Search Results

Sydney IVF™ Blastocyst Cryopreservation Kit is intended for use in assisted reproduction technologies for cryopreservation of blastocysts. Sydney IVF™ Blastocyst Thawing Kit is intended for use in assisted reproduction technologies for thawing of cryopreserved blastocysts.

Sydney IVF™ Blastocyst Freeze/Thaw Kits are aqueous solutions provided in glass vials with silicone rubber stoppers. The Sydney IVF™ Blastocyst Freezing Kit Buffers will be available in 20 mL fill volumes, the Sydney IVF™ Blastocyst Thaw Kit Buffers will be available in 20 mL fill volumes.

The provided text is a 510(k) Premarket Notification for the Sydney IVF™ Blastocyst Freeze/Thaw Kits. This document describes a medical device (freeze/thaw kits for blastocysts in assisted reproductive technologies), not an AI/ML powered device. Therefore, many of the requested categories in the prompt, which are specific to AI/ML device studies, are not applicable.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states: "The Sydney IVF™ Blastocyst Freeze/Thaw Kits were subjected to testing to assure satisfactory operating performance. The Sydney IVF™ Blastocyst Freeze/Thaw Kits passed the requirements of all tests." However, specific numerical acceptance criteria or detailed performance metrics are not provided in this 510(k) summary. It only states that the device "passed the requirements of all tests" and is "similar, with respect to intended use and technological characteristics, to the FDA published predicate device description." This implies the acceptance criteria were met, but the criteria themselves are not listed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The type of testing performed is mentioned, but details on sample size, data provenance (country, retrospective/prospective) are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as this is a medical device (reagents/media) approval, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the same reason as point 3.

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 information is not applicable as this is not an AI/ML device involving human readers or comparative effectiveness studies with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable as this is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable in the context of an AI/ML device. For a medical device like this, "ground truth" would typically refer to established laboratory or clinical standards for performance such as viability, cryosensitivity, or absence of toxicity. These specific types of ground truth are not explicitly described beyond the general statement of "satisfactory operating performance."

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable as this is not an AI/ML device.

Ask a specific question about this device