(79 days)
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
The subject device is a video system center to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment used with endoscopes. The subject device is an update to the Visera Elite II Video System Center cleared under K193026 to add a 2D observation function. The subject device has both a processor function and light source function. By switching on the illumination lamp in the subject device, the device provides light through the endoscopes directly for endoscopic observation. There are two modes: WLI (White light imaging) mode for normal observation and NBI (Narrow-band imaging) mode for enhanced optical image observation. By driving the CCD equipped in an endoscope, the subject device displays an endoscopic images on a monitor.
The provided document is a 510(k) Premarket Notification for the VISERA ELITE II VIDEO SYSTEM CENTER. It describes the device, its intended use, and provides a comparison to a predicate device. It also briefly mentions performance data.
However, the document does not contain the detailed information required to answer all parts of your request, especially regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC study results. The document focuses on technological similarities and differences with a predicate device to establish substantial equivalence for regulatory clearance.
Based on the information available, here's what can be extracted:
I. Acceptance Criteria and Reported Device Performance
The document states that bench testing was conducted to ensure the device performs as intended and meets appropriate design specifications. However, the specific acceptance criteria and detailed quantitative performance results for each of the listed image quality parameters are not provided in this regulatory submission summary.
| Acceptance Criteria (Explicitly Stated/Implied) | Reported Device Performance |
|---|---|
| Image Quality: | |
| - Brightness | "Performs as intended and meets appropriate design specifications" (Specific metrics not provided) |
| - Image Intensity | "Performs as intended and meets appropriate design specifications" (Specific metrics not provided) |
| - Color Performance | "Performs as intended and meets appropriate design specifications" (Specific metrics not provided) |
| - Signal to Noise ratio | "Performs as intended and meets appropriate design specifications" (Specific metrics not provided) |
| Video Latency | "Performs as intended and meets appropriate design specifications" (Specific metrics not provided) |
| Electrical Safety | Complies with ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2014 |
| Software Verification & Validation | Conducted as recommended by FDA guidance. |
II. Sample Size and Data Provenance for Test Set
The document mentions "Bench testing" for performance evaluation.
- Sample size used for the test set: Not specified. It's likely that "test set" refers to physical setups and controlled environments used for bench testing, rather than a dataset of patient images.
- Data provenance: Bench testing suggests controlled laboratory conditions. The document does not specify country of origin for any data or whether it's retrospective or prospective.
III. Number of Experts and Qualifications for Ground Truth
- Number of experts: Not specified.
- Qualifications of those experts: Not specified.
- Method of establishing ground truth: For bench testing, ground truth would typically be established by calibrated measurement devices and reference standards, not human expert consensus on diagnostic images.
IV. Adjudication Method for the Test Set
Not applicable/Not specified as the performance testing described is "Bench testing" of system characteristics (e.g., image quality parameters, electrical safety) rather than diagnostic performance involving human interpretation of clinical cases.
V. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, the document does not indicate that an MRMC comparative effectiveness study was done. The focus is on technical performance and substantial equivalence to a predicate device, not on improving human reader performance.
- Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as no MRMC study was described.
VI. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? The performance data mentioned (image quality, video latency) relate to the standalone technical performance of the device's video system, specifically the added 2D observation function. However, this is not an "algorithm-only" performance in the context of an AI/CADe device, but rather the performance of the optical and electronic components of an endoscope video system. The document does not describe any specific algorithm or AI component in the device.
VII. Type of Ground Truth Used
- For the bench testing described, the "ground truth" would be objective measurements obtained using calibrated equipment against known physical standards (e.g., for brightness, color accuracy, signal-to-noise ratio, latency). It is not pathology, outcomes data, or expert consensus on clinical findings.
VIII. Sample Size for the Training Set
- Not applicable/Not specified. The document does not describe the use of machine learning or AI algorithms that would require a "training set" of data.
IX. How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set for an AI algorithm is mentioned.
Summary of Device and Study Focus:
This 510(k) submission primarily focuses on demonstrating the substantial equivalence of the "VISERA ELITE II VIDEO SYSTEM CENTER" to a predicate device (K193026). The key change for this submission (K201200) is the addition of a 2D observation function to a device that previously only offered 3D observation. The performance data section describes "Bench testing" of standard technical parameters (electrical safety, EMC, software, and image quality aspects like brightness, intensity, color, SNR, and video latency) to affirm that the device functions as intended and meets design specifications for its intended use as an endoscopic video system. It is a general medical device focused on video processing and illumination, not an AI or diagnostic decision support system.
§ 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.