(88 days)
The surgical lights, CHROMOPHARE® D 500 and D 530, 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® D 500 and D 530 surgical lights are suitable for all types of surgical procedures and offer the physician a natural (whiter) and "colder" light. The light quality is based on a optical double filter technique.
The CHROMOPHARE® D 530 provides a light intensity of up to 110000 lux and the CHROMOPHARE® D 500 up to 85000 lux.
The lights have features like easy-to-operate swivel arms, auto-switching on the second lamp in case of failure of the main lamp and an easy to exchange lamp cartridge. For the CHROMOPHARE® D 530 there is also an optional CCD-video camera available and a special version with "EndoLite" for endoscopical procedures. The lights could be combined with other Berchtold lights. The lights have been designed to and meet the requirements of the IEC 601 and UL 2601 regulation for safety.
The provided document is a 510(k) summary for the Berchtold CHROMOPHARE® D 500 and D 530 surgical lights. It describes the device, its intended use, and its substantial equivalence to a previously approved device (CHROMOPHARE® D 650, K965130).
However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically required for AI/algorithm-based medical devices. Instead, it focuses on demonstrating safety and performance equivalence to a predicate device through compliance with general electrical safety standards (IEC 601 and UL 2601) and specifications like light intensity.
Therefore, for the information requested in your prompt, I can only extract limited details based on the provided text. Many aspects you've asked for (e.g., sample size, expert ground truth, MRMC study, AI performance) are not applicable to this type of medical device submission.
Here's an attempt to answer based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Aspect | Reported Device Performance (CHROMOPHARE® D 500 / D 530) |
|---|---|
| Safety Compliance | Meets requirements of IEC 601 and UL 2601 regulations |
| Intended Use | Illuminates locally the operating site on the patient's body with high intensity, shadow-free, "cold" light |
| Maximum Light Intensity (D 530) | Up to 110,000 lux |
| Maximum Light Intensity (D 500) | Up to 85,000 lux |
| Light Quality | Natural (whiter) and "colder" light based on optical double filter technique |
| Features | Easy-to-operate swivel arms, auto-switching on second lamp in case of failure, easy-to-exchange lamp cartridge |
| Equivalence | Substantially equivalent to CHROMOPHARE® D 650 (K965130) |
Regarding the study that proves the device meets acceptance criteria:
The document indicates that safety has been established by meeting the requirements of IEC 601 and UL 2601 regulations. These are international and national (US) standards for the safety of medical electrical equipment. Compliance with these standards typically involves a series of tests performed by accredited laboratories to verify electrical safety, mechanical safety, thermal safety, and other aspects relevant to the device's operational environment and user interaction.
The "study" in this context is the testing and documentation demonstrating compliance with these recognized safety standards, rather than a clinical trial or performance study comparing diagnostic accuracy or clinical outcomes, which would be typical for an AI/algorithm-driven device.
Additional Information (where applicable based on the document):
- Sample size used for the test set and the data provenance: Not applicable for this type of device and submission. Compliance with safety standards involves testing of the device itself according to the standard's methodologies, not a "test set" of data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI devices (e.g., disease presence) is not relevant here. Compliance with safety standards is verified by testing against predefined engineering and safety specifications.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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-assisted diagnostic or assistive tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not contain an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI sense. "Ground truth" for this device's performance would be the measurements of light intensity, color temperature, electromagnetic compatibility, and other physical parameters, verified against the specifications in IEC 601 and UL 2601.
- The sample size for the training set: Not applicable. No AI model is being trained.
- How the ground truth for the training set was established: Not applicable.
§ 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.