(166 days)
The Galileo Electroencephalograph with Evoked Potential option is indicated for use in the detection and display of evoked responses of electrical activity of the brain and the peripheral nervous system.
ACQ board: Analog input 32 channels, Analog output 32 channels, A/D conversion 12 bit, 10 micro sec/point, 4 converter, Accumulator 32 bit, Processor Motorola MC68000, Resident memory 1 MB, Trigger input TTL. Stimulators: a- General features: Working class I type of equipment B (acoustic and visual) I type of equipment CF (electrical), Safety requirements meets standard IEC 601-1-1 (CEI 62-5), Size 220 mm, 450 mm, 80 mm, Weight approx. 2 Kg, Power supply + 15V (0.7 A) -15V (0.7A) +5V (1A), Power absorption approx. 25 VA, Working conditions +5C/+35C; 30-75%RH, Atm pressure 700/1060 mBar, Storage and conveyance conditions -10/50C; 10-95% RH, Atm pressure 500/1060 mBar, Degree of protection against infiltration of liquids and solids IP20. b- Acoustic stimulator: Transducer Telephonics TDH39, Stimulation modes Tone, Click, Noise, Stimulation rate from 50 ms to 9980 ms (step 10 ms), Tone frequency 250,500,1000,1500,2000,2500,3000,4000,5000,7000 8000 Hz, Stimulus output Right monoaural, Left monoaural, Right monoaural + controlateral noise, Left monoaural + con- trolateral noise, binaural, Acoustic level 0,10,20,30,40,50,60,70,75,80,90 dB SL, Threshold adjustment -4,-2,0, +2, +4, +6 dB, Noise level relative to the stimulus's level -40,-30,-20,-10,0, + 10 dB, Polarity of the stimulus (in Click mode) Condensation, Rarefaction, Alternate, Duration tone mode: from 10 to 150 ms, with 10 ms steps click mode: from 50 to 960 us, 10 us steps. c- Visual stimulator: The stimulator generates two video images (pattern A and B), that are alternatively displayed on screen in response to a trigger command. Generally, each picture is composed of an arbitrary bit map of 512x256 pixels; in detail the current resident software, divides the image in 5 fields: 4 quadrants and a fixation area. Each field can contain one of the following textures: black white spatial frequency horizontal bars 1 spatial frequency horizontal bars 2 spatial frequency vertical bars 1 spatial frequency vertical bars 2 spatial frequency chequer board 1 spatial frequency chequer board 2 and the reverse of all of them. A composite video signal 1 Vpp is transmitted to the monitor with separate positive synchronisms and 8 contrast levels (2,5,10,20,30,50,75,100%) related to the maximum contrast level set on the . The line period is 64 us, the frame frequency 60 Hz. d- Electric stimulator: The electric stimulator is constant current type. Other features are: Amplitude from 0 to 50 mA, with two scales (0-5 and 0-50), Precision +/- 10% full range, Duration limited to 0.5 millisec (see Device Hazard Analysis), Isolation between the applied elements and the ground 1500 V AC (see Device Hazard Analysis), Patient's safety limited energy and stimulation frequency; protection against failure of the current sensor, Light indicators stimulus ON, overload, abnormal functioning.
Here's an analysis of the provided text, outlining the acceptance criteria and the study information as requested.
The provided document is a Safety and Effectiveness Summary for the Galileo Evoked Potential EEG Biosound Esaote. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
This type of submission to a regulatory body (like the FDA for a 510(k)) primarily focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than conducting new performance studies against predefined acceptance criteria. The comparison table (807.92(a)(3)) highlights the technical similarities between the Galileo EP Option and its predicate devices (Esaote Phasis and Nicolet Viking II System).
Therefore, based solely on the provided text, I cannot complete the table or answer most of the questions.
Here's what I can extract and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| No acceptance criteria or performance study results are provided in this document. | N/A | N/A (No specific performance metrics are reported against defined criteria.) |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not applicable. This document does not describe a performance study with a test set.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This document does not describe a performance study using expert ground truth.
