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Master Caution Device (MCD) is intended to condition an electrocardiographic signal, so that it can be transmitted digitally via Bluetooth technology and cell-phone or communication device to a remote location. The Master Caution Device (MCD) is designed to be used by a patient to transmit a 12 lead ECG, posture and motion , respiration and skin temperature (IR) signals, in near real-time to enable review at a physician's office, hospital or other remote medical receiving center. Master Caution Device (MCD) target population is adults above the age of 21.

The HealthWatch Master Caution Device (MCD) is a personal, hand-held battery powered, ECG device that can be connected to any approved and market cleared, ten standard ECG electrodes, configuring a 12-lead ECG device.

The MCD is a miniature ECG device with an embedded processor containing data acquisition, data storage, data processing accelerometers, respiration, skin temperature (IR) and BT (Bluetooth) capabilities. The HealthWatch Master Caution Device (MCD) acquires ECG data via the connected electrodes. The HealthWatch Master Caution Device (MCD) transmits the data in near real time to a suitable Bluetooth communication device for forwarding to a remote location for professional review.

A communication device is defined as any device that is capable of receiving the ECG data via Bluetooth and forwarding it via WIFI or cellular network (3G/4G). Communication devices can be cellphones, computers or other dedicated communication modems.

The provided document is a 510(k) premarket notification for the Healthwatch Master Caution Device (MCD). It asserts substantial equivalence to predicate devices rather than providing a detailed study proving device performance against specific acceptance criteria. Therefore, several of the requested sections cannot be fully populated as the information is not present in the document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria or corresponding reported device performance metrics in a readily extractable table. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to relevant performance standards.

The document mentions that "Bench testing demonstrated that the HealthWatch Master Caution Device (MCD™) is as safe and effective as the cleared predicate device." This is a general statement rather than specific performance data.

2. Sample size used for the test set and the data provenance

The document does not detail a specific test set or data provenance for performance evaluation of the MCD itself. It states that for the MCD, performance bench tests were conducted to demonstrate equivalence to the predicate device. However, no sample sizes or data provenance are provided for these bench tests.

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

This information is not provided as the document does not describe a clinical study with a ground truth established by experts for the MCD directly.

4. Adjudication method for the test set

This information is not provided as the document does not describe a clinical study with an adjudication method for the MCD directly.

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 such MRMC comparative effectiveness study is mentioned for the Master Caution Device (MCD). The MCD is described as a device that conditions and transmits ECG signals, not an AI-assisted diagnostic tool.

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

This is not applicable as the MCD is a hardware device for signal acquisition and transmission, not an algorithm, and its intended use is for review by a physician.

7. The type of ground truth used

For the MCD, the document does not indicate the use of specific ground truth types (e.g., pathology, outcomes data) in a clinical study. The device's performance is gauged against its ability to acquire and transmit physiological signals accurately, and its equivalence to predicate devices through bench testing and compliance with standards.

8. The sample size for the training set

This information is not applicable. The MCD is a hardware device for signal acquisition and transmission and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable for the same reasons as above.

Summary based on the document:

The HealthWatch Master Caution Device (MCD) received 510(k) clearance based on demonstrating substantial equivalence to legally marketed predicate devices. The primary arguments for equivalence are:

• Same Intended Use: The MCD's intended use is to condition and transmit electrocardiographic signals and other physiological data (posture, motion, respiration, skin temperature) for remote review.
• Similar Technology: It utilizes the same transmission method (Bluetooth) as its predicate devices.
• Performance Bench Tests: Bench testing was conducted to verify that the MCD is "as safe and effective" as the cleared predicate device, without raising new safety or effectiveness concerns. These tests presumably assessed the device's ability to acquire and transmit the specified signals correctly and reliably. However, specific performance metrics or detailed results from these bench tests are not provided in this summary.
• Compliance with Standards: The device complies with several international and US standards related to medical electrical equipment safety, electromagnetic compatibility, software life cycle processes, risk management, and labeling (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, ISO 62304, ISO 14971, ISO 15223-1, ASTM D4169).
• Reliance on Predicate Device Studies: The document explicitly states, "Due to the comprehensive clinical studies already performed by the predicate and other devices, published in scientific literature, and since the performance testing shows its substantial equivalence, HealthWatch believes that animal and clinical studies are not necessary to determine the substantial equivalence of the HealthWatch Master Caution Device (MCDTM)." This indicates that no new clinical studies or detailed performance studies with human subjects were conducted for the MCD itself to prove its effectiveness beyond substantial equivalence.

