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The Karl Storz VOICE1® SCB R-UI Speech Control Application is indicated for use in speech control of Karl Storz-approved devices and peripherals in conjunction with the Karl Storz SCB® R-UI software.

The Karl Storz VOICE1® SCB R-UI Speech Control Application is an independent application that works in the background of the SCB R-UI. VOICE1® recognizes commands spoken by the user and sends corresponding commands to the SCB R-UI system, enabling the user to control endoscopic and other ancillary surgical equipment and adjust device parameters entirely by speech control.

The provided documents for Karl Storz VOICE1® SCB R-UI Speech Control Application do not contain any information regarding acceptance criteria, device performance results, or details of a study that would prove the device meets specific criteria.

The documents primarily consist of:

• A 510(k) Summary (K083598, page 1) which describes the device, its intended use, technological characteristics, and claims substantial equivalence to a predicate device.
• A Substantial Equivalence Table (page 2) which compares the new device to the predicate device in terms of device type, user input, controlled devices, added functions, other software requirements, and intended use.
• An FDA letter (pages 3-5) confirming the substantial equivalence determination and outlining regulatory responsibilities.
• An Indications for Use statement (page 6).

Therefore, I cannot provide the requested table or answer questions 2 through 9, as no such study details are presented in the provided text.

Based on the information available:

1. Table of acceptance criteria and the reported device performance:
* No acceptance criteria or reported device performance metrics are mentioned in the provided text. The submission focuses on substantial equivalence to a predicate device, rather than presenting a performance study against predefined criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* No information provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
* No information provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* No information provided.

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:
* No information provided.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* No information provided. The device is a speech control application, inherently designed for human-in-the-loop interaction.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
* No information provided.

8. The sample size for the training set:
* No information provided.

9. How the ground truth for the training set was established:
* No information provided.

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The Legend CRF Fluoro and Rad System is designed to perform general purpose radiographic and fluoroscopic x-ray examinations. This device is not intended for mammographic applications.

The Legend CRF Fluoro and Rad System is indicated for use in generating radiographic and fluoroscopic images of human anatomy in all general purpose X-ray diagnostic procedures. This device is not intended for mammographic applications.

The Legend CRF Fluoro and Rad System consists of an X-ray generator, angulating table with X-ray tube and collimator, image intensifier and spot film device. Optionally, the following items may also be part of the system:
-The table may be provided with an undertable bucky for use with an X-ray tube mounted on a ceiling mounted X-ray tube hanger.
-A basic radiographic table for use with an X-ray tube mounted on a ceiling mounted X-ray tube hanger may be included with the system.
-A separate, vertical bucky stand may also be provided for chest or other general purpose radiographic procedures.

The Legend CRF Fluoro and Rad System consists of an X-ray generator, angulating table with X-ray tube and collimator, image intensifier and spot film device. Optionally, the following items may also be part of the system:

• The table may be provided with an undertable bucky for use with an X-ray tube . mounted on a ceiling mounted X-ray tube hanger.
• . A basic radiographic table for use with an X-ray tube mounted on a ceiling mounted Xray tube hanger may be included with the system.
• A separate, vertical bucky stand mav also be provided for chest or other general . purpose radiographic procedures.

This document is a 510(k) premarket notification for the "Legend CRF Fluoro and Rad System" submitted by GE Medical Systems. It addresses the substantial equivalence of this device to previously marketed devices. However, the provided text does not contain information about specific acceptance criteria or a study that proves the device meets such criteria.

The document primarily focuses on:

• Device Description: What the system is composed of.
• Indications for Use: What the system is intended for.
• Conformance to Standards: Which regulatory and voluntary standards the device will conform to.
• Claim of Equivalence: That the device is equivalent to other marketed devices with the same indications for use and meeting similar standards.
• FDA Clearance Letter: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment as this information is not present in the provided text. The document is a regulatory submission for premarket clearance based on substantial equivalence, not a detailed performance study report.

To provide the requested information, a document describing a performance study, including acceptance criteria, methodology, results, and analysis, would be necessary.

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