(87 days)
The AS40 amplifier system is designed for use in the recording of routine EEG, overnight sleep/EEG (PSG, Polysomnography), and other neurophysiological monitoring applications (EMG and Evoked Potentials). This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in either electroencephalography or polysomnography.
The AS40 is a compact 40-channel AC amplifier unit designed for electroencephalography and polysomnography recording applications. The AS40 provides for patient safety isolation, signal conditioning (physiological signal amplification and filtering), and digitization. Communications with a single host computer are accomplished using TCP/IP protocol over a 10BaseT Ethernet network or dedicated cable. A host computer, using the appropriate software, sets the sample rate, starts and stops the data transmission, monitors the digital data, and stores it to hard disk.
This document is a 510(k) Summary for the Grass-Telefactor AS40 Amplifier System, submitted to the FDA. It details the device's characteristics and its comparison to predicate devices to establish substantial equivalence.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the formal sense that would be typically established for a new clinical study. Instead, it presents a comparison of the AS40's technical characteristics with those of two predicate devices, implying that meeting or being comparable to these established specifications demonstrates sufficient performance for a substantially equivalent device.
The table below summarizes the key technical characteristics presented and states the performance of the AS40 as reported in the document. The implicit "acceptance criteria" for a 510(k) submission like this are that the new device's performance should be essentially equivalent to or better than the predicate devices, or that any differences do not raise new questions of safety or effectiveness.
| Technical Characteristic | Implicit Acceptance Criterion (based on predicates) | Reported Grass-Telefactor AS40 Performance |
|---|---|---|
| Device Class, Category | Class II Electroencephalography (same as predicates) | Class II Electroencephalography |
| Power Supply | Medical-grade power supply (same as predicates) | Medical-grade power supply |
| Patient Safety | Patient connections isolated from ground (same) | Patient connections isolated from ground |
| Safety and Electrical Standards Met | IEC601-1, UL2601-1, IEC601.2.26, CSA 22.2No.601.1, IEC601-1-2 | IEC601-1, UL2601-1, IEC601.2.26, CSA 22.2No.601.1, IEC601-1-2 (in process) |
| Recording Capacity | Comparable channel count (40-57 channels, including AUX DC) | 48-channel capacity including 8 non-isolated AUX DC channels |
| Direct support for integrated Oximeter | Yes (same as predicates) | Yes, manufacturer Nonin |
| Calibration/Use Modes | Yes (same as predicates) | Yes |
| Built-in electrode impedance test | Yes, with displayed results (same as predicates) | Yes, results displayed on host controlled LCD display on the device |
| Photic (flash unit) Stimulation Control integrated | Yes (same as predicates) | Yes |
| Host Computer to Device Connection | Industry standard Ethernet interface (same) | Industry standard Ethernet interface |
| Data Output | Digital (same as predicates) | Digital |
| Anatomical Sites | Same (same as predicates) | Same |
| A/D Resolution | 8, 12, 16-bit or better (predicates range) | 16-bit, simultaneous sampling |
| Sampling Rate | Up to 512 Hz - 2048 Hz (predicates range) | Up to 800 Hz |
| Noise | 80dB (predicates range >100dB, >115dB) | >80dB |
| Input Impedance | 10 MOhms or >100MOhms | 10 MOhms |
| Low-Frequency Cutoff | ~0.1 Hz - 0.16 Hz (same as predicates) | 0.16 Hz |
| High-Frequency Cutoff | ~100 Hz - 107 Hz (same as predicates) | 100 Hz |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical study with a specific test set, patient sample size, or data provenance (e.g., country of origin, retrospective/prospective). The "testing" section primarily describes bench testing and compliance with safety, EMI, and EMC standards for the device itself, rather than performance evaluation using patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no clinical test set is described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication method for the test set
Not applicable. As no clinical test set is described, there's no mention of an adjudication method.
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. The device is an amplifier system for physiological signal acquisition, not an AI-assisted diagnostic tool for human readers. No MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a hardware amplifier system, not an algorithm. Its performance is evaluated through technical specifications and compliance with standards, not as a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this device submission, the "ground truth" for its performance is assessed against established engineering and safety standards (e.g., IEC601-1, UL2601-1) and the technical specifications of legally marketed predicate devices, which represent accepted performance parameters in the EEG community.
8. The sample size for the training set
Not applicable. There is no mention of a training set as the device is a hardware amplifier, not an AI-driven system.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set.
§ 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).