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The BioModule 3-M1 is a physiological monitoring telemetry device intended for monitoring ambulatory patients in alternate care settings. The device consists of adhesive electrodes and an electronics module. The device stores and transmits vital sign data including ECG, heart rate, respiration rate, body orientation and activity. The BioModule 3-M1 provides a facility to detect and transmit single lead ECG signals to be received by qualified instruments.

The BioModule 3-M1 collects and transmits measurements captured in alternate care settings as prescribed by the health care professional. Breathing rate values are accurately transmitted only during sedentary periods.

The BioModule 3-M1 is indicated for use as a general patient monitor to provide physiological information as part of general ward monitoring system.

The BioModule 3-M1, a physiological sensor / transmitter is composed of:

• proprietary hardware and firmware, enclosed in
• a user case (puck) with a re-chargeable battery. .
• . a adhesive electrode set and
• A cradle (to recharge battery and transfer internally stored date to an ancillary computer).

The BioModule 3-M1 is a physiological transmitter manufactured by Zephyr Technology Corporation with disposable, off the shelf electrodes that transmits data to a qualified receiving station. The BioModule 3-M1 is positioned against the patient's skin with light pressure then pressed to adhere.

The document provided is a 510(k) summary for the BioModule 3-M1, a physiological monitoring telemetry device. It focuses on establishing substantial equivalence to a predicate device (BioHarness 3.0, K113045) rather than on presenting a detailed study proving performance against specific acceptance criteria for the algorithm's accuracy.

Therefore, many of the requested details about acceptance criteria, specific study design elements (like sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, or MRMC studies), and "reported device performance" in terms of algorithm accuracy, are not present in this type of regulatory submission.

The document primarily states general safety and effectiveness and claims that the device has been tested to confirm these. It emphasizes the similarity in technological characteristics and principles with its predicate device.

Here's a breakdown of the information that can be extracted or inferred based on the provided text, and what is explicitly not available:

1. A table of acceptance criteria and the reported device performance

• The document does not provide a specific table of acceptance criteria (e.g., minimum sensitivity, specificity, accuracy for ECG detection or heart rate measurement) or quantitative reported device performance metrics against such criteria.
• Instead, it states: "A series of factory tests are conducted to verify the intended signals are accurate and can maintain a calibrated energy pattern over its useful life." This is a general statement about manufacturing quality control rather than a clinical performance study.
• The primary "performance" discussed is the capability to "detect and transmit single lead ECG signals" and that "Breathing rate values are accurately transmitted only during sedentary periods." These are functional descriptions, not quantitative performance metrics.

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

• Not provided. The document does not describe a test set or clinical study with patient data. It refers to "factory tests."

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. Since there's no described test set with clinical data requiring expert ground truth, this information is not present.

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

• Not applicable / Not provided. No clinical test set or adjudication process 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

• No, an MRMC comparative effectiveness study was NOT done (or at least not described in this document). The device is a physiological sensor/transmitter, not an AI-assisted diagnostic tool that would involve human readers interpreting output.

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

• The document implies that "factory tests" were done to verify signal accuracy. However, no specific standalone algorithm performance study (e.g., sensitivity/specificity for arrhythmia detection) is described. The focus is on the device's ability to capture and transmit physiological signals reliably, rather than the performance of a sophisticated AI algorithm.

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

• Not provided. Given the nature of "factory tests," the "ground truth" would likely be derived from calibrated signal generators or known physiological inputs, rather than clinical data requiring expert consensus or pathology.

8. The sample size for the training set

• Not provided. The document does not describe a machine learning training set.

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

• Not applicable / Not provided. No training set is mentioned.

Summary of what is present:

• Device Description: BioModule 3-M1, a physiological sensor/transmitter composed of hardware, firmware, user case, adhesive electrode set, and a cradle. It captures electrical pulses from the skin via electrodes, converts them to digital signals, processes them, and transmits them.
• Intended Use/Indications for Use: Monitoring ambulatory patients in alternate care settings, providing physiological information (ECG, heart rate, respiration rate, body orientation, activity) as part of a general ward monitoring system. Breathing rate is accurate only during sedentary periods.
• Predicate Device: Zephyr Technology, BioHarness 3.0, K113045.
• Substantial Equivalence Claim: The BioModule 3-M1 is "substantially equivalent" to BioHarness 3.0, with "incidental and not significant" differences. Both use electrodes, convert analog to digital signals, use microprocessors/firmware/signal processing, and transmit signals for ECG waveforms.
• Safety and Effectiveness Justification: "Factory tests are conducted to verify the intended signals are accurate and can maintain a calibrated energy pattern over its useful life."

In essence, this 510(k) summary focuses on demonstrating that the new device is fundamentally similar to an already cleared predicate device, and that its basic function and manufacturing processes ensure safety and effectiveness, rather than detailing a clinical study with stringent acceptance criteria for an AI algorithm's specific performance metrics.

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