(92 days)
Sydney IVF Sperm Cryopreservation Buffer is intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing.
Sydney IVF Sperm Cryopreservation Buffer consists of an aqueous solution intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing. The IVF technician will use the buffer to cryopreserve washed spermatozoa, including MESA (microsurgical epididymal sperm aspiration) and TESA (testicular sperm extraction) samples.
The provided text describes a 510(k) submission for the Sydney IVF Sperm Cryopreservation Buffer, focusing on demonstrating its substantial equivalence to a predicate device. This submission is for a medical device rather than an algorithm or AI-driven device. As such, many of the requested categories in the prompt, which are typically relevant for AI/ML device evaluations (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details), are not directly applicable or discussed in the provided documentation.
However, I can extract the acceptance criteria for the device's performance based on the specific tests mentioned.
Here's an analysis of the provided text in the context of your request:
1. Table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| pH Testing | Satisfactory operating performance (specific range not provided) | Passed the requirements of all tests |
| Osmolality Testing | Satisfactory operating performance (specific range not provided) | Passed the requirements of all tests |
| Two-cell Mouse Embryo (MEA) Testing | Satisfactory operating performance (specific outcome not provided, but typically involves embryo development percentage) | Passed the requirements of all tests |
| Bacterial Endotoxin (LAL) Testing | Satisfactory operating performance (specific endotoxin limit not provided) | Passed the requirements of all tests |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not specified in the provided document. The text states "Sydney IVF Sperm Cryopreservation Buffer was subjected to the following tests," implying that samples of the buffer were tested, but no number of batches or units is given.
- Data Provenance: Not specified. The tests would have been performed by Cook Urological Incorporated or a contracted lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a chemical buffer, not an AI or diagnostic tool where expert ground truth on data is typically established. The "ground truth" for this device is its physical and biological performance against established scientific and regulatory standards (e.g., pH limits, osmolality ranges, MEA success rates, endotoxin levels), which are determined through laboratory tests.
4. Adjudication method for the test set
- Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers or between human readers and AI outputs in diagnostic imaging or similar fields. For a chemical buffer, the "adjudication" is based on the objective results of the lab tests conforming to predefined specifications.
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
- Not applicable. This is a medical device (a buffer solution), not an AI algorithm. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm. The "standalone performance" is the intrinsic performance of the buffer itself as demonstrated by the specified tests.
7. The type of ground truth used
- The "ground truth" for this device's performance is established by objective laboratory test results that meet predefined specifications for pH, osmolality, embryo toxicity (MEA), and endotoxin levels. These specifications are based on regulatory requirements and scientific understanding for medical devices of this type. It's not based on expert consensus, pathology, or outcomes data in the sense typically applied to diagnostic algorithms.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device. The manufacturing process of the buffer is validated, and batches are tested for quality control.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI model, this question is not relevant.
§ 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.