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The Sulzer Carbomedics AnnuloFlex™ Annuloplasty System is indicated as a reinforcement for repair of the human cardiac mitral and tricuspid valves 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 AnnuloFlex™ Annuloplasty System consists of an annuloplasty ring mounted on a holder assembly for implantation in the mitral or tricuspid position. A complete set of instrumentation is available separately to properly size the annulus and implant the annuloplasty ring.

This report describes the acceptance criteria and the study that proves the device meets those criteria for the AnnuloFlex™ Annuloplasty System. However, it's important to note that the provided documents are from a 510(k) premarket notification and primarily focus on demonstrating substantial equivalence to predicate devices, rather than a rigorous study with acceptance criteria and statistical performance metrics typically seen in AI/ML device submissions.

Here's an analysis based on the provided text, structured to answer your questions where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

• Identical materials, manufacturing, and function to the Sulzer Carbomedics® AnnuloFlex™ Annuloplasty Ring (a previous version).
• Identical function to the Medtronic Duran Flexible Ring (complete ring).
• Identical function to the Baxter Cosgrove-Edwards Ring (partial ring). |

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a "test set" in the context of evaluating an AI/ML device. The testing mentioned refers to:

• Biocompatibility testing on device materials.
• Mechanical testing (e.g., suture retention) on the device components.
• Comparison of the device's design, materials, and function to existing predicate devices already on the market.

Therefore, there is no mention of a sample size for a test set or data provenance related to clinical data for performance evaluation in the way an AI/ML device would be assessed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This submission is for a medical device (annuloplasty ring), not an AI/ML diagnostic or therapeutic device that would require expert-established ground truth for a test set. The "ground truth" for this device's performance is established through physical, mechanical, and biocompatibility testing, and comparison to established predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" in the context of a clinical performance evaluation that would necessitate an adjudication method among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a 510(k) submission for a physical medical device, not a software or AI/ML device. An MRMC study is not relevant to this type of device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device; there is no "algorithm" or standalone performance to evaluate in this context.

7. The Type of Ground Truth Used

The "ground truth" for this device can be interpreted as:

• Biocompatibility Standards: The established scientific understanding and regulatory requirements for materials to be non-toxic, non-hemolytic, and non-pyrogenic when in contact with human tissue.
• Mechanical Engineering Principles and Standards: The expected performance characteristics of a medical implant in terms of material strength, durability, and suture retention.
• Clinical Efficacy of Predicate Devices: The proven safety and effectiveness of the legally marketed predicate annuloplasty rings for their intended use. The new device's "ground truth" for clinical utility is essentially its demonstrated similarity to these established devices.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device and does not involve AI/ML or a "training set."

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

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

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The Sulzer Vascutek® Gelweave Valsalva™ Vascular Prosthesis is indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation.

The Sulzer Vascutek Gelweave Valsalva™ Vascular Graft is a gelatin-sealed, woven polyester graft. 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 preclotting procedures. The gelatin sealant obviates the need for preclotting prior to implantation. This gelatin has been shown to be safe and effective through PMA #P890045 on January 11, 1993.

The provided document, K013022, pertains to a 510(k) premarket notification for a medical device: Sulzer Vascutek® Gelweave Valsalva™ Vascular Prosthesis. This document describes substantial equivalence to a predicate device, not, a study against specific acceptance criteria for performance metrics that would typically apply to software or AI-based devices.

Therefore, many of the requested categories (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are not applicable to this type of device submission.

However, I can extract the information related to device testing and comparison to a predicate device, which serves a similar purpose in the context of a 510(k) submission for a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are implied by the performance of the predicate device (Sulzer Vascutek Gelweave™ Vascular Prosthesis: K952293) and the results of the in-vitro testing demonstrating substantial equivalence. The document doesn't list explicit numerical acceptance criteria for each test but rather states that the new device demonstrated substantial equivalence.

