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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

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.

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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 Baxter Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material are used to access the venous system and to facilitate catheter insertion. The introducers are composed of a housing body to which a sheath is attached distally and a side port/extension tube is connected proximally. The sheath is composed of Oligon™ a polyurethane-based antimicrobial material. (Silver is the antimicrobial agent.) A valve is located in the housing body to provide a seal around a catheter when inserted through the Introducer and to prevent backflow when no catheter is present. A dilator is provided with the Introducer to ease insertion of the device into the vessel. The device will be packaged in a tray sealed with a tyvek lid and sterilized using 100% ethylene oxide.

The provided text describes a 510(k) submission for the "Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material." This is a medical device, and the submission focuses on demonstrating substantial equivalence to predicate devices rather than proving novel efficacy through clinical trials. Therefore, the questions related to AI-specific terms like "AI assistance," "standalone algorithm performance," and "training set" are not applicable.

Here's an analysis based on the provided text for the aspects that are relevant:

Acceptance Criteria and Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format with specific performance metrics. Instead, it relies on demonstrating comparable performance and characteristics to predicate devices. The "acceptance criteria" are implicitly met by showing that the device performs similarly to existing, legally marketed devices.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not explicitly stated. The document refers to "functional testing" and "biocompatibility testing" but does not quantify the number of units or samples tested for each.
• Data Provenance: The document does not specify the country of origin for the data. The testing appears to be internal (Edwards Lifesciences LLC). The studies are retrospective in the sense that they are laboratory/bench tests and material evaluations, not prospective clinical trials on human subjects.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This question is not applicable in the context of this 510(k) submission. The "ground truth" for this type of medical device submission is established through standard engineering principles, materials science, and regulatory compliance (e.g., ISO standards). There's no mention of expert radiologists or similar medical professionals establishing ground truth for a test set in the traditional sense of diagnostic AI. The evaluation is based on objective measurements and established industry standards for device performance and safety.

4. Adjudication Method for the Test Set:

• Not applicable. As there isn't a diagnostic "test set" requiring human interpretation or consensus, there's no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not performed on the subject device because the intended use and indications are the same as the predicate devices. Furthermore, the Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material exhibited comparable design characteristics to the predicate devices in the in vitro testing, thus clinical testing was not performed."
• Effect Size with/without AI assistance: Not applicable, as this device does not involve AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. This device is a physical medical instrument (sheath introducer) and does not involve any algorithms or AI for standalone performance.

7. The Type of Ground Truth Used:

• The "ground truth" for the device's performance and safety is based on:
  • Engineering specifications and design requirements: For functional testing (e.g., integrity, performance for venous access).
  • International Standards Organization (ISO) 10993-1-1994 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests and the FDA General Program Memorandum No. G95-1: For biocompatibility testing.
  • Comparison to predicate devices: The "ground truth" for regulatory approval largely rests on demonstrating substantial equivalence, meaning the new device is as safe and effective as existing legally marketed devices.

8. The Sample Size for the Training Set:

• Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As there is no training set.

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