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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.

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.

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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:

1. 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.
2. 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.
3. 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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable; no such study is described.
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 device is a surgical lamp, not an AI-assisted diagnostic tool.
6. 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.
7. 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.
8. The sample size for the training set: Not applicable; there is no AI or machine learning component mentioned that would require a training set.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

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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.

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.

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The Mach LED SC lighting system is designed for illuminating an examination area and surgical field at the hospital and doctor's practice.
The surgical light Mach LED SC is intended to illuminate the surgical field and the patient.

The surgical light Mach LED SC is intended to illuminate the surgical field and the patient. 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 SC 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 surgical light Mach LED SC will be market with merging of light fields and light intensity control. Colour temperature adjustment not available.
Available accessories for the Mach LED SC 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
• Integrated laser pointer
• Sterilizable handle sleeves

This document is a 510(k) summary for the Dr. Mach LED SC surgical lamp, not a study report for a diagnostic AI device. Therefore, it does not contain information about acceptance criteria and performance data in the context of AI or machine learning algorithms.

The document primarily focuses on establishing substantial equivalence for a physical medical device (a surgical light) relative to existing predicate devices. It discusses non-clinical performance testing for compliance with electrical safety and EMC standards (EN 60601-1, EN 60601-2-42, EN 55015, EN 61000-4), but no clinical performance data is required or presented for this device classification.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as this information is not present in the provided document.

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