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The Kitazato OPU Needles consisting of:

• · Kitazato OPU Needle with Connection Tube (model number Type2)
• · Kitazato OPU Reduced Needle (model number Type3)
• · Kitazato OPU Two-Stage Reduced Needle (model number Type4)
  are intended to obtain oocytes from ovarian follicles.

The Kitazato OPU Needles are single-use sterile devices that are used for ultrasound-guided transvaginal collection of oocytes from ovarian follicles.
All of the Kitazato OPU Needle have a similar general design and device materials. All of the Kitazato OPU Needles are composed of a 304 stainless steel needle, acrylonitrile butadiene styrene (ABS) needle hub, PVC connection tube, and a silicone stopper that is used to connect to a collection tube and vacuum pump.

Here's a breakdown of the acceptance criteria and study information for the Kitazato OPU Needles, 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:

The document describes non-clinical performance tests. It does not specify a "test set" in the context of clinical data or human subjects. The testing involved various batches of the devices for each test. For example:

• Mouse Embryo Assay (MEA): "1-Cell mouse embryos were incubated in extracts of the subject device..." - The specific number of embryos or repetitions is not provided.
• Shelf-life studies: Performed on "real-time aged devices." The number of devices tested for each shelf-life parameter (MEA, endotoxin, tensile, bending, folding, appearance, dimensional) is not specified.

The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective/prospective, as these are non-clinical lab tests performed on the manufactured devices.

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

Not applicable. This report details non-clinical laboratory testing (e.g., chemical, mechanical, biological assays), not clinical studies requiring expert interpretation of medical images or data. Therefore, there is no "ground truth" established by experts in the typical sense for clinical AI performance studies.

4. Adjudication Method for the Test Set:

Not applicable, as this is non-clinical laboratory testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document describes non-clinical performance testing of the device itself (e.g., material properties, sterility, embryotoxicity) and does not involve human readers or AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is a medical device (needles), not an AI algorithm. The performance is assessed based on its physical and biological characteristics, not computational output.

7. Type of Ground Truth Used:

The "ground truth" for these non-clinical tests is based on:

• Quantitative measurements: e.g., endotoxin levels (< 20 EU/device), percentage of expanded blastocysts (≥ 80%), specific dimensions.
• Qualitative observations: e.g., absence of deformation/blockages, no fracture, no burrs/scratches, no signs of cytotoxicity/sensitization/irritation.
• Adherence to established standards: e.g., ANSI/AAMI ST72-2011, ISO 11135:2014, ISO 10993-7:2008, ASTM F929-15, ASTM F88/F88M-15, ASTM D4169-09, ISO 10993-1-2009, ISO 10993-5:2009, ISO 10993-10:2010.

8. Sample Size for the Training Set:

Not applicable. This document pertains to the regulatory submission for a physical medical device, not an AI model. There is no concept of a "training set" in this context.

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

Not applicable. As there is no training set, the establishment of ground truth for it is irrelevant here.

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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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