(63 days)
E-Shield Multi-paired Subdermal Needle Electrodes are intended for use with recording and monitoring equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.
E-Shield Multi-paired Subdermal Needle Electrodes are single use, disposable, monopolar, non-pyrogenic and sterilized stainless steel subdermal needle electrodes. Electrodes are applied in the study of biopotentials such as electroencephalograph (EEG), electromyography (EMG). Electrodes are invasive as they are placed subcutaneously or in contact with nerve or muscle tissue.
The subdermal needle electrodes can be used to record variety of types of neurological and neurophysiological evoked potentials, including but not limited to electroencephalogram (EEG), electromyogram (EMG) in hospital and clinical setting. It is highly recommended to be used of intra-operative neuromonitoring (IOM).
The electrodes consist of a stainless steel needle with a lead wire attached and the lead wires terminate in a safety connector. The electrodes are used under the supervision of a physician. There are three specifications for E-Shield Multi-paired Subdermal Needle Electrodes, 7mm, 13mm and 19mm. The sterilized PET box contains 2 sets of 5-paired, 2 sets of 4-paired or 1 set of single subdermal needle electrodes and a safety shield attached to each set. The safety shield is used to cover the needle sharps and the multi-paired lead wires are designed in group for easy organizing. Grouped wire cable can be separated into multi-paired lead wires to reach different recording sites of a patient over desired length. For instance, it can be used for the recording in one limb muscle groups.
The provided text describes the regulatory submission for the E-Shield Multi-paired Subdermal Needle Electrodes (K142470) and its substantial equivalence to a predicate device (K140200). It focuses heavily on non-clinical testing for safety and effectiveness rather than a clinical study evaluating diagnostic or prognostic performance.
Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies, especially in the context of efficacy for a diagnostic or prognostic medical AI device, is largely not applicable to this submission as it pertains to a needle electrode, not an AI device.
Let's break down what can be extracted based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes non-clinical testing categories and the standards applied. The "performance" here refers to meeting these safety and manufacturing standards, not analytical or clinical performance in the sense of accuracy, sensitivity, or specificity commonly associated with AI/diagnostic devices.
| Testing Item | Standard and Regulations Applied (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Sterilization | ISO 10993-7:2008, ISO 11135-1:2007, ISO 11135-2:2008, ISO 11737-1:2006, ISO 11737-2:2009 | Met requirements of pre-defined acceptance criteria |
| Shelf Life/Packaging | ASTM F88/F88M-09, F1140-13, F1929-12, D4332, F1608, ISO 11607-1, 11607-2, ASTM D4169-09, ISTA 1A, ASTM F2096-11 | Met requirements of pre-defined acceptance criteria |
| Biocompatibility | ISO 10993-5:2009, 10993-10:2010, 10993-11:2009, 10993-12:2012, ASTM F756-08, USP 35-NF30:2012 , ASTM F750-87, USP , USP | Met requirements of pre-defined acceptance criteria |
| Electromagnetic Compatibility & Electrical Safety | IEC 60601-1 | Met requirements of pre-defined acceptance criteria |
| Performance (Material) | ISO 9626:1991, ASTM B193-87(1992), IEC 60028 (1925), GB/T 3048.2-2007 | Met requirements of pre-defined acceptance criteria |
The overall reported performance is: "All the test results demonstrate E-Shield Multi-paired Subdermal Needle Electrodes meet the requirements of its pre-defined acceptance criteria and intended uses."
2. Sample size used for the test set and the data provenance
This section is Not Applicable in the context of an "AI device" test set. The testing performed was non-clinical for safety, sterility, biocompatibility, and material properties. Sample sizes for these types of engineering and materials tests are typically determined by relevant ISO/ASTM standards and Good Manufacturing Practices (GMP) for device validation, not by patient data samples. The data provenance is from laboratory and manufacturing validation processes, not country of origin of patient data or retrospective/prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is Not Applicable. Ground truth, in the context of expert consensus, is relevant for diagnostic performance evaluation. The "ground truth" for this device's testing was established by adherence to the specified international and national standards by qualified testing facilities and personnel.
4. Adjudication method for the test set
Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human experts when establishing ground truth for diagnostic tasks. This device underwent non-clinical testing against established standards.
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 a needle electrode, a hardware medical device for signal acquisition, not an AI algorithm designed to assist human readers in interpreting medical data. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device (needle electrode), not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's regulatory clearance is compliance with the detailed standards and regulations listed for sterilization, shelf life, biocompatibility, electromagnetic compatibility, electrical safety, and material performance (e.g., ISO, ASTM, USP, IEC standards).
8. The sample size for the training set
Not Applicable. This is a physical medical device. It does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not Applicable. As above, this is a physical medical device, not an AI algorithm requiring a training set with established ground truth.
Summary for the provided document:
The regulatory submission for the E-Shield Multi-paired Subdermal Needle Electrodes demonstrates its safety and effectiveness through non-clinical testing against a comprehensive set of national and international standards. These tests cover sterilization, shelf life, biocompatibility, electromagnetic compatibility, electrical safety, and material performance. The device was found to meet all pre-defined acceptance criteria derived from these standards. No clinical trial data or AI/algorithm performance studies were conducted or required, as the device is a needle electrode and not a diagnostic or AI-driven system. The substantial equivalence argument relies on comparing the device's intended use, design, technological characteristics, and materials to a legally marketed predicate device, with the only difference being the addition of a new needle length specification and revised product categories, which did not raise new safety or effectiveness concerns after testing.
§ 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).