(38 days)
The surgical light Mach LED 2SC is intended to illuminate the surgical field and the patient.
The surgical light Mach LED 2SC is intended to illuminate the surgical field and the patient.
The Mach LED 2SC 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 one white LED.
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 kevpad on the lamp head or, by special request of the customer, by a keypad on the wall.
The surgical light Mach LED 2SC will be marketed with merging of light fields and light intensity control. Color temperature adjustment will not be available.
Available accessories for the Mach LED 2SC lighting systems are as follows:
- Camera module .
- Remote control of camera module .
- Remote control with network interface for camera module .
- Single monitor yoke for flat panel monitors .
- Double monitor yoke for flat panel monitors .
- Instrument trays .
- Trays for CRT monitors
- 24V DC battery backup support .
- . Low profile wall control unit
- Integrated laser pointer .
- Sterilizable handle sleeves
The provided document is a 510(k) summary for the Mach LED 2SC surgical lamp, which is a medical device for illuminating surgical fields. The information requested in the prompt is typically found in studies specifically designed to validate the performance of AI/ML or diagnostic devices against certain criteria. This document, however, focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than detailing the design and results of such performance validation studies.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not available in this specific regulatory submission for a surgical lamp.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document speaks to "performance testing" to meet requirements for "Medical Electrical Equipment as defined in the relevant standards for Medical electrical equipment and the EN 61000 group." However, specific acceptance criteria and detailed reported device performance in a tabular format are not explicitly provided in this summary. The comparison table focuses on technological characteristics rather than performance metrics against acceptance criteria.
| Technical Parameter | New Device (Mach LED 2SC) | Predicate Devices (Mach LED 3SC, Mach LED 5SC) | Acceptance Criteria for performance | Reported Device Performance |
|---|---|---|---|---|
| Number of LEDs | 21 | Mach LED 3SC: 28, Mach LED 5SC: 40 | (Implicit from "reduced") | (Met, as the device was cleared) |
| Illumination Depth | Reduced | (Not quantified) | (Implicit from "reduced") | (Met, as the device was cleared) |
| Light Intensity | Reduced | (Not quantified) | (Implicit from "reduced") | (Met, as the device was cleared) |
| Light Head Diameter | Reduced | (Not quantified) | (Implicit from "reduced") | (Met, as the device was cleared) |
| Electrical Safety & EMC | Meets EN 61000 and relevant standards | (Not quantified for predicates) | Requirements of EN 61000 group and other relevant standards for Medical Electrical Equipment | Performance testing conducted to verify requirements are met. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document mentions "performance testing" but does not detail the sample sizes or data provenance for such tests. This is a physical device, not an AI/diagnostic software, so the concept of "data provenance" in the context of image data or patient records is not directly relevant here. The manufacturing location is Ebersberg, Germany.
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)
This information is not applicable/not provided. The device is a surgical lamp, which does not require "ground truth" established by experts in the way an AI diagnostic tool would. Performance is typically measured using physical instruments and standardized testing procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are relevant for subjective assessments or disagreement resolution in diagnostic studies, which is not the case for a surgical lamp's technical performance.
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
This information is not applicable/not provided. MRMC studies are specific to diagnostic tools, especially those involving human interpretation (e.g., radiologists interpreting images). This device is a surgical lamp and does not involve "human readers" in a diagnostic context or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This device is a physical surgical lamp, not an algorithm, so the concept of "standalone performance" in this context is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided. Ground truth, as typically understood in AI/diagnostic studies, is not relevant for the performance testing of a surgical lamp. Its performance is measured against technical specifications and safety standards.
8. The sample size for the training set
This information is not applicable/not provided. This device is a physical product and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As above, there is no "training set" for this physical device.
§ 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.