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Serum Substitute Supplement is intended for use in assisted reproductive procedures that require protein supplementation. These procedures include in vitro fertilization, embryo culture and growth, and embryo cryopreservation.

Serum Substitute Supplement (SSS) is designed for those assisted reproductive procedures that require the use of a protein supplement. In particular, SSS is intended for use during in vitro fertilization, during in vitro embryo culture to the desired stage of embryo development, and for the cryopreservation of human embryos.

Serum Substitute Supplement consists of human serum albumin from therapeutic-grade source material (5mg/mL) and human serum globulins (1mg/mL) in a sterile saline solution.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Serum Substitute Supplement (SSS) device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in terms of a numerical count of embryos or cases. The primary test mentioned is the "mouse embryo assay."
• Data Provenance:
  • Mouse embryo assay: Implied to be lab-based, likely controlled experiments.
  • "Variety of clinical settings": This suggests retrospective observation or long-term clinical experience, but specific study design (e.g., retrospective vs. prospective) is not detailed. The phrase "for a number of years" reinforces a historical, rather than a single prospective study.
  • Country of Origin: Not specified, but given the submission is to the US FDA, it's presumed to be relevant to US regulatory standards, though the clinical settings where it was used are not geographically identified.

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

• The document does not detail the use of "experts" in the traditional sense for establishing ground truth for a test set.
• The "mouse embryo assay" implies standard biological protocols and evaluation by trained lab personnel, but not a panel of clinical experts for ground truth.
• The "variety of clinical settings" suggests that clinical embryologists and reproductive medicine specialists have used and evaluated the product over time, implicitly forming a consensus on its effectiveness, but a formal "ground truth" establishment process by a specific number of qualified experts is not described.

4. Adjudication Method for the Test Set

• No formal adjudication method (like 2+1, 3+1) is mentioned. The mouse embryo assay likely relies on objective biological endpoints (e.g., embryo development rates). The "clinical settings" aspect implies real-world outcomes that are evaluated by the treating physicians, but not via an independent adjudication panel for a specific test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No MRMC comparative effectiveness study was mentioned. This device is a biological supplement, not an AI or diagnostic imaging device that would typically involve human readers. Therefore, there's no discussion of human reader improvement with or without AI.

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

• Not applicable. This device is a serum substitute supplement, not a standalone algorithm. Its performance is intrinsic to its biological function rather than an automated analysis.

7. The Type of Ground Truth Used

• Mouse Embryo Assay: The ground truth for this assay is likely based on established biological criteria for successful embryo development (e.g., grading of blastocyst formation, cell numbers, viability) as observable biological outcomes.
• Clinical Settings: For the human applications, the ground truth is based on outcomes data and expert consensus within the clinical reproductive medicine community. This includes successful in vitro fertilization, embryo culture to desired stages, and effective cryopreservation as observed through clinical practice. The statement that it "has become one of the standard protein supplements" implies a strong, widely accepted clinical ground truth.

8. The Sample Size for the Training Set

• Not applicable. The device is a biological supplement, not a machine learning model, so there is no concept of a "training set" for an algorithm. The development of the formulation and prior clinical experience could be considered analogous to a "training" period for understanding product efficacy, but not in the context of an AI model.

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

• Not applicable. As stated above, there is no training set in the context of an AI device. The product's development and optimization would rely on standard laboratory research and preclinical testing to establish its biological properties and efficacy.

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