(74 days)
Sydney IVF Hyaluronidase is intended for use as to facilitate removal of the cumulus cells surrounding oocvtes in assisted reproduction technology (ART) procedures.
Sydney IVF Hyaluronidase is an aqueous solution containing electrolytes and buffering agents, and is provided in glass vials with silicone rubber stoppers. Sydney IVF Hyaluronidase will be available in 1 mL fill volumes.
The provided documents are a 510(k) Premarket Notification for the Sydney IVF Hyaluronidase. This notification focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way one might find for an AI/ML powered device.
Therefore, many of the requested elements (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or not provided in these documents for the Sydney IVF Hyaluronidase.
The submission confirms that the device was subjected to testing to assure satisfactory operating parameters. However, the specific acceptance criteria for these tests and the detailed results are not disclosed in these public summaries. The overall conclusion is that the device passed the requirements of all tests and is similar, with respect to intended use and technological characteristics, to the FDA published predicate device description.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from "Discussion of Tests") | Reported Device Performance |
|---|---|
| Satisfactory operating parameters for the intended use | "Sydney IVF Hyaluronidase passed the requirements of all tests." |
| Substantial equivalence to predicate device in intended use and technological characteristics | "Sydney IVF Hyaluronidase is comparable... and meets the requirements for 510(k) substantial equivalence." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided. The document states "Sydney IVF Hyaluronidase was subjected to testing," but does not specify the sample size of any biological or non-biological test sets, nor their provenance. This is typical for a 510(k) summary, which focuses on demonstrating equivalence rather than presenting raw study data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable/Not provided. The nature of the testing described (operating parameters) for this type of medical device generally involves laboratory bench testing and characterization. It would not typically involve expert review in the way an AI diagnostic algorithm would for establishing ground truth in a clinical image dataset.
4. Adjudication Method for the Test Set
Not applicable/Not provided. Adjudication methods are relevant for studies where multiple human readers assess data to establish a consensus ground truth, typically in the context of diagnostic performance. This is not described for the testing performed on Sydney IVF Hyaluronidase.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported. This type of study is specifically relevant for evaluating the impact of AI on human reader performance, which is not pertinent to a product like Hyaluronidase.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. Sydney IVF Hyaluronidase is a medical solution, not a standalone algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to AI/ML device studies (e.g., expert consensus, pathology, outcome data) is not entirely applicable here. For this device, "ground truth" would refer to established physical, chemical, and biological specifications and performance characteristics demonstrating the solution's ability to facilitate cumulus cell removal safely and effectively, consistent with its intended use and the predicate device. The document states it "passed the requirements of all tests," implying a comparison against predefined quality and performance standards.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device is not an AI/ML algorithm.
§ 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.