(207 days)
Synthes Wire Mount is intended for use with cerclage wire to augment fracture stabilization with plates when use of screws is contraindicated, as in the presence of intramedullary implants.
The design is a "T" post with a hole perpendicular to the post axis, and a small triangular ridge on the bottom. Placing the post through the dynamic compression screw hole, inserting from the bone side of the plate, creates a stable structure for cerclage wire fixation. The cerclage wire is passed around the bone, through the Wire Mount hole above the outer surface of the plate, and then twisted with the opposite wire end. The device is designed for use in dynamic compression screw holes that accept a 4.5 mm bone screw. The Wire Mount is manufactured from 316L stainless steel.
This document is a 510(k) summary for a medical device called the "Synthes Wire Mount," which sounds like a physical implant rather than a software or AI-driven diagnostic device. Therefore, most of the requested information regarding acceptance criteria, study types (MRMC, standalone), expert involvement, ground truth, and training sets is not applicable to this type of device and document.
However, I can extract the relevant information presented in the document based on its context as a medical device submission.
Here's a breakdown of what can be inferred and what is not applicable:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Equivalence to Synthes Cerclage Wire in augmenting fracture stabilization with plates. | Synthes Wire Mount (with cerclage wire) is at least equivalent to Synthes Cerclage Wire. |
| Intended use in dynamic compression screw holes that accept a 4.5 mm bone screw. | Designed for use in dynamic compression screw holes that accept a 4.5 mm bone screw. |
| Compatibility with various Synthes plates (e.g., DHS, DCS, Condylar Buttress, Cobra Head, Hook, 4.5 mm Narrow, Broad DCP, 90° Child and Adolescent Osteotomy, 110 - 130° Adult Osteotomy, 95° Condylar, and 130° Angle Blade Plates). | Can be used with listed plates. |
| Manufactured from 316L stainless steel. | Manufactured from 316L stainless steel. |
Explanation: The document strongly implies that the acceptance criterion is demonstrating "equivalence" to an existing, predicate device (Synthes Cerclage Wire). The "reported device performance" is the direct statement from the document that this equivalence has been met based on testing. Other criteria are related to material and compatibility.
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 / Not Provided. This document describes a physical medical device. The "test set" would likely refer to engineering or biomechanical testing, not a diagnostic dataset. The document states "results of the testing of both devices" but does not provide details on sample size, study design (e.g., prospective vs. retrospective), or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a physical device like this, "ground truth" would not be established by medical experts in the way it is for diagnostic AI. Performance is typically evaluated through engineering tests, biomechanical studies, or potentially animal/cadaveric studies (though no details are provided here).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This concept is relevant for reconciling expert opinions in diagnostic studies, not for the evaluation of a physical implant.
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. MRMC studies are for evaluating the impact of AI on human diagnostic performance. This document concerns a physical orthopedic implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This criterion applies to AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable / Not Provided. As discussed, "ground truth" in this context would likely be defined by the results of mechanical tests (e.g., tensile strength, fatigue life), or functional performance in a simulated or ex vivo environment. The document only states "results of the testing" without further detail.
8. The sample size for the training set:
- Not Applicable. This applies to AI models.
9. How the ground truth for the training set was established:
- Not Applicable. This applies to AI models.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized figure inside. A registered trademark symbol is located to the right of the word.
953777
Summary of Safety and Effectiveness Information Attachment VII: [510(k) Summary]
SYNTHES (USA) 1690 Russell Road Paoli, PA 19301
(610) 647-9700 Contact: Angela Silvestri August 11, 1995
Device: Synthes Wire Mount is compared to Synthes Cerclage Wire.
Synthes Wire Mount is intended for use with cerclage wire to augment fracture stabilization with plates when use of screws is contraindicated, as in the presence of intramedullary implants. The design is a "T" post with a hole perpendicular to the post axis, and a small triangular ridge on the bottom. Placing the post through the dynamic compression screw hole, inserting from the bone side of the plate, creates a stable structure for cerclage wire fixation. The cerclage wire is passed around the bone, through the Wire Mount hole above the outer surface of the plate, and then twisted with the opposite wire end.
The device is designed for use in dynamic compression screw holes that accept a 4.5 mm bone screw. Among the plates the Wire Mount (and cerclage wire) can be used with include, but are not limited, to Dynamic Hip Screw (DHS), Dynamic Condylar Screw (DCS), Condylar Buttress, Cobra Head, Hook, 4.5 mm Narrow, Broad Dynamic Compression (DCP), 90° Child and Adolescent Osteotomy, 110 - 130° Adult Osteotomy, 95° Condylar (including small stature plates) and 130° Angle Blade Plates (including small stature plates). The Wire Mount is manufactured from 316L stainless steel.
Synthes Cerclage Wire is a straight wire that is also intended to augment fracture stabilization with plates when use of screws is contraindicated, e.g., in the presence of intramedullary implants. Among the plates the Cerclage Wire can be used with include, but are not limited to, DHS, DCS, Condylar Buttress, Cobra Head, Hook, 4.5 mm Narrow, Broad DCP, 90° Child and Adolescent Osteotomy, 110 - 130° Adult Osteotomy, 95° Condylar (including small stature plates), and 130° Angle Blade Plates (including small stature plates). It is also manufactured from 316L stainless steel,
Synthes Wire Mount (with cerclage wire) is at least equivalent to Synthes Cerclage Wire, based on the results of the testing of both devices.
§ 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.