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VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V has been designed to be used with an Olympus video system center, light source, document, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus. Do not use the instrument for any purpose other than its intended use.

This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus.

The provided document does not describe an AI medical device. It is a 510(k) summary for a "VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (HYF-V)", which is a hysterovideoscope for endoscopic diagnosis within the uterus.

The document discusses various non-clinical bench tests (e.g., thermal safety, photobiological safety, noise and dynamic range, composite durability, color performance, image intensity uniformity, resolution, direction of view, field of view), biocompatibility evaluation, sterilization/reprocessing validation, and electrical safety/EMC testing. It explicitly states that software verification and validation testing was not applicable and not performed because the HYF-V does not include any software.

Therefore, I cannot provide details on acceptance criteria and study proving device meets acceptance criteria for an AI device based on this document. The questions regarding sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to the information provided for this hysterovideoscope.

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This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus, including:

• Abnormal uterine bleeding
• Evaluation of abnormal hysterosalpingogram
• Evaluation of abnormal ultrasound image
• Infertility and pregnancy wastage
• Pelvic pain

This subject device is videoscope used for diagnosis within the uterus. New type of CCD is lead to be more easier observation and diagnosis. In HYF-V, a light guide connector and a video connector are separated each other. The light guide connector is to connect with a light source and the video connector is with a video system center.

This 510(k) summary (K022445) is for a Hysteroscope, a rigid or flexible endoscope used for diagnostic and therapeutic procedures within the uterus. The document provided does NOT contain information about specific acceptance criteria or a study that proves the device meets those criteria in the way described in your request.

The information in the provided document is mostly administrative and focuses on establishing substantial equivalence to previously cleared devices, rather than presenting a performance study with detailed acceptance criteria.

Here's a breakdown based on the information provided, and where information is missing:

Reported Device Performance and Acceptance Criteria

(1) A table of acceptance criteria and the reported device performance

The provided 510(k) summary does not contain a table of acceptance criteria or reported device performance in terms of specific metrics like sensitivity, specificity, or accuracy. This type of information is usually associated with AI/CADe (Computer-Aided Detection) devices or novel technologies where quantifiable performance is a key aspect of demonstrating safety and effectiveness.

For the VISERA Hysterovideoscope, the FDA cleared it based on substantial equivalence to existing predicate devices (BF-240 and HYF-P Flexible hysterofiberscope). This means the manufacturer argued that the new device has "no significant change for its safety and efficacy" compared to the predicate device, and therefore detailed performance acceptance criteria in the format you described were not required or presented.

The summary states: "Compare to the predicate device, this subject device "HYF-V" does not incorporate any significant change for its safety and efficacy to the predicate device. Observation within uterus has been spread, therefore clinical date is not necessary for its evaluation of safety and efficacy."

This explicitly states that clinical data (which would include performance studies against acceptance criteria) was deemed not necessary because the device's technological characteristics and intended use are considered similar to already cleared devices.

Study Design Information (Not Applicable/Missing for this submission)

The following points refer to details typically found in the clinical testing of devices, especially AI/CADe. Since this 510(k) was based on substantial equivalence without clinical data, these details are not present in the provided document.

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

• Not Applicable / Not Provided. No test set was used for a performance study.

(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)

• Not Applicable / Not Provided.

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

• Not Applicable / Not Provided.

(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 / Not Provided. This is not an AI/CADe device.

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

• Not Applicable / Not Provided. This is not an AI/CADe device.

(7) The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not Applicable / Not Provided.

(8) The sample size for the training set

• Not Applicable / Not Provided. This is not a machine learning device.

(9) How the ground truth for the training set was established

• Not Applicable / Not Provided.

Summary of K022445 Content Regarding Performance/Testing:

The provided 510(k) summary for the VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V focuses on:

• Device Description: A videoscope for diagnosis within the uterus, featuring a new CCD for easier observation. It has separate light guide and video connectors.
• Intended Use: Endoscopic diagnosis within the uterus for conditions like abnormal uterine bleeding, evaluation of abnormal hysterosalpingogram/ultrasound, infertility, and pelvic pain.
• Technological Characteristics: States it "does not have special technological characteristics compared to the existence videoscope such as GI tract bronchial application."
• Safety Standards: Complies with IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-2-18.
• Materials: No new patient-contacting materials; all are cleared by previous 510(k)s and confirmed with ISO 10993-1.
• Substantial Equivalence: Claims substantial equivalence to Olympus BF-240 and Olympus HYF-P Flexible hysterofiberscope. The core argument for clearance is that it does not present significant changes in safety or efficacy compared to these predicate devices, making clinical data "not necessary."

This type of 510(k) demonstrates safety and effectiveness largely through comparison to predicate devices, rather than through extensive new clinical performance studies with specific acceptance criteria.

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