(134 days)
The Rockwood Clavicle Pin System is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
The Rockwood Clavicle Pin System offers various diameter and length stainless steel threaded pins with pre-loaded nuts. The devices are offered in 5" and 6" overall lengths where the 6" pin ranges in diameter from 2.5mm - 4.5mm and the 5" pin has a 2.5mm diameter.
The submission K103001 for the DePuy Rockwood Clavicle Pin describes the acceptance criteria and the study conducted to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Torque testing: | The new Rockwood Clavicle Pin performed equivalently to the predicate device during torque testing. Specific quantitative values for torque were not provided in the summary. The implied criterion is that the new device's torque resistance is not significantly worse than, and ideally equivalent to or better than, the predicate. |
| Bone model evaluations: | The new Rockwood Clavicle Pin performed equivalently to the predicate device in bone model evaluations. Specific performance metrics (e.g., pull-out strength, mechanical stability within the bone model) were not explicitly detailed in the summary, but the implied criterion is that its performance in a simulated bone environment is not inferior to the predicate. |
| Material Equivalence: (Implied) | The pins are stainless steel, matching the material of the predicate device. |
| Design Characteristics Equivalence: (Implied) | Design characteristics are the same among the various pins, differing only in diameter, threaded length, and overall length, and introducing a shorter 5" overall length in the 2.5mm configuration with corresponding scaled down thread lengths. The implied criterion is that the fundamental design principles and functional aspects remain consistent with the predicate. |
Study Details:
The submission describes a study to prove substantial equivalence:
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: Not explicitly stated. The summary refers to "torque testing" and "bone model evaluations," implying a series of tests, but does not provide the number of pins or bone models tested.
- Data Provenance: The tests were conducted internally by DePuy Orthopaedics, Inc. (manufacturer). The data is prospective, generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This type of information is not applicable to this submission. The "ground truth" here is established through engineering and mechanical testing against predefined performance criteria, rather than expert interpretation of medical images or clinical outcomes.
4. Adjudication Method for the Test Set:
This is not applicable. The assessment is based on quantitative measurements from mechanical and bone model tests against established criteria, not on subjective expert consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This study is for a medical device (bone fixation fastener), not an AI algorithm for diagnostic imaging.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, this is not relevant to the device being submitted. This device is a physical medical implant, not a software algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance demonstration is based on engineering performance specifications and comparative mechanical testing results against a predicate device. This includes:
- Physical measurements and experimental data from torque tests.
- Mechanical performance in controlled bone model environments.
- Material and design specifications.
8. The Sample Size for the Training Set:
Not applicable. This submission describes a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set, this question is not relevant.
§ 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.