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Chord-X Pre-Measured Loops for Mitral Chordal Replacement are indicated for the repair or replacement of chordae tendinae.

The device is a non-absorbable monofilament ePTFE suture using 4 Chord-X ePTFE sutures in a looped configuration provided in the following sizes and meeting the USP standards: 2-0 Suture with 22mm Taper Point Needle (3/8 Circle and 1/2 Circle) and 18mm Taper Point Needle (3/8 Circle and 1/2 Circle) with adjustable loop lengths of 0, 12mm, 16mm, 20mm, and 24mm. Also, 3-0 Suture with 22mm Taper Point Needle (3/8 Circle and 1/2 Circle) and 18mm Taper Point Needle (3/8 Circle and 1/2 Circle) with adjustable loop lengths of 0, 12mm, 16mm, 20mm, and 24mm. All configurations are supplied with two (2) 0.118 X 0.276 X 0.059 inches (3 X 7 X 1.5 mm) pledgets. All suture strands used in the construction of the prosthesis are 32 inches in length. The loops are made simply as a convenience for the surgeon who currently must tie these at the operating table as described in the medical literature (Gillinov AM, Banbury MK. Pre-Measured Artificial Chordae for Mitral Valve Repair. Ann Thorae Surg 2007;84:2127-2129.) It eliminates a step in the operation. They are provided as sterile, single use products and contain no dyes or additives.

The provided text is a 510(k) summary for the "Chord-X Pre-Measured Loops for Mitral Chordal Replacement" device. It is a submission to the FDA for market clearance, demonstrating substantial equivalence to a predicate device. This document focuses on the technical characteristics, biocompatibility, and sterilization of the device, rather than clinical study results establishing performance against acceptance criteria in the way an AI/ML device would be evaluated for clinical performance.

Therefore, many of the requested points regarding acceptance criteria and clinical performance studies for an AI/ML device (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for clinical outcomes) are not applicable or available in this type of regulatory document.

However, I can extract information related to the device's technical specifications and the testing performed to demonstrate its safety and functionality.

Here's a breakdown of the available information:

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

The document focuses on demonstrating substantial equivalence to existing predicate devices (Chord-X ePTFE Suture and Covidien Tetraflouroethylene (TFE) Polymer Pledget) based on material, intended use, and various physical and biological tests. There isn't a direct "acceptance criteria" table with performance metrics in the way one would define for an AI/ML diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the performance is demonstrated by meeting USP standards, passing biological tests, and exhibiting comparable physical properties to the predicate devices.

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 / Not explicitly stated for specific test sets in a clinical performance context. The testing described involves bench testing (physical properties, physicochemical extraction) and biocompatibility testing using animal models or in-vitro methods. The "sample size" would refer to the number of devices or material samples tested for each specific bench or biological test. For instance, for physicochemical extraction, it mentions specific sample amounts (e.g., 123.7 cm² of material). No clinical data or human subject data is mentioned.
• Data Provenance: Not specified, but generally, regulatory submissions like this derive data from laboratory testing conducted by the manufacturer or contracted labs.

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 document does not describe a clinical study requiring expert ground truth for interpretation (like image analysis by radiologists). The "ground truth" for the tests performed is established by adherence to recognized standards (e.g., USP, ISO, ASTM) and validated laboratory methods.

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

• Not applicable. This relates to clinical study design for subjective evaluations, not the objective physical and biological tests performed for this device.

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. MRMC studies are specific to evaluating diagnostic image interpretation, particularly with AI assistance. This device is a surgical implant, not a diagnostic AI tool.

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

• Not applicable. This refers to AI algorithm performance.

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

• For physical/chemical tests: Ground truth is based on engineering specifications, validated test methods (e.g., ASTM standards), and material properties.
• For biological tests: Ground truth is established by standardized biological assays (e.g., cytotoxicity, sensitization, pyrogenicity tests) and their predefined pass/fail criteria, often referencing ISO standards (e.g., ISO 10993 for biocompatibility).

8. The sample size for the training set:

• Not applicable. This refers to AI/ML model training data.

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

• Not applicable. This refers to AI/ML model training data.

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