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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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