(86 days)
The Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material are indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter).
The Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material are used to access the venous system and to facilitate catheter insertion. Edwards Lifesciences wishes to package the Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material in a convenience kit. One of the components of the kit is a silk suture. The suture manufacturer provides the suture either gamma sterilized or non-sterile. Edwards wishes to receive the suture non-sterile, with ethylene oxide sterilization as the final sterilization process for the kit, including the suture. The reason for this submission is the change in sterilization process for the suture component of the kit.
The provided text describes a 510(k) summary for a medical device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for an AI/ML device.
This document pertains to a resubmission for a Percutaneous Sheath Introducer where the change is in the sterilization method for a suture component of a kit. The approval is based on substantial equivalence to a predicate device, not on specific performance data against defined acceptance criteria.
Therefore, I cannot fulfill most of your request directly from the provided text. However, I can extract the relevant information that is present:
Key Takeaways from the document regarding the study and acceptance criteria:
- The device is a Percutaneous Sheath Introducer, not an AI/ML device. Therefore, the questions about AI/ML specific aspects (training set, inference, human-in-the-loop, etc.) are not applicable here.
- The submission is for a change in the sterilization process for a suture component of a kit, not for a new device design or a new AI/ML algorithm.
- The "study" described is primarily focused on demonstrating compliance with USP 25 for non-absorbable surgical sutures after the change in sterilization method (Ethylene Oxide). This is a regulatory compliance and material property assessment, not a clinical performance study with acceptance criteria often seen for new clinical devices or AI algorithms.
- The acceptance criteria are implied to be compliance with USP 25 and successful functional/biocompatibility testing for the ethylene oxide-sterilized sutures.
Based on the provided text, here's an attempt to answer your questions, highlighting what is not applicable or not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with USP 25, Nonabsorbable Surgical Sutures (for EO-sterilized sutures) | "The ethylene-oxide sterilized sutures have been demonstrated to be in compliance with USP 25, Nonabsorbable Surgical Sutures." |
| Functional testing (for EO-sterilized sutures) | "The ethylene-oxide sterilized sutures have successfully undergone functional...testing." |
| Biocompatibility testing (for EO-sterilized sutures) | "The ethylene-oxide sterilized sutures have successfully undergone...biocompatibility testing." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document.
- Data Provenance: Not specified, but given the nature of the tests (USP 25, functional, biocompatibility), it would likely be laboratory/bench testing.
- Retrospective/Prospective: Not applicable in the context of this type of testing.
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)
- Not applicable. This document describes testing for material properties and regulatory compliance of a physical medical device component (suture), not a clinical assessment requiring expert-established ground truth. The "ground truth" here is the standard set by USP 25.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This relates to clinical studies and expert consensus, which is not the subject of this document.
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 AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the tests mentioned (functional, biocompatibility, USP 25 compliance) is primarily established industry and regulatory standards (specifically USP 25 for non-absorbable surgical sutures) and established laboratory testing protocols.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, and thus there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).