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The OsteoMed ExtremiLOCK Wrist Plating System is indicated for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.

OsteoMed ExtremiLOCK Wrist Plating System implants are intended for single use only.

The OsteoMed ExtremiLOCK Wrist Plating System is a rigid fixation and fusion system consisting of plates and screws in various configurations along with the appropriate instrumentation to facilitate modification and implantation. Plates are anatomically pre-contoured in various shapes and sizes. Screws are provided with variable angle locking and non-locking heads and are either fully threaded or partially threaded in various lengths. These screws are either solid core or cannulated and can be used with or without plates. The system also contains K-wire implants.

The implants of the OsteoMed ExtremiLOCK Wrist Plating System are made from Titanium per ASTM F-67 (Plates), Titanium Alloy per ASTM F-136 (plates, screws and washer), and Stainless Steel per ASTM F-138( K-wires). The dimensional modifications to the screws include the addition of flutes (for screw lengths ≤ 16mm), tapered tip, decrease in thread pitch, and of the system has already been cleared through OsteoMed wrist predicate 510(k) K152145.

This document is a 510(k) premarket notification for the OsteoMed ExtremiLOCK Wrist Plating System. It does not describe a study involving an AI/ML powered medical device. Instead, it details the substantial equivalence of a new version of a wrist plating system to a predicate device. Therefore, much of the requested information regarding AI/ML device studies, such as acceptance criteria tables, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance, is not applicable.

However, based on the provided text, I can infer the acceptance criteria and the nature of the "study" (verification testing) for this specific medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify the exact number of screws or plates tested. It broadly refers to "the screws (subject device)" as being part of the verification testing.
• Data Provenance: The testing was conducted internally by OsteoMed as part of their premarket notification process to demonstrate substantial equivalence. The document does not provide details on the country of origin of the data beyond "OsteoMed" (based in Addison, Texas, USA). This is prospective testing, specifically designed to evaluate the new device.

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

• This question is not applicable as the "ground truth" for this device is based on engineering standards (ASTM F543) and mechanical performance comparisons, not human expert interpretation of data. The ground truth is objective mechanical strength and performance.

4. Adjudication method for the test set:

• This is not applicable as the evaluation is based on objective mechanical testing against engineering standards rather than subjective assessments requiring 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:

• This is not applicable. The device is a physical medical implant (wrist plating system), not an AI-powered diagnostic or assistive tool for human readers.

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

• This is not applicable. The device is a physical medical implant, not an algorithm.

7. The type of ground truth used:

• The ground truth used for this premarket notification's "performance characteristics & testing" is engineering standards (specifically ASTM F543) and direct mechanical performance comparison to a legally marketed predicate device.

8. The sample size for the training set:

• This is not applicable. There is no AI/ML training set mentioned or implied for a physical medical implant undergoing mechanical verification testing.

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

• This is not applicable, as there is no AI/ML training set.

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The OsteoMed ExtremiLOCK Wrist Plating System is indicated for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.
OsteoMed ExtremiLOCK Wrist Plating System implants are intended for single use only.

The OsteoMed ExtremiLOCK Wrist Plating System is a rigid fixation and fusion system consisting of plates and screws in various configurations along with the appropriate instrumentation to facilitate modification and implantation. Plates are anatomically pre-contoured in various shapes and sizes. Screws are provided with variable angle locking and non-locking heads and are either fully threaded or partially threaded in various lengths. These screws are either solid core or cannulated and can be used with or without plates. The system also contains smooth variable angle locking pegs and K-wire implants.
The implants of the OsteoMed ExtremiLOCK Wrist Plating System are made from Titanium per ASTM F-67 (Plates), Titanium Alloy per ASTM F-136 (plates, screws, pegs and washer), and Stainless Steel per ASTM F-138( K-wires). The modifications to the plates include the new material of CP Titanium per ASTM F-67 and the screw modifications include the new dual lead technology. The rest of the system has already been cleared through OsteoMed wrist predicate 510(k) K120015. The modification also introduced new sterile packaging configurations for the implants and disposable instruments. The system instruments included facilitate modification and insertion of the implants.

The provided text describes the OsteoMed ExtremiLOCK Wrist Plating System, a medical device, and the basis for its 510(k) clearance. It does not contain information about a study proving that the device meets acceptance criteria related to a diagnostic or AI-driven system.

The "Performance Characteristics & Testing & Clinical" section explicitly states: "Clinical Testing is not required to support substantial equivalence." Instead, the performance evaluation was based on mechanical strength testing of the plates and screws compared to predicate devices.

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving a device meets them, as the provided document does not detail such a study in the context of diagnostic performance, AI, or human-in-the-loop improvements. The information requested (acceptance criteria table, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, training set details) is typical for the validation of diagnostic algorithms or AI systems, which is not what this document describes for the OsteoMed ExtremiLOCK Wrist Plating System.

The document focuses on the mechanical and material performance of a bone fixation system, establishing substantial equivalence to existing predicate devices based on:

• Mechanical strength testing: Plates and screws were tested against predicate devices to ensure they met required mechanical strength criteria for their intended use.
• Material comparison: The system uses materials (Titanium, Titanium Alloy, Stainless Steel) per ASTM standards, similar to predicates.
• Design and Technology: Similarities in design, technology (e.g., variable angle locking), and operational principles to predicates.

In summary, the provided text discusses regulatory clearance for a medical device based on non-clinical, mechanical performance comparisons, not a clinical study assessing diagnostic accuracy or AI performance.

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