(190 days)
The SimplECG is intended to aid in the diagnostic evaluation of patients, 21 years of age and above, on the order of a physician, who experience transient symptoms which may suggest the nead ly assess their cardiac rhythm disturbance. ECC data is recorded, stored, transferred and displayed wirelessly for review by a physician who is skilled in rhythm interpretation.
The Nanowear SimplECG (“SimplECG”) device is a wearable garment (either a shirt or brassiere) that is magnetically attached to a communication module which is secured in place by an elastic pouch. The SimplECG is designed for reliability, patient comfort and ease of use in clinical-quality electrocardiogram (“ECG”) applications. The SimplECG device does not perform any automatic beat or rhythm classification on the acquired ECG data. The intended duration of use of the SimplECG device is up to 24 hours.
The SimplECG Communication Module can collect continuous ECG data from the garment, securely stores it and transfers to a compatible mobile device (iOS), which then uploads the recorded ECG data to a secure Nanowear Inc. (“Nanowear”) server for review by a medical professional (inclusive of a physician, nurse or technician). The device consists of four (4) components:
• The SimplECG Garment: a shirt or brassiere, consisting of a network of nanosensors integrated directly into the garment, that collects ECG signals directly from the skin which are then captured by the communication module.
• The SimplECG Communication Module*: collects, stores and wirelessly transmits ECG signals from the garment to the patient mobile device.
• The SimplECG Mobile Application: allows for patient logging of symptoms and transmission of ECG recordings to a secure, remote server through a patient-supplied mobile device operating on Apple iOS.
• The Nanowear Web Application: allows initiation of a test, and storage and review of patient ECG data sent from the Mobile Application to the server.
*The electronic enclosure for the SimplECG Communication Module is made of Nylon/PA2200.
The provided text describes the SimplECG, a wearable garment with integrated nanosensors for collecting ECG data. This device is intended to aid in the diagnostic evaluation of patients experiencing transient symptoms that may suggest cardiac rhythm disturbance. The 510(k) summary provides details about the device, its comparison to predicate devices, and a list of performance standards it claims conformance to, as well as pre-clinical performance data.
However, the document does not contain specific acceptance criteria, a detailed study description, or reported device performance metrics in a format that would allow for the direct creation of the requested table. The text primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and conformance to general medical device standards.
Here's an analysis of the provided information relative to your request:
1. A table of acceptance criteria and the reported device performance
This table cannot be fully generated from the provided text. The document lists several performance standards (e.g., AAMI / ANSI 60601-1, IEC 60601-2-47) that the device claims conformance to. Conformance to these standards implies meeting their respective requirements, which would serve as acceptance criteria. However, the specific metrics and values that define "acceptance" and the *actual measured performance *of the SimplECG against these metrics are not explicitly stated in the summary. For example, while it states "The ECG acquisition performance of the SimplECG is comparable to the predicate devices," it doesn't provide numerical data to support this.
2. Sample size used for the test set and the data provenance
The document mentions "Pre-clinical testing included... Performance Testing – Bench" and "Equivalency Testing of SimplECG to Standard of Care Device." However, it does not specify the sample size used for these tests (e.g., number of ECG recordings, number of subjects/garments). The data provenance (e.g., country of origin, retrospective or prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states that ECG data is reviewed by "a physician who is skilled in rhythm interpretation." This refers to the clinical use case of the device, where a physician interprets the collected data. However, for the pre-clinical performance testing aimed at establishing "equivaleency" or "comparability" to a standard of care device, the number of experts and their qualifications used to establish ground truth for the test set are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method used for establishing ground truth during its pre-clinical testing.
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
The SimplECG device "does not perform any automatic beat or rhythm classification on the acquired ECG data" and "does not perform any ECG analysis." Therefore, it is a data acquisition and display device, not an AI-assisted interpretation tool. As such, a multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance was not performed nor is it relevant to this device's functionality.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is designed for review by a medical professional. Its function is to collect, store, transfer, and display ECG data. It does not have a standalone algorithm for diagnosis or interpretation, so "standalone (algorithm only)" performance without human-in-the-loop is not applicable to the stated functionality of the SimplECG.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies that "Equivalency Testing of SimplECG to Standard of Care Device" was performed. This suggests that the "ground truth" for the SimplECG's performance would be the data acquired by the "Standard of Care Device." However, the exact nature of this ground truth (e.g., whether the standard of care data itself was validated by expert consensus on arrhythmias) is not explicitly detailed.
8. The sample size for the training set
The document does not mention any "training set." As the SimplECG device does not perform automated classification or analysis, it is unlikely to involve machine learning models that require a training set in the typical sense.
9. How the ground truth for the training set was established
As no training set is mentioned or implied for an AI/ML model, this question is not applicable.
Summary of Missing Information:
The provided 510(k) summary focuses on demonstrating substantial equivalence by comparing the SimplECG's intended use and technical characteristics to predicate devices and by claiming conformance to general medical device standards. It does not provide the granular detail typically found in a clinical or performance study report regarding specific acceptance criteria, measured performance metrics, sample sizes, ground truth establishment, or expert involvement for the pre-clinical performance testing.
§ 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).