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The OIC FLEX-FIX™ System is intended to provide fixation during the healing process following trauma to the Ankle Syndesmosis (Syndesmosis disruption) and as an adjunct in connection with trauma hardware for ankle fractures such as Weber B and C. The device is intended for use in adults.

The OIC FLEX-FIX™ System consists of a medial toggle body, UHMWPE suture tape and a lateral button assembled on a deployment handle, a 3.7mm drill bit, and a 3.5mm washer. The device is provided sterile. EO gas is used to sterilize the device.

The medial toggle body, lateral button and washer are manufactured from material that conforms to: ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Ally for Surgical Implant Applications (UNS R56401)

This document, K233531, is an FDA 510(k) clearance letter for a medical device called the OIC FLEX-FIX™ System, which is an orthopaedic implant for ankle fixation. The provided information focuses on the device's substantial equivalence to predicate devices and does NOT contain any data related to AI/ML software performance or an AI study. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets these criteria in the context of AI/ML, as no such study is described in this document.

The document discusses:

• The device's intended use for ankle syndesmosis and fractures.
• The device's components and materials.
• A comparison to predicate devices, noting similarities in intended use, operating principle, and design, and differences in material and toggle body dimensions.
• Performance testing: "Dynamic tensile testing and Static testing to failure was performed on the device and a predicate. The device was found to have acceptable mechanical characteristics for the intended uses." This refers to biomechanical testing of the physical implant, not a study of AI/ML software performance.

Therefore, I cannot fulfill your request for the following information based on the provided document:

1. A table of acceptance criteria and the reported device performance (in the context of AI/ML).
2. Sample size used for the test set and data provenance (for AI/ML).
3. Number of experts used to establish ground truth and their qualifications (for AI/ML).
4. Adjudication method (for AI/ML).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done (for AI/ML).
6. If a standalone (algorithm only) performance study was done (for AI/ML).
7. The type of ground truth used (for AI/ML).
8. The sample size for the training set (for AI/ML).
9. How the ground truth for the training set was established (for AI/ML).

The document is solely about the clearance of a mechanical orthopaedic implant based on substantial equivalence to existing devices and standard mechanical testing.

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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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