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RemeOs™ Screw LAG Solid is intended for the use in traumatic and orthopedic surgery for the fixation of bone fractures (osteosynthesis) and for the fixation after osteotomies, e.g., for the correction of deformities or malalignments. The absorbable implants serve as temporary fixation and stabilization by osteosynthesis of bone fractures and osteotomies until bony fusion has occurred.

The RemeOs™ Screw LAG Solid is intended to be used for skeletally mature adults.

The RemeOs™ Screw LAG Solid is indicated for the fixation of the medial malleolus.

The RemeOs™ Screw LAG Solid is an absorbable metallic bone fixation fastener. The product is manufactured from an absorbable magnesium-based alloy containing magnesium, zinc (0.55% (w/w)) and calcium (0.45% (w/w)). The material corrodes under physiological conditions into magnesium, calcium and zinc oxides and hydroxides, while producing hydrogen gas as byproduct. The implant serves as temporary fixation and stabilization by osteosynthesis of bones and fragments until bonv fusion has occurred.

The RemeOs™ Screw LAG Solid is provided in one design (Figure 1). The RemeOs™ Screw LAG Solid is a partially threaded solid headed screw with a diameter of 3.5 mm and is offered from lengths 24 to 40 mm in 2 mm increments.

This document describes the De Novo Classification Request for RemeOs™ Screw LAG Solid, an absorbable metallic bone fixation fastener. The provided text primarily focuses on the device's design, biocompatibility, sterilization, MR compatibility, and substantial mechanical and early clinical performance. However, there is no information about an AI/ML-driven device or an AI model’s performance study. The request is for a physical medical device. Therefore, I cannot generate the requested table and study description for an AI device.

The provided text details the acceptance criteria and the study proving the physical medical device (RemeOs™ Screw LAG Solid) meets those criteria. However, your request specifically asks for information related to an AI/ML device's acceptance criteria and performance study, including aspects like sample size for test/training sets, experts, adjudication methods, MRMC studies, and standalone AI performance.

Since the provided text does not describe an AI/ML device, I cannot fulfill your request for an AI model's performance study description based on this input. The information provided is entirely about the physical characteristics and performance of a resorbable metallic screw.

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The devices of Bloretec ActivaPin™ Product Group including ActivaPin™ Fusion, ActivaNail™ Conical, ActivaNail™ Flat and ActivaPin™ HT are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.

The modified ActivaPin™ Product Group is identical to the currently cleared device expect for the modification. The modification of the initial ActivaPin™ Product group 510(k) (K080879) adds one trade name; Biorelec ActivaPin™ HT in the AclivaPin™ Product Group. That device has a small modification to ActivaPin™ Fusion; the instrument accepting hole is made on the both ends instead of one end of the device to enable insertions. The labeling will be revised accordingly.

Bioretec ActivaPin™ Product Group covers Bioretec's bioabsorbable devices AclivaPin™, ActivaPin™ Fusion, ActivaPin™ HT, ActivaNail™ Conical and ActivaNail™ Flat.

The Bioretec ActivaPin™ products do not differ significantly or at all in purpose, design, materials, function or any other feature related to safety and effectiveness. ActivaPin™ HT is almost identical with a predicate device and the other devices of Bioretec's ActivaPin™ Product Group. ActivaPin141 HT is the same kind of device as ActivaPin™ Fusion, but it's both ends have an instrument accepting hole. The diameter of ActivaPin™ HT is 1,5 mm and the lengths are 20 - 70 mm.

The devices of Bioretec ActivaPin™ Product Group are indicated for fixation of bone fractures, osteotomies, arthrodeses and osleochondral fractures in the presence of appropriate immobilization.

The Bioretec ActivaPin™ Product Group devices are made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), and they degrade in vivo by hydrolysis into alphahydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the Bioretec ActivaPin™ products gradually loses their strength, however, maintaining their function at least 8 weeks. Bioabsorption lakes place within approximately two years thus eliminating the need for implant removal surgery.

This document is a 510(k) summary for a Special 510(k) submission, focusing on a modification to an already cleared medical device, the Bioretec ActivaPin™ Product Group. As such, the purpose of this submission is to demonstrate substantial equivalence to previously cleared devices, rather than to present a de novo study with acceptance criteria and a detailed study report for new device performance.

Therefore, many of the requested items (e.g., specific acceptance criteria, detailed study results proving the device meets those criteria, expert ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable or not present in the provided document. The submission relies on the prior clearance of the predicate devices for performance, safety, and effectiveness.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This is a Special 510(k) for a modification (adding a new trade name and a minor design change) to an already cleared device. The "acceptance criteria" here implicitly refer to demonstrating substantial equivalence to the predicate devices, not to a new performance study against specific metrics. The document states: "The modified ActivaPin™ Product Group is identical to the currently cleared device expect for the modification. ... The Bioretec ActivaPin™ products do not differ significantly or at all in purpose, design, materials, function or any other feature related to safety and effectiveness."

2. Sample size used for the test set and the data provenance

Not applicable. No new clinical or performance test set data is presented for this Special 510(k) in the provided summary. The substantial equivalence argument relies on the existing clearances and the minimal nature of the modification.

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

Not applicable. No ground truth establishment for a test set is discussed in this Special 510(k) summary.

4. Adjudication method for the test set

Not applicable. No test set or adjudication method is discussed.

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 bioabsorbable fixation pin, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a physical fixation pin, not an algorithm.

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

Not applicable. No new ground truth is established for this Special 510(k) submission. The safety and effectiveness are supported by the substantial equivalence to predicate devices, which would have had their performance and safety established through prior studies (not detailed in this document). The device itself (a bioabsorbable pin) is evaluated based on its mechanical properties, biocompatibility, and degradation characteristics, often through bench testing and sometimes animal or clinical studies for initial clearance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

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

Not applicable. This is a physical medical device.

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