Intended Use: The Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is intended for use in dermatologic and general surgical procedures.

Indications for Use: The Unipolar and Bipolar handpieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids. The Pixel RF Tips (stationary and rolling), when used with the unipolar handpiece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.

Device Description

The Accent Pixel RF Tips include cleanable, sterilizable, multiple use radiofrequency (RF) energy delivery devices (accessory) intended for use with the Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite]. These Pixel RF Tips are also available as single use, disposable products. The Accent Pixel RF Tips are comprised of the following main components: Pixel Stationary Tip, Pixel Roller Tip.

AI/ML Overview

The provided text is a 510(k) Summary for the Alma Lasers Accent Pixel RF Tips. It describes the device and its intended use, and argues for substantial equivalence to predicate devices, supported by animal and human clinical data. However, the document is a regulatory submission for substantial equivalence rather than a detailed study report proving the device meets specific acceptance criteria.

Therefore, direct answers to many of your questions, particularly those related to detailed study methodologies, sample sizes for training/test sets, ground truth establishment methods, expert qualifications, adjudication, and MRMC studies, are not explicitly stated or available in the provided text.

Here's an analysis of what can be extracted and what is missing:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in this document is primarily centered around demonstrating substantial equivalence to existing predicate devices. This means the device performs similarly to devices already cleared by the FDA for similar indications. The document doesn't outline specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet against a predefined threshold. Instead, the "performance" discussed relates to the device's functional characteristics and its ability to achieve the stated indications for use.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Acceptance Criteria Category (Implied by Substantial Equivalence Review)	Reported Device Performance (Summary from Document)
Intended Use (Same or similar to predicates)	Match: "Intended for use in dermatologic and general surgical procedures." This aligns with the intended use of predicate devices.
Indications for Use (Same or similar to predicates)	Match: "Indicated for dermatological procedures requiring ablation and resurfacing of the skin." This aligns with specific indications of predicate devices (e.g., Matrix RF Applicator, EndyMed FSR applicator). Also "non-invasive treatment of wrinkles and rhytids" when used with Unipolar and Bipolar handpieces.
Device Operation (Similar to predicates)	Similar: "Shares the same or similar... device operation..." (General statement).
Overall Technical and Functional Capabilities (Similar to predicates)	Similar: "Shares the same or similar... overall technical and functional capabilities..." (General statement). Illustrated by comparable RF power ranges, tip matrix, treatment area, handpiece dimensions, and materials in the comparison tables.
Safety and Effectiveness (Demonstrated through data)	Demonstrated: "Animal and human clinical data were submitted to substantiate product performance." (General statement, no specific metrics provided).
Substantial Equivalence Conclusion	Achieved: "The Accent Pixel RF Tips were found to be substantially equivalent to the predicate devices."

Study Information (Based on available text):

Sample size used for the test set and the data provenance:
- Not explicitly stated for either animal or human clinical data. The document only mentions "animal and human clinical data were submitted." The exact numbers of subjects or cases in these studies are not provided.
- Data Provenance: Not specified (e.g., country of origin). "Animal histology data - section 19 - and human clinical data - section 20" are referenced as supporting the indications for use, suggesting prospective collection for the purpose of the submission, but details are absent from this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not stated. The document refers to "animal histology data" and "human clinical data." For clinical data, the assessment of "ablation and resurfacing" or "wrinkles and rhytids" would typically involve expert assessment (e.g., dermatologists, plastic surgeons), but the number or qualifications of these experts are not provided in this summary.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not stated. The methods for evaluating the clinical data (e.g., how efficacy was determined, or how disagreement among evaluators, if any, was resolved) are not detailed.
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 an energy delivery system (RF tips), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to "human readers improving with AI" would not be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As noted above, this device is a medical instrument (RF tips) used in dermatological procedures, not an algorithm. Performance is assessed through its physical effects on tissue and clinical outcomes, not through an algorithm's standalone output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Inferred: For the "animal histology data," the ground truth would typically be pathology (histopathology from tissue samples). For the "human clinical data," the ground truth would likely be clinical assessment / outcomes data by medical professionals, potentially supported by photographic evidence or other objective measurements of skin ablation, resurfacing, or wrinkle reduction.
The sample size for the training set:
- Not applicable/Not stated. This device does not use machine learning in the conventional sense where a "training set" of data is used to teach an algorithm. The "data" mentioned (animal and human clinical data) is for validation or substantiation of the device's performance, not for training a model.
How the ground truth for the training set was established:
- Not applicable. See point 7.

