(198 days)
GM501 Wash is intended for in vitro procedures involving handling and micromanipulation of human occytes and embryos outside of a CO> incubator. Include oocyte and embryo washing (e.g. after oocyte aspiration, after hyaluronidase treatment to remove cumulus cells, before and after cryopreservation, and before embryo transfer) and micromanipulation procedures (e.g. assisted hatching). GM501 Wash is not intended for use in transferring embryos into the uterine cavity.
GM501 Wash is a ready-to-use solution providing supporting conditions for human oocytes and embryos during in vitro Assisted Reproduction Technology (ART) procedures taking place outside of a CO2 incubator, including washing and micromanipulation procedures. GM501 Wash is aseptically filled into sterilized bottles (20, 50 and 500 ml) and has a six-month shelf-life when stored as recommended. This product can also be used for up to seven days after bottle opening.
Here's a breakdown of the acceptance criteria and study information for the GM501 Wash device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criterion | Reported Device Performance (Implied Met) |
|---|---|---|
| pH | 7.2-7.5 | Met (pH testing performed) |
| Osmolality | 270-290 mOsm/kg | Met (Osmolality testing performed) |
| Sterility | No growth (per USP ) | Met (Sterility testing performed) |
| Bacterial Endotoxins | ) | Met (Bacterial endotoxins testing performed) |
| Mouse Embryo Assay (MEA) | >80% blastocysts at 96h following a 1h exposure to GM501 Wash | Met (MEA performed with established protocol) |
| Aseptic Filling Validation | Per ANSI/AAMI/ISO 13408-1:2008(R)2011, ANSI/AAMI/ISO 13408-2:2003(R)2013, and FDA Guidance | Met (Performed) |
| Shelf-Life (6 months) | All above specifications (pH, osmolality, sterility, 1-cell MEA, endotoxin) maintained at 6 months | Met (Shelf-life testing performed) |
| After Bottle Opening (7 days) | All above specifications (pH, osmolality, sterility, 1-cell MEA, endotoxin) maintained 7 days after opening | Met (Stability testing after bottle opening performed) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "test set" sample size for evaluating the device as a whole. However, it mentions the following for the Mouse Embryo Assay (MEA):
- Sample Size for MEA: "One-cell mouse embryos were exposed to GM501 Wash for one hour..." The specific number of embryos used is not provided.
- Data Provenance: The origin of the mouse embryos (e.g., country) is not specified. The study appears to be a prospective evaluation of the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The ground truth for the MEA and other tests (pH, osmolality, etc.) is based on scientific and regulatory standards, not expert consensus on individual cases.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluations are objective laboratory tests with defined criteria, not subjective interpretations requiring adjudication.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a reproductive media product, not an AI-powered diagnostic or assistive tool, so such a study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The phrase "standalone" as typically used in AI/software evaluation does not apply here. The device's performance is inherently "standalone" in that its intrinsic physical and biological properties are tested.
7. The Type of Ground Truth Used
The ground truth used for each parameter is based on:
- Established scientific/regulatory standards and specifications:
- pH, Osmolality, Endotoxin: Standard laboratory measurements against defined numerical ranges.
- Sterility: Absence of microbial growth, per USP .
- Aseptic Filling Validation: Compliance with international and FDA guidelines (ANSI/AAMI/ISO 13408 series, FDA Guidance).
- Mouse Embryo Assay (MEA): The biological response of mouse embryos (% developing to blastocyst stage) against a defined percentage threshold (>80%). This is an established biological assay used in reproductive media testing to assess toxicity and developmental support.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product (reproductive media), not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a machine learning model, this question does not apply.
§ 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.