(206 days)
4K UHD Camera System is used to provide imaging of the operative area in endoscopic surgery.
4K Camera Control Unit
The 4K camera control unit has been designed to be used with endoscopes, 4K camera head, light source, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. The 4K camera head is compatible with the 4K camera control unit only.
4K Camera Head
The 4K camera head has been designed to be used with endoscopes, 4K camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
The proposed system, 4K UHD Camera System, comprises the 4K camera head, objective lens and power cable and video cables. The proposed system is reusable device, and provided non-sterile. The proposed camera head and should be cleaned and disinfected after each use.
The video cables include an SDI video cable and an HDMI video cable. The 4K camera control unit has two models (ES-CS4K100 and ES-CS4K200) with the only difference on signal output terminals, the detail difference refers to Table 3 of this document; the 4K camera head only has one model (ES-CS4K100C). Therefore, the 4K UHD Camera System is available in two models in combination of the 4K camera control unit and 4K camera head.
The Scivita Medical Technology Co., Ltd. 4K UHD Camera System (K200216) is designed to provide imaging for endoscopic surgery. My analysis of the provided text did not reveal a detailed acceptance criteria table nor a specific study demonstrating the device's fulfillment of those criteria. Instead, the document focuses on non-clinical performance testing and substantial equivalence to a predicate device.
Here's an analysis of the available information regarding acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that "the subject device met all predefined acceptance criteria" for various performance tests, but it does not provide specific numerical acceptance criteria or the numerical results (i.e., the reported device performance) for these tests.
| Performance Test Category | Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Not explicitly stated in the document) |
|---|---|---|
| Depth of Field | Met predefined acceptance criteria | Met predefined acceptance criteria |
| Resolution | Met predefined acceptance criteria | Met predefined acceptance criteria |
| Direction of View and Field of View | Met predefined acceptance criteria | Met predefined acceptance criteria |
| Color Reproduction and Signal Noise Ratio | Met predefined acceptance criteria | Met predefined acceptance criteria |
| Geometric Distortion | Met predefined acceptance criteria | Met predefined acceptance criteria |
| Image Frame Frequency and System Delay | Met predefined acceptance criteria | Met predefined acceptance criteria |
| Image Intensity Uniformity | Met predefined acceptance criteria | Met predefined acceptance criteria |
The document details the general specifications of the device, which can be seen as implicit performance benchmarks:
| Specification | Value (Subject Device) |
|---|---|
| Camera Head | 1/3" Three Chip CMOS |
| Signal Output (Resolution) | 4096x2160, 1920x1080 |
| HDMI Output Formats | 2160/59.94p, 2160/50p, 1080/59.94p, 1080/59.94i, 1080/50p, 1080/50i |
| SDI Output Formats | 2160/59.94p, 2160/50p, 1080/59.94p, 1080/59.94i, 1080/50p, 1080/50i |
| Image Recording | Data stored in real-time to external USB device |
| Operation Mode | Continuous operation |
| White Balance | Automatic white balance |
2. Sample Size for the Test Set and Data Provenance
The document does not mention a "test set" in the context of clinical images or patient data. The performance tests mentioned (Depth of Field, Resolution, etc.) appear to be non-clinical engineering/technical evaluations of the device hardware and software, likely using test targets and technical measurements rather than patient data. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a test set of medical data is not applicable based on the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since the tests described are non-clinical technical performance tests, the concept of "ground truth" derived from expert review of medical images is not applicable here. The ground truth for these tests would be objective technical standards and measurements.
4. Adjudication Method for the Test Set
Not applicable, as the tests described are non-clinical technical performance tests, not studies involving human interpretation of medical images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or mentioned in this document. The submission focuses on demonstrating substantial equivalence through technical performance verification and comparison to a predicate device.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device described is a 4K UHD Camera System, which is a hardware system for image acquisition, not an AI algorithm for image analysis. The "software" mentioned as a "Moderate level of concern (LoC)" refers to the device's operational software, not an AI for diagnostic interpretation.
7. Type of Ground Truth Used
For the non-clinical performance tests mentioned ("Depth of Field Test," "Resolution Test," etc.), the "ground truth" would be established by predefined engineering specifications, standardized test methods, and objective measurements. The document does not specify how these performance criteria were set or verified beyond stating that "the subject device met all predefined acceptance criteria."
8. Sample Size for the Training Set
Not applicable. The device is a camera system, not an AI model that requires a training set of data.
9. How Ground Truth for the Training Set Was Established
Not applicable, as the device is a camera system, not an AI model.
§ 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.