(24 days)
The CrossFix® II Meniscal Repair Device is intended for approximation of soft tissue in meniscal repair procedures.
The CrossFix® II Meniscal Repair device is a sterile hand-held, manually operated, single procedure suture placement system for meniscus soft tissue approximation procedures.
The provided text describes the CrossFix® II Meniscal Repair Device, its intended use, and a summary of performance tests conducted. However, it does not contain a detailed study proving the device meets specific acceptance criteria with the level of detail requested in the prompt. The text references "predetermined acceptance criteria" for bench testing but does not list them or provide quantitative results in the form of a table.
Therefore, the following information is extracted from the document, and where specific details are not available, it is noted.
Acceptance Criteria and Device Performance Study for CrossFix® II Meniscal Repair Device
The CrossFix® II Meniscal Repair Device underwent performance tests in a simulated use environment and bench testing to demonstrate its functionality and strength.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly quantified in text) | Reported Device Performance |
|---|---|---|
| Simulated Use Environment | Device insertion, deployment, and removal functionality | Validated |
| Bench Testing | Suture knot pull out force (specific value not reported) | Meets predetermined criteria |
| Suture tensile strength (specific value not reported) | Meets predetermined criteria | |
| Suture diameter (specific value not reported) | Meets predetermined criteria | |
| Handle deployment force (specific value not reported) | Meets predetermined criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the simulated use environment testing or bench testing (e.g., number of devices, number of sutures tested). The data provenance is implied to be from in-vitro bench testing and simulated use, without information on country of origin or whether it's retrospective/prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The "ground truth" for the performance tests would be the established engineering and functional specifications for the device.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The performance tests appear to be quantitative measurements against engineering specifications rather than expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The document focuses on the device's functional performance and equivalence to predicate devices, not on human reader performance with or without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This is not applicable to a mechanical medical device like the CrossFix® II Meniscal Repair Device, which is a suture placement system. There is no algorithm involved in its direct operation.
7. Type of Ground Truth Used
The "ground truth" for the device's performance is based on engineering specifications and predetermined acceptance criteria for mechanical properties (suture knot pull out force, tensile strength, diameter, handle deployment force) and functional operation (insertion, deployment, removal).
8. Sample Size for the Training Set
This is not applicable, as there is no "training set" in the context of this mechanical device's performance validation. The device doesn't involve machine learning or AI that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.