(55 days)
The Parcus GFS II and GFS Mini are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The Parcus GFS II and GFS Mini are designed for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The devices are made from Ultra High Molecular Weight Polyethylene (UHMWPE) and titanium. The GFS II and GFS Mini are provided sterile.
The provided text describes the Parcus GFS II and GFS Mini devices, which are suture retention devices intended for the fixation of ligaments and tendons. The information is from a 510(k) summary submitted to the FDA.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Strength | The device, when assembled with simulated grafts and subjected to cycle loading and ultimate failure conditions, must demonstrate sufficient strength and elongation properties to be substantially equivalent to the predicate device. This implies that the GFS II and GFS Mini should withstand similar forces and deformation as the predicate without premature failure, ensuring safe and effective ligament/tendon fixation. | "Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions. Results were compared with test data for the predicate device and demonstrated substantial equivalency." (This indicates that the GFS II and GFS Mini met the implicitly defined strength and elongation criteria by performing comparably to the predicate device under the specified test conditions.) |
| Elongation | The device, when assembled with simulated grafts and subjected to cycle loading and ultimate failure conditions, must demonstrate elongation characteristics comparable to the predicate device. This ensures the device maintains appropriate stability and does not stretch excessively during use, which could compromise fixation. | "Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions. Results were compared with test data for the predicate device and demonstrated substantial equivalency." (Similar to strength, the GFS II and GFS Mini were found to have comparable elongation to the predicate device, thus meeting the implicit criteria.) |
| Safety and Efficacy | The device must not raise any new concerns regarding safety or efficacy compared to the predicate device, even with new configurations. This is a general regulatory requirement for substantial equivalence. | "While the GFS II and GFS Mini are offered in more suture loop configurations than the predicate GFS device, testing has shown that this does not raise any concerns regarding the safety or efficacy of the device." (This explicitly states that despite design variations, no new safety or efficacy concerns were identified, supporting substantial equivalence.) |
| Biocompatibility | (Not explicitly stated as an acceptance criterion in the provided text, but implied as the device is made from UHMWPE and titanium, which are typically well-established biocompatible materials in medical devices.) | The devices are made from Ultra High Molecular Weight Polyethylene (UHMWPE) and titanium. (Suggests standard biocompatibility for these materials. No specific testing or results are mentioned, but use of these materials usually implies pre-established biocompatibility for such medical applications.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "testing was conducted on the worst case configurations." However, it does not specify the exact number of devices or "worst case configurations" tested.
- Data Provenance: The document does not explicitly state the country of origin of the data. It is a 510(k) submission to the FDA in the USA, implying the testing was performed in a manner compliant with US regulatory standards, likely in the USA or by a recognized testing facility. The data is retrospective in the sense that the testing was performed before submission for regulatory clearance, but it is not clinical data. It is mechanical test data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the provided document. The study described is a mechanical performance study comparing the new devices to a predicate device based on engineering specifications and test data, not a clinical study involving human patients or expert interpretation of diagnostic outcomes. Therefore, there is no "ground truth" established by experts in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Mechanical testing does not involve adjudication by experts. The results are quantitative measurements against predefined engineering standards or comparative values.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or clinical decision support systems where multiple human readers interpret cases with and without AI assistance. The provided document describes a mechanical device and its performance testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical medical implant (a suture retention device), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by engineering test standards and comparative data from the predicate device. The performance of the GFS II and GFS Mini was measured against these mechanical properties, and the "truth" was whether its measured strength and elongation were sufficiently similar to the predicate to establish substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. The document describes a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.