(336 days)
CV Peri-Guard™ is intended for use as a patch for intracardiac, great vessel, valve repair and suture line buttressing (i.e. atrial septal defect (ASD) patch, atrial patch, valve annuloplasty, coronary graft buttress). May be used for repair of ventricular septal defect (VSD) using either a single patch or reinforced patch technique. May also be used in other applications exposed to peak systolic pressure using a reinforced patch technique (i.e. ventricular aneurysm patch, aortic graft suture line buttress).
CV Peri-Guard™ is intended for use as a patch material for intracardiac defects, great vessel, septal defect and annulus repair, and suture-line buttressing.
CV Peri-Guard™ - Cardiovascular Patch. CV Peri-Guard is composed of bovine pericardium, crosslinked with glutaraldehyde. Available in configurations ranging from 1 cm x 1 cm to 14 cm x 16 cm.
The provided document is a 510(k) premarket notification for a medical device (CV Peri-Guard™ Cardiovascular Patch) and its associated FDA clearance letter. It does not contain the detailed information necessary to fully address all aspects of your request, particularly regarding specific acceptance criteria and the comprehensive study design typically associated with AI/ML device evaluations.
Here's an analysis based on the available information, highlighting what can be extracted and what is missing:
The device, CV Peri-Guard™, is a cardiovascular patch made of bovine pericardium. The premarket notification is for an extension of indications for use in intracardiac and great vessel repair. The core argument for substantial equivalence is based on the device's similarity to existing predicate devices (Gore-Tex Cardiovascular Patch, Peri-Guard, and Vascu-Guard) and a history of safe and effective use of the base material.
Missing Information (Crucial for an AI/ML context):
- No AI/ML device: This document describes a traditional medical device (a surgical patch), not an AI/ML diagnostic or predictive device. Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable to this type of submission.
- Quantitative Acceptance Criteria: The document focuses on demonstrating substantial equivalence to existing devices rather than meeting specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy thresholds) that would define "acceptance criteria" for an AI/ML system. The "acceptance criteria" here are qualitative and relate to the overall safety and effectiveness compared to predicates.
- Detailed Study Design for Performance Metrics: While studies are mentioned (calcification, canine, clinical report), the methodology, statistical analysis, and specific performance outcomes in a quantifiable manner (e.g., "device performed at X% sensitivity") are not provided.
Based on the available information, here is an attempt to populate the table and answer the questions, with explicit notes about missing or non-applicable data:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criterion (Implicitly from 510(k)) | Reported Device Performance (Implicitly from 510(k)) |
|---|---|---|
| Material Properties | Physical/mechanical properties substantially equivalent to predicate devices for intracardiac and great vessel repair. | "[T]he physical and mechanical properties critical for performance... are substantially equivalent between CV Peri-Guard and the predicate device." |
| Biocompatibility | Demonstrate biocompatibility, especially non-hemolytic nature for intracardiac use. | "[A] long history of biocompatibility. Peri-Guard has been marketed since 1982 with no indication of biocompatibility problems." "Biocompatibility testing... consistent with this clinical experience and the nonhemolytic nature of CV Peri-Guard is especially relevant." |
| Calcification | Clinically insignificant calcification, comparable to or better than predicates. | "Peri-Guard and Supple Peri-Guard have demonstrated clinical insignificant calcification and significantly less calcification than either a glutaraldehyde-treated control or a competitor's bovine pericardial patch product." "No calcification related to the Peri-Guard patch up to a mean of 17 months post-op in clinical use." |
| In Vivo Performance | Perform in a similar manner in vivo compared to existing materials. | "A Canine implant study show that Supple Peri-Guard and ePTFE perform in a similar manner, in vivo." |
| Clinical Safety & Effectiveness | Safe and effective performance in clinical use, substantially equivalent to alternative materials for intracardiac and great vessel repair. | "The clinical data, gathered under the Peri-Guard Retrospective study protocol, demonstrated that our bovine material performed safe and effectively, and in a substantially equivalent fashion to alternative intracardiac and great vessel patch materials." |
| History of Use | Long history of safe and effective use in similar applications. | "Processed bovine pericardium has been used widely as an implant material for well over two decades and has been shown to be safe and effective in a variety of medical applications." |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not explicitly stated in a quantifiable number.
- For the Calcification Studies: "Peri-Guard and Supple Peri-Guard have been evaluated in a proven model for calcification: the juvenile rat subcutaneous mode." No specific number of rats/samples is provided. Clinical evaluation involved "mittal valve annulus position, and other intracardiac patch positions" with outcome "up to a mean of 17 months post-op." The number of patients is not specified.
- For Canine Studies: "A Canine implant study." Single study mentioned, but sample size (number of canines or implants) not specified.
- For Clinical Report: "The clinical data, gathered under the Peri-Guard Retrospective study protocol." No specific number of patients or cases is mentioned.
- Data Provenance:
- Country of Origin: Not specified. Implicitly, as the submitting company is US-based and FDA is the regulatory body, some studies might be US-based, but this is not confirmed.
- Retrospective or Prospective:
- Clinical Report: Explicitly states "Retrospective study protocol."
- Other studies (Calcification, Canine): Not specified, but likely experimental laboratory/animal studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable in the context of an AI/ML device. The "ground truth" here relates to biological and clinical outcomes assessed through animal models, pathology (in calcification studies), and clinical evaluation. The evaluations would have been conducted by relevant scientific and medical professionals (e.g., pathologists, surgeons, veterinarians), but no specific "expert panel" for establishing a diagnostic ground truth for a test set is described, as would be common for AI/ML performance assessment.
4. Adjudication method for the test set
- Not Applicable. As this is not an AI/ML device assessing a "test set" for diagnostic accuracy, no adjudication method (like 2+1 or 3+1 consensus) for expert decisions is described. The "judgement" of the device's performance is based on direct measurement, observation, and clinical outcomes.
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-assisted device. An MRMC study is not relevant.
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
- Expert Consensus: Not explicitly described for a specific "ground truth" decision-making process.
- Pathology: Likely used in the calcification studies ("juvenile rat subcutaneous mode," "glutaraldehyde-treated control").
- Outcomes Data: Yes, this is a primary ground truth.
- Clinical outcomes (e.g., clinical insignificance of calcification, safe and effective performance over time, "no calcification related to the Peri-Guard patch up to a mean of 17 months post-op" from the clinical report).
- In vivo animal model outcomes (canine study showing similar performance to ePTFE).
- Biocompatibility testing results.
8. The sample size for the training set
- Not Applicable in an AI/ML context. This device does not have a "training set." The "experience" or "data" is derived from historical use of the base material and predicate devices, as well as the studies mentioned.
9. How the ground truth for the training set was established
- Not Applicable. No training set exists for this type of device. The "ground truth" for the overall understanding of the material's performance (analogous to how a training set might inform an AI model) comes from decades of historical clinical use of processed bovine pericardium and predicate devices, as well as the preclinical and clinical studies conducted.
§ 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).