(90 days)
The Parcus GFS is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The Parcus GFS is a titanium implant assembled with #5 suture threaded through four holes. The loops created by this process vary in length from 10mm and are used to suspend the graft. The titanium portion of the assembly is supplied in sizes, Standard and Large, to accommodate tunnels of different diameters.
The provided text describes the Parcus GFS, a suture retention device, and its substantial equivalence to predicate devices, focusing on mechanical performance. However, the document does not contain details about acceptance criteria, the specific study design, or many of the specific information points requested in the prompt (e.g., sample sizes for test/training sets, expert qualifications, etc.). The information provided is primarily a 510(k) summary for regulatory approval.
Here's the information that can be extracted or inferred from the provided text, along with a clear indication of what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from "Substantially Equivalent") | Reported Device Performance |
|---|---|
| Mechanical properties (e.g., pull-out strength) comparable to predicate devices. | Pull-out strength for both Standard and Large GFS was measured. "Results of the pull-out testing demonstrated that the Parcus GFS is substantially equivalent to the predicate devices." |
Explanation of Inference: The core of a 510(k) submission for this type of device often revolves around demonstrating mechanical equivalence to legally marketed predicate devices. While explicit numerical acceptance criteria are not given, the statement "substantially equivalent" implies that the tested performance met the unstated, expected mechanical performance profile of the predicate devices.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: The testing was conducted by Parcus Medical, LLC as part of their 510(k) submission. The exact location of the testing is not stated, but the company is based in Sturgeon Bay, WI, USA. The data is retrospective in the sense that it's presented to justify an existing device for market approval, but it represents prospective testing performed specifically for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/not specified. The "ground truth" for this type of device is its mechanical performance (e.g., pull-out strength), which is measured objectively, not established by expert consensus.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication method: Not applicable. Mechanical test results do not involve adjudication by experts.
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:
- MRMC Study: No, this type of study is not relevant to a mechanical orthopedic device like the Parcus GFS, which is not an AI-powered diagnostic tool. The document describes mechanical testing, not a clinical study involving human readers or AI.
- Effect Size of AI Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Objective mechanical test results, specifically "pull-out strength."
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model that requires a training set. The "training" for such a device would be its manufacturing and quality control processes.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable. (See #8)
In summary, the provided document is a regulatory submission for a physical medical device (suture retention device) and describes its mechanical performance by comparing it to predicate devices. It does not involve AI, diagnostic imaging, or expert-driven evaluations as typically seen in studies for AI-powered medical devices. Therefore, much of the requested information is not present or relevant to this specific HWC/MBI product code.
§ 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.