(88 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, 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 document describes a 510(k) premarket notification for the Parcus Titanium Interference Screw. This is a medical device, not an AI/ML powered device, so many of the questions related to AI/ML studies are not applicable. However, I can provide information based on the performance data presented for this physical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent pull-out strength to predicate devices | "results of the... pullout force demonstrated that there were no significant differences between the Parcus Titanium Interference Screw and the predicate devices." |
| Equivalent insertion torque to predicate devices | "results of the insertion torque testing... demonstrated that there were no significant differences between the Parcus Titanium Interference Screw and the predicate devices." |
| No significant differences in safety and effectiveness compared to predicate devices | "Any differences between the Titanium Interference Screw and the predicate devices are considered minor and do not raise questions concerning safety and effectiveness." (This is a general statement rather than a specific performance metric, but it reflects the overall acceptance for 510(k) clearance.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "the smallest (7mm) and largest (12mm) Parcus Titanium Interference Screws as well as an intermediate size" were measured, and "side by side comparisons were done with the predicate devices." However, the exact number of screws tested for each size or the specific number of predicate devices used for comparison is not provided.
- Data Provenance: The study was conducted by Parcus Medical, LLC for regulatory submission. The document does not specify the country of origin of the data beyond the manufacturer's location in Sturgeon Bay, WI, USA. This was likely a prospective in-vitro study designed to compare the new device to existing predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This question is not applicable as the study involved the physical testing of mechanical properties (pull-out strength and insertion torque) of a medical device, not an AI/ML algorithm requiring expert interpretation or ground truth labeling.
4. Adjudication Method
This question is not applicable as adjudication is typically used in clinical studies or for ground truth establishment in AI/ML tasks. The study involved direct mechanical measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This question is not applicable as the study involves a physical medical device, not an AI/ML system or human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the study involves a physical medical device, not an AI/ML algorithm. The performance described (pull-out strength, insertion torque) is inherent to the device itself.
7. The Type of Ground Truth Used
The "ground truth" for this study would be the objective mechanical measurements of pull-out strength and insertion torque. These are quantitative physical properties measured directly from the devices using established testing methods. Essentially, the "truth" is the measured value from the test equipment.
8. The Sample Size for the Training Set
This question is not applicable. The Parcus Titanium Interference Screw is a physical medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above.
§ 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.