(148 days)
The MatrACELL™ Decellularized Pulmonary Artery Patch Allograft is indicated for repair of the right ventricular outflow tract.
derived from human pulmonary artery tissue and subsequently decellularized. The product is provided in multiple sizes for clinical use.
This document is a 510(k) summary for the MatrACELL™ Decellularized Pulmonary Artery Patch Allograft. It describes the device, its intended use, and its substantial equivalence to predicate devices. It does not present any specific acceptance criteria or a study proving the device meets acceptance criteria in the way typically found for AI/ML medical devices (e.g., performance metrics like sensitivity, specificity, or AUC).
Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed devices, which is the primary pathway for 510(k) clearance. The "performance data" mentioned is not about meeting specific numerical thresholds for diagnostic accuracy, but rather about showing that the device is as safe and effective as its predicates.
Here's a breakdown of the information that can be extracted, and where the requested AI/ML specific information is not available from this document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices for safety and efficacy. | Differences in technological characteristics do not raise new issues of safety or efficacy. Performance and safety evaluated through extensive bench and animal testing in the female juvenile sheep model. Collective results demonstrated substantial equivalence in safety and efficacy. |
Missing from the document: Specific numerical acceptance criteria (e.g., minimum sensitivity, specificity, or precision) for diagnostic/classification performance, as this is not an AI/ML diagnostic device being cleared.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of an AI/ML device. The "test set" here refers to the data used in bench and animal testing. The document mentions a "female juvenile sheep model" for animal testing, but does not specify the number of animals or the specific details of the bench tests.
- Data Provenance: The animal study was conducted using a "female juvenile sheep model." The location of this study (e.g., country of origin) is not specified. It is a prospective study as it involves new animal testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable / Not stated: Ground truth in the context of this device (a tissue allograft) would likely relate to histological analysis, tissue integration, mechanical properties, and functional outcomes in the animal model. The document does not specify the number or qualifications of experts involved in analyzing the results of the bench and animal tests.
4. Adjudication Method for the Test Set
- Not applicable / Not stated: Adjudication methods are typically used to resolve discrepancies among experts when establishing ground truth for diagnostic AI/ML models. This type of formal adjudication process is not described for the evaluation of this tissue allograft.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, not performed: An MRMC comparative effectiveness study is used to assess human reader performance with and without AI assistance. This device is a tissue allograft, not an AI/ML diagnostic or assistive device, so such a study would not be relevant.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- No, not applicable: This device is a tissue allograft, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this submission.
7. The Type of Ground Truth Used
- The implicit "ground truth" for demonstrating substantial equivalence for this device would likely be:
- Histology/Pathology: Assessment of tissue integration, cellular infiltration, inflammation, and degradation in the animal model.
- Mechanical Properties: Bench testing to ensure the patch's physical properties (e.g., tensile strength, flexibility) are suitable and comparable to native tissue or predicate devices.
- Functional Outcomes Data: In the animal model, this would involve assessing the long-term patency, remodeling, and hemodynamic performance of the patched right ventricular outflow tract.
- Safety Data: Assessment of adverse events, host immune response, and complications in the animal model.
8. The Sample Size for the Training Set
- Not applicable: This device is not an AI/ML model that requires a training set. The "development" of the decellularization process might involve various experimental runs, but this is distinct from an AI/ML training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable: As there is no AI/ML training set, the concept of establishing ground truth for it does not apply. The development of the decellularization process would be based on established scientific principles and experimental results to achieve the desired tissue properties.
§ 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).