(107 days)
The PROFILE 3D Ring is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.
The Profile 3D™ Annuloplasty Ring, Model 680R, consists of a titanium core overmolded with silicone and covered with polyester fabric. The ring must be implanted in the mitral position. The ring is marked at three points by colored sutures; two markers correspond to the trigones of the mitral valve and one identifies the midpoint of the device. The device size is identified by the inside diameter of the ring at its widest point. The titanium core enables radiographic visualization of the device.
The provided document describes a 510(k) premarket notification for the Medtronic Profile 3D™ Annuloplasty Ring, Model 680R. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria and performance metrics in the same way a PMA (Premarket Approval) would.
Therefore, many of the requested data points related to clinical studies, acceptance criteria, and specific performance metrics are not applicable or not available in this type of submission. The document explicitly states:
"The Profile 3D™ Annuloplasty Ring was subjected to verification and validation studies. These verification/validation studies demonstrate the modifications to the predicate device are appropriate and do not affect the intended use or performance of the device."
This indicates that the focus of the performance data was on engineering verification and validation (e.g., material testing, mechanical properties, biocompatibility) to ensure the new device performs similarly to the predicate, not on clinical performance against specific acceptance criteria for a diagnostic or treatment outcome.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided document for clinical performance. The 510(k) submission focuses on substantial equivalence to a predicate device. | Not explicitly stated in the provided document for clinical performance against specific metrics. The document states: "These verification/validation studies demonstrate the modifications to the predicate device are appropriate and do not affect the intended use or performance of the device." This implies performance was demonstrated to be comparable/equivalent to the predicate. |
Self-correction: For 510(k) submissions, acceptance criteria are generally focused on demonstrating that the new device is as safe and effective as the predicate, often through non-clinical testing (e.g., mechanical, biocompatibility) or comparison of design features. Specific clinical performance metrics with pre-defined acceptance criteria (like sensitivity, specificity, accuracy for a diagnostic device, or efficacy endpoints for a therapeutic device) are typically not included unless the device has significant technological differences or new indications for use that warrant clinical data. This document does not provide such details.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable / Not provided. The submission focuses on verification/validation studies, likely engineering tests, rather than a clinical test set with human subjects for performance evaluation against specific metrics.
- Data Provenance: Not applicable / Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable / Not provided.
- Qualifications of Experts: Not applicable / Not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable / Not provided.
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
- MRMC Comparative Effectiveness Study: Not applicable. This is a medical device (annuloplasty ring), not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: Not applicable. This is an implantable medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable / Not provided. For this type of device, "ground truth" typically refers to engineering specifications, material properties, and functionality consistent with the predicate device, demonstrated through non-clinical testing.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable / Not provided. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable / Not provided. This is not an AI/machine learning device.
Summary of Device and Performance Information from the Document:
- Device Name: Medtronic Profile 3D™ Annuloplasty Ring, Model 680R
- Intended Use: Reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.
- Predicate Device: CG Future® Annuloplasty System, Model 638R (K061127)
- Performance Data: The device was subjected to verification and validation studies to demonstrate that modifications to the predicate device are appropriate and do not affect the intended use or performance. These are likely engineering and biocompatibility tests rather than clinical outcome studies against specific performance metrics.
- Regulatory Conclusion: The FDA determined the device is substantially equivalent to the predicate device, allowing it to be marketed. This decision is based on a comparison of the new device to a legally marketed predicate, rather than an independent demonstration of safety and effectiveness through a new clinical trial with pre-defined acceptance criteria for performance.
§ 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.”