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The Newdeal TTC Plates are intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions and replantations of small bones in the foot and ankle.

The NEWDEAL® TTC Plates consists of a tibiotalocalcaneal plate, available in different sizes, dedicated to be fixed using NEWDEAL® locking system fixation screws and washers. It is available in different sizes, and is implanted using NEWDEAL® locking system fixation screws and washess. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system creates extemporaneously a single implant/screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socked at the top of each hole, thus blocking each screw head.

This document describes a 510(k) submission for the TTC Plates by Newdeal SAS. The submission is a "traditional" 510(k) given its age, and predominantly focuses on the substantial equivalence of modifications to an already cleared device.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study, formatted to your request:

Acceptance Criteria and Device Performance

Study Details:

This submission is for a modified medical device. The "study" here is a set of mechanical tests designed to demonstrate that the modified device is substantially equivalent to its predicate. It is not a clinical study involving human or animal subjects, nor is it related to AI/algorithm performance.

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

   • Sample Size: Not explicitly stated for the mechanical tests. The description indicates "mechanical tests have been carried out." For mechanical testing, samples typically refer to a specified number of physical units of the device tested under various conditions to ensure statistical significance, but this specific number is not provided in the summary.
   • Data Provenance: The tests were conducted to compare the modified device to the predicate device. The summary does not specify the country of origin for the testing, but the submitting company (Newdeal SAS) is based in France. The data is retrospective in the sense that it's comparing a new version to an existing one, but the mechanical testing itself is a prospective evaluation of the new device's properties.

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

   • This question is not applicable as the "study" involves mechanical testing, not a human-interpreted diagnostic or clinical outcome. Ground truth in this context would be engineering specifications and established testing methodologies.

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

   • Not applicable. Mechanical tests generally follow standardized procedures and results are objectively measured, rather than adjudicated by experts.

4. 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 a bone fixation plate, not an AI or imaging diagnostic tool. No MRMC study was conducted.

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

   • Not applicable. This device is a bone fixation plate, not an AI or algorithm.

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

   • Mechanical Specifications/Engineering Standards: The ground truth for mechanical tests would be established engineering standards, material properties, and performance benchmarks derived from the predicate device and relevant international standards for bone fixation devices. The goal was to prove "similarity" to the predicate, implying the predicate's performance served as the benchmark.

7. The sample size for the training set:

   • Not applicable. This device is a bone fixation plate, not an AI system that requires a training set.

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

   • Not applicable. As above, no training set is relevant for this type of device.

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