(156 days)
PureCeption™ is for in vitro procedures involving sperm separation, washing and isolation.
Not Found
This document is a 510(k) premarket notification FDA approval letter for a medical device called "PureCeption™ Lower Phase, PureCeption™ Upper Phase, and PureCeption™ Sperm Washing Media with HEPES-buffered Ham's F-10 and HSA." This type of document declares that the device is "substantially equivalent" to a legally marketed predicate device.
Crucially, a 510(k) summary (or a 510(k) premarket notification as referenced here) typically does NOT contain detailed study data or acceptance criteria specifications in the format requested. The FDA's 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, which often relies on comparative performance rather than establishing new, standalone effectiveness or performance criteria through in-depth clinical studies as might be seen for a PMA (Premarket Approval) submission.
Therefore, based on the provided text, I cannot extract the specific information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications. The letter only confirms that the device is approved for marketing based on its substantial equivalence.
The "Indications For Use" state: "PureCeption™ is for in vitro procedures involving sperm separation, washing and isolation." This is the only performance-related statement that can be directly extracted.
To answer your request, if this were a document that contained the specific study information, it would typically look for sections detailing:
- Performance Data/Clinical Studies: Where the design, methodology, results, and statistical analysis of performance tests would be presented.
- Acceptance Criteria: Explicit numerical or qualitative targets the device performance needed to meet.
- Test Set/Training Set Details: Information about the data used for evaluation and development.
- Ground Truth: How the "correct" answers or references were determined.
Since this information is not present in the provided FDA letter, I cannot fulfill the request for those details.
§ 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.