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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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For in-vitro fertilisation, handling and embryo culture. It may be used for the culturing of embryos using drop culture

The Micro well group culture dishes are injection molded and disposable. The dishes are round and supplied with a lid. The dishes holds 9 small wells respectively 16 small wells. The polymers used for the dishes are virgin crystal grade polystyrene, which has successfully passed 1- cell embryotoxicity test. The dishes are packed 1 unit in a sleeve, 10 sleeves in a case. The dishes are terminally sterilized by irradiation to achieve a SAL of 10-6. The dishes are non-pyrogenic as tested by LAL, and non-embryotoxic as tested by one cell Mouse Embryo Assay (MEA). The Dishes are single use devices.

This document describes a 510(k) premarket notification for a new medical device, not a study evaluating a device's performance against detailed acceptance criteria for an AI algorithm. Therefore, many of the requested fields are not applicable to the provided text.

The document discusses two new devices: a "Micro well group culture dish, 9-well" and a "Micro well group culture dish, 16-well," for use in in-vitro fertilization (IVF). The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Vitrolife Micro Droplet Culture Dish, K123641) rather than presenting a performance study of a novel AI system.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on the characteristics of the predicate device and established standards for IVF labware. The performance is reported as meeting these standards.

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

• Not applicable. This document describes a medical device (culture dish) and its regulatory approval process, not an AI algorithm's performance study with a test set of data. The "tests" mentioned are for biological safety (sterility, pyrogenicity, embryotoxicity) of the physical product.

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

• Not applicable. Ground truth in the context of an AI algorithm's performance is not relevant here. The ground truth for the physical device characteristics (e.g., sterility) is established by standard laboratory testing protocols and validated methods (e.g., LAL assay, MEA).

4. Adjudication method for the test set:

• Not applicable. There is no "test set" of AI algorithm outputs requiring adjudication by experts.

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 document is not about AI assistance.

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

• Not applicable. This document does not describe an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the performance testing of the physical device, the "ground truth" is based on standardized laboratory assays and biological indicators:
  • Sterility: Achieves a Sterility Assurance Level (SAL) of 10⁻⁶, meaning the probability of a single viable microorganism occurring on a product unit after sterilization is no more than one in a million.
  • Non-pyrogenic: Demonstrated by Limulus Amebocyte Lysate (LAL) assay, with results of < 0.25 EU/mL.
  • Non-embryotoxic: Demonstrated by a 1-cell Mouse Embryo Assay (MEA). This is a biological assay where mouse embryos are cultured in the device's environment to assess any toxic effects.

8. The sample size for the training set:

• Not applicable. There is no AI algorithm being trained.

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

• Not applicable. There is no AI algorithm being trained.

Summary of Device and Regulatory Context:

The document is an FDA 510(k) clearance letter for IVF culture dishes. The primary "study" referred to is the submission of data demonstrating that the new devices are substantially equivalent to a previously cleared predicate device. This equivalence is based on:

• Materials: Both devices use virgin crystal grade polystyrene.
• Intended Use: Both are for in-vitro fertilization, handling, and embryo culture, potentially using drop culture.
• Performance Testing: Both meet the same standards for sterility (SAL 10⁻⁶), non-pyrogenicity (LAL < 0.25 EU/mL), and non-embryotoxicity (1-cell MEA).

The document specifically highlights the differences in physical dimensions, number of wells (9 or 16 in the proposed vs. 12 in the predicate), and well design (round, central array vs. square, distributed array). However, the submission argues that these differences "do not impact the use of the identified predicate device to support the proposed device, as they do not raise any new types of safety or effectiveness questions." This is the core argument for substantial equivalence, which is a regulatory pathway, not a clinical efficacy study for an AI device.

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The Vitrolife Culture Dish 60 mm, Vitrolife Culture Dish 40 mm and Vitrolife Centre Well Dish are intended for IVF, suitable for use in preparing, storing, manipulating, or transferring human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other reproduction procedures.

The Vitrolife 5 Well Culture Dish is intended for preparing, storing, manipulating or transferring human gametes or embryos for in vitro fertilization (IVF), or other in vitro fertilization techniques.

The Vitrolife ICSI Dish is intended for IVF, suitable for holding oocytes and sperm during fertilization via intracytoplasmic sperm injection (ICSI).

The Vitrolife Micro Droplet Culture Dish is intended for IVF. It may be used with sperm and for the culturing of embryos using drop culture.

The HertART disposable dishes are injection molded. The dishes are supplied with a lid. The polymers used for the dishes are virgin crystal grade polystyrene, which has successfully passed the USP class VI test for cytotoxicity, as well as 1-cell embryotoxicity test. The HertART dishes are packed in sleeves of x units in a box for a total of y units, as defined below:

Vitrolife Culture Dish 60 mm: Round dish with lid: ø63 x 15,15 mm One round well 60 mm in diameter Well Volume: 24,00 mL
Vitrolife Culture Dish 40 mm: Square dish with lid; 65,96 mm x 65,96 mm x 13,20 mm One round well: 40 mm in diameter, Well volume of 12,56 mL
Vitrolife 5-well Culture Dish: Square dish with lid: 65,96 mm x 65,96 mm x. 13,20 mm 5 round wells, Well Volume: 1,7 mL
Vitrolife Centre Well Dish: Square dish with lid: 65,96 mm x 65,96 mm x 13,20 mm 1 well, round bottom, oval opening.
Vitrolife ICSI Dish: Square dish with lid: 65,96 mm x 65,96 mm x 11,70 mm 1 square well with rounded corners
Vitrolife Micro-droplet Culture Dish: Square dish with lid: 65,96 mm x 65,96 mm x 13,20 mm 12 round wells holds drops up to 50 µL Well Volume: 12.5 µL

The dishes are terminally sterilized by gamma irradiation to achieve a SAL of 10 °. The dishes are non-pyrogenic as tested by LAL, and non-embryotoxic as tested by 1-cell Mouse Embryo Assay (MEA). The dishes are disposable and intended for single use.

The provided text describes a 510(k) summary for various IVF dishes and primarily focuses on demonstrating substantial equivalence to predicate devices. It does not contain information related to acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), study designs (e.g., MRMC, standalone), sample sizes for test/training sets, data provenance, ground truth establishment, or expert involvement typically associated with AI/software medical device studies.

The document details the physical characteristics, intended use, and material composition of the Vitrolife Culture Dishes and compares them feature-by-feature to existing predicate devices. The "Discussion" sections within each comparison consistently state that the differences do not impact safety or effectiveness and therefore support substantial equivalence.

Specifically, the studies mentioned are not performance studies in the AI/software sense, but rather tests to assure material compatibility and safety:

• USP class VI test for cytotoxicity: This is a standard biocompatibility test for materials that will come into contact with the body.
• 1-cell embryotoxicity test (MEA): This is a biological assay used to assess the potential toxicity of materials to embryos. The document notes that the subject device uses a "more sensitive 1-cell MEA assay" compared to the predicate's 2-cell MEA, but this is a test of the material's safety, not a measure of the device's diagnostic or predictive performance.
• LAL test (Limulus Amebocyte Lysate): This is a test for bacterial endotoxins (pyrogens).

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information to describe acceptance criteria, device performance, or study details relevant to AI/software medical devices. The document is a regulatory submission for physical medical devices used in IVF, focusing on substantial equivalence based on material and design characteristics, not on the performance of a diagnostic or assistive AI algorithm.

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