(111 days)
PremiPatch PTFE Pledgets are indicated for use in cardiovascular tissue. Pledgets are used to mechanically secure and support sutures in fragile tissue and organ parenchymas, when a non-absorbable suture is indicated. Pledgets are also used to aid in suture buttressing.
The PremiPatch PTFE Pledgets are pre-cut sections of non-absorbable undyed polytetrafluorothylene (PTFE) which are supplied sterile. The PremiPatch PTFE Pledgets are used as a suture buttress for nonabsorbable sutures. The pledgets are available in two application styles: firm and soft and various shapes and sizes. Depending on the size they are available package two or six per pouch.
This document is a 510(k) Premarket Notification from the FDA for the PremiPatch PTFE Pledgets. It is a regulatory document and, as such, does not describe the acceptance criteria or a study that proves the device meets specific performance acceptance criteria in the way a clinical or performance study report would for an AI/machine learning device.
Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device, which is the primary pathway for 510(k) clearance. The performance data mentioned is primarily non-clinical bench testing to ensure the new device performs similarly to the predicate and meets its own specifications, rather than a study against a specific set of clinical performance metrics.
Therefore, many of the requested categories for AI/ML device studies (such as sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to this type of medical device submission.
Here's a breakdown of what can be extracted and how it relates to your request:
1. A table of acceptance criteria and the reported device performance
The document states: "The non-clinical test data provided in this submission demonstrated that the PremiPatch PTFE Pledgets meet the performance specifications."
While specific numeric acceptance criteria and detailed performance results are not provided in this summary document, the types of tests conducted are mentioned:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Flexibility | Met performance specifications |
| Bridge rupture | Met performance specifications |
| Material Biocompatibility: | |
| ISO-10993 compliance | Deemed supportive based on prior evaluation of PTFE material in predicate device (K133890) |
| Sterility & Packaging: | |
| Package integrity | Demonstrated through accelerated aging data |
| Shelf life | Demonstrated through accelerated aging data |
Note: The actual numerical specifications and results would be in the full submission, not this summary. The "acceptance criteria" here are implied by the types of tests performed to establish equivalence and safety/performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This device is a physical medical device (pledgets), not an AI/ML diagnostic or predictive system. Therefore, there is no "test set" in the context of image data or patient records with specific sample sizes for AI model evaluation.
- Sample Size for Physical Testing: Not explicitly stated in this summary. The bench testing would have involved a sufficient number of device samples to establish performance specifications based on engineering and quality control standards.
- Data Provenance: Not applicable in the context of AI/ML data provenance. The data comes from internal non-clinical bench testing performed by Aesculap, Inc. (Pennsylvania, USA-based company).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device requiring expert-established ground truth for a diagnostic task. The "ground truth" for a physical device like a pledget is its material properties and mechanical performance as measured against engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no concept of adjudication for this type of device and testing.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical performance evaluations, the "ground truth" would be objective measurements from laboratory equipment and established engineering benchmarks/standards for material properties (e.g., tensile strength, flexibility, rupture force) and biocompatibility (e.g., ISO-10993 standards).
8. The sample size for the training set
Not applicable. This is not an AI/ML device with 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).