(14 days)
The CHROMOPHARE® Exxx is intended to be used to provide of the device: visible illumination of the surgical field or the patient. The surgical lights BERCHTOLD CHROMOPHARE® E805, E800, E 655, E 650, E 550 and E 520 are intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.
The new BERCHTOLD CHROMOPHARE® E805, E800, E655, E650, E550, and E520 (collectively known and referred to in this document as CHROMOPHARE® Exxx) surgical lights are suitable for all types of surgical procedures. With the use of gas-discharging lamps or Halogen bulbs in these lights, 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, auto switching to the secondary lamp in case of failure of the primary lamp, and an easy-to-exchange lamp cartridge. Each light functions with an optional integrated CCD video camera and/or with upward "EndoLite" for endoscopic procedures. The lights could be combined among each other.
The CHROMOPHARE® Exxx surgical lamps' acceptance criteria and the study that proves the device meets the acceptance criteria are described below.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the CHROMOPHARE® Exxx surgical lights are based on their similarity to predicate devices (CHROMOPHARE® X65 and CHROMOPHARE® D650) and compliance with relevant electrical and surgical lamp performance standards.
The table below summarizes the key performance characteristics of the new devices (CHROMOPHARE® E805 and CHROMOPHARE® E655 are shown as examples for the metal halide discharging lamp technology, and CHROMOPHARE® E800, E650, E550, and E520 for the Halogen lamp technology) and compares them to the predicate devices, effectively serving as the reported device performance against the implicit acceptance criteria set by the predicate devices and performance standards.
| Characteristic | Legally marketed device (CHROMOPHARE® X65) Acceptance Criteria | New devices (CHROMOPHARE® E805) Reported Performance | New devices (CHROMOPHARE® E655) Reported Performance | Legally marketed device (CHROMOPHARE® D650) Acceptance Criteria | New devices (CHROMOPHARE® E800) Reported Performance | New devices (CHROMOPHARE® E650) Reported Performance | New devices (CHROMOPHARE® E550) Reported Performance | New devices (CHROMOPHARE® E520) Reported Performance |
|---|---|---|---|---|---|---|---|---|
| Intended use | Illumination of the operating site on a patient's body | same | same | Illumination of the operating site on a patient's body | same | same | same | Same |
| Input power | 120V, 1- phase lines, 60Hz | same | same | 120V, 1- phase lines, 60Hz | same | same | same | Same |
| Protection against electrical shock | Class I | same | same | Class I | same | same | same | Same |
| Diameter of light body | 650mm | 799mm | 649mm | 650mm | 799mm | 649mm | 579mm | 579mm |
| Diameter of polygon reflectors | 580mm | 680mm | 520mm | 580mm | 680mm | 520mm | 460mm | 460mm |
| Number of mirrored reflector elements | 800 | 720 | 720 | 800 | 720 | 720 | 720 | 720 |
| Lamp technology | Metal halide discharging | same | same | Halogen | same | same | same | Same |
| Polygon Reflector | Multi-piece | Single piece | Single piece | Multi-piece | Single piece | Single Piece | Single piece | Single piece |
| Power consumption of bulb | 72W | 150W | same | 150W | same | same | same | 150W |
| Light / heat filter technology incl. UV light filter mechanism | ThermoSorb® | same | same | ThermoSorb® | same | same | same | Same |
| Color rendering index Ra | 94 | same | same | 94 | 93 | 93 | 93 | 93 |
| Color temperature | 4500°K | 4300°K | 4300°K | 4500°K | 4300°K | 4300°K | 4300°K | 4300°K |
| Central illuminance (at 1m) | 80000 - 160000lux | same | same | 70000 - 130000lux | 80000 - 160000lux | 80000 - 160000lux | 65000 - 130000lux | 80000lux |
| Light field diameter | 170 - 280mm | 200 - 330mm | same | 150 - 280mm | 200-300mm | 170 - 280mm | 150 - 250mm | 200mm |
| Depth of Illumination | 1250mm | 1200mm | 1300mm | 1200mm | same | 1300mm | 1250mm | 1250mm |
| Total irradiance Ee | 550W/m² | 560W/m² | 560W/m² | 485W/m² | 560W/m² | 507W/m² | 455W/m² | 280W/m² |
| UV- irradiance (≤400nm) | 2.0W/m² | same | same | 2.6W/m² | same | Same | same | Same |
| Light focusing mechanism | Rotating of Handle | same | same | Rotating of handle | same | Same | same | No |
| Life time of bulb | 5000h | same | same | 1000h | same | Same | same | Same |
| Bulb life time indicator | Yes | same | same | No | same | Same | same | Same |
| Automatic switching to the reserve bulb | Yes | same | same | Yes | same | Same | same | Same |
| Bulb replacement indicator | Yes | same | same | Yes | same | Same | same | Same |
| Reusable steam sterilizable lamp handle | Yes | same | same | Yes | same | Same | same | Same |
| Additional light controls in separate wall box | Standard | same | same | Optional feature | Standard | Standard | Standard | No |
| EndoLite in the light head (ambient illumination for minimally invasive surgeries) | Optional feature | same | same | Optional feature | same | Same | same | No |
| CCD video camera located in sterilizable lamp handle | Optional feature | same | same | Optional feature | same | Same | same | No |
| Automatic regulation of intensity | No | AUTOlux | No | Not specified | Not specified | Not specified | Not specified | Not specified |
Study Proving Device Meets Acceptance Criteria
The study demonstrating that the CHROMOPHARE® Exxx devices meet the acceptance criteria is a performance summary and comparison to predicate devices, and compliance with recognized standards. This is a common approach for 510(k) submissions where substantial equivalence is being claimed.
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Sample size used for the test set and the data provenance:
- The document** does not specify a separate "test set" in the context of a clinical study or a dataset for an algorithm.**
- The evaluation is based on a comparison of the technical specifications and performance metrics of the new devices against established predicate devices (CHROMOPHARE® X65 and CHROMOPHARE® D650) and relevant standards.
- Data provenance: The data appears to be derived from the product specifications and performance testing conducted by the manufacturer, BERCHTOLD Holding GmbH, presumably in Germany (country of origin of the submitter). The nature of the data is technical specifications and performance characteristics, not patient-derived data, and thus doesn't fit the retrospective/prospective dichotomy in the typical clinical study sense.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the submission does not describe a study involving expert assessment of a test set to establish "ground truth" for a diagnostic or AI algorithm. The device is a surgical lamp, and its performance is evaluated against engineering and performance standards, as well as comparison to existing legally marketed devices.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable for the same reasons as above. There was no test set requiring expert adjudication.
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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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (often AI-powered) where human reader performance is being evaluated, typically with and without AI assistance. The CHROMOPHARE® Exxx is a surgical lamp, not a diagnostic or AI-assisted device in that context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. The CHROMOPHARE® Exxx is a physical medical device (surgical lamp), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context refers to established engineering and performance standards for surgical lamps, specifically:
- IEC 60601-2-41:2001 for performance of surgical lamps.
- IEC 60601-1 for electrical safety.
- IEC 60601-1-2 for electromagnetic compatibility (implied by electrical safety).
- Additionally, the performance of the predicate devices (CHROMOPHARE® D650 and CHROMOPHARE® X65) serves as a benchmark for "ground truth" to establish substantial equivalence.
- The "ground truth" in this context refers to established engineering and performance standards for surgical lamps, specifically:
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The sample size for the training set:
- This is not applicable. The device is not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established:
- This is not applicable for the same reasons 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.