Therapeutic Ultrasound: Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: Pain relief, muscle spasms and joint contractures. Relief of pain, muscle spasms and joint contractures that may be associated with: Adhesive capsulitis, Bursitis with slight calcification, Myositis, Soft tissue injuries, Shortened tendons due to past injuries and scar tissues. Relief of sub-chronic, chronic pain and joint contractures resulting from: Capsular tightness, Capsular scarring. For TENS, Interferential, premodulated(IFC), NMS and Microcurrent: Symptomatic relief of chronic intractable pain, Post-traumatic acute pain, Post-surgical acute pain. Additionally for EMS, NMS, Hi-Volt and Russian: Relaxation of Muscle spasms, Prevention or retardation of disuse atrophy, Increasing local blood circulation, Muscle re-education, Maintaining or increasing range of motion, Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for a medical device (CT 1000 SonicStimu Combo) and not a study proving the device meets specific acceptance criteria based on performance data.

Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be found in the provided document. The document primarily focuses on establishing substantial equivalence to a predicate device for regulatory approval.

Here's what can be extracted and what cannot:

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

Cannot be provided. This document is a 510(k) clearance letter, not a performance study. It does not contain acceptance criteria for specific performance metrics or reported device performance data in that context. The clearance is based on substantial equivalence to a predicate device, implying similar safety and effectiveness without necessarily requiring new, detailed performance studies against defined acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. This information is not part of a 510(k) clearance letter for this type of device. There's no "test set" of patient data described for performance evaluation.

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)

Cannot be provided. No such clinical study or expert-adjudicated test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. Not applicable as no test set requiring ground truth adjudication is mentioned.

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

Cannot be provided. This device is an Ultrasound and Muscle Stimulator, not an AI-powered diagnostic imaging tool that would typically involve MRMC studies for reader performance improvement.

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

Cannot be provided. Not applicable as this is a physical therapy device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided. No ground truth definition is relevant for this type of 510(k) clearance.

8. The sample size for the training set

Cannot be provided. This 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

Cannot be provided. Not applicable.

What is provided in the document:

Device Name: CT 1000 SonicStimu Combo
Regulation Number: 21 CFR 890.5860
Regulation Name: Ultrasound and muscle stimulator
Regulatory Class: Class II
Product Code: IMG, GZJ, LIH
Manufacturer: Shenzhen Dongdixin Technology Company, Limited
Indications for Use:
- Therapeutic Ultrasound: Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as pain relief, muscle spasms, joint contractures, adhesive capsulitis, bursitis with slight calcification, myositis, soft tissue injuries, shortened tendons, capsular tightness, and capsular scarring.
- For TENS, Interferential, premodulated (IFC), NMS, and Microcurrent: Symptomatic relief of chronic intractable pain, post-traumatic acute pain, post-surgical acute pain.
- Additionally for EMS, NMS, Hi-Volt, and Russian: Relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion, immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
Regulatory Basis: Substantial equivalence to legally marketed predicate devices, implying that the device has the same intended use as legally marketed predicate devices, and the same or similar technological characteristics. The safety and effectiveness are considered to be equivalent to that of the predicate device.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/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 stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Shenzhen Dongdixin Technology Company, Limited % Kang Jian Ping No. 3 Building, Xilibaimang Xusheng Industrial Estate Nanshan District Shenzhen, China 518108

Re: K120217

Trade/Device Name: CT 1000 SonicStimu Combo Regulation Number: 21 CFR 890.5860 Regulation Name: Ultrasound and muscle stimulator Regulatory Class: Class II Product Code: IMG, GZJ, LIH Dated: undated Received: November 19, 2012

Dear Kang Jian Ping:

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 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

Letter Dated: November 21, 2012

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Page 2 - Mr. Kang Jian Ping

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/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/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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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File No: DDX -CT1000-FDA-04 Version: 1.2

DONGDIXIN
TECHNOLOGY CO., LTD.
莱迪欣

Indications for Use Statement

510(k) Number (K120217):

Device Name: SonicStimu Combo therapeutic device

Indications for Use:

Therapeutic Ultrasound

Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

Pain relief, muscle spasms and joint contractures. 1.
Relief of pain, muscle spasms and joint contractures that may be associated with: 2.
- · Adhesive capsulitis
- · Bursitis with slight calcification
- · Myositis
- · Soft tissue injuries
- · Shortened tendons due to past injuries and scar tissues
1. Relief of sub-chronic, chronic pain and joint contractures resulting from:
- · Capsular tightness
- · Capsular scarring

For TENS, Interferential, premodulated(IFC), NMS and Microcurrent:

Symptomatic relief of chronic intractable pain 1.
1. Post-traumatic acute pain
Post-surgical acute pain 3.

Additionally for EMS, NMS, Hi-Volt and Russian:

Relaxation of Muscle spasms 1.
1. Prevention or retardation of disuse atrophy
1. Increasing local blood circulation
1. Muscle re-education
1. Maintaining or increasing range of motion
1. Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

Prescription Use V (Part 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 NEEDED)

Concurrence of CDRH, Office of Device Evalu (Division Sign-Off) (Division Sign-Off)
Division of Surgical, (Calimpedic, Carrier, Sevision of Survision of Survision of Survision of Survision of Survision of Survision of Survision of Survisi Section 04 -Page 1 of 1 ن ن ت : ن : : ن : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : 510(k) Number

Regulation Number and Section

§ 890.5860 Ultrasound and muscle stimulator.

(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. The device also passes electrical currents through the body area to stimulate or relax muscles.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.