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The BRM SWING-OFF SCREW is indicated for surgical fixation of bone fractures, osteotomies and bone reconstruction in order to position and maintain bony fragments in a desired orientation and to provide stable fixation of the osteotomy site until a stable bony union occurs.

Examples include but are not limited to:

-Fixation of small bone fragments
-Weil osteotomy
-Mono-cortical fixation
-Osteotomies and fractures fixation in foot and hand

The BRM SWING OFF Screw is made of titanium alloy (Ti6A14V- ELI) according to ISO 5832-3 and ASTM F 136. It is self-drilling and self-tapping and consists of a screw with a flat thin head which is integrated with a short round shaft. The shaft is fixed on a standard surgical shaft and separates from the screw when the head comes in contact with cortical bone.

The screw is available in two different diameters (2.0 and 2.7 mm) and in length from 10 to 15 mm for Ø 2.0 mm and from 10 to 17 mm for Ø 2.7 mm. The screws are anodized and color-coded (yellow) to be easily recognized. The head design facilitates maximum loading and compression. The self-drilling tip easily penetrates the cortical shell. A Swing-Off Terminal Screw Driver is offered for ease of use.

The provided text is a 510(k) summary for a medical device called "BRM SWING-OFF SCREW," which is a bone fixation screw. The document focuses on establishing substantial equivalence to predicate devices based on indications for use, material, technology, and design specifications. It does not include information about acceptance criteria, device performance metrics, or any clinical or technical studies demonstrating performance through quantitative metrics.

Therefore, I cannot fulfill the request as the necessary information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided text.

Specifically, the document states: "Based on available 510k information including engineering analyses and insertion testing, AIT bone fixation (screw) devices are deemed substantially equivalent to the predicate devices in terms of indications for use, material, technology and design specifications." This indicates that some engineering analyses and insertion testing were performed, but no details of these tests, their results, or how they relate to specific acceptance criteria are provided in a quantifiable manner as you've requested.

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The ARS and SLANT SCREW medical devices are indicated for the fixation of bone fractures and bone reconstruction. Examples include but are not limited to:
· Fixation of bone fragments in long or small bone fractures
· arthrodesis in hand or foot surgery
· mono or bi-cortical osteotomies in the foot or hand
· distal or proximal metatarsal or metacarpal osteotomies
· fixation of osteotomies for hallux valgus treatment (such as Scarf, Chevron, etc.)

The ARS and SLANT Screws are made of titanium alloy (Ti6A14V) according to ISO 5832-3 and ASTM F 136. They are self-drilling, self-tapping and designed with a double thread for better grip on tissue. The ARS and SLANT Screws are intended for single use only.
The titanium ARS and SLANT SCREWs are cannulated for use with a guide wire and have double-threading and different pitch for the proximal and distal threads. The headless screws can be completely embedded in the bone thus avoiding any protrusion that could cause irritation to the tissue. The double-thread design assures compression and stability of the fractures. Both screws have reverse-cutting flutes in the head threaded portion to facilitate removal of the screw.
The code to clearly identify each product is laser-marked on the unthreaded cylindrical screw part. The screws are color coded (anodized) to be easily recognized ARS (blue) from SLANT (green).

The provided text is related to a 510(k) submission for bone fixation screws, not an AI/ML powered medical device. Therefore, it does not contain information about acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), ground truth establishment, sample sizes for training/test sets, expert qualifications, or details of a comparative effectiveness study that would be relevant to an AI/ML device.

The document is a traditional medical device submission for orthopedic screws and focuses on demonstrating substantial equivalence to predicate devices based on material, design, and indications for use.

Therefore, I cannot fulfill the request as the provided input does not describe an AI/ML powered medical device.

Ask a specific question about this device