(167 days)
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.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).