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The TruForm™ Sievers Annuloplasty Ring is indicated for the correction of mittal valvular insufficiency where the lessions are not so severe as to require total valve replacement.

The TruForm™ Sievers Annuloplasty Ring, Model TRH is a semi-flexible implantable annuloplasty ring designed to reduce and stabilize the valve annulus in patients undergoing mitral repair. The inner core of the ring is made of a titanium alloy. Silicone covers the inner core and a sewing cuff made of braided polyester encompasses the ring. Three points of the ring are marked with polyester suture to aid in suture placement for implantation. The ring is available in ten (10) sizes: 24 mm; 26 mm; 28 mm; 30 mm; 32 mm; 34 mm; 36 mm; 38 mm; 40 mm; and 42 mm.

The provided text describes the regulatory clearance for a medical device called the TruForm™ Sievers Annuloplasty Ring, Model TRH. It is a 510(k) premarket notification, which means the device is being declared substantially equivalent to existing, legally marketed predicate devices.

However, the document does not describe a study involving an algorithm or AI, nor does it present acceptance criteria for an AI device. The TruForm™ Sievers Annuloplasty Ring is a physical medical implant used for cardiac surgery.

Therefore, I cannot extract the information requested about acceptance criteria and studies proving the device meets them in the context of an AI device. The document focuses on the equivalence of a physical annuloplasty ring to its predicates through non-clinical testing and shared characteristics.

If there was a misunderstanding and the request was for a physical device, the acceptance criteria are generally met by demonstrating substantial equivalence to a predicate device through:

• Same intended use and indications for use.
• Similar technological characteristics.
• Addressing any differences that could raise new questions of safety and effectiveness through testing.

The non-clinical tests performed for this physical device to support substantial equivalence include:

• Biocompatibility
• Sterilization
• Computational Finite Element Analysis (FEA)
• Tensile strength of ring materials
• Suture pull-out testing
• MRI Compatibility
• Packaging
• Shelf-life

These tests demonstrate that the device is equivalent to the predicate and/or reference devices, implying it meets the safety and performance requirements for its intended use.

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The NeoForm™ Annuloplasty Ring is indicated for the correction of mitral valvular insufficiency where the lesions are not so severe as to require total valve replacement.

The NeoForm™ Annuloplasty Ring, Model 4200 is a rigid implantable annuloplasty ring designed to reduce and stabilize the valve annulus in patients undergoing mitral repair. The inner core of the ring is made of a titanium alloy. Silicone covers the inner core and a sewing cuff made of polyester fabric encompasses the ring. Three points of the ring are marked with polyester suture to aid in suture placement for implantation. The ring is available in four sizes: 26 mm; 28 mm; 30 mm; and 32 mm.

This document describes the 510(k) summary for the NeoForm™ Annuloplasty Ring, Model 4200. This is a medical device and the submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing performance metrics against specific acceptance criteria for an AI/algorithm-based device.

Therefore, many of the requested points, such as specific acceptance criteria related to AI performance, sample sizes for test sets in an AI context, expert qualifications for ground truth in AI, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this type of medical device submission.

Here's a breakdown of the relevant information from the provided text:

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

The document does not present quantitative acceptance criteria for the performance of the annuloplasty ring in a numerical or statistical sense as one would expect for an AI algorithm. Instead, the "acceptance " is based on demonstrating substantial equivalence to a predicate device through functional and safety testing. The reported "performance" is that the device met these requirements and is equivalent to the predicate.

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

• Sample Size: The document states "representative samples of the devices underwent testing" for functional and safety tests. Specific sample sizes for each test are not provided.
• Data Provenance: The data provenance (e.g., country of origin, retrospective/prospective) is not specified in this summary.

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

This is not applicable as this is not an AI/algorithm-based device and does not involve establishing ground truth from expert readings in that context. The "truth" for the device's functional and safety performance is based on engineering and materials science standards and testing.

4. Adjudication method for the test set

This is not applicable as there is no expert reading or interpretation requiring adjudication in the context of an AI/algorithm.

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 is not applicable. This device is an annuloplasty ring, not an AI-assisted diagnostic or treatment tool.

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

This is not applicable. This is a physical medical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for this medical device is established by:

• Engineering specifications and design requirements: The device's physical properties, materials, and mechanical behavior.
• Performance against established standards: Biocompatibility standards, sterilization efficacy, material strength standards, etc.
• Comparison to a legally marketed predicate device: Demonstrating that the new device performs similarly or equivalently to a device already deemed safe and effective.

8. The sample size for the training set

This is not applicable as this is not an AI/algorithm-based device.

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

This is not applicable as this is not an AI/algorithm-based device.

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