(140 days)
The SimpleSENSE System is intended for use at home, or at a healthcare facility, under the direction of a licensed medical professional, to record, display and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; and d) Activity including posture. The device is intended for use when the clinician decides to evaluate the physiologic signals as an aid to diagnosis and treatment. The SimpleSENSE System is intended to be used by patients at rest and not performing any activities or movements. ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The device does not produce alarms and is not intended for active patient monitoring (real-time). The device is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The device is not intended for use in the presence of a pacemaker.
The Nanowear SimpleSENSE device is the next generation diagnostic monitoring technology that captures electrocardiographic (ECG) signals, respiration rate though thoracic impedance, heart sounds, activity including posture with sensors embedded on a wearable textile garment. The signals are stored and wirelessly transmitted to a smartphone, and forwarded to a medical professional for review. The garment is designed to be unobtrusive to everyday activity and provide an easy and efficient means of capturing ECG, respiration rate, heart sounds and activity data from patients. The garment is designed to be unobtrusive to everyday activity and provide an easy and efficient means of capturing ECG data from patients. The device consists of three (3) components:
- The SimpleSENSE Garment: an integrated network of nanosensor electrodes for measuring ECG and respiratory rate from thoracic impedance, and incorporating a MEMS microphone for measuring heart sounds.
- The SimpleSENSE Signal Acquisition Unit (SAU): data acquisition, storage, and transmission to an iPhone 7 using iOS 13.4. Incorporates an accelerometer to measure activity.
- The SimpleSENSE Mobile Application: mobile application for to start/stop a recording and to forward the test report to the medical professional.
Here's a breakdown of the acceptance criteria and study information for the Nanowear SimpleSENSE device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary provided does not explicitly list acceptance criteria in a quantitative table format with corresponding reported performance values for clinical metrics. Instead, it describes various performance evaluations against design specifications and equivalence to predicate devices.
However, based on the Performance testing section, we can infer some key areas of evaluation:
| Acceptance Criteria (Inferred from Performance Testing) | Reported Device Performance |
|---|---|
| Verification of multiparametric data capture (ECG, Respiration Rate, Heart Sounds) | Performance demonstrated to design specifications. (Specific quantitative results not provided in this summary). |
| Verification of Bluetooth and iPhone connectivity | Performance demonstrated to design specifications. |
| Verification of encryption of acquired data | Performance demonstrated to design specifications. |
| Respiration Rate detection range and accuracy | "Respiration Rate detection range 6 - 22 breaths per minute (BPM) with accuracy ± 2 BPM" (This is explicitly stated as a characteristic, implying it was an acceptance criterion for this parameter). Performance demonstrated to design specifications (for respiration rate overall). |
| Battery safety and charging status indication | Performance demonstrated to design specifications. |
| Signal Acquisition Unit (SAU) performance and durability | Performance demonstrated to design specifications. |
| MicroSD card durability, capacity, and data storage testing | Performance demonstrated to design specifications. |
| Battery charger verification | Performance demonstrated to design specifications. |
| Biocompatibility of the garment | Performance demonstrated to design specifications. |
| Electrocardiograph sensor performance | Performance demonstrated to design specifications. |
| Electrical current requirements for transthoracic impedance sensor | Performance demonstrated to design specifications. |
| MEMS microphone testing | Performance demonstrated to design specifications. |
| Garment conductive inlays testing for flexibility and electrical performance | Performance demonstrated to design specifications. |
| Garment compression requirements | Performance demonstrated to design specifications. |
| Garment fastening mechanisms | Performance demonstrated to design specifications. |
| Use cycles for the base garment | Performance demonstrated to design specifications. |
| Shelf life | Performance demonstrated to design specifications. |
| Equivalency to predicate/reference devices for specific signal acquisition and display | "The performance data provided demonstrate that the SimpleSENSE device is substantially equivalent to the indicated predicate device." (Implied acceptance criterion for equivalence across all measured parameters compared to predicates). Specific objective measurements for equivalence are not detailed in this summary. |
2. Sample Size Used for the Test Set and Data Provenance
The summary states that "Equivalency testing against predicate/reference devices" was performed as part of the performance testing. However, it does not provide any details regarding the sample size used for clinical testing or the data provenance (e.g., country of origin, retrospective or prospective) for this equivalency testing.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts or their qualifications used to establish ground truth for any clinical test sets. The indications for use mention evaluation by a "licensed medical professional" and "physician who is skilled in rhythm interpretation" for the ECG data, but this pertains to the intended clinical use of the device, not necessarily how the ground truth for regulatory testing was established.
4. Adjudication Method
The document does not mention any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in clinical test sets.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance. The SimpleSENSE system is a data acquisition and display device intended for manual assessment, not an AI-driven interpretive device.
6. Standalone (Algorithm Only) Performance
The SimpleSENSE system itself is described as a device that records, displays, and stores physiological data for manual assessment by a clinician. It does not appear to have an inherent AI algorithm that provides interpretations or diagnoses. Therefore, a standalone (algorithm only) performance study as typically understood for AI devices would not be applicable or described for this device. The phrase "manual assessment of cardiac rhythm disturbances" reinforces this.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any clinical testing (e.g., expert consensus, pathology, outcomes data). Given the nature of the device as a data recorder for manual assessment, it is implied that the "ground truth" for equivalency would come from comparisons to the outputs of the predicate devices or conventionally accepted methods for measuring parameters like ECG, respiration rate, and heart sounds.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. As the device is for data acquisition and display rather than AI interpretation, a separate training set for an algorithm is not discussed.
9. How Ground Truth for the Training Set Was Established
Since no training set for an AI algorithm is mentioned, the method for establishing ground truth for such a set is also not applicable or described in this summary.
§ 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).