In summary, the provided document is a 510(k) submission focused on demonstrating substantial equivalence. It confirms that animal histology and human clinical data were submitted to support the device's performance and indications for use, but it does not provide the detailed study protocols, participant numbers, or specific methodological information that would be found in a clinical study report.

Summary

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Section 5-510(k) Summary or 510(k) Statement
K121150
Page 1 of 8
SEP 21 2012

I. General Information
Submitter:	Alma Lasers, Inc.
	485 Half Day Road Suite 100
	Buffalo Grove IL 60089
Contact Person:	Kathy Maynor - Regulatory
	352-586-3113 (cell)
Summary Preparation Date:	June 28, 2012

II. Names
Device Name(s):	Accent Pixel RF Tips
Primary Classification Name(s):	Electrosurgical cutting and coagulation device and accessories

III. Predicate Devices#### Predicate Devices III.

・

Alma Lasers Family of Accent RF Systems [Accent, Accent Elite] (K072699, K070004, . K101147)
Syneron Medical Matrix RF Applicator (K073572, K090025) .
EndyMed RF Applicator (K083461, K101510, K120513) .

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Page 2 of (8)

Product Description IV.

The Accent Pixel RF Tips are comprised of the following main components:

Pixel Stationary Tip .
Pixel Roller Tip .
V. Intended Use & Indications for Use

Intended Use

The Alma Lasers family of Accent RF Systems (Accent XL, Accent Elite) with Unipolar and Bipolar Handpieces are intended for use in dermatologic and general surgical procedures.

Indications for Use

The Unipolar and Bipolar handpieces, when used as a combined treatment, are indicated for the noninvasive treatment of wrinkles and rhytids.

The Pixel RF Tips (stationary and rolling), when used with the unipolar handpiece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.

VI. Rationale for Substantial Equivalence

The Accent Pixel RF Tips shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices. Additionally, animal and human clinical data were submitted to substantiate product performance.

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	K0XXXX	K072699, K070004,K101147	K073572, K090025	K083461, K101510, K120513
	Alma Lasers, Ltd.		Syneron Medical	EndyMed
	Family of Accent RF Pixel Tips withPixelRF Module/ Handpiece	Alma Lasers Family ofAccent RF Systems[Accent, Accent XL,Accent Elite] (w/ UniPolar& BiPolar Handpieces]	Matrix RF Applicator	RF applicator
Characteristic
Product Code		General & Plastic Surgery	General & Plastic Surgery	General & Plastic Surgery
Regulation		• NUV,GEI, ISA 21 CFR878.4810	• GEI, OUH - 21 CFR 878.4400	• GEI, OUH - 21 CFR 878.4400
Intended Use		Intended for use indermatologic and generalsurgical procedures	Intended for use indermatologic and generalsurgical procedures	Intended for use indermatologic and generalsurgical procedures

Section 5: Page 3

Premarket Notification, Special 510(k) Submission for
Alma Lasers Accent Pixel® Tips

