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EasySuite™ Surgical Light Control (ESLC) allows the control of surgical lighting during a surgical procedure from the EasySuite™ touch panel user interface.

The EasySuite™ Surgical Light Control (ESLC) is an optional function in the EasySuite™, which is an integrated operating room system for configurable communication of images from sources to displays within the operating room for management of audio systems, and for control of devices such as room lights. The ESLC function allows control of surgical lights from the EasySuite™ touch panel user interface.

This document describes the EasySuite™ Surgical Light Control (ESLC), a software application that allows control of surgical lights from the EasySuite™ touch panel user interface.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain explicit quantitative acceptance criteria or detailed performance metrics. The device is a "Surgical Light Accessory" and its function is to control surgical lights. The primary claim for performance is its substantial equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document states that "Verification and validation testing was performed by Image Stream personnel." However, it does not specify the sample size used for the test set (e.g., number of test cases, scenarios, or a defined testing protocol with associated metrics).

The data provenance is internal to the manufacturer ("Image Stream personnel"). No information is given regarding the country of origin of the data, and it implies a prospective validation/verification process rather than retrospective data analysis.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. As this is a control system for surgical lights, ground truth might relate to correct operation or functionality rather than diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the device (a control system), a formal adjudication method (like 2+1 or 3+1 for diagnostic tasks) is unlikely to be directly applicable. Testing would likely involve functional checks against specified requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this device. This device is a surgical light control system, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a software application designed to control hardware (surgical lights) via a human-machine interface (touch panel). Therefore, the concept of "standalone algorithm performance without human-in-the-loop" as typically understood in AI/diagnostic contexts does not directly apply. The "algorithm" (software) is inherently designed to be interacted with by a human operator to control a physical device. The verification and validation testing would have focused on the software's ability to execute commands and control the lights as intended.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not explicitly state the "type of ground truth." For a device like this, ground truth would likely be established empirically through:

• Functional Verification: Confirming that the system correctly sends commands to the surgical lights and that the lights respond as expected (e.g., turn on/off, adjust intensity).
• Requirements Traceability: Ensuring that all specified functional and performance requirements are met by the implemented software.
• Predicate Device Comparison: Demonstrating that the new device functions similarly to the cleared predicate device in its control capabilities.

8. The Sample Size for the Training Set

This information is not provided and is largely not applicable in the context of this device. The ESLC is described as a software application, not a machine learning or AI algorithm that would typically require a "training set" of data to learn from. Its functionality is deterministically programmed based on specified requirements.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no indication that this device uses a training set or machine learning model in the conventional sense.

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MainStream® OR Surgical Light Control (MSLC) allows the control of surgical lights from the Mainstream® OR touch panel user interface. It does not perform calculations. It displays surgical light status on the MainStream® OR display and allows control of the surgical lights. The safety features and controls of the surgical light system take precedence over the MainStream® OR surgical light control.

MSLC is an optional function in the MainStream® OR integrated operating room system. (The MainStream® OR system includes a touch panel user interface for quick routing of surgical images to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights. MainStream® OR also includes an audio management system and a single point of entry for querying surgical charts and image archives.)

The MainStream® OR Surgical Light Control (MSLC) is an optional function in the MainStream ® OR, which is an integrated operating room system for configurable communication of images from sources to displays within the operating room, for management of audio systems, and for control of devices such as room lights.

The MSLC function allows control of surgical lights from the MainStream® OR touch panel user interface.

The provided text does not contain information about acceptance criteria and a study to prove the device meets those criteria. This device, the MainStream® OR Surgical Light Control (MSLC), is a surgical light accessory that enables control of surgical lights from an integrated operating room system's touch panel. The submission primarily focuses on establishing substantial equivalence to a predicate device (SCB/Steris OR-Light Interface Box) based on functional similarities and safety principles rather than performance metrics.

The document states that the MSLC does not perform calculations and that the safety features and controls of the surgical light system take precedence over the MSLC. This implies that the MSLC's function is primarily an interface and control mechanism, and its safety is intrinsically linked to the underlying surgical lighting system it controls.

Therefore, I cannot provide a table of acceptance criteria or details about a study as requested. The available information describes the device's function and its classification, but not specific performance testing or clinical studies.

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