(24 days)
The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver is intended to reattach soft tissue to bone in orthopedic surgical procedures. The device 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 CrossFT™ Knotless Biocomposite Suture Anchors with Disposable Driver are sterile, single use devices. The CrossFT™ Knotless Biocomposite Suture Anchors with Disposable Driver are manufactured from polylactide copolymer (96L/4D PLA) and ß-Tricalcium Phosphate (ß-TCP). The anchors are provided sterile, single use and preloaded on a disposable driver. The anchors are available in three sizes and nine configurations.
This document is a 510(k) Pre-market Notification for a medical device, specifically a suture anchor, and not an AI/ML medical device. Therefore, the information requested about acceptance criteria, study design for AI/ML devices, ground truth establishment, and expert involvement is not applicable.
The document discusses the substantial equivalence of the "CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver" to a legally marketed predicate device. The performance data section outlines the types of engineering and biological tests conducted to demonstrate the device's reliability, strength, and safety, not the performance of an AI algorithm.
To directly answer your prompt based on the provided text, but with the understanding that this is not an AI/ML device:
1. A table of acceptance criteria and the reported device performance:
The document describes the types of tests performed but does not provide specific numerical acceptance criteria or reported performance values for each test. It states that testing was completed to demonstrate the device "performs as intended and is substantially equivalent to the predicate device."
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Reliability | Device consistently operates as designed. | Testing completed to show performance as intended. |
| Ultimate Fixation Strength | Sufficient strength to reattach soft tissue to bone. | Testing completed to show performance as intended. |
| Cyclic | Withstands repeated stress cycles without failure. | Testing completed to show performance as intended. |
| Sterilization | Achieves and maintains sterility. | Testing completed to show performance as intended. |
| Pyrogenicity | Meets endotoxin limits (non-pyrogenic). | Bacterial endotoxin testing met endotoxin limits. |
| Biocompatibility | Biologically compatible without adverse reactions. | Testing completed to show performance as intended. |
| Shelf-life | Maintains functionality and safety over its intended shelf life. | Testing completed to show performance as intended. |
| User Validation | Device is usable and effective by intended users. | Testing completed to show performance as intended. |
| Packaging | Maintains device integrity during storage and transport. | Testing completed to show performance as intended. |
| Transportation | Withstands transportation stresses. | Testing completed to show performance as intended. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the individual tests. The document only mentions "Completed testing includes the following" list.
- Data Provenance: Not specified. It's implied this is internal company testing, but no details on country of origin or retrospective/prospective nature of data are provided (as these are not relevant for a hardware/biomaterial device).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a hardware medical device (suture anchor), not an AI/ML diagnostic tool requiring expert interpretation for ground truth. Ground truth for this device would be established through engineering and biological test standards and measurements (e.g., tensile strength, material composition analysis, sterility testing results).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for establishing expert consensus on medical image interpretations or diagnoses, which is not relevant for the testing of a suture anchor.
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:
- No. This is not an AI/ML device. MRMC studies are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML device.
7. The type of ground truth used:
- The "ground truth" for this type of device is established through:
- Engineering test standards and specifications: e.g., defined strength requirements, material properties.
- Biological/Chemical test standards: e.g., endotoxin limits, biocompatibility standards.
- Functional performance assessments: e.g., how the device behaves during simulated use (reliability, cyclic loading).
8. The sample size for the training set:
- Not Applicable. This is a hardware medical device and does not have a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply. The device's performance is validated against established scientific and engineering principles, and industry standards for medical 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.