Search Results

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.

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.

Ask a specific question about this device

The TS3201/6401 amplifier system is designed for use in the recording of routine EEG, long-term EEG with patient video and overnight sleep/EEG recording applications (Polysomnography). This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in electroencephalography.

The Grass TS3201/TS6401 systems are 32-channel and 64-channel (respectively) devices for acquiring and conditioning EEG signals and transmitting them to a personal computer for display and storage. The system consists of one or more miniature pager-size 32channel preamplifier units, which plug into a small "belt-pack" designed to be worn by the patient. The belt-pack provides further signal conditioning, safety isolation and communication to a remotely located interface panel and data acquisition computer. Up to two TS3201 or TS6401 belt-packs, in any combination, can be plugged into the interface panel to provide for up to 128 channels of EEG monitoring from a single subject. Each belt-pack includes one additional pair of inputs for standard electrodes for monitoring EOG (eye movement) or ECG. Additionally, each belt-pack also includes a patient call pushbutton, which can be used to signal the control room or automatically trigger event marks or recording devices.

The provided text describes the Grass® TS3201/6401 EEG Amplifier System, but it does not contain acceptance criteria or a detailed study proving the device meets specific acceptance criteria in the format requested.

The document is a 510(k) Summary of Safety and Effectiveness, which typically focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study outcome against them.

Here's an analysis of what is available in relation to your request, and where information is missing:

Analysis of Provided Information

Missing Information:
The document does not explicitly state specific quantifiable acceptance criteria for performance characteristics (e.g., sensitivity, specificity, accuracy for a diagnostic task), nor does it present a detailed study with sample sizes, data provenance, ground truth establishment, or statistical results that would directly prove the device meets such criteria.

Instead, the document relies on demonstrating:

1. Technological Equivalence: The device has similar design, function, and intended use as legally marketed predicate devices.
2. Performance Specifications Equivalence: "Each system has similar performance specifications, which are well agreed upon by the EEG community (amplifier filter settings, gain, and resolution)." (This implies that the device meets industry-standard performance inherent to its class, but doesn't quantify them here).
3. Safety and EMC Standards Compliance: "The Grass TS3201/6401 system has been extensively tested to the applicable safety, EMI and EMC standards for medical electrical devices, and specifically EEG equipment. Third party testing and certification to IEC601-1-2, UL2601-1-2, UL2601-1. CSA22.2#601-1 has been completed or is in process." This is compliance with regulatory standards, not diagnostic performance acceptance criteria.
4. Functional Requirements Verification: "Additional performance testing and bench testing has been completed to verify operation of all functional requirements and performance specifications." This indicates testing was done, but no details are provided.

Response to your specific points based on the provided text:

1. A table of acceptance criteria and the reported device performance

   • Not Available. The document states that the device has "similar performance specifications, which are well agreed upon by the EEG community (amplifier filter settings, gain, and resolution)" to predicate devices. However, no specific numerical acceptance criteria or reported device performance values are provided in a table or otherwise. The focus is on equivalence rather than meeting absolute thresholds.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not Available. The document mentions "performance testing and bench testing" but does not provide any details on sample size, data provenance, or study design (retrospective/prospective). This type of detail is typically not included in a 510(k) summary focused on substantial equivalence for a non-diagnostic AI device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not Applicable/Not Available. This device is an EEG amplifier system, which conditions and transmits physiological signals. It is not an AI/diagnostic device that produces an interpretation or diagnosis requiring expert-established ground truth on a test set in the way a medical imaging AI would. The "ground truth" for an amplifier would relate to the fidelity of the signal acquisition, which is typically assessed against known input signals or reference equipment in bench testing, not expert interpretation of patient data for a diagnostic outcome.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not Applicable/Not Available. See point 3. This concept does not apply to the type of device and testing described.

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/Not Available. The device is an EEG amplifier system, which provides the raw signal data. It is not an AI-assisted diagnostic tool that aids human readers in interpretation. Therefore, an MRMC study with AI assistance is irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

   • Not Applicable/Not Available. This device is hardware for signal acquisition; it is not an algorithm, nor does it operate in a "standalone" interpretative capacity that would be measured like an AI algorithm. It's a foundational component for EEG monitoring.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • Not Applicable (in the context of diagnostic AI). For an EEG amplifier, the "ground truth" would be the accurate capture and transmission of bioelectrical signals. This is verified through engineering tests (e.g., inputting known electrical signals and verifying output fidelity, noise levels, frequency response) rather than a clinical ground truth like pathology for a diagnostic device. The document does not specify the exact methods for verifying these engineering characteristics beyond "performance testing and bench testing."

8. The sample size for the training set

   • Not Applicable/Not Available. This is not an AI-driven device with a training set.

9. How the ground truth for the training set was established

   • Not Applicable/Not Available. This is not an AI-driven device with a training set.

In conclusion: The provided 510(k) summary focuses on demonstrating that the Grass® TS3201/6401 EEG Amplifier System is substantially equivalent to existing predicate devices by having similar design, function, intended use, and meeting applicable safety and EMI/EMC standards. It explicitly states that "Each system has similar performance specifications, which are well agreed upon by the EEG community (amplifier filter settings, gain, and resolution)." However, it does not provide the kind of detailed performance study and acceptance criteria specific to AI/diagnostic efficacy that your request seeks. The "testing" mentioned refers to compliance with safety regulations and verification of functional requirements, not a clinical trial comparing diagnostic accuracy.

Ask a specific question about this device