(95 days)
The CHROMOPHARE® X 65 is intended to be used to provide used to provide visible illumination of the surgical field or the patient.
The surgical light BERCHTOLD CHROMOPHARE® X65 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® X 65 surgical light is suitable for all types of surgical procedures. With the use of gas-discharging lamps in the new light BERCHTOLD realizes a higher illumination intensity with a lower heat radiation. The light incorporates 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. Also an optional CCD-video-camera is available and a special version with "EndoLite" for endoscopical working. The light could be combined with other BERCHTOLD lights.
The provided text is for a 510(k) premarket notification for a surgical lamp (CHROMOPHARE® X 65). This type of device approval primarily relies on demonstrating substantial equivalence to a previously approved predicate device, rather than performing clinical studies with specific acceptance criteria and outcome measurements like those for diagnostic AI devices.
Therefore, the requested information about acceptance criteria, device performance, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable to this submission.
Here's why and what information is provided:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. For a surgical lamp, "acceptance criteria" would generally refer to adherence to design specifications, electrical safety standards (e.g., IEC 60601-1), electromagnetic compatibility (EMC), and performance specifications like illumination intensity, color temperature, and shadow reduction. The document does not provide a formal table of such criteria against measured performance for the CHROMOPHARE® X 65.
- What is reported: The device "realizes a higher illumination intensity with a lower heat radiation." This is a qualitative claim of improvement over the predicate, but not quantitative data against defined acceptance criteria within the provided text.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. There is no "test set" in the context of clinical performance data for this device. The assessment is primarily based on engineering design, specifications, and comparison to existing technology.
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. No experts were used for establishing a "ground truth" for a test set, as this is not a diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication method akin to clinical performance studies were used.
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-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. Ground truth in the context of clinical diagnostic accuracy is not relevant here. The "ground truth" for a surgical light's performance would be objective measurements of its physical properties (e.g., lux values, color rendering index, temperature at surgical site). These are not detailed in the summary.
8. The sample size for the training set:
- Not Applicable. There is no "training set" for this device, as it is not an AI/ML product.
9. How the ground truth for the training set was established:
- Not Applicable. (See point 8).
Summary of Relevant Information from the Provided Text:
The entire submission is focused on demonstrating substantial equivalence of the new device (CHROMOPHARE® X 65) to a legally marketed predicate device (BERCHTOLD CHROMOPHARE® D650, K965130).
- Rationale for Equivalence: "Any difference that exists between the CHROMOPHARE® D650 and the X 65 has no negative effect on safety or efficacy and actually enhances the usefulness in the chosen application."
- Key Technological Difference/Improvement: The new light uses "gas-discharging lamps" which enables "a higher illumination intensity with a lower heat radiation."
- Intended Use: To provide visible illumination of the surgical field or the patient.
- Predicate Device: BERCHTOLD CHROMOPHARE® D650 (K965130).
In essence, for this type of device, the "study" is the comparison against the predicate device based on technical specifications and design principles, rather than clinical performance data with specific acceptance criteria that would be expected for a diagnostic or therapeutic AI device.
§ 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.