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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.

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.

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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:

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.

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