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510(k) Data Aggregation
(94 days)
Suzhou Haishen Medical Device Associates Co., Ltd
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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(101 days)
Suzhou Haishen Medical Device Associates Co., Ltd
This product is intended for use with recording, monitoring equipment for the recording of bioelectrical signals, such as electromyograph (EMG). The electrodes are sterile and for single patient use only.
Medical disposable sterile needle electrodes are sterile, single use products that penetrate the skin and directly contact the extracellular fluid during use, forming a good electrolyte interface. The pointed part of the needle electrode makes contact with the nerves, muscles, or other tissues under examination to collect and transmit the corresponding bioelectrical signals (myoelectric currents) to the electromyography (EMG) recorder. Needle electrodes are used in conjunction with EMG diagnostic instruments and serve as accessories to the EMG machine for detecting myoelectric potentials. Medical disposable sterile needle electrodes are invasive since they are positioned subcutaneously and are used under the supervision of a licensed physician. The subject device, available in configurations with and wires, which encompasses subdermal, monopolar, spiral, and concentric designs. The subject device's configurations of monopolar and concentric needles correspond to those without lead wires, while the configurations involving spiral and subdermal designs include lead wires.
This appears to be an FDA 510(k) clearance letter for a Medical Disposable Sterile Needle Electrode. The document describes the device, its intended use, and non-clinical testing performed to establish substantial equivalence to a predicate device.
Crucially, this document is for a medical device (a physical needle electrode), not a software/AI-driven device that would involve a test set, ground truth experts, MRMC studies, or training sets in the way your request describes. Therefore, many of the requested criteria are not applicable.
However, I can extract the information that is present and explain why other sections are not relevant.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this type of device are primarily based on non-clinical performance (physical and biological safety) and demonstrating substantial equivalence to a predicate device. There isn't a "performance" metric in the sense of accuracy, sensitivity, or specificity as one would find for an AI algorithm.
| Test / Attribute | Acceptance Criteria (Implied by standard and "Pass" result) | Reported Device Performance |
|---|---|---|
| Non-Clinical Testing | Meets specified standards for functional performance. | |
| Surface quality | Acceptable surface finish; no defects impacting safety or performance. | Pass |
| Sharpness index | Meets specified sharpness requirements for penetration. | Pass |
| Toughness | Withstands expected stresses without breakage or loss of integrity. | Pass |
| Connection strength | Connections (e.g., needle to wire) maintain integrity during use. | Pass |
| Electrical conductivity | Conducts electrical signals effectively as intended. | Pass |
| Conductive terminals and needle body insulation | Insulation prevents unintended electrical paths. | Pass |
| Sterility testing | Achieves and maintains sterility (SAL of $10^{-6}$). | Pass (and SAL $10^{-6}$ demonstrated) |
| Biocompatibility Testing | Meets biological safety requirements per ISO 10993-1 for subdermal communicating devices with muscle. | |
| 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 | Validated according to ISO 11135:2014, achieving SAL of $10^{-6}$ and meeting EO residuals per ISO 10993-7. | Yes (meets ISO 11135, SAL $10^{-6}$, and ISO 10993-7 residuals) |
| Shelf-Life | Maintains performance and safety for stated duration. | 3 years (based on accelerated and real-time aging) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to this type of device. The "tests" mentioned are physical and chemical laboratory tests on manufactured samples of the device, not clinical data sets of patients. There is no concept of "data provenance" in the context of clinical images or patient data.
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 is not applicable. There is no "ground truth" established by experts in the context of an electromyography needle electrode. The performance is assessed through standardized laboratory tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. There is no "test set" requiring adjudication in the context of an electromyography needle electrode.
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
This is not applicable. This is a physical medical device, not an AI software. MRMC studies are used for evaluating diagnostic imaging AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned, "ground truth" in the AI/software sense is not applicable. For this device, the "truth" is established by adherence to recognized international standards for biocompatibility (ISO 10993 series), sterilization (ISO 11135), and general physical performance testing (e.g., surface quality, sharpness, electrical conductivity).
8. The sample size for the training set
This is not applicable. There is no "training set" for a physical medical device.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set" or associated "ground truth" for a physical medical device. The "truth" is established through engineering design, material science, and adherence to established manufacturing and testing standards.
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