(161 days)
The Parcus Titanium Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair
The Parcus Titanium Interference Screw is a cannulated, threaded, tapered fastener for use in interference fixation of ligaments and tendons in patients requiring ligament or tendon repair. The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136) and is available in sizes ranging from 7-12mm in diameter and 20-35mm in length.
The provided text pertains to the 510(k) premarket notification for the "Parcus Titanium Interference Screws." This is a medical device for orthopedic fixation, specifically for ligaments and tendons. The document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than a study evaluating the performance of a diagnostic AI device against acceptance criteria. Therefore, most of the requested information regarding AI device-specific acceptance criteria and studies (such as MRMC studies, human-in-the-loop performance, expert qualifications for ground truth, sample sizes for training/test sets concerning AI, etc.) is not applicable to this document.
However, I can extract information related to the device's performance testing where described, as it serves a similar purpose to acceptance criteria demonstration for physical medical devices.
Here's an analysis based on the closest applicable information in the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Pull-out Strength | Demonstrated no significant differences compared to competitive devices (based on K083619 submission). |
| Insertion Torque | Demonstrated no significant differences compared to competitive devices (based on K083619 submission). |
| Pyrogenicity (LAL testing) | Concluded that the device does not raise any additional concerns regarding pyrogenicity. |
| Substantial Equivalence (to Predicate Device K083619) | Determined to be the exact same device as the predicate, with the only changes being the inclusion of MR Conditional parameters into the Instructions for Use. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document mentions that pull-out strength and insertion torque were measured for the smallest (7mm), largest (12mm), and an intermediate size of the Parcus Titanium Interference Screws. The exact number of samples for each size is not specified in this document.
- Data Provenance: The performance data for pull-out strength and insertion torque is referenced as being included with the submission of K083619 (the predicate device). This suggests the performance data was likely generated through in-vitro mechanical testing. The country of origin for this data is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - This medical device is a physical fixation screw, not an AI diagnostic device. Ground truth as typically understood for AI studies (e.g., expert consensus on image interpretation) is not applicable here. The "ground truth" for this device's performance would be the direct measurements of mechanical properties.
4. Adjudication method for the test set
N/A - As above, adjudication methods for expert disagreement on ground truth are not applicable to the mechanical testing of a physical medical device.
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
N/A - This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A - This is not an AI algorithm.
7. The type of ground truth used
For the mechanical performance testing (pull-out strength, insertion torque), the ground truth is the direct physical measurement of these properties, likely using laboratory equipment. For pyrogenicity, the ground truth is established through LAL testing laboratory results. For substantial equivalence, the "ground truth" is the physical and functional characteristics of the device itself compared to a legally marketed predicate device.
8. The sample size for the training set
N/A - This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
N/A - As above, no training set for an AI model.
§ 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.