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The BT3/6 (3/6-lead) and BT12 (12-lead), hereafter referred to as the "BT devices", are battery powered devices capable of acquiring and transmitting a standard electrocardiogram (EKG) to be applied by medically trained persons for the purpose of cardiac monitoring and diagnosis performed by medical professionals. The collected data is processed by the B1 device and then transmitted via a standard wireless link to a monitoring device, such as a P or hand-held device for display, review, printing, saving and post event processing by medical professionals. The collected data is not interpreted by the BT device as this is done by the monitoring device operated by medical professionals. Use of the BT devices is not restricted to adult population, but is also intended for infants weighing less than 10 kg (22 lbs.). Measurements taken by the BT devices are only significant if considered in connection with other clinical findings. No therapy or drugs can be administered based solely on ECG data derived from the BT devices. The BT devices are not intended for monitoring critical patients and are not intended for intracardial use.

BT3/6. BT12 is a compact ECG device which is worn on the body and is capable of wireless data transmission. With the BT3/6 type, 2 ECG leads (II - III according to Einthoven) can be measured via a 4-pin cable. The receiving unit can calculate four additional leads (lead I according to Einthoven, aVL, aVR, aVF according to Goldberger).Type BT12 has a 10-pin cable, which, in addition to the leads of the BT3/6 variant, can also measure the 6 leads according to Wilson. With this cable, one can select among 3-, 6- or 12-channel ECG measurements. The cables of the BT are pluggable and therefore can be easily changed. The electrode clips on the patient cables are suitable for connection to button and tab electrodes. It has an integrated electrode contact detector and a heart rate meter, the results of which are displayed on an integrated LCD display. Thanks to the integrated radio data transmission technology, BT3/6, BT12 is able to transmit ECG data online over a range of up to 10 m to a monitor or recording unit for further evaluation. BT3/6, BT12 can be used in all medical applications where the long, stiff trunk cables are a problem due to their weight, their motion artifacts or their electromagnetic susceptibility or because they limit the patient in his freedom of motion. Especially significant are the applications in which it is necessary for the patient to move around freely, for example when the patient is undergoing a stress electrocardiogram. BT3/6, BT12 is compact and simple to operate. A clip allows the device to the patient's clothing. BT3/6, BT12 is powered by two standard AA cells. Patient contacting components are the electrodes. BT3/6, BT12 is intended for use with approved. biocompatible electrodes only.

Here's an analysis of the provided text to extract the requested information regarding the acceptance criteria and study for the BT3/6, BT12 device.

Important Note: The provided document is a 510(k) Premarket Notification. 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a full clinical comparative effectiveness study in the same way a PMA submission might. Therefore, some of the requested information (like effect size for MRMC studies or ground truth for training sets) may not be explicitly present because it's not a required component of a 510(k) for this type of device.

Acceptance Criteria and Device Performance

The device demonstrates compliance with recognized standards and shows performance characteristics that are comparable to or better than a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't define explicit "acceptance criteria" in a pass/fail sense for clinical performance. Instead, it compares the BT3/6, BT12 device's technical specifications and intended use against a legally marketed predicate device (Card Guard CG-7000DX-BT). The "acceptance" is based on demonstrating substantial equivalence, meaning the new device is as safe and effective as the predicate.

Here's a table summarizing the comparison for key parameters:

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

The document does not describe a clinical "test set" in the context of diagnostic performance evaluation for a medical device that interprets ECGs. The BT3/6, BT12 device does not interpret ECG data; it merely acquires and transmits it.

The testing mentioned relates primarily to hardware safety and performance standards. The submission states: "The BT3/6, BT12 has been tested according to IEC 60601-1 and IEC 60601-1-2 by accredited laboratories and has shown full compliance to these standards and the standards listed in chapter 9 of this 510(k)." This refers to engineering and electrical safety testing, not clinical studies with patient data to evaluate diagnostic accuracy.

Therefore, there is no information on:

• Sample size for a clinical test set.
• Data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As the device does not interpret ECG data, there was no need for experts to establish ground truth for a diagnostic test set. The device's function is to accurately acquire and transmit the raw ECG signal.

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

Not applicable. There was no clinical test set requiring adjudication in the context of diagnostic performance.

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. This device is a wireless ECG acquisition and transmission device, not an AI-assisted diagnostic tool. No MRMC study was mentioned or performed in the context of reader improvement with AI assistance.

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

Not applicable. The device's primary function is signal acquisition and transmission, not algorithmic interpretation by itself. Its performance is evaluated on its ability to accurately capture and transmit the raw ECG signal according to technical specifications, not on a standalone diagnostic algorithm.

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

Not applicable for diagnostic ground truth. The "ground truth" for this device would be its adherence to technical specifications and standards for signal integrity, electrical safety, and wireless transmission, as outlined in IEC 60601-1, IEC 60601-1-2, and the hardware aspects of ANSI/AAMI EC11 and EC38. Compliance with these standards by accredited laboratories serves as the "proof" of its foundational performance.

8. The sample size for the training set

Not applicable. This device is a hardware product for signal acquisition and transmission, not a machine learning model that requires a training set of data.

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

Not applicable. As above, there is no training set for this type of device.

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