(44 days)
The Healix BR and Gryphon BR Anchors are intended for:
Shoulder: Rotor 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.
The Healix BR and Gryphon BR Anchors are absorbable threaded suture anchors manufactured of "Biocryl Rapide" material. The threaded anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The Healix BR Anchor is provided in three sizes: one with an outer diameter of 4.5mm. another with an outer diameter of 5.5mm and the third with an outer diameter of 6.5mm. The Gryphon BR Anchor is provided as size 3.0mm. The suture options may or may not include tapered needles to facilitate suture passage through tissue. The Healix BR and Gryphon BR Anchors are currently offered with absorbable Panacryl, non-absorbable Ethibond or partially absorbable Orthocord suture options.
1. Acceptance Criteria and Reported Device Performance:
The document provided does not specify explicit acceptance criteria for device performance based on quantitative metrics. Instead, the "Safety and Performance" section states: "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices." This implies that the acceptance criteria were met by demonstrating substantial equivalence to pre-existing, legally marketed devices.
Therefore, the table would reflect this:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K071481, K070925, K071177, K032717, K060830) in terms of safety and performance for stated indications. | Demonstrated substantial equivalence to predicate devices based on performance and safety testing. |
2. Sample Size and Data Provenance:
The document does not provide details on the sample size used for any specific tests or studies. It also does not specify the provenance (e.g., country of origin, retrospective/prospective) of any data used for testing. The statement is general, referring to "performance and safety testing."
3. Number and Qualifications of Experts for Ground Truth:
This information is not provided in the document. The substantial equivalence claim is against predicate devices, not based on expert-established ground truth on a new dataset.
4. Adjudication Method:
This information is not provided in the document. As no specific "test set" with ground truth established by experts is mentioned, adjudication methods like 2+1 or 3+1 are not applicable here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. The submission focuses on substantial equivalence to predicate devices rather than direct comparative effectiveness with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
This information is not applicable as the device is a physical bone anchor, not an algorithm or AI-based system. Therefore, an "algorithm only" performance study would not be relevant.
7. Type of Ground Truth Used:
The concept of "ground truth" as typically applied in AI/software evaluation (e.g., expert consensus, pathology, outcome data) is not directly relevant here. The "ground truth" in this context is implicitly the established safety and performance profile of the predicate devices to which this device is compared for substantial equivalence.
8. Sample Size for the Training Set:
This information is not applicable as the device is a physical bone anchor and does not involve AI or algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as the device is a physical bone anchor and does not involve AI or algorithms that require a "training set."
§ 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.