(83 days)
Halux® Iris is designed to provide the required illumination for surgeries, procedures, and examinations of patients. The Halux® Iris Examination and Surgical Lamp is to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms and all other health care facilities where the need for additional illumination exists.
Whether in the doctor's office, examination rooms, emergency facilities, intensive care clinics, pre- or post-operative rooms, the Iris provides high intensity light where it is needed. The Iris is user friendly. With its high quality illumination, the halux® Iris is perfect for lighting all kinds of examinations and treatments. Outstanding features of this luminaire include the unique shape of the lamp housing, the combination facetted and parabolic technology of its reflector, and its smooth operating and spring-loaded articulating arm. Highlights of our examination lamp:
Smooth Operation and adjustability
Precise positioning
Compact and enclosed articulation system with counterbalance system.
A specially designed reflector system insures a precise light source that renders true colors. The Iris is available in ceiling wall and floor versions.
halux® Iris is a medical product manufactured in accordance with EG 93/42 Class 1 and is constructed in accordance with EN 60 601-2-41 (UL2601).
This document describes a 510(k) premarket notification for the "Halux® Iris Examination and Surgical Lamp". The primary purpose of this notification is to demonstrate substantial equivalence to a predicate device, not to present a study proving the device meets an extensive set of acceptance criteria in the way a clinical trial for a novel AI device would.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable to this type of regulatory submission for a simple medical lamp. The "study" here is primarily an engineering and bench testing comparison to a predicate device.
Here's the information that can be extracted and what is not applicable:
-
Table of acceptance criteria and the reported device performance:
Items Acceptance Criteria (Predicate Device K042395) Reported Device Performance (Halux® Iris) Manufacturer Burton Medical Waldmann Lighting Model number(s) Outpatient Plus or CoolSpot Halux® Iris K number K042395 SAME (Implied substantial equivalence) Electrical requirements 120 V. 50-60 Hz SAME (120 V. 50-60 Hz) Light Output 4800 footcandles 45000 lux at 0.8 m (4180 footcandles) Color temperature 3600 K 4000 K Wattage 150 watts (three 50 watt halogen) One 50 watt Halogen Power source Transformer SAME (Transformer) Operating environment Minor surgeries SAME (Minor surgeries, examinations) Bulb operating life 2000 hrs. Up to 4000 hrs. Case material Steel and plastics SAME (Steel and plastics) Warranty 3 years 2 years Safety listing UL UL Note: The "acceptance criteria" for this submission are effectively the specifications and performance of the predicate device, which the new device aims to be "substantially equivalent" to or better in some aspects.
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "bench and laboratory testing" and "user testing data" but does not provide specific sample sizes for these tests. For a medical lamp, this would likely involve a small number of units tested in a lab setting rather than human subjects or a large data set.
- Data Provenance: The testing was conducted by Waldmann Lighting, the manufacturer. The document doesn't specify country of origin for the data beyond that. It is "retrospective" in the sense that it's a comparison to an existing device, but the testing itself would be prospective to evaluate the new device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device (medical lamp), not an AI/diagnostic software. "Ground truth" in the context of expert consensus on medical images or diagnoses is not relevant here. The "truth" is established by direct measurement of physical properties (e.g., light output, color temperature, safety standards).
-
Adjudication method:
- Not Applicable. See point 3.
-
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 not an AI device or a diagnostic device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm.
-
The type of ground truth used:
- The "ground truth" for this device's performance is based on direct physical measurements and adherence to safety standards. For example, light output is measured in footcandles/lux, color temperature in Kelvin, and electrical safety is verified against UL standards and EN 60 601-2-41 (UL2601). The "ground truth" for substantial equivalence is the performance and specifications of the predicate device.
-
The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device; there is no "training set."
-
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.