(91 days)
The NIM™ surgeon control probes are indicated to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots via minimally invasive Transoral endoscopic thyroidectomy via vestibular approach - TOETVA.
The NIM™ surgeon control probes carry stimulation current from the patient interface to the patient. It also enables the user to adjust stimulation current and key functions from the surgical site. All probes are single use devices.
The provided text is a 510(k) summary for a medical device (NIM™ 35cm long Surgeon Control Probe). It describes the device, its intended use, and why it is considered substantially equivalent to a predicate device. However, it does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device, as implied by the detailed questions (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance, etc.).
The "Performance Testing Discussion" section (Page 6) details typical engineering verification and validation tests for a physical medical device, such as electromechanical performance, sterilization validation, electrical safety, biocompatibility, stability, packaging performance, and usability testing. These are standard tests for hardware devices, not for assessing the performance of an AI model's diagnostic or predictive capabilities.
Therefore, I cannot provide a table of acceptance criteria for AI performance or answer most of the specific questions about the study proving the device meets AI-related acceptance criteria, as this information is not present in the provided document.
Here's what I can infer from the document regarding the performance testing that was conducted:
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Acceptance Criteria & Reported Performance: The document states that "Design performance testing was completed to ensure the functionality and intended use of the NIM™ 35cm long surgeon control probe was met in accordance with external standards, and device specifications via pre-defined acceptance criteria." It also notes that "This performance testing was used to support substantial equivalence, proving the subject device is as safe and effective as its predicate device." While specific numerical performance values against acceptance criteria are not provided, the conclusion is that the tests yielded "passing results" and demonstrated the device is "safe and effective."
The performance tests listed are:
- Electromechanical, dimensional, and visual design performance
- Sterilization validation to ISO 11135:2014
- Electrical safety & EMC testing to IEC 60601
- Biocompatibility testing and risk analysis to ISO 10993-1:2018
- Stability testing of proposed shelf life
- Packaging performance of environmental conditioning to ISTA 3A and distribution simulation to ASTM D4169
- Usability testing to IEC 62366-1:2015
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Sample Size for Test Set and Data Provenance: The document states "Bench engineering test samples were subjected to simulated real-life conditions during functional testing to establish baseline data and accelerated aging data." It does not specify the exact number of samples. Data provenance is not applicable in the sense of patient data; it's product performance testing.
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Number of Experts Used to Establish Ground Truth and Qualifications: This information is not relevant to the type of device and testing described. The "ground truth" for this device is established by engineering specifications, international standards, and physical measurements/tests.
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Adjudication Method: Not applicable for engineering performance testing of a physical device.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating human performance, often with AI assistance, in interpreting medical images/data. This device is a surgical nerve stimulating probe, not an image analysis or diagnostic AI.
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Standalone (algorithm only) Performance: Not applicable. There is no algorithm in the described function that operates standalone for diagnostic or predictive purposes. The "algorithm" here would literally be the electrical stimulation function itself, which is a physical property.
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Type of Ground Truth Used: For this device, the ground truth is based on engineering specifications, applicable international standards (e.g., ISO, IEC, ASTM), and established physical principles.
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Sample Size for Training Set: Not applicable. This document describes the validation of a physical medical device, not the training of an AI model.
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How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided document is for a physical medical device (a surgical nerve stimulating probe) seeking 510(k) clearance based on substantial equivalence to a predicate device, supported by standard engineering performance and usability testing. It does not involve AI or an algorithm in the sense that would require the detailed AI-specific study information requested in your prompt.
§ 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.