(116 days)
The Sony LMD-2451MT LCD Monitor is intended to provide 3D and 2D color video displays of images from surgical endoscopic/laparoscopic camera systems and other compatible medical imaging systems. The LMD-2451MT is a widescreen, high-definition, medical grade monitor for real-time use during minimally invasive surgical procedures and is suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.
The Sony LMD-2451MT LCD Monitor is intended primarily for use in a medical environment for displaying images captured during minimally invasive surgical procedures. The monitor features a 24-inch widescreen LCD display panel and employs full WUXGA high-definition (HD) performance. The LMD-2451MT also features Sony's ChromaTru® technology for accurate and consistent color matching across multiple monitors. The monitor is 2D/3D switchable and, therefore, is compatible with both 2D and 3D camera systems to show color and texture variations in full HD in both 2D and 3D modes. In addition to digital signals, the LMD-2451MT accepts analog signals and converts them to digital signals. The 3D mode of the Sony LMD-2451MT LCD Monitor enables more realistic depth perception and spatial orientation than is available in the 2D mode. A micro-polarizer 3D filter is built into the monitor and lightweight circular polarizer 3D glasses are supplied as accessories. The Sony LMD-2451MT LCD Monitor is designed with the flexibility to support a variety of formats with two built-in option slots to select, expand, and change input/output signals.
The provided text is a 510(k) summary for a medical device, the Sony LMD-2451MT LCD Monitor. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria beyond compliance with recognized standards for electromagnetic compatibility and electrical safety.
Therefore, I cannot populate the requested table and answer many of the questions based solely on the provided text. The document is a regulatory submission demonstrating substantial equivalence, not a detailed technical performance study report.
Here's an breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General performance | Not explicitly stated as quantitative acceptance criteria for image quality, resolution, or color accuracy. The document implies compliance with standards is the primary "acceptance." | "demonstrated that the device is in compliance with applicable requirements of recognized standards for electromagnetic compatibility and electrical safety." |
| "The monitor is 2D/3D switchable and, therefore, is compatible with both 2D and 3D camera systems to show color and texture variations in full HD in both 2D and 3D modes." | ||
| "The 3D mode... enables more realistic depth perception and spatial orientation than is available in the 2D mode." | ||
| Color Accuracy | Not explicitly stated. | "features Sony's ChromaTru® technology for accurate and consistent color matching across multiple monitors." (This is a feature description, not a performance metric with acceptance criteria.) |
| Resolution | Not explicitly stated. | "employs full WUXGA high-definition (HD) performance." (This is a specification, not a performance metric with acceptance criteria tested against.) |
| Electromagnetic Compatibility | Applicable requirements of recognized standards | In compliance with applicable requirements of recognized standards |
| Electrical Safety | Applicable requirements of recognized standards | In compliance with applicable requirements of recognized standards |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document states "Testing... demonstrated compliance" but does not detail the nature of this testing (e.g., number of units tested, types of image data used). This is a monitor, so "data provenance" in the sense of patient data is not applicable. The "testing" refers to product safety and performance testing.
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):
- Not applicable. This device is a display monitor. "Ground truth" in the context of diagnostic interpretation by experts is not relevant to its performance testing for regulatory submission. Its performance is measured against technical specifications and safety standards, not against human judgment for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See answer to point 3.
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. This is a passive display monitor, not an AI-powered diagnostic tool. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a display monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. For a display monitor, the "ground truth" would be the technical specifications (e.g., color accuracy measured by spectroradiometer, resolution by pixel count verification) and compliance with safety standards, not medical ground truth established by experts or pathology.
8. The sample size for the training set:
- Not applicable. This is a hardware device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. See answer to point 8.
In summary: The provided 510(k) summary focuses on establishing substantial equivalence for a medical monitor by comparing its intended use, technological characteristics, and compliance with general safety and EMC standards to a predicate device. It does not provide the kind of detailed performance study data, acceptance criteria, or ground truth establishment protocols that would be found in submissions for AI/ML-driven diagnostic devices.
§ 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.