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The Endosee Hysteroscope and Disposable Diagnostic (Dx) Cannula are used to permit viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic procedures.

Generally recognized indications for diagnostic hysteroscopy include:

• Abnormal bleeding
• Infertility and pregnancy wastage
• Evaluation of abnormal hysterosalpingogram
• Intrauterine foreign body
• Amenorrhea
• Pelvic Pain

The Endosee Hysteroscope and Disposable (Dx) Cannula can also be used to permit viewing of the adult urinary bladder through a minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic procedures.

The Endosee system is a handheld, battery-operated endoscope that consists of two components: a reusable Handheld Monitor and a sterile, single use cannula. The Endosee is intended for use in viewing the cervical canal and uterine cavity for the purpose of performing diagnostic hysteroscopy procedures in an outpatient or in an office setting. The Endosee can also be used to permit viewing of the urinary bladder, via the urethra, for the purpose of performing diagnostic cystoscopy procedures in an outpatient or office setting.

The Disposable Diagnostic (Dx) Cannula is inserted through the cervix to view the cervical canal and uterine cavity. The Dx Cannula can also be inserted through the urethra to view the bladder. This enables the evaluation and diagnosis of the uterine cavity or the urinary bladder for pathology. The cannula includes a camera and LED light source at the distal end to illuminate the desired location for better user visualization, as well as to capture image and video of the diagnostic site. The video signal is electronically transferred to the Handheld Monitor of the Endosee Hysteroscope by an electrical connector, and an LCD touchscreen monitor on the reusable Handheld Monitor is used for viewing.

The provided text describes non-clinical performance testing for the Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula to support expanding its indications for use to include cystoscopy applications.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated, but the study utilized "cadaveric specimens."
• Data Provenance: Retrospective (cadaveric specimens) from an unspecified country (likely the US, given the FDA submission).

3. Number of Experts and Qualifications

• Number of Experts: Not explicitly stated. The text mentions "all participants" in the simulated operating room environment, but their specific qualifications are not detailed beyond being able to "affirm that the cannula enabled visualization." It can be inferred they are likely medical professionals, potentially urologists, given the context of cystoscopy applications and a simulated operating room.

4. Adjudication Method

• Adjudication Method: Not explicitly stated. The acceptance criteria indicate that "all participants must affirm" the visualization. This suggests a form of consensus or agreement among the participants, but the specific method (e.g., voting, discussion) is not described.

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

• MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not explicitly conducted as described in the provided text. The study focused on the standalone performance of the device's visualization capabilities.

6. Standalone Performance Study

• Standalone Study: Yes, a standalone performance study was conducted. The purpose was to "determine that the subject device enables acceptable visualization of the bladder in a standard urological procedure as it is currently designed." This refers to the algorithm/device itself (the cannula with its camera and light source) and its ability to provide clear visuals, not its performance in conjunction with human interpretation in a comparative effectiveness study.

7. Type of Ground Truth Used

• Ground Truth: Expert consensus based on direct visualization. The ground truth was established by the "participants" in the simulated operating room environment affirming that they could see all intended targets in the bladder using the device.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable/not mentioned. This was a direct performance validation study of a physical device's visualization capabilities, not an AI/algorithm development study.

9. How Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable. As this was not an AI/algorithm development study, there was no separate training set for which ground truth would need to be established by experts for machine learning purposes.

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