(90 days)
The Drager Sola surgical lights (Sola 1000, 700, 500) are intended to locally illuninate an operating or examination area of the patient's body with high intensity light.
The Drager Sola 300 is intended to be used as an examination light or as a satellite light within a surgical lighting system.
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The provided document describes the acceptance criteria and a study demonstrating the Dräger Sola surgical lights meet these criteria.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard / Requirement) | Reported Device Performance |
|---|---|
| Electrical Hazards | |
| IEC 60601-1 (Generic Standard) | Passed all requirements |
| IEC 60601-2-41 (Specific Additional Electrical Requirements) | Fulfill the requirements |
| Mechanical Strength | |
| IEC 60601-2-41 (Specific requirements) | Fulfill the requirements |
| Calculated with safety factor of 4x | Met (stated to be 4x) |
| Movable Parts | |
| IEC 60601-2-41 (Conformity) | Conform to requirements |
| Light head maintains position | Achieved via mechanical/electromechanical brakes |
| Feather arm compensates weight | Achieved via optimal compensation |
| Suspended Loads | |
| Detachment of light head prevented | Not possible when properly installed; safety mechanisms for screws |
| Loads calculated with safety factor of 4x | Met (stated to be 4x) |
| Illumination | |
| IEC 60601-2-41 (Additional requirements for illumination of infrared and ultraviolet emission) | Fulfill the requirements |
| FDA Guidance Document (General) | Intended to locally illuminate an operating or examination area with high intensity light |
| Accuracy of Operation Data | |
| IEC 60601-2-41 (Additional requirements) | Fulfill the requirements |
| Bulb Explosion | |
| Potential danger from glass splinters eliminated | Fully enclosed light system eliminates potential danger |
| Diffusing Lens | |
| Cannot be broken when properly used | Manufacturing standards and in-house inspection eliminate residual risks |
| IEC 60601-1 (General) | Met |
| Insufficient Energy (Power Supply) | |
| Switchover to emergency power supply initiated upon interruption/reduction | Relay initiates switchover to user-provided emergency power supply |
| Labeling | |
| IEC 60601-2-41 (Additional requirements to exactly define intended use) | Fulfill the requirements |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical count of devices tested. The report indicates that the "Sola series were tested," implying a representative sample of Dräger Sola 1000, 700, 500, and 300 models.
- Data Provenance: The document is dated December 1998 and refers to "many years of experience in manufacturing lights" and this product being "on the market in Europe for 4 years" (referencing the current and previous product MLxx0) with no registered complaints. This suggests a retrospective analysis of field performance data and compliance testing based on European market experience. The testing against IEC standards is described as having been performed on the devices. The report originates from Germany ("Dräger Medizintechnik GMBH").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The report does not mention a specific number of experts or their qualifications for establishing ground truth in the context of a "test set" for performance evaluation, as one might see in a clinical study.
- The evaluation is based on compliance with established international engineering and medical device safety standards (IEC 60601-1, IEC 60601-2-41) and internal engineering calculations and experience. The implication is that the "ground truth" for safety and performance is defined by these standards and the engineering principles applied during development and testing.
4. Adjudication method for the test set:
- No adjudication method (e.g., 2+1, 3+1, none) is described in the context of a typical clinical test set with human readers. The evaluation is focused on compliance testing against objective engineering standards and internal risk assessments, which would not involve such adjudication.
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:
- No. This document describes a submission for a surgical lamp (Dräger Sola series), which is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. As mentioned above, this is a physical medical device (surgical lamp), not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's compliance is primarily defined by:
- International engineering standards and regulations: IEC 60601-1 and IEC 60601-2-41.
- Engineering calculations and safety factors: E.g., 4x safety factor for mechanical strength and suspended loads.
- Manufacturing standards and in-house inspection: For components like diffusing lenses.
- Retrospective field experience: "No complaints have been registered," "No complaints have been received which have necessitated a change in the product."
8. The sample size for the training set:
- Not applicable. As this is a physical medical device and not an AI/machine learning algorithm, there is no concept of a "training set" in the context described. The device's design and manufacturing rely on established engineering principles and standards, not data-driven model training.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of 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.