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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 ATS SIMULUS Annuloplasty Rings are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty rings provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.

The ATS SIMULUS Annuloplasty Rings are implantable, fully flexible, annular rings (Figure 1). The rings reduce and stabilize the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair. The body of the ring is made of braided Polyester. The ring contains a circumferential flexible radiopaque marker. The entire circumference of the ring is radiopaque. The annuloplasty rings and accessories are designed as an integrated system to ease implantation. Malleable stems connects the double ended sizers to their handle. The rings are available in the following sizes: 23 mm, 27 mm, 31 mm, 31 mm, 33 mm and 35 mm. The size refers to the inner diameter of the ring. Green trigone markers are spaced at 120° from the radial seam, which is located midpoint of the posterior segment.

The provided text is a 510(k) Summary for a medical device called the ATS SIMULUS Annuloplasty Ring. It describes the device, its intended use, and indicates that testing was performed. However, this document does not contain the specific details about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies.

The section "8. Testing Summary:" on page 1 states: "Testing included LAL, Sterility Validation, Class IV Biocompatibility tests on the predicate device. Mechanical testing was carried out on complete modified rings and ring components. All test results were satisfactory."

This statement confirms that testing was done and that the results were "satisfactory," but it lacks the granular information required to complete the table and answer the specific questions about acceptance criteria and study methodology.

Therefore, I cannot provide a detailed response to your request based solely on the provided text. The document is primarily focused on demonstrating substantial equivalence to a predicate device for regulatory clearance rather than providing a detailed performance study report.

Here's what can be inferred and what information is missing:

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

• Acceptance Criteria: Not explicitly stated in the provided text. For LAL, Sterility Validation, Biocompatibility, and Mechanical Testing, there would be specific regulatory or internal acceptance criteria (e.g., LAL endotoxin levels below a certain threshold, sterility assurance level (SAL) of 10^-6, specific cytotoxicity or sensitization limits, certain force/stress limits for mechanical tests). These are not published here.
• Reported Device Performance: The text generically states, "All test results were satisfactory." This is not a quantitative or specific performance report.

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

• Sample Size: Not specified for any of the tests mentioned (LAL, Sterility, Biocompatibility, Mechanical).
• Data Provenance: Not explicitly stated. Given it's a 510(k) submission, the testing would have been conducted by or for the applicant (Genesee Biomedical, Inc.) likely in the US, but this is an inference, not stated fact for the data origin. It would be retrospective for the submission, based on tests performed prior to filing.

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

• This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical assessments). The tests mentioned (LAL, Sterility, Biocompatibility, Mechanical) are laboratory-based and generally do not involve "expert consensus" for ground truth in the way clinical studies do. Standards and validated methods define the "ground truth" for these types of tests.

4. Adjudication method for the test set

• Not applicable for the types of tests described (LAL, Sterility, Biocompatibility, Mechanical).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, the document does not mention any MRMC comparative effectiveness study. These are typically for diagnostic devices where human readers interpret results.

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

• Not applicable. This device is an implantable annuloplasty ring, not an algorithm.

7. The type of ground truth used

• For LAL, Sterility, Biocompatibility, and Mechanical testing, the ground truth is established by validated laboratory methods and regulatory standards. For example, sterility is determined by absence of microbial growth in culture, LAL by an enzymatic reaction, biocompatibility by absence of adverse biological responses in standardized tests (e.g., ISO 10993 series), and mechanical performance by meeting engineering specifications under controlled conditions. It's not "expert consensus," "pathology," or "outcomes data" in the clinical sense for these specific tests.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set. The "predicate device" is mentioned for some tests, but that's for demonstrating equivalence, not for training a model.

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

• Not applicable, as there is no training set for this type of device.

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