(115 days)
Airlock® osteosynthesis plate systems are indicated for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric patients.
Airlock® osteosynthesis plate systems are bone fixation devices intended to be permanently implanted. Plates are designed with different shapes and are made of Titanium (Alloy Ti-6Al-4V ELI). The system uses either 3mm or 3,5mm locking and non-locking screws. The drill hole are aligned to make sure there is no risk of conflict between the screws. The plates vary essentially through different curvatures, lengths, number of holes and shape.
This document is a 510(k) premarket notification for the "Airlock® osteosynthesis plate system." It's a review by the FDA to determine substantial equivalence to a legally marketed predicate device, not a study proving device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving it cannot be extracted from this document, as it outlines regulatory approval based on equivalence rather than detailed performance study results.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not applicable. This document is a 510(k) summary for regulatory clearance, not a performance study report with acceptance criteria and measured performance. It states that the device has "similar technological characteristics" and "mechanical characteristics" to the predicate device, implying equivalence rather than direct performance measurement against specific acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document does not detail a test set sample size or data provenance from a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This document does not describe a process for establishing ground truth using experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document does not describe an adjudication method for a test set.
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 document is for a mechanical medical device (osteosynthesis plate system), not an AI-assisted diagnostic device. Therefore, an MRMC study with human readers and AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document is for a mechanical medical device (osteosynthesis plate system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. This document does not describe the establishment of a ground truth for a performance study. The approval is based on substantial equivalence to a predicate device, supported by material and mechanical properties comparisons.
8. The sample size for the training set
Not applicable. This document does not describe a training set as it pertains to a mechanical medical device and regulatory clearance based on equivalence.
9. How the ground truth for the training set was established
Not applicable. This document does not describe a training set or its ground truth establishment.
§ 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.