(60 days)
The Parcus GFS Naked are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The Parcus GFS Naked devices are designed for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The devices are made from medical grade titanium and are provided sterile.
The provided text does not contain detailed acceptance criteria or a study design that typically accompanies AI/CADe devices. This document describes a medical device, the Parcus GFS Naked, which is a physical implant (a smooth or threaded metallic bone fixation fastener). The information provided is a 510(k) premarket notification summary for this physical device, not an AI or software device.
Therefore, many of the requested categories (such as experts, adjudication methods, MRMC studies, standalone performance, ground truth for training data, etc.) are not applicable to this type of medical device submission.
However, based on the provided text, I can extract information related to the performance data and "acceptance criteria" through the lens of establishing substantial equivalence for a physical device.
Here's the information that can be extracted and how it relates (or doesn't) to your request:
Acceptance Criteria and Device Performance (Interpreted for a Physical Device)
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device: Performance characteristics (strength, elongation) of the Parcus GFS Naked devices must be comparable to the predicate devices (GFS II Standard, GFS II Large, and GFS Mini) to ensure similar safety and effectiveness for fixing ligaments and tendons. | Testing was conducted on worst-case configurations (implied across sizes to cover the range of the GFS Naked). Devices were evaluated for strength and elongation under cyclic loading and ultimate failure conditions. The results were compared with test data for the predicate device and demonstrated substantial equivalency. |
| Material Composition: Must be made from medical grade materials. | Devices are made from medical grade titanium. |
| Sterility: Must be provided in a sterile form. | Devices are provided sterile. |
| Biocompatibility: (Not explicitly stated as an acceptance criterion in this summary, but generally required for implants). | Implied by the use of medical-grade titanium and clearance through the 510(k) process for implants. |
Study Details (Interpreted for a Physical Device)
1. Sample sized used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number (e.g., "N=X devices"). The text states "Testing was conducted on the worst case configurations." This implies a selection of devices or conditions representing the most challenging scenarios for the device, but not a specific count of individual devices tested.
- Data Provenance: Not applicable in the context of patient data for AI. This refers to in-vitro mechanical testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a mechanical performance study of a physical implant, not a diagnostic or AI device where expert consensus on "ground truth" (e.g., disease presence) would be established.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this is a mechanical performance study.
4. 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 physical implant validation, not an AI assistance device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical implant. The "standalone" performance here refers to the device's inherent mechanical properties without human intervention during use, which was tested.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering Specifications and Predicate Device Data: The "ground truth" for this study is based on established engineering principles for mechanical strength and elongation, and critically, the previously established performance data of the legally marketed predicate devices. The goal was to show that the new device's performance aligns with these established benchmarks.
7. The sample size for the training set:
- Not Applicable. This is a physical implant study, not an AI device with a "training set."
8. How the ground truth for the training set was established:
- Not Applicable. As above, this is a physical implant.
In summary, the provided document is a 510(k) summary for a physical medical device. The "study" described is a mechanical performance testing regimen designed to demonstrate substantial equivalence to predicate devices based on properties like strength and elongation, not a clinical study involving patients or an evaluation of an AI algorithm.
§ 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.