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The NewLife Dish's intended use is to hold zygotes/embryos during micromanipulation or other tissue culture procedures in the IVF laboratory.

NewLife Dishes are used in the tissue culture techniques performed by embryologists when injecting a single sperm into an egg, or assisting an embryo in hatching prior to reimplantation.

The dishes are disposable tissue culture labware used in procedures that have been developed to aid infertile couples achieve pregnancy. Specifically, the ICSI procedure is beneficial in cases where the male infertility is impaired.

NewLife Dishes are fabricated from polysterene and are 60 mm. diameter. Dishes are made with or without clear lids, etched or unetched. Etched dishes have a center circle with 8 smaller circles inside the larger circle, and a 9th circle inside the 8 circles. There are numbers 1 through 8 outside the large circle, with the number 1 at the top of the dish. Unetched dishes have center circles, but no other circles are etched on the dishes. Dishes are disposable, intended for one time use only.

Here's a breakdown of the acceptance criteria and study information for the NewLife Dish, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Mouse Embryo Bioassay: The text states, "25 ul tissue culture medium...For NewLife Dishes, the MEA is performed in the test dish, providing continuous exposure." and "Control droplets of medium were not exposed to product before receiving embryos." It further mentions "embryos were cultured in the media beginning at the two-cell stage." However, it does not specify the number of dishes or the precise number of embryos used per assay for either the test or control groups within each lot. It just describes the procedure.
• Data Provenance: The study appears to be prospective testing conducted by the manufacturer, Humagen Fertility Diagnostics, Inc., on each lot of their NewLife dishes. There is no information about the country of origin of the data beyond the manufacturer being in Charlottesville, VA, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• This information is not provided in the document. The ground truth (embryo development, endotoxin levels, sterility) is established by laboratory testing methods (mouse embryo bioassay, Limulus Amebocyte Lysate assay, gamma radiation verification) rather than human expert consensus for the test set.

4. Adjudication Method for the Test Set

• This information is not applicable as the "ground truth" for the performance criteria is determined by laboratory assay results and compliance with specified numerical thresholds, not by human expert review requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This device is a piece of labware, and its performance is evaluated through direct biological and chemical testing, not by comparing human reader performance with and without AI assistance.

6. If a Standalone Study Was Done

• Yes, a standalone study was done. The performance evaluation for the NewLife Dish (toxicity, endotoxin, sterility, packaging integrity) directly assesses the device itself against established criteria, without involving human users for performance assessment.

7. The Type of Ground Truth Used

• The ground truth used for evaluating the device's performance is a combination of:
  • Biological Assay Outcomes: The development of mouse embryos to expanded and/or hatching blastocysts, compared against control, as an indicator of non-toxicity.
  • Chemical Assay Results: Endotoxin levels measured by the Limulus Amebocyte Lysate assay.
  • Physical/Biological Validation: Sterility assurance levels achieved through gamma radiation and validation of packaging to maintain sterility over a defined shelf life.
• In essence, the ground truth is based on established laboratory and manufacturing control standards relevant to medical devices used in assisted reproduction.

8. The Sample Size for the Training Set

• This device does not involve a "training set" in the context of an AI/machine learning model. The product is a manufactured item, and its performance is assessed through testing of each production lot against predetermined specifications. Therefore, this question is not applicable.

9. How the Ground Truth for the Training Set Was Established

• As there is no training set for an AI/machine learning model, this question is not applicable. The "ground truth" for the device's performance (i.e., the acceptance criteria) was established through industry standards and scientific understanding of what constitutes a safe and effective tissue culture dish for IVF procedures.

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