(27 days)
The ConMed Linvatec Soft Tissue to Bone System 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 Soft Tissue to Bone System includes anchors in a range of sizes and materials from 3.5 mm to 6.5 mm diameter and 15 mm to a 17 mm length with one (1) to three (3) non-absorbable suture configurations. The anchor sizes correspond to a series of general surgical instruments such as; bone taps, bone punches, drivers, and a suture passer.
This 510(k) premarket notification for the ConMed Linvatec Soft Tissue to Bone System indicates that substantial equivalence was demonstrated without a clinical study. The submission focuses on comparing the new device to legally marketed predicate devices based on design, manufacturing materials, intended use, principles of operation, and technical characteristics.
Therefore, many of the requested categories related to clinical study design and performance metrics cannot be filled.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (No specific performance criteria tied to a clinical study are mentioned in this 510(k). The focus is on substantial equivalence to predicates based on design and materials.) | Substantially equivalent to predicate devices (LM Bone Anchor, ThRevo® Anchor, ConMed Linvatec Bio Mini-Revo®) in design, manufacturing materials, intended use, principles of operation, and technical characteristics. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No clinical test set data is provided in this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No clinical test set data or ground truth establishment by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set, and therefore no adjudication, is mentioned.
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 device is a medical implant (soft tissue to bone system), not an AI diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a medical implant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No clinical ground truth was established for this submission, as it relies on substantial equivalence to predicates.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of this device's submission, as it is a physical implant and not an AI or algorithm-based device.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no ground truth establishment for one.
Summary of Device and Acceptance:
The ConMed Linvatec Soft Tissue to Bone System is a nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures. The acceptance of this device by the FDA (as indicated by the 510(k) clearance K091549) was based on its substantial equivalence to three legally marketed predicate devices:
- LM Bone Anchor (renamed ConMed Linvatec Ultrafix RC®) (K963812)
- ThRevo® Anchor, Disposable Driver, Hi-Fi™ Sutures (K073481)
- ConMed Linvatec Bio Mini-Revo® (K053561)
The FDA determined that the new device is substantially equivalent to these predicates in its design, manufacturing materials, intended use, principles of operation, and technical characteristics. Therefore, no new clinical studies or performance data were required or submitted to demonstrate its safety and effectiveness beyond this comparison to already cleared devices.
§ 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.