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The HALLU® PLATES are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metastarso-phalangeal joint, including cases of.

• Hallux rigidus .
• Severe hallux valgus (IM angle >20° and HV angle >40° ) .
• . Deformity from rheumatoid arthritis
• Failed previous surgical procedure .
• Traumatic arthritis .
• Neuromuscular instability .

Addition of a screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.

The Newdeal HALLU® PLATES is a low profile Titanium plate dedicated to first metatarsophalangeal arthrodesis. The system includes both HALLU" -FIX C plates as well as HALLU -FIX S plates. The plates are used in conjunction with Newdeal SNAP-OFF® screws.

The provided document describes a Special 510(k) Summary for a medical device called "Modified Newdeal HALLU® PLATES." This type of submission is for modifications to a device already cleared by the FDA, relying on the substantial equivalence principle rather than extensive clinical efficacy studies.

Therefore, the "study" conducted is a mechanical equivalence test rather than a typical clinical study proving performance against acceptance criteria in a human population.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not specified. The document states "Mechanical tests have been carried out," but does not detail the number of plates tested or the specifics of the test setup (e.g., number of cycles, loads applied).
• Data Provenance: The tests were conducted by the manufacturer, Newdeal SAS, which is located in France. The data is thus prospective test data generated to support the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

• This question is not applicable in this context. For mechanical equivalence testing, the "ground truth" is defined by established engineering and biomechanical principles and standards used to compare the mechanical properties of the modified device to its predicates. There are no "experts" establishing ground truth in the sense of clinical interpretation or diagnosis.

4. Adjudication Method for the Test Set

• This question is not applicable. Mechanical tests are typically analyzed objectively based on sensor readings and engineering calculations, not through an adjudication process like those used in clinical image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• This question is not applicable. This device is a bone fixation plate, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

• This question is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is established through objective mechanical testing against the known mechanical properties of the legally marketed predicate devices. This involves comparing engineering parameters such as strength, fatigue resistance, and stiffness, as relevant to the device's function.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" as this is not an AI/ML device. The "training" for such a device would be the design and manufacturing processes guided by engineering principles.

9. How the Ground Truth for the Training Set was Established

• This question is not applicable for the same reason as above.

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