(90 days)
The HAART 300 Aortic Annuloplasty Device is intended to correct annular dilatation and/or maintain annular geometry of the aortic valve in patients with tri-leaflet 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 300 Aortic Annuloplasty Device is designed to return aortic annular geometry toward normal for a given leaflet size and to assist in producing adequate leaflet competence by recovering normal coaptation geometry and area. It consists of a titanium frame covered with polyester fabric that is sewn onto the frame using braided polyester suture. The device has an elliptical base geometry and three subcommissural posts positioned 120° apart around its circumference. The device is available in four sizes: 19 mm, 23 mm, and 25mm. 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 300 Aortic Annuloplasty Device. Both the device and pledgets are provided sterile by gamma irradiation sterilization and are intended for single-use. The HAART 301 Instrument Set provides accessory instruments to facilitate proper sizing and implantation of the device.
The provided text describes the HAART 300 Aortic Annuloplasty Device, but it does not contain the specific information required to complete the requested table and answer all questions regarding acceptance criteria and a study proving the device meets them. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study designed to meet those criteria for a novel device.
The document discusses performance data, but it presents it as "Nonclinical and clinical performance testing has demonstrated that the HAART 300 Aortic Annuloplasty Device is substantially equivalent to the predicate device." It does not outline explicit acceptance criteria that the device had to meet. Instead, it lists studies conducted to support the substantial equivalence claim.
Therefore, I cannot fully complete the requested table and answer several of the questions based solely on the provided text.
However, I can extract information about the studies performed and some performance metrics, which are presented as outcomes of those studies, rather than pre-defined acceptance criteria.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
I cannot provide a table of acceptance criteria because they are not explicitly stated in the document. The document describes performance data that was collected during various studies to demonstrate substantial equivalence.
Here's a table based on the reported device performance from the studies mentioned:
| Area of Performance Tested | Reported Device Performance (as outcomes of studies contributing to substantial equivalence) |
|---|---|
| Non-Clinical Studies | |
| Biocompatibility | Successfully completed (per ISO 10993-1:2009) |
| Computational Structural Analysis | Successfully completed |
| Tensile Testing | Successfully completed |
| Suture Pull-out Testing | Successfully completed |
| Sterilization Validation | Successfully completed (per ISO 11137-1:2006, ISO 11137-2:2006) |
| Biological Testing | Successfully completed (per ISO 10993-1:2009) |
| Shelf Life Validation | Successfully completed (per ISO 11607:2006, ASTM F88-09, F1886-09, F192904, D4169-09) |
| Fatigue Testing | Successfully completed |
| Magnetic Resonance Compatibility | Successfully completed (per ASTM F2052-06e1, F2119-07, F2182-11a) |
| Animal Studies | Successfully completed |
| Clinical Performance | |
| Survival Rate (6 months) | Kaplan-Meier survival estimate of 98.4% |
| Survival Rate (2 years) | Kaplan-Meier survival estimate of 94.7% |
| Device-Related Deaths | None during the 2-year follow-up period |
| Reduction of Aortic Insufficiency | Percentage of patients with >mild AI: 94.9% at baseline reduced to 23.3% at 6 months (N=56) and 25% at 2 years (N=48) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set (Clinical Study): 65 patients
- Data Provenance:
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: Prospective, multi-centered, single-arm study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the text. The document mentions "transthoracic echocardiography (TTE)" for assessing aortic insufficiency, implying expert interpretation, but it does not specify the number or qualifications of experts involved in establishing ground truth (e.g., for AI severity classification).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the text.
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
This information is not provided in the text. The device is an annuloplasty ring, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical medical implant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical study's assessment of aortic insufficiency, the "ground truth" seems to be based on transthoracic echocardiography (TTE) assessments, which are typically interpreted by medical professionals (e.g., cardiologists). Patient survival and device-related deaths are outcomes data.
8. The sample size for the training set
This information is not applicable as the device is a physical implant and not an algorithm that requires a "training set" in the context of machine learning. The clinical study of 65 patients represents a prospective evaluation, not a training set.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
§ 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.”