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Kitazato IUI Catheter is used for the introduction of washed spermatozoa into the uterine cavity through the cervix. Kitazato IUI Stylet is used to provide rigidity and assist in maintaining the shape of the catheter shaft.

The Kitazato IUI Catheter is a set of intrauterine insemination (IUI) catheters comprised of two different models that include either no stainless steel core (Type 4) or a stainless steel core (Type 5). Each type of catheter has a 10 cm or 18 cm catheter shaft length that incorporates an outer stiffener component and a syringe connector. The distal tip of the catheter shaft is rounded and includes two side holes 3 mm from the tip of the catheter for sperm delivery. The catheter shaft also includes depth marker bands at 5, 6, 7, and 8 cm from the distal tip to aid in delivery of the device to the targeted depth.

The catheter is composed of a polyvinyl chloride shaft and an acrylonitrile butadiene styrene (ABS) connector. The Stylet Cannula (Type 6) used with the Type 4 catheter is composed of a stainless steel cannula (SUS304) and an ABS syringe connector. The Stylet Cannula's stainless steel core provides rigidity and assists in maintaining the shape of the catheter shaft when the uterine cervix is sharply curved. The Stylet Cannula is inserted into the catheter shaft through the connector end and then the IUI Catheter is inserted into the cervix. During an IUI procedure, the catheter is introduced into the uterine cavity through the cervix, and the spermatozoa are injected into the uterine cavity by a syringe (not included) that is coupled at the connector end (6% taper connection) of the catheter shaft.

This document describes the Kitazato IUI Catheter. Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each individual non-clinical performance test (e.g., number of catheters tested for tensile strength, number of samples for HSSA, etc.). It only states that the device "passed all the testing."

Data provenance is not explicitly mentioned as country of origin, however, the submission sponsor is KITAZATO Corporation in Japan, and the predicate device is from KITAZATO Medical Co., Ltd. This implies the studies were likely conducted or overseen by the Japanese manufacturer. The studies are non-clinical, implying they are laboratory-based tests rather than human studies, therefore the retrospective or prospective nature is not applicable in the same way it would be for clinical trials.

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

Not applicable. The reported studies are non-clinical performance tests for a medical device (catheter), not diagnostic studies requiring expert interpretation of results to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable, as these are non-clinical performance tests with objective pass/fail criteria, not subjective human-interpreted data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC comparative effectiveness study is designed for evaluating diagnostic tools where human readers are involved in interpreting results. This document describes non-clinical performance tests of a physical medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, standalone performance was done in the sense that the device itself was subjected to a series of tests to verify its physical, chemical, and biological properties without human intervention in the device's function during the test itself (e.g., tensile strength, sterility, biocompatibility).

7. The Type of Ground Truth Used

The ground truth for these non-clinical tests is established by recognized international standards and specifications (e.g., ANSI/AAMI, USP, ISO 10993, ISO 11607). For instance:

• Mechanical properties: Engineering specifications for tensile strength, dimensions.
• Sterility: Absence of microbial growth, as defined by USP .
• Endotoxin: Endotoxin levels below a specified threshold, as defined by ANSI/AAMI ST72.
• Biocompatibility: Absence of cytotoxicity, sensitization, and irritation as evaluated against ISO 10993 standards and FDA guidance.
• HSSA: A specific percentage of sperm motility after a defined period (≥70% at 24 hours).
• Package Integrity: Meeting requirements of ISO 11607.

8. The Sample Size for the Training Set

Not applicable. This report details acceptance criteria and performance data for a medical device based on non-clinical testing, not a machine learning or AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as above (no training set for a non-AI medical device).

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Kitazato IUI Catheter consist of the following versions:

• Kitazato IUI Catheter with Outer Stiffener with Stylet Cannula, 18 cm, model number . Type 3-v1
• . Kitazato IUI Catheter with Outer Stiffener without Stylet Cannula, 18cm, model number Type 3-v2
  Kitazato IUI Catheter is used for the introduction of washed spermatozoa into the uterine cavity through the cervix.

Kitazato IUI Catheter with Outer Stiffener Type with Stylet Cannula and without Stylet Cannula are recommended for uterine cervix with an anatomical curve because the catheter shaft can be easily manipulated. The Kitazato IUI Catheter is composed of an 18 cm catheter shaft that incorporates an outer stiffener component and a syringe connector. The distal tip of the catheter shaft is rounded and includes two side holes 3 mm from the tip of the catheter for sperm delivery. The catheter shaft also includes depth marker bands at 5, 6, 7, and 8 cm from the distal tip, and a movable stopper to aid in delivery of the device to the targeted depth.
The catheter is composed of a polyvinyl chloride shaft and an ABS connector. The Stylet Cannula of the Type 3-v1 version of the device is composed of a stainless steel cannula (SUS304) and an ABS syringe connector. The Stylet Cannula provides rigidity and assists in maintaining the shape of the catheter shaft when the uterine cervix is sharply curved. The Stylet Cannula is inserted into the catheter shaft through the connector end and then the IUI Catheter is inserted into the cervix. The spermatozoa can be introduced into the uterine cavity by the syringe that is connected to the stylet cannula with no need to remove the stylet cannula from the IUI Catheter. The syringe connector on both the catheter and stylet cannula has a 6% taper that is compatible with 6% taper connection syringe (note: syringe is not included with the catheter).

The provided text is a 510(k) summary for the Kitazato IUI Catheter. It describes the device, its intended use, and demonstrates substantial equivalence to a predicate device. However, it does not include descriptions of acceptance criteria as typically understood in a medical device study (e.g., specific performance metrics like sensitivity, specificity, or accuracy compared to a benchmark). Instead, it discusses the device's technical specifications and the results of non-clinical (laboratory) tests to demonstrate that the device meets those specifications and is comparable to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a typical "acceptance criteria" table with performance metrics like accuracy, sensitivity, or specificity, as it's a 510(k) submission focused on substantial equivalence rather than a clinical performance study of an AI/algorithmic device. Instead, it lists the results of non-clinical tests against established specifications.

Relevant Study Information:

2. Sample size used for the test set and the data provenance:

   • The document describes non-clinical testing (mechanical, dimensional, endotoxin, sterility, biocompatibility, phthalates release, human sperm survival assay, and shelf life). It does not specify sample sizes for these tests, nor does it refer to a "test set" in the context of clinical data for algorithmic performance. Data provenance would be from manufacturing and laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This document does not describe a study involving expert-established ground truth for an algorithmic device's performance. The "ground truth" for the non-clinical tests are the objective specifications and assay results.

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

   • Not applicable. This document does not describe adjudication for a test set.

5. If a multi-reader multicase (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 is a medical device (catheter) and not an AI/algorithmic device. No MRMC study was conducted.

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

   • Not applicable. This is a medical device (catheter) and not an AI/algorithmic device. No standalone algorithm performance was assessed.

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

   • For the non-clinical tests, the "ground truth" is based on pre-defined engineering specifications, chemical/biological standards, and laboratory assay results. For example, sperm motility percentage is a direct measurement against a set threshold.

8. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set."

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

   • Not applicable. (See #8)

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