(90 days)
The DePuy Interference Screw Systems are intended to be used to provide interference fixation of bone-patellar tendon-bone grafts in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction and of soft tissue grafts in ACL reconstruction.
The DePuy Interference Screw Systems are cannulated fully threaded cancellous bone screws available in three diameters (7, 8, and 9mm) in three lengths (20, 25,and 30mm), and manufactured from titanium alloy (DePuy Profile Round Head Interference Screw) and from Poly-L-lactic acid (DePuy Phantom Absorbable Interference Screw).
- Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical properties (specifically pull-out loads) comparable to previously cleared predicate devices for PCL reconstruction. | "Mechanical testing has shown that the mean pull-out loads of the Profile Round Head Interference Screws and the Phantom Absorbable Interference Screws are comparable to those published for the previously cleared Linvatec BioScrew indicated for interference fixation in PCL reconstruction." The submission states that the DePuy devices are "identical in design and materials" to their own previously cleared devices (K955733, K981670, K961234), with the only difference being the additional indication for PCL reconstruction. This implies that the design and material properties relevant to the new indication are sufficiently similar or demonstrated to be comparable through testing. |
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Sample Size for Test Set and Data Provenance:
The document does not specify the exact sample size used for the mechanical testing. The data provenance is not explicitly stated in terms of country of origin, but the testing was conducted to support a submission to the FDA (United States). The testing appears to be prospective, as it was conducted to demonstrate substantial equivalence for a new indication. -
Number of Experts and Qualifications:
Not applicable. This is a medical device submission based on mechanical testing and substantial equivalence, not a study requiring expert readers for image or data interpretation. -
Adjudication Method:
Not applicable for this type of submission. -
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This submission focuses on the mechanical equivalence of a new indication for a medical device through lab testing, not human performance with AI assistance. -
Standalone Performance:
Yes, a standalone performance assessment was conducted in the form of mechanical testing of the device's pull-out loads. The performance was assessed independently of human interaction during the test. -
Type of Ground Truth Used:
The "ground truth" in this context is the established mechanical performance (pull-out loads) of a legally marketed predicate device (Linvatec BioScrew) for PCL reconstruction, as presented in published literature. The DePuy devices' performance was compared against this established benchmark. -
Sample Size for Training Set:
Not applicable. This is a medical device submission based on mechanical testing and substantial equivalence. There is no "training set" in the context of an algorithm or AI. -
How Ground Truth for Training Set Was Established:
Not applicable, as there is no training set. The comparison was made against published data for a predicate device.
§ 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.