This device is a dual channel battery operated electrical stimulator for use with skin surface electrodes. The output current in each channel can be adjusted from 0-25 ma in 1 ma increments. The pulse repetition rate is fixed at 80 Hz. The output waveform is bipolar symmetrical constant current.

AI/ML Overview

The provided text describes the eSWALLOW™ Dysphagia Therapy Unit, an electrical stimulator intended for muscle re-education for pharyngeal contraction. However, the document is a 510(k) summary for a medical device regulatory submission, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics for a novel technology.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, study design (sample size, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) is not present in the provided text.

Here's what can be extracted based on the information given:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied)	Reported Device Performance
Comparability to predicate device (Vital Stim, K023347)	"Tests were performed on the device which demonstrated that the device performs comparably to and is substantially equivalent to the predicate device."
Electrode resistance within acceptable limits	"Tests include: Electrode resistance..."
Output accuracy within acceptable limits	"...output accuracy..."
Software Validation completed successfully	"...Software Validation..."
EMC compatibility testing completed successfully	"...and EMC compatibility testing."
Technological characteristics similar to predicate (pulse type, rate, output)	"Because the technological characteristics and intended use are nearly identical to the predicate device (including pulse type, rate, and output) we have determined that the eSWALLOW™ device is substantially equivalent to the predicate device."

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified.
Data Provenance: Not specified (no clinical data is presented, only engineering tests).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not specified. The document does not describe a clinical study with a "ground truth" established by experts. The "tests" mentioned are engineering/technical tests.

4. Adjudication method for the test set:

Not applicable/Not specified.

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 MRMC comparative effectiveness study was done. This device is an electrical stimulator, not an AI-driven diagnostic or assistive device for human readers.

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

Not applicable/Not specified. This is a therapeutic electrical stimulator, not an algorithm. The "Software Validation" mentioned refers to validating the device's internal software, not an AI algorithm's standalone performance.

7. The type of ground truth used:

Not applicable. The tests performed are engineering/technical tests (e.g., measuring electrode resistance, output accuracy) against established technical specifications, not against clinical ground truth from human patients.

8. The sample size for the training set:

Not applicable. This device is not an AI algorithm requiring a training set.

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

Not applicable. This device is not an AI algorithm requiring a training set.

Summary

{0}------------------------------------------------

510(k) SUMMARY

2202

FEB 1 0 2011

K092202 eSWALLOW™ USA Device: eSWALLOW™ Dysphagia Therapy Unit Page 1 of 2, 510(k) Summary

Date Prepared	February 9, 2011
Summary prepared by:	William H. "Bill" Ingram, President
Applicant	eSwallow USA
Device Name	Dysphagia Therapy Unit
Trade Name	eSWALLOW™ USA3477 Creek CircleGuntersville, AL 35976Phone: 256-571-0443Toll Free: 866-964-3102Sales: 800-455-3101FAX: 256-571-7539
Common Name	Electrical Stimulator
Classification	Class: IIProduct Code: IPFRegulation: 21 CFR890.5850
Identification ofPredicate Devices andSummary of SubstantialEquivalence	The eSWALLOW™ Dysphagia Therapy Unit is substantiallyequivalent with respect to intended use, design, risks, devicecharacteristics and performance aspects to:Vital Stim, K023347, CHATTANOOGA GROUP
Device Description	This device is a dual channel battery operated electrical stimulatorfor use with skin surface electrodes. The output current in eachchannel can be adjusted from 0-25 ma in 1 ma increments. Thepulse repetition rate is fixed at 80 Hz. The output waveform isbipolar symmetrical constant current.

{1}------------------------------------------------

eSWALLOW™ Dysphagia Therapy Unit Page 2 of 2, 510(k) Summary

Intended Use andIndications	This device is intended for muscle re-education by application ofexternal stimulation to the muscles necessary for pharyngealcontraction.
TechnologicalCharacteristics andSubstantial Equivalence	The eSWALLOW™ Dysphagia Therapy unit has many similartechnological characteristics and is substantially equivalent to thepredicate.The method of use for the eSWALLOW™ device is exactly the sameas the predicate.The materials used in the eSWALLOW™ are also similar to thoseused in the predicate. Both devices use an electronic circuit boardmounted inside a plastic box. Both units are powered by alkalinebatteries. Both units use constant current sources and have nearlyidentical pulse widths, intensities, and open circuit voltages. Theoutput circuit design provides a constant current source allowingfor variations in electrode resistances.
PerformanceTesting/Data	Tests were performed on the device which demonstrated that thedevice performs comparably to and is substantially equivalent tothe predicate device. Tests include: Electrode resistance, outputaccuracy, Software Validation, and EMC compatibility testing.
Conclusion	Because the technological characteristics and intended use arenearly identical to the predicate device (including pulse type, rate,and output) we have determined that the eSWALLOW™ device issubstantially equivalent to the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread.

FEB 10 201

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

eSWALLOWTM USA % Kamin & Associates Mr. Daniel Kamm. P.E. 8870 Ravello Court Naples, Florida 34114

Re: K092202

Trade/Device Name: eSWALLOWIM Dysphagia Therapy Kit Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: December 8, 2010 Received: December 14, 2010

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

{3}------------------------------------------------

Page 2 -- Mr. Daniel Kamm, P.E. --

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm113809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolli-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYourIndustry/default.htm.

Sincerely vours.

A.j. B. 12 h
for.

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and . Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known): K092202 Device Name: eSWALLOW™ Dysphagia Therapy Kit

This device is intended for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092202

Page 1 of 1

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).