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

• Sample Size for Test Set: Not specified in the publicly available 510(k) summary. For in-vitro testing of medical devices like vascular grafts, the sample size would typically be determined by statistical methods for materials testing, but the summary does not detail these.
• Data Provenance: The document implies the data was generated through in vitro testing performed by Sulzer Carbomedics Inc. and possibly by reference to prior animal testing and biocompatibility studies for the Gelweave™ series. The country of origin for the data is implicitly the USA (Austin, Texas) where the submitter is located. The testing is essentially prospective in the sense that it was conducted specifically to support this 510(k) submission to demonstrate equivalence.

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

• Not applicable. This is a physical medical device. "Ground truth" in the context of expert consensus, pathology, or outcomes data typically refers to diagnostic or prognostic accuracy for imaging or AI devices. For this device, performance is established through physical properties testing, biocompatibility, and animal studies.

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

• Not applicable. Adjudication methods are typically for subjective assessments or disagreements in data labeling/ground truth establishment, which isn't relevant for the objective measurements of physical properties of a vascular graft.

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 not an AI or imaging device involving human readers or interpretation.

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

• Not applicable. This is not an algorithm or AI device.

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

• The "ground truth" for this device's performance is based on objective measurements of physical properties (e.g., water porosity, burst strength) and biological evaluations (biocompatibility, animal testing) against established standards and the performance of a legally marketed predicate device.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device.

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

• Not applicable. This is not a machine learning or AI device.

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The AnnuloFlo® System is intended for use in the repair of the human cardiac 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 prosthesis 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 retaining the native valve apparatus.

The AnnuloFlo® annuloplasty ring employs materials with a long and satisfactory history of use in cardiovascular applications. All materials are non-ferrous, have extensive history in implants and do not present a significant risk during Magnetic Resonance Imaging (MRI). The annuloplasty ring consists of a titanium stiffener ring enclosed in a sewing ring of silicone and knitted polyester fabric.

The mitral AnnuloFlo® annuloplasty ring is kidney shaped. The curved posterior segment of the ring corresponds to the native posterior leaflet. The open segment of the ring corresponds to the anterior leaflet.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any specific criteria. The text is a 510(k) summary and an FDA clearance letter for the AnnuloFlo® Annuloplasty System. It focuses on the device's description, intended use, indications for use, and a comparison to a predicate device for the purpose of demonstrating substantial equivalence for FDA clearance.

The document does not contain details regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training data was established.

Therefore, I cannot fulfill your request with the given input.

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Sulzer Carbomedics CardioFix™ Pericardium is indicated for the following uses:
• Intracardiac Repair
► Ventricular repair using a reinforced patch technique (i.e., minimum of double thickness).
► Atrial Repair.
• Great vessel repair and suture line buttressing using a reinforced patch technique (i.e., minimum of double thickness) for applications exposed to peak systolic pressure.
• Pericardial Closure.

The Sulzer Carbomedics CardioFix™ Pericardium is prepared from bovine pericardium stabilized using a dye-mediated process referred to as the PhotoFix® process. This photooxidation process creates crosslinks in the bovine tissue. No aldehyde chemistry is used during any phase of manufacturing including the tissue fixation or sterilization processes. The CardioFix™ Pericardium is sterilized by ethylene oxide and is supplied sterile in a sealed container with 22% buffered ethanol solution. The package is designed to facilitate convenient aseptic transfer of the pericardium into the sterile field. Rinsing of the pericardium before implantation is not required. The CardioFix™ Pericardium is available in the following sizes: 1 cm x 1 cm, 4 cm, 6 cm x 8 cm, 8 cm x 14 cm, 10 cm x 16 cm, and 14 cm x 16 cm.

The provided text describes a 510(k) submission for the Sulzer Carbomedics CardioFix™ Pericardium, focusing on its substantial equivalence to predicate devices. However, it does not contain the detailed information typically found in a study report proving a device meets specific acceptance criteria. The document is primarily a summary of the device, its indications for use, and a confirmation of 510(k) clearance by the FDA.

Therefore, I cannot fully answer your request. However, I can extract the information that is present and explain why other sections cannot be completed based on the provided text.

