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The Xenon BrightStar Illumination System is intended to provide intraocular illumination in vitreoretinal surgery.

The Xenon BrightStar Illumination System consists of the Illumination Unit and accessories. The Illumination Unit uses a Xenon Short Arc Lamp and utilizes two internal focusing systems to focus the light into the end of an optical fiber of two individually controlled ports. Both ports can be individually controlled by choice of an UV cut-off filter and a light intensity setting. Accessories trother system include single use and reusable fiber optic probes, fibers and micro instruments which are delivered sterile or require sterilization prior to use.

This 510(k) summary describes a traditional medical device (an ophthalmic light source), not an AI/ML-driven device. As such, it does not contain the information requested in your prompt regarding acceptance criteria, study details, expert involvement, or AI performance metrics.

The document primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and intended use. There is no mention of a study to "prove the device meets acceptance criteria" in terms of algorithmic performance, as this device does not involve an algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and study details for an AI/ML device based on the provided text.

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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.

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.

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