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The Duran Band (Model H607H), Duran Ring and Band (Models 610R and 610B), the Duran AnCore Ring and Band (Models 620R and 620B) and the Duran AnCore Ring and Band with Chordal Guide (Models 620R and 620B) are indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves.

Note: The Chordal Guide feature of the Duran AnCore Ring/Band with Chordal Guide (Models 620R and 620B) is indicated only for chordal replacement surgery of pathological mitral valves.

The Duran product family (including the Duran products listed in Section II -DEVICE IDENTIFICATION), consist of permanent, implantable, flexible annuloplasty rings or bands made of polyester fabric with a 3-mm cross-section. A silicone marker, impregnated with barium sulfate enables radiographic visualization. The individual ring and band sizes range from 23mm to 35mm, in two-millimeter increments.

The Duran products are used with associated accessories that include a holder, handle and sizers. The ring or band is provided on a holder to facilitate implantation of the device. The sizers are used to assess appropriate ring or band size and the handle interfaces with the holder to allow for proper positioning of the ring or band.

This K032810 summary describes the Medtronic Heart Valves' Duran Product Family, which includes various annuloplasty rings and bands. The submission indicates that these devices are substantially equivalent to a previously cleared device, the Duran Ring (Model H608H - K980534), and references earlier cleared devices as well.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative "acceptance criteria" in the typical sense of a pre-defined threshold that the device must meet (e.g., accuracy > 90%). Instead, it focuses on demonstrating substantial equivalence to a predicate device. The "performance data" provided relates to material properties and sterilization efficacy, showing that the new devices perform equivalently or meet established safety standards.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: The document does not describe a traditional "test set" or a study involving a specific number of implanted devices or clinical cases for the purpose of evaluating device performance in humans. The testing described focuses on laboratory-based material properties and sterilization.
• Data Provenance: Not applicable in the context of a clinical test set. The data originates from Medtronic's internal testing and historical usage of similar materials/devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the submission is for a medical device (annuloplasty rings/bands) and relies on material and manufacturing equivalency to a predicate device, rather than a diagnostic device requiring expert interpretation for ground truth establishment.

4. Adjudication method for the test set:

This information is not applicable for the same reasons as #3.

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 as the device is an implantable medical device (annuloplasty ring/band), not an AI-powered diagnostic or interpretation tool that would involve human readers.

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

This information is not applicable as the device is not an algorithm or AI system.

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

The ground truth or basis for acceptance in this submission relies on:

• Historical Performance: Long-term safe and effective use of the same materials and manufacturing processes in previously cleared predicate devices (since 1978).
• Industry Standards: Compliance with recognized international standards for sterilization (ISO 10993-7).
• Laboratory Testing: Mechanical and biological performance verified through internal Medtronic testing (e.g., suture pull-out force).
• Substantial Equivalence: Direct comparison to a legally marketed predicate device (Duran Ring Model H608H) to demonstrate similar fundamental technology, materials, and intended use.

8. The sample size for the training set:

This information is not applicable as the device is not an AI/ML model that requires a training set.

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

This information is not applicable as the device is not an AI/ML model that requires a training set.

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For use in those patients undergoing surgery of diseased or damaged mitral valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty bands provide support for and restrict dilatation of the posterior mitral valve annulus.

The Medtronic KHONSARI Annuloplasty Band [Model H609M] is an implantable, flexible, adjustable band. The band reduces and stabilizes the mitral valve annulus in patients undergoing mitral valve repair. The body of the band is made of braided polyester and has drawstrings that permit segments of the annulus to be independently shortened.

The band contains a flexible (non-metallic) radiopaque marker that enables radiographic visualization of its entire length. Eight radially spaced surgeon's flags indicate recommended locations for implantation sutures. Each annuloplasty band is attached to a holder. A circumferential groove in the holder protects the drawstrings from entrapment by the implanting sutures. The stem of the handle is malleable to facilitate seating of the band during placement.

The four adjustable drawstrings are coiled within cylindrical canisters on the holder. A retaining suture secures each end of the band to the holder. The drawstrings will automatically release from the holder as it is removed from the band.

The provided document is a 510(k) summary for the Medtronic KHONSARI™ Annuloplasty Band. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria, a study proving the device meets those criteria, or most of the particular points requested in the prompt (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth types).

The document focuses on demonstrating substantial equivalence to a previously cleared device (Medtronic SCULPTOR® Annuloplasty Ring) based on similar materials, manufacturing processes, intended use, and existing performance data from the predicate device.

Here's an attempt to answer the questions based only on the provided text, with many fields necessarily left blank or marked as "Not provided in the document."

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not provided in the document. The studies mentioned are described generally (e.g., "Physical performance studies," "Sterilization validation"), but no specific sample sizes for these tests are reported.
• Data Provenance: Not applicable/Not provided. The "studies" described are engineering and manufacturing validation tests, not clinical studies with patient data from a specific country or with a retrospective/prospective design.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not applicable/Not provided. The "test set" in this context refers to validation tests of the device's physical properties and manufacturing processes, not a dataset requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. Adjudication methods are typically used in clinical studies involving human interpretation or subjective endpoints, which is not the type of study described here.

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

• Not applicable. This device is a medical implant (annuloplasty band) and not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study involving AI assistance for human readers would have been conducted or reported for this type of submission.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• For the engineering and manufacturing validation described: The "ground truth" would be established engineering specifications, established sterilization standards, and material property measurements. The document states that the processes "meet all procedure requirements" and the device "performs as intended."

8. The Sample Size for the Training Set

• Not applicable/Not provided. There is no "training set" in the context of an AI/machine learning model for this medical device submission. The manufacturing process validation and performance studies are not described as involving a training set.

9. How the Ground Truth for the Training Set was Established

• Not applicable/Not provided. As there is no training set (as per question 8), this question is not relevant.

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