Here's a breakdown of what can and cannot be answered:

1. Table of acceptance criteria and the reported device performance:

The document mentions "Comprehensive in vitro performance testing has been performed for the Sulzer Carbomedics CardioFix™ Pericardium and Bio-Vascular Peri-Guard Pericardium predicate device." It also states, "In vitro performance testing performed for the CardioFix™ Pericardium and predicate device, which included uniaxial tension, suture retention, and suture hole elongation provides evidence that the CardioFix™ Pericardium is substantially equivalent to the predicate devices."

However, the document does not provide the specific acceptance criteria (e.g., numerical thresholds for uniaxial tension, suture retention, or suture hole elongation) or the actual numerical results ("reported device performance") for either the CardioFix™ Pericardium or the predicate device that would allow for a direct comparison against such criteria.

The acceptance criteria for 510(k) submissions are typically framed around demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device that is not subject to premarket approval. The "acceptance criteria" here are implied to be that the CardioFix™ performs comparably to the predicate on these tests. Without the actual data from the testing, a table cannot be completed with specific performance metrics.

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

• Sample size for test set: Not specified in the provided text for the in vitro tests.
• Data provenance: For in vitro tests, it's generally retrospective as these are lab tests done on manufactured samples. The country of origin is not specified but implicitly assumed to be from Sulzer Carbomedics Inc. which is in Austin, Texas, USA.

The document also mentions "animal testing demonstrates acceptable in vivo performance for the CardioFix™ Pericardium," and later, in the FDA letter, it states, "You also included results of rat subcutaneous implantation tests assessing calcification potential."

• Sample size for animal test set: Not specified.
• Data provenance for animal study: Animal testing (specifically rat subcutaneous implantation) as described in the text is prospective for the duration of the study, though the reporting within the 510(k) is retrospective. The country of origin is implicitly the location of Sulzer Carbomedics, Inc. (USA) or the location where their research was conducted.

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):

This information is not applicable or not provided in the context of this device and study types.

• For the in vitro performance tests (uniaxial tension, suture retention, suture hole elongation), "ground truth" is established through physical measurement according to validated test methods, not by expert consensus in the typical sense of medical imaging or clinical ground truth.
• For the animal study (rat subcutaneous implantation for calcification), "ground truth" would be established through histological analysis and quantitative assessment of calcification, typically performed by pathologists or histotechnicians, but the number and qualifications of such experts are not mentioned.

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

This information is not applicable or not provided for the types of tests described. Adjudication methods are typically used when subjective assessments by multiple experts are involved, such as in clinical trials or image interpretation studies, to resolve discrepancies. The in vitro and animal studies described here are objective measurements or pathological assessments.

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. An MRMC study is relevant for AI-powered diagnostic or assistive devices where human readers interpret images or data. The CardioFix™ Pericardium is a medical implant (cardiovascular patch), not a diagnostic or AI device.

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

This is not applicable. The CardioFix™ Pericardium is a medical implant, not an algorithm or AI device.

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

• For in vitro performance tests: The "ground truth" is derived from physical measurements using established laboratory test methods (e.g., force transducers for tension and retention, calipers or imaging for hole elongation).
• For the animal study (calcification): The "ground truth" for calcification assessment would typically be derived from pathology/histology and potentially quantitative biochemical assays.

8. The sample size for the training set:

This is not applicable. The CardioFix™ Pericardium is a medical implant, not a machine learning model; therefore, there is no "training set."

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

This is not applicable for the same reason as point 8.

Summary of what is present in the text related to the "study":

The "study" described is a set of in vitro performance tests and animal testing for the Sulzer Carbomedics CardioFix™ Pericardium, conducted to demonstrate substantial equivalence to a predicate device (Bio-Vascular Peri-Guard Pericardium).

• In vitro tests included: Uniaxial tension, suture retention, and suture hole elongation.
• Animal testing: Rat subcutaneous implantation tests assessing calcification potential. The FDA noted that "calcification development is delayed in the CardioFix™ compared to the control device," but also cautioned that the rat model is not validated for human correlation.

This document serves as a 510(k) summary, which typically provides an overview rather than the detailed methodology and results of such studies. For the specific numerical data and detailed test protocols, one would normally refer to the full 510(k) submission or supporting technical documentation, which is not provided here.

