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The MJ-FLEX THE NEW METAIZEAU NAIL™ is intended for the treatment of diaphyseal fractures of long bones.

The MJ-FLEX THE NEW METAIZEAU NAIL™ is indicated to treat:

• upper extremity and clavicle fractures in all patients except newborns and infants;
• lower extremity fractures in pediatic patients, except newborns and infants, where the flexibility of the implant is paramount not to disrupt the growth plate;
• lower extremity fractures in small adults where the medullary canal is narrow.

The Orthofix MJ-FLEX THE NEW METAIZEAU NAIL™ is an intramedullary implant system specifically designed for Elastic Stable Intramedullary Nailing (ESIN) fracture fixation.
The System consists of implantable components (intramedullary nails) and instrumentation.
Nails are supplied in different diameters and lengths, in order to assure compatibility with patient anatomy, and in both Titanium alloy and Stainless Steel materials.

This document is a 510(k) summary for the Orthofix MJ-FLEX THE NEW METAIZEAU NAIL. It pertains to a medical device (bone fixation fastener), not an AI/ML powered device. As such, the typical acceptance criteria and study data requested for AI/ML devices are not applicable.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through mechanical testing and a comparison of design, materials, and indications for use.

Here's a breakdown of the requested information, adapted to what is available in the provided text:

Acceptance Criteria and Device Performance for Orthofix MJ-FLEX THE NEW METAIZEAU NAIL

1. Table of Acceptance Criteria and Reported Device Performance

• Indications for Use
• Site of application
• Patient population
• Conditions of use
• Mechanical performances
• Basic design
• Operating principles
• Materials
• Size and range of variants | "The Orthofix MJ-FLEX THE NEW METAIZEAU NAIL™ is substantially equivalent to the predicate device in indications for use, site of application, patient population, conditions of use, mechanical performances, basic design, operating principles, materials. The Orthofix MJ-FLEX THE NEW METAIZEAU NAIL™ is similar to its predicate in size and range of variants." |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated in the document for the mechanical or endotoxin testing. These are typically material and device performance tests, not clinical studies with patient data.
• Data Provenance: Not applicable in the context of patient data, as the tests described are laboratory-based mechanical and chemical tests of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. The ground truth for mechanical and endotoxin testing is established by scientific standards (e.g., ASTM F 1264-16e1) and laboratory procedures, not by expert consensus on clinical cases.

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

• Not applicable. This is not a clinical study involving human interpretation or 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

• Not applicable, as this is not an AI/ML powered device.

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

• Not applicable, as this is not an AI/ML powered device.

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

• For mechanical performance: The ground truth is defined by the technical specifications and performance requirements outlined in the ASTM F 1264-16e1 standard.
• For biocompatibility: The ground truth is defined by the limits for bacterial endotoxin established by regulatory guidelines.

8. The sample size for the training set

• Not applicable, as this is not an AI/ML powered device, and therefore no "training set" in the machine learning sense exists.

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

• Not applicable.

Summary of the Study Provided:

The study described is a premarket notification (510(k)) submission to the FDA, demonstrating the substantial equivalence of the Orthofix MJ-FLEX THE NEW METAIZEAU NAIL to a legally marketed predicate device (OrthoPediatrics PediFlex™ Flexible Nail System - K082375).

The study primarily consisted of non-clinical performance testing, specifically:

• Mechanical Testing: Performed according to ASTM F 1264-16e1 "Standard Specification and Test Method for Intramedullary Fixation Devices." The results indicated that the subject device's mechanical strength was equivalent to or better than the predicate devices and capable of withstanding expected loads without failure.
• Bacterial Endotoxin Testing: This testing was conducted to ensure the device's safety from endotoxin contamination, and it met the expected limits.

Clinical data was explicitly stated as "not needed to support the safety and effectiveness of the Subject Device," as substantial equivalence was demonstrated through non-clinical means. This type of submission relies on proving that the new device is as safe and effective as a device already on the market, based on similarities in design, materials, performance, and intended use.

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