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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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The Kitazato OPU Needles consisting of:

• Kitazato OPU Needle with Connection Tube, model number Type 2
• . Kitazato OPU Reduced Needle, model number Type 3

are intended to obtain oocytes from ovarian follicles.

The Kitazato OPU Needles are intended to puncture into the vaginal wall and obtain oocytes from ovarian follicles. The OPU Needle with Connection Tube, model number Type 2, product consists of Aspiration Needle with Connection Tube and Silicone Stopper Connector. The OPU Reduced Needle, model number Type 3, product consists of Reduced Aspiration Needle with Connection Tube and Silicone Stopper Connector.

Here's a breakdown of the acceptance criteria and study information for the Kitazato OPU Needle based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of needles for tensile testing, number of samples for endotoxin testing). It broadly states that "The Kitazato OPU Needles were tested."

• Sample Size: Not explicitly stated for each test, but implied to be sufficient for demonstrating compliance with specifications.
• Data Provenance: Not explicitly stated, but the submission is from KITAZATO Medical Co., Ltd. in Tokyo, Japan. It is reasonable to infer the testing was conducted in Japan or at a facility accredited by the manufacturer. The studies are retrospective as they were conducted to demonstrate the device meets criteria before market approval.

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

This type of information is generally not applicable for the non-clinical performance studies described in this 510(k) summary. These tests are laboratory-based and measure physical, chemical, and biological properties, not human interpretation of medical data. Therefore, there is no "ground truth" established by human experts in the clinical sense for these specific tests.

4. Adjudication Method for the Test Set

This is not applicable because the tests are laboratory-based and yield objective measurements or observations (e.g., pass/fail, numerical values, presence/absence of microbial growth). There is no "adjudication" required in the context of expert review or consensus for these non-clinical tests.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical medical instrument (OPU Needle), not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument and does not involve any algorithms or AI.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests are the pre-defined acceptance criteria and specifications themselves. For example:

• For Mechanical Tensile Testing, the ground truth is "withstanding 22N."
• For Endotoxin Testing, the ground truth is "≤20 EU/device."
• For the Mouse Embryo Assay, the ground truth is "≥80% expanded to blastocyst stage within 96 hours."
• For Biocompatibility and Sterilization, the ground truth is compliance with "applicable voluntary standards."

These are objective, measurable performance standards.

8. The Sample Size for the Training Set

This is not applicable. As a physical medical device, there is no "training set" like there would be for an AI algorithm. The manufacturing process is controlled, and products are testedbatch-wise or according to a sampling plan defined by a quality management system.

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

This is not applicable for the same reason as point 8.

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Kitazato IUI Catheters are used for the introduction of washed spermatozoa into the uterine cavity through the cervix.

Kitazato IUI Catheters are sterile, single-use catheters for use in infusion of washed spermatozoa into the uterine cavity. Catheters are composed of a catheter shaft and a connector. The connector is connected to a syringe (not included with the catheter), and washed spermatozoa are aspirated through the tip of the catheter shaft connected to the syringe. During the insemination procedure, the shaft of catheter is introduced into the uterine cavity through the cervix, and then spermatozoa are injected into the uterine cavity. The Kitazato IUI Catheter has the following types; IUI Catheter with Stainless Steel Center Core Type and IUI Catheter without Stainless Steel Center Core Type.

The provided 510(k) summary for the Kitazato IUI Catheters outlines non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than a study proving performance against medical acceptance criteria. This type of filing (510(k)) aims to show that a new device is as safe and effective as a legally marketed predicate device, not necessarily to establish de novo medical performance standards through clinical trials or direct comparative effectiveness.

Therefore, the information requested for AI device studies (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training) is not applicable to this 510(k) submission, as it focuses on demonstrating equivalence through non-clinical bench testing.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for each test. The summary indicates that "all the specifications have met the acceptance criteria," suggesting sufficient samples were tested for each non-clinical evaluation.
• Data Provenance: Not specified, but the tests are non-clinical, likely conducted in a laboratory setting by the manufacturer (KITAZATO Medical Co., Ltd., Japan) or a contracted testing facility.

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

• Not applicable. This submission relies on objective non-clinical test results against defined physical, chemical, and biological specifications, not expert-derived ground truth.

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

• Not applicable. Adjudication methods are typically associated with human interpretation of data (e.g., medical images) to establish ground truth for performance evaluation, which is not the case here.

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 is a medical device (catheter), not an AI-powered diagnostic or assistive technology. No MRMC study was performed.

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

• Not applicable. This is a physical medical device, not an algorithm.

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 technical specifications and industry standards for mechanical properties, dimensions, biocompatibility (endotoxin, HSSA), and sterility. For example, for endotoxin, the ground truth is a value of "≤20 EU/device."

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

• Not applicable. As above, no training set was used.

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