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The INVOcell Culture Device is indicated for use in preparing, holding, and transferring human gametes or embryos during In Vitro Fertilization/Intravaginal Culture (IVF/IVC) and Intra-Cytoplasmic Sperm Injection Fertilization/ Intravaginal Culture (ICSI/VC) procedures. The INVOcell Culture Device is indicated for use with the INVOcell Retention Device. The INVOcell Culture Device is not indicated for incubation periods exceeding 120h.

The INVOcell Retention Device is indicated for use with the INVOcell Culture Device to aid in retention of the INVOcell Culture Device in the vaginal cavity during the incubation period. The INVOcell Retention Device is not indicated for use exceeding 120h.

The INVOcell Intravaginal Culture System consists of the INVOcell Culture Device and the INVOcell Retention Device.

The INVOcell Culture Device is a radiation sterilized, single-use polystyrene container that holds and maintains the gametes and/or embryos during intravaginal culture for a maximum duration of 120 hours. The INVOcell Culture Device consists of three components: Inner Vessel, Outer Rigid Shell, and Retention Device.

The Inner Vessel holds the culture medium along with the gametes and /or embryos. It has a rotating valve at its top, which allows for access to the chamber when loading and retrieving gametes/embryos and provides a seal during incubation. At the bottom of the Inner Vessel, there is a physical stop to limit the penetration depth of the retrieval catheter into the Inner Vessel to protect embryos during retrieval.

The Outer Rigid Shell that is made of polystyrene, protects the Inner Vessel from the vaginal environment when the device is in use. The Inner Vessel fits into the bottom portion of the Outer Rigid Shell and is sealed in position by the top portion of the Outer Rigid Shell cap with a silicone O-ring, which provides a liquid-tight seal to prevent contamination of the Inner Vessel.

The Retention Device aids in the retention of the INVOcell Culture Device during incubation in the vaginal cavity for a maximum duration of 120 hours. The Retention Device is single-use and provided non-sterile. It is a 70 mm diameter cup-shaped silicone retention device that includes holes to allow flow of vaginal secretions during use.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the INVOcell Intravaginal Culture System.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The information for "acceptance criteria" and "reported device performance" is primarily found in the "Summary of Non-Clinical Performance Testing" and "Summary of Clinical Performance Testing" sections, as well as the comparison table in Section VI.

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

• Test Set Sample Size:
  • Study 1 (Comfort and Retention): 29 subjects.
  • Study 2 (Effectiveness and Safety):
    • INVOcell arm (IVC/IVF and IVC/ICSI): 240 fresh embryo transfers.
    • Traditional IVF and ICSI arm: 685 fresh embryo transfers.
• Data Provenance:
  • Study 1: Single center, location not specified but implies a clinical setting.
  • Study 2: Multicenter, retrospective cohort study. Data collected from four fertility clinics in the U.S. for the 3-year period of January 2017 to December 2019.

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

This document does not specify the number or qualifications of experts used to establish ground truth for the clinical studies. Clinical outcomes (e.g., pregnancy, live birth, birth defects) would typically be recorded by medical professionals in the clinics involved.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication methods (e.g., 2+1, 3+1) for the clinical data in either study. For a retrospective cohort study like Study 2, data would typically be extracted from existing patient records.

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

There is no mention of an MRMC study or AI assistance in this document. The device is an intravaginal culture system, not an imaging or diagnostic AI device that would involve human readers.

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

Not applicable as this is a medical device for in vitro fertilization, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Non-Clinical (Lab tests): Ground truth was established by direct measurement against predefined laboratory standards (e.g., blastocyst development percentage, absence of contamination, pH range).
• Clinical (Study 1): Ground truth was established by direct observation and patient self-report (e.g., device expulsion, vaginal findings from speculum exam, patient discomfort questionnaire).
• Clinical (Study 2): Ground truth was established through retrospective clinical outcomes data (e.g., fresh embryo transfers, embryo development stages, clinical pregnancy rates, live birth rates, implantation rates, miscarriage rates, pre-term birth rates, reported birth defects). This would have come from the patient records at the participating clinics.

8. The Sample Size for the Training Set

Not applicable. This document describes a medical device, not an AI/ML algorithm that requires a training set. The clinical studies described are performance validation studies.

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

Not applicable, as there is no training set for an AI/ML algorithm mentioned.

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