(30 days)
The ADAPT® Tissue is indicated for use as a patch in the repair of cardiac defects including intracardiac defects, septal defects, valve and annulus repair.
The ADAPT® Tissue medical 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. The products range in size from 4cm² to 84cm² and can range in thickness from 0.25-0.80mm.
This document is a 510(k) Pre-Market Notification from Admedus Regen PTY LTD for their ADAPT® Tissue device. It primarily focuses on establishing substantial equivalence to previously cleared predicate devices (CardioCel and VascuCel) rather than presenting new performance data for the ADAPT® Tissue itself.
Therefore, many of the typical acceptance criteria and study details for an AI/ML device would not apply here. The key criteria for this submission are focused on demonstrating that "ADAPT® Tissue" is essentially the same device as the "CardioCel", with a minor labeling change (refining the indications for use).
However, I can extract the relevant information based on the document's content:
1. A table of acceptance criteria and the reported device performance:
Since this is a substantial equivalence submission based on an existing device (CardioCel), the "acceptance criteria" here are that the ADAPT® Tissue should be functionally equivalent to CardioCel. The reported performance refers to the nonclinical testing already performed for CardioCel.
| Acceptance Criteria (for ADAPT® Tissue to be SE to CardioCel) | Reported Device Performance (from CardioCel, applied to ADAPT® Tissue) |
|---|---|
| Device Description: Bovine pericardial patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT® TEP technology; sterile, light yellow to beige colored, moist, pre-cut sheet, acellular collagen. | Identical. The ADAPT® Tissue device is stated to be identical in design and manufacturing to CardioCel. |
| Materials: Bovine Pericardium | Identical. Bovine Pericardium. |
| Design and Scientific Principles: Glutaraldehyde fixed bovine pericardium using ADAPT® TEP technology. | Identical. Glutaraldehyde fixed bovine pericardium using ADAPT® TEP technology. |
| Performance: Long-term implant for the repair of cardiac defects. | Substantially Equivalent. The nonclinical testing performed for CardioCel supports the specific ADAPT® Tissue indication. |
| Sterilization Method: Propylene oxide. | Identical. Propylene oxide. |
| Biocompatibility: Biocompatible; meeting the requirements of ISO 10993. | Substantially Equivalent. Biocompatible; meeting the requirements of ISO 10993. |
| Intended Use/Indications for Use: Subset of predicate device's indications. | Substantially Equivalent. The indication for use statement of the proposed device (repair of cardiac defects including intracardiac defects, septal defects, valve and annulus repair) is a subset of the predicate device (CardioCel) indication for use. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as no new human clinical study was performed for the ADAPT® Tissue's specific submission. The submission relies on "nonclinical testing performed in support of the general intended use for CardioCel." Details about the sample size, provenance, and type of study for the original CardioCel testing are not included in this summary.
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 is not applicable as this is not an AI/ML diagnostic or image analysis device relying on expert interpretation for ground truth. It's a biocompatibility and performance assessment of a surgical patch.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for the reasons stated above.
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 device is a surgical patch, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "performance" verification of such a device, the "ground truth" would typically involve:
- Biocompatibility testing: In vitro and in vivo studies (animal models) to assess tissue integration, immune response, and toxicity, with outcomes often measured by histological analysis, inflammatory markers, and gross observations.
- Mechanical property testing: Laboratory tests to evaluate tensile strength, elasticity, and suture retention.
- Degradation studies: In vitro and in vivo studies to assess how the material degrades over time in a physiological environment.
- Sterility testing: Laboratory verification of sterility.
These "truths" are established through standard scientific and regulatory testing methods, not expert consensus in the diagnostic sense. The document states "The nonclinical testing performed in support of the general intended use for CardioCel also demonstrates substantial equivalence." This implies a reliance on these types of scientific evaluations performed for the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set in that context.
9. How the ground truth for the training set was established
Not applicable. For the same reason as above.
§ 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).