(91 days)
The ATS SIMULUS™ Adjustable Flexible Annuloplasty Rings Model 735AF are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty rings provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.
The ATS SIMULUS™ Adjustable Flexible Annuloplasty Rings Model 735AF are implantable, adjustable flexible, annular rings (Figure II.1). The rings reduce and stabilize the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair. The body of the ring is made of tubular braided Polyester. The ring contains circumferential flexible radiopaque markers. The entire circumference of the ring is radiopaque. The rings are available in the following six sizes: 25 mm, 27 mm, 31 mm, 33 mm and 35 mm. The size refers to the inner circumference of the ring, trigone to trigone.
The provided text is a 510(k) summary for the ATS SIMULUS Adjustable Flexible Annuloplasty Ring Model 735AF. It describes the device, its intended use, and states that certain tests were conducted. However, it does not contain details about specific acceptance criteria or a study proving the device meets those criteria in the way typically expected for a software or AI-driven device performance study.
The document states:
- Testing Summary: "Testing included LAL, Sterility Validation, and Class VI Biocompatibility tests on the predicate device. Mechanical testing was carried out on complete modified rings and ring components. All test results were satisfactory."
This indicates that the testing performed was primarily related to the physical properties, sterility, and biocompatibility of the annuloplasty ring as a medical implant, rather than a performance study involving diagnostic accuracy or similar metrics.
Therefore, many of the requested details cannot be extracted from this document, as they pertain to a different type of device evaluation (e.g., for AI/software).
Here's a breakdown of what can and cannot be answered based on the input:
| Section | Information from Provided Text |
|---|---|
| 1. Table of Acceptance Criteria and Reported Device Performance | Cannot be provided in the requested format. The document states "All test results were satisfactory" for LAL, Sterility Validation, Class VI Biocompatibility, and mechanical testing. However, it does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic device) or numerical performance metrics for these tests. It simply confirms satisfactory completion. |
| 2. Sample size used for the test set and data provenance | Not applicable/Not provided. This device is a physical implant, not a data-driven system requiring a test set of data. The "tests" mentioned are physical and biological evaluations of the device itself. |
| 3. Number of experts used to establish ground truth and qualifications | Not applicable/Not provided. Ground truth, in the context of diagnostics, would typically be established by experts reviewing images, pathology, or clinical outcomes. For a physical implant, "ground truth" relates to its material properties and performance under stress, which are assessed through engineering and biological assays, not expert review of data. |
| 4. Adjudication method for the test set | Not applicable/Not provided. |
| 5. Multi-reader multi-case (MRMC) comparative effectiveness study | Not applicable/Not provided. This is relevant for diagnostic devices (especially imaging AI), not for an annuloplasty ring. |
| 6. Standalone (algorithm only without human-in-the-loop) performance | Not applicable/Not provided. This device does not have an algorithm. |
| 7. Type of ground truth used | Not explicitly stated as "ground truth" but implied for physical testing: Material specifications, known biological responses (for biocompatibility), engineering standards for mechanical strength, and sterility parameters. |
| 8. Sample size for the training set | Not applicable/Not provided. This device does not use a training set as it's not a machine learning model. |
| 9. How ground truth for the training set was established | Not applicable/Not provided. |
In summary, the provided K071214 document is a 510(k) summary for a physical medical device (an annuloplasty ring), not a diagnostic or AI-driven device. As such, the testing described focuses on the device's physical and biological integrity, sterility, and safety, rather than performance metrics related to data analysis or diagnostic accuracy. The document states that all conducted tests were "satisfactory," which is the equivalent of meeting acceptance criteria for this type of submission, but it doesn't provide the detailed quantitative criteria or results typical of a performance study for software/AI.
§ 870.3800 Annuloplasty ring.
(a)
Identification. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”