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The AnnuloFlo™ System is intended for use in the repair of the human cardiac mitral valve. The AnnuloFlo™ annuloplasty ring is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

The AnnuloFlo™ System consists of an annuloplasty ring, and a complete set of instrumentation provided in a tray to properly size the annulus and implant the annuloplasty ring. The annuloplasty ring is designed to reinforce the native annulus while revailing the native appratus.

This document describes the "AnnuloFlo™ System" (K970375), an annuloplasty ring for human cardiac mitral valve repair. The provided text is a 510(k) summary and the FDA's clearance letter, which focuses on regulatory approval and substantial equivalence rather than a detailed scientific study with specific acceptance criteria and performance metrics.

Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, sample sizes for test and training sets, expert qualifications, and ground truth establishment is not available in the provided text. The document is a regulatory submission summary, not the full study report.

Here's what can be extracted and what is explicitly not available based on the provided text:

1. A table of acceptance criteria and the 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 available. The document summarizes testing but does not provide details on sample sizes for specific mechanical or biocompatibility tests, nor does it describe a "test set" in the context of, for example, clinical performance or image analysis. The data provenance is also not specified.

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 / Not available. This device is a physical medical implant, not an AI/diagnostic software. "Ground truth" in this context would relate to the validity of material properties or mechanical performance, which are evaluated through standardized tests, not expert consensus in the way a diagnostic AI would be. No information about expert involvement in establishing "ground truth" for the tests mentioned is provided.

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

• Not applicable / Not available. As above, this pertains more to diagnostic accuracy studies involving human interpretation or complex data, not the material and mechanical testing described 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

• No, not done. This is an implantable medical device, not an AI or diagnostic tool. MRMC studies are not relevant for this type of product.

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

• No, not applicable. This is an implantable medical device, not an algorithm.

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

• For biocompatibility: Established biological safety standards and in-vitro testing criteria (implied by "non-toxic, non-hemolytic, non-pyrogenic").
• For mechanical performance: Standardized ASTM test methods (e.g., for suture retention strength) and comparison to established predicate device performance or industry standards.
• For shelf life: Accelerated aging studies and package integrity tests (implied).
• For MRI compatibility: Material properties (non-ferrous) and potentially specialized testing for interaction with MRI fields (implied).

8. The sample size for the training set

• Not applicable / Not available. The device is not an AI model, so there is no "training set."

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

• Not applicable / Not available. No training set exists.

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The Gelweave™ vascular graft (bifurcated configuration) is indicated for repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease.

The Gelweave™ vascular graft (bifurcated configuration) is a gelatin-sealed, woven polyester graft, with a base graft porosity of 350 ml/min/om2. The woven polyester material has been impregnated with an absorbable mammalian gelatin which seals the prosthesis in the same manner as the fibrin deposited in traditional procedures. The gelatin sealant obviates the need for preclotting prior to implantation. The gelatin is of United States Pharmacopeia (USP) standard and is derived from bovine bone. The result is a vascular prosthesis that does not require preclotting even when patients have been anticoagulated or when bleeding is a prime concern.

This document is a 510(k) summary for a medical device called the Vascutek Gelweave™ Vascular Graft (bifurcated configuration). It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared device. However, it does not contain information about acceptance criteria or a study proving that a device meets such criteria, as it's not describing a new AI/software-based medical device performance study.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets them, because that information is not present in the provided text. The document is primarily focused on demonstrating substantial equivalence of a new configuration (bifurcated) to an existing one (straight) for a physical vascular graft, not an AI or software device.

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The reusable CarboMedics Handle is intended for use with the CarboMedics Valve Holder (referred to herein as the "Valve Holder") for the purpose of assuring a firm grasp of the valve and to facilitate sewing ring exposure.

The reusable CarboMedics Handle is a one-piece, injection molded handle and is provided in one size only. The CarboMedics Handle consists of a threaded polysulfone tip injection molded to a bendable handle. The reusable CarboMedics Handle is manufactured using a polysulfone injection molding process. The CarboMedics Handle consists of a white polysulfone threaded tip injection molded onto a bendable stainless steel shaft, injection molded to a white polysulfone handle. It is supplied non-sterile and must be cleaned and sterilized prior to initial use and each reuse.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state the sample size used for the pull-out and push-out tests. It mentions "the results were an average" and "a standard deviation," implying multiple measurements were taken, but the exact number of samples is not provided.

The data provenance is from internal testing conducted by CarboMedics, the manufacturer of the device. The data is retrospective as it pertains to testing performed on a device for which the design is being qualified.

3. Number of Experts and Qualifications

Not applicable. This device is a mechanical handle, and its performance is evaluated through physical tests (pull-out and push-out strength) rather than expert interpretation of data.

4. Adjudication Method

Not applicable for a physical performance test. The results are quantitative measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a medical device (handle) and not an AI-assisted diagnostic or interpretative tool that would involve human readers.

6. Standalone Performance

Yes, a standalone performance study was done. The reported pull-out and push-out strengths are direct measurements of the device's mechanical integrity under specific load conditions, without any human-in-the-loop during the testing. This assesses the algorithm/device (the handle) without human interaction influencing the outcome of the test.

7. Type of Ground Truth

The ground truth used for these tests is the physical measurement of force required to cause separation. This can be categorized as physical property measurement or engineering specification compliance. The criteria (minimum failure load) are established engineering thresholds for the device's intended function.