4. Adjudication method for the test set
- Not applicable. This document does not describe a performance study with a test set requiring adjudication.
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
- No. This document does not mention an MRMC study. The device is an Evoked Potential Electroencephalograph, which is a diagnostic tool, not an AI-assisted interpretation system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document does not describe a standalone algorithm performance study. The device itself is a standalone medical device.
7. The type of ground truth used
- Not applicable. This document does not describe a performance study that required establishing ground truth. The submission relies on demonstrating substantial equivalence to predicate devices, implying that the established clinical principles and diagnostic interpretations for those predicate devices would apply to this new device.
8. The sample size for the training set
- Not applicable. This document does not describe any machine learning or AI components that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. There is no training set described in the document.
In summary: The provided text is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices based on technical specifications and intended use. It does not include information about formal performance studies with acceptance criteria, test sets, or ground truth establishment. Such details would typically be found in more comprehensive testing protocols or clinical study reports, which are not part of this "Safety and Effectiveness Summary."
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Safety and Effectiveness Summary Galileo Evoked Potential EEG Biosound Esaote
UNDES AOTTE Biosound, Inc. DUPLICATE 8000 Castleway Drive Indianapolis. IN 46250 317 849.1793 800 428.4374 fax 317 841.8616 http://www.biosound.com/
FEB 26 1997
Safety and Effectiveness Summary
The following safety and effectiveness summary has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR 807.92(a).
807.92(a)(1)
Submitter Information
Gerald A. Richardson, Official Correspondent
Biosound Esaote
8000 Castleway Drive
Indianapolis, Indiana 46250
Phone: (317) 849-1793
Facsimile: (317) 841-8616
Contact Person: Gerald A. Richardson
Date: February 10, 1997
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Safety and Effectiveness Summary Galileo Evoked Potential EEG Biosound Esaote
807.92(a)(2)
Trade Name: Galileo Evoked Potential
Common Name: Evoked Potential Electroencephalograph
Classification Name(s): Electroencephalograph
Classification Number: 84 GWQ
807.92(a)(3)
Predicate Device(s)
Additional Substantial Equivalence information is provided in the following substantial Equivalence Comparision Table.
807.92(a)(5)
Intended Use(s)
The Galileo Electroencephalograph with Evoked Potential option is indicated for use in the detection and display of evoked responses of electrical activity of the brain and the peripheral nervous system.
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Substantial Equivalence Comparison Table
| Item | Galileo EP Option | Esaote Phasis |
|---|---|---|
| K922488 | ||
| General Structure | ||
| Intended use | Evoked Potentials | EMG-EP |
| General system approach | Computer based equipment withspecialized hardware/peripherals | Same |
| User input devices | ASCII standard keyboardFunction keyboard | Same |
| User output devices | Digital color monitorStandard Centronics printerDedicated thermal printer | Same |
| CPU | MC68000 | MC68010 |
| Operating channels | 24/32 | 2-4 |
| Signal acquisition | 12 bit A/D conversion | 16 bit A/D conversion |
| Trigger In | TTL | Same |
| Trigger Out | TTL | Same |
| Accumulator | 32 bit | Same |
| Preset | 1-9999 | 1-32000 |
| Standard EP | ||
| Programs | ||
| Somatosensory | Yes | Yes |
| Auditory | Yes | Yes |
| Visual | Yes | Yes |
| P300 | Yes | Yes |
| Electric Stimulator | ||
