(118 days)
Human Serum Albumin (HSA) is intended for those assisted reproductive procedures that require the use of a protein supplement. In particular. HSA 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.
Human Serum Albumin consists of human serum albumin from therapeutic-grade source material (10mg/mL) in a sterile saline solution.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional for supporting embryonic growth | "Mouse embryo assay confirms product is both functional for its intended use, the support of embryonic growth." |
| Absence of toxic components in formulation | "Mouse embryo assay confirms... that no toxic components are present in the formulation." |
| Meeting criteria outlined in Notice of Final Rule, 63 FR 48428, Docket number 97N-0335 | "Human Serum Albumin is suitable for its intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335." |
| Sterility (Condition for Release) | "Sterility testing will be performed as a condition of release." |
| Endotoxin Content (Condition for Release) | "Endotoxin testing will be performed as a condition of release." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified directly for the mouse embryo assay. The description mentions "HSA is assayed by mouse embryo assay prior to release to market," implying a continuous testing process rather than a single, fixed test set.
- Data Provenance: The mouse embryo assay is performed in-house by Irvine Scientific as a pre-market release condition. It is a prospective test for each lot produced. The document also mentions "Human Serum Albumin has been used in a variety of clinical settings, for their intended use, for a number of years," suggesting retrospective clinical experience contributes to the overall understanding of its performance, though this isn't a controlled test set in the traditional sense for regulatory submission. The specific country of origin for the mouse embryo assay is not explicitly stated beyond Irvine Scientific's location in Santa Ana, CA, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The "ground truth" for the mouse embryo assay is established by the biological outcome of the embryos (growth, absence of toxicity), as evaluated by laboratory personnel following established protocols. No panel of human expert readers is described.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The mouse embryo assay relies on direct biological observation of embryo development. There is no mention of human expert adjudication or resolution of discordant interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance
- MRMC Study: No. This device (Human Serum Albumin) is a biological reagent, not an AI or imaging device. Therefore, MRMC studies and the concept of AI assistance for human readers are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is not an algorithm or AI-driven device. Its performance is assessed through biological assays and clinical usage.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- Ground Truth: The primary ground truth for the mouse embryo assay is biological outcome/observation (embryo growth and the absence of toxic effects). Additionally, general outcomes data from "a variety of clinical settings" over "a number of years" contributes to the understanding of its real-world performance as a protein supplement. The "Notice of Final Rule" referenced likely provides a regulatory definition or standard for what constitutes acceptable performance in this context.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set. The "historical information contained in professional literature" and "variety of clinical settings" could be considered analogous to a broad historical "training" or experience base for the product's efficacy, but not a formally defined training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable, as there is no formal training set for an algorithm. The understanding of the product's effectiveness and safety has been established through years of clinical use and scientific research in the field of assisted reproductive technologies, summarized as "historical information in professional literature" and "clinical settings."
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.