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The DRPx Locking Distal Radius Plate System is indicated for the fixation of intra- and extra-articular fractures and osteotomies of the distal radius.

The DRPx Locking Distal Radius Plate System consists of titanium plates for the distal radius, a dorsal spanning plate, bone pegs, bone screws and instruments to facilitate implantation. The Distal Radius plates come in a variety of sizes and are pre-contoured to match the anatomy of the distal radius. They accept 2.0mm locking pegs, 2.3mm locking screws, and 2.6mm and 3.5mm locking and non-locking bone screws range in length from 6mm to 30mm. The system also includes instruments used to implant the plates. The dorsal spanning plate is being added to the system in this submission.

This document (K212601) is a 510(k) premarket notification for a medical device called the DRPx Locking Distal Radius Plate System. The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating the device's performance against specific acceptance criteria in a clinical setting.

Therefore, the requested information concerning acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for a study proving the device meets acceptance criteria cannot be fully provided from this document.

This document describes mechanical performance testing rather than clinical performance.

Here's an analysis based on the provided text, highlighting what can be extracted and what cannot:

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

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

• Test Set Sample Size: Not specified for the mechanical tests. ASTM F382 typically defines the number of samples required for such tests.
• Data Provenance: The mechanical tests were performed by Orthopaedic Implant Company (OIC). The country of origin of the data is implicitly the USA (where OIC is located) if the testing was done in-house or by a US-based laboratory. The testing described is retrospective in the context of device submission, meaning it was completed prior to the submission.

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

• Not applicable. This document describes mechanical testing to industry standards (ASTM F382) and does not involve human experts establishing ground truth for a clinical test set. The "ground truth" for mechanical testing is adherence to the specified test parameters and achieving acceptable results according to the standard.

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

• Not applicable. This pertains to clinical studies involving human interpretation or assessment, which is not the nature of the described mechanical testing.

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. An MRMC study is relevant for AI-powered diagnostic/interpretive devices. This submission concerns a physical orthopaedic implant, not an AI system assisting human readers.

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

• Not applicable. This pertains to AI algorithms. The DRPx Locking Distal Radius Plate System is a physical medical device.

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

• Mechanical Test Standards: For the mechanical performance testing, the "ground truth" is defined by the technical specifications and acceptance criteria of the ASTM F382 standard for metallic bone plates. There is no clinical "ground truth" in this context.

8. The sample size for the training set

• Not applicable. This concept applies to machine learning models, not to the design and testing of a physical orthopaedic implant.

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

• Not applicable. See point 8.

In summary: K212601 is a 510(k) submission for a physical medical device. The "study" mentioned refers to mechanical performance testing performed to demonstrate the device's physical properties meet established engineering standards (ASTM F382). It does not involve clinical trials with human subjects, evaluation of clinical outcomes, or the use of AI. Therefore, most of the requested fields related to clinical studies, human experts, and AI are not applicable to the information contained in this document.

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The DRPx Locking Distal Radius Plate System is indicated for the fixation of intra- and extra-articular fractures and osteotomies of the distal radius.

The DRPx Locking Distal Radius Plate System consists of titanium plates for the distal radius, bone peos, bone screws and instruments to facilitate implantation. The Distal Radius plates come in a variety of sizes and are precontoured to match the anatomy of the distal radius. They accept 2.0mm locking screws, and 2.6mm and 3.5mm locking and non-locking bone screws. The bone screws range in length from 6mm to 30mm. The system also includes instruments used to implant the plates.

This a 510(k) premarket notification for the DRPx Locking Distal Radius Plate System. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the context of an AI/ML device.

Therefore, this document does not contain the information requested regarding acceptance criteria for an AI/ML device and a study proving the device meets those criteria. The provided text describes the regulatory clearance of an orthopedic implant system and focuses on its mechanical properties and equivalence to predicate devices, not on AI/ML performance.

Specifically, the document refers to:

• Performance Testing: Single cycle bend testing and bending fatigue testing performed on the plates per ASTM F382.
• Conclusion: The device was found to have acceptable mechanical characteristics for its intended uses.

This type of testing is relevant for the mechanical integrity of an implant, not for the performance metrics typically associated with AI/ML systems (like sensitivity, specificity, AUC, etc.).

Ask a specific question about this device