(368 days)
The Matrix RF Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles.
The Matrix RF Applicator is composed of a connector, cable, handpiece and disposable tips. Treatment using the Matrix RF Applicator is based on delivery of bipolar radio frequency to the skin surface via an array of electrode-pins.
The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics in a structured format suitable for the requested table. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with discrete performance metrics against predefined acceptance criteria.
However, I can extract the information that is present and indicate where certain requested details are missing or not explicitly stated in this document.
Missing Information:
- Specific acceptance criteria (e.g., target accuracy, sensitivity, specificity, or changes in wrinkle severity by a specific percentage).
- Reported device performance against specific metrics (e.g., actual measured reduction in wrinkles, or success rates for ablation/resurfacing).
- The exact sample size used for any test set (since no explicit study is detailed with performance metrics).
- Data provenance (country of origin, retrospective/prospective).
- Number and qualifications of experts for ground truth.
- Adjudication method for a test set.
- Whether an MRMC comparative effectiveness study was done.
- Whether a standalone algorithm performance study was done.
- The type of ground truth used for performance evaluation.
- Sample size for a training set.
- How ground truth for a training set was established.
Based on the provided text, here is what can be inferred and what remains unknown regarding acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| New Indication Effectiveness: The device must be effective for additional indications: ablation and resurfacing of the skin for wrinkle treatment. | "The device was found to be effective for the new indication, supporting the additional indication of the device for ablation and resurfacing of the skin for wrinkle treatment." (No specific quantitative performance metrics are provided). |
| Safety: The additional indication should raise no new issues of safety. | "The overall specifications, principle of operation, performance characteristics of Matrix RF Applicator device have not been changed. Therefore, the additional indication for use of the Matrix RF Applicator device should raise no new issues of safety." |
| Substantial Equivalence: Device must be substantially equivalent to predicate devices. | The FDA granted 510(k) clearance, indicating substantial equivalence to the predicate devices listed (Matrix RF Applicator K073572, Thermage ThermaCool System K052936, Accent K070004). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in this 510(k) summary. The document does not detail a specific clinical study with a test set. It mentions "The device was found to be effective," implying some form of evaluation, but no specifics on patient numbers or methodology are provided.
- Data Provenance: Not specified.
- Retrospective/Prospective: Not specified.
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)
- Not specified. The document does not detail the establishment of a ground truth for a test set in the context of performance metrics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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
- Not applicable. This device is a medical applicator for dermatological procedures, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated. Given the claim of "effectiveness for the new indication," it would likely be based on clinical outcomes relevant to wrinkle treatment, ablation, and resurfacing, but the specifics are not provided.
8. The sample size for the training set
- Not applicable, as this is a physical device and not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
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元 前 官 河北公
510(K) Summary of Safety and Effectiveness
JAN - 8 2010
This summary of safety and effectiveness information is being submitted in accordance with ihe requirements of the SMDA 1990 and 21 CFR 807,92.
| Submitter: | Syneron Medical Ltd.,Industrial Park. P.O.B. 550Yokneam Illit, 20692, IsraelTel. +972-73-244-2200 (ext. 591);Fax +972-73-244-2202 |
|---|---|
| Name of the Device: | Matrix RF Applicator |
| Predicate Devices: | This is a 510(k) submission for the Matrix RF Applicator that issubstantially equivalent to the following cleared devices.- Matrix RF Applicator, manufactured by Syneron, Ltd., andsubject of K073572- Thermage ThermaCool System, manufactured byThermage and subject of K052936- Accent, manufactured by Alma Lasers, Ltd., and subject ofK070004 |
| Device description: | The Matrix RF Applicator is composed of a connector, cable,handpiece and disposable tips. Treatment using the Matrix RFApplicator is based on delivery of bipolar radio frequency to theskin surface via an array of electrode-pins. |
| Indications for Use: | The Matrix RF Applicator is intended for dermatological proceduresrequiring ablation and resurfacing of the skin, and for the treatmentof facial wrinkles. |
5-1
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Image /page/1/Picture/0 description: The image shows the word "Syneron" in a stylized font. The letters are slightly distorted, giving the word a unique appearance. The image is simple and focuses on the company name.
Conclusion:
The overall specifications, principle of operation, performance characteristics of Matrix RF Applicator device have not been changed. Therefore, the additional indication for use of the Matrix RF Applicator device should raise no new issues of safety. The device was found to be effective for the new indication, supporting the additional indication of the device for ablation and resurfacing of the skin for wrinkle treatment.
07/16/2020
Avi Hirshzon
ಿಡೀಪ
VP QA and Regulatory Affairs
Syneron Medical Ltd.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing right, resembling a bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Syneron Medical Ltd. % Mr. Avi Hirshnzon VP, QA and Regulatory Affairs Industrial Park P.O.B. 550 Yokneam Illit, 20692, Israel
JAN - 8 2010
Re: K090025
Trade/Device Name: Matrix RF Applicator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 02, 2009 Received: November 06, 2009
Dear Mr. Hirshnzon:
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. Iisting 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 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
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Page 2 – Mr. Avi Hirshnzon
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 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours.
Sincerely yours,
For
N. Mulla
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K090025
Device Name: Matrix RF Applicator
Indications for Use:
The Matrix RF Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles.
| Prescription Use | X |
|---|---|
| (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 Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
| 510(k) Number | 2090025 |
|---|---|
| --------------- | --------- |
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.