(87 days)
The HAART 200 Aortic Annuloplasty Device is intended to correct annular dilatation and/or maintain annular geometry of the aortic valve in patients with bicuspid valve morphology with moderate to severe aortic insufficiency who are undergoing aortic valve repair due to symptoms or as part of a repair for an aortic root aneurysm.
The HAART 200 Aortic Annuloplasty Device is designed to reshape the bicuspid valve annulus to a symmetric 180° configuration, to create circular annular geometry, and to improve leaflet coaptation by bringing both cusps toward the midline of the valve. It consists of a titanium frame covered with polyester fabric that is sewn onto the frame using braided polyester suture. The device has a circular base geometry and two subcommissural posts positioned 180° apart around its circumference. The device is available in four sizes: 19, 21, 23, and 25 mm. The device is provided attached to a disposable holder by means of a single polyester suture. Twelve (12) polyester pledgets are provided with each HAART 200 Aortic Annuloplasty Device. Both the device and pledgets are provided sterile by gamma irradiation sterilization and are intended for single-use. The HAART 201 Instrument Set provides accessory instruments to facilitate proper sizing and implantation of the device.
This document is a 510(k) Premarket Notification from the FDA regarding the HAART 200 Aortic Annuloplasty Device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with acceptance criteria and a test set for an AI/ML device. Therefore, it does not contain the specific information requested in the prompt regarding acceptance criteria and study details for an AI/ML device.
However, I can extract the information provided about the clinical study conducted for the HAART 200 Aortic Annuloplasty Device, interpreting it as the "performance data" that proves the device meets certain clinical outcomes.
Here's an attempt to answer your prompt based on the provided text, while acknowledging the limitations due to the document's focus:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, pre-defined manner for clinical performance in the way an AI/ML device might. Instead, it reports clinical outcomes that demonstrate device safety and effectiveness.
| Performance Metric (Interpreted Acceptance Criteria) | Reported Device Performance |
|---|---|
| Patient Survival | 100% at 2 years |
| Recurrent Aortic Insufficiency (AI) | 26.7% of patients had > mild AI at 6 months (N=15) |
| 7.1% of patients had > mild AI at 2 years (N=14) | |
| Reduction in Aortic Insufficiency from Baseline | Baseline: 71.5% of patients had > mild AI |
| Serious Adverse Events (SAEs) | 9 serious adverse events reported |
| Reoperations for Recurrent AI | 2 reoperations for recurrent AI caused by long annular suture tail |
| Unanticipated Adverse Events | None reported |
2. Sample size used for the test set and the data provenance:
- Sample Size: 16 patients were implanted with the device.
- Data Provenance:
- Country of Origin: Not explicitly stated, but given the FDA context, it's likely to involve U.S. data or data from regions adhering to similar clinical trial standards.
- Retrospective or Prospective: Prospective. The document states: "A prospective, multi-centered, single-arm study was conducted..."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The assessment of aortic insufficiency was done by "transthoracic echocardiography (TTE)", but details about expert reviewers (e.g., number, qualifications, blinding) are absent. This document is not describing an AI/ML study directly.
4. Adjudication method for the test set:
- This information is not provided in the document. For instance, it doesn't mention how TTE readings were adjudicated if there were multiple readers.
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:
- No. This document describes a clinical study for a medical device (an annuloplasty ring), not an AI/ML algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This document is not about an AI/ML algorithm. It describes the performance of a physical medical device.
7. The type of ground truth used:
- The primary clinical ground truth appears to be patient outcomes and clinical assessments, specifically:
- Transthoracic Echocardiography (TTE) assessments for aortic insufficiency (AI) severity.
- Adverse Event reporting and follow-up.
- Survival data.
- Reoperation data.
8. The sample size for the training set:
- This is not applicable as this study is for a physical medical device, not an AI/ML algorithm that requires training data separate from a test set. The study describes a single-arm clinical trial (the "test set" in your prompt's context).
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above. There is no concept of a "training set" for an AI/ML algorithm in this document. Clinical outcomes were directly measured in the implanted patients.
§ 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.”