(99 days)
The Contour 3D™ Ring is indicated for the reconstruction and/or remodeling of pathological tricuspid valves.
The Contour 3D™ Annuloplasty Ring, Model 690R, consists of a titanium core encapsulated with silicone and covered with polyester fabric. The titanium core enables radiographic visualization of the device. The Contour 3D™ Ring is for single-use only. It is available in six sizes for the tricuspid position: 26, 28, 30, 32, 34, and 36 mm. The device size is identified by the inside diameter of the ring at its widest point. The ring is marked at three (3) points by colored sutures. The three (3) markers correspond to the commissures of the tricuspid valve. The ring is packaged with a single annuloplasty ring assembled on a disposable holder.
The provided document describes the Medtronic Contour 3D™ Annuloplasty Ring, Model 690R. This document is a 510(k) Summary for a medical device and therefore focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with strict acceptance criteria and a detailed analysis of device performance against those criteria as would be found in a clinical trial for a novel AI device.
Therefore, many of the requested elements are not applicable or cannot be extracted from this type of regulatory submission. The device is a physical annuloplasty ring, not an AI/software device, so terms like "AI assistance," "training set," "test set," "multi reader multi case (MRMC)," and "effect size" are not relevant in this context.
Here's an analysis based on the information provided, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for an already existing device type (annuloplasty ring) being compared to a predicate device, the "acceptance criteria" are primarily related to general performance, safety, and equivalence to the predicate. Specific quantitative "reported device performance" metrics, as would be found for an AI model's accuracy, sensitivity, or specificity, are not provided. The performance data section broadly states that the device was subjected to verification and validation studies and that the results demonstrate the Contour 3D™ Ring is safe and effective.
| Acceptance Criterion (Implicit from 510(k)) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility: Device materials are safe for human implantation. | Testing confirmed biocompatibility in accordance with EN ISO 10993-1:2003. |
| Structural Integrity (Computational): The ring can withstand expected physiological forces. | Computational structural analysis was conducted. |
| Tensile Strength: The ring can endure pulling forces without breaking. | Testing confirmed tensile strength. |
| Suture Pull-out Strength: The ability of sutures to remain attached to the ring. | Testing confirmed suture pull-out performance. |
| Fatigue Resistance: The ring can withstand repeated stress cycles over time. | Testing confirmed fatigue resistance. |
| MRI Compatibility: Safe for use in MRI environments. | MRI compatibility testing was performed. |
| Radiopacity: Observable via X-ray for placement and monitoring. | Radiopacity testing was performed. |
| Sterilization Efficacy: The sterilization process renders the device sterile. | Sterilization validation was performed in accordance with EN ISO 17665-1:2006 and EN 556-1:2001. |
| Bioburden Control: Level of microorganisms on the unsterilized device. | Bioburden testing was performed. |
| Pyrogenicity: Absence of fever-inducing substances. | Pyrogen testing was performed. |
| Shelf Life Stability: Device maintains integrity and sterility over its shelf life. | Shelf life validation was performed. |
| Substantial Equivalence: Features and performance are comparable to the predicate device. | Review determined the device is substantially equivalent to the MC³ Tricuspid Annuloplasty System (K020864). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of patient numbers or specific units tested for each criterion. The testing would have involved a sufficient number of annuloplasty rings or simulated environments to statistically validate each performance characteristic.
- Data Provenance: The studies were conducted internally by Medtronic. The document does not specify country of origin for any physical test components or if any of the "bio-related" tests involved animal or human cadaveric data. All tests are considered retrospective laboratory or bench tests for device verification and validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For a physical medical device's verification and validation testing (e.g., tensile strength, fatigue), "experts" are typically engineers, material scientists, and quality assurance specialists. Their qualifications are inherent in their roles in designing and conducting such tests, following established regulatory standards (e.g., ISO, FDA guidance). There's no concept of "ground truth" derived from expert consensus in the way it applies to diagnostic image interpretation.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are common in clinical trials or studies where human interpretation of data (e.g., images for AI model validation) requires consensus. For physical device performance testing, results are typically objective measurements, not subjective interpretations 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 is a physical medical device, not an AI-assisted diagnostic tool. No human readers or AI assistance are involved in the performance testing described.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
For each performance test, the "ground truth" is the objective physical measurement or outcome. For example:
- Tensile Strength: The force at which the device breaks.
- Biocompatibility: Standardized assays measuring cellular response or toxicity.
- Sterility: Absence of microbial growth after incubation.
These are determined by established scientific methods and industry standards, not by expert consensus on clinical findings or pathological diagnosis in the context of patients.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model. There is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no training set, there's no ground truth for it.
§ 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.”