(398 days)
The Tigon Medical Gryphon Anchor Line is made up of four families of soft tissue fixation devices: Tomahawk Anchor, Dual Anchor, Eye-Deal Anchor, and Tenodesis Anchors. The entirety of the gryphon anchor line is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff repairs, Bicep tenodesis.
Elbow, Wrist, and Hand: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair;
Knee: Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquus advancement), Iliotibial band tenodesis;
Foot and Ankle: Hallux valgus repairs, Medial or Lateral instability repairs/reconstructions, Achilles tendon repairs/ reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy
In addition to these indications, the Tenodesis Anchors, a sub family of the gryphon anchor line will also be indicated for:
Foot and Ankle: Flexor hallucis longus for Achilles tendon reconstructions, tendon transfers in the foot and Ankle
Knee: ACL Repair
Hand/Wrist: Carpometacarpal joint arthroplasty, carpal ligament reconstructions and repairs, tendon transfer in hand/wrist
The Tigon Medical Gryphon Anchor Line consists of four sub-families of suture anchors: Tomahawk anchors, Dual anchors, Tenodesis anchors, and Eye-Deal anchors. It consists of a range of anchors sizes between 3.75 mm diameter and 6 mm length to 10.5 mm diameter and 23 mm length. The Tomahawk Anchors, Dual Anchors, and Tenodesis anchors are made from VESTAKEEP® i4R PEEK per ASTM F2026 while the Eye-Deal Anchors are made from Ti6Al4V ELI per ASTM F136.
The anchors are available with many configurations of sutures and suture tapes or without suture. All the anchors in this system may be loaded with a combination of USP #2 suture cables and/or tape equivalent while the Dual Anchors and Tenodesis anchors may be loaded with a combination of USP 2 and USP 5 suture cables and/or tape equivalent.
All anchors are inserted with stainless steel inserters per ASTM F899. The shafts that are used with the Tomahawk anchors may be reprocessed and will be available sterile packed and attached to the anchor and suture.
The provided document describes the predicate device and the new device for a 510(k) submission, confirming substantial equivalence through non-clinical testing. However, it does not include the detailed acceptance criteria and a study proving the device meets those criteria in the format requested. Specifically, the document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing, indicating the new device performs "as well as or better than" the predicate. It lacks explicit numerical acceptance criteria for performance metrics beyond a comparative statement with the predicate.
Therefore, for aspects requiring quantitative acceptance criteria, specific study details (sample size for test set, data provenance, number and qualifications of experts, adjudication method, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training set), the information is not present in the provided text.
Based on the available information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study Proving Acceptance |
|---|---|---|
| Mechanical Strength: Device to be substantially equivalent or better than the predicate's mechanical strength. | The worst-case implant in the Tigon Medical Gryphon Anchor Line has a mechanical strength of 262.3 N, (compared to the predicate's 143.6 N). | Axial Pullout Strength testing per ASTM F543. |
| Fatigue Testing: Device to be substantially equivalent or better than the predicate for cyclic loading. | Up to 500 cycles were done from unloaded (5N) to loaded (60N) condition until failure, found to be substantially equivalent. | Fatigue Testing. |
| Insertion Performance: Device to be substantially equivalent to the predicate product. | Found to be substantially equivalent to the predicate product. | Insertion Performance Testing. |
| Sterilization Validation: Achieve an SAL of 10-6 for sterile components; EO Residual Testing, Sterility Testing, and Bioburden Testing conducted. | Sterilization Validation activities conducted including EO Residual Testing, Sterility Testing, and Bioburden Testing. Implants and one inserter type supplied sterile to assure an SAL of 10-6. | Sterilization Validation activities. |
| Endotoxin Levels: Continuously monitored on a lot-by-lot basis. | Endotoxin testing has been conducted and will be continuously monitored on a lot-by-lot basis. | Endotoxin testing. |
| Shelf-Life and Packaging Integrity: Demonstrated through accelerated and real-time testing. | Accelerated Shelf-Life Testing and Packaging Performance/integrity testing conducted; real-time shelf-life testing is ongoing. | Accelerated and real-time shelf-life testing, Packaging Performance/integrity testing. |
| Biocompatibility: Evaluated per ISO 10993-1. | Evaluated for biocompatibility according to ISO 10993-1. | Biocompatibility Summary. |
Missing Information Specifics:
The provided text focuses on demonstrating substantial equivalence to existing predicate devices through mechanical and other non-clinical testing. It explicitly states: "Mechanical testing has been done, including cyclical loading and tensile strength which demonstrated the proposed products met the acceptance criteria for the proposed indications." and "The device was found to be substantially equivalent to the predicate for maximum pullout strength per ASTM F543."
However, the document does not provide the following information from the input request:
- Sample size used for the test set and the data provenance: Not specified for any of the tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a medical device, not an AI/diagnostic software. The ground truth refers to performance against established engineering standards and predicate devices.
- Adjudication method for the test set: Not applicable for performance testing against engineering standards.
- 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 device is a physical medical implant (suture anchors), not an AI diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical tests, the ground truth is typically defined by established engineering standards (e.g., ASTM F543) and the performance of legally marketed predicate devices. For biocompatibility, it's ISO 10993-1.
- The sample size for the training set: Not applicable as this is a physical medical device and not an AI/ML model.
- How the ground truth for the training set was established: Not applicable.
§ 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.