(416 days)
The HealthePod is a medical device designed for self-testing. It comprises the following medical features:
- ECG 1-lead .
- Heart rate .
- Body temperature ●
The Card Guard® CG-1411USB HealthePod is a medical and non-medical monitor designed for self-testing by patients. It contains 4 sensors designed to execute the following features:
- . ECG 1-lead
- . Heart rate
- . Ambient temperature
- Body temperature .
- Pedometer walking steps and walking distance, .
- Calorie Meter .
- Stopwatch, Count down, Alarm clock .
- Date/Time .
HealthePod can communicate measured data and patient information to a PC with a receiving medical Application such as PMP4. Two dry electrodes are assembled on the device PCB. It features an LCD, three buttons and a USB connector for communication with PC.
The provided text does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance metrics. The document is primarily a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone performance study with detailed acceptance criteria and results.
Based on the available information, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided text. The document states that "The HealthePod constitutes a safe and reliable device. Its material composition and operation present no adverse health effect or safety risks when used as intended. The device is as safe, as effective and performs as well as or better than its cleared predicate devices." This is a general statement of compliance and equivalence, not a table of specific performance metrics against defined acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The document does not describe any specific test set for performance evaluation, nor does it mention sample sizes, country of origin, or whether any testing was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. As there's no mention of a specific test set or ground truth establishment process, the number and qualifications of experts are not discussed.
4. Adjudication Method for the Test Set
This information is not provided. An adjudication method would typically be relevant for studies involving human interpretation or expert review, which is not detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not provided. There is no mention of an MRMC study or any assessment of human reader improvement with or without AI assistance. The HealthePod is described as a self-testing device with sensors, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not explicitly detailed in terms of performance metrics. While the device is a "self-testing" unit, indicating standalone operation, the document doesn't present a standalone performance study with quantitative results against specific criteria. It implies that the functionality (ECG 1-lead, heart rate, body temperature) works as intended and is equivalent to predicate devices.
7. The Type of Ground Truth Used
This information is not provided. Since no specific performance study with a test set is outlined, the type of ground truth used to validate performance (e.g., expert consensus, pathology, outcomes data) is not mentioned. For a device measuring physiological parameters, ground truth would typically come from established medical devices or clinical observations.
8. The Sample Size for the Training Set
This information is not provided. The document does not describe the development or training of any algorithms, so there is no mention of a training set or its size.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. As there is no mention of a training set, the method of establishing its ground truth is also not discussed.
Summary of Device and Equivalence Claim (from the document):
The HealthePod is a medical and non-medical monitor designed for self-testing. Its medical features include:
- ECG 1-lead
- Heart rate
- Body temperature
The device sought clearance based on substantial equivalence to the following predicate devices:
- Card Guard's CG-2206 K963725 (for one-lead feature and electronic design similarity)
- Card Guard's PMP4 SelfCheck ECG K042254 (for over-the-counter distribution and one-lead configuration)
- TaiDoc Technology Corporation Clever TD-1112 IR thermometer K061800
The conclusion states that the "HealthePod constitutes a safe and reliable device... The device is as safe, as effective and performs as well as or better than its cleared predicate devices." This implies that the performance is considered acceptable because it meets or exceeds the performance of already cleared devices, but the specific studies and acceptance criteria for this device are not detailed.
§ 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).