(90 days)
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.
| Acceptance Criterion (Nonclinical Test) | Reported Device Performance |
|---|---|
| Suture retention strength | Meets established specifications (Specific values not provided) |
| Probe burst strength | Meets established specifications (Specific values not provided) |
| Tensile strength | Meets established specifications (Specific values not provided) |
| Biocompatibility | Meets established specifications (Specific results not provided) |
| Sterilization validation | Meets established specifications (Specific results not provided) |
| Packaging and shelf-life | Meets established specifications (Specific results not provided) |
| Animal testing (Safety & Performance) | Performance, as well as burst pressures of repaired vessels at various time points (Specific results not provided) |
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.
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).