(38 days)
The Hilger Dual-Stim Nerve Stimulator provides electrical stimulation to nerves during diagnostic and surgical procedures.
The Hilger Dual-Stim Nerve Stimulator is a self contained, battery powered device. There is an option to provide a line powered option in the future. Two modes of nerve stimulation are provided, a Clinical Mode and a Surgical Mode.
The provided document describes the Hilger Dual-Stim Nerve Stimulator, a device used for electrical nerve stimulation during diagnostic and surgical procedures. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than conducting a de novo clinical study with specific acceptance criteria based on performance metrics. Therefore, the requested information regarding acceptance criteria, study details, and expert involvement for ground truth cannot be fully provided in the format typically associated with AI/ML device evaluations.
However, based on the provided text, the device's "acceptance criteria" are implied through its compliance with safety standards and a design control process, and its equivalence to predicate devices in terms of intended use and technical characteristics.
Here’s a breakdown of the information that can be extracted, and where limitations exist:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criterion | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness | Demonstrated through compliance with design control process and safety standards. | "The safety and effectiveness of the Hilger Dual-Stim Nerve Stimulator was demonstrated by testing in compliance with the Design Control process." |
| Intended Use Equivalence | Same as predicate devices. | "The intended use... of the Hilger Dual-Stim Nerve Stimulator is the same as the predicate devices." |
| Technological Equivalence | Equivalent to predicate devices. | "The technical characteristics of the Hilger Dual-Stim Nerve Stimulator are equivalent to those of the predicate devices." |
| Safety Standards Compliance | Meet specified international safety standards (EN/IEC 60601-1, -1-2, -2-10, -2-40). | The device "met" or was tested "in compliance with" these standards. |
| Software Verification & Validation | Successfully completed. | "Software verification and validation" was performed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This document describes a traditional 510(k) submission for a non-AI/ML device where a "test set" in the context of data evaluation (like for AI performance) is not relevant. The device underwent engineering testing (software V&V, safety standard compliance) rather than performance evaluation against a labeled dataset.
- Data Provenance: Not applicable in the context of a dataset for AI evaluation. The "data" here refers to test results from design verification and validation activities.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts & Qualifications: Not applicable. Ground truth, in the context of expert consensus for labeling data, is not mentioned because this is not an AI/ML device submission. The "ground truth" for this device's performance relies on engineering specifications and compliance with safety standards as verified by qualified engineers and testers.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no mention of an adjudication process for a "test set" as understood in AI/ML performance evaluation. The compliance was determined through internal design control processes and testing against engineering requirements and safety standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating human reader performance with and without AI assistance, which is not applicable to this nerve stimulator device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This device is an electrical nerve stimulator; it does not rely on an algorithm to interpret data or make diagnostic decisions in a standalone capacity. Its function is to provide electrical stimulation for human interpretation of nerve response.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context is based on engineering specifications, international safety standards (e.g., EN/IEC 60601 series), and the established performance of predicate devices. The device's electrical output parameters (current, pulse width, frequency) are measured and compared against these defined specifications and those of the predicates.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. This is not an AI/ML device that requires a training set or ground truth for such a set.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" referenced in the document is the internal design control process and associated testing, which included:
- Software verification and validation: Ensuring the device's software functions as intended and meets specifications.
- Declaration of safety standard compliance: Demonstrating that the device adheres to relevant international safety standards (EN/IEC 60601-1, EN/IEC 60601-1-2, EN/IEC 60601-2-10, EN/IEC 60601-2-40). This would involve electrical safety testing, EMC testing, and other relevant tests depending on the specific standard.
The conclusion states that these activities were sufficient to demonstrate the safety and effectiveness of the Hilger Dual-Stim Nerve Stimulator and to show its substantial equivalence to predicate devices, thus raising "No new questions of safety or effectiveness."
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.