(26 days)
The GRYPHON BR Anchor is intended for:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair
The GRYPHON PEEK Anchor is intended for:
Shoulder: Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair
The Gryphon™ Anchor with Permacord™ is a suture anchor preloaded on a disposable inserter assembly intended for fixation of suture to bone. Gryphon Anchors are available in absorbable BR and non-absorbable PEEK materials. Permacord suture is non-absorbable. The Gryphon Anchor with Permacord suture is supplied sterile and is for single use only.
This looks like a 510(k) submission for a medical device, specifically a suture anchor, and not an AI/ML device. Therefore, the typical acceptance criteria and study design for AI/ML performance evaluation do not apply here.
The document describes the Gryphon™ Anchor with Permacord™ as a suture anchor preloaded on a disposable inserter assembly, available in absorbable BR and non-absorbable PEEK materials with non-absorbable Permacord suture.
Here's an analysis based on the provided text, focusing on the information available and noting where AI/ML specific criteria are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is not an AI/ML device, the "acceptance criteria" are not related to diagnostic accuracy metrics (e.g., sensitivity, specificity). Instead, they relate to safety and performance specifications for a medical implant like a suture anchor. The document states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance (e.g., pull-out strength, in-vitro testing) | "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use." |
| Material Equivalence | "The proposed Gryphon Anchors with Permacord suture have the same anchor materials and design as predicate Gryphon Anchors (K090124, K100012, K103712)." |
| Functional Equivalence | "The proposed device principal operation is the same as predicate Gryphon Anchors (K090124, K100012, K103712)." |
| Suture Equivalence | "The Permacord suture is the same suture as referenced in predicate Healix Advance ™ Anchor with Permacord™ (K133794)." |
The study that "proves" the device meets the acceptance criteria is described as "Verification activities were performed on the implant and / or its predicates. Testing assessments include pull out testing and in-vitro testing." This non-clinical testing demonstrated that the device is "substantially equivalent" to predicate devices.
2. Sample Size for Test Set and Data Provenance:
This information is not applicable as the described testing is non-clinical performance and material testing for a physical medical device, not an AI/ML diagnostic or predictive model. There isn't a "test set" in the context of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable. Ground truth, in the context of AI/ML, refers to clinically verified labels or outcomes. For a physical device, testing involves engineering and materials science experts conducting physical tests, not clinical evaluations of patient data for ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as points 2 and 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
This information is not applicable. MRMC studies are used to evaluate the impact of AI on human reader performance, which isn't relevant for a physical implant device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used:
For the performance testing, the "ground truth" would be the objective measurement of mechanical properties (e.g., maximum load at failure for pull-out strength) under controlled laboratory conditions, compared against pre-defined engineering specifications or predicate device performance. It is not expert consensus, pathology, or outcomes data in the AI/ML sense.
8. Sample Size for the Training Set:
This information is not applicable as there is no AI/ML algorithm being trained.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no AI/ML algorithm being trained.
In summary, the provided document describes a 510(k) submission for a physical medical device (suture anchor) and focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and material characterization. The concepts of acceptance criteria, test sets, ground truth, and studies as typically applied to AI/ML devices are not relevant to this submission.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.