The Pixel8-RF System includes the system main body, a bipolar handpiece with disposable micro-needle type electrodes, a footswitch and an LCD touch screen control panel. The RF Energy is delivered to a target tissue using a handpiece and disposable tip (micro needle electrode tip), the being placed in light contact with the tissue and the handpiece being held at right angles to the target tissue. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. The Pixel8-RF System creates heat within the target tissue using micro-needles inserted from the tip.

AI/ML Overview

This FDA 510(k) summary for the PiXel8-RF System does not contain information about acceptance criteria or a study proving the device meets said criteria in the way you've outlined for AI/ML device studies. This document is a premarket notification for a medical device that uses radiofrequency energy for dermatological and general surgical electrocoagulation and hemostasis. It is not an AI/ML device.

Here's why your request cannot be fully answered with the provided document:

Nature of the Device: The PiXel8-RF System is an electrosurgical device, not an AI/ML diagnostic or predictive system. Therefore, the concepts of sensitivity, specificity, AUC, human reader improvement with AI, standalone performance, training/test sets, or ground truth established by expert consensus are not applicable in this context.
Regulatory Pathway: This is a 510(k) submission, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves performance testing to ensure safety and effectiveness are comparable, not necessarily a clinical study demonstrating superior performance or meeting specific diagnostic performance metrics characteristic of AI/ML.

However, I can extract the relevant "performance data" and "conclusion" provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implicit via Substantial Equivalence): The implicit acceptance criterion for a 510(k) is demonstrating that the device is as safe and effective as its predicate device. This means its performance characteristics should be comparable, and it should not raise new questions of safety or effectiveness. Specific quantitative acceptance criteria (e.g., minimum accuracy, sensitivity) for the device's function are not typically presented in this summary format for non-AI devices. Instead, compliance with recognized safety and performance standards, and comparable functional output, are key.
Reported Device Performance:

Performance Metric/Study Type	Reported Outcome
IEC 60601-1	Performed for General Requirements for basic safety and essential performance.
IEC 60601-1-2	Performed for General Requirements for basic safety and essential performance: electromagnetic compatibility.
IEC 60601-2-2	Performed for particular requirements for the basic safety and essential performance of high-frequency surgical equipment.
In-Vivo Testing	Conducted on 3 types of tissue (Liver, Kidney, and Muscle). Results showed measurable thermal damage and no instances of unexpected injury.
Clinical Study	No clinical study was conducted to support this 510(k) submission (as substantial equivalence was demonstrated through other means like technical comparison and bench/in-vivo testing).
Technical Comparison (with K180654)	System Type: BiPolar RF (Same)Output Energy Type: High Frequency (Same)Max Power: 25 W @ 500 ohm (Same)Total RF Treatment Level: Up to 20 (Same)RF Duration: 50 ms – 950ms (Same)Tips: MicroNeedle Electrodes (25, 49, 64 pins for subject vs. 25, 64 pins for predicate - difference noted but deemed not to raise new safety/effectiveness questions)Frequency: 4 MHz (Subject) vs. 2 MHz (Predicate) - difference noted but deemed not to raise new safety/effectiveness questions.

Regarding the other aspects of your request, which are pertinent to AI/ML studies, the document provides no relevant information:

Sample size used for the test set and the data provenance: Not applicable. The "test set" for this device would be the tissues used in the in-vivo study (3 types: Liver, Kidney, Muscle). The geographical origin of these tissues or animals is not specified, nor is the setting (retrospective/prospective, as it's an animal study).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the in-vivo study was based on direct pathological analysis of tissue, not expert consensus on images. The qualifications of the pathologists are not mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is for AI/ML image interpretation, not device performance testing.
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 is not an AI/ML device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the in-vivo testing, the ground truth was pathology (analysis of thermal damage).
The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established: Not applicable.

Conclusion stated in the document:
"The difference in the frequency does not raise new or different questions of safety or effectiveness. The performance data demonstrate that the subject device is as safe and effective as its predicate device for the intended use. Therefore, the PiXel8-RF system is substantially equivalent to its predicate device."

