(400 days)
useful, safe and effective for forewarning presence of environmental magnetic fields that might be potentially harmful for certain individuals with implanable devices such as pacemakers or ICD's.
a device that in presence of magnetic fields produce sound and light signals to be noticed by the hearing and sight senses of an individual who is using it.
The provided text is a K960849 510(k) Summary for the "Magno Alarm" device. Based on this document, here's an analysis of the acceptance criteria and study described:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state formal "acceptance criteria" in a quantitative, metrics-based format commonly seen in modern medical device submissions (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by the device's intended purpose and the qualitative claims made.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| 1. Forewarning of Environmental Magnetic Fields: Device should detect and warn of potentially harmful environmental magnetic fields for individuals with implantable devices. | The Magno Alarm has a "lower activation threshold from that of typical pacemakers and/or ICD's," providing a "safety factor of at least two (2) for the patient to get a warning." It produces "sound and light signals" in the presence of magnetic fields. |
| 2. Non-interference with Pacemakers/ICD's: Device should not disrupt the proper function of implantable cardiac devices. | "The Magno Alarm has been designed so that it does not interfere with the function of pacemakers/ICD's." |
| 3. Safety and Effectiveness: Device should be safe and effective for its stated purpose. | The device is described as "useful, safe and effective for forewarning presence of environmental magnetic fields" and "a safe, effective and useful device." |
| 4. Substantial Equivalence to Predicate Device: Device performance should be comparable to a predicate device (test magnets). | The Magno Alarm is "presented to be substantially equivalent to the test magnets employed as an external and noncontacting auxiliary tool for pacemakers/ICD's." The document then outlines three "bases of substantial equivalence" focusing on their respective interactions with magnetic fields and information they provide. |
| 5. Electromagnetic Compatibility (EMC): Device should operate without significant electromagnetic interference to or from other devices. | "The Magno Alarm has been tested for electromagnetic compatibility and the test results is included in the supplement to our 510(k) (K960849) of 08-12-96." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide any details regarding a specific "test set" for performance evaluation, nor does it mention sample sizes. It does not state the country of origin of data or whether it was retrospective or prospective.
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 ground truth for a test set. The claims appear to be based on the device's design characteristics and a comparison to predicate devices, rather than a clinical study with expert-adjudicated outcomes.
4. Adjudication Method for the Test Set:
Since there is no mention of a test set or expert involvement, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not done or described. The device is a standalone alarm, not an interpretation aid for human readers. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not applicable.
6. Standalone (Algorithm Only) Performance:
Yes, a form of standalone performance is described. The Magno Alarm itself is the "algorithm only" in this context. Its performance is characterized by its "lower activation threshold" compared to pacemakers/ICDs, providing a "safety factor of at least two (2)". It produces "sound and light signals" in the presence of magnetic fields. The EMC testing also falls under standalone performance.
7. Type of Ground Truth Used:
The "ground truth" implicitly used for the device's claim of effectiveness appears to be:
- Physical Principles and Known Thresholds: The understanding of how pacemakers/ICDs respond to magnetic fields and the design intention of the Magno Alarm to have a lower activation threshold.
- Predicate Device Functionality: The working principle of test magnets and how the Magno Alarm's function relates to or complements this.
There is no mention of expert consensus, pathology, or outcomes data being used for ground truth.
8. Sample Size for the Training Set:
The document does not provide any information about a "training set" or its size. This type of submission predates the common use of AI/ML models that require distinct training and testing sets. The device's design appears to be based on engineering principles and existing knowledge of medical devices, rather than machine learning.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set, there is no description of how its ground truth was established.
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510(k) Summary
MAR 2 7 1997
Background:
MAR 2 7 1997
Cardiac Assist Devices, Inc. has design, developed, and extensively tested a device that is useful, safe and effective for forewarning presence of environmental magnetic fields that might be potentially harmful for certain individuals with implanable devices such as pacemakers or ICD's.
Motivation for the development of the Masno Alarm:
The motivation for developing the Magno Alarm was the fact that the pacemakers/ICD's are equipped with a magnetic field sensory mechanism that is an integral part of the device. Trais magnetic field sensory mechanism, within the pacemaker/ICD's, is intended for a non-invasive and non-contact mode alteration of the implantable device via a test magnet by and under Although this magnetic field sensory mechanism within the supervision of a physician. implantable devices offers a useful remote, non-invasive and non-contact access for mode alteration of the implantable device, however, it does not have any safeguard against inadvertent exposure to environmental magnetic field. In other words, if an individual whose heart's function depends on a pacemaker or an ICD is inadvertently exposed to a magnetic field of, say the refrigerator door seal, then the mode of hisher implanted device may change; such occurrence may be extremely harmful to the individual. To protect the individual with implanted heart assisting devices such as pacemakers/ICD's against accidental exposure to environmental magnetic fields. Cardiac Assist Device, Inc. has device that has a lower activetion threshold from that of typical pacemakers and/ or ICD's. The lower activation threshold of the Magno Alarm provides a safety factor of at least two (2) for the patient to get a warning regarding the presence of magnetic field in hisher environment. The warning of the Masno Alarm enables the natient to retrace his/her steps to safety, before the environmental magnetic field can cause an undesirable of the implantable pacemaker/CD. The Masno Alarm has been designed so that it does not interfere with the function of pacemakers/ICD's. The Magno Alarm is a device that in presence of magnetic fields produce sound and light signals to be noticed by the hearing and sight senses of an individual who is using it. In coaclusion. the Magno Alarm is a safe, effective and useful device a person to sense presence of environmental magnetic fields by producing audio and visual signals. The Magno Alarm is presented to be substantially equivalent to the test magnets employed as an external and noncontacting auxiliary tool for pacemakers/ICD's. Next section of this supplement presents the bases of the substantial equivalence of the Magno Alarm and the predicate device.
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Bases of Substantial Equivalence:
- The Magno Alarm is used to ascerain and verify the proper magnetic field environments a) for pacemakers/ICD users. The test mannet interacts with pacemakers/ICD's via the magnetic field. While the test magnet employs magnetic field to make pacemakers/ICD's to operate in a particular mode (the mamet mode). the Magno Alarm detects the magnetic field(s) that prevents the pacemakers/ICD's from operating in a particular mode (the normal mode)
- b) Use of the test magnet generates information useful to the implantable pacemaker/ICD patients that is under the magnet mode. The pacemaker's pacing rate, under the test magnet, is an indication of the remained buttery life of the pacemaker. Similarly, use of Magno Alarm generates information useful to the implantable pacemaker/ICD patients. that is, when the device (Magno Alarming, the environmental mannetic field is safe for the implantable pacemaker/ICD.
- Both the test magnet and the Magno Alarm do not physically contact the implantable c) device while they perform their intended functions.
The Magno Alarm has been tested for electromagnetic compatibility and the test results is included in the supplement to our 510(k) (K960849) of 08-12-96.
§ 870.3690 Pacemaker test magnet.
(a)
Identification. A pacemaker test magnet is a device used to test an inhibited or triggered type of pacemaker pulse generator and cause an inhibited or triggered generator to revert to asynchronous operation.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.