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The intended use of the ETG-4000 is the measurement of relative levels of cerebral deoxyhemoglobin and oxyhemoglobin.

The ETG-4000 is a device that measures relative changes in tissue concentration of oxy-hemoglobin and deoxy-hemoglobin and total hemoglobin (678-1200 m) that sam near-infrared light (670-1300nm) that can the surface area of the cerebra. Sed is absorbed by the hemoglobin in the blood.

The ETG-4000 displays the changes of overall Hemoglobin concentration in time- course images (motion images and still images) based on the data from multiple point measurements.

This is a non-invasive test that is done by contacting an array of small optical fiber tips on the surface of the scalp.

The ETG-4000 beams frequency modulated near-infrared light into the surface of the brain. The light passes through the scalp, skull and upper layer of illiough several or the optical noves read by the hemoglobin in the blood and is reflected back and is collected by optical fibers.

The ETG-4000 measures relative changes in tissue concentration of oxy-hemoglobin and deoxy-hemoglobin at multiple points on the head simultaneously by utilizing the changes of light absorption.

The ETG-4000 provides data that show the activity status of the cerebral cortex by displaying the changes of oxy-hemoglobin and deoxy-hemoglobin concentration in the brain surface, and the metabolic and circulatory status of the cerebral cortex in a time-course graphic representation of oxy-hemoglobin, deoxy-hemoglobin and total hemoglobin, 2D dynamic images and 3D dynamic images.

This document is a 510(k) summary for the Hitachi ETG-4000 Optical Topography System. It states that the device measures relative changes in tissue concentration of oxy-hemoglobin and deoxy-hemoglobin and total hemoglobin using near-infrared light. It is intended for non-invasive measurement of cerebral activity by displaying changes in hemoglobin concentration over time. The document claims substantial equivalence to the predicate device, Hitachi ETG-100 (K011320), based on similar materials, technology, and functional methodology. It also states that the device is non-invasive and complies with applicable safety standards.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria in terms of numerical thresholds or performance metrics (e.g., accuracy, sensitivity, specificity, or error rates). The document focuses on demonstrating substantial equivalence to a predicate device (Hitachi ETG-100, K011320) rather than setting and meeting new performance acceptance criteria as would typically be seen for a novel device or a device with new claims.

The closest statements to "reported device performance" are:

• "The ETG-4000 system has been developed and validated in accordance with design controls and applicable standards."
• "Testing has permitted the determination that the system is safe and effective for the indicated applications."
• "There are no new safety issues associated with this system as compared with the predicate device."

Since specific numerical acceptance criteria are not provided, a table cannot be meaningfully constructed. The "performance" is implicitly tied to demonstrating equivalence to the predicate device, which itself would have had its own "performance" deemed acceptable at the time of its clearance.

2. Sample Size for the Test Set and Data Provenance

The document does not provide any information regarding the sample size used for a test set or the provenance of any data (e.g., country of origin, retrospective or prospective). The submission relies on design control validation and comparison to a predicate device, not a distinct clinical performance study with a test set as typically defined for algorithm-driven devices.

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

The document does not mention the use of experts to establish a ground truth for a test set. This type of information is usually found in submissions for diagnostic algorithms that require expert interpretation for ground truth labeling. The ETG-4000 is described as measuring physiological changes, not making diagnostic interpretations independently.

4. Adjudication Method for the Test Set

Since no test set or expert ground truth establishment is mentioned, there is no information on an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe an MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The device is an "Optical Topography System" that measures physiological parameters. It does not appear to be an AI-assisted diagnostic tool that would be evaluated in the context of human reader performance.

6. Standalone (Algorithm Only) Performance Study

The document does not describe a standalone performance study for an algorithm. The ETG-4000 itself is the device designed to measure and display physiological data. Its performance is stated to be safe and effective, and substantially equivalent to its predicate.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to performance studies for diagnostic AI algorithms (e.g., pathology, outcomes data, expert consensus) is not discussed in this 510(k) summary. The device measures "relative changes in tissue concentration of oxy-hemoglobin and deoxy-hemoglobin and total hemoglobin." The "truth" of these measurements would be a comparison to a gold standard measurement method or established physiological norms, but this type of comparative study is not detailed.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This indicates that the ETG-4000, as described in this 2004 submission, is likely a hardware-based measurement system with embedded algorithms, rather than a machine learning or AI algorithm that would typically require a distinct training phase with a large dataset.

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

Since no training set is mentioned, there is no information on how ground truth for a training set was established.

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