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Dewin Blastocyst Medium (with HSA and without HSA) is intended for culture from the 8-cell stage to the blastocyst stage of embryo development. Dewin Blastocyst Medium (with HSA) is also intended for use in transfer of blastocyst stage embryos into the uterine cavity.

Dewin Blastocyst Medium (with HSA and without HSA) is intended for embryo culture from the cleavage to blastocyst stage of development and can also be used for transfer of blastocyst stage embryos to the uterine cavity.

Dewin Blastocyst Medium is comprised of salts, buffering agents, energy substrates, antioxidant, vitamins, nutrient supplements, amino acids, and gentamicin. Dewin Blastocyst Medium is offered with and without Human Serum Albumin (HSA).

Dewin Blastocyst Medium (with HSA and without HSA) is aseptically filtered and filled into glass bottles with polypropylene caps. The device is provided in 25 mL and 50 mL volumes. Dewin Blastocyst Medium (with HSA and without HSA) has a four-month shelf-life when stored as recommended and is for singleuse only.

The provided text describes a 510(k) premarket notification for a medical device called "Dewin Blastocyst Medium." This submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed clinical study demonstrating the device's performance against specific acceptance criteria in a human population.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of human clinical performance (e.g., how human readers improve with AI, MRMC studies, standalone algorithm performance, number of experts, adjudication methods, details of ground truth establishment for clinical data sets) is not applicable to this document.

This document focuses on the non-clinical performance data used to establish substantial equivalence for a reproductive medium. The acceptance criteria described here are related to the physical, chemical, and biological properties of the medium itself, and not to its clinical effectiveness in human patients or the performance of an AI algorithm.

However, I can extract information related to the non-clinical performance acceptance criteria and the methods used to demonstrate those were met, as described in the document.

Here's a breakdown of the relevant information from the provided text, addressing the closest applicable points from your request:

Non-Clinical Acceptance Criteria and Performance Study for Dewin Blastocyst Medium

The provided document describes the non-clinical testing performed to demonstrate the safety and effectiveness of Dewin Blastocyst Medium and its substantial equivalence to a predicate device (Sydney IVF Blastocyst Medium). The "acceptance criteria" here refer to the specifications for the medium's properties and its biological compatibility.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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

• Sample Size: Not specified in terms of number of human embryo samples or patients for a clinical trial. The testing is non-clinical.
• Data Provenance: The manufacturer is DonneVie Medical Technology (Shanghai) Co. Ltd. (China). The document implies testing was conducted by or for the manufacturer. The data is non-clinical performance data for the product itself, not human clinical trial data.

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

• Not Applicable. This is non-clinical laboratory testing of a product's properties, not an AI or diagnostic device that requires expert human interpretation for establishing ground truth on clinical images/data.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

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

• No. This is a non-clinical submission for a medical medium, not a diagnostic imaging AI device.

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.

7. The Type of Ground Truth Used

• For the non-clinical performance tests, the "ground truth" is defined by the established scientific and regulatory standards/methods used to evaluate the physical, chemical, and biological properties of the medium.
  • Biocompatibility: ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2010 (Sensitization, Intracutaneous Reactivity).
  • Sterile Filtration/Aseptic Fill: ISO 13408-1:2008 and ISO 13408-2:2018.
  • Shelf-life Parameters: USP <791> (pH), USP <785> (Osmolality), USP <85> (Endotoxin), USP <71> (Sterility), ASTM F1980-16 (Real-time aging).
  • Mouse Embryo Assay (MEA): 2021 FDA guidance "Mouse Embryo Assay for Assisted Reproduction Technology Devices."
  • Transportation: ASTM D4169-16.

8. The Sample Size for the Training Set

• Not Applicable. This refers to a manufactured product and its testing, not a machine learning model.

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

• Not Applicable. See point 8.

Summary regarding the nature of the submission:

This 510(k) submission is for a reproductive medium, which is a substance used in laboratory procedures. The "acceptance criteria" and "study" described in the document pertain to the quality control and non-clinical performance of this medium itself (e.g., its chemical composition, sterility, and ability to support embryo development in a lab setting, as demonstrated by Mouse Embryo Assay). It is not a submission for an AI-powered diagnostic device, which would involve human reader studies, clinical ground truth from patient data, and AI algorithm performance metrics.

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