(64 days)
Sydney IVF Embryo Biopsy Medium is intended for use in assisted reproduction technologies to facilitate the aspiration of blastomeres for pre-implantation genetic diagnosis.
Sydney IVF Embryo Biopsy Medium is an aqueous solution containing electrolytes and buffering agents, and is provided in glass vials with silicone rubber stoppers. Sydney IVF Embryo Biopsy Medium will be available in 20 mL fill volumes.
Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this document describes a traditional medical device (culture medium), not an AI/ML powered device. As such, many of the typical AI/ML study components (like expert consensus, ROC curves, multi-reader studies, etc.) are not applicable here.
Device Name: Sydney IVF Embryo Biopsy Medium
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Satisfy operating parameters and requirements of specified tests. | "Sydney IVF Embryo Biopsy Medium passed the requirements of all tests." |
| Comparable with respect to intended use to the predicate device. | "Sydney IVF Embryo Biopsy Medium is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence." |
| Similar technological characteristics to the predicate device. | "This device is similar, with respect to intended use and technological characteristics, to the FDA published predicate device description." |
Note: The document does not explicitly list numerical acceptance criteria or performance metrics because it's a traditional device submission focused on "substantial equivalence" to a predicate, rather than an AI/ML device with performance benchmarks.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. For a traditional medical device like a culture medium, the "test set" would likely refer to batches of the product manufactured and subjected to quality control and performance testing (e.g., pH, osmolarity, sterility, and potentially cell culture performance). The document only states that the device was "subjected to testing." Data provenance (country of origin, retrospective/prospective) is not applicable or stated for this type of device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. For a culture medium, ground truth isn't established by human experts in the same way it would be for diagnostic imaging. Performance is typically assessed through laboratory tests and functional assays.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication typically refers to resolving disagreements among multiple human readers or experts, which is not relevant for testing a laboratory medium.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving interpretation by human readers. It is not applicable to a culture medium.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. The device is a physical culture medium, not an algorithm. Therefore, a standalone algorithm performance study was not done.
7. Type of Ground Truth Used
The concept of "ground truth" as it applies to AI/ML or diagnostic performance is not directly applicable here. For this type of device, the "ground truth" or standard of comparison relies on established scientific and manufacturing standards for culture media, and comparison to the predicate device's expected performance in supporting IVF procedures. This would likely involve:
- Physicochemical standards: pH, osmolarity, endotoxin levels, sterility, etc.
- Functional assays: Ability to support cell viability, growth, and development (e.g., embryo development in vitro).
8. Sample Size for the Training Set
This information is not applicable and not provided. "Training set" is a term used in machine learning. This device is a physical product, not an AI model, and therefore does not have a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As there is no training set for a physical culture medium, the concept of establishing ground truth for it is irrelevant.
§ 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.