(168 days)
The SSU Flexible Video-Uretero-Renoscope System is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.
E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.
The videoscopes in the modified Flexible Video-Uretero-Renoscope SSU System are sterile single-use, flexible video-endoscopes. The distal tip houses the CMOS (Complementary Metal Oxide Semiconductor) imaging sensor and the LED light source. The raw data captured at the distal tip CMOS imaging censor is transferred to the E-Box adaptor, where it is converted to a standard NTSC (National Television System Committee) video signal by the PCB (Printed Circuit Board), which is then driven into one of the CCUs (C-MAC, C-HUB II, or X-LINK + IMAGE 1S Connect) for further processing and video formatting for output to a display monitor. The videoscopes and E-Box are powered by the CCUs through the connecting cords.
Here's a summary of the acceptance criteria and study information based on the provided text, focusing on the performance of the SSU Flexible Video-Uretero-Renoscope System:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in numerical terms for the performance characteristics. Instead, it compares the subject device's performance characteristics to those of a predicate device (KARL STORZ Flexible Video-Uretero-Renoscope System K141250) to demonstrate substantial equivalence. The "Acceptance Criteria" column below will reflect the predicate device's corresponding specifications where applicable, or indicate "Met design specifications" if specific targets for the subject device are not detailed but performance testing was done.
| Characteristic | Acceptance Criteria (Predicate Device K141250) | Reported Device Performance (SSU Flexible Video-Uretero-Renoscope SSU System) |
|---|---|---|
| Maximal Outer diameter Insertion Portion | Same as subject device | 3.2 mm |
| Outer diameter Insertion Tube | Same as subject device | 2.9 mm |
| Outer diameter Distal End | Same as subject device | 3.2 mm |
| Insertion portion length | 675 mm | 700 mm |
| Working channel | Present | Present |
| Inner diameter Working Channel | Same as subject device | 1.2 mm |
| Tip deflection up/down | Same as subject device | 270°/270° |
| Field of view | 90° | 110° |
| Direction of View | Same as subject device | 0° |
| Depth of Field | 4 - 60 mm | 5 - 50 mm |
| On-axis Resolution (at 5/4 mm) | 11.0 Lp/mm at 4 mm | 12.5 Lp/mm at 5 mm |
| On-axis Resolution (at 15/12 mm) | 4.0 Lp/mm at 12 mm | 4.5 Lp/mm at 15 mm |
| On-axis Resolution (at 50/60 mm) | 1.0 Lp/mm at 60 mm | 1.25 Lp/mm at 50 mm |
| Chip type | Same as subject device | CMOS |
| Chip location | Same as subject device | Distal |
| Illumination source | Same as subject device | LED |
| Compatible CCU | Image 1S | C-MAC, C-HUB II, Image 1S |
| How device is provided | Unsterile, reusable | Sterile single-use |
| EO Sterilization cycle | N/A | EO, Overpressure 2.7 bar absolute, 8.5 % ETO in 91.5 % C02 |
| Sterilizing Agent | N/A | Ethylene Oxide (EO) |
| Electrical Safety and EMC | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18 | Met requirements of these standards |
| IEC 62471 | Met requirements of this standard | Met requirements of this standard |
| ISO 10993 | Met requirements of this standard | Met requirements of this standard |
| ISO 8600 | Met requirements of this standard | Met requirements of this standard |
| Performance Testing (General) | Not explicitly detailed | Performed (Color Contrast Enhancement, Image intensity uniformity, Depth of field & Spatial Resolution, Distortion, Signal-to-Noise Ratio (SNR) & Sensitivity) - Met design specifications. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." This indicates that no clinical test set (i.e., human patient data) was used.
The performance was evaluated through non-clinical bench testing. The sample size for these bench tests is not explicitly stated in the provided text, nor is the provenance of the data from these bench tests (e.g., if specific components were sourced from different countries or if testing was done in a specific lab location). The submitter, KARL STORZ SE & Co. KG, is located in Tuttlingen, Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical testing was performed, no experts were used to establish ground truth for a clinical test set. The performance was evaluated against design specifications and recognized consensus standards by the technical personnel conducting the bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical test set was used, no adjudication method was applicable or performed.
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. The device itself is an endoscope system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an endoscope system that requires human operation and interpretation. It is not an algorithm performing a standalone task.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical bench testing, the "ground truth" implicitly used would be engineering and physical measurements taken against established specifications and recognized consensus standards. For example, "on-axis resolution" would be measured using standardized targets and optical equipment, with the expected values derived from known optical principles and predicate device data.
8. The sample size for the training set
Not applicable. This device is a hardware medical device (an endoscope system), not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its design and performance are based on engineering principles and verified through bench testing.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI algorithm.
§ 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.