(147 days)
The MatriStem UBM™ Pericardial Patch is intended for the reconstruction and repair of the pericardium.
The MatriStem UBM Pericardial Patch is a 4-layer multi-laminate device comprised of stacked urinary bladder matrix (UBM) sheets. The Pericardial Patch serves as a patch to reconstruct the pericardium and restore the native anatomy. The Pericardial Patch is available in three sizes: 7x10 cm, 7x15 cm, and 10x15 cm. Each device is packaged in a double peel-open pouch and an outer carton. The device is terminally sterilized using electron-beam irradiation.
This document describes the regulatory submission for the MatriStem UBM™ Pericardial Patch, a medical device intended for the reconstruction and repair of the pericardium. It is a 510(k) premarket notification, which means the manufacturer (ACell, Inc.) is seeking to demonstrate that their device is substantially equivalent to legally marketed predicate devices, and therefore does not require a full premarket approval (PMA).
The information provided covers bench testing and an animal study to support the substantial equivalence claim. However, it's important to note that this submission does not involve an AI/ML-based device and therefore the questions relating to AI-specific acceptance criteria, multi-reader multi-case studies, expert adjudication methods, and training/test set ground truth establishment for an AI algorithm are not applicable to this document. The device is a biological patch, not a diagnostic or prognostic AI tool.
Therefore, many of the requested items regarding AI/ML aspects will be answered as "Not Applicable" or "No" as the study described is for a physical medical device.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a physical medical device and not an AI model, the acceptance criteria are based on physical, chemical, and biological properties, and functionality in an in vivo model.
| Acceptance Criteria Category | Specific Test/Measurement | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Material Properties | Basement Membrane Presence | Present | Met |
| Hydration Uptake | (Not specified, assumed within acceptable range for function) | Met | |
| Moisture Content | (Not specified, assumed within acceptable range for function) | Met | |
| Hydrated Onset Temperature | (Not specified, assumed within acceptable range for function) | Met | |
| Biocompatibility/Safety | Endotoxin | (Not specified, assumed below regulatory limits) | Met |
| Bioburden Enumeration | (Not specified, assumed below regulatory limits) | Met | |
| Cytotoxicity | Non-cytotoxic | Passed | |
| Sterilization Validation | Sterility achieved | Met (leveraged from reference devices) | |
| Biocompatibility | Biocompatible | Met (leveraged from reference devices) | |
| Viral Inactivation | Effective viral inactivation | Met (leveraged from reference devices) | |
| Mechanical Properties | Suture Retention Strength | (Not specified, assumed meets or exceeds predicate) | Met |
| Tensile Strength | (Not specified, assumed meets or exceeds predicate) | Met | |
| Device Stiffness | (Not specified, assumed meets or exceeds predicate) | Met | |
| Tearing Strength | (Not specified, assumed meets or exceeds predicate) | Met | |
| Ball Burst Strength | (Not specified, assumed meets or exceeds predicate) | Met | |
| Dimensional & Packaging | Dimensional Confirmation | Conforms to specified sizes (7x10 cm, 7x15 cm, 10x15 cm) | Met |
| Packaging Testing | Maintains sterility and integrity | Met (leveraged from reference devices) | |
| In Vivo Performance | Device Biocompatibility (Animal Study) | Full necropsy and histology evaluation of local tissues post-implantation showing biocompatibility over 90 days. | All acceptance criteria met. |
| Cardiac Function (Animal Study) | Similar or improved echocardiography measurements compared to sham. | All acceptance criteria met. | |
| Cellular Infiltration & Remodeling (Animal Study) | Similar or improved histopathologic outcomes versus predicate CorMatrix device. | All acceptance criteria met. | |
| Overall Function | Functioned as Intended | Yes | Yes |
Note: Specific quantitative acceptance criteria for most bench tests are not provided in this public summary but are typically part of internal design control documentation and would have been submitted to the FDA. The document states "All acceptance criteria were met" for the animal study, indicating the successful completion of the pre-defined endpoints.
2. Sample sizes used for the test set and the data provenance
-
Test Set Sample Size (Animal Study):
- Total pigs: 12
- Sham group (no repair): 2 pigs
- ACell MatriStem UBM Pericardial Patch group: 5 pigs
- Predicate CorMatrix Pericardial Patch group: 5 pigs
-
Data Provenance: The study was a "90-day Good Laboratory Practices (GLP) animal study" performed in a porcine (pig) model. The country of origin is not specified but generally, GLP studies adhere to international standards. It is a prospective animal study designed to evaluate the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable (N/A) for an AI/ML context. This is a physical medical device.
- For the animal study, the ground truth was established through objective biological and physiological assessments:
- Histology evaluation: Performed by pathologists.
- Full necropsy examination: Performed by veterinary pathologists.
- Echocardiography measurements: Performed by specialists in echocardiography (likely veterinary cardiologists or trained technicians).
- The document implies that these assessments were performed by qualified personnel as part of a GLP study, but the specific number and qualifications of individuals are not detailed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A for an AI/ML context. This pertains to consensus among human readers for image interpretation, which is not relevant for this device.
- For the animal study, the "adjudication" of results would rely on standardized GLP protocols for sample collection, pathology, and data analysis to ensure consistency and objectivity. Any disagreements in interpretation (e.g., in histology slides) would typically be resolved by senior pathologists or consensus panels within the pathology group, but this is not an "adjudication method" in the AI sense.
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 is a study for a physical implantable medical device, not an AI diagnostic/assistance tool.
- The comparative effectiveness was demonstrated by comparing the subject device to a predicate device and a sham in an animal model based on biological and physiological outcomes, not human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Pathology and Outcomes Data (from an animal model).
- Histology evaluation: Provides microscopic ground truth on tissue response, cellular infiltration, and remodeling.
- Full necropsy examination: Provides macroscopic ground truth on device integration and tissue health.
- Echocardiography measurements: Provides functional ground truth on cardiac performance.
- The "ground truth" for the device's performance in vivo was established by these objective biological and physiological assessments in directly implanted animals.
8. The sample size for the training set
- N/A. This is a physical medical device. There is no "training set" in the context of machine learning.
- The development process for this device would involve extensive internal research and development, materials characterization, and process optimization, but this does not constitute a "training set" for an AI model.
9. How the ground truth for the training set was established
- N/A. As there is no AI training set, this question is 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).