(63 days)
The Synthes 5.0mm and 7.3mm Crimp Positioning Pins are intended for use with multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.
The 5.0mm Crimp Positioning Pins are designed for use in the 5.0mm locking or 4.5mm LCP holes of Synthes plates. The 7.3mm Crimp Positioning Pins are designed for use in the 7.3mm locking holes of Synthes plates.
The proposed 5.0mm and 7.3mm Crimp Positioning Pins are designed to fit into the screw holes of existing Synthes fixation plates for the purpose of providing a guide for Cerclage cable positioning as well as a crimping point for Cerclage cable tension fixation.
The Crimp Positioning pins are available in versions composed of implant quality stainless steel and titanium.
This document is a 510(k) premarket notification for the "Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins". It establishes substantial equivalence to predicate devices and describes the intended use and device characteristics.
However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory clearance document, not a clinical or performance study report. Therefore, I cannot complete the table or answer most of the questions as the requested information is absent from the provided text.
Here is what can be inferred or stated as not present:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
Study Details
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified in the document. This document is a 510(k) clearance, not a study report.
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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 specified in the document.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified in the document.
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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:
- No MRMC study was done, nor is this device an AI-based system. This is a medical implant, not a diagnostic or AI device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified in the document.
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The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. This is a physical medical device, not an AI model.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.