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Vasomedical-Biox 12 - Channel Ambulatory ECG Holter Recorder, Model 1304, is a Non-Invasive device intended to acquire ambulatory 12 - Channel ECG signals from the upper body surfaces. Cardiac Rhythm is acquired via ECG signals.

Vasomedical-Biox 3 - Channel Miniature Ambulatory ECG Holter Recorder, Model 1303, is also a Non-Invasive device intended to acquire ambulatory 3 - Channel ECG signals from the upper body surfaces. Cardiac rhythm is also acquired via ECG signals.

The Holter Recorders are intended for adults and children who are over the age of six years.

The Models 1304 and 1303 work with the CB Series ECG Analysis Software which has been previously cleared under (K083820)

"The Intended Use of the modified devices as described in its labeling, has not changed as a result of the modifications".
The system is only for measurement, recording and display. It makes no diagnosis.

Vasomedical-Biox 12 - Channel Ambulatory ECG Holter Recorder and Vasomedical-Biox 3 - Channel Miniature Ambulatory ECG Holter Recorders are intended to be used as a Holter Ambulatory Electrocardiograph device for the purpose of screening ECG rhythms for periods up to 72 hours. Cardiac rhythm is acquired by 12 Channel or 3 Channel ECG signals.

The Recorders are portable, microprocessor based devices that are worn by a patient with the use of a supplied Carrying Case and Strap.

This 510(k) summary does not contain information typically found in a study or a clear set of acceptance criteria for the device performance beyond its substantial equivalence to a predicate device. The document primarily focuses on describing the device, its intended use, and comparing its technological characteristics to a previously cleared predicate device to establish substantial equivalence.

Based on the provided text, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not provide a table of specific, quantifiable acceptance criteria (e.g., accuracy, sensitivity, specificity for cardiac event detection) or detailed reported device performance against such criteria. The core argument for clearance is "substantial equivalence" to a predicate device (Vasomedical-Biox, 3-Channel Ambulatory ECG Holter Recorder, Model 1305, K083820). The document states:

"Technological and functional characteristics of the devices listed in this Special 510(k) Notification for Modification are essentially the same as those of the Predicate device. The devices listed in this 510(k) Premarket Notification is therefore substantially equivalent to the predicate device."

The only "performance" reported are the device specifications in Table 1, which are hardware characteristics rather than clinical performance metrics.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not mention any specific test set, clinical study, or patient data (retrospective or prospective) used to demonstrate performance for the devices (Model 1304 and 1303). The clearance is based on technological and functional equivalence to the predicate device (Model 1305).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since no specific test set or clinical study is mentioned for performance evaluation in this document, there is no information regarding experts used to establish ground truth.

4. Adjudication Method

No adjudication method is mentioned as no performance study is detailed in this document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or implied in this 510(k) summary. The devices (Holter recorders) are for data acquisition, recording, and display, and do not involve an AI component requiring human-in-the-loop performance evaluation in this context.

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

This refers to an ECG Holter recorder, which is a physical device for signal acquisition and recording. It is not an AI algorithm. Therefore, the concept of a "standalone" algorithm performance study without a human-in-the-loop does not directly apply in the way it would for diagnostic AI software. The performance of the recording hardware is typically assessed through technical specifications and verification/validation, rather than a standalone algorithm performance study in the AI sense. The document does not detail any such performance validation study.

7. The Type of Ground Truth Used

As no specific performance study is detailed, no type of ground truth (expert consensus, pathology, outcomes data, etc.) is mentioned. The clearance relies on substantial equivalence of the device's design and specifications, rather than a clinical performance study with established ground truth.

8. The Sample Size for the Training Set

The concept of a "training set" applies to machine learning or AI models. The devices described are hardware Holter recorders. Therefore, there is no training set applicable in this context.

9. How the Ground Truth for the Training Set was Established

Again, as these are hardware devices and not AI, there is no training set and thus no ground truth establishment for a training set.

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