K 121150

.• •

39 (દ

12115

{3}------------------------------------------------

K0XXXX	K072699, K070004,K101147	K073572, K090025	K083461, K101510, K120513
Alma Lasers, Ltd.		Syneron Medical	EndyMed
Family of Accent RF Pixel Tips with PixelRF Module/ Handpiece	Alma Lasers Family of Accent RF Systems[Accent, Accent XL,Accent Elite] (w/ UniPolar& BiPolar Handpieces]	Matrix RF Applicator	RF applicator	K121150Page
Characteristics	The Alma Lasers family of Accent RFSystems (Accent, Accent XL, AccentElite) with Unipolar and BipolarHandpieces are intended for use indermatologic and general surgicalprocedures:	The Matrix RF Applicatoris intended fordermatological proceduresrequiring ablationand resurfacing of the skin,and for the treatment offacial wrinkles.	The Glow by EndyMed is anoninvasive device intendedfor use in Dermatologic andGeneral Surgical procedures.-The TC applicator is indicatedfor mild to moderate facialwrinkles and rhytides.
Indicationsfor Use	Indicated for: The non-invasive treatment ofwrinkles and rhytids usinga combined treatment withUnipolar and Bipolarhandpieces		The FSR applicator isindicated for Dermatologicalprocedures requiring ablationand resurfacing of the skin.
	The Unipolar and Bipolar handpieces,when used as a combined treatment,are indicated for the non-invasivetreatment of wrinkles and rhytids.
	The Pixel RF Tips (stationary androlling), when used with the unipolarhandpiece, are indicated fordermatological procedures requiringablation and resurfacing of the skin.
	Supported by animal histology data- section 19 - and human clinicaldata - section 20.

Premarket Notification, Special 510(k) Submission for
Alma Lasers Accent Pixel" Tips

Section 5: Page 4

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	K0XXXX	K072699, K070004,K101147	K073572, K090025	K083461, K101510, K120513
	Alma Lasers, Ltd.		Syneron Medical	EndyMed
	Family of Accent RF Pixel Tips withPixelRF Module/ Handpiece	Alma Lasers Family ofAccent RF Systems[Accent, Accent XL,Accent Elite] (w/ UniPolar& BiPolar Handpieces]	Matrix RF Applicator	RF applicator
Characteristic
RF Power(or Energy)	• UniPolar- Recommended Range -Stationary Tips45-60 W		• Bipolar - Up to 25 Joulesper cm²	• Bipolar up to 65 watts
	- Recommended Range - RollerTips35-55 W	• UniPolar & UniLargeUp to 200 W (1.51 W/mm²)(Nominal 120-140 W)	(Tunable SelectPulse™fractional technology – 3programs which emulate thetissue effects of commonskin resurfacing fractionallaser technologies)	Up to 62mj/pin
	- Maximum for Accent SystemUp to 200 W (2.08 W/mm²)(Nominal 35-80 W - PixelRF Tips –range of 0.15 to 2.08 W/mm²)	• BiPolar & BiFolarSUp to 420 W (1.51 W/mm²)(Nominal 250-290 W)

.. •

Premarket Notification, Special 510(k) Submission for
Alma Lasers Accent Pixel® Tips

Section 5: Page 5

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5

K 121150

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{5}------------------------------------------------

	0XXXX	K072699, K07000 K101147	073572, K09002	083461, K101510, K12051
	Alma Lasers, Ltd		yneron Medic	indyMed
	amily of Accent RF Pixel Tips withPixelRF Module/ Handpiece	lma Lasers Family of ccent RF Systems	latrix RF Applicator	. ****************************************************************************************************************************************************************************RF applicator
		Accent, Accent XL, Accent Elite] (w/ UniPol & BiPolar Handpieces]
Characteri
tic
Tip Matrix	Stationary PixelRF Tips	ot applicab		2 matrix spo
	· ~ 110 Pixel points (1.0 pixels/mm²)	. .	64 Matrix Points – per pulse	(1.3 matrix spots/mm
		K072699 & K070004
	oller PixelRF Tips		0.4 points/mr
	~132 Pixel points per cm(1.3 pixels/mm²
	Treatment Stationary. PixelRF Tips (Unipolar) .	UniPolar & UniLarg		10.x 15.mm
Area	12 mm dia	13 to 19 mm dia	x 12 mm — disposable
	• Roller PixelRF Tips (Unipolar)	BiPolarS & BiPola	spot' size (unipola
	10 x 22.7 mm circumference 'roller'	95 to 13 mm dia
landpiece	Pixel - Handpiece - 160 x 155 mm	UniPolar - 169 x 205 mm	5.9 x 6.3 inches (15	Inknowi
Dimensions		BiPolar - 167 x 203 mm	cm)

	Premarket Notification, Special 510(k) Submission for Alma Lasers Accent Pixel® Tips		ection 5: Page

・・・・・・・・ . .

