(18 days)
The Elekta Neuromag® with Maxwell Filter non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning.
The Elekta Neuromag with Maxwell Filter adds support for separating brain signals from external disturbances and reducing mcasurements artifacts.
The provided text does not contain a study that proves the device meets specific acceptance criteria. Instead, it is a 510(k) summary for the Elekta Neuromag® with Maxwell Filter, seeking substantial equivalence to a predicate device. This document describes the device, its intended use, and indications for use, but not a clinical or performance study with defined acceptance criteria and results.
Therefore, I cannot populate the table or answer most of the questions as the requested information (performance data, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not present in the provided text.
The document focuses on demonstrating that the new device has "similar fundamental technical characteristics" to the predicate device to establish substantial equivalence.
Here's what can be extracted based on the document's content:
1. A table of acceptance criteria and the reported device performance
The provided document does not contain specific acceptance criteria or reported device performance metrics from a study. It is a 510(k) summary for substantial equivalence, not a performance study report.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in the document.
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 provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided in the document.
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 mentioned or described in the document. The device is a MEG system, not an AI-assisted diagnostic tool for human readers in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable in the context of this device as described. The Elekta Neuromag® with Maxwell Filter is a diagnostic device that measures MEG/EEG signals to be interpreted by trained physicians. It's not an algorithm operating in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not provided in the document.
8. The sample size for the training set
Not applicable/provided. This document is not describing a machine learning or AI algorithm with a training set.
9. How the ground truth for the training set was established
Not applicable/provided. This document is not describing a machine learning or AI algorithm with a training set.
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ELEKTA NEUROMAG Oy
JAN 2 5 2005
Special 510lk)
| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition | Sida/Page |
|---|---|---|---|
| Louise Lindblad | 12 | ||
| Avser/Regarding | Directory | ||
| Elekta Neuromag® with Maxwell Filter |
Section 4 - 510(k) Summary
As Required by 21 CFR 807.87(k) 510(k) Summary
Subscribers Name & Address 1.
Elekta Neuromag Oy Elimäenkatu 22 B, P.O. Box 68 FIN-00511 Helsinki, Finland Tel: + 358 9 756 240 0 Fax: + 358 9 756 240 11
- Contact Person for this submission: Ms Louise Lindblad, Elekta Instrument AB, P.O. Box 7593, Stockholm, Sweden S-103 93
Official Correspondent: Mr Peter Löwendahl
Trade Name 2.
Elekta Neuromag with Maxwell Filter
Device Classification 3.
| Common Name | ClassificationNumber | Class | Regulation Number |
|---|---|---|---|
| Electroencephalograph | GWQ | II | 882.1400 |
4. Regulatory History (Unmodified Predicate Device)
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------11-05-2002 11-02-2-4-4-4-4-4-4-4-4-4-4-4-4-4-4A . A . S440-44-44A MILLER------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ovirocSEAR A FLARIE S. A. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. LAND AND ANNUAL CONSULER OFSERVER AND ALL PLANEA CONTRACT COLUMN A COLLEGION AND CONSULTION OF- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - ------------------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ู้1ﮨﮯ ﺍﻭﺭ ﺍﺱ |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------CtPA 4 1 Pr Ph 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1LA 400 -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------A MARK MANAGER A LINE LE MALES LE WATER------------------------------------------------------------------------------------------------------------------------------------------------------------------------------No. of Canadian A1 | 1-------1104 400 400111------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
ર . Other relevant submissions
| ----------------------------------THE I SE LEASE44-110-4-4-4-4-4----------------------------------------All come of aAVICECComments of the controllerConcessionCompany of the call of the collection ofA Class Cattle Charge | CARIt1 |
|---|---|
| 1Neuromao Vertorview****NAME - A 4 - 46 ----No. of Children of CanA BREAK ALL AR A A B A A A B A A A B A A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B-------------------- | A BRAND A CONSULT OF CHILIP OF CHILING OF CHILING OF CHILING OF CHILIP OF CHILING OF CHILIP OF CHILINERS OF CHILIP OF CHILINERS OF CHILING OF CHILIP OF CHILIP OF CHILITERY OF1/00 / 1/01 |
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ELEKTA NEUROMAG Oy
Dokumentnamn/Name of document
| ELEKTA NEUROMAG Oy | Special 510(k) | ||
|---|---|---|---|
| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition | Sida/Page |
| Louise Lindblad | 13 | ||
| Avser/Regarding | Directory | ||
| Elekta Neuromag® with Maxwell Filter |
Device Description (for detailed description see Section "Device Description") 6.
