(188 days)
The CorMatrix® Tyke™ is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defect and annulus repair, suture-line buttressing, and cardiac repair.
CorMatrix® Tyke™ is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defect and annulus repair, suture-line buttressing, and cardiac repair.
CorMatrix® Tyke™ is derived from the same multi-laminate SIS-ECM material as the CorMatrix ECM for Cardiac Tissue Repair (4-ply). The CorMatrix® Tyke™ will be supplied as a 2-ply, lyophilized, sterilized sheet of SIS-ECM. With the exception of the differing layer counts, the device design and construction are identical to the FDA-cleared CorMatrix ECM for Cardiac Tissue Repair (K063349).
The provided text describes the 510(k) premarket notification for the CorMatrix® Tyke™ device, a medical implant for cardiac repair in neonates and infants. The document focuses on demonstrating substantial equivalence to a predicate device, the CorMatrix® ECM® for Cardiac Tissue Repair.
However, the information provided does not contain details about acceptance criteria, a specific study proving the device meets those criteria in a typical clinical trial format (e.g., sample size for test set, expert qualifications, adjudication methods for ground truth, MRMC study, training set details, or standalone algorithm performance).
The document primarily discusses non-clinical testing of the material properties and a non-clinical investigational study in an animal model. It does not describe a study involving human subjects or a diagnostic AI/ML device where such details would be relevant.
Therefore, many of the requested categories cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot, based on the provided document:
1. Table of acceptance criteria and reported device performance:
The document describes performance testing for material properties and an in-vivo non-clinical study, but does not present a table of specific acceptance criteria with corresponding device performance values. It generally states that the device "exceeds the biomechanical requirements for its intended use" and that the in-vivo study showed "optimal healing features" and "no adverse changes recorded."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biomechanical Properties | |
| Tensile Strength (implied, not quantified) | Device possesses "adequate material properties" and "exceeds biomechanical requirements." |
| Suture Retention (implied, not quantified) | Device possesses "adequate material properties" and "exceeds biomechanical requirements." |
| Burst Strength (implied, not quantified) | Device possesses "adequate material properties" and "exceeds biomechanical requirements." |
| Withstands Tension/Hemodynamic Forces (implied) | Material "withstands the tension, and hemodynamic forces exerted on the material when used for pediatric cardiovascular repair, pericardial reconstruction, and venous cardiac outflow reconstruction." |
| In-vivo Performance (Non-clinical Study) | |
| Structural Integrity Restoration (implied) | "Structural integrity of the arteriotomy sites were restored through fibrocellular integration of the ECM implant and formation of a fully mature, stable, and endothelialized neointima." |
| Host Cellular Response/Remodeling (optimal) | "Optimal healing features in both the Control (Cardiac Tissue Repair) and Test (Tyke) groups." |
| Absence of Adverse Changes | "No adverse changes recorded." |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document mentions a "non-clinical investigational study," which implies an animal study, not human patients. The specific number of animals or data points for this study is not provided.
- Data Provenance: The study was "in vivo," meaning conducted in living organisms, likely animals, but the specific country of origin of the data is not specified. It was a prospective study in the sense that outcomes were observed after implantation.
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 information is not applicable/provided as the study described is a non-clinical/animal study examining material properties and biological responses, not a study requiring human expert interpretation for ground truth, like for an AI diagnostic device. Histological techniques were used for evaluation, which would involve pathologists/histologists, but their number and qualifications are not disclosed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable/provided. Adjudication methods are typically relevant for human reader studies or when establishing ground truth from multiple expert interpretations, which is not the type of study described here.
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:
This is not applicable/provided. The device is a medical implant, not an AI/ML diagnostic system intended to assist human readers. Therefore, an MRMC study is not relevant to proving its effectiveness.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable/provided. The device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical in-vivo study, the ground truth was established through histological techniques to evaluate structural integrity and host cellular response. This implies direct observation and analysis of tissue samples, which would typically be interpreted by veterinary pathologists or similar experts.
8. The sample size for the training set:
This is not applicable/provided. There is no mention of a "training set" as this is a physical medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established:
This is not applicable/provided. As above, no training set for an algorithm is described.
§ 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).