(13 days)
XLTEK Clear Signal Sub-dermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and are for single patient use only.
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Here's an analysis of the provided text regarding the XLTEK Clear Signal Sub-dermal Needle, focusing on acceptance criteria and study information.
It's important to note that this document is a 510(k) clearance letter from the FDA. While it confirms the device's substantial equivalence to a predicate device, it does not contain the detailed study information typically found in a clinical study report or a 510(k) summary. The provided text primarily focuses on the regulatory aspects of the clearance.
Therefore, many of the requested details about specific acceptance criteria and the studies proving them are not available in the provided document. The 510(k) process relies heavily on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical trial data for every new device. This means that the "proof" often points to the predicate device's established safety and effectiveness.
Here's what can be extracted based on the provided text, and where information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in this document. The document focuses on regulatory clearance based on substantial equivalence. This type of detail would typically be in the 510(k) summary or a specific testing report. | Not explicitly stated in this document. Device performance is implicitly deemed acceptable by the FDA's clearance, suggesting it performs comparably to its predicate for stated indications. |
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 specified in this document.
- Data Provenance: Not specified in this document.
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)
- Number of Experts: Not specified in this document.
- Qualifications of Experts: Not specified in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified in this document.
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 device is an electrode for recording biopotential signals (EMG, EEG, Nerve potential signals), not an AI-assisted diagnostic tool. Therefore, a MRMC study concerning human readers with/without AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device (sub-dermal needle electrode), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of an algorithm's ground truth. For a physical device like this, "ground truth" would relate to its physical properties, biocompatibility, electrical performance, sterility, and mechanical integrity, which are typically assessed through bench testing and, if necessary, animal or human studies to demonstrate safety and effectiveness. The specifics of these tests are not in this clearance letter.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML algorithm that requires a "training set" and corresponding ground truth.
Summary regarding the XLTEK Clear Signal Sub-dermal Needle 510(k) Clearance:
The provided document is an FDA 510(k) clearance letter. This type of clearance indicates that the device (XLTEK Clear Signal Sub-dermal Needle) has been found substantially equivalent to a legally marketed predicate device. This means the FDA believes it is as safe and effective as the predicate device for its stated indications for use: "recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals."
The letter itself does not provide the detailed scientific or clinical study reports, specific acceptance criteria, or performance data that would be found in the 510(k) summary or the underlying submission. The "proof" of meeting acceptance criteria for a 510(k) device often relies on:
- Demonstration of substantial equivalence to a predicate device.
- Bench testing (electrical performance, mechanical strength, biocompatibility).
- Sterilization validation.
- Biocompatibility testing.
- Performance data from the predicate device.
To obtain the specific study details for this device, one would typically need to review the 510(k) summary document filed by the manufacturer, which is usually publicly available through the FDA's 510(k) database.
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).