(251 days)
Sydney IVF Hyaluronidase is intended for use to facilitate removal of the cumulus cells surrounding oocytes in assisted reproduction technology (ART) procedures.
Sydney IVF Hyaluronidase is an enzymatic preparation containing 80 IU/mL Hyaluronidase (of ovine origin) in a Bicarbonate buffered media supplemented with 5 mg/mL Human Serum Albumin (HSA) and 10 ug/mL Gentamicin.
Sydney IVF Hyaluronidase is provided sterile (aseptically filtered) and is packaged in glass vials with Fluorotec coated rubber stoppers held in place with a tamper evident seal. It is available in a 5 pack carton box with each vial containing 1 mL of Sydney IVF Hvaluronidase.
The provided text describes the Sydney IVF Hyaluronidase device and its substantial equivalence to a predicate device, focusing on its formulation, shelf-life, and performance. However, it does not contain the kind of detailed information typically found in a study demonstrating the device meets specific acceptance criteria with reported device performance against those criteria in a tabular format, nor does it provide information about the methodology of such a study (sample sizes, expert involvement, adjudication, etc.).
The document is a 510(k) summary for regulatory clearance, which primarily focuses on demonstrating substantial equivalence to a previously cleared device. It mentions "performance data" and "stability & shelf life" but doesn't present a formal study report with acceptance criteria and results in the requested format.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study effect size.
- Standalone performance.
- Type of ground truth used (beyond "MEA data").
- Sample size for the training set.
- How ground truth for the training set was established.
However, I can extract the relevant information known about the device's performance based on the document:
The document states that the Sydney IVF Hyaluronidase (the proposed device) and the predicate device (K023353 - Sydney IVF Hyaluronidase) share similar performance specifications and that the proposed device has been validated in stability studies.
Here's what can be pieced together from your request and the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Predicate Device Specification (K023353) | Proposed Device Performance (Sydney IVF Hyaluronidase) |
|---|---|---|
| Osmolality | 285-295 mOsm/kg | Same (285-295 mOsm/kg) |
| Endotoxin |
§ 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.