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MINIARS screw system is intended for fixation of intra-articular fractures, non-union and osteotomies of small bones and small bone fragments. Some examples include:

• arthrodesis of small joints (foot and hand surgery);
• intra-articular metatarsal and metacarpal fractures;
• osteotomies for hallux valgus treatment.

MINIARS screw system is intended for fixation of intra-articular and extra-articular fractures, non-union and osteotomies of small bones and small bone fragments. MINIARS screws are implants that will be in contact with body tissues for more than 30 days. Instrumentation used to assist in their implantation will be in temporary contact (inferior to 24 hours) with body tissues. The MINIARS screws are intended for single use only. The implant is a solid, one piece, cannulated and partially thread shaped design. MINIARS screws are available in two different external thread diameters: 2.2 mm e 2.6 mm. MINIARS screws are available in a range of lengths from 10mm to 30mm. All the screws sizes available are described in table 5.1. The screws are partially threaded: the proximal and distal parts are threaded while the middle part is cylindrical, as visible in figure 5.1. The thread shape has been designed to facilitate the compression of the bone fragments and the hold in cancellous bone thanks to the particular profile design: the wide thread pitch of the distal part penetrates in bone tissue faster than the thread of the proximal part, reducing and compressing the fracture through screw advance. Distal thread presents self-drilled and self-tapping grooves. The screws present a hexagonal torx 6 head which is conforming to ISO 10664 standard. All the MINIARS screws are supplied in a sterile state (beta rays); the single screw is packed into a double blister which allows the usage in surgery. The MINIARS Screws are made of Titanium Alloy (Ti6A14V ELI gr. 5) and is available in the range of sizes reported in the table below.

The provided document is a 510(k) premarket notification for the MINIARS Screws, a medical device for bone fixation. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance characteristics against predefined acceptance criteria for AI/diagnostic devices. Therefore, much of the requested information regarding AI/diagnostic device studies (e.g., sample size for test set, expert qualifications, MRMC studies, standalone performance, training set details) is not applicable or cannot be extracted from this document.

However, I can extract information related to the device's physical and mechanical performance tests that were conducted to support its substantial equivalence.

Here's the breakdown of the information that can be extracted, and where applicable, a note indicating that the information is not provided or not applicable for this type of device submission:

1. A table of acceptance criteria and the reported device performance

The document states that "The results demonstrated that the performance of the subject device is substantially equivalent to the predicate devices." Implied acceptance criteria are that the performance of MINIARS screws must be comparable to the predicate devices in the specific tests conducted. The document does not provide specific numerical acceptance thresholds or detailed performance metrics from the predicate devices for direct comparison in a table.

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

This information is not provided in the document as these are mechanical tests, not clinical studies in the typical sense for AI/diagnostic devices.

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)

This information is not applicable for mechanical performance testing of a bone screw. Ground truth in this context would be physical measurements and engineering analyses, not expert medical opinion.

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

This information is not applicable for mechanical performance testing of a bone screw.

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

This information is not applicable as this is not an AI or diagnostic device.

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

This information is not applicable as this is not an AI device.

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

The "ground truth" for the performance tests would be the established engineering and material science principles, physical measurements obtained from the tests (e.g., stress values, force measurements, torque values, displacement), and comparison against the known properties or performance of predicate devices. There is no expert consensus, pathology, or outcomes data used for these specific tests outlined.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI model requiring a training set.

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

This information is not applicable as this is a physical medical device, not an AI model requiring a training set.

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