The Omega Xp Laser System is indicated for use as an adjunctive treatment modality to provide temporary relief of pain associated with rotator cuff tendonitis.

Device Description

The Omega Xp Laser System is a non-invasive, portable therapeutic medical laser designed to deliver light energy to the target tissue. The System operates by either AC or battery power and can be used with a variety of laser probes. The Omega Xp Laser System is intended to emit energy in the infrared spectrum to provide temporary relief of pain associated with rotator cuff tendonitis.

The Omega Xp Laser System is comprised of a Base Unit and select Laser Probes. The Base Unit houses the electronics, circuits and controls to power the Laser Probes. The Laser Probes are connected to the Base Unit by an umbilical cord. The Laser Probes house the laser diode and circuitry to deliver the light energy to the designated treatment areas.

AI/ML Overview

The provided text describes the Omega Xp Therapeutic Laser System, a Class II device for temporary relief of pain associated with rotator cuff tendonitis. However, it does not provide explicit acceptance criteria in a quantitative or tabular format for device performance. Instead, it relies on a determination of substantial equivalence to predicate devices and summarizes the safety and efficacy studies with general statements.

Below is an attempt to structure the information based on your request, highlighting where specific details are missing or implied:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, quantified acceptance criteria are not provided in the document. The "reported device performance" is primarily the conclusion of substantial equivalence and a statement that the device performs as intended without new safety or efficacy issues.

Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Intended Use: "The Omega Xp Laser System is indicated for use as an adjunctive treatment modality to provide temporary relief of pain associated with rotator cuff tendonitis."	The clinical trial assessed the device's ability to provide temporary pain relief associated with rotator cuff tendonitis. Outcome was deemed sufficient to support the claim.
Safety: No new safety issues raised.	The device performs as intended and does not raise any new safety issues.
Efficacy: No new efficacy issues raised.	The device performs as intended and does not raise any new efficacy issues.
Technical Characteristics: Similar to predicate devices (Photo Thera, Inc. Acculaser Pro 4 (K023060) and Stargate International, Inc. Excalibur Light Therapy System (K041530)).	The Omega System and the named predicate devices have the same intended uses and similar technical and performance characteristics.
Compliance with Standards: - ISO 9000:2000 - EN46001 - Directive 89/336 (electromagnetic compatibility) - 21 CFR 1010 and 1040 (applicable performance standards)	The device is manufactured to comply with these international standards and applicable FDA performance standards.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in the provided text. The document only mentions "the randomized, blinded clinical trial conducted."
Data Provenance: Not explicitly stated. The documentation is from a US FDA submission, but the origin of the clinical trial data (e.g., country) is not specified. It is a retrospective summary for a 510(k) submission, confirming the clinical trial was completed prior to submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the given text. For a device like a therapeutic laser, "ground truth" often refers to patient-reported pain scores or functional outcomes, not necessarily expert consensus on images.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? This type of study (MRMC) is typically relevant for diagnostic imaging devices where different readers interpret cases. For a therapeutic device like the Omega Xp Laser System, a "multi-reader multi-case" study in the traditional sense is not applicable or mentioned. The study was a "randomized, blinded clinical trial," which compares the device's effect to a control (e.g., sham treatment or standard care).
Effect size of human readers with/without AI assistance: This is not applicable as the device is a therapeutic laser, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was a standalone study done? This concept is also not applicable as the Omega Xp Laser System is a physical therapeutic device operated by a human, not an AI algorithm. Its "performance" is its ability to deliver light energy and the resulting clinical outcome in patients, which is always with human involvement for operation and patient interaction.

7. Type of Ground Truth Used

For a therapeutic device, the "ground truth" for efficacy is typically clinical outcomes data, such as:

Patient-reported pain reduction (e.g., using a Visual Analog Scale - VAS or Numeric Rating Scale - NRS).
Improvement in functional ability.
Other subjective or objective measures of disease activity related to rotator cuff tendonitis.

