The Ultra V Therapeutic Ultrasound device provides 1 and 3 MHz ultrasound therapy to provide deep heating effects for the treatment of pain and contractures associated with the chronic and sub-chronic conditions of:

Adhesive capsulitis, bursitis, bursitis with slight calcification, and myositis.
Soft tissue injuries and shortened tendons due to past injuries and scar tissue
Joint contractures resulting from capsular tightness and scarring.

Device Description

The XLTek Ultra V is a Therapeutic Ultrasound

AI/ML Overview

The provided text is a 510(k) summary for the XLTek Ultra V Therapeutic Ultrasound device and the FDA's response letter. It primarily focuses on demonstrating substantial equivalence to a predicate device for marketing purposes.

Crucially, this document does not contain information about specific acceptance criteria, a detailed study proving the device meets those criteria, or the other specific elements requested in your prompt.

The 510(k) process for a device like a therapeutic ultrasound often relies on demonstrating that the new device has the same technological characteristics and intended use as a legally marketed predicate device. This typically involves performance testing to ensure the device operates within expected parameters (e.g., ultrasound frequency, intensity, output power accuracy) rather than a clinical study establishing efficacy or comparing it to human readers.

Therefore, I cannot populate the table or answer most of your specific questions based only on the provided text.

Here's a breakdown of what can be extracted and what cannot:

What can be extracted:

Device Name: Ultra V Therapeutic Ultrasound
Intended Use/Indications for Use: Provides 1 and 3 MHz ultrasound therapy to provide deep heating effects for the treatment of pain and contractures associated with chronic and sub-chronic conditions of:
- Adhesive capsulitis, bursitis, bursitis with slight calcification, and myositis.
- Soft tissue injuries and shortened tendons due to past injuries and scar tissue.
- Joint contractures resulting from capsular tightness and scarring.
Predicate Device: Excel Tech Ultra Max [510(k) K944065, formerly called Ultra SX]. Also refers to Ultra SX [510(k) K923076].

What cannot be extracted from the provided text:

A table of acceptance criteria and reported device performance.
Sample size used for the test set.
Data provenance (country of origin, retrospective/prospective).
Number and qualifications of experts for ground truth.
Adjudication method for the test set.
Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
Standalone algorithm-only performance study.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
Sample size for the training set.
How ground truth for the training set was established.

To obtain the information you're seeking, you would typically need to review the full 510(k) submission, which would detail any performance testing, design verification and validation activities, and specific data if they were required and performed for this type of device. Given that this is a therapeutic ultrasound (not an AI-driven diagnostic tool), many of the questions related to AI-specific evaluation (like MRMC studies, ground truth for AI, training sets) are unlikely to be relevant to this particular device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo for "XLTEK" in bold, stylized font. Below the logo, the text "510(k) NOTIFICATION OF A NEW DEVICE" is present, indicating the document's purpose. To the right of the logo is a circular symbol with a triangle inside.

Ultra V Therapeutic Ultrasound APRIL 7, 2000

Section E- 510(k) Summary

$\kappa001166$

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR § 807.92.

Name:	Cameron MahonDirector of R & D
Address:	Excel Tech, Ltd.2568 Bristol CircleOakville, OntarioCanada, L6H 5S1
Telephone:	(905) 829-5300
Fax:	(905) 829-5304
E-mail:	research@xltek.com
Common Names:	Therapcutic Ultrasound
Classification Name:	Stimulator, Ultrasound and Muscle, for use inapplying Therapeutic Deep Heat
Predicate Devices:	Excel Tech Ultra Max [510(k) K944065,formerly called Ultra SX].
Description:	The XLTek Ultra V is a Therapeutic Ultrasound
Substantial Equivalence:	The Ultra V is similar in design and function tothe Excel Tech Ultra SX [510(k) K923076, alsoknown as the Ultra Max].
Indications for Use:	The Ultra V Therapeutic Ultrasound deviceprovides 1 and 3 MHz ultrasound therapy toprovide deep heating effects for the treatment ofpain and contractures associated with the chronicand sub-chronic conditions of:
	Adhesive capsulitis, bursitis, bursitis with1.slight calcification, and myositis.Soft tissue injuries and shortened tendons2.due to past injuries and scar tissueJoint contractures resulting from capsular3.tightness and scarring.

・・

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

JUL - 7 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Camerom Mahon, P. Eng., M. H. Sc. Director of R & D Excel Tech, Ltd. 2568 Bristol Circle Oakville, Ontario, Canada L6H 5S1

Re: K001166

Trade Name: Ultra V Therapeutic Ultrasound Regulatory Class: II Product Code: IMG Dated: April 7, 2000 Received: April 10, 2000

Dear Mr. Mahon:

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 stated in the enoredure) to ice ice 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 control provisions of the Act. The general morelors, marions 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 (1 remancer ripp. Charge of 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 moponently 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.

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.

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Page 2 - Camerom Mahon, P. Eng., M. H. Sc.

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) 594-4659. 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

DmnR Vachner.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ultra V Therapeutic Ultrasound APRIL 7, 2000

510(K) NOTIFICATION OF A NE

rent of indications Section Destate

Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

XLTek Ultra V Therapeutic Ultrasound Device Name:

The Ultra V provides 1 and 3 MHz ultrasound therapy to Indications for Use: provide deep heating effects for the treatment of pain and contractures associated with the chronic and subchronic conditions of:

Adhesive capsulitis, bursitis, bursitis with slight 】. calcification, and myositis.
1. Soft tissue injuries and shortened tendons due to past injuries and scar tissue
Joint contractures resulting from capsular 3. tightness and scarring.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dmns R. lochner
Division Sign-Off

(Division Sign-Off) · Division of General Restorative Devices >10(k) Number_KUQULLe

Prescription Use
(Per 21§ CFR 801.109)

Over-The Counter Use __ OR

(Optional Format 1-2-96)

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.