(62 days)
The DePuy Rockwood Clavicle Pin is intended to be used to repair an acute fracture, mal-union or nc union of the clavicle.
The DePuy Rockwood Clavicle Pin consists of three sub-components, a pin and two nuts, and is provided pre-assembled. The clavicle pin has machine threads on one end and cancellous threads on the other end. The clavicle pin has a trocar point on the machine thread end and two nuts on the cancellous thread end. The pin is available in four diameters, 2.5, 3.0, 3.8 and 4.5mm, in one length, 152mm. The two locking nuts have slightly varying outer diameters. One nut is tightened on the pin to compress the fracture and prevent pin migration. The second nut is used to lock the first nut in place. The two sub-component nuts are also available separately.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
This 510(k) submission does not provide specific acceptance criteria or an analytical or clinical study demonstrating the device's performance against such criteria. Instead, it relies on the concept of substantial equivalence to predicate devices. This means that the manufacturer is asserting that their new device is as safe and effective as devices already legally marketed, without needing to conduct new performance studies.
Therefore, many of the requested categories will be "N/A" or "Not Applicable" because the basis for clearance is not through direct performance testing against acceptance criteria, but rather a comparison to existing devices.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| N/A (No specific performance criteria stated for this 510(k) submission as clearance is based on substantial equivalence to predicate devices.) | N/A (No performance data is presented against specific criteria. The submission focuses on demonstrating similarity to predicate devices in design, material, and intended use.) |
Supporting Study Details
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Sample size used for the test set and the data provenance: N/A - No specific test set for performance evaluation was conducted. The submission relies on existing marketing history and literature for predicate devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A - No ground truth established as part of a performance study.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A - No performance study or adjudication process mentioned.
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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: N/A - This device is a physical medical implant (clavicle pin), not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: N/A - This device is a physical medical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A - No ground truth was established for a new performance study. The "ground truth" for the substantial equivalence argument is implied by the established safety and effectiveness of the predicate devices. The document mentions "Published and unpublished literature documents the use of Hagie, modified Hagie, and Knowles pins in the treatment of clavicle fractures thereby justifying the use of the very similarly designed Rockwood Clavicle Pin in the clavicle." This suggests a reliance on existing clinical outcomes data and expert consensus reflected in the existing literature for the predicate devices.
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The sample size for the training set: N/A - This device is a physical implant; it does not involve machine learning or a "training set."
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How the ground truth for the training set was established: N/A - Not applicable for this type of device.
Summary of the Basis of Substantial Equivalence
The core of the submission for the DePuy® Rockwood™ Clavicle Pin is its demonstration of substantial equivalence to previously marketed predicate devices. The key elements presented for this argument are:
- Similar Design: The device is a trocar-pointed, threaded pin. A minor design difference (trocar point location) is highlighted as an advantage (medial or lateral insertion) that doesn't fundamentally change its function or raise new safety/effectiveness concerns compared to the predicates.
- Similar Material: All compared devices are made of 316L Stainless Steel.
- Similar Intended Use: All devices are intended for bone fixation of fractures, specifically for the clavicle (for the subject device) or generally for fractures (for the predicates). The use of predicate pins in clavicle fractures is supported by literature.
- Similar Product Code: All devices fall under the same regulatory product code (87 JDW).
The provided table explicitly lists these similarities across the Rockwood Clavicle Pin and several predicate devices (DePuy Hagie & Modified Hagie Pins, DePuy Tibia Bolt, Onyx Medical Corp. & O'Tec Corp. Hagie Pins, Syntec-Trichung Knowles Pin). The FDA's clearance letter confirms their agreement with the substantial equivalence claim.
§ 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.