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Intended Use: Single use, limited exposure (

The Tao Embryo Transfer Catheter system consists of two devices which are used for introducing embryos into the uterine cavity. This sterile, single use embryo transfer system consists of a pellethane outer sleeve and a polyethelene inner catheter. The outer sleeve has a distal portion which has an easy-to-shape design. At the tip, the outer sleeve is protected by a sphere-shaped soft cap. The revolutionary design of the cap not only significantly minimizes trauma when passing the cervix, but it also minimizes possible mucus, blood and bacterial contamination of the inner catheter and embryos. The inner catheter has two different designs, with one having an end-port and the other a side-port.

This document describes the 510(k) submission for the Tao Embryo Transfer Catheter System. The submission focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant regulations, rather than presenting a study with specific performance metrics against pre-defined acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove its fulfillment cannot be extracted from the provided text.

Here is an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the given document. The document focuses on demonstrating substantial equivalence based on indications for use, materials, and physical construction, rather than specific performance metrics.

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

No test set or associated sample size is mentioned. The submission is a 510(k) for substantial equivalence, not a clinical trial report.

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 no test set requiring expert ground truth is described.

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

This information is not applicable as no test set requiring adjudication is described.

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. The device is a physical embryo transfer catheter system, not an AI-assisted diagnostic or decision support tool. An MRMC study is not relevant in this context.

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

This information is not applicable. The device is a physical medical device, not an algorithm.

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

This information is not provided as no specific "ground truth" for performance evaluation is mentioned. The basis for approval is substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set:

This information is not applicable as the device is a physical medical device, not a machine learning algorithm that requires a training set.

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

This information is not applicable for the same reason as above.

Summary of what the document does provide regarding "acceptance criteria" (implicitly):

While not framed as explicit "acceptance criteria" with performance metrics, the document implies that the "acceptance criteria" for this 510(k) submission are met by demonstrating:

• Conformance with 21 CFR 884.6110 Assisted Reproduction Catheters: This is a regulatory standard that the device must meet.
• Substantial equivalence to legally marketed predicate devices: This involves comparing the new device's indications for use, materials, and physical construction to existing, approved devices. The differences in proprietary design (sphere-shaped cap) are noted, but the overall similarity is asserted.
• Safety and Efficacy: Although not explicitly detailed with performance data, the implication of substantial equivalence is that the device is as safe and effective as its predicates. The safety aspects are mainly addressed through materials (pellethane, polyethelene) and sterilization (ETO).

In essence, for this 510(k) submission, the "acceptance criteria" are regulatory compliance and demonstrable substantial equivalence to predicates, rather than specific quantitative performance targets from a clinical study.

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