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For use in assisted reproduction techniques, (ART), such as IVF, GIFT or similar in vitro procedure to aid in facilitating pregnancy.

Medi-Cult Hyaluronidase is for the removal of cumulus and corona radiatacells which must be removed in order to facilitate access to the oocyte and minimize contamination of the injected needle before ICSI.

Sperm Preparation Medium supplemented with Hyaluronidase. It is a HEPES buffered salt solution supplemented with Hyaluronidase. It is ready-to-use and contains Synthetic Serum Replacement (SSR) and Human Serum Albumin (HSA). The Hyaluronidase raw material is derived from Bovine testes in the USA. It contains antibiotics - Penicillin and Streptomycin.

The provided text describes the "Medi-Cult Hyaluronidase" device and its intended use, along with some clinical data. However, it does not explicitly define acceptance criteria in a quantitative manner or outline a formal study designed to "prove the device meets acceptance criteria" with specific statistical endpoints and detailed methodologies typically found in studies for diagnostic or AI-driven devices.

The document focuses more on demonstrating substantial equivalence to predicate devices and showing good clinical performance in real-world settings rather than a controlled study against pre-defined acceptance metrics for a novel technology.

Here's an analysis based on the provided text, addressing your points where possible, and noting where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the device's performance in a formal study. Instead, it relies on historical clinical use and comparisons to national averages. The "performance" is implicitly defined by live birth rates achieved by clinics using the product, which are presented as being "well" or "best" in comparison.

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

• Test Set (Clinical Data): The "test set" here refers to the clinical usage data presented.
  • Norway: Data from "the largest IVF clinics in Norway" that only used Medi-Cult media since the late 1980s for IVF and since 1996 for ICSI. The exact number of cycles or patients is not provided for each clinic, just the aggregated live birth rates for 1996 and 1997.
  • Sweden: Data from a single clinic, the Carl von Linne Clinic, for the year 1997. Again, the exact number of cycles or patients is not provided.
• Data Provenance:
  • Country of Origin: Nordic countries (Norway, Sweden).
  • Retrospective or Prospective: The data appears to be retrospective, as it refers to collected live birth rates from past clinical practice (e.g., "The data collected since the introduction of ICSI in Norway in 1996").

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

This information is not applicable as the document describes a medical device (culture medium) used in clinical procedures, not a diagnostic or AI device requiring expert ground truth for image interpretation or similar tasks. The "ground truth" here is the clinical outcome of live birth, directly measurable from patient records.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated in point 3. The clinical outcomes (live birth rates) are direct observations, not interpretations requiring adjudication.

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

This is not applicable. The device is a culture medium used in assisted reproduction, not an AI-assisted diagnostic tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a biological culture medium, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used is outcomes data, specifically "live birth rates per started cycle" or "live birth rates per embryo replacement." This is a direct clinical outcome measure.

8. The Sample Size for the Training Set

The concept of a "training set" in the context of machine learning or AI is not applicable to this device. The product development and validation were based on established biological and chemical principles, prior clinical use (since the late 1980s), and a "number of trials" (not detailed in this summary, but mentioned in the "Clinical Testing section" which is not provided but alluded to).

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

This is not applicable as there is no "training set" in the AI/ML sense. The "ground truth" for the development of the medium would have been established through a combination of scientific research, in vitro studies demonstrating efficacy in supporting gamete and embryo development, and early clinical observations by pioneering IVF clinics (e.g., "designed in accordance with the specification of the clinic that developed ICSI (Palermo et al. Lancet 1992 340 8810 17-18)"). The overall clinical performance data (like the Nordic data) serves as post-market surveillance evidence rather than a "training set" for an algorithm.

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