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The patient magnet is used to close the reed switch of a pulse generator when held above the reed switch, 1 inch from the generator's surface, and oriented with the magnet's axis parallel to the longitudinal axis of the reed switch.

The patient magnet is used daily to check that the pulse generator battery is working. When you pass or hold the magnet over the pulse generator, a reed switch inside the pulse generator closes like a gate. When the magnet closes the switch, the normal signal (stimulation) cannot pass, and the pulse generator is temporarily turned OFF. When the magnet is removed, the switch (gate) opens immediately, and the pulse generator is turned back ON and can stimulate again.

The patient magnets are made from Neodymium grade 35 (NdFeB-35) and the entire surface of the magnet is coated with either polypropylene copolymer. The magnet is 1.48 in. x 0.195 in; 50 gauss (G) minimum magnetic flux density at a distance of 1 inch from its surface. Also supplied with Patient Magnet, are a watchband and a belt-clip that allows that patient to wear the magnet on the wrist like a watch or clipped on belt like a pager for easy deployment.

Here's the analysis of the provided text regarding the acceptance criteria and study for the Cyberonics Patient Magnet:

Acceptance Criteria and Device Performance (Based on Intended Use):

Study Information:

The provided document (K092364) is a 510(k) summary for a Class I medical device (Cyberonics Patient Magnet). For Class I devices, particularly those that are substantially equivalent to existing predicate devices, a formal clinical study with detailed performance metrics and ground truth establishment is typically not required or presented in the 510(k) summary.

The primary method for demonstrating safety and effectiveness for such devices is through substantial equivalence to a predicate device, as highlighted in the document. This relies on demonstrating that the new device has the same intended use and similar technological characteristics (e.g., materials, magnetic properties) as a legally marketed predicate device.

Therefore, many of the specific questions regarding a clinical study (sample size, experts, adjudication, MRMC, standalone performance, ground truth for training/test sets) are not applicable or not detailed in this type of regulatory submission.

Here's how to address the specific points based on the available information:

• 2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

  • Not Applicable / Not Provided. The document does not describe a formal clinical test set or study with explicit sample sizes. The claim of performance is based on the device's physical specifications and its substantial equivalence to a predicate device.

• 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):

  • Not Applicable / Not Provided. There is no indication of a test set requiring expert ground truth establishment.

• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

  • Not Applicable / Not Provided. No test set or expert assessment 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:

  • No. This is not an AI-enabled device. The document describes a simple patient magnet.

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

  • No. This is not an algorithm-based device. Performance is inherent to the physical properties of the magnet.

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

  • Not Applicable / Not Provided. Ground truth is not established through these means for this type of device. The "ground truth" for this device's function is its physical ability to generate a sufficient magnetic field to close a reed switch as specified.

• 8. The sample size for the training set:

  • Not Applicable / Not Provided. There is no training set for this device.

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

  • Not Applicable / Not Provided. There is no training set for this device.

Summary of Approach (Implied by 510(k) Summary):

The device's performance regarding its ability to close a reed switch at a specific distance and orientation is a direct consequence of its physical design (material, dimensions, stated magnetic flux density). For a Class I device like a patient magnet, the "proof" it meets acceptance criteria (its intended use) comes from:

1. Engineering specifications and measurements: The stated "50 gauss (G) minimum magnetic flux density at a distance of 1 inch from its surface" is a key performance metric that demonstrates its capability.
2. Substantial Equivalence: The primary regulatory pathway for this device, which relies on demonstrating the new device is as safe and effective as a legally marketed predicate device (Pacesetter Systems, Pacemaker Test Magnet - K813153) that performs the same function. This implies that the predicate device has already demonstrated its safety and effectiveness for this function.

In essence, for this specific device, the "study" is the inherent engineering design and the comparison to an already approved equivalent product, rather than a clinical trial or AI validation study.

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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.

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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