(186 days)
Nihon Kohden's TEC-7511A cardiolife and TEC-7521A cardiolife defibrillators are intended for medical purposes. The devices will deliver an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart mythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The devices deliver the electrical shock through paddles attached to the main unit. These devices will serve as a cardiac monitor, with the ability to measure heart rate and to sound an alarm when the falls outside preset upper and lower limits. The devices will also condition a physicilogical signal to be transmitted via radiofrequency from one location to another, e.g. a central monitoring station, and will recondition a physiological signal to the original format when received from another device, e.g. transmitter.
Nihon Kohden's TEC-7511A and TEC-7521A cardiolife defibrillators are intended for medical purposes. These devices will deliver an electical shock of a maximum of 360 joules of energy used for defibiliating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arthythmias. The devices deliver the electrical shock through paddles attached to the main unit. The devices will serve as a cardiac monitor, with the ability to measure heart rate and to sound an alam when the heart rate falls outside preset upper and lower limits. The devices will also condition a physiological signal to be transmitted via radiofrequency from one location to another. e.o. a central monitoring station. and will recondition a physiological signal to the original format when received from another device, e.g. transmitter.
The provided text describes a 510(k) submission for Nihon Kohden's TEC-7511A and TEC-7521A cardiolife defibrillators, filed in 1997. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria as would be expected for novel AI/software devices today.
Therefore, many of the requested details regarding acceptance criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies are not available in this document. The device in question is a physical medical device (defibrillator/monitor) and the testing described is primarily for safety, electromagnetic compatibility, environmental factors, and software validation of its basic operational functions, not for diagnostic performance based on AI.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not specify quantitative acceptance criteria for performance metrics in the way modern AI/software devices do (e.g., accuracy, sensitivity, specificity thresholds). Instead, it states that tests were performed to verify operation and that the devices performed "within specifications." The "performance" here refers to the device's ability to operate as designed (e.g., deliver a shock, monitor heart rate, transmit signals) rather than its diagnostic accuracy.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electromagnetic Compatibility | Verified operation |
| Environmental | Verified operation |
| Safety | Verified operation |
| Performance Testing (e.g., shock delivery, cardiac monitoring, signal transmission) | Verified operation; performed within specifications |
| Software Validation (acquiring, processing, displaying, recording) | Confirmed that devices performed within specifications |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The described tests are likely bench testing and functional verification, not clinical trials with a patient test set in the traditional sense.
- Data Provenance: Not applicable in the context of diagnostic data. The "data" here refers to the operational outcomes of the device during testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "ground truth" for these tests would be the expected functional outcome based on engineering specifications and regulatory standards, not expert consensus on diagnostic images or signals.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This type of study is relevant for AI-powered diagnostic tools where human reader performance is compared with and without AI assistance. This device is a defibrillator and monitor, not an AI diagnostic agent.
- Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- Standalone Performance Done: The "software validation" section could be considered a form of standalone performance testing for the embedded software. It states that the software functions of acquiring, processing, displaying, and recording were tested and "confirmed that the devices performed within specifications." However, this is not a diagnostic algorithm's standalone performance.
7. Type of Ground Truth Used
- Type of Ground Truth: Engineering specifications, regulatory standards (e.g., for safety, EMC), and functional design requirements. For example, for defibrillation, the ground truth is the device delivering the specified energy; for heart rate monitoring, it's accurately displaying the simulated or actual heart rate.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not employ a machine learning algorithm that requires a training set in the modern sense. The software is likely deterministic and programmed according to established engineering principles.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable.
§ 870.5300 DC-defibrillator (including paddles).
(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load 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. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.