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The TriMed Clavicle Fixation Plates and Screws are in fixation of fractures, malunions, non-unions, and osteotomies of the clavicle.

The TriMed Clavicle Fixation System is a multi-indication plate and screw fixation system which provides surgical options for fractures, malunions, non-unions and osteotomies of the Clavicle.

TriMed Clavicle Plates have been updated for better plate contour fit to bone, updated lengths (so there is less subcutaneous plate prominence for the patient), and reduced plate thickness. TriMed Clavicle Plates are compatible with 2.7mm / 3.2mm locking and non-locking screws.

All TriMed plates and screws are manufactured from implant grade 316 stainless steel.

The provided text is a 510(k) premarket notification for a medical device, the TriMed Clavicle Fixation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies in the same way a new, novel AI/software medical device would.

Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software medical device, specifically with details like "sample size used for the test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "stand-alone performance," "type of ground truth," and "training set size," is not directly applicable to this document.

This document describes a hardware medical device (bone fixation plates and screws), not an AI or software device. The "study" mentioned is a non-clinical performance evaluation (mechanical testing), not a study involving human readers or AI algorithms.

Here's a breakdown of the relevant information from the document, interpreted in the closest possible way to your request, but highlighting the fundamental difference in the type of device and evaluation:

1. Table of Acceptance Criteria and Reported Device Performance

For this hardware device, "acceptance criteria" are related to mechanical properties and biocompatibility, typically established by recognized standards, and "reported device performance" refers to the results of tests demonstrating compliance with these standards.

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

• Test set size: Not applicable in the context of clinical data for an AI device. For mechanical testing, the sample size would refer to the number of plates and screws subjected to each test. This specific number is not disclosed in the 510(k) summary, but standard testing regimens for ASTM and ISO typically involve multiple samples to ensure statistical validity.
• Data provenance: Not applicable in the sense of country of origin for clinical data. The data provenance here refers to the laboratory and testing methods, which follow established international standards (ASTM, ISO, FDA Guidance).

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

• This is not applicable as the device is a hardware implant, not an AI/software device requiring expert interpretation of outputs or images to establish ground truth. Ground truth for mechanical properties is typically based on physical measurements and adherence to specified limits in standards.

4. Adjudication method for the test set

• Not applicable for this type of device. Adjudication methods are relevant for subjective interpretations, like image analysis in AI studies.

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 a hardware medical device, not an AI device. No MRMC studies were conducted as there is no AI component.

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

• Not applicable. This is a hardware medical device, not an AI algorithm.

7. The type of ground truth used

• For this device, the "ground truth" for non-clinical testing refers to:
  • Mechanical properties and limits defined by recognized standards (ASTM F382-17, ASTM D543-17). These standards prescribe methodology and expected performance ranges for bone fixation devices.
  • Biocompatibility requirements outlined in ISO 10993-1:2018. These standards define acceptable levels for cytotoxicity, sensitization, and irritation based on material properties and biological responses.

8. The sample size for the training set

• Not applicable. This is a hardware medical device. There is no "training set" in the context of machine learning.

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

• Not applicable, as there is no training set for a hardware device.

Conclusion from the document:

The 510(k) submission states: "Clinical testing was not necessary for the determination of substantial equivalence." and "Mechanical testing data and engineering analyses show the subject devices are substantially equivalent to that of the predicate devices for the desired indications." This indicates that the device's acceptable performance is demonstrated through its fulfillment of established mechanical and biocompatibility standards, and importantly, its similarity ("substantial equivalence") to already legally marketed devices with a known safety and efficacy profile.

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