The text states "Further evidence of the safety and efficacy of the Omega System was assessed by the randomized, blinded clinical trial conducted," implying that clinical outcomes were the "ground truth" for efficacy.

8. Sample Size for the Training Set

Sample Size for Training Set: This information is not provided in the text. For a traditional medical device (non-AI), there isn't typically a "training set" in the machine learning sense. The clinical trial data would be the primary evidence for efficacy.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: This is not applicable in the context of this device. The efficacy of the device was established through a "randomized, blinded clinical trial," where the "ground truth" for participant outcomes would have been gathered during the trial (e.g., pain scores, functional assessments, etc.).

Summary

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JUL 1 - 2005

APPENDIX D

SUMMARY OF SAFETY AND EFFICACY

Advanced Medical Technologies, Inc. Omega Xp Therapeutic Laser System (as per 21 CFR Part 807.92)

November 11, 2004

GENERAL INFORMATION I.

Device Generic Name: Low Level Laser Therapy (LLLT) Therapeutic Laser Trade Name: Omega XP Laser System Device Classification: Class II, Performance Standards 21CFR Part 890.5500 - Infrared Lamp, Non-heating NHN Product Code: Advanced Medical Technologies Applicant Name and Address: 101 Waterside Drive Centerville, MA 02632 508 / 790-9300 Nell Camera, President lasertherapeutics@comcast.net 510(k) Number: K043353

DEVICE DESCRIPTION II.

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K04333)3

III. INDICATIONS FOR USE

The Omega Xp Laser System is indicated for use as an adjunctive treatment modality to provide temporary relief of pain associated with rotator cuff tendonitis.

IV. Predicate Devices

Predicate devices to the Omega Xp Laser System are the Photo Thera, Inc. Acculaser Pro 4 (K023060) and the Stargate International, Inc. Excalibur Light Therapy System (K041530).

V. Summary of the Technical Characteristics of the Omega XP Laser System as Related to the Referenced Predicate Devices.

The Omega System and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices utilize infrared diodes to emit infrared light energy to human tissues. The Omega System and the named predicate devices have the same intended uses and similar technical and performance characteristics.

VI. Testing

Testing of the System includes functional performance testing and electrical safety testing. The Omega Xo Laser System is manufactured to comply with the following international standards:

ISO 9000:2000 EN46001 Directive 89/336 regarding electromagnetic compatibility

VII. Conclusions

Pursuant to the testing and comparison to the predicate devices, the Omega XP Laser has the same intended uses, with similar functional and performance characteristics. The System is designed to comply with applicable performance standards promulgated by Federal Food and Drug Administration, such as 21 CFR 1010 and 1040. Further evidence of the safety and efficacy of the Omega System was assessed by the randomized, blinded clinical trial conducted.

The Omega Xp Laser System performs as intended and do not raise any new safety or efficacy issues.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird with three curved lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 - 2005

Advanced Medical Technologies Incorporated C/o Ms. Joyce Heinrich Regulatory Consultant Texas Applied Biomedical Services Incorporated 12101 Cullen Boulevard # A Houston, Texas 77047

Re: K043353

Trade/Device Name: Omega Xp laser System Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, Non-heating for adjunction use in pain therapy Regulatory Class: II Product Code: NHN Dated: March 31, 2005 Received: April 4, 2005

Dear Ms. Heinrich:

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 such 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); 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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Page 2 -- Ms. Joyce Heinrich

This letter will allow you to begin marketing your device as described in your Section 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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APPENDIX A

Indications for Use Statement

510(k) Number (if known): K043353

Device Name:

Advanced Medical Technologies, Inc. Omega Xp Laser System

Indications for Use:

The Omega Xp Laser System is intended for use as an adjunctive treatment modality to provide temporary relief of pain associated with rotator cuff tendonitis.

AND/OR Over the Counter Use: Prescription Use: X X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODDE)

Zele

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Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.