(189 days)
The disposable hypodermic EMG needle electrode is used for muscle stimulation, motor unit action potential recording and drug delivery. The motor nerves are monitored by detecting EMG activity in the muscles they innervate.
The drug used should be Botox Botilium Toxin type A.
Note: Technomed Europe does not supply any drugs with the Disposable hypodermic EMG needle electrodes nor does Technomed Europe offer for sale any form of drugs.
The disposable hypodermic EMG needle electrode is designed for single use only. It consists of a stainless steel cannula electrically insulated with a PTFE coating, except for the lancet point and the inner surface of the tube. The coating is to ensure easy skin penetration and to ensure electrical insulation on the entire cannula, except for the point.
A husk fitting together with a wire with connection to an extension cable has been attached to the cannula. This cable will enable the electrical signal to be transferred to a stimulating or recording device.
The provided text describes a 510(k) premarket notification for a "Disposable hypodermic EMG needle electrode" (K062437) from Technomed Europe. This submission focuses on establishing substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI or diagnostic device.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or cannot be extracted from this document, as it outlines a regulatory submission for a medical device that has a long history of use and is compared to existing, legally marketed predicate devices.
Here's an attempt to answer the questions based on the available information, noting where data is absent:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance metrics in the way a clinical study for a novel diagnostic algorithm would. The basis of this 510(k) submission is "substantial equivalence" to predicate devices, meaning the device performs similarly without raising new questions of safety or effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness substantially equivalent to predicate devices | "The Disposable hypodermic EMG needle electrode is safe and effective and is substantially equivalent to the predicate devices." (Conclusion) |
| Performance characteristics confirmed by bench testing | "Technomed Europe has been bench testing the Disposable hypodermic EMG needle electrode to confirm performance characteristics of this device." (Non-clinical data) |
| Design, materials, chemical composition, packaging, and technological characteristics equivalent to predicate devices | "The design, materials, chemical composition, packaging and other technological characteristics of the subject device is equivalent to those of the predicate devices." (Comparison to predicates) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This submission relies on bench testing and comparison to predicate devices, not human or patient data in a "test set" as would be used for an AI or diagnostic algorithm.
- Data Provenance: Not applicable. The "non-clinical data" refers to "bench testing" performed by Technomed Europe (Netherlands).
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)
Not applicable. "Ground truth" in the context of expert consensus or pathology is not relevant for this device's type of regulatory submission (a physical medical device establishing substantial equivalence). The determination of equivalence is made by the FDA based on the submitted information.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no human-involved "test set" and thus no adjudication method described.
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
Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical EMG needle electrode, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this type of submission is essentially regulatory compliance and demonstrating that the device is as safe and effective as existing, legally marketed predicate devices. It relies on:
- Bench testing results to confirm performance characteristics.
- Comparison of design, materials, and technological characteristics to established predicate devices (K973444: Teca Myoject disposable needle electrode; K002992: Medtronic Disposable Hypodermic Needle Electrode).
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an algorithm being developed or tested.
9. How the ground truth for the training set was established
Not applicable. There is no "training set."
Summary of what can be extracted from the document:
The document describes a 510(k) submission for a manual disposable hypodermic EMG needle electrode. The manufacturer, Technomed Europe, sought to demonstrate that their device is "substantially equivalent" to two existing predicate devices (Teca Myoject and Medtronic Disposable Hypodermic Needle Electrode).
The "study" in this context consisted of:
- Non-clinical bench testing to confirm performance characteristics. The specific tests and results are not detailed in this summary.
- Detailed comparison of the device's design, materials, chemical composition, packaging, and other technological characteristics to the predicate devices, concluding that they are equivalent.
The FDA's review of this information led to a determination of substantial equivalence, allowing the device to be marketed. The document does not describe a clinical trial, an AI algorithm, or patient data-driven performance metrics, which are often the focus of the requested information.
§ 890.1385 Diagnostic electromyograph needle electrode.
(a)
Identification. A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).(b)
Classification. Class II (performance standards).