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The Edwards Percutaneous Sheath Introducer is 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 Perculaneous Sheath Introducer is intended to access the venous system and to facilitate catheter insertion. The Percutaneous Sheath Introducers allow access to the venous system for administration of fluids, blood sampling and for pressure monitoring through the additional lumens.

The triple lumen percutaneous sheath introducer is used to access the venous system and to facilitate catheter insertion. The multi-lumen feature of the Introducer also allows access to the venous system for administration of fluids, blood sampling and for pressure monitoring through the additional lumens. The introducer is recommended to facilitate insertion of 7.5 - 8.5 French devices.

The introducer is composed of a valve housing to which a sheath is attached distally and three side arm/extension tubes are connected proximally. The valves located in the housing body provide a seal around a catheter when inserted through the introducer and prevent backflow when no catheter is present. A dilator is provided with the introducer to ease insertion of the device into the vessel.

The devices are provided sterile and non-pyrogenic; they are intended for single use only.

The provided document describes a traditional 510(k) premarket notification for a medical device, the Edwards Percutaneous Sheath Introducer, and does not include information about AI/ML device performance or studies. Therefore, many of the requested fields are not applicable.

Here's the information that can be extracted or inferred based on the document's content, formatted to match your request:

Acceptance Criteria and Device Performance Study for Edwards Percutaneous Sheath Introducer (K121185)

This device is a traditional medical device (Percutaneous Sheath Introducer), and the provided documentation focuses on its functional and safety testing for regulatory submission. It does not involve AI or machine learning algorithms, thus many of the requested sections (e.g., sample size for test/training set, expert ground truth, MRMC study, standalone performance) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the provided document. The submission states "All data met pre-determined acceptance criteria" for functional/safety testing, but does not detail the number of units or tests performed.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The tests are laboratory/bench tests for device functionality and safety, likely conducted by Edwards Lifesciences LLC.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This device is not an AI/ML diagnostic or predictive tool, so "ground truth" derived from expert consensus on medical images or patient data is not relevant to its regulatory submission. The "ground truth" for these tests would be the physical properties and performance metrics of the device itself.

4. Adjudication method for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in interpreting medical data, typically for AI/ML diagnostic tools. This submission involves technical performance testing, not human interpretation of medical data.

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

• No, an MRMC study was not done. This device is a physical medical instrument (Percutaneous Sheath Introducer), not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an algorithm or AI device. The tests performed are for the physical device's standalone performance in various functional aspects.

7. The type of ground truth used

• Ground Truth Type: For the functional/safety tests, the "ground truth" refers to the established engineering specifications, performance standards (e.g., ISO 10993-1), and design requirements for the device. For example, for "Tensile testing," the ground truth would be the minimum force required to remove parts as specified in the design.

8. The sample size for the training set

• Not applicable. This device does not use an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. As there is no AI/ML algorithm or training set, the concept of establishing ground truth for a training set does not apply.

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