(169 days)
VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400: The camera control unit has been designed to be used with Olympus endoscopes, camera heads, light source, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
VISERA 4K UHD XENON LIGHT SOURCE OLYMPUS CLV-S400: The light source has been designed to be used with Olympus endoscopes, camera control unit, light guide cables, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB: The camera head has been designed to be used with Olympus endoscopes, camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
The VISERA 4K Ultra-High Definition (UHD) SYSTEM has been designed to be used with Olympus camera heads, endoscopes, camera control unit, light source, monitors, light guide cables and other ancillary equipment for endoscopic diagnosis, treatment and observation. The VISERA 4K UHD SYSTEM consists of a camera control unit (CCU), light source, camera head, endoscope, monitors, printer, medical image storage device, cables and workstation.
The primary components of the subject system, which are part of this submission, are:
- VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400
- VISERA 4K UHD XENON LIGHT SOURCE OLYMPUS CLV-S400
- 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB
The VISERA 4K UHD SYSTEM receives optical image from a variety of endoscopes that are attached to the camera head via coupler and use image sensor to convert optical image into electronic signal. The CCU acts as the the control center of the system. The light source supplies light.
The VISERA 4K UHD SYSTEM can provide high quality 4K images. The VISERA 4K UHD SYSTEM supports wider color gamut. The new 4K camera heads incorporate a complementary metal oxide semiconductor (CMOS) image sensor. A camera control unit introduces a touch panel graphical interface.
The provided text is a 510(k) premarket notification for the Olympus VISERA 4K UHD SYSTEM. This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than detailing a specific clinical study with acceptance criteria for device performance in diagnosing or treating a disease.
Therefore, the information requested in your prompt (e.g., sample size for test/training set, number of experts for ground truth, adjudication method, MRMC study, standalone performance) is not available in this type of FDA submission. These details are typically found in clinical trial reports or performance study reports, which are not usually part of a 510(k) summary unless explicitly referenced for a particular claim that deviates significantly from a predicate device.
However, based on the provided text, I can extract information about the device's technical specifications and how its performance was demonstrated to meet regulatory requirements for substantial equivalence.
Here's an interpretation of the "acceptance criteria" and "study" based on the available information:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied to be the technical specifications and safety standards that the device must meet to function as intended and be considered substantially equivalent to the predicate device. The "reported device performance" refers to the results of non-clinical testing performed to demonstrate compliance with these specifications and standards.
| Acceptance Criteria Category | Reported Device Performance (VISERA 4K UHD SYSTEM) |
|---|---|
| Intended Use/Indications for Use | Designed to be used with Olympus endoscopes, camera heads, light source, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. |
| Image Resolution (CCU) | 4K (4096pxl × 2160pxl) |
| Image Quality / Features | Provides high quality 4K images, supports wider color gamut. |
| Camera Head Image Sensor Type | Complementary metal oxide semiconductor (CMOS) image sensor. |
| CCU Interface | Touch panel graphical interface. |
| Power Supply (CCU & Light Source) | 100-240V~ ±10%, 50/60Hz±1Hz (Same as predicate) |
| Input Power (CCU) | 350 VA |
| Input Power (Light Source) | 500 VA (Same as predicate) |
| Examination Lamp (Light Source) | Xenon short-arc lamp (ozone-free) 300W (Same as predicate) |
| Average Lamp Life (Light Source) | Approximately 500 hours of continuous use (Same as predicate) |
| Reprocessing (Camera Head) | End user sterilized - EOG/STERRAD (Differs from predicate's AUTOCLAVE, but validated) |
| Electrical Safety | Complies with IEC 60601-1: 2005+A1, IEC 60601-2-18: 2009 (Updated standards from predicate) |
| Laser Product Safety | Complies with IEC 60825-1: 2007 (Applicable to devices containing laser components, not explicitly stated for predicate components) |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2: 2007 (Updated standard from predicate) |
| Risk Management | Risk analysis carried out in accordance with ISO 14971:2007; design verification tests and acceptance criteria identified and performed based on this assessment. |
| Software Validation | Performed in accordance with FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." |
| General Performance (Functional Evaluation) | Performance testings were conducted to demonstrate that the VISERA 4K UHD SYSTEM performs according to specifications and functions as intended. Test results obtained verified the safety and effectiveness of the devices in accordance with design specifications and applicable standards. |
| Reprocessing Validation (Cleaning, Disinfection, Ster.) | All cleaning, disinfection, and sterilization methods have been validated. |
Study that Proves the Device Meets the Acceptance Criteria:
The "study" or evaluation demonstrating the device meets the acceptance criteria is detailed in the section titled "VII. Summary of non-clinical testing." This section describes a series of tests performed, rather than a single clinical study.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document is for a medical device that provides imaging, not an AI/diagnostic algorithm that interprets data. Therefore, there isn't a "test set" in the sense of clinical cases or patient data for an algorithm to process. The "test set" would be the manufactured devices themselves.
- The document does not specify the number of units tested.
- Data provenance (country of origin, retrospective/prospective) is not applicable or provided for this type of technical performance testing. The manufacturer is Olympus Medical Systems Corp. based in Japan, with the official correspondent in the USA, suggesting testing would adhere to international standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a technical performance and safety validation for hardware and software functionality, not an AI diagnostic algorithm requiring expert "ground truth" for clinical cases. Ground truth would be the established technical specifications and recognized standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for technical performance and safety testing. Compliance is determined by meeting predetermined technical specifications and standard requirements.
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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, an MRMC comparative effectiveness study was not done. This device is an imaging system (hardware and associated software for control and display), not an AI-based diagnostic tool intended to assist human readers in interpreting clinical cases. Its purpose is to provide the image data.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is an imaging system, not a standalone diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is the predefined design specifications, engineering requirements, and international consensus standards (e.g., IEC 60601 series, ISO 14971) for medical device safety and performance.
- For specific performance aspects like resolution, color gamut, etc., the ground truth would be established by objective measurements against known reference values or technical benchmarks.
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The sample size for the training set:
- Not applicable. This document does not describe an AI/ML algorithm that requires a training set of data.
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How the ground truth for the training set was established:
- Not applicable.
In summary: The submission for the VISERA 4K UHD SYSTEM demonstrates substantial equivalence through a series of non-clinical performance tests, electrical safety tests, electromagnetic compatibility (EMC) tests, reprocessing validation, software validation, and risk analysis. These tests confirm that the device meets its technical specifications and adheres to relevant international safety and performance standards. The "acceptance criteria" are these technical specifications and standards, and the "study" is the comprehensive non-clinical testing program.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.