(57 days)
The GRYPHON X Anchor is intended for:
Shoulder: Biceps Tenodesis;
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, Medial Patellofemoral Ligament Reconstruction;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament
Reconstruction
The HEALIX TRANSTEND Anchor is intended for:
Shoulder: Rotator Cuff, Partial Thickness Rotator Cuff, Biceps Tenodesis, Acromio-Clavicular Separation, Deltoid Repair;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Mid-Foot Reconstruction, Hallux Valgus Repair, Metatarsal Ligament/Tendon Repairs;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique
Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Lateral Epicondylitis Repair;
Wrist: Scapholunate Ligament Reconstruction;
Hip: Capsular Repair, Acetabular Labral Repair
The subject devices of this Traditional 510(k) are the GRYPHON X Anchors and the HEALIX TRANSTEND Anchors.
The proposed GRYPHON X Anchor is suture anchor preloaded on a disposable inserter assembly and is intended for fixation of suture to bone for various orthopedic procedures. The proposed anchor will be available with various suture offerings: ORTHOCORD™ Suture, PERMACORD™ Suture, DYNACORD™ Suture, and PERMATAPE™ 1.3mm Suture, offered in either single strand or double strand configurations with needle attachments. The GRYPHON X Anchors are offered with either a push-in (“P”) or threaded (“T”) anchor design and are available in absorbable BIOCRYL RAPIDE (BR) (P and T anchors) or non-absorbable PEEK materials (P anchors only). The implant is supplied sterile, ready to use.
The proposed HEALIX TRANSTEND Anchor is a suture anchor preloaded on a disposable inserter assembly and is intended for fixation of suture bone for various orthopedic procedures. This proposed device will be loaded with either one or two strands of PERMATAPE 1.3mm Suture and will be offered in PEEK material only. The implant is supplied sterile ready to use.
The proposed GRYPHON X product portfolio also contains a reusable instrument sterilization tray with lid (sold separately) – it's intended to store and protect the reusable instruments during transport and sterilization
This document is an FDA 510(k) Premarket Notification for orthopedic bone fixation devices (suture anchors). It details the substantial equivalence of the GRYPHON™ X Anchor and HEALIX TRANSTEND™ Anchor to existing predicate devices.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Preamble: The document states that the FDA has reviewed the 510(k) and determined the device is "substantially equivalent" to legally marketed predicate devices. This means that, for the purpose of this FDA clearance, the new devices (GRYPHON X and HEALIX TRANSTEND anchors) are considered as safe and effective as the already-marketed predicate devices. The basis for this determination is laid out in the acceptance criteria and non-clinical testing section below.
Regarding the specific requirements for "device meets the acceptance criteria" as requested in your prompt, it's important to understand that for a 510(k) submission like this, the "acceptance criteria" are primarily defined by:
- Substantial Equivalence: Demonstrating that the new device has the same intended use and similar technological characteristics as a predicate device, or that any differences do not raise new questions of safety or effectiveness.
- Performance Testing: Providing data from non-clinical (and sometimes clinical, though not typically required for Class II 510(k)s unless new questions of safety/effectiveness are raised) tests to support the substantial equivalence claim.
Therefore, the "acceptance criteria" table below will reflect the comparative aspects and performance tests mentioned in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from 510(k) requirements and established by predicates) | Reported Device Performance (from "Non-clinical Testing" and "Safety and Performance" sections) |
|---|---|
| Technological Characteristics - Similarity to Predicate: |
- Anchor design
- Materials
- Principle of operation
- Intended use | The anchor design, materials, principle of operation, and intended use of the subject devices are identical to that of the predicate devices. The main differences are additional suture configurations and additional indications for use (GRYPHON X only), which are addressed by the non-clinical testing. |
| Performance - Fixation Strength: - At T=0 (initial fixation)
- Over healing period (for absorbable materials) | Verification activities included an assessment of fixation strength for proposed indications at T=0 and over the healing period (for absorbable configuration). The results demonstrated that the devices continue to meet established design inputs and corresponding criteria. |
| Performance - Insertion Force | Verification activities included an assessment of insertion force. The results demonstrated that the devices continue to meet established design inputs and corresponding criteria. |
| Performance - Fatigue Strength | Verification activities included an assessment of fatigue strength. The results demonstrated that the devices continue to meet established design inputs and corresponding criteria. |
| Performance - Needle Attachment Strength (for pre-loaded sutures) | Verification activities included an assessment of needle attachment strength for the pre-loaded sutures in scope of the submission. The results demonstrated that the devices continue to meet established design inputs and corresponding criteria. |
| Overall Safety and Effectiveness - No New Issues | Results of the analyses demonstrated that there were no new issues of safety or effectiveness related to device performance. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes used for the non-clinical testing (e.g., number of anchors tested for fixation strength, insertion force, etc.). It generally refers to "verification activities" and "analyses" demonstrating that the devices meet criteria.
The data provenance is non-clinical testing, performed to support product safety and performance, typically done in vitro (bench testing). The document does not provide details on the location/country of origin of this data or if it's retrospective or prospective, but for 510(k) non-clinical testing, it is always prospective, often conducted by the manufacturer or a contract research organization.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- For this type of 510(k) submission, there isn't a "ground truth" derived from expert clinical assessment in the same way as, for example, an AI/imaging device. The "ground truth" here is the established performance characteristics and safety profile of the predicate devices.
- Expert involvement for establishing ground truth (e.g., radiologists for imaging studies) is not applicable or described in this document for these mechanical orthopedic implants. The "experts" involved are likely engineers, material scientists, and regulatory affairs professionals who conducted and reviewed the bench testing against predefined engineering specifications and regulatory standards. Their specific number or qualifications are not specified in this summary.
4. Adjudication Method for the Test Set
- Since this is primarily non-clinical, bench testing, adjudication methods (like 2+1, 3+1 concensus for clinical interpretations) are not applicable. The device performance is measured against engineering specifications and industry standards for mechanical properties.
- Any "adjudication" would involve internal quality control and regulatory review processes, rather than interpretation of clinical data by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those that involve human interpretation of images (e.g., AI in radiology).
- The devices in this submission are mechanical orthopedic implants (suture anchors). Their effectiveness is proven through biomechanical testing (fixation strength, fatigue, etc.) and by demonstrating substantial equivalence to currently marketed devices, not through human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This question pertains to AI/software devices. The devices submitted are physical medical implants (suture anchors), not algorithms.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is implicitly established by engineering specifications, industry standards relevant to orthopedic implants, and the performance characteristics of the identified predicate devices.
- The tests performed (fixation strength, fatigue strength, insertion force, needle attachment strength) are benchmarked against what is considered acceptable for such devices on the market. The statement "Results of the analyses demonstrated that the devices continue to meet established design inputs and corresponding criteria" confirms this.
- There's no mention of pathology, outcomes data, or expert consensus in a clinical diagnostic sense being used as ground truth for this mechanical device.
8. The Sample Size for the Training Set
- Not applicable. This question is typically relevant for machine learning or AI models, which require training data. The devices in this submission are mechanical orthopedic implants. They do not involve "training sets" in the computational sense.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As explained in point 8, there is no "training set" for these mechanical devices.
§ 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.