(120 days)
The Sony PVM-2551MD OLED Monitor is intended to provide color video displays of images from surgical camera systems. The PVM-2551MD is a widescreen, highdefinition monitor for real-time use during minimally invasive surgical procedures including arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), thorascopy, endoscopy (general, gastroenterological and ENT surgery) and general surgery.
The Sony PVM-2551MD OLED Monitor is a color video monitor and is intended primarily for use in a medical environment for displaying images captured during minimally invasive and general surgical procedures. The monitor features a 24.5inch widescreen OLED panel and Sony's TRIMASTER™ technology, which has been developed to provide accurate color reproduction, precision imaging, and quality picture consistency. The monitor employs full high-definition (HD) performance with 1920 x 1080 pixels, an aspect ratio of 16:9, and a pixel efficiency of 99.99%. OLED (an acronym for Organic Light-Emitting Diode) is a flat-panel screen technology that represents an advance in display technology. It is an emissive technology that generates light from each pixel. The process that is the basis of OLED is electroluminescence. In the Sony PVM-2551MD OLED Monitor, the OLED panel makes use of an organic material, which emits light when an electric current is applied. Being self-emitting, the strength of luminescence can be controlled by the amount of electric current. This results in quick motion picture response, high contrast and wide dynamic range, and rich color reproduction. In addition to digital signals, the Sony PVM-2551MD OLED Monitor accepts analog signals and converts them to digital signals. The Sony PVM-2551MD OLED Monitor is designed with the flexibility to support a variety of formats as standard and also has two built-in option slots to select, expand, and change input/output signals.
Please note that the provided 510(k) summary for the Sony PVM-2551MD OLED Monitor does not describe a study involving AI or machine learning for medical diagnosis or classification. Therefore, I am unable to provide information on topics such as AI effectiveness, expert ground truth adjudication for AI, or training/test set details for AI.
The document describes a medical monitor, which is a display device, not an AI-powered diagnostic tool. The "Performance Testing" section is very brief and focuses on compliance with recognized standards for electromagnetic compatibility and electrical safety, which are typical for hardware devices.
Here's the information based on the provided document, with an emphasis on what is present and what is explicitly not present:
Acceptance Criteria and Device Performance Study for Sony PVM-2551MD OLED Monitor
This document describes the 510(k) submission for the Sony PVM-2551MD OLED Monitor, a color video monitor intended for displaying images captured during surgical procedures. The performance testing described focuses on the device's compliance with safety and electromagnetic compatibility standards, rather than diagnostic accuracy or an AI algorithm's performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with recognized electrical safety standards. | "demonstrated that the device is in compliance with applicable requirements of recognized standards for electromagnetic compatibility and electrical safety." |
| Electromagnetic Compatibility (EMC) | Compliance with recognized EMC standards. | "demonstrated that the device is in compliance with applicable requirements of recognized standards for electromagnetic compatibility and electrical safety." |
| Image Display Functionality | Ability to provide color video displays of images from surgical camera systems, with features like accurate color reproduction, precision imaging, quality picture consistency, high-definition (1920x1080), 16:9 aspect ratio, 99.99% pixel efficiency, quick motion picture response, high contrast, wide dynamic range, rich color reproduction. (These are performance claims, not explicitly defined acceptance criteria in the context of a "study" here, but rather characteristics of the product.) | The device incorporates a 24.5-inch widescreen OLED panel and TRIMASTER™ technology to achieve these characteristics. It accepts analog and digital signals. |
| Equivalence to Predicate | Substantial equivalence to the Stryker Vision Elect WHDTV (K081995) in overall purpose and function, with differences not affecting safety or effectiveness. | The submission concludes substantial equivalence based on similarities in overall purpose and function. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. This document describes performance testing for a hardware display device, not an AI or diagnostic algorithm that would typically use a "test set" of patient data. The testing mentioned refers to engineering compliance tests.
- Data Provenance: Not applicable. No patient data or medical images were used for performance evaluation in the context of a "test set" as understood for AI devices. The testing relates to the device's physical and electronic characteristics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. Ground truth, in the context of medical image interpretation for an AI device, is not relevant to the evaluation of a display monitor.
4. Adjudication Method for the Test Set
- Not applicable. No "test set" of medical cases requiring expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This document does not mention an MRMC study. The device is a display monitor, and the study described is not a comparative effectiveness study involving human readers or AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- No. This device is a display monitor, not a standalone algorithm.
7. Type of Ground Truth Used
- Not applicable. Ground truth for diagnostic accuracy is irrelevant for evaluating a medical display monitor's compliance with safety and EMC standards.
8. Sample Size for the Training Set
- Not applicable. There is no AI or machine learning algorithm described, and thus no training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no AI or machine learning algorithm described, and thus no training set or ground truth establishment relevant to AI.
§ 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.