KI 21150

Page 6 of 8

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	0XXX	K072699, K07000 K101147	073572, K09002	083461, K101510, K1205
	lma Lasers, Ltd		neron Medic	EndyMed
	amily of Accent RF Pixel Tips wit ixel8f Module/ Handpiece	ma Lasers Family of cent RF Systems cent RF Systems cent RF Systems cent Elited (w/1L) (Lift (Lift) BiPolar Handy (w/10ces)	atrix RF Applicator	RF applicato:

Charactertice
Patient	tationary Pixel Tips – Aluminum	andpiece	nknow	nknow
MaterialsContac	Roller Pixel®F Tips – Aluminum,Sapphire	nodized aluminum arelrin plastic		::
provideoHow	sposable and Reusable Stationary Roller Pixel® Tips:	ot applicab	sposable tip – up topulses	isposable tip - up tooulses
	ble TipslableReusable, cleanable, sterilizand disposable tips also avail
ElectricalReqs	. …,10-120 V; 50-60 Hz; 5	0-120 V, 50-60 Hz, 5	0 - 230 VAC, 50-60 Hz,7.5A	0-230 VAC, 1-3 A, 5Hz
System Dimensions(;;)	6 x 17 x 16 AccentXL; 21 x 17 x 38 ccent; 26 x 18 x 16 Accent Beauty	6 x 17 x 16 Accent)l x 17 x 38 Acce	.87 x 15.35 x 11 abletop system)	15 x 30 x 19 cm; 45 xin.
System Weight	10(XL)	ર PasS	4 lbs (7 k	3 kg; 72.5

Section 5: Page 7

Premarket Notification, Special 510(k) Submission for:
Alma Lasers Accent Pixel® Tips

2 || K 1 50

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ge 7 of 8

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Safety and Effectiveness Information VII.

The review of the indications for use and technical characteristics provided demonstrates that the Accent Pixel RF Tips are substantially equivalent to the predicate devices. Additionally, animal and human clinical data were submitted to substantiate performance.

VIII. Conclusion

The Accent Pixel RF Tips were found to be substantially equivalent to the predicate devices.

The Accent Pixel RF Tips share the identical indications for use, similar design features, and functional features with, and thus are substantially equivalent to, the predicate devices.

{8}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

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

Alma Lasers Incorporated % Ms. Kathy Maynor Regulatory Consultant 485 Half Day Road, Suite W No. 100 Buffalo Grove, Illinois 60089

Re: K121150

Trade/Device Name: Pixel RF Tips Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accesories Regulatory Class: Class II Product Code: GEI Dated: August 31, 2012 Received: September 11, 2012

Dear Ms. Maynor:

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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

SEP 21 2012

{9}------------------------------------------------

Page 2 - Ms. Kathy Maynor

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.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/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 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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Page 1 of 2

Indications for Use Statement

510(k) Number (if known): KAB

K 121150

Device Name: Pixel RF Tips

Indications for Use:

Intended Use

The Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is intended for use in dermatologic and general surgical procedures.

Indications for Use

The Unipolar and Bipolar handpieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids.

The Pixel RF Tips (stationary and rolling), when used with the unipolar handpiece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.

Nilke. Sgle. for nxm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

Prescription Use . V

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Premarket Notification, Special 510(k) Submission for: Alma Lasers Accent Pixel® Tips

{11}------------------------------------------------

K121150

. ' .

・

· .

.
"

Concurrence of CDRH, Office of Device Evaluation (ODE)

・

Page . . :

. " .

Premarket Notification, Special 510(k) Submission for:
Alma Lasers Accent Pixel® Tips

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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.