(15 days)
The CHROMOPHARE® E 778 and E 558 is intended to be used to provide visible illumination to the surgical field of the patient. The surgical lights BERCHTOLD CHROMOPHARE® E 778 and E 558 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® E 778 and E 558 surgical lights are suitable for all types of surgical procedures. With the use of Light Emitting Diodes (LEDs) 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. 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 510(k) summary for the BERCHTOLD CHROMOPHARE® E 778 and E 558 surgical lights does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically associated with AI/ML-driven medical devices.
This document describes a traditional medical device (surgical lamps) seeking substantial equivalence to a predicate device. The performance data provided are technical specifications of the surgical lights themselves, not a medical "performance" in the sense of diagnostic accuracy or clinical outcome that would require a study with a test set, ground truth, or expert review.
Therefore, many of the requested details are not applicable or cannot be extracted from this document.
However, I can extract the "acceptance criteria" in the context of device specifications and the "study" (referring to the testing against standards) as best as possible from the provided text.
Acceptance Criteria and Device Performance for BERCHTOLD CHROMOPHARE® E 778 and E 558 Surgical Lights
The acceptance criteria for the BERCHTOLD CHROMOPHARE® E 778 and E 558 surgical lights are primarily defined by their compliance with recognized international standards for medical electrical equipment and the direct comparison of their technical specifications to a predicate device. The "study" proving the device meets these criteria refers to the testing conducted to demonstrate conformance to these standards and the tabulated comparison to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the technical specifications of the predicate device and the specified performance standards. The "Reported Device Performance" column reflects the new device's compliance or its specific values where applicable.
| Acceptance Criterion (Based on Predicate/Standard) | CHROMOPHARE® E 778 (New Device Performance) | CHROMOPHARE® E 558 (New Device Performance) |
|---|---|---|
| Safety and Electrical Standards | ||
| Conforms to IEC 60601-1 (Electrical Safety) | Conforms | Conforms |
| Conforms to IEC 60601-1-2 (EMC) | Conforms | Conforms |
| Protection against electrical shock (Class I) | Same as predicate (Class I) | Same as predicate (Class I) |
| Surgical Lamp Performance Standards | ||
| Conforms to IEC 60601-2-41:2001 (Surgical Lamps) | Conforms | Conforms |
| Illumination Characteristics | ||
| Color rendering Index Ra (>= 94 predicate) | Same (94) | Same (94) |
| Central illuminance (at 1m) | 80000 - 160000lux (Same as predicate) | 70000 - 140000lux |
| Light field diameter | 140 - 285mm | 140 - 285mm |
| Depth of illumination | 690mm | 805mm |
| Total Irradiance Ee | 505W/m² | 442W/m² |
| UV- irradiance (≤400nm) | 0 | 0 |
| Other Technical Specifications | ||
| Lamp technology | Light Emitting Diode | Light Emitting Diode |
| Life time of bulb (>= 5000h predicate) | 20000h | 20000h |
| Light focusing mechanism | Pressure Sensitive Handgrip | Pressure Sensitive Handgrip |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of clinical/diagnostic performance. The "test set" for this device would refer to sample units of the manufactured surgical lights that underwent laboratory testing to verify compliance with the specified standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-41). The document does not specify the number of units tested.
- Data Provenance: The testing data would be generated from laboratory tests conducted on the physical devices. The country of origin for the data is not explicitly stated but would presumably be Germany, where BERCHTOLD Holding GmbH is located, or a certified testing laboratory. The data is prospective in the sense that it describes the performance of the newly manufactured devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is not a device that generates diagnostic output requiring expert interpretation for ground truth. The "ground truth" for a surgical light is its adherence to physical performance specifications (e.g., illuminance, color temperature, safety standards).
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication method (like 2+1, 3+1) is relevant for evaluating the performance of a surgical light's physical specifications or compliance with engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC study is not relevant for this type of medical device. This is not an AI/ML device, nor one where human readers interpret output.
6. Standalone (Algorithm Only) Performance Study
No. This is not an algorithmic device. Performance is determined by the physical properties and operation of the surgical light.
7. Type of Ground Truth Used
The "ground truth" for this device is the defined technical specifications outlined in international standards (e.g., IEC 60601-2-41) and the predicate device's performance. Measured physical parameters of the surgical light (e.g., central illuminance, irradiance, color rendering index) are compared directly against these established values/ranges.
8. Sample Size for the Training Set
Not applicable. This device 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
Not applicable. No training set is used.
§ 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.