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510(k) Data Aggregation
(83 days)
SYNTHES (USA) CALVICLE HOOK PLATE
Intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.
Synthes Clavicle Hook Plate is an anatomically designed L-shaped plate featuring a distal joint bridging hook with a rounded end. The shaft of the plate contains either dynamic compression screw holes or LCP plate holes. The plates accept 3.5 mm cortex, 4.0 mm cancellous and 3.5 mm locking screws (LCP Clavicle Hook Plate only).
The provided text is a 510(k) summary for a medical device, the Synthes Clavicle Hook Plate. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (i.e., a performance study with metrics like accuracy, sensitivity, specificity, etc., typically associated with AI/software devices or diagnostic tools).
This document demonstrates "substantial equivalence" to predicate devices, which is a regulatory pathway for medical devices that are similar to devices already on the market. This typically involves comparing design specifications, materials, and intended use, rather than conducting new performance studies that generate specific metrics like those requested.
Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.
Here's what can be inferred or stated based on the text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. | Not applicable. |
| (No specific performance criteria or metrics (e.g., accuracy, sensitivity) are mentioned. The acceptance criteria for a 510(k) for this type of device typically revolve around demonstrating substantial equivalence to a predicate device in terms of design, materials, and intended use.) | (No specific performance metrics are reported other than the device being "substantially equivalent" to predicate devices.) |
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. No performance study with a test set is described. The approval is based on substantial equivalence to predicate devices, not on a new clinical 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. No performance study with ground truth established by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No performance study with a test set is described.
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 device is a metallic bone fixation appliance, not an AI or diagnostic tool where MRMC studies would typically be performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a metallic bone fixation appliance, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No performance study requiring ground truth is described.
8. The sample size for the training set:
Not applicable. This device is a metallic bone fixation appliance, not an AI or data-driven device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This device is a metallic bone fixation appliance, not an AI or data-driven device that requires a training set.
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