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The Hysteroscope is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and to obtain an endometrial tissue sample (biopsy) in an outpatient or office setting. The sample is used for cytologic diagnosis. Generally recognized indications for diagnostic hysteroscopy include abnormal uterine bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain.

The Hystero-V hysteroscope is a handheld, battery operated portable hysteroscope consisting of a sterile, single-use cannula and a reusable handle with an LCD touchscreen monitor. It is intended to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and endometrial tissue sample (biopsy) in an outpatient or office setting. The disposable cannula has a light source and camera at the distal end that are used for visualization and to capture image and video of the diagnostic area. The image and video signals are transferred electronically from the cannula to the monitor on the handle via an electrical connection so that the physician can view the anatomy during the procedure. The cannula also has a fluid channel that can infuse fluids during the procedure or evacuate tissue. The fully assembled Hystero-V hysteroscope has an overall length of 465 mm (18.3 inches); the working length of the disposable cannula component is 254 mm (10 inches). When assembled, the Hystero-V hysteroscope weighs 0.5 pounds. The materials used in construction of the cannula-stainless steel, nylon, and polycarbonate-contact tissue for less than 24 hours. The device has been tested for biocompatibility and was shown to be biocompatible. The handle does not contact the patient.

The provided text describes a 510(k) premarket notification for the Hystero-V Hysteroscope, asserting its substantial equivalence to a predicate device. The information details various non-clinical performance tests but explicitly states that no clinical or animal testing was necessary or performed. Therefore, the following response will be based on the non-clinical testing reported.

Here's an analysis of the acceptance criteria and the study (non-clinical testing) proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each individual test. The context implies that the testing was performed on a sample of the Hystero-V Hysteroscope devices/components as part of the validation process.
• Data Provenance: The data comes from bench tests and engineering evaluations performed by the manufacturer, Hysterovue, Inc. It is therefore prospective in nature, as it was conducted specifically for this submission. The origin is implied to be within the company's testing facilities, likely in the US (Bellevue, WA). For biocompatibility, data was leveraged from a previously cleared device (K17500).

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

• Number of Experts: Not applicable. The ground truth for these non-clinical tests is established by objective engineering standards (e.g., ISO, IEC) and the device's own specifications. These are not subjective interpretations requiring expert consensus.
• Qualifications of Experts: Not applicable for establishing ground truth in this context. The testing would have been conducted by engineers and technicians with expertise in medical device testing, regulatory compliance, and relevant standards.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. These were objective pass/fail tests against predefined standards and specifications, not subjective assessments requiring adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was explicitly stated as not necessary and not performed.

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

• Standalone Performance: Not applicable in the context of an AI algorithm. This device is a hardware hysteroscope. The software component described is for controlling the device and displaying images, not for AI-powered diagnostics or analysis.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical tests, the ground truth was established by:
  • International Standards: ISO 10993 (biocompatibility), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-18 (thermal safety), ISO 8600-5 (image quality), ISO 8600-3 (field of view/direction of viewing).
  • Device Specifications: The manufacturer's internal product specifications for mechanical integrity (bending, torque, pull tests) and functional performance (no leaks in working channel, image quality).
  • Predicate Device Data: For biocompatibility, the ground truth was largely established by the prior clearance of the Uro-V cystoscope (K17500), which used identical materials, manufacturing, and sterilization.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device does not use machine learning or AI that would require a "training set." The software mentioned is an operating system/control software, not an AI algorithm.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI algorithm. The software functionality was verified and validated against its design requirements and specifications, which are based on standard software engineering practices and the functional needs of the hysteroscope.

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