(95 days)
Nihon Kohden's TEC-7531A cardiolife 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 electrical shock is delivered through paddles attached to the main unit. This device will supply a periodic electrical pulse intended to pace the heart when applied to the chest surface through electrodes. This device serves as a cardiac monitor, with the ability to measure heart rate and to sound an alarm when the heart rate falls outside preset upper and lower limits. This device will also condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g. a central monitoring station, and will recondition a physiological signal to its original format when received from another device, e.g. transmitter.
The TEC-7531A cardiolife will be available for use by a physician, or under the supervision of a physician, for adult and pediatric patients within a medical facility and in remote environment.
The TEC-7531A cardiolife 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 electrical shock is delivered through paddles attached to the main unit. This device will supply a periodic electrical pulse intended to pace the heart when applied to the chest surface through electrodes. This device serves 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. This device will also condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g. a central monitoring station, and will recondition a physiological signal to its original format when received from another device, e.g. transmitter. The TEC-7531A cardiolife will be available for use by a physician, or under the supervision of a physician, within a medical facility and in remote environment.
The provided 510(k) summary for K971355 focuses on establishing substantial equivalence for the Nihon Kohden TEC-7531A cardiolife portable defibrillator based on safety and performance testing, rather than an AI/ML device study with specific acceptance criteria in the manner requested.
The document states: "The TEC-7531A cardiolife 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 results confirmed that the devices performed within specifications."
It explicitly mentions the absence of established performance standards: "To date, no performance standards or special controls are known or established for this device as required by Section 514 of the Food, Drug and Cosmetic Act and implemented by 21 CFR Part 861."
Therefore, it is not possible to extract the detailed information requested for an AI/ML device study.
However, I can extract what is provided regarding the device's testing and demonstrate its "acceptance" by the FDA:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by testing) | Reported Device Performance |
|---|---|
| Compliance with Electromagnetic Standards | Verified operation of the device |
| Compliance with Environmental Standards | Verified operation of the device |
| Compliance with Safety Standards | Verified operation of the device |
| Performance according to specifications | Verified operation of the device |
| Software functions for acquiring, processing, displaying, and recording operational within specifications | Software validation confirmed performance within specifications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the summary. The summary refers to "testing procedures" without detailing sample sizes of data or test conditions.
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)
This information is not provided in the summary. The testing described focuses on device functionality and engineering standards, not on clinical agreement with expert interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the summary.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted and is not relevant to this type of device (a portable defibrillator, not an AI/ML diagnostic tool). The device is a direct treatment and monitoring tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. The TEC-7531A is a hardware device with embedded software, not an AI algorithm. Its "standalone" performance would refer to its physical and functional operation. The summary states, "Software validation tested the operation of the software functions of acquiring, processing, displaying and recording of the results confirmed that the devices performed within specifications," which implies standalone software testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's testing appears to be based on engineering specifications and established performance standards for medical devices (electromagnetic compatibility, environmental resistance, safety standards), and the objective performance of its internal software functions. It is not based on clinical "ground truth" like pathology or outcomes data in the context of an AI-driven diagnosis.
8. The sample size for the training set
This information is not applicable as this device is not an AI/ML system that undergoes a separate "training" phase with data.
9. How the ground truth for the training set was established
This information is not applicable as this device is not an AI/ML system.
§ 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.