The CO2 laser is indicated for coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.

The Er: YAG handpiece is designed specificial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).

Device Description

The Cortex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The CO2 laser is delivered via an articulated arm that is permanently attached to the console. There is an additional Er: YAG handpiece that attaches to a port on the console and contains the laser cavity in the head of the handpiece. The user interface is a touch screen located on the console. The user activates the laser emission by means of a footswitch.

AI/ML Overview

The provided document is a 510(k) summary for the Cortex CO2 / Er:YAG Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study for meeting explicit acceptance criteria in terms of device performance metrics like sensitivity, specificity, or improvement over human readers.

Here's an analysis based on your requested information:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, no specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding device performance results are reported for the Cortex CO2 / Er:YAG Laser System in the context of a clinical study. The submission instead relies on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technical specifications and intended use.

The "Performance Data" and "Results of Clinical Study" sections explicitly state "None." The "Technical Specifications Comparison" tables serve as the primary "performance" data, showing that the device's specifications are similar to the predicates.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Technical Specifications)
CO2 Laser System
Laser type: Sealed-off CO2 laser tube	Sealed-off CO2 laser tube
Wavelength: 10.6 micron (10,600nm)	10.6 micron (10,600nm)
Power to tissue: 0.5 - 40 W	0.5 - 40 W
Super pulse peak power: 500W	500W
Laser operation modes: CW, Super pulse	CW, Super pulse
Tissue exposure modes: Continuous, Single Pulse, Repeat Pulse	Continuous, Single Pulse, Repeat Pulse
Aiming beam: 3mW (650nm diode) adjustable	3mW (650nm diode) adjustable
Articulated arm: 7-joint articulated arm	7-joint articulated arm
Working radius: 130cm	130cm
Cooling type: Closed loop liquid	Closed loop liquid
Power input requirements: 110VAC/60Hz or 220VAC/50Hz +/- 10%	110VAC/60Hz or 220VAC/50Hz +/- 10%
Dimension (Wide): 34cm	34cm
Dimension (Depth): 46cm	46cm
Dimension (Height): 96cm	96cm
Er:YAG Laser Handpiece
Wavelength: 2940nm	2940nm
Max Power: 2.4 W	2.4 W
Max Fluence: 8 J/cm2	8 J/cm2
Pulse Width: 300 µs	300 µs
Repetition Rate: Up to 10 pulse per second	Up to 10 pulse per second
Spot Size: 1.5mm, 3mm, 6mm, 9mm	1.5mm, 3mm, 6mm, 9mm

The implied "acceptance criteria" is that these specifications are either identical or functionally equivalent to the predicate devices, leading to the conclusion: "The Cortex CO2 / Er:YAG Laser System is comparable to the predicate device in terms of indications for use, technical specifications, operating performance features, general design."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states "Performance Data: None" and "Results of Clinical Study: None." Therefore, there was no test set or associated data provenance (country of origin, retrospective/prospective). This submission relies on technical comparison, not clinical data from a test set.

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 applicable. No test set or clinical study was conducted, thus no expert-established ground truth was required for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set was used.

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 is a laser device, not an AI-assisted diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical laser system and does not involve AI algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical study or performance data requiring ground truth was presented. The "ground truth" for this 510(k) submission is the technical specifications and established safety/effectiveness of the predicate devices, against which the new device is compared.

8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, so there is no training set.

9. How the ground truth for the training set was established
Not applicable. No training set exists for this type of device submission.

Summary

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Attachment 5 510(K) Summary Cortex CO2 / Er:YAG Laser System

