(194 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, a voltage applied between pairs of probes in a series of pulses. The waveform of the voltage is adjustable as determined by clinician-chosen parameters. These parameters include volts/cm, pulse length, number of pulses to be delivered between electrode pairs, the distance between probes, and the timing mode (90PPM or ECG synchronization). Up to six probes may be placed in an array within the tissue. The probes of the array are matched as pairs by the system. When probes are activated via a foot-pedal, the scheduled voltage is delivered to tissue between subsequent pairs of probes. Soft tissue between the probes is ablated.
The provided FDA 510(k) summary for the Angiodynamics NanoKnife System (K183385) does not detail acceptance criteria or a comparative effectiveness study involving human readers with and without AI assistance, as the device is an electrosurgical device for soft tissue ablation, not an AI/imaging diagnostic device.
However, based on the information provided regarding performance testing of the device, I will extract and present the relevant information to address the prompt's requests as much as possible, focusing on the device's technical and safety performance rather than AI-specific criteria.
Here's a breakdown of the acceptance criteria (implied by compliance with standards and performance data) and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/imaging diagnostic device, performance is not measured in terms of metrics like sensitivity, specificity, or AUC. Instead, performance is demonstrated through adherence to safety and performance standards, and comparison to a predicate device's operational characteristics.
| Acceptance Criteria Category | Specific Criteria (Implied by Compliance) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with IEC 60601-1 (medical electrical equipment safety) | Device tested against ES60601-1:2005/(R)2012 And A1:2012. |
| Compliance with IEC 60601-1-2 (electromagnetic compatibility) | Device tested against IEC 60601-1-2 Edition 4.0 2014-02. Modifications made to improve EMC performance to comply with the new revision. | |
| Compliance with IEC 60601-1-6 (usability) | Device tested against IEC 60601-1-6 Edition 3.1 2013-10. | |
| Biocompatibility | Compliance with ISO 10993 (biological evaluation of medical devices) | Additional biocompatibility testing performed per ISO 10993-1:2009/(R)2013 due to standard changes. Patient contact materials are identical to predicate. |
| Sterilization | Compliance with ISO 11135, ISO 10993-7, ASTM F1980 (sterilization of healthcare products) | Additional sterilization testing performed due to consensus standard changes. Design of sterilized disposable probes and cycle are identical to predicate. |
| Software/Firmware | Compliance with IEC 62304 (medical device software life cycle processes) | Device tested against IEC 62304 Edition 1.1 2015-06. Firmware and UI software updated to support new components. |
| Functionality/Performance (Ablation) | Similar ablation performance to predicate device across expected operating conditions. | Animal study conducted to characterize thermal effects on tissue. The overall performance of the subject device was similar to the performance of the predicate device. Ablation volume similarity demonstrated with a P-value of 0.670 for comparison of mean ablation volume between predicate (NK 2.2) and subject (NK 3.0). |
| Mechanical/Packaging | Compliance with ASTM D4169 (shipping containers performance), ASTM F1886-98 (seal strength) | Device tested against these standards. |
| Electrosurgical Specific Guidance | Compliance with FDA Electrosurgical Devices Guidance | Device evaluated against FDA guidance document: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, dated August 15, 2016 (specifically Section E, subsection 1, regarding thermal effects). |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly mentions an "animal study" was conducted for "System Testing" to characterize the device's performance over the expected range of operating conditions, particularly for evaluating "Thermal Effects on Tissue."
- Test Set Description: Animal study data.
- Sample Size: The exact number of animals or ablation procedures performed in the animal study is not specified in the provided text.
- Data Provenance: Not explicitly stated (e.g., country of origin, specific institution), but animal studies are typically conducted under controlled laboratory conditions. The document does not specify whether it was retrospective or prospective, but animal studies for device characterization are generally prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This device is an electrosurgical ablation system, not an AI diagnostic tool requiring expert interpretation of images for ground truth establishment. The "ground truth" for its performance relates to physical parameters like ablation volume, which would be measured directly in the animal study.
4. Adjudication Method for the Test Set
- Not Applicable. As above, this is a physical device performance test (ablation volume), not a diagnostic interpretation where adjudication of human judgments would be necessary.
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
- Not Applicable. This is not an AI-assisted diagnostic device. Therefore, no MRMC study involving human readers and AI assistance was conducted or would be relevant for this type of device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware electrosurgical device with control software. Its "standalone performance" is its ability to deliver the specified electrical parameters and achieve the intended ablation effect, as demonstrated in the animal study. There is no independent "algorithm" in the sense of an AI model whose performance is measured in isolation.
7. The Type of Ground Truth Used
- Direct Measurement/Experimental Observation: For the performance study (animal study), the "ground truth" was likely the directly measured ablation volume or tissue effect observed in the animal models, rather than expert consensus, pathology in the diagnostic sense, or long-term outcomes data as might be used for diagnostic tools. The P-value for ablation volume comparison supports this.
8. The Sample Size for the Training Set
- Not Applicable. This device is not an AI/machine learning system that requires a "training set" of data in the conventional sense. Its "training" or development involves engineering design, component selection, software development, and iterative testing/validation.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for an AI model, the concept of establishing ground truth for it is irrelevant. The "ground truth" for the device's design and functioning is based on established engineering principles, electrical safety standards, and physiological understanding of tissue ablation.
§ 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.