(25 days)
The Bio-logic Ceegraph/Sleepscan Netlink Traveler is indicated for use in the recording and analysis of EEG tests. Typical routine EEG tests are 20-30 minutes in duration, but the Ceegraph/Sleepscan Netlink Traveler can also be used for longer tests, including continuous long-term EEG monitoring with patient video. Similarly, the Bio-logic Ceegraph/SleepScan Netlink Traveler is indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of Sleep-related disorders. It is intended to record and present this data in a form that can improve the speed of diagnosis and assist in potential treatment decisions. In general, EEG and Sleep testing is indicated for use whenever it is necessary to measure and record a patient's electrophysiological data relating the electrical activity of the brain, by attaching multiple electrodes at various locations on the body.
The Netlink Traveler can be used for patients of all ages, from children to adults, including geriatric patients.
The use of the Ceegraph/Sleepscan Netlink Traveler is to be performed under the prescription and supervision of a physician or other trained health care professional.
The Netlink Traveler patient connection module (headbox) consists of a molded plastic enclosure approximately 5.75 x 3.9 x 1.75 in size and weighing approximately 1 lb. The Netlink Traveler can be configured to perform up to 40 channel data recordings, having 32 AC channels, and an external 8 DC channels (oximetry, body position, etc.), and additional special channels. Power to the box is supplied by an internal battery, and an external medical-grade power supply/charger may also be connected. There are two primary modes of operation: "Ambulatory Mode" (no power or Ethernet) where data is stored to internal flash memory and "Headbox Mode" (data communicated to host computer via Ethernet). External power is not required in Ambulatory Mode because the Netlink Traveler always derives its power from the battery. However, connecting the Netlink Traveler to external power supply/charger is recommended when longer tests are required in order to extend battery capacity. The AC channel electrodes are connected to safety touch-proof jacks on either of the 2 optional electrode connection accessories, the quick-disconnect box and the Netlink Traveler Electrode Block. These are connected to the Netlink Traveler box via a 68-pin cable and connector. The DC channels connect on a separate 8-pin connector. Other connectors (Ethernet, photic strobe out, Netlink) are located on the side of the Netlink Traveler box.
The Netlink Traveler consists of a digital board, an analog board and an LCD display board. The analog board is very similar in function to the analog board marketed in the Netlink Predicate Device. This board provides signal amplification and conversion of the data from the 32 channel electrodes to digital. The 68-pin electrode array connector allows the use of existing patient connection hardware, such as the 32-channel electrode connection panel called the "quick disconnect box", and the new Netlink Traveler Electrode Block. The connection panel called the "quick disconnect box", and the new Netlink Traveler Electrode Block. The Electrode Block may be configured for several arrays and is especially designed to be worn comfortably by the patient. The digital board contains a microprocessor along with program and data memory, and provides control functions for reading and processing of the analog data, converting it to digital, and communicating it to the host computer and/or to the compact flash memory card. Additional features of the Netlink Traveler include the color LCD display to facilitate functions such as electrode impedance collection, setup and impedance features.
The Bio-logic Ceegraph/Sleepscan Netlink Traveler is an EEG/Sleep recording device. The provided text is a 510(k) summary for this medical device, which addresses its safety and effectiveness.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a quantitative table format as per your request. Instead, it demonstrates substantial equivalence to predicate devices by comparing various parameters and highlighting similarities or differences. The underlying "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the predicate devices, with no adverse effects on product safety and effectiveness.
The table below summarizes the comparison points provided in the document between the Netlink Traveler and its predicate devices:
| Parameter for comparison | Netlink Traveler's Reported Performance (vs. Predicate Devices) |
|---|---|
| Intended Use | No differences (similar to both Netlink and Traveler predicate devices). |
| Patient Population | No differences (similar to both Netlink and Traveler predicate devices). |
| Recording capacity | Up to 32 AC channels, 4 DC channels, and 4 special channels (oximetry, etc.). |
| The Netlink predicate had up to 40 channels with 8 DC. The Traveler predicate had up to 24 AC channels with no DC. | |
| Host Computer to Headbox Connection | No differences (similar to Netlink predicate device). Traveler predicate did not connect to host except for setup via serial port. |
| Computer Control Software | Uses same Ceegraph and Sleepscan (Vision) software as Netlink predicate, with minor additions for new hardware. Traveler predicate used a separate setup application. |
| Patient Information and Tracking | Uses P&TI ACCESS database (similar to Netlink predicate). Traveler predicate used DB4, compatible via import. |
| Safety Characteristics | No differences (basic patient connection and isolation circuits are the same for both predicate devices). |
| Power Source | Battery powered (similar to Traveler predicate). Netlink predicate used a medical-grade power supply. |
| Data Quality | 18-bit resolution. |
| Traveler predicate had 12-bit resolution. No differences noted against Netlink predicate. | |
| Patient Connections | Electrode connections located on Electrode Block or optional Quick-Disconnect box. |
| Netlink predicate had direct headbox connections. Traveler predicate used montage cables. | |
| Impedance display on headbox | Uses an LCD display. |
| Netlink predicate used LEDs. Traveler predicate did not provide this. | |
| Physical Characteristics | Smaller than both Netlink and Traveler predicate devices. |
| Product Labeling | Similar safety, information, and warning labels; differences due to box size/shape. |
| Anatomical sites | No differences (similar to both Netlink and Traveler predicate devices). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The safety and effectiveness analysis primarily relies on design control processes, hazard/risk analysis (FMECA), and comparison to predicate devices, rather than a separate clinical or performance test set with a defined sample size.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As there is no explicitly defined "test set" with ground truth establishment described, this detail is absent.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device is a digital EEG/Sleep recorder, not an AI-assisted diagnostic tool that would typically undergo such a study for improved human reader performance. The software "does not make any final decisions that result in any automatic forms of diagnosis or treatment."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document does not report a standalone performance study. The device is a data acquisition system. While it contains an embedded microprocessor that performs control functions for reading and processing analog data, it does not function as a standalone diagnostic algorithm. Its output, specifically from the software, "does not make any final decisions that result in any automatic forms of diagnosis or treatment."
7. Type of Ground Truth Used
The document does not describe the use of a "ground truth" in the context of a performance study. The safety and effectiveness are established through design controls, risk analysis, and substantial equivalence to legally marketed predicate devices. For a device like an EEG/Sleep recorder, the "ground truth" would implicitly be the accurate physical recording of electrophysiological signals, which is assessed through hardware design, signal processing specifications (e.g., 18-bit resolution), and adherence to relevant standards.
8. Sample Size for the Training Set
The document does not describe a training set. This device is developed based on engineering principles and comparison to predicate devices, not through machine learning models requiring training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as no training set or machine learning model is described in the provided document.
In summary:
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and adherence to design and risk management standards (ISO-13483, FDA QSR Design Control, EN-14971). It does not contain details about specific clinical performance studies, test sets, ground truth establishment, or AI-related metrics (like MRMC studies) that are common for devices involving diagnostic algorithms or AI. The Netlink Traveler is primarily a data acquisition device, and its safety and effectiveness are supported by its design, risk analysis, and comparison to existing, cleared devices.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).