Search Results

Nihon Kohden's cardiolife, model number TEC-6100A, is intended for medical purposes. The device will deliver an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device also serves as a cardiac monitor, with the ability to measure heart rate.

The TEC-6100A cardiolife device is classified as Class II by the Division of Cardiovascular. Respiratory and Neurological Devices and the Cardiovascular Device Classification Panel under 21 CFR, Part 870.5300 DC-Defibrillator, Low-energy (including paddles) as per Product Classification Code 74 LDD and under 21 CFR Part 870.2300 Monitor. Cardiac (including Cardiotachometer) as per Product Classification Code 74 DRT. Common names for the TEC-6100A cardiolife device include Low-energy DC-defibrillator and Cardiac Monitor. The device will deliver an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The electrical shock is delivered through paddles attached to the main unit. The device also serves as a cardiac monitor, with the ability to measure heart rate.

The provided text describes the 510(k) submission for the Nihon Kohden TEC-6100A cardiolife Mini Defibrillator, dated March 31, 1997. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed results from a clinical study for acceptance criteria.

Based on the information provided in the 510(k) summary (SECTION 2), here's an analysis of the acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states:
"The TEC-6100A cardiolife device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software functions of acquiring, processing, displaying and recording of the device. The results confirmed that the device performed within specifications."

However, specific acceptance criteria (e.g., precise thresholds for electromagnetic compatibility, temperature ranges for environmental testing, accuracy of defibrillation energy delivery, or heart rate monitoring accuracy) and quantitative performance results are not detailed in this summary. The summary only broadly states that the device "performed within specifications."

Therefore, a table cannot be fully constructed with specific acceptance criteria and reported device performance values from the provided text.

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

The document describes "electromagnetic, environmental, safety and performance testing procedures" and "software validation." These likely refer to engineering and bench testing, not clinical studies involving patient data. Therefore, the concept of a "test set" in terms of patient data or clinical images, its sample size, or data provenance (country of origin, retrospective/prospective) is not applicable or not described in this regulatory submission.

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

This information is not applicable as the described tests are technical/engineering evaluations of the device's physical and software functions, not diagnostic performance evaluations that would require expert ground truth.

4. Adjudication Method for the Test Set:

Not applicable, as there's no mention of a clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence through technical testing and comparison to predicate devices, not on evaluating human reader performance with or without AI assistance.

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

The "software validation" mentioned implies standalone testing of the software functions for "acquiring, processing, displaying and recording." However, this is specific to the device's operational software, not a diagnostic algorithm. Therefore, while software was tested in a standalone capacity, it's not a "standalone (algorithm only)" study in the context of diagnostic AI.

7. The Type of Ground Truth Used:

For the "electromagnetic, environmental, safety and performance testing procedures" and "software validation," the ground truth would be based on engineering specifications, international standards, and functional requirements for the device. For example, a defibrillator's energy output would be verified against its specified joule range using calibrated measurement equipment. No clinical "ground truth" (e.g., pathology, outcomes data) is discussed in the context of these tests.

8. The Sample Size for the Training Set:

Not applicable. This device is a defibrillator and cardiac monitor, not an AI/ML diagnostic algorithm that would have a "training set" in the modern sense. The "software validation" refers to testing the device's pre-programmed operational software.

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

Not applicable, as there is no training set for an AI/ML algorithm.

Ask a specific question about this device