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The AnnuloFlex 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 AnnuloFlex™ Annuloplasty System consists of an annuloplasty ring mounted on a holder assembly for implantation in the mitral position. A complete set of instrumentation is available separately to properly size the annulus and implant the annuloplasty ring.

This document is a 510(k) summary for the Sulzer Carbomedics AnnuloFlex™ Annuloplasty System. This device is a medical implant, not an AI or software device, so the typical acceptance criteria and study designs associated with AI performance metrics (like sensitivity, specificity, F1-score, sample sizes for test/training sets, expert adjudication, MRMC studies) are not applicable.

Instead, the "acceptance criteria" for such a device are based on demonstrating substantial equivalence to legally marketed predicate devices, supported by biocompatibility and mechanical efficacy testing.

Here's an breakdown of the information provided in the context of a medical device submission:

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

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

• Sample Size: Not applicable in the context of this device. The testing described (biocompatibility, mechanical suture retention) are laboratory-based tests on the device materials and components, not a "test set" of patient data or images.
• Data Provenance: Not applicable. The testing represents lab-generated data from material and mechanical assessments of the device itself.

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

• Not applicable. Ground truth for AI software involves expert labels of data. For a hardware medical device like this, "truth" is established through engineering specifications, material science, and mechanical testing standards.

4. Adjudication method for the test set:

• Not applicable. There is no expert adjudication of a "test set" in the sense of AI performance evaluation. The data is physical test results against pre-defined engineering and safety standards.

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, an MRMC study was not done. This device is an implanted annuloplasty ring, not an AI or imaging device that would involve human readers.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• For this device, the "ground truth" (or functional equivalent for a hardware device) is based on established biocompatibility standards (e.g., ISO 10993 for non-toxicity, non-hemolysis, non-pyrogenicity) and mechanical engineering standards for durability, suture retention, and performance under simulated physiological conditions. It also relies heavily on the documented performance and safety profiles of the predicate devices to which it claims substantial equivalence.

8. The sample size for the training set:

• Not applicable. There is no "training set" for physical medical device testing in the AI sense.

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

• Not applicable.

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The Sulzer Carbomedics Low Profile Mitral Rotator is intended for use in rotating the CPHV™ mitral valve in situ when necessary to avoid anatomical obstruction.

The sterile, single use Sulzer Carbomedics Low Profile Mitral Rotator is intended for use in rotating the CarboMedics® Prosthetic Heart Valve (CPHV™) mitral valve in situ when necessary to avoid anatomical obstruction. The Sulzer Carbomedics Low Profile Mitral Rotator design includes a socket that the bendable is inserted into and locked in place. This allows the surgeon to orient the valve into the position of greatest advantage for each patient. The Low Profile Mitral Rotator with the corresponding CPHV size on the rotator. The Low Profile Mitral Rotator will be made available in sizes corresponding with previously approved CPHV™ sizes. The Low Profile Valve Rotators are intended for use with the CPHV™ Mitral 700 valve series. The Sulzer Carbomedics Low Profile Mitral Rotator will be manufactured from polyetherimide previously used with instrumentation approved with the CPHV". Polyetherimide has a history of use in medical device applications.

This document is a 510(k) premarket notification for a medical device called the Sulzer Carbomedics Low Profile Mitral Rotator. It's an application for clearance to market an equivalent device, not a study reporting on the performance of an AI/ML system. Therefore, most of the requested information regarding AI/ML performance metrics, studies, and ground truth establishment is not applicable to this document.

However, I can extract information related to the device's intended use and equivalence claim, which can be seen as meeting its "acceptance criteria" for market clearance based on substantial equivalence.

Here's the breakdown of what can be extracted or inferred from the provided text:

Acceptance Criteria and Device Performance (in the context of 510(k) substantial equivalence):

For a 510(k) submission, the primary "acceptance criterion" is to demonstrate substantial equivalence to a previously legally marketed predicate device. This involves showing similar intended use, technological characteristics, and safety and effectiveness.

