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The Activ Ankle range is intended for the fixation of fractures, osteotomies and pseudarthroses of the distal and the diaphyseal fibula, the distal tibia and for the syndesmotic repair in adults.

The Activ Ankle range consists of plates with screws designed for fixation of fractures, osteotomies and pseudarthroses of the distal and the diaphyseal fibula, the distal tibia and for the syndesmotic repair in adults. Washers are also available for use with screws. The implants of the Activ Ankle range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. The instruments of the Activ Ankle range will be provided non sterile for sterilization by health care professionals prior to use. Single use kits (Initial A) contain implants and instruments, or instruments only. Materials: Titanium alloy Ti-6Al-4V ELI (conform to ASTM F 136 and ISO 5832-3).

This document is a 510(k) summary for the Activ Ankle range, which are metallic bone fixation appliances. It explicitly states that no clinical studies were performed to demonstrate that the device meets acceptance criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. Therefore, the detailed information requested regarding acceptance criteria based on human performance, sample sizes for test sets, expert ground truth adjudication, MRMC studies, and standalone algorithm performance cannot be provided from this document.

Here's what can be extracted regarding the non-clinical testing and the basis for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical studies were performed, there are no acceptance criteria related to human performance or device efficacy in a clinical setting. The "acceptance criteria" here relate to the non-clinical mechanical performance.

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

• Test set sample size: Not applicable for clinical performance. For mechanical tests, the specific number of devices tested is not detailed in this summary.
• Data provenance: Not applicable for clinical performance. The mechanical testing would have been conducted in a laboratory setting by Newclip Technics or a contracted lab.

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

Not applicable, as no clinical test set requiring expert ground truth was established.

4. Adjudication method for the test set:

Not applicable.

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 is a medical device for bone fixation, not an AI-powered diagnostic tool.

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

Not applicable.

7. The type of ground truth used:

Not applicable for clinical performance. For the mechanical tests, the "ground truth" would be the measured physical properties and performance metrics against established standards (ASTM F382) and comparison to predicate devices.

8. The sample size for the training set:

Not applicable, as this is not an AI/machine learning device requiring a training set.

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

Not applicable.

Summary of Device Substantiation:

The Activ Ankle range demonstrates its safety and effectiveness through substantial equivalence to existing legally marketed devices (predicates). This equivalence is based on similarities in:

• Intended use (fixation of fractures, osteotomies, pseudarthroses of specific ankle bones and syndesmotic repair).
• Design (plates with screws and washers).
• Materials (Titanium alloy Ti-6Al-4V ELI).
• Mechanical safety and performance, as confirmed by comparative static and fatigue bend tests (ASTM F382) and endotoxins testing.

The document explicitly states: "No clinical studies were performed." The conclusion of substantial equivalence is based on non-clinical comparative data against the identified predicate devices.

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The Activ Ankle Locking Plating System is intended for the fixation of fractures and pseudarthrosis of the distal and the diaphyseal fibula and for syndesmotic repair in adults.

The Activ Ankle Locking Plating System consists of a plate with many screws as holes (slots) designed for fixation of fractures, osteotomies and pseudarthrosis of the distal and diaphyseal fibula and for the syndesmotic repair in adults. The plates and screws are manufactured from titanium alloy and color anodized. Washers are also available for use with syndesmosis screws. The Activ Ankle Locking Plating System will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization.

This document describes the 510(k) premarket notification for the "Activ Ankle Locking Plating System," a medical device, and therefore does not contain information about software or AI-enabled insights, acceptance criteria, or study results in the context of AI/ML performance.

The document discusses the device's intended use, materials, and mechanical testing results to demonstrate substantial equivalence to predicate devices, as required for FDA 510(k) clearance.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, ground truth establishment, or multi-reader multi-case studies because this document is about a bone fixation device and does not involve AI or clinical performance studies of an AI algorithm.

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