a. TENS: The device is intended for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post traumatic acute pair.
b. NMS: The device in recommended for use for the following conditions:

Relaxation of muscle spasms
Prevention of retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining and increasing range of motion.

Device Description

The "Mantra Combo" combined TENS and NMS dual channel device is housed in small lightweight cabinet and is battery powered. The same circuitry is used to for both TENS and NMS.

AI/ML Overview

This document is a 510(k) Summary for a medical device called "Mantra Combo." It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting novel performance studies with specific acceptance criteria and results.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be fully provided from the given document, as it does not contain such a study design or results.

Here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance:

This information is not available in the provided document. The document states "Performance testing was conducted on the 'Mantra Combo' combined TENS & NMS device to demonstrate the integrity, suitability and substantial equivalence of the device." However, it does not detail specific acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity) or quantitative performance metrics against those criteria. Instead, it relies on demonstrating equivalence to predicate devices.

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

Sample Size: This information is not available within the document. Since the submission focuses on substantial equivalence based on identical design and circuitry, it's highly probable that no new clinical test set of patients was used for a performance study.
Data Provenance: This information is not available. Given the likely absence of a new clinical test set, questions of data provenance (country of origin, retrospective/prospective) are not applicable in this substantial equivalence argument.

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

This information is not available. Since there is no described clinical test set or study involving patient data endpoints, the concept of establishing ground truth by experts for a test set is not applicable here.

4. Adjudication method for the test set:

This information is not available. As no new clinical test set is described, there's no mention of an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: No, an MRMC comparative effectiveness study was not done.
Effect Size: Therefore, no effect size for human readers' improvement with AI assistance is reported. This device is a transcutaneous electrical nerve stimulator and a neuromuscular stimulator, not an AI-powered diagnostic or assistive technology.

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

No, a standalone performance study for an algorithm was not done. The device described is a physical TENS/NMS unit, not an algorithm.

7. The type of ground truth used:

This information is not applicable/available. Given the nature of the device and the submission's focus on substantial equivalence through design and circuitry, the concept of "ground truth" as it applies to diagnostic accuracy or clinical outcomes is not addressed in relation to a new study.

8. The sample size for the training set:

This information is not applicable/available. The device is not an AI/machine learning model, so there is no "training set."

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

This information is not applicable/available. As there is no training set mentioned, there is no ground truth established for it.

Summary of Device and Evidence Presented:

The "Mantra Combo" device is a transcutaneous nerve stimulator (TENS) combined with a neuromuscular stimulator (NMS). The basis for its 510(k) clearance is substantial equivalence to two previously cleared predicate devices:

Mantra TENS Model NT3 (K041520) for TENS functionality.
Classic NMS™ manufactured by Care Rehab Inc (K021905) for NMS functionality.

The document explicitly states that the Mantra Combo is "physically identical to both the Manta TENS NT3 and Classic NMS™ consisting of exactly the same cabinet, PCB and circuity." It also asserts that the TENS functionality (modes and programs) and the NMS functionality (modes and programs) are "identical" to their respective predicate devices.

Therefore, the "performance studies" referenced are likely non-clinical (e.g., electrical safety, electromagnetic compatibility, perhaps output parameter verification) to confirm that the new device indeed replicates the performance characteristics of the predicates. The clinical effectiveness and safety are implicitly accepted based on the established safety and effectiveness of the equivalent predicate devices.

Summary

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091236

Page. 1/2

SECTION 5.0

Mantra International (HK) Ltd 1504 Vigor Industrial Building, Block B, 20 Cheung Tat Road Tsing Yi Hong Kong Tel: +852 2432 7181

JUL 3 0 2009

510(k) Summary

General Information

Trade Name of Device:

"Mantra Combo"

Common/Usual Name:

Classification Name:

Submitters Name and Address:

Manufacturer:

Transcutaneous Nerve Stimulator combined with Neuromuscular Stimulator

Stimulator, Nerve, Transcutaneous for Pain Relief, Combined with Powered Muscle Stimulator

Mantra International (HK) Ltd. 1504 Vigor Industrial bldg Block B, 14-20 Cheung Tat Road Tsing Yi, Hong Kong, China

Mantra International (HK) Ltd. 1504 Vigor Industrial bldg Block B, 14-20 Cheung Tat Road Tsing Yi, Hong Kong, China Registration Number: 3003741750

Device Description

The "Mantra Combo" combined TENS and NMS dual channel device is housed in small lightweight cabinet and is battery powered. The same circuitry is used to for both TENS and NMS.

Indications for Use

b. NMS: The device in recommended for use for the following conditions:

Relaxation of muscle spasms
Prevention of retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining and increasing range of motion.

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Lo91236. Page 2/2

Substantial Equivalence

This product is substantialiy equivalent to the Mantra TENS Model NT3 (K041520) Combined with the Classic NMS™ manufactured by Care Rehab Inc of McLean Virginia (K021905). The device is physically identical to both the Manta TENS NT3 and Classic NMS™ consisting of exactly the same cabinet, PCB and circuity. The TENS functionality (Modes and programs) of the Mantra COMBO is identicy.
the Mantra NT3 TENS and the NMS function in the Mantra COMBO is identical the Mantra NT3 TENS and the NMS functionality (modes and programs) is identical
the Mantra NT3 TENS and the NMS finctionality (modes and programs) is identical that of the Classic NMS™. Since the Classic NMS™ is also produced by Mantra International Ltd, all the technical characteristics, (including lead wires) are identical. The user can select either TENS or NMS modalities. In this way it is simply "two products in one".

Performance Studies

Performance testing was conducted on the "Mantra Combo" combined TENS & NMS device to demonstrate the integrity, suitability and substantial equivalence of the device

6. Conclusion

ડી.

Based upon the Indications for use and performance studies the "Mantra Combo" has been shown to be substantially equivalent for its intended use.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2009

Mantra International, Ltd. c/o Mr. Brent Reider President, International Trade Group, Inc. 4663 Kate Lane Oxford. OH 45056

Re: K091236

Trade/Device Name: Mantra Combo Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: II Product Code: GZJ Dated: July 2, 2009 Received: July 7, 2009

Dear Mr. Reider:

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.

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 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 1000-1050.

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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/ucm115809.htm 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/cdrh/mdr/ 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 toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Joe Callaway for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K011236

Device Name: Mantra Combo (Combined TENS & NMS device)

Indications For Use:

a. TENS: The device is intended for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and post traumatic acute nain surgical and post traumatic acutes an a

b. NMS: The device is recommended for use for the following conditions:

Relaxation of muscle spasms
Relaxation of muscle spasms
Prevention of retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining and increasing range of motion
Maintaining and increasing range of motion.

iption Use _ AND/OR Over-The-Counter Use R 801 Subpart D)

(21 CFR 807 Subpart C)

EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

07/20/09

ivision Sten of vision of Ophthalmic, Neurological and Ear, and Throat Devi

510(k) Number K091236

page 1 of 1

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).