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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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