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The HALLU® Lock Plates are intended for fixation of fractures, osteotomies or arthrodesis of the first metatarso-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.
  The HALLU® Lock plates must be fixed with the SURFIX® fixed angle locking system and with the SURFTX®-Alpha variable angle locking system of 2.7mm or 3.0mm diameter (screws and lock-screws).
  Addition of a Newdeal® QWIX® screw crossing the joint is strongly recommended for optimal arthrodesis consolidation

The Newdeal HALLU® Lock Plate System is a low profile Titanium plate dedicated to first metatarso-phalangeal arthrodesis. The HALLU Lock C plates are pre-bent with 10° valgus and 10° dorsiflexion. The HALLU Lock S plates are available with 10° valgus and 10° or 5° dorsiflexion. Pre-operative bending is possible to completely fit to the anatomical shape of the joint. Their fixation is provided by SURFIX and SURFIX ALPHA locking screws.

The provided text describes a medical device, the "Newdeal HALLU® Lock Plate System," which is a bone fixation appliance. It is a 510(k) summary, indicating that it aims to demonstrate substantial equivalence to an existing device rather than presenting entirely new clinical trial data for novel acceptance criteria.

Therefore, the structure of the response will reflect the information available in a 510(k) summary for a substantially equivalent device, focusing on mechanical testing rather than extensive clinical studies.

Here's the information as requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided text describes mechanical testing, not a clinical study involving human subjects or data related to patient outcomes. Therefore, information regarding "sample size used for the test set" in the context of clinical data, "data provenance (e.g. country of origin of the data, retrospective or prospective)," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth (e.g., pathology, outcomes data)," "training set sample size," and "how ground truth for training set was established" are not applicable to this type of submission.

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

Not applicable (as per explanation in point 2). The ground truth for mechanical testing is typically based on established biomechanical standards and measurements, not expert clinical consensus.

4. Adjudication Method for the Test Set

Not applicable (as per explanation in point 2).

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 a bone fixation plate, and the submission focuses on mechanical equivalence. An MRMC study is relevant for diagnostic imaging AI, which is not the subject here.

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

Not applicable. This device is a physical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the mechanical testing performed, the ground truth would be established through objective physical measurements and engineering analyses under controlled laboratory conditions, demonstrating that the new device's mechanical properties (e.g., strength, stiffness, fatigue resistance) fall within acceptable predefined limits or are equivalent to the predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable (as per explanation in point 8).

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