8. Sample Size for the Training Set

Not applicable in the context of this device and testing. This is not an AI/ML model that requires a training set. The "training" for the manufacturing process would be the established injection molding procedures.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set in the sense of an AI/ML model for this device. The ground truth for the performance tests (pull-out and push-out) is based on engineering principles and the intended use of the device, establishing minimum strength requirements that the device must meet.

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The reusable CarboMedics Mitral Rotators are intended for use in rotating the CarboMedics mitral heart valves (Model 700 and S700) in sim when necessary to avoid anaromical obstruction

The CarboMedics Mirral Rotator is a one-piece, injection modeled rotator, manufactured from either blue polysulfone or blue polyetherimide. The CarboMedics Mitral Rotators are supplied non-sterile and must be cleaned and sterilized prior to initial use and each reuse. The reusable Carbo Medics Mitral Rotators are manufactured using a polysulfone or polyetherimide injection molding process. The CarboMedics Mitral Rotators are one-piece, hand-held instruments.

This document is a 510(k) summary for the CarboMedics Mitral Rotator, a reusable device intended for rotating CarboMedics mitral heart valves in situ. This type of regulatory submission is focused on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study on device performance against specific acceptance criteria.

As such, the provided text does not contain the requested information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details on ground truth for training or testing sets.

The document highlights the following:

• Intended Use: Rotating CarboMedics mitral heart valves (Model 700 and S700) in situ to avoid anatomical obstruction.
• Materials: Blue polysulfone or blue polyetherimide, selected for their history of use in medical device applications.
• Biocompatibility: Tests were conducted on both materials in accordance with Tripartite Guidance and ISO 10993, with "acceptable results."
• Clinical History: The device has been used in clinical applications since 1986, including under IDE G880074.
• Substantial Equivalence: CarboMedics asserts the device is safe, effective, and substantially equivalent to the CarboMedics Extended Mitral Rotator heads (510(k) #K951368, approved June 20, 1995) in intended use, design, composition, and function.

In summary, this document is a regulatory filing for market clearance based on substantial equivalence, not a detailed scientific study outlining performance metrics against specific acceptance criteria. Therefore, the requested information cannot be extracted from this text.

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The Vascusoft™ Plus Vascular Graft is indicated for systemic vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries. Coronary vascular repair and blood access fistula (e.g. hemodialysis) are contraindicated with this device.

The Vascusoft™ Plus Vascular Graft is a warp knitted polyester prosthesis with a porosity of 2591 ml/min/cm² which is available in a straight tube and bifurcated configurations.

This document is a 510(k) summary for a medical device (VASCUTEK VASCUSOFT™ PLUS VASCULAR GRAFT), not a study report describing the acceptance criteria and performance of an AI/ML powered device. Due to this, the questions you've asked about AI/ML device performance, such as sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set details, are not applicable here.

However, I can extract the non-AI-specific acceptance criteria and general performance claims from the provided text as best as possible, interpreting your request in the context of this document.

Acceptance Criteria and Reported Device Performance (Non-AI Context)

Responses to Specific Questions in the Context of this Document:

1. A table of acceptance criteria and the reported device performance: See the table above. The "acceptance criteria" here are interpreted as the aspects that needed to be demonstrated for substantial equivalence or safety/effectiveness. The "reported device performance" reflects what the document states about the Vascusoft™ Plus.

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

   • Sample Size: Not specified for any of the in-vitro or animal tests. The document only states "Comprehensive performance testing has been performed" and "Animal testing has demonstrated acceptable in-vivo performance."
   • Data Provenance: Not specified. It's a regulatory submission, so likely company-sponsored internal testing, but the country of origin or whether it's retrospective/prospective isn't mentioned.

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 describes physical and biological testing of a vascular graft, not expert review of AI output.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is for AI model output adjudication, not physical device testing.

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 traditional medical device, not an AI-powered one.

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 concensus, pathology, outcomes data, etc): For the physical and biological testing, the "ground truth" would be established by standardized measurement methods (e.g., using calibrated equipment for burst strength, standardized assays for biocompatibility) and observable biological responses in animal models. It's not a "ground truth" in the AI sense.

8. The sample size for the training set: Not applicable. This device does not have a "training set."

9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a non-AI medical device. The concepts of acceptance criteria for AI performance, expert adjudication, training/test sets, and ground truth for AI models are not relevant to its content.

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The Vascutek Graft Sizer Set is designed to aid the surgeon in accurately matching the size of vascular graft to the artery. The size of graft to be selected will correspond with the number indicated on the graft sizer which best fits the outside of the vessel.

The Vascutek Graft Sizer Set consists of nine individual double-ended 'C' shaped graft sizers. The nine sizers are secured within a clip and are available in a size range from 5 to 32 mm. The graft sizers are supplied sterile and are for single use only.

This document is a 510(k) summary for the Vascutek Graft Sizer Set. It does not contain the detailed information required to answer your questions about acceptance criteria, study data, ground truth establishment, or sample sizes related to AI/device performance.

The provided text focuses on:

• Device Description: What the graft sizer set is, its components, and its intended use.
• Biocompatibility: Results of biocompatibility tests for the device material.
• Substantial Equivalence: A comparison to a previously cleared device (Meadox Graft Sizer).

There is no mention of:

• Acceptance criteria for device performance (e.g., accuracy of sizing relative to actual vessel diameter).
• Any studies involving device performance data (e.g., how well it aids surgeons in matching graft size).
• Any AI or algorithm-based components.
• Human readers, experts, or ground truth establishment in the context of device performance.
• Training or test sets.

Therefore, I cannot populate the table or answer the specific questions based on the information provided in this 510(k) summary. This document is a regulatory submission for a medical device and not a performance study report.

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