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Freezing Pack is for freezing of 1-4 cell stage embryos.

Thawing Pack is for thawing of embryos.

The products:

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• "Medi-Cult Freezing Pack with EFM" Cat.No. 1026 -
• "Medi-Cult Thawing Pack with EFM and IVF" Cat.No 1063 -
• "Medi-Cult Thawing Pack with EFM" Cat.No 1098 -

Products formulation: All products are based on Embryo Freezing Medium (EFM)

The Freezing Packs contains 3 different solutions reflecting a 3-step procedure and 4 vials:

• 1 x Vial 1: Embryo Freezing Medium (EFM) .
• 1 x Vial 2: EFM and propanediol .
• 2 x Vial 3; EFM, propanediol and Sucrose. ●

For thawing the Thawing Packs are used. They are composed as follows:

• Vial 1: Embryo Freezing Medium (EFM), propanediol and sucrose. ◆
• Vial 2: EFM, propanediol and Sucrose. .
• . Vial 3: EFM and Sucrose.
• Vial 4: EFM (Cat.No. 1098) or Universal IVF Medium (Cat.No. 1063) .

Product testing control contents:

• Bioburden, production-test -
• -Integrity filter testing, production-test
• -Sterility, OC-test
• pH, QC-test -
• Osmolarity, OC-test -
• Endotoxin, QC-test ﮯ

The provided text is a 510(k) summary for Medi-Cult Freezing and Thawing Packs, an in vitro fertilization (IVF) product. It describes the product's formulation, indications for use, and quality control tests, and then presents clinical data from IVF clinics as evidence of its performance.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific pregnancy rates or live birth rates that the device must achieve to be considered effective. Instead, it presents clinical data from various clinics using Medi-Cult products and compares these results implicitly against national averages or other clinics where available. The underlying acceptance criterion appears to be that the device performs at least comparably to established IVF practices or predicate devices.

• Chelsea and Westminster Hospital: 20.8%
• CARE at Park Hospital: 20.0%
• The Woking Nuffield Hospital: 15.8%
• Leeds General Infirmary: 14.1%
• Nurture: 7.8%
• Holly House Fertility and IVF: 17.4%
• Guy's and St Thomas Assisted Conception Unit: 27.1% |
  | Overall performance comparable to UK national average | Several UK clinics using Medi-Cult products show performance above the UK national average of 12.1% (e.g., Chelsea, CARE, Guy's and St Thomas). Some are below. |
  | No serious adverse events | No registered complaints and no evidence of serious adverse events in the last 1.5 years. |

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

The "test set" in this context refers to the clinical data used to support the safety and effectiveness.

• Trondheim, Norway: 966 embryo replacements. Data provenance: Norway, retrospective (1988-1998).
• Oslo, Norway: Number of embryo replacements not explicitly stated in the table, but the rate of 18.3% is given. Data provenance: Norway, retrospective (1994-1996).
• Carl von Linne Clinic, Sweden: "birth rate per frozen embryo replacement was 22%" for the year 1997. Specific number of replacements not stated. Data provenance: Sweden, retrospective (1997).
• UK Clinics: Total of 1,360 "frozen embryo replacement" (FER) cycles across 7 clinics. Data provenance: UK, retrospective (April 1, 1996 to March 31, 1997).

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

• The document implies that the ground truth (clinical pregnancy and live birth outcomes) was established by the clinics themselves as part of their standard clinical practice and reporting.
• No specific number of experts or their qualifications for establishing the ground truth for the test set (as in, for a specific study design with independent adjudication) are mentioned. The data are "clinical data from clinics" and "national data," suggesting routine clinical outcomes reported by the medical staff (e.g., obstetricians, gynecologists, embryologists) at those IVF units.

4. Adjudication Method for the Test Set

• No specific adjudication method (e.g., 2+1, 3+1) is mentioned or implied. The data appear to be raw reported clinical outcomes directly from the IVF clinics or national registries. This is typical for retrospective analyses of real-world clinical performance.

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

• No MRMC or AI-assisted study was performed. These are cryopreservation media, not AI-driven diagnostic or assistive devices.

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

• This is not applicable to a cryopreservation media product. The "device" is a physical product (liquid media), not an algorithm.

7. The Type of Ground Truth Used

• The ground truth used is clinical outcomes data, specifically:
  • Clinical pregnancies (defined as positive pregnancy test confirmed by ultrasound)
  • Live birth rates (birth of a live infant)
• These are based on actual patient results from IVF treatments using the Medi-Cult products.

8. The Sample Size for the Training Set

• This concept is not applicable as this is not an AI/machine learning device. The product formulation was developed based on published scientific data and established IVF practices ("formulated according to data published in peer-reviewed international journals by internationally recognised scientists in the field"). There isn't a "training set" in the computational sense.

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

• Not applicable. The "ground truth" for the development of the media would be the scientific understanding of cryopreservation principles for embryos, established through decades of research and clinical practice in reproductive medicine, rather than a specific "training set" with ground truth established for an algorithm.

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