(153 days)
The NanoKnife System with six outputs is indicated for the surgical ablation of soft tissue.
The NanoKnife System is a software-controlled low-energy direct-current (LEDC) generator which surgically ablates soft tissue. Included for use with the system are the NanoKnife Single Electrode Probes and optional Probe Spacer. With the NanoKnife System, electrical current is delivered between pairs of probes in a series of pulses. The waveform of the current is adjustable as determined by clinician-chosen parameters. These parameters include volts/cm, pulse length, number of pulses to be delivered between electrode pairs, distance between probes, and the timing mode (90PPM, 240PPM or ECG synchronization). Up to six probes may be placed in an array within the tissue. The array are matched as pairs by the system. When probes are activated via a foot-pedal, the scheduled current is delivered to tissue between subsequent pairs of probes. Soft tissue between the probes is ablated.
Please note that the provided document is a 510(k) summary for a medical device which aims to demonstrate substantial equivalence to a predicate device. It is not a clinical study report or a publication detailing a clinical trial with acceptance criteria and statistical analysis of a new device's performance against a pre-defined set of criteria in a clinical setting.
Therefore, many of the requested categories, such as "Sample size used for the test set," "Number of experts used to establish ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "Standalone performance," are not directly applicable or explicitly stated in this type of regulatory submission. The document focuses on demonstrating that modifications to an existing device do not alter its safety or effectiveness.
However, I will extract and present the information that is available and relevant to your request based on the provided text.
Acceptance Criteria and Device Performance (Based on Technical and Safety Requirements for Substantial Equivalence)
The document primarily focuses on verifying that the modified NanoKnife System continues to meet its specified performance and safety requirements, which are implicitly the "acceptance criteria" for substantial equivalence to the predicate device. The performance data section describes the types of tests conducted to ensure this.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional/Performance Specifications: | |
| - ECG synchronization operation is correct | Verified (Performance testing confirms specifications met) |
| - Power supply regulation is correct | Verified (Performance testing confirms specifications met) |
| - AC/DC board voltages are within specification | Verified (Performance testing confirms specifications met) |
| - Charge bank verification is successful | Verified (Performance testing confirms specifications met) |
| - Hardware safety measures (e.g., over/under current pulse intervention, overlength pulse) are functional | Verified (Performance testing confirms specifications met) |
| - Field Programmable Gate Array firmware functionality is correct | Verified (Performance testing confirms specifications met) |
| - Voltage and current accuracy is within specification | Verified (Performance testing confirms specifications met) |
| - Pulse duration is accurate | Verified (Performance testing confirms specifications met) |
| - Minimum capacitance is met | Verified (Performance testing confirms specifications met) |
| - Pulse amplitude is accurate | Verified (Performance testing confirms specifications met) |
| - Pulse frequency is accurate | Verified (Performance testing confirms specifications met) |
| - Pulse intervals are correct | Verified (Performance testing confirms specifications met) |
| - Pulse count is accurate | Verified (Performance testing confirms specifications met) |
| - Maximum energy delivered is within specification | Verified (Performance testing confirms specifications met) |
| - Emergency Stop Button functionality is correct | Verified (Performance testing confirms specifications met) |
| Environmental/Durability: | |
| - Withstands shipping environmental and vibration/handling stress | Verified (Ship testing environmental and vibration/handling) |
| - Meets reliability standards | Verified (Reliability testing) |
| Electromagnetic Compatibility (EMC): | |
| - Complies with EN 60601-1-2:2001/A1:2006 | Verified (EMC testing confirms compliance) |
| Electrical Safety: | |
| - Complies with IEC 60601-1-2:2001/A1:2004 | Verified (Electrical safety testing confirms compliance) |
| Software Validation: | |
| - Software performs as specified and validated | Verified (Software validation testing) |
| Shelf Life: | |
| - Single Electrode Probes have a 3-year shelf life | Demonstrated (Increased shelf life specification based on testing/analysis) |
| Biological Impact (Thermal Ablation): | |
| - Potential thermal ablation volumes lie within electroporation volumes | Verified via worst-case computational modeling (Pennes bioheat model, finite element analysis) |
Detailed Information as Available from the Document:
-
A table of acceptance criteria and the reported device performance:
(See table above) These are implicitly the acceptance criteria for determining substantial equivalence based on the technical changes. The "reported device performance" is that the device "meets all the specified performance specifications." -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document describes engineering and in-vitro testing of the modified device, not a clinical study with a "test set" in the sense of patient data. Therefore, information on sample size for a test set (e.g., number of patients/cases), data provenance (country of origin), or retrospective/prospective nature is not applicable or provided. The tests mentioned are laboratory-based. -
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 information is not applicable as the document describes technical/engineering testing, not a clinical study requiring expert-established ground truth on patient data. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the document does not describe a clinical study requiring adjudication of expert-derived ground truth. -
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 information is not applicable. The device (NanoKnife System) is an electrosurgical device for soft tissue ablation, not an AI-powered diagnostic or interpretive tool that assists human readers. No MRMC study is mentioned or relevant to this type of device and submission. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The NanoKnife System is a medical device (hardware and software) that performs a physical intervention (ablation). It is not an algorithm designed for standalone diagnostic performance. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the engineering and performance testing described:- Functional/Performance Testing: The "ground truth" is adherence to predefined engineering specifications, design requirements, and regulatory standards (e.g., voltage accuracy, pulse duration, EMC compliance).
- Biological Impact Modeling: The "ground truth" for the modeling was based on established physics and biological models (Pennes bioheat model, finite element analysis) using "clinically-relevant input parameters."
-
The sample size for the training set:
This information is not applicable. The NanoKnife System is not an AI/machine learning device that requires a "training set" in the conventional sense. The "training" for such a device would be its design, development, and testing against engineering specifications. -
How the ground truth for the training set was established:
This information is not applicable for the reasons stated in point 8.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.