(302 days)
For fractures and osteotomies of the calcaneus, including, but not limited to
-extra-articular, intra-articular
-joint depression
-tongue type
-severely comminuted fractures
The LOQTEQ® VA Calcaneus Plate 3.5 is an anatomical, polyaxial angular stable, asymmetrical titanium plate (L/R version) for the treatment of calcaneus fractures. The shape of the plate is adapted to the lateral, anatomical shape of the calcaneus.
The polyaxial, angle-stable plate-screw-connection (VA technology) allows up to 15° angulating of the screws. Thus, the screws can be placed under the posterior articular facet into the sustentaculum tali, ensuring a stable supply of the fracture.
The provided text describes a medical device, the LOQTEQ® VA Calcaneus Plate 3.5, and its substantial equivalence to predicate devices, focusing on mechanical safety testing. However, it does not contain information relevant to the acceptance criteria and study proving device meets the criteria for an AI/ML powered medical device as requested in the prompt.
Specifically, the document discusses:
- Device Name: LOQTEQ® VA Calcaneus Plate 3.5
- Intended Use/Indications for Use: Temporary fixation, correction or stabilization of the calcaneus for fractures and osteotomies (extra-articular, intra-articular, joint depression, tongue type, severely comminuted fractures).
- Predicate Devices: Synthes Locking Calcaneal Plate (K991407 - Primary) and aap Bone Plate and Screw Implants (K072411).
- Testing Performed: Customized static and dynamic 3-point-bending tests of bone plates according to ASTM F2193 and ASTM F382, and mechanical testing for screws according to ASTM F543.
- Conclusion: The device functioned as intended, had similar results to predicate devices, and was found to be substantially equivalent.
The document does NOT contain any of the following information:
- A table of acceptance criteria and reported device performance (for an AI/ML device)
- Sample size used for the test set or data provenance
- Number of experts used to establish ground truth or their qualifications
- Adjudication method
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
- If a standalone (algorithm only) performance study was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set
- How the ground truth for the training set was established
Therefore, I cannot fulfill your request using the provided text. The document describes a traditional medical device (bone plate and screws) and its mechanical testing, not an AI/ML medical device.
§ 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.