(95 days)
The implants of the Activ Fuse range are intended for bone reconstruction of the ankle joint in adults including fractures fixation and arthrodeses of the ankle, distal tibia, talus and calcaneus.
The Activ Fuse range consists of plates and screws designed for bone reconstruction of the ankle joint in adults including fractures fixation and arthrodeses of the ankle, distal tibia, talus and calcaneus. The system includes a modular plate design for a lateral calcaneal extension. The Activ Fuse range will be provided non-sterile for sterilization by health care professionals prior to use, or provided sterile by gamma sterilization. Materials: Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3). Function: The implants of the Activ Fuse range are intended for bone reconstruction of the ankle joint in adults including fractures fixation and arthrodeses of the ankle, distal tibia, talus and calcaneus.
This document is a 510(k) Summary for the Activ Fuse range of orthopedic implants. It describes the device, its intended use, and substantial equivalence to predicate devices, focusing on non-clinical testing. It explicitly states that no clinical studies were performed.
Therefore, it is not possible to provide the requested information regarding:
- Acceptance criteria and reported device performance related to a study proving the device meets acceptance criteria. The document refers to engineering analysis and comparative static and dynamic tests, but not to a study with acceptance criteria in the context of AI/software performance or human-in-the-loop studies.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document centers on demonstrating substantial equivalence through non-clinical tests (engineering analysis, mechanical testing) rather than clinical performance or AI/software validation.
Here's a summary of what is available in the document regarding the device's evaluation:
1. Table of acceptance criteria and reported device performance:
The document doesn't present "acceptance criteria" and "reported device performance" in the context of a study proving the device meets the acceptance criteria as typically understood for AI/software or clinical trials. Instead, it discusses the safety and effectiveness of the medical device (implants) based on non-clinical testing.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance | Static and Dynamic Tests: "The analysis showed that the Activ Fuse range is as safe and as effective as the predicates." |
| Material Conformance | Material: Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3). Same material as predicate devices. |
| Biocompatibility/Safety | Endotoxin testing: Performed using LAL quantitative kinetic chromogenic method. |
| Functional Equivalence | Function: The implants are intended for bone reconstruction of the ankle joint in adults including fractures fixation and arthrodeses of the ankle, distal tibia, talus and calcaneus. (Similar to predicate devices). |
2. Sample sized used for the test set and the data provenance: Not applicable. The document discusses mechanical tests of physical devices, not a test set of data.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. The ground truth for mechanical testing is derived from engineering standards and physical measurements.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. "No clinical studies were performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is for a physical medical device (orthopedic implants), not software/AI.
7. The type of ground truth used: For the non-clinical tests, the "ground truth" would be the engineering and material specifications, and the results of standardized mechanical tests (e.g., strength, durability, fatigue).
8. The sample size for the training set: Not applicable. There is no training set for a physical implant device.
9. How the ground truth for the training set was established: Not applicable.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.