(36 days)
The BRIGHTSTAR Surgical Light is intended for use in surgical and non-surgical applications to provide illumination of the surgical field or the patient. It is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
The light is available in a single, double or 3 light head version. Each model offers the option of wall controls, integrated light controls or a combination of both. The light from a single bulb is distributed off a reflector in a controlled manner to provide a defined pattern. The size of the pattern is adjusted by changing the focal point of the bulb relative to the reflector. The light is comprised of seven main components: Suspension Arm, Extension Arm, Counterbalance Arm, Yoke, Light Housing, Light Core, and Controls. The BRIGHTSTAR uses software to coordinate the wall mounted and light mounted controls.
Based on the provided text, the document is a 510(k) Pre-market Notification for the BRIGHTSTAR Surgical Light, submitted by Hill-Rom, Inc. in 1998. The primary goal of this submission is to demonstrate substantial equivalence to existing predicate devices, rather than establishing de novo performance criteria for a novel device. Therefore, the "acceptance criteria" discussed are largely based on matching or exceeding the performance of the predicate devices. There is no traditional "study that proves the device meets the acceptance criteria" in the sense of a clinical trial or a statistically powered performance study against defined thresholds. Instead, the submission relies on a comparison table and a summary of similarities and differences in design and performance specifications against already cleared devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a surgical light, the "acceptance criteria" are implied by the performance of the predicate devices. The new device (BRIGHTSTAR) aims to be substantially equivalent or better in key performance metrics.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate Devices) | Reported BRIGHTSTAR Performance |
|---|---|---|
| Number of Bulbs | 1 | 1 |
| Back-up Bulb | Yes | Yes |
| Spare Bulb Storage | Yes (one predicate states no, another no) | Yes |
| Color Temperature | 4,000-4,800°K | 4,200°K |
| Pattern Size | 6.5-11.8 inches | 6-11 inches |
| Focal Length | 1 meter | 1 meter |
| Illumination (Ft Candles) | 9,293 - 12,000 Ft Candles | 12,000 Ft Candles |
| Illumination (Lux) | 100,000 - 129,170 Lux | 130,000 Lux |
| Cavity Penetration | 90% +/- 5% | 90% +/- 5% |
| Shadow Control | 30-35% of light source blockage | 30-35% |
| Depth of Field | 19.68 - 26 inches | 20 minimum inches |
| Rotation | 360° | 360° |
| Heat Filtering | IR Filter | IR Filter |
| Filter Material | IR Glass | IR Glass |
| Reflector Material | Regular Reflector / Vacuum Metalized A | Vacuum Metalized A |
| Task Light | No / Yes (20 Watt) | Yes, 20 Watt |
| Sterile Handle Cover | Yes | Yes |
| 'Zero' Drift Arm | Yes | Yes |
| Diameter | 22.4 - 24 inches | 25 inches |
| Mounting Options | Ceiling (Single or Double) | Ceiling |
| Supply Voltage | 110V, 120V, 220/240V, 230/240V | 120V, 220/240V |
| Power (Watts) | 150 - 220 Watts | 180 Watts |
| Bulb Life | 1,000 Hrs | 1,000 Hrs |
| Bulb Type | Quartz Halogen | Quartz Halogen |
| Bulb Voltage | 24V DC | 24V DC |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe a "test set" in the context of a clinical performance study with human subjects or a large dataset analysis. The comparison is based on the technical specifications of the BRIGHTSTAR surgical light and those of the identified predicate devices (Amsco SQ240 Surgical Light and Berchtold Chromophare). The data provenance is internal Hill-Rom specifications and presumably publicly available specifications or regulatory filings of the predicate devices. It is a retrospective comparison of device specifications, not a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No "ground truth" establishment by experts for a test set is described. The comparison is based on objective device specifications.
4. Adjudication Method for the Test Set
Not applicable. No "adjudication method" for a test set is described, as there is no traditional test set or expert assessment of subjective outcomes.
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 is a pre-AI era device (1998) and a surgical light, not an image analysis or diagnostic device. There is no mention of AI or human reader improvement studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a surgical light, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" here is the established performance and safety characteristics of already legally marketed predicate surgical lights. The BRIGHTSTAR demonstrates substantial equivalence to these established devices through a direct comparison of specifications and features.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device (surgical light), not a machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical medical device (surgical light), not a machine learning algorithm.
§ 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.