(196 days)
The Olympus ureteroscopes can be utilized for endoscopic observation and therapy in the ureters, urethra, and urinary bladder.
Semi-rigid optical instrument for the visualization of the following diagnostic and therapeutic procedures:
- Transurethral inspection of the ureters and renal pelvis for diagnosis
- Transurethral insertion of catheters, guide wires, cannulas, forceps, electrodes, baskets, lithotripsy probes and laser fibres into the ureter
- Transurethral treatment and removal of tissue, catheters, guide wires, debris and stones from urethra, urinary bladder and ureters
- Transurethral treatment and removal of tissue and stones from the ureters and renal pelvis.
The products are not intended for treatment of infants. For children (>2 years) and adults, refer to the particular constitution and anatomy of the patient.
The OES Elite Ureteroscopes are inserted directly through the natural orifice urethra and are used to visualize a wide range of therapeutic procedures or to support diagnosis. The OES Elite Ureteroscopes are reusable semi-rigid endoscopes, which consist of an image relay system inside the main body and an outer tube that guides an image fiber bundle to transmit the endoscopic image. For therapeutic procedures, the device is used in combination with surgical instruments which can be introduced through the instrument channels.
The OES Elite Ureteroscopes and accessories are delivered in non-sterile condition. They are reusable and fully reprocessable. Before first and each subsequent use the device must be inspected and reprocessed according to defined and validated reprocessing methods in the instructions for use.
The OES Elite Ureteroscopes are available in different working lengths, ocular directions, image sizes, directions of views and with one or two instrument channels.
This document is a 510(k) summary for the Olympus OES Elite Ureteroscopes and Accessories. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results or AI performance metrics.
Therefore, the requested information regarding acceptance criteria for AI performance, sample sizes for AI test/training sets, expert qualifications, ground truth establishment, MRMC studies, standalone AI performance, etc., cannot be directly extracted from the provided text. The document pertains to the device's physical and optical characteristics and reprocessing validation, not an AI component.
However, I can extract the acceptance criteria and performance data that are present in the document, which relate to the ureteroscope's physical and optical properties.
Here's the information that can be derived from the text, formatted as closely as possible to your request, but acknowledging the limitations for AI-specific data:
Acceptance Criteria and Device Performance for Olympus OES Elite Ureteroscopes and Accessories
1. A table of acceptance criteria and the reported device performance
The document presents a comparison of the subject device (OES Elite Ureteroscopes) to predicate devices, implying that the subject device's performance is acceptable if it is comparable to or better than the predicate, and does not raise new safety or effectiveness concerns. The "acceptance criteria" are implicitly defined by the performance characteristics of the predicate devices and the internal design specifications of the new device that were verified.
| Characteristic | Acceptance Criteria (Predicate Devices - Implied) | Reported Device Performance (Subject Devices) |
|---|---|---|
| General technology | Semi-rigid endoscope, image fiber relay, optical fiber illumination | Same as predicate device |
| Distal end | Objective cover glass, instrument channel(s), light emission surface | Same functional components as predicate device |
| Proximal end | Irrigation connector, instrument port, eyepiece cup, finger rests, light guide connector | Same functional components as predicate device, with design variations (e.g., stopcocks, finger rest design, ocular type) |
| Insertion tube profile (distal) | Triangular (dual-channel), oval (single-channel) | Triangular (dual-channel), oval (single-channel), minor differences exist |
| Irrigation inflow (with inserted wire) | 0.2 ml/min - 17 ml/min | 0.7 ml/min - 9.7 ml/min |
| Maximum working length | (330 mm - 430 mm) ± 5 mm | (330 mm - 430 mm) ± 1 mm |
| Outer circumference on distal tip | 7 Fr - 8.4 Fr | (8.4 Fr - 10.4 Fr) ± 0.4 Fr. |
| Maximum insertion portion width | 10.2 Fr - 11.2 Fr | 11.7 Fr. - 13.05 Fr. |
| Minimum instrument channel width | 2.3 Fr - 5.4 Fr | 2.4 Fr. - 5.4 Fr. |
| Direction of view | 5° ± 3° | 5° ± 5° or 0° ± 5° |
| Field of view | 61° ± 3° | (86° - 95°) ± 12° |
| Illumination | (0.193 - 0.277) mlm/klx | Minimum: (0.081 - 0.150) mlm/klx |
| Resolution | ≥ 5 lp/mm @ best working distance | ≥ 9.5 lp/mm @ best working distance |
| Distortion | Relative Distortion in air (max value): -19.8 % | Relative Distortion in air (max value): -40.0% |
| Moiré filter | Not included | Included |
| Total number of fibers/pixels | 30000 pixel | 30000 pixel or 50000 pixel |
| Automated cleaning | No | Yes |
| Autoclavability | Yes | Yes |
Study Proving Device Meets Acceptance Criteria:
The study described is a series of non-clinical performance and verification tests to ensure the subject devices function as intended and meet design specifications, as well as being substantially equivalent to the predicate devices.
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test. It refers to "nonclinical testing," "design verification and validation testing," and "comparative testing" of the physical devices. Data provenance is implied to be from internal testing by the manufacturer (Olympus Winter & Ibe GmbH). The nature of these tests (e.g., mechanical, optical) means they are conducted in a laboratory setting, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for device performance (e.g., resolution, dimensions, flow rate) is established through standardized engineering and laboratory measurements, not through expert human interpretation of medical images or clinical outcomes.
4. Adjudication method for the test set
Not applicable, as ground truth is based on direct measurement and engineering standards, not subjective expert assessment.
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 document is for a medical device (ureteroscope), not an AI-powered diagnostic or assistive tool. No human reader studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for a physical medical device.
7. The type of ground truth used
The ground truth for the device's physical and optical characteristics is based on engineering specifications, direct measurements, and adherence to established international and national standards (e.g., ISO 8600 series for endoscopes, IEC for electrical safety, ASTM for transport, ISO 10993 for biocompatibility, FDA guidance for reprocessing).
8. The sample size for the training set
Not applicable. There is no AI "training set" for this device.
9. How the ground truth for the training set was established
Not applicable. There is no AI "training set" for this device.
§ 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.