(328 days)
For drilling of the zona pellucida.
Acidified Tyrodes Solution is a ready-to-use product with a pH between 2.3 and 2.5 for zona perforation.
Here's a breakdown of the acceptance criteria and study information for Medi-Cult Acidified Tyrodes Solution, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Product Properties | pH | Between 2.3 and 2.5 |
| Quality Control | Bioburden | Production-test (passed, implied) |
| Integrity filter | Production-test (passed, implied) | |
| Sterility | QC-test (passed, implied) | |
| pH | QC-test (matched specification, implied) | |
| Clinical Performance | Safety | No registered complaints, no evidence of serious adverse events in the last 1.5 years |
| Effectiveness | Routinely used for zona pellucida perforation, specific clinical testing cited |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a distinct "test set" in the context of a controlled trial with a defined number of cases. The clinical support comes from established use and a published study.
- Data Provenance: The text mentions:
- "initial clinical testing of Medi-Cult acidified Tyrodes has been done by Dr. Alan Handyside, Dept. Of Obstetrics and Gynecology, St. Thomas' Hospital, Londn, UK and by Søren Ziebe, the National Hospital, Copenhagen, Denmarke." This implies prospective clinical observation/use.
- "The culture media from Medi-Cult have been used by many European IVF-units since the end of the 1980'ties." This suggests a long history of retrospective use data.
- One specific publication is cited: "Søren Ziebe, Anders Nyboe Andersen, Anne-Grethe Andersen, Anne Lis Mikkelsen and Svend Lindenberg. Results of intracytoplasmic sperm injection in relation to indication Acta Obstetricia et Gynecological Scandinavica 1997; 335-339." This is a prospective clinical study, though the specific number of cases utilizing the Medi-Cult solution solely is not broken out.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device and its submission. The product is a chemical solution for a specific mechanical action (zona drilling). "Ground truth" in this context would likely refer to the physical effect of the solution (e.g., successful zona perforation) and the subsequent clinical outcomes (e.g., fertilization rates, pregnancy rates). Experts involved would be the clinicians performing the IVF procedures using the solution. The text cites:
- Dr. Alan Handyside, Dept. Of Obstetrics and Gynecology, St. Thomas' Hospital, London, UK.
- Søren Ziebe, the National Hospital, Copenhagen, Denmark.
- Other unnamed "many European IVF-units."
Their qualifications are implied by their roles in Obstetrics and Gynecology departments and IVF units, indicating expertise in reproductive medicine.
4. Adjudication Method for the Test Set
This is not applicable as there's no mention of a formal adjudication process for a "test set" in the context of expert review for image-based or diagnostic device performance. The assessment is based on clinical outcomes and the absence of adverse events.
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
This is not applicable. This device is a chemical solution, not an AI-powered diagnostic or interpretive tool. Therefore, a MRMC study comparing human reader performance with or without AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. As a chemical solution, there is no "algorithm" or standalone "performance" in the sense of an AI or software device. The device's function is purely chemical/physical.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's effectiveness relies on:
- Clinical Outcomes Data: Successful zona drilling (implied by routine use), subsequent fertilization, and embryo development (implied by the clinical study reference). The stated indication is "For drilling of the zona pellucida."
- Absence of Adverse Events: This serves as ground truth for safety.
- Published Data: The product is "based on published data" regarding acidified Tyrodes solution for zona perforation.
8. The Sample Size for the Training Set
This is not applicable. This device is a chemical solution, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above (no training set).
§ 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.