| Output | Controlled current 0-50 mA | Controlled current 0-100mA |
| Stimulus indicator | Yes | Yes |
| Overload indicator | Yes | Yes |
| Delivered energylimitation | Yes | Yes |
| Acoustic Stimulator | ||
| Output | Earphone TDH39 | Same |
| Mode | Clicks, Tone, Noise | Same |
| Polarity | Rarefaction, condensation,alternate | Same |
| Level | 0-130 dB (SPL) | 0-124 dB (SPL) |
| Zero level adjustment | Yes | Yes |
| Visual Stimulators | ||
| Output for flashstimulator | Yes | Yes |
| Output | Video composite | Same |
| Type | Checkerboard, bars, strips | Same |
| Mode | Reversal, double pattern | Same |
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807.92(a)(4)
Device Description
| ACQ board | |
|---|---|
| Analog input | 32 channels |
| Analog output | 32 channels |
| A/D conversion | 12 bit, 10 $\mu$ sec/point, 4 converter |
| Accumulator | 32 bit |
| Processor | Motorola MC68000 |
| Resident memory | 1 MB |
| Trigger input | TTL |
Stimulators
| a- General features | |
|---|---|
| Working class | I type of equipment B (acoustic and visual)I type of equipment CF (electrical) |
| Safety requirements | meets standard IEC 601-1-1 (CEI 62-5) |
| Size | 220 mm, 450 mm, 80 mm |
| Weight | approx. 2 Kg |
| Power supply | + 15V (0.7 A)-15V (0.7A)+5V (1A) |
| Power absorption | approx. 25 VA |
| Working conditions | +5C/+35C; 30-75%RH |
| 4 |
·
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| Atm pressure | 700/1060 mBar |
|---|---|
| Storage and conveyance conditions | -10/50C; 10-95% RH |
| Atm pressure | 500/1060 mBar |
Degree of protection against infiltration of liquids and solids
| IP20 | |
|---|---|
| -- | ------ |
b- Acoustic stimulator
| |
i
| Transducer | Telephonics TDH39 |
|---|---|
| Stimulation modes | Tone, Click, Noise |
| Stimulation rate | from 50 ms to 9980 ms (step 10 ms) |
| Tone frequency | 250,500,1000,1500,2000,2500,3000,4000,5000,70008000 Hz |
| Stimulus output | Right monoaural, Left monoaural, Right monoaural+ controlateral noise, Left monoaural + con-trolateral noise, binaural |
| Acoustic level | 0,10,20,30,40,50,60,70,75,80,90 dB SL |
| Threshold adjustment | -4,-2,0, +2, +4, +6 dB |
| Noise level relative to the stimulus's level | -40,-30,-20,-10,0, + 10 dB |
| Polarity of the stimulus (in Click mode) | Condensation, Rarefaction, Alternate |
| Duration | tone mode: from 10 to 150 ms, with 10 ms stepsclick mode: from 50 to 960 us, 10 us steps |
5
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c- Visual stimulator
The stimulator generates two video images (pattern A and B), that are alternatively displayed on screen in response to a trigger command.
Generally, each picture is composed of an arbitrary bit map of 512x256 pixels; in detail the current resident software, divides the image in 5 fields: 4 quadrants and a fixation area. Each field can contain one of the following textures:
- black white spatial frequency horizontal bars 1 spatial frequency horizontal bars 2 spatial frequency vertical bars 1 spatial frequency vertical bars 2 spatial frequency chequer board 1 spatial frequency chequer board 2
and the reverse of all of them.
A composite video signal 1 Vpp is transmitted to the monitor with separate positive synchronisms and 8 contrast levels (2,5,10,20,30,50,75,100%) related to the maximum contrast level set on the .
The line period is 64 us, the frame frequency 60 Hz.
d- Electric stimulator
The electric stimulator is constant current type. Other features are:
| Amplitude | from 0 to 50 mA, with two scales (0-5 and 0-50) |
|---|---|
| Precision | +/- 10% full range |
| Duration | limited to 0.5 millisec (see Device Hazard Analysis) |
| Isolation between the applied elements and the ground | 1500 V AC (see Device Hazard Analysis) |
| Patient's safety | limited energy and stimulation frequency; protectionagainst failure of the current sensor |
| Light indicators | stimulus ON, overload, abnormal functioning. |
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).