(184 days)
The Mach LED MC lighting system is designed for illuminating an examination area and surgical field at the hospital and doctor's practice.
The surgical light Mach LED MC is intended to illuminate the operating site on the patient's body with a high intensity, shadow-free and "cold" light.
The surgical light Mach LED MC is intended to illuminate the operating site on the patient's body with a high intensity, shadow-free and "cold" light.
This 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 Mach LED MC 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-coloured LED's: warm white, cold white, green and red. The four different colours are merged inside the lamphead by a computer-calculated optical system with light quide and facetted lenses.
The surgical light Mach LED MC will be market with merging of light intensity control, colour temperature adjustment and integrated laser pointer.
Available accessories for the Mach LED MC lighting systems are as follows:
- Camera module
- Remote control for 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
- Sterilizable handle sleeves
The provided document pertains to a 510(k) summary for a surgical lamp, the Mach LED MC. This type of device does not involve AI or algorithms, and therefore, many of the requested details about acceptance criteria, study design for AI performance, ground truth, and training sets are not applicable.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as quantitative performance metrics in a defined table. Instead, the device's performance is demonstrated by meeting general regulatory standards for medical electrical equipment.
| Acceptance Criteria Category | Reported Device Performance (Compliance) |
|---|---|
| Electrical Safety | Complies with EN 60601-1 |
| Specific Requirements for Surgical Luminaires | Complies with EN 60601-2-42 |
| Electromagnetic Compatibility (EMC) Emissions | Complies with EN 55015 |
| Electromagnetic Compatibility (EMC) Immunity | Complies with EN 61000-4 |
| Illumination Quality | "high intensity, shadow-free and "cold" light" (Qualitative) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. Performance testing was likely conducted on a single or a limited number of device units. This is not a study involving patient data.
- Data Provenance: Not applicable, as this is hardware performance testing, not data-driven. The testing was conducted by third-party laboratories (TÜV SÜD Product Service and mikes-testingpartners GmbH).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for hardware performance is defined by the technical specifications and standards (e.g., specific lux levels, color temperature ranges, safety limits).
4. Adjudication method for the test set
Not applicable. Performance testing against established standards (EN 60601 series, EN 55015, EN 61000-4) typically involves direct measurement and comparison with predefined limits, not expert adjudication.
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
Not applicable. This is a surgical lamp, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not have an algorithm in the context of AI or data processing for diagnosis/decision-making.
7. The type of ground truth used
The ground truth used for this device is based on established international and European standards for medical electrical equipment (EN 60601-1, EN 60601-2-42, EN 55015, EN 61000-4). These standards define objective, measurable parameters for safety and performance.
8. The sample size for the training set
Not applicable. There is no AI model or algorithm being trained for this device.
9. How the ground truth for the training set was established
Not applicable. There is no AI model or algorithm being trained for this device.
Summary of Study:
The study conducted for the Mach LED MC was a non-clinical performance data testing to verify that the device meets the requirements for Medical Electrical Equipment as defined in the following standards:
- EN 60601-1 (General requirements for basic safety and essential performance)
- EN 60601-2-42 (Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis)
- EN 55015 (Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment)
- EN 61000-4 (Electromagnetic compatibility (EMC) - Testing and measurement techniques)
The testing was performed according to external procedures at TÜV SÜD Product Service and mikes-testingpartners GmbH. No clinical data was required or submitted for this device classification. The conclusion was that the device met these requirements.
§ 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.