(29 days)
MAQUET LUCEA LED® Surgical Light Systems are intended to be used to provide visible illumination of the surgical area or the patient during surgical operations, diagnostics and treatment.
MAQUET LUCEA LED® Surgical Light Systems have been developed in order to provide MAQUET EUGEAEED Surgied Lightnology. An innovative design combined with a functional shape offers an efficient product to the surgical staff. functional shape oners an cindical provide hights provide high quality illumination Designed for minor ourgory, without any compromises on the major enhancements offered by MAQUET surgical lights. The LUCEA LED® Surgical Lights are well-suited for installation in surgical suites, examining rooms, doctor's surgeries and external consultations.
Here's an analysis of the provided text regarding the acceptance criteria and study for the LUCEA LED® Surgical Light System:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices for a surgical light system. As such, it does not present quantifiable acceptance criteria for specific performance metrics in the way a diagnostic AI device's summary might. Instead, the "acceptance criteria" are implied by conformance to various medical device standards, and the "reported device performance" is the claim of meeting these standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to electrical safety standards (UL 60601-1) | Test data supports conformance to UL 60601-1, 1st Edition, 2006-04-26 |
| Conformance to particular safety standards for luminaires (IEC 60601-2-41) | Test data supports conformance to IEC 60601-2-41:2000 |
| Conformance to general requirements for basic safety and essential performance (IEC 60601-1) | Test data supports conformance to IEC 60601-1:1988 + A1:1991 + A2:1995 |
| Conformance to electromagnetic compatibility standards (IEC 60601-1-2) | Test data supports conformance to IEC 60601-1-2:2007 |
| Conformance to FCC regulations for radio frequency emissions (FCC Part 15) | Test data supports conformance to FCC Part 15 |
| Equivalence in intended use and features to predicate devices | The device is "similar to the predicate devices" with described modifications, and considered "safe and effective when used as intended." |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of an AI device's performance evaluation (e.g., a set of images or cases). The testing described is engineering and regulatory compliance testing for a physical medical device (a surgical light). Therefore, concepts like sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable in the way they would be for an AI algorithm.
The testing involved evaluating the physical device against the listed standards. The "data provenance" for this type of testing is typically the testing laboratory or manufacturer's internal quality assurance processes.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. For a surgical light system, "ground truth" as it relates to expert consensus on medical findings is not relevant. The device's performance is objectively measured against engineering and electrical safety standards.
4. Adjudication Method
Not applicable. This is not a study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, this document does not mention or describe an MRMC comparative effectiveness study. This type of study is typically conducted for diagnostic or AI-powered devices to assess the impact of AI on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The LUCEA LED® Surgical Light System is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is defined by established engineering standards, product specifications, and regulatory requirements. The device's performance is measured against these objective, quantifiable benchmarks. For example, light intensity is measured in lumens, color temperature in Kelvin, and electrical safety against specific resistance and leakage current limits.
8. The Sample Size for the Training Set
Not applicable. The LUCEA LED® Surgical Light System is a physical medical device, not an AI model that requires training data.
9. How the Ground Truth for the Training Set was Established
Not applicable. As described above, there is no AI training set for this device.
§ 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.