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510(k) Data Aggregation
(6 days)
The CHROMOPHARE® E 668 is intended to be used to provide visible illumination to the surgical field of the patient. The surgical lights BERCHTOLD CHROMOPHARE® E 668 is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.
The new BERCHTOLD CHROMOPHARE® E 668 surgical light is suitable for all types of surgical procedures. With the use of Light Emitting Diodes (LEDs) in this light, BERCHTOLD realizes high illumination intensity with a lower heat radiation and less pattern variation compared to previous generations of BERCHTOLD products. The light features easy-to-operate swivel arms. Each light functions with an optional integrated CCD video camera and/or with upward "EndoLite" and/or with downward "GuideLite" for endoscopic procedures. The lights could be combined among each other.
The provided text describes a 510(k) summary for the BERCHTOLD CHROMOPHARE® E 668 surgical lamp. The submission focuses on demonstrating substantial equivalence to a predicate device (BERCHTOLD CHROMOPHARE® E 558), rather than a study proving the device meets specific acceptance criteria for a novel AI or diagnostic system.
Therefore, many of the requested elements (like sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, and training set details) are not applicable or cannot be extracted from this type of regulatory submission as they pertain more to performance studies of diagnostic or AI-driven devices.
However, I can extract the acceptance criteria based on the comparison to the predicate device and the conformity to relevant standards.
1. A table of acceptance criteria and the reported device performance
For a substantial equivalence submission like this, the "acceptance criteria" are implicitly established by the characteristics of the predicate device and relevant performance standards. The new device is accepted if its performance characteristics are substantially equivalent to the predicate and conform to identified standards, without raising new questions of safety or effectiveness.
| Characteristic / Acceptance Criteria (Predicate E 558) | Reported Device Performance (New Device E 668) | Met/Not Met (Substantially Equivalent) |
|---|---|---|
| Intended use: Illumination of the operating site on a patient's body | Same | Met |
| Input power: 120V, 1-phase lines, 60Hz | Same | Met |
| Protection against electrical shock: Class I | Same | Met |
| Diameter of light body: 568mm | 638mm | Met (Difference assessed not to alter safety/efficacy) |
| Diameter of reflectors: 36x35mm, 36x40mm | 48x35mm, 48x40mm | Met (Increased number, assessed not to alter safety/efficacy) |
| Lamp technology: Light Emitting Diode | Same | Met |
| Reflector: 72 individual reflectors | 96 individual reflectors | Met (Increased number, assessed not to alter safety/efficacy) |
| Power consumption of bulb: <2.5W each | Same | Met |
| Light/heat filter technology incl. UV light filter mechanism: None | Same | Met |
| Color rendering Index Ra: 94 | Same | Met |
| Color temperature: 3600K, 4000K, 4500K, 5000K | Same | Met |
| Central illuminance (at 1m): 70000 - 140000lux | 80000 - 160000lux | Met (Increased range, assessed not to alter safety/efficacy) |
| Light field diameter: 140 - 285mm | 150 - 290mm | Met (Increased range, assessed not to alter safety/efficacy) |
| Depth of illumination: 805mm | 850mm | Met (Increased, assessed not to alter safety/efficacy) |
| Total irradiance E₀: 442 W/m² | 600 W/m² | Met (Increased, assessed not to alter safety/efficacy) |
| UV-irradiance (≤400nm): 0 W/m² | Same | Met |
| Light focusing mechanism: Pressure Sensitive Handgrip | Same | Met |
| Life time of bulb: 20000h | Same | Met |
| Reusable steam sterilizable lamp handle: Yes | Same | Met |
| Additional light controls in separate wall box: Standard | Same | Met |
| Ambient Illumination for minimally invasive surgeries: Optional upward "EndoLite" and/or downward "GuideLite" | Same | Met |
| CCD video camera located in sterilizable lamp handle: Optional feature | Same | Met |
| Conforms to IEC 60601-2-41:2001 (performance) | Conforms to IEC 60601-2-41:2001 (performance) | Met |
| Conforms to IEC 60601-1 (electrical safety) | Conforms to IEC 60601-1 (electrical safety) | Met |
| Conforms to IEC 60601-1-2 (electrical safety) | Conforms to IEC 60601-1-2 (electrical safety) | Met |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not involve a "test set" in the context of an AI or diagnostic device. The evaluation is based on device specifications and adherence to international safety and performance standards for surgical lamps. No patient data or clinical study data (retrospective or prospective) from any country of origin is mentioned.
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)
Not applicable. There is no "ground truth" establishment by experts for a test set in this device submission. The device is a surgical lamp, and its performance is validated against engineering specifications and international standards, not against expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication method described for this type of device.
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 light, not an AI or diagnostic system. Therefore, no MRMC comparative effectiveness study was performed or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical light, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for this device's performance is established by its engineering specifications and its ability to meet the requirements of recognized international standards (IEC 60601-2-41, IEC 60601-1, IEC 60601-1-2) for safety and performance of surgical lights.
8. The sample size for the training set
Not applicable. This device is a physical surgical light, not a machine learning model. There is no training set in this context.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for it.
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