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The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model 6200, is intended for use in patients with tricuspid valvular insufficiency. It is intended to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.

The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model 6200, is constructed of a titanium core with a silicone sewing ring margin covered with a polyester cloth.

Here's an analysis of the provided information regarding the acceptance criteria and study for the Carpentier-Edwards® Physio Tricuspid™ annuloplasty ring, model 6200:

Summary of Acceptance Criteria and Device Performance for K103520

This 510(k) submission describes a medical device, an annuloplasty ring, and its substantial equivalence to predicate devices, rather than an AI/ML powered device. Therefore, the questions related to AI/ML specific aspects (training set, test set, ground truth experts, MRMC studies, standalone performance) are not applicable in this context. The acceptance criteria here refer to the successful completion of design verification and validation testing for a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable: This is a physical medical device, not an AI/ML system. There is no "test set" in the context of data for an algorithm. The testing involves physical prototypes or materials of the device. The provenance of the "data" would refer to where the biomechanical, material, and biocompatibility testing was performed. This information is not detailed in the summary, but such testing is typically done in controlled laboratory environments.

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)

• Not Applicable: This is a physical medical device. There is no "ground truth for a test set" in the sense of expert annotation for an algorithm. However, the summary mentions "Design validation by surgeons in simulated use environment." While the number of surgeons and their specific qualifications are not provided in this summary, these would be the "experts" involved in validating the device's usability and surgical handling.

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

• Not Applicable: As this is not an AI/ML system evaluating data, there is no "adjudication method" for a test set of data. The design validation by surgeons would likely involve observation, feedback, and potentially consensus or individual assessments of the device's performance in a simulated environment.

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 is a physical medical device, not an AI/ML system, so MRMC studies involving human readers and AI assistance are irrelevant here.

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. Standalone performance refers to an AI system operating independently; this concept does not apply to a heart valve ring.

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

• Not Applicable (in the AI/ML sense): For a physical medical device, "ground truth" relates to established engineering standards, material science properties, biological compatibility guidelines, and successful clinical outcomes (which are implicitly aimed for). The successful completion of the listed functional/safety tests against established benchmarks and standards (e.g., ISO 10993 for biocompatibility, ASTM standards for MR compatibility) serves as the "ground truth" that the device meets its design requirements. Surgical design validation by experts also contributes to establishing usability "ground truth."

8. The sample size for the training set

• Not Applicable: This is a physical medical device, not an AI/ML system. There is no concept of a "training set" for an annuloplasty ring. Device development involves iterative design, prototyping, and testing.

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

• Not Applicable: There is no training set or ground truth in the AI/ML sense. For a physical device, the "ground truth" for its development involves engineering principles, material specifications, regulatory standards, and clinical needs that guide its design and subsequent testing.

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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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