The Elekta Neuromag with Maxwell Filter adds support for separating brain signals from external disturbances and reducing mcasurements artifacts.
7. Indications for use:
The Flekta Neuromag® with Maxwell Filter non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning.
8. Intended Use:
The Elckta Neuromag® with Maxwell Filter is intended for use as a magnetoencephalographic (MEG) device which non-invasively detects and displays hiomagnetic signals produced by electrically active nerve tissue in the brain. When interpreted by a trained clinician, the data enhances the diagnostic capability by providing useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions.
9. Substantial Equivalence
The Elekta Neuromag® with Maxwell Filter is substantially equivalent to its predicate device the Elekta Neuromag® (K041264) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate device and are listed on the comparison charts provided in this 510k submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings and body. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 5 2005
Elekta Neuromag Oy c/o Ms. Louise Lindblad Elekta Instrument AB P.O. Box 7593 Stockholm, Sweden SE-103 93
Re: K050035
K050035
Trade/Device Name: Elekta Neuromag® with Maxwell Filter Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: January 4, 2005 Received: January 7, 2005
Dear Ms. Lindblad:
We have reviewed your Section 510(k) premarket notification of intent to market the devices in discri we nave reviewed your bection of the device is substantially equivalent (for the indications felerenced above and nave determined we are are and and one marketed in interstate for use stated in the encrosule) to tegans atment date of the Medical Device Amendments, or to commerce provide to May 20, 1976, the exactions of the Federal Food, Drug, devices that have occh reculasined in access approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r out may, mercrore, manel are as not, and include requirements for annual registration, listing of general controls provisions of use tice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 above) ans. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in ther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i lease be advised that i Dr i seem that your device complies with other requirements of the Act that I DA has made a actoriniations administered by other Federal agencies. You must or any I edetal slated and registanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IC Fart 6077, adoling (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms. Louise Lindblad
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ough manteeing your antial equivalence of your device to a legally premarket nothleation: "The PDA mining of basification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for Jour at 11-10-11 5. Also, please note the regulation entitled, Colliact the Office of Compulance an (21 t notification" (21CFR Part 807.97). You may obtain Misolanding by reference to premainterial interest of the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ELEKTA NEUROMAG OY
. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
Dokumentnamn/Name of document
| ELEKTA NEUROMAG Oy | Special 510(k) | ||
|---|---|---|---|
| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition | Sida/Page |
| Louise Lindblad | 16 | ||
| Avser/Regarding | |||
| Elekta Neuromag® with Maxwell Filter | Directory |
Section 7- Indications for Use Statement
| 510(k) Number | defined K050035 |
|---|---|
| Device Name | Elekta Neuromag® with Maxwell Filter |
| Indications for Use | The Elekta Neuromag® with Maxwell Filter non-invasively measuresthe magnetoencephalographic (MEG) signals (and, optionally,electroencephalographic (EEG) signals) produced by electrically activetissue of the brain. These signals are recorded by a computerized dataacquisition system, displayed, and may then be interpreted by trainedphysicians to help localize these active areas. The locations may thenbe correlated with anatomical information of the brain. MEG isroutinely used to identify the locations of visual, auditory,somatosensory, and motor cortex in the brain when used inconjunction with evoked response averaging devices. MEG is also usedto non-invasively locate regions of epileptic activity within the brain.The localization information provided by MEG may be used, inconjunction with other diagnostic data, in neurosurgical planning. |
X Prescription Use_ (Per 21 CFR 801 Subpart D)
— — — — — — — —
AND/OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K650035 58 98, 11 1 0 0 2 0 0 0 0 0 0 0 0 0 0 5 5 5 9 756 2400 Fax +358 9 756 24011
1 1 0 0 0 0 0 0 0 Elekta Neuromag O
§ 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).