(553 days)
The Acculaser™ Pro4 is indicated for adjunctive use in providing temporary relief of pain associated with iliotibial band syndrome.
The Acculaser™ Pro4 is a low level laser therapy device. It is non-thermal and emits infrared energy at 830 nm.
The provided document is a 510(k) summary for the Acculaser™ Pro4, a low-level laser therapy device. It primarily focuses on demonstrating substantial equivalence to predicate devices for market clearance rather than detailing specific acceptance criteria and a study proving device performance against those criteria in the way a clinical trial typically does for a PMA.
However, based on the available information, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative acceptance criteria. Instead, it makes a general claim about safety and effectiveness.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| The device is safe for its intended use. | Bench test and clinical performance data demonstrate that the Acculaser™ Pro4 low level laser therapy device is safe. |
| The device is effective in providing adjunctive therapy for the temporary relief of pain and disability associated with iliotibial band syndrome (ITBS). | Bench test and clinical performance data demonstrate that the Acculaser™ Pro4 low level laser therapy device is effective in providing adjunctive therapy for the temporary relief of pain and disability associated with ITBS. |
| The device is substantially equivalent to legally marketed predicate devices. | Based on the same intended use and similarity in design and technological characteristics, the Acculaser™ Pro4 is substantially equivalent to the predicate devices (K020657, K010175, K012580). |
2. Sample size used for the test set and the data provenance:
The document mentions "clinical performance data" but does not specify the sample size for any clinical tests or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. Given the nature of a low-level laser for pain relief, "ground truth" might refer to patient-reported outcomes or clinical assessments, but the document does not elaborate.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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:
The Acculaser™ Pro4 is a low-level laser therapy device for pain relief, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The Acculaser™ Pro4 is a physical medical device, not a standalone algorithm. Therefore, "standalone (algorithm only)" performance is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document broadly refers to "clinical performance data." For a pain relief device, the "ground truth" would most likely involve patient-reported outcomes related to pain and disability as assessed by clinicians or through patient surveys. However, the exact type of data and its collection methodology are not detailed.
8. The sample size for the training set:
The document refers to "bench test and clinical performance data" but does not mention a training set in the context of machine learning, as this device would not typically involve such a concept. If a clinical study was done, it would be a "study population" or "test set," not a "training set."
9. How the ground truth for the training set was established:
As there is no mention of a training set in this context, this question is not applicable.
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Sponsor: PhotoThera, Inc.
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MAR 1 9 2004
510(k) SUMMARY-Acculaser™ Pro4
ubmitter Name: Photo Thera, Incorporatud Career Children Comments of Arm
| Submitter Address: | 2260 Rutherford Rd.Suite 101Carlsbad, CA 92008 |
|---|---|
| Contact Person: | Jackson Streeter, M.D.Chief Executive Officer |
| Phone Number: | 760-496-3700 |
| Fax Number: | 760-496-3707 |
| Email: | jstreeter@photothera.com |
| Date Prepared: | September 13, 2002 |
| Device Trade Name: | Acculaser™ Pro 4 |
| Device Common Name: | Low level laser therapy device |
| Classification Name: | Lamp, Non-heating, for Adjunctive Use in Pain Therapy21 CFR 890.550; NHN |
| Predicate Devices: | K020657, Acculaser, Inc., Acculaser™ Pro LLLTK010175, MicroLight Corp., MicroLight 830™ Laser SystemK012580, TUCO Innovations, Inc., TUCO Erchonia PL2000 |
| Device Description: | The Acculaser™ Pro4 is a low level laser therapy device. It isnon-thermal and emits infrared energy at 830 nm. |
| Intended Use: | The Acculaser™ Pro4 is indicated for adjunctive use in providingtemporary relief of pain associated with iliotibial band syndrome. |
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| Sponsor:PhotoThera, Inc. | K02 3060 2/2Acculaser™ Pro4Traditional 510(k) Premarket Notification |
|---|---|
| Performance Testing: | Bench test and clinical performance data demonstrate that theAcculaser™ Pro4 low level laser therapy device is safe andeffective in providing adjunctive therapy for the temporary relief ofpain and disability associated with ITBS. |
| Conclusion: | Based on the same intended use and similarity in design andtechnological characteristics, the Acculaser™ Pro4 is substantiallyequivalent to the predicate devices. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the circumference of the circle.
Public Health Service
MAR 1 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PhotoThera, Inc. c/o Ms. Patsy Trisler Regulatory Consultant 5610 Wisconsin Avenue, Suite 304 Chevy Chase, Maryland 20815
Re: K023060
Trade/Device Name: Acculaser™ Pro 4 Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, non-heating, for adjunctive use in pain therapy Regulatory Class: II Product Code: NHN Dated: December 22, 2004 Received: December 22, 2004
Dear Ms. Trisler:
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. Patsy Trisler
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Miriam C Provost
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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Sponsor: PhotoThera, Inc.
610(k) Number (if known):
Device Name;
Acculaser™ Pro4
Indications for Use:
The Acculaser™ Pro4 is indicated for adjunctive use in providing temporary relief of pain associated with iliotibial band syndrome.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH; Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use(Per 21 CFR 801.109) | X |
| OR | |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) | |
| Miriam C. Provost(Division Sign-Off)Division of General, Restorative,and Neurological Devices | |
| 510(k) Number | K023060 |
Section 4.0
§ 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.