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Kitazato ET Catheters are intended for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilization.

Kitazato ET Catheters are sterile, single-use catheters for use in embryo transfer procedures. The catheter is used to hold and deliver embryos to the uterine cavity during a procedure. Catheters are available in 3Fr and 4Fr sizes, both of which are provided in lengths of 220 mm and 250 mm, as well as one version that is 3Fr and 400 mm length that has the same uterine insertion depth as the other device versions, but allows the user to be positioned further from the patient during a procedure. Devices also include versions with and without an echo reflective chip in the tip of the catheter. The echo reflective chip aids in visualization of the catheter during a transfer procedure; all transfer procedures are to be done under ultrasound guidance. Both the Type 2 devices also include a stainless steel or polyimide core to provide additional rigidity to the catheter. The guide is used to navigate the pathway through the cervical canal to allow for easier catheter insertion Guides are provided with a 30° pre-curved distal shaft and are available in lengths of 170 mm and 200 mm. Guides also include a styrene elastomer stopper to aid in positioning the targeted uterine insertion depth. The guides are also available with a straight or bulb tip design, and with and without an echo reflective chip in the tip of the guide. An obturator with a length of 170 mm or 200 mm is provided with the Type 2 versions of the device to prevent ingress of fluid into the guide lumen during guide insertion. The Stylet is an optional accessory used when additional rigidity is needed during insertion of the guide through the cervix, and is provided in two lengths, 170 mm and 200 mm. The stainless steel core of the Stylet can be shaped to aid in guide delivery through the cervix.

This document describes a 510(k) premarket notification for the Kitazato ET Catheters. The focus of the provided text is on demonstrating the substantial equivalence of the Kitazato ET Catheters to a legally marketed predicate device (Guardia™ Access Embryo Transfer Catheter Sets). As such, the information provided is geared towards comparing the new device to an existing one, rather than establishing the performance of a novel AI/software medical device against defined acceptance criteria in the way a traditional clinical study would for an AI-powered diagnostic.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI medical device (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size and ground truth establishment) is largely not applicable to this submission.

This submission is for a physical medical device (catheters) and relies on bench testing and biocompatibility studies to show substantial equivalence, not a clinical study involving human readers and AI performance.

However, I can extract information related to relevant non-clinical performance and "acceptance criteria" where applicable to this physical device, as described in the document.

Acceptance Criteria and Device Performance for Kitazato ET Catheters (Physical Device)

This submission focuses on demonstrating substantial equivalence of a physical medical device (embryo transfer catheters) to a predicate device, primarily through non-clinical performance data. Therefore, the "acceptance criteria" are related to established norms for medical device safety and performance rather than AI-specific metrics like AUC, sensitivity, or specificity in a diagnostic context.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance:

• Not Applicable in the traditional sense of an AI/ML test set. The "tests" here are non-clinical bench and lab experiments on the physical device components and assembled units (e.g., sterilization validation, biocompatibility, mechanical testing, Mouse Embryo Assay).
• Data Provenance: The studies are described as "performed to support substantial equivalence." The source of the materials and specific lab locations are not specified beyond the manufacturer (Kitazato Corporation) and their correspondent (Emergo Global Consulting, LLC) being based in Japan and the USA respectively. These are prospective tests of the manufactured device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not Applicable. Ground truth, in the context of expert consensus for image or data interpretation, is not relevant here as this is a physical device submission. The "ground truth" for these tests comes from established international standards (ISO, ASTM, AAMI/ANSI, USP) and verified laboratory procedures.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations (e.g., in MRMC studies for AI). Here, the tests follow defined protocols with measurable outcomes.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is not relevant for this type of physical medical device submission.

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

• No. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• For this physical device, the "ground truth" is derived from:
  • Established Industry Standards: Compliance with ISO, ASTM, AAMI/ANSI, and USP standards.
  • Laboratory Measurements and Biological Assays: Objective measurements (e.g., dimensions, tensile strength) and biological assays (e.g., Mouse Embryo Assay, cytotoxicity testing) with predefined acceptance limits.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device where a "training set" would be used to develop an algorithm.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. See point 8.

Summary for this specific FDA Submission (K192540):

The FDA 510(k) clearance for the Kitazato ET Catheters is based on demonstrating substantial equivalence to an existing legally marketed predicate device. This is achieved through a comprehensive set of non-clinical performance tests, including sterilization validation, biocompatibility studies, endotoxin testing, packaging and transportation simulation, and specific bench performance tests (dimensional verification, appearance, tensile strength, Luer taper inspection, colorfastness, echo test). Additionally, a Mouse Embryo Assay (MEA) is performed to confirm the device's compatibility with embryos. The "acceptance criteria" are the successful completion of these tests in accordance with relevant international and national standards, with all predetermined criteria reported as met. The study design is not a clinical AI performance study, but a series of laboratory and bench tests on the physical device.

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