The Pulsaderm ACE-All Blue is a device that uses Blue Light Emitting Diodes to provide LED Light therapy to the skin. Blue light is emitted for the treatment of mild to moderate acne.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for the Pulsaderm ACE-All Blue device, which is an LED light therapy system for treating mild to moderate acne. This type of document focuses on establishing substantial equivalence to existing legally marketed devices rather than presenting a standalone study with detailed clinical performance metrics against specific acceptance criteria.

Therefore, the document does not contain the requested information about acceptance criteria and a study proving the device meets those criteria in the typical sense of a clinical trial demonstrating efficacy against a defined endpoint. Instead, it relies on demonstrating equivalence in technological characteristics and safety to predicate devices.

However, I can extract the information that is present concerning performance testing and a lay-user study, and explicitly state what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Pulsaderm ACE-All Blue Technical Specifications
Wavelength (nm)	N/A (Compared to Predicates)	Blue light 415 +/- 5 nm
Dose Rate (mW cm2)	N/A (Compared to Predicates)	Blue light: 25 mW cm2
Dose (J/cm2)	N/A (Compared to Predicates)	12 J/cm2
Lay-User Study
Lay users able to properly use device by reading instructions without assistance	Not explicitly stated as a numerical acceptance criterion, but implied goal is high success rate.	98% of lay users were able to properly use the device by reading instructions in the user manual without any assistance.
Lay users able to read and comprehend user manual and package labeling.	Not explicitly stated, but implied goal is successful comprehension.	The conclusion was that an average lay user can read and comprehend correctly the user manual and package labeling.
Safety and Conformity
Compliance with IEC 60601-1:2012	Yes	Conforms
Compliance with IEC 60601-1-2:2014	Yes	Conforms
Compliance with IEC 62471:2006	Yes	Conforms
Biocompatibility testing to ISO 10993	Yes	Tested to ISO 10993
Risk Management System conforming to ISO 14971:2007	Yes	Designed and developed under a Risk Management System conforming to ISO 14971:2007

Missing Information: The document focuses on technical specifications comparison, safety standards compliance, and a lay-user study for usability, rather than clinical efficacy against a pre-defined acceptance criteria for acne treatment effectiveness.

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

Sample Size for Test Set: The document does not specify the exact sample size for the "lay-user study". It only mentions "study data was collected".
Data Provenance: The lay-user study was described as being conducted "with Institutional Review Board (IRB) approval and oversight." No specific country of origin is mentioned, but the company is based in Fort Myers, FL, USA, suggesting a US-based study. The study was prospective in nature, as it involved observing users reading instructions and attempting to use the device.

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 as the "ground truth" for the lay-user study was based on observed successful use of the device by the participants themselves, as per the instructions. There were no "experts" establishing a disease-related ground truth, as the study was about usability of instructions.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the lay-user study (observing proper usage based on instructions), an adjudication method in the traditional sense (e.g., 2+1 reads of medical images) would not be applicable. The assessment was likely direct observation of user interaction with instructions and the device.

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

No, an MRMC comparative effectiveness study was not done. This type of study is irrelevant for this device, which is a standalone light therapy device, not an AI-assisted diagnostic or interpretation tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device itself is a "standalone" light therapy device. The non-clinical testing included a "lay-user study" which assessed the ability of users to follow instructions to operate the device correctly. This is a form of standalone performance assessment in terms of usability and safety, but not clinical efficacy. No "algorithm only" performance was assessed as it's not an AI/software device.

7. The Type of Ground Truth Used

For the lay-user study, the "ground truth" was defined by the ability of participants to correctly follow the instructions and use the device as intended. This is an operational or usability ground truth, not a clinical one (like pathology or outcome data).

8. The Sample Size for the Training Set

This information is not applicable and not provided. The Pulsaderm ACE-All Blue is an LED light therapy device; it does not involve machine learning algorithms that require a "training set" of data.

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

This information is not applicable as there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 15, 2016

Nutra Luxe MD, LLC Ms. Gloria Avendano Regulatory Affairs Manager 12801 Commonwealth Dr., Unit 5 Fort Myers, FL 33913

Re: K162371

Trade/Device Name: Pulsader ACE-All Blue Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery And in dermatology Regulatory Class: Class II Product Code: OLP Dated: October 31, 2016 Received: November 16, 2016

Dear Ms. Avendano

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): pending K162371

Device Name: Pulsaderm ACE-All Blue

Indications for Use:

Pulsaderm ACE-All Blue is indicated to treat mild to moderate acne on the face.

