(33 days)
The TRUMPF Surgical lights are intended to locally illuminate an operating or examination area of the patient's body with high intensity light.
TruLight 5520 and 5320 light heads consist of 2 light modules containing LEDs which illuminate the area of a patient. The light heads are equipped with illuminated non-sterile hand grips. The light heads can be controlled on the control panel on the light head or on an optional wall control panel. Illuminance can be adjusted between 30 and 100%. Reducing the Illuminance does not change the color temperature of the light. The illuminance can also be adjusted to "endo" mode, which is 5%. The optional Adaptive Light Control (ALC) feature allows the lighting settings to be selectively adjusted to the working distance. The three settings for a working distance of approx. 0.8, 1.0 and 1.2 meters are selected on the control panel or on the wall control panel. The light head then selects the light setting suitable for this working distance. The Adaptive Light Control Plus (ALC+) offers automatic control of the light intensity. If the light head is moved during surgery, the motion detection function automatically measures the distance between the luminaire and the wound area. The light head then selects the light setting suitable for this working distance.
The provided document is a 510(k) summary for a surgical light (TruLight 5520 and 5320). It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against acceptance criteria for an AI/CAD-like device. Therefore, much of the requested information regarding AI/CAD-specific study details (such as sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) is not present in this document.
However, I can extract information related to the device's performance characteristics and the general approach to demonstrating safety and effectiveness.
Here's the information as best as can be extracted from the provided text:
1. Table of Acceptance Criteria (Implied) and Reported Device Performance
The acceptance criteria are not explicitly listed in a table format. Instead, the document states that the new devices (TruLight 5520 and 5320) were tested to the same standards as the predicate devices and were found to have "similar or improved performance features" and are "not any less safe or effective." The key performance characteristic highlighted is illumination.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1-2: 2007 (Electromagnetic Compatibility) | Complies with the requirements of IEC 60601-1-2: 2007. |
| Compliance with IEC 60825-1: 2007 (Laser Safety) | Tested to IEC 60825-1: 2007 (2nd Edition). Compares to similar devices with Class 2 lasers. |
| Illumination performance (similar/improved to predicate devices) | Tested to the same standards as predicate devices; found to have similar or improved performance features. Illuminance adjustable between 30% and 100%, and "endo" mode at 5%. |
| Safety and Effectiveness (not less than predicate devices) | Verified through testing to standards, risk analysis, and comparison to predicate devices, including those with Class 2 lasers. |
| Sterilization of reusable handle grips | withstands at least 350 steam sterilization cycles under specified conditions. The instructions are the same as for predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable/not provided. This document describes testing for a physical medical device (surgical light), not an algorithm or AI system that operates on a "test set" of data in the common sense for AI/CAD. The "testing" refers to physical product testing protocols and standard compliance.
- Data Provenance: Not applicable/not provided for AI/CAD context. The testing is based on device performance against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "Additional third-party experts" were involved in a risk analysis. A specific number is not provided.
- Qualifications of Experts: Not specified beyond being "third-party experts" involved in a risk analysis.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable/not provided in the context of an AI/CAD test set. The document refers to a "thorough risk analysis by TRUMPF and additional third-party experts."
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:
- MRMC Study: No, this is not an AI/CAD device. Therefore, no MRMC study, human-in-the-loop analysis, or effect size related to AI assistance is mentioned or relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No, this is a physical medical device. This concept is not applicable.
7. The type of ground truth used:
- Type of Ground Truth: The "ground truth" here is compliance with established international and national standards (e.g., IEC 60601-1-2 for EMC, IEC 60825-1 for laser safety) and inherent physical performance characteristics of the surgical light (e.g., illuminance, durability of sterilization). The core claim is "substantial equivalence" to predicate devices, meaning its performance, safety, and effectiveness are comparable.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is not an AI/CAD device that undergoes a "training" process with a dataset.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: 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.