(29 days)
VascuCel is indicated as a patch in great vessel repair, peripheral vascular reconstruction and suture line buttressing.
The VascuCel device is a bovine pericardial patch prepared from glutaraldehyde-crosslinked bovine pericardium using the ADAPT® TEP technology. It is a sterile, light yellow to beige colored, moist, pre-cut sheet of acellular collagen. It is offered in a 2 x 8 cm size and a 0.8 x 8 cm size.
This document is a 510(k) summary for VascuCel, a bovine pericardial patch. It does not describe a study proving a device meets acceptance criteria in the typical sense of a clinical trial or algorithm performance study with specific metrics like accuracy, sensitivity, or specificity. Instead, it argues for "substantial equivalence" to a predicate device based on existing clinical literature and verification/validation testing.
Therefore, the following information, based on the provided text, will address the user's request in the context of a 510(k) submission for substantial equivalence. Many requested fields regarding specific performance metrics, sample sizes for test/training sets, expert consensus, and MRMC studies are not applicable or not provided in the context of this type of regulatory submission.
1. A table of acceptance criteria and the reported device performance
Since this is a submission for substantial equivalence based on a predicate device and established clinical practice, the "acceptance criteria" are primarily related to general safety and effectiveness and comparative performance to the predicate. Specific quantitative performance metrics (like sensitivity/specificity for an AI device) are not present.
| Acceptance Criterion (Implicit) | Reported Device Performance (VascuCel) |
|---|---|
| Biocompatibility | Made from glutaraldehyde-crosslinked bovine pericardium, similar to predicate. Verification and validation testing conducted on CardioCel (predicate) demonstrated safety. |
| Material Properties | Sterile, light yellow to beige colored, moist, pre-cut sheet of acellular collagen. Dimensions are 2 x 8 cm and 0.8 x 8 cm. |
| Sterility | "Sterile" (stated in device description). |
| Intended Use Equivalence | Indicated for great vessel repair, peripheral vascular reconstruction, and suture line buttressing, which is a subset of the predicate device's broader indications and aligns with established clinical practice for bovine pericardial patches. |
| Safety and Effectiveness | Safety and effectiveness of bovine pericardial patches for reconstruction and repair of cardiac and vascular anatomy is well established in clinical literature. Verification and validation testing on CardioCel (predicate) demonstrated safety and effectiveness for proposed indications. Clinical data demonstrating acute safety of VascuCel is also provided. |
| Substantial Equivalence | The device is substantially equivalent to the currently marketed predicate device (K130872 CardioCel) based on technical information, intended use, laboratory verification tests, and clinical performance data. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of an algorithm or statistical performance study. The submission refers to "clinical data demonstrating the acute safety of VascuCel" but does not give a sample size, provenance, or whether it was retrospective or prospective. For the predicate device, it mentions "clinical performance data that was performed on CardioCel."
- Data Provenance: Not specified for the "clinical data demonstrating acute safety of VascuCel." The predicate device information (CardioCel) likely drew from various clinical studies and literature, which are not detailed here.
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 is not a study requiring expert-established ground truth in the context of image interpretation or diagnostic performance. The device is a patch for surgical repair. The "ground truth" for its safety and effectiveness relies on established medical understanding and clinical outcomes from surgical use.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is typically relevant to studies involving multiple expert readers interpreting data for ground truth establishment.
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 device is a surgical patch, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (surgical patch), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the claims of safety and effectiveness relies on:
- Established Clinical Literature: The document states, "The safety and effectiveness of bovine pericardial patches for the reconstruction and repair of cardiac and vascular anatomy is well established in clinical literature and is the current standard of care in clinical practice." This implies a broad body of outcomes data and expert consensus over time.
- Verification and Validation Testing: Performed on the predicate device (CardioCel), which would involve various laboratory and potentially animal studies to confirm material properties and biological response.
- Acute Safety Clinical Data: Provided for VascuCel, suggesting actual patient outcome data, though details are absent.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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).