K110897

JUL - 1 2011

This 510(K) Summary of safety and effectiveness for the Cortex CO2 / Er:YAG Laser 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:	Sandstone Medical Technologies, LLC		Sandstone MedicalTechnologies LLC CortexCO2 / Er:YAG-Laser System	Sandstone MedicalTechnologies LLC CO2 Laser(Predicate Device)
Address:	105 Citation CourtBirmingham, AL 35209	Laser type	Sealed-off CO2 laser tube	Sealed-off CO2 laser tube
Contact Person:	Mark Rohrer	Wavelength	10.6 micron (10,600nm)	10.6 micron (10,600nm)
Telephone:Email:	205-290-8251 - phonessmed@bellsouth.net	Power to tissue	0.5 -40 W	0.5 -40 W
Preparation Date:	March 19, 2011	Super pulse peakpower	500W	500W
Device Trade Name:	Cortex CO2 / Er:YAG Laser System	Laser operationmodes	CW, Super pulse	CW, Super pulse
Common Name:	CO2 LaserEr:YAG Laser	Tissue exposuremodes	Continuous, Single Pulse,Repeat Pulse	Continuous, Single Pulse,Repeat Pulse
Classification Name:	Instrument, Surgical, Powered, laser79-GEX, 21 CFR 878-48	Aiming beam	3mW (650nm diode)adjustable	3mW (650nm diode)adjustable
Legally Marketed PredicateDevice:	LS-40 CO2 Laser System (K)093793MLT Erbium:YAG Laser System (K)032599	Articulated arm	7-joint articulated arm	7-joint articulated arm
Description of the CortexCO2/Er:YAG Laser System	The Cortex system and controls are contained in a singleconsole. Electrical power is supplied to the console by thefacility's power source. The CO2 laser is delivered via anarticulated arm that is permanently attached to the console.There is an additional Er: YAG handpiece that attaches to aport on the console and contains the laser cavity in the headof the handpiece. The user interface is a touch screenlocated on the console. The user activates the laseremission by means of a footswitch.	Working radius	130cm	130cm
Intended use of the CortexCO2 / Er:YAG Laser System	The CO2 laser is indicated for coagulation, vaporization,ablation or cutting of soft tissue in dermatology and plasticsurgery, general surgery, podiatry and otorhinolaryngology.	Cooling type	Closed loop liquid	Closed loop liquid
	The Er:YAG handpiece is designed specifically forsuperficial skin ablation resulting in skin dermabrasion, andthe treatment of wrinkles. In addition this system is intendedfor coagulation, vaporization, ablation, or cutting of softtissue (skin) in dermatology, plastic surgery (includingaesthetic surgery).	Power inputrequirements	110VAC/60Hz or220VAC/50Hz +/- 10%	110VAC/60Hz or220VAC/50Hz +/- 10%
Dimension (Wide)	34cm	34cm
(Depth)	46cm	46cm
(Height)	96cm	96cm

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Attachment 5 510(K) Summary Cortex CO2 / Er:YAG Laser System

Performance Data: None

. ..

Results of Clinical Study: None

Summary of Technological Characteristics:

Technical Specifications Comparison for the CO2 Laser (including console specification)

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Attachment 5 510(K) Summary Cortex CO2 / Er:YAG Laser System

Technical Specifications Comparison for the ER:YAG Laser Handpiece

し

...

	Sandstone MedicalTechnologies LLCCortex CO2 / Er:YAGLaser System	Sandstone MedicalTechnologies LLCEr:YAG Laser(Predicate)
Wavelength	2940nm	2940nm
Max Power	2.4 W	2.4 W
Max Fluence	8 J/cm2	8 J/cm2
Pulse Width	300 µs	300 µs
Repetition Rate	Up to 10 pulse per second	Up to 10 pulse per second
Spot Size	1.5mm, 3mm, 6mm,9mm	1.5mm, 3mm, 6mm,9mm

Conclusion:	The Cortex CO2 / Er:YAG Laser System iscomparable to the predicate device in terms ofindications for use, technical specifications, operatingperformance features, general design.
-------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

Sandstone Medical Technologies, LLC % Mr. Mark Rohrer Managing Member 105 Citation Court Homewood, Alabama 35209

JUL - 1 2011

Re: K110897

Trade/Device Name: Cortex Co2/Er: Y AG Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and in plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: May 18, 2011 Received: May 24, 2011 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・、

Dear Mr. 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 (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. Ilsting 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

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Page 2 - Mr. Mark Rohrer

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 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/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/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 tollofre and (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Jk.

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

K110892

510(k) Number (if known):

Device Name:

Cortex Co2 / Er:YAG Laser System

The CO2 laser is indicated for coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nel RPO Page 1 of 1
(Division Sign Off) mkn

(Division Sign-6 Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110897

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.