal Tibia T Plates, a bone fixation device. This type of device falls under the category of traditional medical hardware and therefore does not typically involve the kinds of studies (e.g., AI algorithms, MRMC studies, ground truth establishment) that would be relevant to software-as-a-medical-device (SaMD) or AI/ML-powered devices.

As such, many of the requested elements for describing acceptance criteria and study details are not applicable to this specific device. The approval for this device is based on substantial equivalence to predicate devices. The "performance" in this context refers to meeting design specifications and mechanical testing standards, not clinical performance derived from AI predictions or human reader performance.

Here's an attempt to address the request based on the provided document, highlighting what is (and isn't) present:

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

The provided document (K080522) does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics in the way one would see for an AI/ML device (e.g., sensitivity, specificity, AUC). For traditional orthopedic implants like this, acceptance criteria would typically relate to:

• Design Specifications: Conformance to material standards (e.g., stainless steel, titanium), dimensions, screw hole configurations (combination and locking).
• Mechanical Testing: Bench testing for strength, fatigue life, and torsional rigidity, often compared to the predicate device or established standards for such implants.
• Biocompatibility: Confirmation that the materials meet biocompatibility standards for implantable devices.

The document implicitly states that the device "conforms to the appropriate Synthes (USA) standards and has demonstrated substantial equivalence to currently marketed predicate devices." This implies that the device met internal design and testing standards, which serve as its acceptance criteria.

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

• Sample Size: Not applicable in the context of an "AI/ML test set." For mechanical testing of medical hardware, "samples" would refer to the number of physical plates tested. This information is not provided in the 510(k) summary.
• Data Provenance: Not applicable in the context of an "AI/ML test set." The testing would be conducted in a laboratory environment, not on patient data.

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 a bone fixation plate is its mechanical performance and proper surgical application, not a diagnosis or classification by an expert. Clinical experts (surgeons) would validate the design and usability, but not establish "ground truth" in the AI sense.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods are relevant for subjective interpretations, typically in imaging or clinical diagnosis, not for the objective mechanical testing of a medical device.

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 device is not an AI algorithm assisting human readers. It is a physical orthopedic implant.

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

• Not applicable. This is not an algorithm.

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

• Not applicable in the context of AI/ML. For this device, the "ground truth" for its performance would be derived from engineering standards, mechanical testing results, and established clinical performance of predicate devices that demonstrate safe and effective bone fracture fixation.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" as it's not an AI/ML algorithm.

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

• Not applicable.

Summary regarding K080522:

The provided 510(k) summary for the Synthes 3.5 mm LCP Distal Tibia T Plates is for a traditional, physical medical device (an orthopedic implant), not a software or AI/ML-based device. Therefore, the questions related to acceptance criteria, test sets, ground truth establishment, expert involvement, and AI performance metrics are generally not relevant or applicable to this submission. The device received 510(k) clearance based on its substantial equivalence to existing predicate devices, meaning it was determined to be as safe and effective as devices already on the market through conformance to design specifications and mechanical testing results (which are not detailed in this summary document but would have been part of the full submission).

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