Prescription Use (21 CFR Part 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR Part 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary Pulsaderm ACE - All Blue

1. General Information

Submitter: NutraLuxe MD, LLC 12801 Commonwealth Dr. Unit 5 Fort Myers, FL 33913

Contact Person:

Gloria Avendano Regulatory Affairs Manager Nutra Luxe MD 12801 Commonwealth Dr. Unit 5 Fort Myers, FL 33913 Gloria@nutraluxemd.com

Summary Preparation Date: August 20th, 2016

2. Device

Device Name:	Pulsaderm ACE - All Blue
Common/Usual Name:	Acne Light Therapy System
Classification Name:	Over-the-counter powered light based laser for acne
Classification Regulation:	21CFR 878.4810
Classification Panel:	General and Plastic Surgery
Product Code:	OLP

3. Predicate Devices:

Pulsaderm ACE-All Blue is substantially equivalent to the following predicate devices;

Device	510(k) Number	Manufacturer
Nutra Light Blue	K132838	Nutra Luxe MD, LLC
Tanda Mini Skincare System	K124042	Syneron Beauty Inc.

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4. Device Description:

The Pulsaderm ACE-All Blue is a device that uses Blue Light Emitting Diodes to provide LED Light therapy to the skin. Blue light is emitted for the treatment of mild to moderate acne.

5. Indications for use:

Pulsaderm ACE-A11 Blue is indicated to treat mild to moderate acne on the face.

6. Technological Characteristics and substantial equivalence:

Pulsaderm ACE-All Blue is substantially equivalent to Nutra Light Blue (K132838) and Tanda Mini Skin Care System (K124042). Pulsaderm ACE-All Blue is a smaller version of the predicate device Nutra Light Blue (K132838) and shares the same features and characteristics as the predicate. Pulsaderm ACE-All Blue uses the same technology to deliver blue light and same indications for use as the predicates. Pulsaderm ACE-All Blue uses the same dose rate and treatment regimen as Tanda Mini Skin Care System (K124042). Any minor technological differences between the Pulsaderm ACE-All Blue and the predicate devices raise no new issues of safety or effectiveness.

Comparison table:

Device name	Pulsaderm ACE-All Blue	Nutra Light Blue	Tanda mini skin caresystem
510(K)	Pending	K132838	K124042
Intended use	Indicated to treatmild to moderateacne on the face	Indicated to treatdermatologicalconditions. Specifically,blue light modules areindicated to treat mild tomoderate inflammatoryacne.	Indicated for over thecounter use for thetreatment of mild tomoderate acne
Energy type	Light Emitting diodes(LED's)	Light Emitting diodes(LED's)	Light Emitting diodes(LED's)
OTC	Yes	Yes	Yes
Wavelength(nm)	Blue light 415 +/-5 nm	Blue light 415 +/- 5 nm	Blue light 415+/- 5 nm
Dose RatemW cm2	Blue light: 25 mW cm2	Blue light: 75 mW cm2	Blue light 22.4 mW cm2
DoseJ/cm2	12 J/cm2	14 J/cm2	12 J/cm2

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7. Performance Data:

Performance testing was conducted and confirm compliance to design specifications; similar wavelength, output power and energy type as FDA cleared predicate devices. Pulsaderm ACE-All Blue has been tested and found in conformance with test standards: IEC 60601-1:2012, 60601-1-2:2014, and IEC 62471:2006. Biocompatibility testing to ISO 10993. Pulsaderm ACE-All Blue was designed and developed under a Risk Management System conforming to ISO 14971:2007.

8. Non clinical-testing

A lay-user study and self-selection study was conducted with Institutional Review Board (IRB) approval and oversight to determine if lay users could read the product labeling and then selfassess if the Pulsaderm ACE-ALL Blue would be beneficial for them to use. Study data was collected and demonstrated that the intended users of the device could successfully follow the instructions and use the device as intended. The performance data supplied in this 510(k) demonstrated that 98% of lay users were able to properly use the device by reading instructions in the user manual without any assistance.

In summary, the conclusion was that an average lay user can read and comprehend correctly the user manual and package labeling.

9. Conclusion

Based upon the analysis of the performance characteristics, safety characteristics and intended use for the Pulsaderm ACE-All Blue, Nutra Luxe MD, believes that no significant differences exist between this device and the predicates. Therefore, Substantial equivalence is requested.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.