(71 days)
This instrument has been designed to be used with an Olympus video system, light source, accessory equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the urethra, bladder, and ureter.
The subject device is used for endoscopic diagnosis and treatment within the urethra, I ho storeet de roo is as optical system is modified from image guide to CCD and the resolution is improved.
The provided text is a 510(k) summary for the OLYMPUS VIDEO URETEROSCOPE, NTSC. It focuses on establishing substantial equivalence to a predicate device based on modifications to an existing device (optical system modified from image guide to CCD, and improved resolution).
This type of submission does not typically include a detailed study with acceptance criteria and device performance results in the way a clinical trial or performance study for a novel high-risk device would. Instead, the focus is on demonstrating that the new device's technological characteristics and performance are comparable to a legally marketed predicate device.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not provided in this type of regulatory document. The primary "study" is the comparison to the predicate device.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a table. The "acceptance criteria" here are implicitly linked to demonstrating substantial equivalence to the predicate device, K951855, particularly concerning the improved resolution due to the CCD modification.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. This document relies on engineering and performance testing to show equivalence, not typically a clinical "test set" in the sense of a diagnostic algorithm.
- Data Provenance: Not applicable in the context of a 510(k) for an endoscopic device modification. The "data" would be engineering specifications and comparison to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth and expert consensus are not typically part of a 510(k) submission for a device like this, which focuses on hardware changes and their impact on image quality/resolution in comparison to a predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) 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:
- Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device.
7. The type of ground truth used:
- Not applicable in the typical sense of a diagnostic algorithm. The "ground truth" for demonstrating equivalence would be the performance characteristics (e.g., resolution measurements) of both the modified device and the predicate device, against established engineering standards and clinical expectations for visual inspection.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established:
- Not applicable.
Summary regarding the "Study":
The "study" cited in this 510(k) is the demonstration of substantial equivalence to the predicate device (A2560, K951855). The primary and explicitly mentioned modification is:
- Predicate Device: A2560 Ureteroscope (K951855)
- Modification: "the optical system is modified from image guide to CCD and the resolution is improved."
The acceptance criteria would have been to demonstrate that the new device performs at least as well as, or better than, the predicate device in terms of image quality and resolution for its intended clinical use, and that any technological differences do not raise new questions of safety or effectiveness. The document itself does not provide the specific data from this comparison but states that the FDA found it substantially equivalent.
§ 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.