(150 days)
The Theralase™ TLC-1000 Therapeutic Medical Laser System is indicated for adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice.
The Theralase™ TLC-1000 Therapeutic Medical Laser System is a non-heating infrared lamp as defined in 21 CFR 890.5500. The TLC-1000 system is a precision medical device as wontion of a hand held portable multiple laser probe (5 x 905 NIR laser diodes and 4 x 660 visible red laser diodes) and a laser controller unit with a rechargeable battery.
Acceptance Criteria and Device Performance for Theralase™ TLC-1000 Therapeutic Medical Laser System
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Efficacy (Pain Relief) | Statistically significant difference in pain reduction (VAO scores) between active laser and sham laser groups. | p-value < 0.05 at 12th treatment session; p-value < 0.01 at 30-day post-treatment follow-up. This indicates a statistically significant improvement in pain relief for the active laser group compared to the sham group. |
| Responder Rate (Active Laser) | High percentage of subjects in the active laser group experiencing a positive response (likely defined as significant pain reduction). | 92.4% responder rate for the "Active" Laser group at the end of laser treatment sessions and 30-day follow-up. |
| Safety | No significant adverse effects observed due to laser treatment. | No adverse effects from the laser treatments were observed by the principal investigators during the clinical investigational study. |
Study Proving Device Meets Acceptance Criteria:
The Theralase™ TLC-1000 Therapeutic Medical Laser System's performance was evaluated in a prospective, single-blind, randomized, controlled multi-center clinical study.
2. Sample Size and Data Provenance:
- Sample Size for Test Set: A total of 122 adult male and female subjects were enrolled in the study.
- Data Provenance: The study was conducted at three investigational sites in the United States of America, making the data provenance prospective and multi-country (specifically, U.S. based).
3. Number of Experts and Qualifications for Ground Truth:
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for assessing individual subject pain levels. However, it indicates:
- Diagnosis of Knee pain for 6 years and older with a pain level of at least 4 as measured by a Visual Analog Scale (VAS). This implies that pain levels were assessed by healthcare professionals.
- Failed conservative therapy by a Physician, Orthopedist, or Chiropractor. This indicates that the inclusion criteria for subjects, and therefore the determination of their initial condition, involved qualified medical professionals.
Given the study design, the "ground truth" for individual pain relief would likely be derived from the patient-reported Visual Analog Scale (VAS) scores, which are a direct measure of the patient's subjective experience of pain.
4. Adjudication Method for the Test Set:
The study was described as single-blind. This means that the subjects were blinded to whether they received the active laser or the sham laser. It does not explicitly state any independent adjudication method for individual cases or outcomes beyond the statistical analysis of the collected VAS scores.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this device does not involve image interpretation or diagnostic tasks that would typically utilize such a study design. The study focuses on direct therapeutic effect (pain relief).
6. Standalone (Algorithm Only) Performance:
No, a standalone (algorithm only) performance study was not performed. This device is a therapeutic laser system, not an AI algorithm. Its performance is directly tied to its physical application by a healthcare professional to a patient.
7. Type of Ground Truth Used:
The primary ground truth used was patient-reported outcomes, specifically Visual Analog Scale (VAS) scores for pain relief. The study also used clinical diagnosis by medical professionals (Physician, Orthopedist, or Chiropractor) for subject inclusion criteria (e.g., diagnosis of knee pain, failure of conservative therapy).
8. Sample Size for the Training Set:
N/A. This device is a medical device, not an AI algorithm that requires a training set in the typical machine learning sense. The study described is a clinical trial to evaluate the device's efficacy and safety in human subjects, not to train a model.
9. How the Ground Truth for the Training Set was Established:
N/A. As mentioned above, there is no "training set" in the context of this device. The clinical study serves as the evidence for its effectiveness, rather than data used to train an algorithm.
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KOSO342
JUL 1 1 2005
SUMMARY OF SAFETY AND EFFICACY
Theralase™ Inc.
TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM
April 215t, 2005
GENERAL INFORMATION l.
| Device Generic Name: | TLC-1000 |
|---|---|
| Trade Name: | Theralase TLC-1000 Therapeutic Medical Laser System |
| Device Classification: | Class 2, Performance Standards21 CFR Part 890.5500 - Infrared Lamp, Non-Heating |
| Product Code: | NHN |
| Applicant Name and Address: | Theralase Inc.600 Alden Road, Suite 101Markham, OntarioL3R 0E7, CANADAPhone: [1]-905-947-8455Fax: [1]-905-947-8550 |
| 510(k) Number: | K050342 |
DEVICE DESCRIPTION II.
