(134 days)
The flexible video cystoscope with digital video processor and disposable sheath system is intended for use in endoscopic access and examination of the lower urinary tract, including the bladder and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The digital video processor is intended for use with the VSI flexible video scope.
The VSI flexible endoscope is a flexible endoscope with connections to a video processor and display monitor. The EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscope for image visualization and capture.
This appears to be a 510(k) premarket notification for a medical device, specifically a modified flexible videoscope with EndoSheath® Systems. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study proving the device meets specific acceptance criteria in the way a new, innovative AI device might.
Therefore, much of the requested information regarding AI device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies, is not applicable or available in this type of regulatory document for this specific device.
However, I can extract and infer some information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list a table of acceptance criteria with numerical performance metrics as might be seen for an AI diagnostic device. Instead, acceptance for a Special 510(k) is based on compliance with design controls and demonstrating that the modifications do not raise new questions of safety or effectiveness, thus maintaining substantial equivalence to the predicate device.
| Acceptance Criteria (Implied for a Special 510(k) Device Modification) | Reported Device Performance (Implied from the "Conclusion" and FDA Letter) |
|---|---|
| Compliance to 21 CFR 820.30 Design Control requirements | Certified compliance to 21 CFR 820.30 Design Control requirements |
| Risk Analysis procedure completion | Description of internal Risk Analysis procedure provided |
| Biocompatibility testing passed | V&V activities including biocompatibility testing addressed |
| Scope/sheath/processor system functional and performance testing passed | V&V activities including scope/sheath/processor system functional and performance testing addressed |
| Software validation completed | Software validation addressed via comprehensive Design Validation and Verification planning |
| Maintains substantial equivalence to predicate device | FDA determined the device is substantially equivalent to predicate devices |
| Safe and effective for intended use | Shown to be safe and effective for intended use |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The performance testing mentioned (biocompatibility, functional, software validation) would have involved specific test samples (e.g., a certain number of endoscopes, sheaths, or software tests), but these are not clinical 'test sets' in the context of an AI study.
- Data Provenance: Not specified. These are likely internal laboratory and engineering tests rather than a "dataset" from a specific country.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study requiring expert-established ground truth for a diagnostic output. The ground truth for engineering and biocompatibility tests would be established through defined standards and measurements.
4. Adjudication method for the test set:
- Not applicable.
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 MRMC comparative effectiveness study was done, as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI device.
7. The type of ground truth used:
- For the performance testing mentioned (biocompatibility, functional, software validation), the ground truth would be based on engineering specifications, recognized standards (e.g., ISO for biocompatibility), and predefined pass/fail criteria for device functionality and software operation.
8. The sample size for the training set:
- Not applicable, as this is not an AI device with a training set.
9. How the ground truth for the training set was established:
- Not applicable, as this is not an AI device with a training set.
Summary of what the document does indicate:
- This is a Special 510(k) Premarket Notification for a device modification. This means the focus is on showing the modified device is substantially equivalent to existing, predicate devices, rather than proving novel performance from scratch.
- The manufacturer provided certification of compliance to 21 CFR 820.30 Design Control requirements and described their internal Risk Analysis procedure.
- Validation and Verification (V&V) activities were performed, including biocompatibility testing, scope/sheath/processor system functional and performance testing, and software validation. These are standard engineering and quality control tests for medical devices.
- The FDA concluded the device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective as those devices for its intended use.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.