(184 days)
-
- Relaxation Training
-
- Muscle Re-education
The MuscleSense™ II is an EMG (Electromyography) device intended for medical use for muscle re-education and relaxation training. The MuscleSense II, AT , and Pathway MR-25 are all indicated for relaxation training and muscle reeducation. All three devices are used in conjucnction electrodes. The MuscleSense™ II tnresold sensitivity testing confirmed the device to fall within an acceptable sensitivity range to effectively monitor muscle activity. There is no electrical current being delivered to the patient. The device is supplied with pre-gelled conductive electrodes which have been cleared for marketing by the Food and Drug Administration under K851522/A. The device is battery powered or by a UL544 approved wall mounted power supply.
The provided text is a 510(k) summary for the MuscleSense™ II EMG device. While it describes the device's intended use and specifications, it does not contain any information about a study that proves the device meets specific acceptance criteria.
The summary states: "The MuscleSense™ II threshold sensitivity testing confirmed the device to fall within an acceptable sensitivity range to effectively monitor muscle activity." However, this is a general statement and does not provide details about acceptance criteria or the study methods used.
Therefore, I cannot populate the requested table and answer the subsequent questions fully. Here's why and what information would be needed:
Missing Information:
- Specific Acceptance Criteria: The document mentions "an acceptable sensitivity range" but does not define what that range is or any other specific performance metrics (e.g., accuracy against a known standard, precision, correlation with other EMG devices under specific conditions).
- Study Details: There is no mention of a formal study being conducted, its design, methodology, or results.
- Sample Size, Ground Truth, Experts, Adjudication, etc.: All of these details are dependent on a described study, which is absent from the provided text.
Based only on the provided text, here's what can be inferred or stated:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (What they would be, if specified) | Reported Device Performance (As stated, without quantified criteria) |
|---|---|
| Device falls within an acceptable sensitivity range to effectively monitor muscle activity (Specific range not provided). | "The MuscleSense™ II threshold sensitivity testing confirmed the device to fall within an acceptable sensitivity range to effectively monitor muscle activity." (No specific numerical performance given). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information provided. The text only mentions "threshold sensitivity testing" without details on experimental design or sample size.
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):
No information provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
No information 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:
Not applicable. This device is an EMG device, not an AI-assisted diagnostic tool for "human readers." No such study is mentioned or implied.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a "standalone" EMG device used for measurement. The description of "threshold sensitivity testing" implies an evaluation of the device's intrinsic measurement capabilities, which is a form of standalone performance assessment, but no details of such a study are given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
No information provided. For EMG sensitivity, ground truth would typically involve a known electrical signal input or comparison to a gold-standard device, but this is not detailed in the summary.
8. The sample size for the training set:
Not applicable/No information provided. Device testing is described, not an AI training process.
9. How the ground truth for the training set was established:
Not applicable/No information provided. Device testing is described, not an AI training process.
In summary, the provided 510(k) document is very limited in its description of performance testing beyond a general statement of compliance. To answer these questions fully, a detailed study report or test protocol would be required.
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510(k) Summary
Smith & Nephew, Inc. DonJoy Division 2777 Loker Ave. West Carlsbad, CA 92008
JUL 1 0 1997
Contact Person: Dan W. Miller
Phone: (760) 438-9091
Date Prepared: April 11, 1997
INTRODUCTION
The MuscleSense™ II is an EMG (Electromyography) device intended for medical use for muscle re-education and relaxation We consider the Smith & Nephew MuscleSense™ II training. portable EMG to be substantially equivalent to the Autogenics Systems' AT Dual Channel EMG and the Promethius Group Pathway™ MR :5 EMG System. The MuscleSense II, AT , and Pathway MR-25 are all indicated for relaxation training and muscle reeducation. All three devices are used in conjucnction electrodes. The MuscleSense™ II tnresold sensitivity testing confirmed the device to fall within an acceptable sensitivity range to effectively monitor muscle activity. There is no electrical current being delivered to the patient. The device is supplied with pre-gelled conductive electrodes which have been cleared for marketing by the Food and Drug Administration under K851522/A. The device is battery powered or by a UL544 approved wall mounted power supply.
Smith & Nephew, Inc. DonJoy Division
Dan A. Milich
Dan W. Miller Director, Regulatory Affairs & Quality Assurance
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SPECIFICATIONS
Input Impedance: 1010 Ohms 0.5 µV rms Sensitivity: 45-300 Hz Bandwidth: 1159B CMRR : 60 Hz, 24dB Notch Filter: 0.28 µV Input Noise: Bias Current: 5 nA 0-50uV rms ×1 Range: 0-500pV rms x10 0-2500μV rms x50 PEAK, COUNT, RATIO Modes : Power Source 7 Vdc wall mount supply external: (UL544 approved) 6 Vir rechargeable battery pack: Ni Jad battery pack (optional) 8 hours battery life: Dimensions 6" width: ર " length: 3.25" height: 25 oz weight: -20°C to +50°C Storage Temperature: (-4°F to +122°F) 0°C to +50°C Operating Temperature: (+32°F to +122°F)
Note: Electrical specifications are typical.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, serif font. The text is centered horizontally in the image. The text is black against a white background.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dan W. Miller Director, Regulatory Affairs & Quality Assurance Smith & Nephew DonJoy, Inc. --------------------------------------------------------------------------------------------------------------------------------------------------... 2777 Loker Avenue West Carlsbad, California 92208-6601
JUL 1 0 1997
Re: K970051 MuscleSense II Dual Channel Electromyography Device Trade Name: Requlatory Class: II Product Code: 84HCC Dated: April 11, 1997
Received: April 15, 1997
Dear Mr. Miller:
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 You provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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. Dan W. Miller
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 leqally 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) 594-4648. 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 premarket notification" (21 CFR 807.97). 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.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
MuscleSense II Dual Channel Electromyography Device Device Name:_
Indications For Use:
- l) Relaxation Training
-
- Muscle Re-education
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Call
Division Sign Off)
Division of Cardiovascular, Respiratory,
ad Neurological Devices
10(k) Number K970051
X
on Use
Over The Counter Ice
Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.