Search Results

The Techno-Scope projects sounds associated with the heart, arteries, and veins and other internal organs. It also acquires the electrical signal from electrodes and produces a visual display of the electrocardiograph signal and heart rate.

The Techno-Scope is not intended to be used as a diagnostic device.

The Techno-Scope™ Visual Stethoscope is comprised of a manual stethoscope which can project sounds associated with the heart, arteries, veins and other internal organs. It also has an electrocardiograph (ECG) display unit. The electrocardiograph consists of 3 leadless nondisposable electrodes. It is placed on the chestpiece of the stethoscope, opposite the diaphragm. It can display real time ECG through high resolution LCD. It also calculates and displays the heart rate according to the ECG. The healthcare professional can listen to internal organ sounds simultaneously while seeing the ECG signals.

The provided 510(k) summary for the Techno-Scope Visual Stethoscope (K050097) does not contain information about acceptance criteria or a dedicated study demonstrating the device meets performance criteria in the way typically expected for AI/Machine Learning devices. This document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use, rather than a performance study with specific metrics and acceptance criteria.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types and establishment for test/training sets) cannot be fulfilled from the provided text.

Based on the document, here's what can be inferred or stated:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the conventional sense for AI/ML device performance. The device is a "Visual Stethoscope" which combines a manual stethoscope with an ECG display. Its performance is framed in terms of:

• Display of cardiac biopotentials: The device "produces a visual display of the electrocardiograph signal and heart rate."
• Sound amplification/pickup: The device "projects sounds associated with the heart, arteries, veins and other internal organs."

The document states the device has "similar technological characteristics and to be equivalent to the CADIscope" with specific areas of comparison including "Display of cardiac biopotentials," "Sound Amplification," and "Sound Pickup." There are no explicit quantitative acceptance criteria or reported performance metrics (e.g., accuracy, sensitivity, specificity) for these functions within this document.

2. Sample size used for the test set and the data provenance

Not applicable. The document describes a comparison of technological characteristics to a predicate device, not a performance study using a test set of data.

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 for a test set is described.

4. Adjudication method for the test set

Not applicable. No test set or adjudication is described.

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 not an AI/ML device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device, and no standalone algorithm performance is mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No ground truth is described. The comparison is based on functional characteristics relevant to a stethoscope and ECG display.

8. The sample size for the training set

Not applicable. No training set is described as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. No training set is described.

Ask a specific question about this device

To provide warm relief

Ready Heat™ blanket

This document is a 510(k) premarket notification letter from the FDA regarding the "Ready Heat™ Blanket." It primarily addresses regulatory approval and does not contain specific information about acceptance criteria or a study proving the device meets them.

Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence to predicate devices, not performance testing details.

Ask a specific question about this device