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510(k) Data Aggregation
(240 days)
ARTSMedia Semen Wash Medium (AM Semen Wash) is intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination).
ARTSMedia Semen Wash Medium (AM Semen Wash) is intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination).
ARTSMedia Semen Wash Medium consists of physiological salts, energy substrates, buffering agents, Gentamicin Sulphate, and water.
Furthermore, ARTSMedia Semen Wash Medium is aseptically filtered and provided in a volume of 20 mL. 50 mL. and 100 mL in pre-sterilized glass bottles closed with Fluorotec-coated stoppers and aluminum caps. The ARTSMedia Semen Wash Medium is tested for pH, osmolality, endotoxin, sterility, and sperm toxicity before lot release. The device has a shelf-life of 18 months when stored at 2-8°C and is for single-use only.
The provided text describes a 510(k) premarket notification for a medical device called "ARTSMedia Semen Wash Medium." It compares the new device to a predicate device and presents non-clinical performance testing. However, the document does NOT contain information about a study involving an AI/Machine Learning enabled device, human readers, or the establishment of ground truth for such a study. Therefore, I cannot extract the requested information regarding acceptance criteria and study proving device performance for an AI/ML device.
The document is solely about a reproductive media and supplements device and its substantial equivalence based on physical and chemical properties and biocompatibility, not an AI/ML diagnostic or assistive device.
Therefore, for all the requested information, the answer will be "Not applicable / No information provided in the given text."
Here's a breakdown of why based on the input text:
- A table of acceptance criteria and the reported device performance: The document provides a table comparing characteristics like pH, Osmolality, Human Sperm Survival Assay, and Endotoxin for the subject and predicate devices. These are "performance" metrics for a biological solution, but not for an AI/ML device's diagnostic accuracy or similar.
| Parameter | Acceptance Criteria (from predicate/comparison) | Reported Device Performance (ARTSMedia Semen Wash Medium) |
|---|---|---|
| Human Sperm Survival Assay (% motility compared with control after 24 hours) | ≥ 80% | ≥ 80% |
| Endotoxin (EU/ml) | < 0.25 | < 0.25 |
| pH | 7.2-7.6 | 7.2-7.6 |
| Osmolality (mOsm/kg) | 270 - 300 | 270 - 300 |
| Sterility | No growth | No growth |
- Sample sized used for the test set and the data provenance: Not applicable. The "testing" here refers to chemical, biological, and sterility tests on the medium itself, not a test set for an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device is not relevant here.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating human performance with and without an AI assistant, which is not relevant to this product.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This product is a physical medium, not an algorithm.
- The type of ground truth used: Not applicable. The performance metrics are direct measurements from laboratory tests (e.g., pH meter, osmolality meter, sperm survival assays).
- The sample size for the training set: Not applicable. This is not an AI/ML product.
- How the ground truth for the training set was established: Not applicable.
The provided document is a 510(k) clearance letter for a non-AI/ML medical device. Your request pertains specifically to AI/ML device performance and testing.
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