The Theralase™ TLC-1000 Therapeutic Medical Laser System is a non-heating infrared lamp as defined in 21 CFR 890.5500. The TLC-1000 system is a precision medical device as wontion of a hand held portable multiple laser probe (5 x 905 NIR laser diodes and 4 x 660 visible red laser diodes) and a laser controller unit with a rechargeable battery.
INDICATIONS FOR USE lll.
The Theralase™ TLC-1000 Therapeutic Medical Laser System is indicated for adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice.
ALTERNATIVE PROCEDURES OR PRACTICES IV.
The primary alternatives for use in treating chronic or acute knee pain include the use of TENS, steroids, non-steroidal anti-inflammatory drugs (NSAIDS) and barbiturated drugs (known to be addictive and relatively toxic).
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SUMMARY OF CLINICAL STUDIES V.
The Theralase™ TLC-1000 Therapeutic Medical Laser System was evaluated in a The Theralase - TLC-1000 Therapeatio Modical tudy that compared the "Active" Laser with prospective, single billid, fandomized ochtronical ducted at three investigational sites in the a Shaff Laser. The multi ochor study included a total of 122 adult male and female subjects Offited States of Amentod. The Stady the following conditions were met: diagnosis of To years and older. Enfoliment oooured in the followith a pain level of at least 4 as measured Knee pain ulsolder, modelate to severe symptomating while and failed conservative therapy by a f ain Ecver Abousement who had not had previous knee surgery.
Clinical Data Analysis and Results
Statistical analyses were performed by generally accepted statistical techniques to evaluate Statistical analyses were performed by gonomiry desepted and prethe differences between the VAO soorco from pro treatingts in Group A (Active Laser) and Group B (Sham Laser).
The statistical analyses of the data demonstrate that the difference between the two TTIe Statistical analyses of the Gata demonomount.o the unt (p-value < 0.05 at the 12" treatment session and p-value < 0.01 at the 30 day post-treatment follow up).
The Theralase™ TLC-1000 Therapeutic Medical Laser System responder rate was 92.4% for The Theralase - TEO 1000 Therapount the end of the laser treatment sessions and 30 day Subjects in the "Active" Easer group at the one of the subjects treated with the "Sham" Laser.
No adverse effects from the laser treatments were observed by the principal investigators during the clinical investigational study.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract image of an eagle with three lines representing its wings and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL I 1 2005
Mr. Roger White President and CEO Theralase Incorporated 600 Alden Road, Suite 101 Markham, Ontario L3R OE7 (Canada)
Re: K050342
K030542
Trade/Device Name: Theralase™ TLC-1000 Therapeutic Medical 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: April 28, 2005 Received: April 29, 2005
Dear Mr. White:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector 910(s) presidentially equivalent (for the indications ferenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosule) to regally the enactment date of the Medical Device American For de Free commerce prior to May 20, 1976, the excerdance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosment Act (Act) that do not require approvine approvisions of the Act. The You may, therefore, market the devices, basyer revents for annual registration, listing of general Controls provisions of the Free labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (560 addre) arols. Existing major regulations affecting your device
it may be subject to such additional controls. It hay be subject to such additional venevaliations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oode of receits concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that I DA s issuation of a business with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of any I edical statutes and regalations and limited to: registration and listing (21 Comply with an the Act 31equirements)01); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Roger White
This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of the support of a list of a location to the legal This letter will allow you to begin maketing your advice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivales of type, premarket notification. The IDA Intellig of substantal organ in the spermits your device to proceed to the market. ..
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs the regulation and 10 10 10 10 10 10 15 - Algo, please note the regulati If you desire specific advice for your device of our of ... Also, please note the regulation entitled, contact the Urice of Comphance at (210) 216 of 807.97). You may obtain
"Misbranding by reference to premarket notification the Original of Small "Misbranding by reference to premarket notification (cr on on the Division of Small
other general information on your responsibilities under the Act from the Division of Smal other general information on your responsionities and its toll-free number (800) 638-2041 or 1 Manufacturers, International and Consulter Assistance as to comments of the industry/support/index.html.
Sincerely yours,
Miriam C. Provost
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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INDICATIONS FOR USE
510(k) Number (if known): K050342
Theralase™ TLC-1000 Therapeutic Medical Laser System Device Name: ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
Indications For Use:
The Theralase™ TLC-1000 Therapeutic Medical Laser System is indicated for The Theralase - TEC-1000 Therapoutio Mouloal Labor by of The There disorders with standard chiropractic practice.
Prescription Use: X
(Per 21CFR 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)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Page 1 of 1
§ 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.