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510(k) Data Aggregation
(31 days)
THE CARDIOBEEPER CB250 IS INDICATED FOR USE BY THE PATIENT IN TRANSMITTING ECG INFORMATION FROM A REMOTE LOCATION To A RECEIVING CENTER.
The CardioBeeper ® CB250 is a single-lead, compact, hand-held, battery powered, personal transtelephonic ECG transmitter enclosed in a billfold wallet. The device has been designed to enable the user to transmit a rhythm strip to a central receiving station using acoustic coupling. The ECG information is transmitted as a frequency modulation of the basic 1700Hz tone. The device is sealed (not hermetically) for life. There are no user-servicable parts inside. The batteries are not replaceable and the unit should be discarded after depletion.
The provided text describes a 510(k) summary for the Meridian Medical Technologies Ltd CardioBeeper® CB250. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results as typically found in clinical trials for AI/software devices. Therefore, much of the requested information cannot be directly extracted from this type of regulatory submission.
However, based on the information available, here's a breakdown of what can be inferred or stated as not provided:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a formal table of acceptance criteria and reported device performance in the way a clinical study report would. Instead, it focuses on demonstrating substantial equivalence based on design comparisons and technical specifications to legally marketed predicate devices.
The "performance" is implicitly deemed acceptable if the device's technical specifications are comparable to or improved over the predicate devices. The table provided (on page 1) is a comparison of technical specifications between the CardioBeeper® CB250 and two predicate devices (CardioBeeper® CB12L and CardioBeeper® CBII).
| Feature | CardioBeeper® CB250 | CardioBeeper® CB12L | CardioBeeper® CBII |
|---|---|---|---|
| Batteries: | Two 3V LiMno2 cells | 9V disposable alkaline | 9V disposable alkaline |
| Current Drain: | 7mA max | 18mA max | 18mA max |
| Expected life: | >3 years in normal operation | Approx 1 year until batteries need replaced | Approx 1 year until batteries need replaced |
| Operating Range: | 5 to 50 degrees C, <80%RH | +10 to +40° C, 30% to 70% RH | +10 to +40° C, 30% to 70% RH |
| Amplifier - CMRR: | 80dB min | 80dB min | 80dB min |
| Frequency Response: | 0.05 to 150 Hz | 0.05Hz to 150Hz | 0.05Hz - 35Hz |
| System noise: | <40μV r.t.i. | <40μV r.t.i. | <40μV r.t.i. |
| FM Output - Center Frequency: | 1700±20Hz | 1700±20Hz | 1700Hz±20Hz |
| Sensitivity: | 127.5 Hz/mV ±5% | 127.5 Hz/mV ±5% | 127.5 Hz/mV ±7.5% |
| Transmissions: | Modified Lead 1 (real time) | Modified Lead 1 (real time) | Modified Lead 1 (real time); Rolling loop |
Acceptance Criteria (Inferred): The implicit acceptance criteria are that the CardioBeeper® CB250's technical specifications are either equivalent to or demonstrate improvements over the predicate devices, maintaining safety and effectiveness. For instance, the improved battery life and reduced current drain would likely be considered favorable, while maintaining critical electrical characteristics like CMRR, frequency response, system noise, and sensitivity indicates functional equivalence.
The "study" in this context is the detailed comparison and analysis of the device's design, materials, and technical specifications against the predicate devices, as presented in the 510(k) submission.
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. This 510(k) summary does not describe a clinical performance study using a test set of patient data. The substantiation for equivalence is based on device design and technical specifications, not an evaluation of diagnostic accuracy on a dataset.
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. No test set requiring expert-established ground truth is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable / Not provided. No test set requiring adjudication is mentioned.
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
Not applicable / Not provided. This device is a transtelephonic ECG transmitter, not an AI or imaging diagnostic aid. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable / Not provided. This is a hardware device for transmitting ECG signals, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable / Not provided. As this is not a diagnostic device relying on interpretation, there is no "ground truth" in the traditional sense of medical diagnostic studies. The "ground truth" for this regulatory submission is the established performance and safety of the predicate devices.
8. The sample size for the training set
Not applicable / Not provided. This device does not involve machine learning or AI, and therefore no "training set" is relevant.
9. How the ground truth for the training set was established
Not applicable / Not provided. As no training set is relevant, no ground truth for a training set was established.
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