(76 days)
The DePuy Mitek Tibial Tapered Screw and Tibial Sheath are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.
The proposed INTRAFIX System consists of two components, a non-absorbable INTRAFIX Expansion Sheath and a non-absorbable INTRAFIX Expansion Screw. Also included within the system is the instrumentation to place devices and establish the tunnel. The device functions by establishing the tunnel and placing the expansion Sheath into the tunnel by the use of Sheath Inserter. This is followed by screwing an Expansion Screw into the Sheath expanding the Sheath which compresses the graft against the tunnel and creating fixation.
The provided text describes a 510(k) summary for the INTRAFIX® PEEK Tapered Screw, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than a separate clinical study with predefined acceptance criteria for the device itself. Therefore, the questions related to clinical study design, sample sizes, expert involvement, and ground truth for a device performance study are not directly applicable in the context of this 510(k) summary.
However, I can extract the information relevant to non-clinical testing which served as the "study" to demonstrate substantial equivalence, and interpret "acceptance criteria" as meeting the performance of the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance of Predicate Device) | Reported Device Performance (INTRAFIX® PEEK Tapered Screw) |
|---|---|
| Torque Capability (of predicate INTRAFIX® Tapered Screws) | Demonstrated equivalent Torque Capability |
| Pullout Strength (of predicate INTRAFIX® Tapered Screws) | Demonstrated equivalent Pullout Strength |
Note: The document states "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices." This implies that the PEEK Tapered Screw's performance in these non-clinical tests was comparable to or met the performance standards of the predicate devices. The exact numerical values for these metrics are not provided in this summary, but the conclusion is that equivalence was achieved.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified in the provided summary.
- Data provenance: Non-clinical testing. The country of origin and whether it was retrospective or prospective is not applicable or specified for this type of testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This was non-clinical engineering and mechanical testing, not a study requiring expert clinical ground truth.
4. Adjudication method for the test set
- Not applicable. This was non-clinical engineering and mechanical testing.
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. This is a medical device for orthopedic fixation, not an AI diagnostic or image analysis device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device for orthopedic fixation.
7. The type of ground truth used
- The "ground truth" for demonstrating substantial equivalence in this context was the established performance (e.g., torque capability, pullout strength) of the predicate devices.
8. The sample size for the training set
- Not applicable. This is a medical device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. This is a medical device; there is no "training set."
§ 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.