(87 days)
This medical monitor is intended to provide color video displays and images from medical equipment which include laparoscopy and endoscopy systems for surgery and various medical imaging systems.
32HR734S LCD monitor is intended to provide color video displays of images from surgical endoscope, laparoscopic camera system and other compatible medical imaging systems. This Medical Monitor has multiple video interface ports such as DP, HDMI, DVI, SDI input. This monitor displays color video and images from medical equipment which include various medical imaging systems. This monitor can be covered over 100% of the sRGB spectrum.
This document is a 510(k) premarket notification for a medical monitor (32HR734S). It states that no clinical studies were considered necessary and therefore none were conducted. The substantial equivalence determination is based on non-clinical tests including electrical safety and electromagnetic compatibility (bench tests against IEC 60601-1, IEC 60601-1-2, IEC TR 60601-4-2 standards) and software validation (developed according to a software development process and verified/validated per IEC 62304).
Given the information provided, it is not possible to fill out the table and answer all questions related to acceptance criteria, device performance, study details, and ground truth as no clinical studies were performed. The document primarily focuses on demonstrating substantial equivalence through technical and regulatory compliance rather than clinical performance metrics.
However, I can extract the information regarding the non-clinical tests that were performed.
Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Electrical Safety | Complies with IEC 60601-1 Edition 3.2 2020-08: General requirements for basic safety and essential performance. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 Edition 4.1 2020-09: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. |
| Electromagnetic Immunity (Guidance) | Complies with IEC TR 60601-4-2 Edition 1.0 2016-05: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems. |
| Software Validation | Software designed, developed, verified, and validated according to IEC 62304 and FDA guidance "The content of premarket submissions for Device Software Functions (June 14, 2023)." |
Study Information (Based on provided non-clinical data):
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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):
- Test set sample size: Not applicable/not specified for clinical performance. For bench testing, it refers to the physical device unit(s) tested.
- Data provenance: Bench tests and software validation were conducted to verify compliance with international standards. Specific country of origin for test data is not provided, but the applicant is LG Electronics Inc. from Korea, South. The testing is non-clinical.
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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 as no clinical ground truth was established for this device based on the provided document. The "ground truth" for non-clinical testing refers to compliance with established technical standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical adjudication was performed. Compliance with technical standards is determined through validated test procedures and results.
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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 MRMC or comparative effectiveness study was performed. The device is a medical monitor, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a display monitor, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for clinical performance. The "ground truth" for the non-clinical tests was adherence to and compliance with international standards for electrical safety, EMC, and software validation.
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The sample size for the training set:
- Not applicable as no machine learning algorithm was trained for this device. The software validation refers to the development and testing of the monitor's embedded software functionality.
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How the ground truth for the training set was established:
- Not applicable as no machine learning algorithm was trained.
§ 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.