(128 days)
The ConMed Linvatec CrossFT™ BC Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
The ConMed Linvatec CrossFT™ BC Suture Anchor is a device that is used to assist the surgeon in reattaching soft tissue to bone. The device includes anchors, manufactured of 96L/4D PLA co-polymer + β-TCP and two (2), or three (3) Hi-Fi® sutures manufactured of polyethylene and polypropylene. The device is bioabsorbable and is available in sizes between 4.5mm to 6.5mm diameter and 17mm lengths. A disposable driver is included to implant the suture anchor.
I am sorry, but the provided text does not contain the detailed information necessary to complete all sections of your request. The document is a 510(k) summary and FDA clearance letter for a medical device (suture anchor), which primarily focuses on substantial equivalence to predicate devices rather than a detailed study proving performance against specific acceptance criteria.
Here's what I can extract and what is missing based on the provided text:
Acceptance Criteria and Study Information for ConMed Linvatec CrossFT™ BC Suture Anchor
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (What did the device achieve) |
|---|---|
| Fixation strength | Verified and validated (specific quantitative results not provided) |
| Cyclic loading | Verified and validated (specific quantitative results not provided) |
| Insertion torque | Verified and validated (specific quantitative results not provided) |
| Material degradation | Verified and validated (specific quantitative results not provided) |
| Packaging/transportation qualification | Verified and validated (specific quantitative results not provided) |
The document states "The verification and validation testing of the ConMed Linvatec CrossFT™ BC Suture Anchor includes fixation strength, cyclic loading, insertion torque, material degradation and packaging/transportation qualification." However, it does not provide the specific quantitative acceptance criteria (e.g., minimum pull-out strength in Newtons, maximum displacement under cyclic loading) nor the numerical results obtained by the device for these tests.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical assessments). For a mechanical device like a suture anchor undergoing physical and material testing, the "ground truth" is established through standardized engineering and material science testing methods and reference standards. The document does not mention the use of human experts in this context.
4. Adjudication method for the test set
Not applicable in the context of purely physical/mechanical device testing as described.
5. 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 is a medical device for surgical implantation, not an AI or diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
For the mentioned tests (fixation strength, cyclic loading, insertion torque, material degradation, packaging/transportation qualification), the ground truth would be established by:
- Standardized Test Methods: Adherence to recognized ASTM, ISO, or other industry standards for mechanical testing of orthopedic implants and materials.
- Material Specifications: Compliance with established specifications for the raw materials (PLA co-polymer + β-TCP) and components (sutures).
- Predicate Device Performance: Comparison to the established performance characteristics of the predicate devices, as the basis for substantial equivalence.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not a machine learning algorithm.
Summary of Missing Information & Why:
The provided document is a 510(k) summary, which is a premarket notification to the FDA. Its primary purpose is to demonstrate "substantial equivalence" to legally marketed predicate devices, not to provide a detailed technical report of the device's performance against specific, quantitative acceptance criteria. While it states that "verification and validation testing" was performed, it does not disclose the specific numerical results of these tests or the exact acceptance criteria used. These details would typically be found in the full design history file or specific test reports, which are not part of the publicly available 510(k) summary. For mechanical devices, the "ground truth" is typically derived from engineering standards and material properties, rather than expert consensus or pathology in the clinical sense.
§ 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.