(38 days)
The surgical light Mach LED 2MC is intended to illuminate the on the patient's body with a high intensity, shadow-free and "cold" light.
The Mach LED 2MC lighting system is designed for illuminating an examination area and surgical field at the hospital and doctor's practice.
The surgical light Mach LED 2MC is intended to illuminate the operation site on the patient's body with a high intensity, shadow free and "cold" light.
The Mach LED 2MC consists of lamp housing, LED modules, optical, electrical and mechanical components, one sterilizable handle sleeve as well as the cables.
One LED-module consists of 4 different-colored LEDs: warm white, cold white, green and red. The four different colors are merged inside the lamp head by a computercalculated optical system with light guide and facetted lenses.
The light system can be added to the ceiling mounted suspension system supporting the horizontal arms and spring arms. The horizontal arms can be rotated horizontally with 360°, the spring arms can be rotated horizontally with 360° and moved vertically with 50° downwards and 45° upwards.
The light system is operated by a keypad on the lamp head or, by special request of the customer, by a keypad on the wall.
The surgical light Mach LED 2MC will be marketed with merging of light fields, light intensity control, color temperature adjustment and integrated laser pointer.
The provided text is a 510(k) summary for the Mach LED 2MC surgical lamp. It does not contain information about acceptance criteria, device performance, or study results in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and non-clinical data. It explicitly states that "No clinical data is required for this device classification submission."
Therefore, I cannot provide the requested information from the given text.
Here's why each point cannot be fulfilled:
- A table of acceptance criteria and the reported device performance: The document only lists "Technical Parameter" for the new device and predicate devices (Number of LEDs, which is a design characteristic, not a performance metric like illuminance or color temperature), and states that "Performance testing was conducted to verify that Mach LED 2MC meet the requirements for Medical Electrical Equipment as defined in the relevant standards for Medical electrical equipment and the EN 61000 group." However, it does not provide the specific acceptance criteria or the actual performance results in a table.
- Sample sized used for the test set and the data provenance: No specific test set or data provenance is mentioned beyond general performance testing against standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment by experts is not applicable as no clinical or interpretative study is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable; no such study is described.
- 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: Not applicable; this device is a surgical lamp, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this device is a physical surgical lamp, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable; no clinical study or ground truth for diagnostic purposes is mentioned.
- The sample size for the training set: Not applicable; there is no AI or machine learning component mentioned that would require a training set.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.