(87 days)
The Advantage EMG System, Model #A100 is a Diagnostic Electromyography (EMG)/Evoked Response Electrical Stimulation System for the diagnosis of nervous and muscular system disorders in adult and pediatric patients.
The technological characteristics remain unchanged as a result of the modification to the device. Using surface electrodes, signals are recorded from the surface of the skin, or directly from the nerves or muscles by means of needle electrodes. It is also possible to provide a timed stimulus to the patient, so that the response to the stimulus can be recorded and analyzed. The signals from the subject are taken through the headbox to the control modules and the computer for display and analysis. The computer is based on the Intel XX086 architecture. The only modification made to the device is the removal of diodes contained in the pre-amplifier circuitry.
This 510(k) summary (K974010) is for a modification to an existing device, the Advantage EMG System, Model #A100. The submission focuses on demonstrating that a corrective modification (removal of diodes) did not adversely affect the device's safety or effectiveness, rather than establishing initial performance criteria or conducting studies for a new device. Therefore, much of the requested information about acceptance criteria for device performance, specific study designs (like MRMC or standalone performance), and ground truth establishment (as typically applied to diagnostic algorithm performance) is not directly present in this document.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
This document does not outline specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for the diagnostic function of the EMG system, nor does it report such metrics. The "performance" described relates to the safety and effectiveness after a modification.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Corrective action is effective (to a prior identified issue). | Confirmed through failure investigation, ESD, and actual use testing. |
| Modification does not adversely affect safety of the product. | Confirmed through failure investigation, ESD, and actual use testing. |
| Modification does not adversely affect effectiveness of the product. | Confirmed through failure investigation, ESD, and actual use testing. |
| Remains substantially equivalent to the predicate device. | FDA determined the device is substantially equivalent (K974010). |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the context of evaluating diagnostic performance. The testing described was to support the effectiveness of a corrective modification.
- Sample Size: Not specified for any particular test set. The document mentions "actual use testing" but no details on the number of subjects or tests.
- Data Provenance: Not explicitly stated. Given the submitter's address is in Canada, it's possible testing data originated there, but this is not confirmed. The testing was conducted to support the effectiveness of a corrective action.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. The study was not designed to establish "ground truth" for diagnostic performance in the way a new diagnostic algorithm would be evaluated. It was focused on the impact of a hardware modification.
4. Adjudication method for the test set
Not applicable and not provided.
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, an MRMC comparative effectiveness study was not done. This device is an EMG system, not an AI-powered diagnostic tool, and the submission concerns a hardware modification.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device in the context of AI. The performance evaluation relates to the physical device's function after a modification.
7. The type of ground truth used
Not applicable in the conventional sense of diagnostic algorithm evaluation. The "truth" being established was that the corrective action worked and did not negatively impact the device's operation. This was verified through:
- Failure investigation: Likely involved analysis of the original failure mode.
- Electrostatic Discharge (ESD) testing: Verifying the device's resilience to static electricity.
- Actual use testing: Implies functional validation under practical conditions.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable.
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K 974010
510(k) SUMMARY II.
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| JAN 16 1998 | |
|---|---|
| Date: | October 16, 1997 |
| Submitter's Name and Address: | Advantage MedicalA Division of CME Telemetrix, Inc.100 - 100 Collip CircleLondon, ON Canada N6G 4X8 |
| Contact Person: | Robert SnowGeneral ManagerAdvantage MedicalA Division of CME Telemetrix, Inc.100 - 100 Collip CircleLondon, ON Canada N6G 4X8Tel # 519-858-5011Fax # 519-858-5020 |
| Trade Name: | Advantage EMG System, Model #A100 |
| Common Name: | EMG System |
| Classification Name: | Diagnostic Electromyograph |
| Substantial EquivalentDevice: | Advantage EMG System, Model #A100 (K885246) |
| Classification: | Class II, 21 C.F.R. § 890.1375 |
| Intended Use: | The Advantage EMG System, Model #A100 is aDiagnostic Electromyography (EMG)/Evoked ResponseElectrical Stimulation System for the diagnosis of nervousand muscular system disorders in adult and pediatricpatients. |
| TechnologicalCharacteristics: | The technological characteristics remain unchangedas a result of the modification to the device. Usingsurface electrodes, signals are recorded from thesurface of the skin, or directly from the nerves ormuscles by means of needle electrodes. It is also |
WA01A/130252
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possible to provide a timed stimulus to the patient, so that the response to the stimulus can be recorded and analyzed.
The signals from the subject are taken through the headbox to the control modules and the computer for display and analysis. The computer is based on the Intel XX086 architecture.
The only modification made to the device is the removal of diodes contained in the pre-amplifier circuitry. P
Testing to Support Substantial Equivalence:
To provide support that the proposed corrective modification would be effective, and would not adversely affect the device, a failure investigation, along with electrostatic discharge and actual use testing were conducted consistent with 21 C.F.R. &&20.100 (corrective and preventive action) and 820.198(d) (failure investigations). The analyses and testing confirmed that the proposed corrective action is effective, and that it did not affect the safety or effectiveness of the product.
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Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right, and its body is composed of three curved lines. The seal is simple and iconic, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
·General Manaqer JAN 16 1998 Advantage Medical The Research Park, University of Western Ontario #100 - 100 Collip Circle London, Ontario N6G 4X8
K974010 Re: Advantage EMG System, Model #A100 Trade Name: Requlatory Class: II Product Code: IKN 1997 Dated: October 20, October 21, 1997 Received:
Dear Mr. Snow:
Mr. Robert Snow
Canada
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Robert Snow
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
a M. Witten, Ph.D., M.D. Celi Director Division of General and Restorative Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
K 974010
510(k) Number:
Device Name:
、・
Advantage EMG System, Model #A100
p
Indications for Use:
The Advantage EMG System, Model #A100 is a Diagnostic Electromyography (EMG)/Evoked Response Electrical Stimulation System for the diagnosis of nervous and muscular system disorders in adult and pediatric patients.
(Please Do Not Write Below This Line - Continue on Another Page if Needed)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| General Restorative Devices | |
| 510(k) Number | 1974010 |
Prescription Use or Over-The-Counter Use
WA01A/136286.1
§ 890.1375 Diagnostic electromyograph.
(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).