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

The TriMed Clavicle Fixation Plates are designed to provide total immobilization of the clavicle. The plates utilize 2.7mm and 3.2mm locking cortical screw to secure the plates to the bone. All plates and screws are similar to predicate devices. The TriMed Clavicle Fixation Plates are available in a variety of shapes and sizes to provide superior and anterior fixation of the clavicle.

The provided text describes a 510(k) submission for the TriMed Clavicle Fixation System. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies or standalone performance evaluations.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not applicable to this type of regulatory submission. The primary "study" conducted for this device is an engineering analysis comparing its mechanical properties to those of existing devices.

Here's a breakdown of the information as it relates to the provided document:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) process for this type of device does not typically require the establishment of specific numerical performance acceptance criteria and a detailed study proving the device meets those in the way, for example, a diagnostic AI device would. Instead, the focus is on demonstrating that the device is as safe and effective as a legally marketed predicate device.

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

• Sample Size for Test Set: Not applicable. No clinical or performance test set (in the sense of a data set for an algorithm) was described. The "test" involved an engineering analysis comparing the device's mechanical properties to predicates.
• Data Provenance: Not applicable. The "data" comes from the engineering analysis, comparing the new device's specifications and performance to specifications of predicate devices.

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

• Number of experts: Not applicable. Ground truth, in the context of an AI device, is not relevant here as this is a medical implant, not an AI diagnostic tool. The "ground truth" for proving substantial equivalence relies on established engineering principles and comparison to predicate device specifications.

4. Adjudication method for the test set

• Adjudication method: Not applicable. There was no test set requiring expert adjudication.

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

• MRMC Study: Not applicable. This is a medical implant (clavicle fixation system), not an AI diagnostic or assistive device. Therefore, a multi-reader multi-case comparative effectiveness study with or without AI assistance is not relevant.

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

• Standalone Performance: Not applicable. This is a medical implant, not an algorithm.

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

• Type of Ground Truth: Not applicable in the context of typical AI algorithm validation. For this 510(k) submission, the "truth" for substantial equivalence is derived from:
  • Engineering analysis results: Comparing the bending strength of the new device to predicate devices.
  • Predicate device information: Specifications, indications for use, and design features of the legally marketed predicate devices (K100944 and K012655).

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable. There is no training set for this device.

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