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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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The INVOcell Culture Device is indicated for use in preparing, holding, and transferring human gametes or embryos during In Vitro Fertilization/Intra Vaginal Culture (IVF/IVC) and Intra-cytoplasmic Sperm Injection Fertilization/Intravaginal Culture (ICSI/IVC) procedures. The INVOcell Culture Device is indicated for use with the INVOcell Retention Device and the INVOcell Holding Block. The INVOcell Culture Device is not indicated for incubation periods exceeding 72h.

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 72 hours.

The INVOcell Holding Block is indicated for use with the INVOcell Culture Device to aid in temperature maintenance of the INVOcell Culture Device during loading and collection procedures and to aid in positioning and observation of the INVOcell Culture Device during human gamete/embryo loading and collection procedures.

The INVOcell Intravaginal Culture System is comprised of three parts: the INVOcell Intravaginal Culture Device, the INVOcell Retention Device, and the INVOcell Holding Block. All devices are designed to be utilized together.

INVOcell Intravaginal Culture Device: a single-use plastic container that serves to house and protect the gametes and/or embryos during intravaginal culture. It is provided sterile. The culture device consists of two components: the inner chamber and the outer shell.

INVOcell Retention Device: aids in the retention of the INVOcell Intravaginal Culture Device during incubation in the vagina. It is a single-use device that is provided nonsterile. The device is a cup-shaped silicone piece that includes to allow flow of vaginal secretions. The device comes in four sizes (65, 70, 75, and 80 mm). It is accompanied by a fitting kit, which is utilized to determine the appropriate diameter of the INVOcell Retention Device to ensure appropriate retention, and is intended to be reprocessed.

INVOcell Holding Block: designed to hold and maintain temperature of the inner vessel of the INVOcell Intravaginal Culture Device during loading and retrieval procedures. The block does this passively by serving as a heat sink. Prior to use, the block is preheated to body temperature. The block then can be utilized to hold the Intravaginal Culture Device inner vessel, and will maintain appropriate temperature for short periods of time. The block is solid stainless steel, with a conical hole in the top for the inner vessel. The block also includes a glass window on the side, to allow viewing of the embryos in the inner vessel during retrieval.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

Key Takeaways:

• Device: INVOcell Intravaginal Culture System, comprising the INVOcell Culture Device, INVOcell Retention Device, and INVOcell Holding Block.
• Purpose: Intended for preparing, holding, and transferring human gametes or embryos during intravaginal in vitro fertilization (IVF) or intravaginal culture (IVC) procedures.
• Approval Basis: FDA De Novo classification. This means there was no existing predicate device, so the manufacturer had to demonstrate safety and effectiveness.
• Study Types: Primarily non-clinical bench studies and two clinical studies.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text has an excellent table summarizing the non-clinical/bench studies, their purpose, methods, acceptance criteria, and results. I will reproduce key parts of that table and also synthesize clinical performance criteria from the "Special Controls" section.

Acceptance Criteria and Reported Device Performance for INVOcell Intravaginal Culture System

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

Non-Clinical/Bench Studies:

• Sample sizes vary per test (e.g., 30 samples for seal integrity, 9 INVOcell devices for mouse embryo assay).
• Data provenance is retrospective as these are lab tests performed by the manufacturer to establish device performance under controlled conditions. The country of origin is not specified but would be where the manufacturer's R&D/testing facilities are located, presumably the USA given the FDA De Novo filing.

Clinical Studies:

• Study 1: INVOcell OUS Safety and Efficacy

  • Test Set Sample Size: 450 total cycles (310 IVF, 140 ICSI) involving a total of 442 subjects. This is the pooled data across all sites.
    • Lima, Peru: 134 subjects / 138 cycles (IVF only)
    • Bogota, Colombia: 220 subjects / 225 cycles (125 IVF / 100 ICSI)
    • Sao Paulo, Brazil: 40 subjects / 40 cycles (20 IVF / 20 ICSI)
    • Cochabamba, Bolivia: 48 subjects / 48 cycles (IVF only)
  • Data Provenance: Prospective clinical investigations conducted at assisted reproductive facilities in Peru, Colombia, Bolivia, and Brazil.
  • For comparison of fertilization, cleavage, and embryo quality, data was compared against retrospective literature reports (Bergh et al. for fertilization/cleavage, Lundin et al. for embryo quality).

