(91 days)
The NanoKnife System with six outputs is indicated for surgical ablation of soft tissue, including prostate tissue.
The NanoKnife System is a device used for tissue ablation using irreversible electroporation (IRE), a method of focal ablation which uses high voltage electrical pulses to change the permeability of the cell membrane leading to cell death. During the procedure, electrical pulses between probe pairs produce an electric field which induces electroporation of cells within the targeted abation area. The NanoKnife System with six outputs is currently indicated for the surgical ablation of soft tissue by the United States Food and Drug Administration (FDA).
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Goal) | Reported Device Performance (Primary Effectiveness Endpoint) |
|---|---|
| Rate of subjects with a negative in-field biopsy at 12 months: ≥ 0.52 (52%) | 71.1% of subjects (86/121; 95% CI: 62.1%, 79.0%) had a negative in-field biopsy at 12 months. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: A total of 121 subjects were enrolled and subsequently treated with the NanoKnife System.
- Data Provenance: The study was a prospective, nonrandomized pivotal study. The document does not explicitly state the country of origin of the data, but the submission is to the U.S. FDA, implying the study was conducted to support a U.S. market application.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided in the given text. The ground truth for effectiveness was based on biopsy results, which are pathological findings, not subjective expert readings of images.
4. Adjudication Method for the Test Set:
- This information is not applicable as the primary effectiveness endpoint was based on objective biopsy results ("negative in-field biopsy"), not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. This study evaluated the performance of the NanoKnife system itself for tissue ablation, not how human readers' performance improved with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
- Not applicable. The NanoKnife System is a medical device for surgical ablation, not an AI algorithm. The study assessed the device's clinical effectiveness directly.
7. The Type of Ground Truth Used:
- The primary effectiveness ground truth was based on pathology, specifically the result of an "in-field biopsy at 12 months" (negative or positive). Safety ground truth was based on the incidence and grading of adverse events (AEs) using CTCAE v5.0.
8. The Sample Size for the Training Set:
- Not applicable. The NanoKnife System is a physical medical device, not an AI model that requires a "training set" in the machine learning sense. The "PRESERVE" study was a clinical trial to evaluate the device's performance.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As stated above, this is a physical medical device, not an AI model. Therefore, there is no "training set" or ground truth establishment in this context.
§ 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.