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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

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.

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Water for Assisted Reproduction Procedures is to be used for in assisted reproduction procedures. It may be used for reconstitution of media used for aspiration, incubation, transfer or storage of gametes or embryos for IVF or other assisted reproduction procedures. It may also be used as the final rinse for labware or other assisted reproduction devices which will contact the gametes or embryos.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device named "Water for Tissue Culture, Model 1500" or "Water for Assisted Reproduction Procedures". This document clears the device for market but does not contain the specific acceptance criteria or details of a study proving the device meets those criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance criteria through a detailed clinical study in the way a PMA (Pre-Market Approval) submission would.

Therefore,Based on the provided text, the following information about acceptance criteria and a detailed study is not available:

1. A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) clearance letter or the Indications for Use statement.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
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: This is irrelevant as the device is "Water for Assisted Reproduction Procedures," not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Irrelevant as the device is "Water for Assisted Reproduction Procedures," not an AI diagnostic device.
7. The type of ground truth used: Not provided, as the nature of the device (water) doesn't typically require 'ground truth' in the same way a diagnostic imaging device would. The focus is on purity and sterility.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

Summary of what the document does provide:

• Device Name: Water for Tissue Culture, Model 1500 (also referred to as Water for Assisted Reproduction Procedures)
• Intended Use: For use in assisted reproduction procedures; specifically for reconstitution of media used for aspiration, incubation, transfer, or storage of gametes or embryos in IVF or other assisted reproduction procedures, and as a final rinse for labware or other assisted reproduction devices that will contact gametes or embryos.
• Regulatory Class: Class II
• Procode: 85 MTW
• Regulatory Mechanism: 510(k) clearance, indicating substantial equivalence to a predicate device.

To obtain the detailed acceptance criteria and study data, one would typically need to review the full 510(k) summary and submission documents which are usually publicly available on the FDA website, but are not part of the provided text.

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