Therefore, the document emphasizes regulatory compliance and comparison to existing devices rather than a detailed performance study with specific acceptance criteria and outcome measurements for the MCD as a standalone product.

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The PulmoTrack TM 2020 is intended for the analysis, interpretation and documentation of lung sounds. The PulmoTrack TM 2020 is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds. The PulmoTrack TM 2020 is indicated for patient population above two years old

The PulmoTrackTM 2020 is a computer based electronic stethoscope that utilizes an acoustic contact sensor to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea and thorax and provides high fidelity audio outputs, visual displays, printed reports and automated identification of lung sounds. The data transfer may be done via Bluetooth wireless communication.

The PulmoTrack™ 2020 is a computer-based electronic stethoscope that acquires, amplifies, filters, records, and analyzes pulmonary sounds. Its intended use is for the analysis, interpretation, and documentation of lung sounds, specifically quantifying the presence of wheezing during pulmonary function testing, provocation tests, bronchodilator administration, or physical examinations. It is indicated for patients above two years old, to be used by or under the supervision of a physician.

This device did not undergo a clinical study as it claimed substantial equivalence to its predicate device, PulmoTrack™ 2010 (WIM-PC™) (K071955), without raising new safety and/or effectiveness concerns. The only technical modification was the data transfer from A/D to the PC via a Bluetooth wireless channel. Therefore, the performance validation focused on demonstrating that the PulmoTrack™ 2020 performed according to its specifications and as well as the predicate device, particularly concerning biocompatibility and wireless functionality.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

A specific "test set" for a clinical performance study (as would be typical for a novel device) is not explicitly described. Because this was a 510(k) submission based on substantial equivalence to a predicate device with only a minor technological change (Bluetooth), the performance validation was likely focused on technical specifications and functional testing rather than a clinical study with a patient test set. The document states "All testing results demonstrated satisfactory performance," implying internal verification and validation activities. There is no information provided about country of origin of data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. No clinical study involving a test set and expert ground truth establishment is described for the PulmoTrack™ 2020 in this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. No clinical study involving a test set and adjudication 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

Not applicable. No MRMC study was conducted or described. The PulmoTrack™ 2020 is an electronic stethoscope that provides analysis and interpretation of lung sounds, but the provided documentation does not detail a study comparing human reader performance with and without AI assistance.

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

The device itself is an electronic stethoscope with automated identification of lung sounds. The "Performance Validation" section broadly states that the device "underwent validation testing to ensure performance according to its specifications." This would imply standalone performance testing for its ability to analyze and identify lung sounds as per its design. However, specific details of such standalone testing (e.g., against a known dataset of pre-recorded lung sounds with established ground truth) are not provided in this 510(k) summary.

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

The document does not explicitly state the type of ground truth used for validating the automated identification of lung sounds. For a device like this, ground truth would typically come from:

• Expert auscultation/consensus: A panel of experienced physicians listening to the same lung sounds and agreeing on the presence or absence of wheezing.
• Spirometry/pulmonary function tests: Objective measures of lung function that correlate with the presence of wheezing.

Given the nature of the submission (substantial equivalence with minor changes), it's more likely that the validation focused on ensuring the device accurately captured and processed sounds, and that its automated identification algorithm performed comparably to the predicate device, which would have had its own original validation methods for ground truth.

8. The sample size for the training set

Not applicable. The document does not describe a new training set for an AI/algorithm. The device is claiming substantial equivalence to a predicate, implying it uses the same underlying technology/algorithms as the PulmoTrack™ 2010.

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

Not applicable. As no new training set is described for the PulmoTrack™ 2020, how its ground truth was established is not part of this submission. It would rely on the original methodologies used to develop and validate the predicate device's technology.

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