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510(k) Data Aggregation
(94 days)
Disposable Laryngeal Electrodes
The disposable laryngeal electrodes are intended to be used as a disposable, self-adhesive electrodes attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures.
The Disposable Laryngeal Electrodes are single used electrodes constructed from an medical-grade ink with a conductive polymer film covered by an insulating coating, a connector made of polypropylene and a cable assembly. The electrodes are designed to monitor the recurrent nerve during thyroid, anterior cervical, carotid endartecrectomy surgery and vagus nerve monitoring during brain surgery. The monitoring is performed with a surface electrode that is attached to an endotracheal tube placed on the vocal cord. A neutral adhesive electrode is placed on the patient's shoulder. Both adhesive electrodes are connected to a reusable recording cable and to the nerve monitor.
The provided document is a 510(k) summary for a medical device called "Disposable Laryngeal Electrodes." It describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study conducted, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Adhesive property | The electrode should be able to be firmly adhered. | Pass |
| Electrode Impedance | Each path of the electrode should be able to conduct, impedance: ≤100 Ω. | Pass |
| Security (Electrical) | Normal state (μΑ): AC: ≤0.01mA (10μA) and DC: ≤0.1mA(100μA); Application part pressurized state (mA): ≤5mA | Pass |
| Sterility testing | The products were sterile both before and after aged. | Pass |
| In vitro cytotoxicity | Non-cytotoxic (as per ISO 10993-5) | Non-cytotoxic |
| Skin sensitization | Non-sensitive (as per ISO 10993-10) | Non-sensitive |
| Intracutaneous reactivity | Non-irritation (as per ISO 10993-23) | Non-irritation |
| Acute systemic toxicity | Non-acute systemic toxicity (as per ISO 10993-11) | Non-acute systemic toxicity |
| Pyrogen | Non-pyrogenic (as per ISO 10993-11) | Non-pyrogenic |
| Sterilization ETO | Sterility Assurance Level (SAL) of 10^(-6) demonstrated per ISO 11135:2014; Meets EO residuals per ISO 10993-7 | Demonstrated and met |
| Shelf-life | 3 years (based on accelerated aging testing) | Established 3 years |
| Electrical safety | Meets requirements of IEC 60601-1 | Met requirements |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for the individual tests (adhesive property, electrode impedance, security, sterility, biocompatibility tests). It only states that testing was performed.
The data provenance is from non-clinical laboratory testing conducted by Suzhou Haishen United Medical Device Associates Co., Ltd. The document does not specify the country of origin of the data beyond the manufacturer's location (Suzhou, Jiangsu Province, China). The studies are by nature prospective as they are conducted specifically for the purpose of demonstrating device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The testing performed is bench testing (e.g., electrical, mechanical, biological) against established engineering and biological standards, not clinical performance requiring expert interpretation of diagnostic outputs or ground truth establishment by clinical experts.
4. Adjudication method for the test set
Not applicable. As the studies are bench tests against objective criteria and standards, there is no need for expert adjudication methods like 2+1 or 3+1. The results are quantitative measurements or pass/fail determinations based on predefined criteria.
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. This device is a passive electrode for EMG monitoring during surgery, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this section is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electrode, which is a hardware component. There is no algorithm or AI component to be evaluated in a standalone manner.
7. The type of ground truth used
The "ground truth" for the non-clinical tests are established international standards and internal requirements for medical devices. Specifically:
- Performance (electrical/physical): Internal requirements, and likely general engineering principles for electrodes.
- Biocompatibility: ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-23, and FDA guidance on ISO 10993-1.
- Sterilization: ISO 11135:2014 and ISO 10993-7.
- Electrical safety: IEC 60601-1.
8. The sample size for the training set
Not applicable. This device is a hardware component and does not involve AI or machine learning models that require a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth to establish for it.
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