(106 days)
The NT 2000 is intended for use for lesioning of neural tissue. The NT 2000 is indicated for use in the peripheral nervous system. The NT 2000 is to be used only with FDA cleared NeuroTherm RF probes and Smith & Nephew SPINECATH and ACUTHERM catheters.
The NeuroTherm NT 2000 is a desktop RF lesioning generator, which is used for the lesioning of neural tissue. The device is a second generation device that is a modification of the NeuroTherm NT 1000 (K052878) previously cleared by FDA. The NT 2000 is a multi-lesioning, 4 channel portable generator that can provide continuous or pulsed RF output at 460 KHz, monopolar or dual electrode modes, and a Simplicity mode for large lesion creation. The device includes sensory and motor stimulation functions to fine tune electrode placement for procedures, and is also designed to connect to various lesioning probes which are inserted into patients for lesioning of neural tissue during medical procedures. Device features include a touch screen monitor incorporating microprocessor and graphics display for user interface as well as self diagnostics, calibration checks, and recordkeeping functions.
Here's a breakdown of the acceptance criteria and study information for the NeuroTherm NT 2000 Lesioning Generator based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical efficacy through extensive studies. Therefore, much of the requested information (like detailed sample sizes for test/training sets, number of experts for ground truth, MRMC studies, standalone performance with metrics like AUC, sensitivity, specificity) is not typically found in this type of submission for this class of device. The "performance testing" described is primarily bench and software testing to ensure the device operates as designed and meets electrical safety standards.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for a radiofrequency lesion generator, the "acceptance criteria" are primarily related to substantial equivalence to existing, legally marketed predicate devices, and demonstrating that the new device performs as intended and safely according to its design specifications. Actual quantitative performance metrics for disease detection (like sensitivity, specificity, AUC) are not applicable or presented here for this type of device.
| Acceptance Criteria Category | Specific Criterion (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Intended Use | Intended for lesioning of neural tissue; indicated for use in the peripheral nervous system; to be used only with FDA cleared NeuroTherm RF probes and Smith & Nephew SPINECATH and ACUTHERM catheters. (Matches predicate devices). | The NT 2000's stated "Intended Use" and "Indication for Use" are consistent with the predicate devices, specifically the NeuroTherm NT 1000, and align with the general purpose of RF lesion generators. |
| Technology | Based on the same fundamental radiofrequency lesioning technology as predicate devices (e.g., 460 kHz frequency for RF energy delivery). | The NT 2000 utilizes RF energy delivery for neural tissue lesioning, similar to its predicates. It operates at 460 kHz, which is comparable to the 480 kHz of the NT 1000 and Cosman G4. |
| Functional Modes | Should include continuous RF thermal and pulsed RF modes, sensory and motor stimulation functions, and multi-channel capabilities (e.g., monopolar, bipolar/dual electrode modes). | The NT 2000 offers continuous and pulsed RF modes, sensory and motor stimulation, and both monopolar (4 channels) and bipolar ("dual") electrode modes. It introduces "Continuous independent simultaneous energy delivery" during multi-channel RF, which is an enhancement over the sequential delivery of the NT 1000 but is also present in the Cosman G4. |
| Technical Specifications (Key) | Power output (e.g., comparable maximum output), frequency, number of channels, safety features (excess power, excess temperature), electrical safety/EMC compliance. | Power Output: Max 50W into 100 Ω (comparable to Stryker Multi-Gen and Cosman G4, an increase from NT 1000's 30W into 200 Ω). |
| Frequency: 460 kHz (comparable to predicates). | ||
| Channels: 4 monopolar channels (similar to Stryker and Cosman, an increase from NT 1000's 3 channels). | ||
| Safety Features: Yes (excess power, excess temperature), mimicking predicates. | ||
| Electrical Safety/EMC: IEC 60601 compliant (same as all predicates). | ||
| Physical Design: While dimensions and weight vary slightly, they are within the general range for this type of device. | ||
| Safety and Effectiveness (Overall) | Any differences between the NT 2000 and the predicate 4-channel devices should not raise new issues of safety or effectiveness. This is the overarching acceptance criterion for a 510(k) submission – demonstrating that the device is as safe and effective as a legally marketed predicate device. | The conclusion explicitly states: "Any differences between the NT 2000 and the predicate 4-channel devices do not raise new issues of safety or effectiveness." This is supported by bench and software testing. |
| Performance Testing | Device should operate as designed according to internal specifications for hardware and software. | Bench Testing: "Bench testing supports that the NT 2000 performs as expected." |
| Software Testing: "Software testing supports that the NT 2000 performs as expected." | ||
| Compliance with Standards | Compliance with relevant industry standards, particularly for electrical medical equipment. | "This device is IEC 60601 compliant as appropriate." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for the Test Set: Not applicable. For this type of device (RF lesion generator), the "test set" isn't a dataset of patient images or clinical outcomes. The testing primarily involves bench testing (physical device performance under various conditions) and software testing (functionality, robustness, safety of the embedded software). The document does not specify numbers of test cases or samples for these engineering tests, as it's standard industry practice to ensure comprehensive testing within internal development.
- Data Provenance: Not applicable. There is no patient-derived data for this type of testing. The "data" here would be measurements from bench tests and outputs from software verification/validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts and Qualifications: Not applicable. The "ground truth" for an RF lesion generator's performance is its ability to consistently and safely deliver radiofrequency energy according to its specifications, and to function reliably. This is established through engineering and software verification and validation, not through expert clinical consensus on a "test set" of patient data.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no "adjudication" in the clinical sense for this type of device's testing. The device's performance against its specifications would be objectively measured and verified during engineering and software tests.
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
- MRMC Study / Effect Size for Human Readers: Not applicable. This device is a therapeutic/interventional medical device (a radiofrequency lesion generator), not an AI-powered diagnostic or interpretive tool that assists human "readers" (e.g., radiologists interpreting images). Therefore, an MRMC study and related metrics are not relevant to its regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable as this is not an AI algorithm. The device, by its nature, is a "standalone" system in terms of its ability to generate RF energy, but it always requires a human operator for its clinical application (human-in-the-loop). Its "performance" is measured by its engineering specifications and safety features, which are evaluated in bench and software testing.
7. The type of ground truth used
- Type of Ground Truth: For this device, the "ground truth" is defined by its engineering specifications and international safety standards (IEC 60601). For example, if the device is spec'd to output 50W, the ground truth for that parameter is "50W +/- tolerance." For software, the ground truth is the documented functional requirements and logic.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device does not employ machine learning or AI that would require a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable. As there is no training set, there is no method for establishing its ground truth.
§ 882.4400 Radiofrequency lesion generator.
(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(b)
Classification. Class II (performance standards).