• Study 2: INVOcell Intravaginal Culture Device Comfort and Retention Study

  • Test Set Sample Size: 29 women.
    • 12 women used the Intravaginal Culture Device + Retention Device.
    • 17 women used the Intravaginal Culture Device alone.
  • Data Provenance: Non-random, prospective study, country of origin not specified, but likely where primary clinical trials were conducted (e.g., US or one of the OUS sites).

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

• Non-Clinical/Bench Studies: The "ground truth" here is objective measurement by qualified lab personnel following standardized protocols (e.g., ISO, ASTM, USP standards). The number and specific qualifications of these experts are not detailed in the text but are inherent to regulatory-compliant lab testing.
• Clinical Study 1:
  • Ground Truth: Clinical outcomes (fertilization, cleavage, embryo quality, clinical pregnancy rate, miscarriage rate, birth rate).
  • Experts: The clinical investigations were conducted by "physicians with expertise in assisted reproductive technology and techniques including oocyte retrieval, clinical embryology, and embryo transfer." The specific number of experts per site or their years of experience are not provided, but the description implies highly qualified fertility specialists. The reported literature (Bergh et al., Lundin et al.) represents consensus in the field (published research) rather than real-time expert adjudication of the INVOcell data.
• Clinical Study 2:
  • Ground Truth: Patient-reported comfort and objective observation of device retention/expulsion.
  • Experts: The study was conducted by clinicians, but the "ground truth" for comfort was self-reported by the 29 women, and retention was observed by clinical staff. No specific expert adjudication process is described beyond the reporting of clinical observations.

4. Adjudication Method for the Test Set

• Non-Clinical/Bench Studies: Adjudication is generally not applicable in this context. Results are driven by objective measurements and adherence to acceptance criteria/standards.
• Clinical Study 1 (OUS Safety and Efficacy): No formal adjudication method (e.g., 2+1) for clinical outcomes is explicitly described. The outcomes (fertilization, cleavage, pregnancy, birth rates) were calculated from the pooled data collected at the investigational sites. The comparison was against published literature, not simultaneous "gold standard" expert-adjudicated controls from the study.
• Clinical Study 2 (Comfort and Retention): No formal adjudication method is mentioned. Retention was observed, and comfort was self-reported by patients.

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, an MRMC comparative effectiveness study was not done.
• This device is an intravaginal culture system, a physical medical device, not an AI or imaging diagnostic tool that involves "human readers" or AI assistance in interpretation. The provided text does not mention any AI components or MRMC studies.

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

• No, a standalone (algorithm only) performance study was not done.
• As noted above, this device is a physical system for culturing embryos, not an algorithm.

7. The Type of Ground Truth Used

• Non-Clinical/Bench Studies: The ground truth was based on objective measurements and adherence to established and validated laboratory standards (e.g., ISO, ASTM, USP) for sterility, biocompatibility, physical properties, pH, and embryo compatibility (Mouse Embryo Assay).
• Clinical Study 1 (OUS Safety and Efficacy):
  • Clinical Outcomes Data: The ground truth for effectiveness was derived from observed clinical outcomes such as fertilization rates, cleavage rates, embryo quality assessments (performed by embryologists at the clinical sites), clinical pregnancy rates, miscarriage rates, and live birth rates.
  • Expert Consensus/Literature: Comparisons for fertilization, cleavage, and embryo quality were made against published literature/expert consensus from studies by Bergh et al. and Lundin et al.
• Clinical Study 2 (Comfort and Retention): The ground truth was a combination of patient self-reported discomfort and observed device retention/expulsion by clinical staff.

8. The Sample Size for the Training Set

• Not applicable in the context of this device. A "training set" typically refers to data used to train machine learning algorithms. This device is a physical medical device, not an AI system.
• For the non-clinical and clinical studies, there isn't a "training set" in the AI sense. The studies are designed to demonstrate performance and safety. The clinical studies establish the safety and effectiveness of the device as used in a real-world setting.

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

• Not applicable for this device. As explained above, there is no AI component or "training set" in the sense used for machine learning.

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