(140 days)
Indications for use of the SD Trans-Osseous Fastening fractured bone fragments together while the fracture heals. This fastener is specifically useful in fastening split fractures, such as found in tibial buttress fractures.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "SD Trans-Osseous Fastener." This type of letter generally concerns regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria as would be found in a clinical study report or a premarket approval (PMA) application.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria. Specifically:
- A table of acceptance criteria and the reported device performance: Not present. The letter is a clearance for marketing, not a performance report.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- 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: This device is a trans-osseous fastener, a mechanical implant, not an AI diagnostic or assistance tool. Therefore, an MRMC study with AI assistance is not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present.
- The sample size for the training set: Not applicable for a physical medical device.
- How the ground truth for the training set was established: Not applicable for a physical medical device.
The letter explicitly states that the device is "substantially equivalent" to predicate devices, which is the basis for 510(k) clearance. This means that the device is deemed as safe and effective as a legally marketed device that existed prior to May 28, 1976 (or has been reclassified). The document is a regulatory approval, not a scientific study detailing performance metrics.
§ 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.