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

October 25, 2023

Rohrer Aesthetics Mark Rohrer President 105 Citation Court Homewood, Alabama 35209

Re: K233147

Trade/Device Name: PiXel8-RF Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, OUH Dated: September 27, 2023 Received: September 27, 2023

Dear Mark Rohrer:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.10.25 08:03:32 -04'00'

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K233147

Device Name PiXel8-RF

Indications for Use (Describe)

The PiXel8-RF system is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatis.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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This 510(K) Summary of safety and effectiveness for the PIXEL8-RF System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

Applicant:	Rohrer Aesthetics
Address:	Rohrer Aesthetics105 Citation CourtBirmingham, AL 35209
Contact Person:	Mr. Mark Rohrer
Telephone:	205-356-1172 – phonemrohrer@rohreraesthetics.com
Preparation Date:	September 18, 2023
Type of Submission:	Special 510K
Device Trade Name:	Pixel8-RF System
Common Name:	Micro-Needle Fractional RF
Regulation Name:	Electrosurgical Cutting and Coagulation Device79-GEI
Regulation Number:	21 CFR 878.4400
Product Code:	GEI, OUH
LegallyMarketedPredicate Device(s):	Pixel8-RF (K180654)
Description of thePIXEL8-RF System:	The Pixel8-RF System includes the system main body, a bipolarhandpiece with disposable micro-needle type electrodes, afootswitch and an LCD touch screen control panel.
	The RF Energy is delivered to a target tissue using a handpieceand disposable tip (micro needle electrode tip), the being placedin light contact with the tissue and the handpiece being held atright angles to the target tissue. As the RF energy passesthrough the tissue, it generates an electrothermal reactionwhich is capable of coagulating the tissue. The Pixel8-RF System

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510(K) Summary PiXel8-RF System

creates heat within the target tissue using micro-needles inserted from the tip.

Intended use of the The PIXEL8-RF system is intended for use in dermatologic and PIXEL8-RF System general surgical procedures for electrocoagulation and hemostatis.
Performance Data: The following performance data was provided in support of the substantial equivalence determination:

IEC 60601-1 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance

IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility

IEC 60601-2-2 Medical electrical equipment part 2: particular requirements for the basic safety and essential performance of high frequency surgical equipment

In-Vivo testing was conducted on 3 types of tissue: Liver, Kidney and Muscle with results analyzed in a pathology lab. Results showed measurable thermal damage and no instances of unexpected injury.

Results of Clinical Study: No clinical study was conducted to support this 510K submission.

Technical Specifications Comparison:

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510(K) Summary PiXel8-RF System

	PiXel8 RF System(Subject Device)	Pinxel RF System(Predicate Device)K180654
Model	Pixel8 RF System	Pinxel RF System
Manufacturer	Rohrer Aesthetics	Rohrer Aesthetics
System Type	BiPolar RF	BiPolar RF
Output Energy Type	High Frequency	High Frequency
Frequency	4 MHz	2 MHz
Max Power	Max 25 W@ 500 ohm	Max 25 W @ 500 ohm
Total RF TreatmentLevel	Up to 20 (Max power 25 W)	Up to 20 (Max power 25W)
RF Duration	50 ms – 950ms	50ms - 950ms
Tips	MicroNeedle Electrodes25, 49 and 64 pins	MicroNeedle Electrodes25 and 64 pins
User interface	8" Touch LCD Display	Color touch LCD Display
System cooling	Air cooling	Air cooling
Dimensions (includingHandpiece cablehanger	24 inches x 17 inches x 63inches	24 inches x 17 inches x 63inches)
Weight	8 lbs (without cart)	8 lbs (without cart)
Electrical rating	Single phase 110 - 230VAC, 60-60Hz Power consumption:500VA (Fuse: 250V/6.3A)	Single phase 110 - 230VAC, 60-60Hz Power consumption:500VA (Fuse: 250V/6.3A)

Conclusion:

The difference in the frequency does not raise new or different questions of safety or effectiveness. The performance data demonstrate that the subject device is as safe and effective as its predicate device for the intended use. Therefore, the PiXel8-RF system is substantially equivalent to its predicate device.

Regulation Number and Section

§ 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.