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The Pasteur Pipettes are intended for handling and transferring of liquids, media and gametes during assisted reproductive technology procedures.

The Pasteur Pipettes are radiation-sterilized, single use, transparent low-density polyethylene pipettes intended for handling and transferring of liquids, media and gametes during assisted reproductive technology (ART) procedures. The pipettes are provided in two sizes, 1 mL (Model 16201) and 3 mL (Model 16202). Each pipette includes an integrated bulb end that is used to aspirate and expel liquid, media and gamete to and from the device. The pipettes also include a molded volume scale along the body of the pipette. The volume scale only provides an estimate of the aspirated volume. The pipettes will not come in contact with the human body during use.

The provided FDA 510(k) summary for the HertART Pasteur Pipette 3mL and 1mL describes the device, its intended use, comparison to a predicate device, and non-clinical performance data. However, the document does not contain information related to a study that proves the device meets specific acceptance criteria in the context of diagnostic accuracy, comparative effectiveness with human readers (MRMC), or standalone algorithm performance.

The document focuses on demonstrating substantial equivalence based on the device's physical properties, sterilization, packaging, and general biological safety (MEA and Endotoxin testing). It's a medical device clearance for a labware item, not an AI/ML or diagnostic device that would typically involve the type of performance studies you're asking about.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy.
2. Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for a diagnostic study.
3. Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
4. Standalone (algorithm only) performance.
5. Ground truth types for diagnostic studies.
6. Training set sample size or ground truth establishment for a diagnostic algorithm.

The information extracted from the document pertains to the quality and safety of the physical pipettes as labware for assisted reproductive technology procedures.

Here is a summary of the non-clinical performance data and acceptance criteria as described in the document, which are focused on device quality and safety:

Acceptance Criteria and Reported Device Performance (Non-Clinical)

Regarding the specific questions you asked:

1. A table of acceptance criteria and the reported device performance: See the table above. These are quality and safety performance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical labware device's non-clinical testing. The "test set" would refer to sample pipettes used in the described physical and biological tests. No specific numbers are provided for these samples in this summary beyond the general statement of "testing conducted."
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. "Ground truth" in this context would be laboratory standards for sterility, endotoxin levels, and physical integrity, not a consensus interpretation by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the biological and physical tests, the "ground truth" is defined by established international standards (ISO, ASTM, USP) for sterility, material properties, and biological safety.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

This document clearly outlines the non-clinical testing for a physical medical device (Pasteur Pipette) to demonstrate its performance and safety for its intended use as assisted reproduction labware. The requests about AI/ML performance, diagnostic accuracy, and expert involvement for ground truth are not relevant to this specific device and the information provided in the 510(k) summary.

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