Since this is a 510(k) submission for a non-AI/ML medical device, the following points are not applicable:

1. Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not a diagnostic or AI system. Testing would typically involve mechanical bench testing or biocompatibility assessments, not a "test set" of patient data in the AI sense.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the AI sense is established.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Summary from the provided text:

The document describes a 510(k) premarket notification for a mechanical medical device, the Sulzer Carbomedics Low Profile Mitral Rotator. The primary study and "acceptance criteria" focus on demonstrating substantial equivalence to an existing predicate device (Sulzer Carbomedics Extended Mitral Rotator, K951368). The equivalence is based on similar intended use and technological characteristics (e.g., material, function). The FDA's letter (K974648) confirms that the device was deemed substantially equivalent, allowing its marketing. No AI/ML-specific performance metrics or studies are mentioned in this submission.

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Sulzer Vascutek Fluoropassiv™ Fabric is indicated for vascular patch grafting and for intracardiac patching. The Fluoropassiv™ Thin Wall Carotid Patch is, in addition, indicated for patch closure after endarterectomy, particularly of the carotid arteries.

The Sulzer Vascutek Fluoropassiv™ Cardiovascular Fabric product line consists of a non-crimped Gelseal™ patch, Gelsoft™ patch, and a Thin Wall Carotid patch. Each product line is fluoropolymer coated and gelatinsealed, knitted polyester, with a base fabric porosity of 1433 ml/cm²/min, and 3495 ml/cm²/min, respectively, and are available in various square or rectangular sizes. The polyester fabrics have been impregnated with an absorbable mammalian gelatin which seals the prostheses 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 Sulzer Vascutek Fluoropassiv™ Cardiovascular Fabric, including the Gelseal™ patch, Gelsoft™ patch, and Thin Wall Carotid patch, underwent comprehensive in vitro and in vivo testing to demonstrate its substantial equivalence to the predicate device, Sulzer Vascutek Cardiovascular Fabric (K963611).

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the statement that the testing "provides evidence that Sulzer Vascutek Fluoropassiv™ Fabric is substantially equivalent to the predicate fabric." While specific numerical acceptance criteria are not explicitly stated in the provided text, the device's performance across several key metrics was deemed acceptable compared to the predicate.

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • The document does not specify the precise sample sizes used for each in vitro test (burst strength, suture retention, tensile strength, water porosity) or for the animal testing.
   • Data Provenance: The nature of the studies (in vitro performance testing and animal testing) suggests these were prospective studies conducted specifically for this 510(k) submission. No information is provided regarding the country of origin for the data.

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

   • This information is not provided. The study primarily relies on objective physical property measurements and animal model observations rather than expert consensus on subjective assessments.

3. Adjudication method for the test set:

   • This information is not provided. Given the nature of the tests (physical properties and animal studies), and the lack of human interpretation, a formal adjudication method as typically used for image-based or clinical diagnostic studies is unlikely to have been applied in this context.

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

   • No. This type of study is not relevant for evaluating the performance of a cardiovascular fabric, which is an implantable medical device assessed through physical and biological property testing rather than human interpretation of data.

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

   • Yes, in a sense. The in vitro performance testing and animal testing are standalone assessments of the device's physical and biological properties, independent of human clinical application interpretation. There is no algorithm involved.

6. The type of ground truth used:

   • In vitro testing: The ground truth for performance metrics like burst strength, suture retention, tensile strength, and water porosity is based on direct physical measurements and established engineering standards, compared against the properties of the predicate device.
   • Animal testing: The ground truth for in vivo performance and biocompatibility is established through direct observation and analysis of biological responses in animal models.
   • Biocompatibility: The ground truth for biocompatibility is established through well-characterized materials and testing according to relevant standards to ensure suitability for intended use.
   • Gelatin sealant: The safety and effectiveness of the gelatin sealant were previously established and approved through PMA# P890045 for the Sulzer Vascular Gelseal™ Vascular Graft.

7. The sample size for the training set:

   • This concept is not applicable here as this is not a machine learning or AI-based device. The device's performance is established through direct physical and biological testing, not through training on a dataset.

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

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

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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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