(63 days)
The Macro-Micro Depth Electrodes are intended for use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.
Depth electrodes described in this application are single patient use, disposable, sterile and non-sterile devices. The electrodes are invasive as they are placed in contact with nerve tissue. The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physicians in the areas of biopotential recording, monitoring and stimulation/response studies understand the use of depth electrodes. The main components of the depth electrodes are: 1. Contract strip with macro depth electrode contacts and connector contacts; 2. Stylet; Inner lumen: 3. 4. Micro wire electrode(s) for insertion and placement through the macro electrode inner lumen. The lead wires terminate in a safety connector that cannot be connected to an AC power outlet. The materials are the same as used in the predicate devices and/or are common to depth electrodes.
The provided text is a 510(k) premarket notification for a medical device called "Macro-Micro Depth Electrodes." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics typically seen for novel devices.
Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in the provided document.
Instead, the document highlights:
- Substantial Equivalence: The primary assertion is that the Macro-Micro Depth Electrodes are "substantially equivalent" to predicate devices (K891920, K964644 from AD-TECH Medical Instrument Corporation and K033173 from Fhc, Inc.). This means the device has the same intended use and similar technological characteristics, and "no new questions of safety or effectiveness are raised."
- Technological Characteristics: The document lists the components (contact strip, stylet, inner lumen, micro wire electrode) and states that the materials are the "same as used in the predicate devices and/or are common to depth electrodes."
- Intended Use: The device is for "recording, monitoring and stimulation of electrical signals at the subsurface level of the brain."
In summary, there is no detailed study or acceptance criteria reported within this 510(k) summary because the approval mechanism relies on demonstrating equivalence to already approved devices, not on proving efficacy through new clinical trials against specific performance benchmarks.
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).