(30 days)
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.
The CONMED Argo Knotless® Anchor 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 tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.
The CONMED Argo Knotless® Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10⁻⁶. The threaded anchor and the suture eyelet are manufactured of PolyEtherEtherKetone (PEEK) material. Each size features a single use driver, a threaded anchor, suture eyelet, a 1.0mm UHMWPE Hi-Fi™, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. A maximum of six (6) Hi-Fi #2 suture, or 1.3mm Hi-Fi ribbon suture, or (2) two limbs of Hi-Fi tape, or one (1) bioresorbable reinforced implant can be threaded through the eyelet. The repair sutures are then tensioned and cleated on the driver cleat, if deemed necessary by the surgeon. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.
The provided FDA 510(k) clearance letter pertains to the CONMED Argo Knotless® Anchor, a medical device for reattaching soft tissue to bone. This document is a clearance letter, not a detailed study report. Therefore, it does not contain the level of detail typically found in a clinical study for AI/software devices. In particular, it does not include any information about AI or software, MRMC studies, or standalone algorithm performance. The acceptance criteria and performance data described relate to the mechanical and material properties of the physical medical device.
Here's an analysis of the provided information based on your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for each test. Instead, it indicates that "Testing has been completed to demonstrate that CONMED Argo Knotless® Anchor performs as intended and is substantially equivalent to the predicate device." The performance data is summarized by the types of tests conducted.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Insertion success | Testing completed successfully |
| Ultimate Pull Displacement Resistance | Testing completed successfully |
| Cyclic Loading performance | Testing completed successfully |
| Material/Biocompatibility | |
| Biocompatibility | In accordance with ISO 10993-1 and FDA# G95-1 |
| Pyrogen (Bacterial Endotoxin) | Testing completed successfully |
| Sterilization & Packaging | |
| ETO Sterilization to SAL of 10⁻⁶ | Device sterilized via Ethylene Oxide Sterilization - SAL (10⁻⁶) |
| Shelf-life validation | Testing completed successfully |
| Packaging integrity (Transportation) | Testing completed successfully |
| Packaging and Labeling User Validation | Testing completed successfully |
| User Interaction | |
| User Validation | Testing completed successfully |
2. Sample size used for the test set and the data provenance
The document does not specify specific sample sizes for any of the performance tests (e.g., insertion, pull displacement, cyclic loading).
The data provenance is from CONMED Corporation, the manufacturer, as part of their 510(k) submission. These are typically retrospective in the sense that the device has been manufactured and tested, and the results are then compiled for the submission. The tests are likely performed in a controlled laboratory or testing facility setting and do not involve human patient data in the context of device performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is generally applicable to AI/software performance where ground truth is established by human experts. For this physical device, the "ground truth" for mechanical properties is established through engineering standards and validated test methods. Therefore, experts would be engineers and technicians familiar with these standards and methods, but the document does not specify their number or qualifications beyond their implied role in executing the listed tests.
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 typically used in clinical studies to resolve discrepancies in expert interpretations (e.g., radiology reads). For physical device performance testing, the results are typically quantitative and objective, measured against established engineering specifications, rather than subject to expert interpretation requiring adjudication.
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 physical medical implant, not an AI or software device. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant to this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As noted above, this clearance is for a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance of this physical device is based on engineering specifications, industry standards (e.g., ISO 10993-1 for biocompatibility), and validated test methods. These tests establish whether the mechanical properties (insertion, pull displacement, cyclic loading) and material properties (biocompatibility, pyrogenicity) meet predetermined safety and performance benchmarks for orthopedic implants.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no "training set" for a physical medical device, this question is not relevant.
§ 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.