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510(k) Data Aggregation
(196 days)
NEUROMETRIX BIOAMPLIFIER
The NeuroMetrix Bioamplifier is intended for amplification and transmission of the electrical activity of peripheral nerves and muscles recorded through surface electrodes.
The NeuroMetrix Bioamplifier ("Bioamplifier") is a one channel wireless electromyography amplifier. This device is intended to differentially measure, amplify, digitize, and wirelessly transmit bioelectrical signals from peripheral nerves and muscles transduced by surface electrodes, which are provided separately. The Bioamplifier consists of the following components: Amplifier/Digitization Unit, Battery, RF Trigger, and Bluetooth. The Bioamplifier is typically used with a host device that controls the operation of the Bioamplifier and may provide other functionality such as a user interface, electrical or other stimuli, data analysis, data storage, and document generation.
This 510(k) summary for the NeuroMetrix Bioamplifier primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria based on performance metrics. Therefore, much of the requested information regarding specific acceptance criteria, performance data, sample sizes, expert involvement, and ground truth derivation is not explicitly provided in this document.
However, I can extract and infer some information based on the premise of substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Formal, quantifiable acceptance criteria with corresponding reported device performance metrics are not explicitly stated in this 510(k) summary. The document focuses on demonstrating comparable functionality and validation of components to a predicate device.
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Amplification & Digitization: Equivalent ability to measure, amplify, and digitize bioelectrical signals from peripheral nerves and muscles. | "performance of all Bioamplifier system components has been validated." (General statement, no specific metrics provided) |
| Wireless Transmission: Equivalent ability to transmit digitized data to a host device. | Bluetooth wireless link successfully provides communication to a host device. |
| Power Source: Comparable reliable power source. | Powered by a high-capacity rechargeable Li-polymer battery. |
| RF Trigger functionality: Equivalent ability to precisely trigger data acquisition. | Includes an RF receiver that allows a host device to precisely trigger data acquisition. |
| Safety & Effectiveness: No new safety or effectiveness issues raised compared to the predicate. | "Therefore any differences in system component technologies do not raise new safety or effectiveness issues." |
2. Sample Sizes Used for the Test Set and Data Provenance
This document does not provide information on a specific "test set" in the context of a clinical performance study. The validation mentioned ("performance of all Bioamplifier system components has been validated") likely refers to engineering and bench testing, not a clinical study with human subjects.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable/Not provided. Since there's no mention of a clinical test set requiring a ground truth determination for diagnostic accuracy, there's no information on experts or their qualifications.
4. Adjudication Method
Not applicable/Not provided. As there's no clinical test set for diagnostic accuracy, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This 510(k) summary does not describe an MRMC comparative effectiveness study, as it's a device for signal amplification and transmission, not an AI diagnostic algorithm.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This device is a hardware component (bioamplifier) with embedded software, not a standalone algorithm in the sense of AI. While its components' performance was validated, it wasn't a "standalone algorithm" performance study.
7. Type of Ground Truth Used
Not applicable/Not provided. For a hardware device focused on signal acquisition and transmission, the "ground truth" would relate to the accuracy of the signal capture and transmission, likely evaluated through instrumentation and bench testing against known calibration signals, rather than clinical outcomes or pathology. This document does not detail the specifics of such testing.
8. Sample Size for the Training Set
Not applicable/Not provided. This device is not an AI/ML algorithm that requires a "training set." Its software components relate to the device's operational control, amplification, and digitization processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided. As there is no training set for an AI/ML algorithm, this information is not relevant.
In summary, the NeuroMetrix Bioamplifier 510(k) emphasizes substantial equivalence to a predicate device by comparing their intended use, system components, and functionality. It states that "the performance of all Bioamplifier system components has been validated," implying internal testing to ensure the device performs as intended and comparably to the predicate. However, it does not provide detailed specific performance metrics or clinical study data that would typically be described when proving adherence to quantitative acceptance criteria for a diagnostic accuracy claim.
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