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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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The Uro-N Cystoscope is intended for direction of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract via a cystoscope.

The UroViu Uro-N Cystoscope System consists of (1) a hand-held, battery operated portable endoscope contained within a reusable handle and (2) a disposable cannula with an injection needle. The fully assembled Uro-N system has overall length of 522 mm (~21 inches). The disposable cannula working length is 269 mm (~11 inches) and total length is 388 mm (~15 inches). The injection needle is 23 Ga (OD 0.635mm, ID 0.318mm). The combined handle and cannula weigh less than 1 pound. The reusable handle has a connector and locking mechanism for attaching and detaching the cannula. The catheter is sterilized by electron beam and is intended for single use only.

The provided text is a 510(k) summary for the Uro-N Cystoscope, demonstrating its substantial equivalence to predicate devices rather than proving it meets specific acceptance criteria through a standalone study with performance metrics. Therefore, many of the requested sections regarding acceptance criteria, performance, sample sizes, expert ground truth, and comparative effectiveness against human readers are not directly addressed in this document.

However, I can extract information related to the device's testing and safety/effectiveness claims based on comparison to its predicates.

Here's the summary based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of quantitative acceptance criteria with corresponding device performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices, implying that if it functions similarly and passes specified engineering and biocompatibility tests, it meets the necessary safety and effectiveness profiles.

The performance evaluation is primarily comparative and based on the established safety and effectiveness of the predicate devices.

| Aspect | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Summary) |
|:--------------------------------|:---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Meets ISO 10993 requirements for medical devices with less than 24 hours of patient tissue contact. Materials must be biocompatible (e.g., stainless steel for the needle). | The Uro-N Cystoscope and cannula are made from materials reviewed and cleared in K171500. The only new material, stainless steel for the needle, passed cytotoxicity testing. |
| Electrical Safety | Compliance with IEC 60601-1 (medical electrical equipment - general requirements for basic safety and essential performance), specifically Class I, Type CF, defibrillation proof. | The device complies with IEC 60601-1, as reviewed and cleared in K171500 (predicate device). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (medical electrical equipment - electromagnetic disturbances - requirements and tests). | The device complies with IEC 60601-1-2, as reviewed and cleared in K171500 (predicate device). |
| Software Verification and Validation | Software should be verified and validated to ensure proper function and safety. The software level of concern is "Moderate." | No change was made to the software from the predicate device (K171500), which was previously reviewed and cleared. |
| Mechanical Performance | The device should be mechanically sound, withstand simulated use, and maintain structural integrity (e.g., resistance to bending, pulling, torque, and leaks). It should also maintain acceptable temperature at the tip surface, field of view, direction of view, and image quality comparable to the predicate diagnostic cystoscope. | Mechanical testing included: simulated use testing, mechanical testing (bending, pulling, torque, and presence of leaks), temperature at the surface of the tip testing, field of view testing, direction of view testing, and image quality testing. The results of these tests are not provided in detail, but the conclusion states "The information submitted... confirms that the Uro-N Cystoscope raises no new questions of safety and effectiveness and that it is substantially equivalent to the predicate devices." |
| Sterility | Disposable components (cannula, needle) must achieve a Sterility Assurance Level (SAL) of 10^-6. | Disposable cannula and needle are sterile following exposure to ethylene oxide (EO) with an SAL of 10^-6. |
| Cleanability (Reusable Handle) | The reusable handle, not provided sterile, must be cleanable and disinfectable according to company instructions to prevent cross-contamination. | The handle is cleaned and disinfected following company instructions (implies this is met). |
| Duration of Use | Less than 24 hours for patient contact components. | Less than 24 hours. |

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

The document does not specify a "test set" in the context of collected patient data or images for performance evaluation. The substantial equivalence argument relies on engineering and bench testing, as well as the prior clearance of the predicate devices.

• Sample Size: Not applicable as no clinical or image-based test set was used for de novo performance evaluation against acceptance criteria.
• Data Provenance: Not applicable. The testing was laboratory/bench-based.

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

Not applicable. As no clinical test set requiring expert interpretation was used for de novo performance evaluation, no experts were involved in establishing ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication was used.

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

No MRMC comparative effectiveness study was reportedly done. The submission is a 510(k) for substantial equivalence, not a clinical efficacy study involving human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The Uro-N Cystoscope is a medical device, not an AI algorithm. Its performance is evaluated through physical, electrical, and materials testing, and by demonstrating equivalence in function and safety to predicate devices.

7. Type of Ground Truth Used

The "ground truth" for the device's acceptable performance is based on demonstrating compliance with regulatory standards (e.g., ISO, IEC), confirmed biocompatibility, and functional equivalence to legally marketed predicate devices through various engineering and bench tests. There is no biological or diagnostic "ground truth" (like pathology or outcomes data) established for a test set in this summary.

8. Sample Size for the Training Set

Not applicable. The Uro-N Cystoscope is a physical device, not an AI/machine learning model, so there is no training set in the context of data for algorithm development.

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

Not applicable, as there is no training set.

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