(167 days)
The Parcus PEEK CF Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The Parcus PEEK CF 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 Carbon Fiber Reinforced Polyetheretherketone (PEEK CF) and is available in sizes ranging from 7-12mm in diameter and 20-35mm in length.
The provided document is a 510(k) summary for a medical device (Parcus PEEK CF Interference Screw). It does not include information about AI/ML models, diagnostic performance, or studies involving human readers in the way typically associated with the requested criteria.
Therefore, most of the requested information, such as acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI, cannot be found in this document.
The document mainly focuses on demonstrating substantial equivalence to predicate devices through comparisons of material properties and mechanical performance.
Here's an attempt to answer the questions based only on the provided text, recognizing that it pertains to a physical medical device clearance, not an AI/ML diagnostic:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Equivalence: The new device's material (PEEK CF) should be substantially equivalent to materials in existing cleared devices (Parcus Titanium Interference Screws, Smith & Nephew PEEK Interference Screws, and other PEEK CF implants). | The Parcus PEEK CF Interference Screw is "essentially the same as the Parcus Titanium Interference Screws aside from the difference in material." The carbon reinforcement in PEEK CF is noted to have a clinical history of 20+ years without biocompatibility reactions. Several PEEK CF medical implants are already on the market (e.g., Zimmer Spine BAK® Vista® Radiolucent Interbody Fusion System and the Depuy Spine OCELOT™ Stackable Cage System). |
| Mechanical Performance Equivalence: Pull-out strength and insertion torque should be comparable to predicate devices. | "The pull out strength and insertion torque was measured for the smallest (7mm) and largest (12mm) Parcus PEEK CF Interference Screws as well as an intermediate size. Test results were compared to the results of the corresponding size of Parcus Titanium Interference Screws and demonstrated substantial equivalence." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions testing the "smallest (7mm) and largest (12mm) Parcus PEEK CF Interference Screws as well as an intermediate size." It does not specify the number of samples for each size or the specific provenance of the data (e.g., country of origin, retrospective/prospective). This was likely a mechanical bench test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a physical interference screw, not a diagnostic AI/ML system requiring expert ground truth establishment for a test set in that context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" here would be established mechanical engineering principles and testing protocols for pull-out strength and insertion torque, comparing the device's performance to established benchmarks or predicate device performance. It's based on mechanical testing data. The material equivalence is supported by biocompatibility data (implied, by referring to 20+ years of clinical use of carbon fibers and existing PEEK CF implants).
8. The sample size for the training set
Not applicable. This is not an AI/ML system.
9. How the ground truth for the training set was established
Not applicable.
§ 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.