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The CorMatrix® ECM® for Carotid Repair is intended for use as a patch material for vascular reconstruction and repair of the carotid artery, including patch closure following carotid endarterectomy and suture line buttressing.

The CorMatrix ECM for Carotid Repair is an extracellular matrix (ECM) scaffold derived from porcine small intestinal submucosa (SIS). SIS is developed from a select layer of tissue that is recovered from porcine small intestine. During processing, the inner and outer muscle layers of the material are removed, leaving an intact submucosa with a portion of the tunica propria layer attached to the outer surface. Following processing, the remaining acellular ECM material is cut to specific shapes and sizes, lyophilized, and terminally sterilized using Ethylene Oxide gas. The CorMatrix ECM for Carotid Repair is derived from the same SIS-ECM material as CorMatrix's two commercially available products, the CorMatrix ECM for Pericardial Closure and the CorMatrix ECM for Cardiac Tissue Repair. The CorMatrix ECM for Carotid Repair will be supplied as a multilaminate, Iyophilized, sterilized sheet of SIS-ECM. The CorMatrix ECM will be provided in four sizes: 1x10cm, 1x15cm, 2x10cm and 2x15cm sheets.

This looks like a 510(k) premarket notification for a medical device called the CorMatrix ECM for Carotid Repair. Based on the provided text, there is no acceptance criteria or study of an AI/ML powered device. This document describes the "substantial equivalence" of a biologic patch material to predicate devices. Therefore, a table of acceptance criteria and device performance for an AI/ML powered device, an MRMC study, or a standalone study are not applicable and cannot be extracted from this text.

Here's an analysis of what is provided, framed in terms of the closest relevant aspects, and explicitly stating where information requested is not present for an AI/ML device:

Analysis of CorMatrix® ECM® for Carotid Repair

This document describes a 510(k) premarket notification for a medical device. The device is a patch material for vascular reconstruction and repair of the carotid artery, derived from porcine small intestinal submucosa. The submission focuses on demonstrating "substantial equivalence" to existing predicate devices through nonclinical bench and animal testing. This is not an AI/ML powered device.

Therefore, most of the requested information related to AI/ML device acceptance criteria, study design, and ground truth establishment (especially for AI models) is not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Note: This device is a biologic patch material, not an AI/ML algorithm. The "acceptance criteria" here refer to performance specifications for the physical properties of the patch, not diagnostic accuracy metrics typically associated with AI/ML.

Disclaimer: The document explicitly states that the collective results "demonstrate that the CorMatrix ECM for Carotid Repair meets the established specifications necessary for consistent performance for its intended use" and "does not raise new questions of safety or efficacy." However, specific numerical acceptance thresholds and the exact measured performance values are not detailed in this summary.

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 for test set: Not applicable in the context of an AI/ML test set. The testing involved nonclinical bench tests and animal studies. Specific "sample sizes" for these tests (e.g., number of patches tested for suture retention, number of animals in the in vivo study) are not provided in this summary.
• Data provenance: Not applicable in the context of human clinical data for an AI/ML device. The testing was nonclinical (bench and animal). The country of origin for the animals or bench test materials is 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)

• This is not applicable as the ground truth here refers to the physical and biological properties of a material, established through standardized testing procedures, not expert interpretation of diagnostic images or data for an AI/ML algorithm.

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

• This is not applicable for the type of bench and animal testing described. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human experts in interpreting data, which is not the nature of the testing 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

• No, an MRMC comparative effectiveness study was not done. This device is a surgical patch, not an AI/ML diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

• No, a standalone study was not done. This concept is only relevant for AI/ML algorithms, which this device is not.

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

• The "ground truth" for this device's performance is established through standard nonclinical testing methodologies (e.g., ASTM standards for material strength, biocompatibility assays, in vivo animal model observations for biological response and vessel burst pressure). It is based on objective measurements and observations from these tests.

8. The sample size for the training set

• Not applicable. This is a hardware/biologic device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As this is not an AI/ML algorithm, there is no training set or associated ground truth generation process.

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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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