(29 days)
The Harmony vLED Surgical Lighting System is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures.
The Harmony vLED Surgical Lighting System is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures.
The Harmony vLED Surgical Lighting System is designed to replace existing surgical lights, or to be installed as part of major renovations to existing facilities or in new facilities.
The Harmony vLED Surgical Lighting System accessories are as follows:
- STERIS ACT Interface o
- o Camera Module
- Dual or Single Flat Panel Monitors o
- o 24VDC Battery Backup support
- Remote Power Module Unit 0
- Sterile Disposable Handle Covers o
The provided text describes the STERIS® Harmony vLED Surgical Lighting System (K100395) and its performance testing to demonstrate substantial equivalence to a predicate device. However, this document does not contain the specific details required to complete your request for acceptance criteria and a study proving device conformance to those criteria.
The document states: "Performance testing was conducted to verify that the Harmony vLED Surgical Lighting System meets the requirements for Medical Electrical Equipment as defined in CEI/IEC 60601-1 and IEC 60601-2-41." This indicates that the device's performance was evaluated against these safety and performance standards for medical electrical equipment. However, the specific acceptance criteria within these standards for this particular device and the results of that testing demonstrating the device meets those criteria are not provided in the given text.
Therefore, I cannot populate the table of acceptance criteria and reported device performance, nor can I provide answers to the questions regarding sample size, ground truth, expert involvement, or comparative effectiveness studies based on the information given.
To answer your request, I would need access to the actual performance testing report, which would detail the specific tests conducted, the acceptance limits for each test, and the actual measurements obtained from the Harmony vLED Surgical Lighting System.
Based on the provided text, the following information is available (though insufficient for your request):
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided as the specific acceptance criteria and detailed performance results are not included in the text. The text only states that the device meets the "general requirements for safety as defined in CEI/IEC 60601-1 and IEC 60601-2-41 for Medical Electrical Equipment."
2. Sample sized used for the test set and the data provenance:
- Not provided. The document does not specify the number of devices or components tested. Data provenance is also not mentioned beyond the manufacturer being STERIS Corporation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. For a surgical light, "ground truth" and expert adjudication are typically not involved in performance testing for electrical and safety standards like CEI/IEC 60601-1 and IEC 60601-2-41. These standards involve objective measurements (e.g., light intensity, electrical leakage, temperature, etc.) against pre-defined limits.
4. Adjudication method for the test set:
- Not applicable / Not provided. See point 3.
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 device is a surgical light, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical light; there is no algorithm for standalone performance to evaluate in this context.
7. The type of ground truth used:
- Not applicable. Performance testing for a surgical light against IEC standards relies on objective measurements against engineering specifications, not "ground truth" in the diagnostic sense (e.g., pathology, expert consensus).
8. The sample size for the training set:
- Not applicable. There is no "training set" for a surgical light being tested against electrical and safety standards.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.