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The Simplici-T™ Annuloplasty System is indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves. Appropriate repair and annular remodeling may correct combined valvular insufficiency and stenosis.

The Simplici-TTM Annuloplasty System is a single use, permanent, flexible, implantable device intended for the repair of a patient's mitral and tricuspid valves. The Simplici-T™ Annuloplasty Band is a 100 mm long band, constructed from a double velour polyester fabric wrapped around a small radiopaque silicone marker strip. Two locking running stitches run the entire 100mm band length creating a flat, low profile. A whipstitch on the side closes the band together. Implantation of the band is aided with the disposable band holder. The band is released from the holder by depressing the thumb trigger found on the handle of the holder. By depressing the thumb trigger, the holder bottom fingers push the band off of pins attached to the holder top. The device is sterilized by Steam Sterilization and has a One-year shelf life. The device is packaged on a holder in double aseptic pouches and shipped within a shelf-carton that includes instructions for use and product traceability labels.

The provided document, K052970, for the Simplici-T™ Annuloplasty System (Model 670), primarily focuses on its substantial equivalence to predicate devices and describes the device itself. It does not contain the detailed information requested regarding specific acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or the specific methodology for establishing ground truth.

The document states:

"The Simplici-TTM Annuloplasty System was subjected to verification and validation studies. The verification/validation studies demonstrate that the modifications to the predicated device are appropriate and do not affect the intended use or performance of the device."

This statement confirms that studies were conducted to ensure the device performs as intended and is safe, but it lacks the quantitative and methodological details to fulfill the request. Therefore, I cannot construct the requested table or provide the detailed information for points 2 through 9 based solely on the provided text.

The document is a 510(k) summary, which typically provides a high-level overview to establish substantial equivalence to a legally marketed predicate device rather than comprehensive study reports with detailed performance endpoint data.

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The CG Future® Annuloplasty Band is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.

The CG FUTURE Band is a single use, permanent, semi-rigid, implantable device intended for the repair of a patient's mitral valve. The CG FUTURE Band consists of a partial band of polyester fabric covering a formed, metallic (MP35N) wire stiffener material with eyelets formed at both ends. The stiffener element is over-molded with LSR silicone. The band is marked at three locations (the two trigone locations and the center) with green-colored suture. Two trigone markers identify the eyelets in the stiffener to facilitate anchoring of the stiffener into the trigones by the surgeon with sutures. The individual band size (26, 28, 30, 32, 34, 36, and 38mm) represents the widest, straight-line distance as measured at the inside of the fabric-covered band. The band is designed for implantation in the mitral position only. The CG FUTURE Band is used with associated accessories that include a holder, sizers and a handle. Implantation of the band is aided with the disposable band holder. The band is released from the holder by cutting suture at two points. The CG FUTURE Band sizer set is used to assess appropriate band size. The sizers cover all seven sizes of the CG FUTURE Band and are marked with the band size and the trigone locations. The sizers are reusable and are provided non-sterile. The reuseable annuloplasty handle, which is available in two lengths, interfaces with both the holder and the sizers.

The provided document is a 510(k) summary for the CG Future® Annuloplasty Band, describing a device modification. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed performance data from a clinical study for acceptance criteria.

Therefore, many of the requested items (e.g., specific acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth methodologies) cannot be extracted from this document as it's not a clinical trial report.

However, based on the summary, here is the information that can be extracted or reasonably inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria or detailed performance metrics. It generally states that "The CG FUTURE Band was subjected to verification and validation studies. The verification/validation studies demonstrate that the modifications to the predicated device are appropriate and do not affect the intended use or performance of the device."

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

Not explicitly stated. The "verification and validation studies" mentioned are typically engineering and bench tests for device modifications, not clinical efficacy studies with patient data.

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

Not applicable. This is not a study requiring expert-established ground truth on patient data.

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

Not applicable.

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 medical device modification submission, not an AI-assisted diagnostic study.

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

Not applicable.

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

Not applicable. The performance is assessed against engineering specifications and the predicate device's established performance, not against a clinical ground truth like pathology for diagnosis.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would have a "training set."

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

Not applicable.

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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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