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The Genzyme Surgical Products Millennium Valve Introducer/Rotator Handle is indicated for use during open and minimally invasive cardiac valve surgeries. This instrument is indicated for surgical introduction and rotation of a Sulzer Carbomedics Low Profile Mitral Valve Sizer and Rotator.

The Millennium Valve Introducer/Rotator Handle (Introducer/Rotator Handle) consists of a handle, flexible shaft, and tip. The Handle includes two knobs that control the orientation and position of the tip. The proximal knob tightens the cable that adjusts the tip between 0 and 90 degrees. The distal knob rotates the tip between 0 and 360 degrees.

The provided document describes a 510(k) premarket notification for the Genzyme Surgical Products Millennium Valve Introducer/Rotator Handle. This type of submission is a regulatory pathway for medical devices that are substantially equivalent to a legally marketed predicate device. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or performance study for a diagnostic algorithm would.

The document primarily focuses on establishing "substantial equivalence" based on operational and technological characteristics. Therefore, many of the requested categories are not applicable to this type of regulatory submission.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as performance metrics with thresholds (e.g., accuracy > 90%). The "acceptance criteria" for a 510(k) submission like this are essentially demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety/effectiveness.
• Reported Device Performance: The document provides a comparison of characteristics between the proposed device and predicate devices. This isn't "performance" in the statistical sense, but rather a functional comparison.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable to this 510(k) submission. There is no "test set" in the context of evaluating a diagnostic algorithm's performance. The submission relies on comparative analysis with predicate devices and descriptive information.

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 applicable. There is no "ground truth" establishment in the context of a performance study for this type of mechanical surgical instrument.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable.

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 applicable. This device is a surgical instrument, not an AI or diagnostic tool designed to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This device is a surgical instrument, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not applicable.

8. The sample size for the training set

This information is not applicable. There is no "training set" for this type of mechanical surgical instrument.

9. How the ground truth for the training set was established

This information is not applicable.

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The Sulzer Carbomedics Low Profile Mitral Rotator is intended for use in rotating the CPHV™ mitral valve in situ when necessary to avoid anatomical obstruction.

The sterile, single use Sulzer Carbomedics Low Profile Mitral Rotator is intended for use in rotating the CarboMedics® Prosthetic Heart Valve (CPHV™) mitral valve in situ when necessary to avoid anatomical obstruction. The Sulzer Carbomedics Low Profile Mitral Rotator design includes a socket that the bendable is inserted into and locked in place. This allows the surgeon to orient the valve into the position of greatest advantage for each patient. The Low Profile Mitral Rotator with the corresponding CPHV size on the rotator. The Low Profile Mitral Rotator will be made available in sizes corresponding with previously approved CPHV™ sizes. The Low Profile Valve Rotators are intended for use with the CPHV™ Mitral 700 valve series. The Sulzer Carbomedics Low Profile Mitral Rotator will be manufactured from polyetherimide previously used with instrumentation approved with the CPHV". Polyetherimide has a history of use in medical device applications.

This document is a 510(k) premarket notification for a medical device called the Sulzer Carbomedics Low Profile Mitral Rotator. It's an application for clearance to market an equivalent device, not a study reporting on the performance of an AI/ML system. Therefore, most of the requested information regarding AI/ML performance metrics, studies, and ground truth establishment is not applicable to this document.

However, I can extract information related to the device's intended use and equivalence claim, which can be seen as meeting its "acceptance criteria" for market clearance based on substantial equivalence.

Here's the breakdown of what can be extracted or inferred from the provided text:

Acceptance Criteria and Device Performance (in the context of 510(k) substantial equivalence):

For a 510(k) submission, the primary "acceptance criterion" is to demonstrate substantial equivalence to a previously legally marketed predicate device. This involves showing similar intended use, technological characteristics, and safety and effectiveness.

Since this is a 510(k) submission for a non-AI/ML medical device, the following points are not applicable:

1. Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not a diagnostic or AI system. Testing would typically involve mechanical bench testing or biocompatibility assessments, not a "test set" of patient data in the AI sense.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the AI sense is established.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Summary from the provided text:

The document describes a 510(k) premarket notification for a mechanical medical device, the Sulzer Carbomedics Low Profile Mitral Rotator. The primary study and "acceptance criteria" focus on demonstrating substantial equivalence to an existing predicate device (Sulzer Carbomedics Extended Mitral Rotator, K951368). The equivalence is based on similar intended use and technological characteristics (e.g., material, function). The FDA's letter (K974648) confirms that the device was deemed substantially equivalent, allowing its marketing. No AI/ML-specific performance metrics or studies are mentioned in this submission.

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The reusable CarboMedics Mitral Rotators are intended for use in rotating the CarboMedics mitral heart valves (Model 700 and S700) in sim when necessary to avoid anaromical obstruction

The CarboMedics Mirral Rotator is a one-piece, injection modeled rotator, manufactured from either blue polysulfone or blue polyetherimide. The CarboMedics Mitral Rotators are supplied non-sterile and must be cleaned and sterilized prior to initial use and each reuse. The reusable Carbo Medics Mitral Rotators are manufactured using a polysulfone or polyetherimide injection molding process. The CarboMedics Mitral Rotators are one-piece, hand-held instruments.

This document is a 510(k) summary for the CarboMedics Mitral Rotator, a reusable device intended for rotating CarboMedics mitral heart valves in situ. This type of regulatory submission is focused on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study on device performance against specific acceptance criteria.

As such, the provided text does not contain the requested information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details on ground truth for training or testing sets.

The document highlights the following:

• Intended Use: Rotating CarboMedics mitral heart valves (Model 700 and S700) in situ to avoid anatomical obstruction.
• Materials: Blue polysulfone or blue polyetherimide, selected for their history of use in medical device applications.
• Biocompatibility: Tests were conducted on both materials in accordance with Tripartite Guidance and ISO 10993, with "acceptable results."
• Clinical History: The device has been used in clinical applications since 1986, including under IDE G880074.
• Substantial Equivalence: CarboMedics asserts the device is safe, effective, and substantially equivalent to the CarboMedics Extended Mitral Rotator heads (510(k) #K951368, approved June 20, 1995) in intended use, design, composition, and function.

In summary, this document is a regulatory filing for market clearance based on substantial equivalence, not a detailed scientific study outlining performance metrics against specific acceptance criteria. Therefore, the requested information cannot be extracted from this text.

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