(90 days)
The Synthes 2.4 mm Cannulated Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodeses. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.
The Synthes 2.4 mm Cannulated Screw is a machined metallic screw with a cannulation that is self-tapping and self-drilling and that can be guided into position via a guidewire.
The provided text is a 510(k) summary for a medical device (Synthes 2.4 mm Cannulated Screw) seeking substantial equivalence to existing devices. It focuses on device description, indications for use, and a declaration of substantial equivalence.
It does not contain information on acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
Therefore, I cannot populate the requested tables and information based solely on the provided text. The document is a regulatory approval summary, not a technical performance study report.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific quantitative acceptance criteria or performance metrics are provided in the document. | No specific quantitative performance data is provided in the document. |
Other Requested Information (Not Present in Document):
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
- 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 provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
- 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 is not an AI/imaging device).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study is detailed.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
This document primarily serves to state that the device is "substantially equivalent" to other legally marketed devices, indicating it meets the same safety and effectiveness profile based on comparison rather than extensive de novo performance studies.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.