(433 days)
The NanoKnife System with six outputs is indicated for the surgical ablation of soft tissue.
The NanoKnife System transmits low energy direct current (LEDC) energy from the Generator to Electrode Probes placed in a target area for the surgical ablation of soft tissue. The NanoKnife System includes multiple components. The first component of the system is the Generator. The Generator operates outside of the sterile field and consists of an LCD Display, Console. Power Unit and Power Cord situated on a wheeled trolley and a Double Footswitch/Foot Pedal. The last component of the NanoKnife System is the sterile, single-use, disposable Electrode Probe. The NanoKnife System has the same device configuration as the Oncobionic System with 6 Probe Output (K080202) with minor design modifications to the hardware componentry and software. The range of parameters, pulse amplitude and pulse length, have been narrowed, a third option to the unsynchronized pulse per minute has been added, and touch screen capability in the GUI have been provided to the end user. The fundamental operating principle and design of the NanoKnife System is identical to the Oncobionics predicate devices.
The provided text contains information about the NanoKnife® System's 510(k) premarket notification. However, it does not include details about acceptance criteria, specific device performance metrics, or a study designed to prove the device meets acceptance criteria. The document focuses on demonstrating substantial equivalence to predicate devices through bench testing, rather than reporting on clinical performance against specific metrics.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results or effect size.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document explicitly states:
- Substantial Equivalence: "The NanoKnife System is substantially equivalent to its predecessors... The NanoKnife System is a modified version of these predicate devices..." (Page 1, Section "PREDICATE DEVICE")
- Testing: "All necessary bench testing was conducted on the NanoKnife System to support a determination of substantial equivalence to the predicate device. The bench testing verifies that the NanoKnife System meets all the specified performance specifications and thus, is substantially equivalent to the predicate devices." (Page 1, Section "TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION")
This indicates that the submission relied on bench testing to show that the new device's technical specifications met those of the predicate devices, thereby establishing substantial equivalence. It does not provide data from a study measuring the device's clinical performance against pre-defined acceptance criteria relevant to its intended use (surgical ablation of soft tissue).
§ 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.