(149 days)
The Wave Electrode is to be used exclusively for external prosthetic fittings of the upper limbs.
Wave Electrode is an active analogue electrode for detecting any surface electromyographic signals, used for controlling prosthetic devices. It is compact and low-power, ensuring an accurate and fast reading of muscle electrical potentials generated voluntarily by the user. It also provides a real-time output signal proportional to the detected muscle activation. Through the Wave Electrode it is possible to non-invasively detect the electrical signal produced by the residual muscles on the patient's amputated limb (unilateral amputees, starting from a transradial amputation level) and send an electrical signal to the electronic board of the prosthetic hand with a proportional width to the detected contraction. Wave Electrode is only compatible with the Adam's Hand that, according to the Requlation Number 890.3420, are classified as class I medical device. Wave Electrode is available in two different models: Mod. AE02-50, with notch filter centred on the 50 Hz frequency; Mod. AE02-60, with notch filter centred on the 60 Hz frequency
This document is a 510(k) Premarket Notification from BionIT Labs Srl for their Wave Electrode (AE02-60; AE02-50) devices, seeking clearance from the FDA. The document focuses on demonstrating substantial equivalence to predicate devices, and therefore does not contain acceptance criteria or performance studies in the way you might expect for a novel device or AI/ML algorithm.
Here's an analysis based on the provided text, highlighting what is present and what is absent regarding your requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance statistics. Instead, it relies on demonstrating compliance with recognized electrical safety, EMC, and biocompatibility standards, and functional compatibility with a specific prosthetic hand. The performance is assessed by meeting these standards and ensuring the device operates as intended alongside the "Adam's Hand®" prosthetic hand.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The non-clinical performance data refers to "internal testing" and testing by "an accredited laboratory," but specifics on sample sizes, types of data (e.g., specific scenarios, duration), provenance, or study design are omitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided as there is no mention of a ground truth established by experts in the context of diagnostic or interpretive performance for an AI/ML algorithm. The device is a cutaneous electrode for EMG signal detection, and its performance is evaluated against engineering and biological safety standards, not against an expert-derived ground truth for an interpretation task.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. As explained above, there's no mention of a ground truth derived from expert adjudication for interpretive tasks.
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 MRMC comparative effectiveness study was done or mentioned. This type of study is typically relevant for AI/ML-driven diagnostic or interpretive devices that assist human readers. The Wave Electrode is a hardware device for signal acquisition, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm-only performance study was done or mentioned. The device itself is hardware. The document states it is an "analog device and has no on-board programmable electronics (FW and or PEMS)."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the nature of the device (cutaneous electrode), the "ground truth" implicitly refers to:
- Engineering specifications and recognized standards: Performance is measured against criteria for electrical safety (IEC 60601-1, IEC 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993 series).
- Intended function: The ability to "detect, process, and transmit physiological signals" and operate as intended "in conjunction with 'Adam's Hand®' prosthetic hand."
There is no mention of ground truth related to medical diagnoses, pathology, or outcomes data, as these are not relevant to the function of a cutaneous EMG electrode.
8. The sample size for the training set
This information is not applicable/not provided. The Wave Electrode is described as an analog device without programmable electronics or software. Therefore, there is no AI/ML algorithm that would require a "training set."
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reasons as point 8.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).