(20 days)
Water for Assisted Reproductive Technologies (A.R.T.) Use is intended for use in A.R.T. laboratory procedures requiring a non-pyrogenic high purity grade of water.
Water for Assisted Reproductive Technologies (A.R.T.) Use is intended for use in A.R.T. laboratory procedures.
Water for Assisted Reproductive Technologies (A.R.T.) Use is intended for use in assisted reproductive technology procedures.
Water for Assisted Reproductive Technologies (A.R.T.) Use is a water intended for use in A.R.T. laboratory procedures requiring a non-pyrogenic high purity grade of water.
Water for Assisted Reproductive Technologies (A.R.T.) Use is highly purified water of USP WFI grade.
The provided text describes a medical device called "Water for Assisted Reproductive Technologies (A.R.T.) Use." It is a water product intended for use in A.R.T. laboratory procedures. The document is a 510(k) submission, seeking substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-pyrogenic high purity grade of water | Water for A.R.T. Use is USP WFI grade. |
| Supports embryonic growth as shown by mouse embryo assay | Assayed by mouse embryo assay prior to release to market, assurance that it will support embryonic growth. |
| No toxic components present as shown by mouse embryo assay | Assayed by mouse embryo assay prior to release to market, assurance that no toxic components are present. |
| Suitable for intended use in A.R.T. laboratory procedures | Conclusion from performance testing and historical information in professional literature shows suitability for intended use. |
| Meets criteria outlined in Notice of Final Rule, 63 FR 48428, Docket number 97N-0335 | Found to meet these criteria. |
| Substantial equivalence to other 510(k) cleared Irvine Scientific products | Found to be substantially equivalent. |
| USP 24 testing prior to release | USP 24 testing will be performed as a condition of release. |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" with a particular sample size in the context of a clinical study or a separate validation study. Instead, it mentions that the product is "assayed by mouse embryo assay prior to its release to market." This suggests that the mouse embryo assay is a routine quality control measure applied to batches of the product, rather than a one-time test set for regulatory submission.
- Sample Size: Not explicitly stated as a fixed sample size for a "test set." It refers to ongoing "mouse embryo assay" and "USP 24 testing" for each lot.
- Data Provenance: The document states that the "equivalent of Water for Assisted Reproductive Technologies (A.R.T.) Use has been used in a variety of clinical settings for the same intended use for a number of years and has become the standard medium." This implies historical clinical use data, but the specific origins (e.g., country) are not provided. The mouse embryo assay and USP 24 testing are internal to the manufacturer prior to market release.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this device appears to be defined by adherence to established quality standards (USP WFI grade, non-pyrogenicity, support for embryonic growth, absence of toxic components) determined through laboratory assays (mouse embryo assay, USP 24 testing). There is no indication of human expert consensus being used to establish ground truth for a "test set" in the way it might be for an AI diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of an adjudication method, as the tests are laboratory assays with clear pass/fail criteria rather than assessments requiring human interpretation and consensus.
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 device is a water product for laboratory use, not an AI diagnostic device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable in the context of the device described. The "performance" of the water is assessed through laboratory assays (mouse embryo assay, USP 24 testing) which can be considered "standalone" without human-in-the-loop interpretation in the sense of a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used is primarily based on:
- Laboratory Assay Results: Mouse embryo assay for embryonic growth support and absence of toxic components.
- Pharmacopoeial Standards: USP WFI (Water for Injection) grade and USP 24 testing for purity and quality.
- Historical Clinical Usage: The past performance of equivalent products in clinical settings.
8. The sample size for the training set
Not applicable. This device is a laboratory reagent, not a machine learning algorithm. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning model, the concept of establishing ground truth for it does not apply.
§ 884.6170 Assisted reproduction water and water purification systems.
(a)
Identification. Assisted reproduction water purification systems are devices specifically intended to generate high quality, sterile, pyrogen-free water for reconstitution of media used for aspiration, incubation, transfer or storage of gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction procedures. These devices may also be intended as the final rinse for labware or other assisted reproduction devices that will contact the gametes or embryos. These devices also include bottled water ready for reconstitution available from a vendor that is specifically intended for reconstitution of media used for aspiration, incubation, transfer, or storage of gametes or embryos for IVF or other assisted reproduction procedures.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, water quality testing, design specifications, labeling requirements, biocompatibility testing, and clinical testing).