The SmartXide UltraSpeed laser is incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic urgery, and urology for surgical and aesthetic applications.

Also, the SmartXide UltraSpeed laser is indicated for periodontal applications such as, but not limited to:

· Removal of diseased or Inflamed soft tissue in the periodontal pocket (sulcular debridement)
· Biopsies
Frenectomy, Frenum release
Gingivoplasty
Papillectomy
· Vestibuloplasty
· Hyperplasia
Operculectomy
· Drainage (abscess)
· Flap surgerv
· Fibroma (nonmalignant tumor, mucosa, tongue)
Epulis
· Aphthous ulcers
· Removal of soft tissue, cysts, and tumors

· Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long iunctional enithelium).

Device Description

DEKA SmartXide UltraSpeed is a 10,600 nm CO2 laser devices whit a maximum power of 40W. The laser source delivers the laser output through interchangeable laser handpieces. Handpiece activation is by footswitch.

AI/ML Overview

The provided text is a 510(k) summary for a medical device, the DEKA SmartXide UltraSpeed laser. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It's crucial to understand that a 510(k) submission primarily focuses on substantial equivalence to a predicate device, not necessarily extensive clinical performance studies or AI model validation. Therefore, the information requested in your prompt regarding acceptance criteria, training/test sets, expert ground truth, and AI performance metrics will likely not be present in this type of document because the device in question is a laser surgical instrument, not an AI-driven diagnostic or therapeutic device. No AI or machine learning components are mentioned for this device.

Based on the provided document, here's an attempt to address your points, highlighting where the information is not applicable or not provided:

The DEKA SmartXide UltraSpeed is a 10,600 nm CO2 laser device for incision, excision, ablation, vaporization, and coagulation of body soft tissues. The 510(k) submission establishes its substantial equivalence to a predicate device (DEKA Smart US 20D/UltraSpeed and Smart Clinic laser, K081181) based on similar indications for use, principle of operation, and performance characteristics.

Regarding Acceptance Criteria and Device Performance (as requested for an AI/diagnostic device):

Since this is a laser surgical instrument and not an AI/diagnostic device, the concept of "acceptance criteria" in the context of sensitivity, specificity, or similar performance metrics for an AI model is not applicable. The "device performance" instead refers to its physical specifications and its ability to perform its intended surgical functions safely and effectively.

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

For a laser surgical instrument, acceptance criteria are generally related to its technical specifications and compliance with safety standards rather than diagnostic performance metrics.

Criteria (for a laser surgical instrument)	Reported Device Performance (from the document)
Laser Type	CO2
Wavelength (nm)	10600
Power (Watts)	40
Spot Sizes (mm)	0.2; 0.4
Exposure Modes	Continuous, single and repeated pulse
Pulse width (ms)	0.02-70
Repetition rate (Hz)	5-100
Aiming beam	Diode laser, 4.0 mW
Biological Safety	Compliance with ISO 10993-1
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2
Laser Safety & Performance	Compliance with IEC 60601-2-22, IEC 60825-1

Study Proving Device Meets Acceptance Criteria:

The document states: "Tests results demonstrated compliance to related standards." This indicates that non-clinical performance tests were conducted according to the listed international standards (ISO 10993-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) to ensure the device operates safely and effectively as designed.

The following points are largely N/A (Not Applicable) or N/P (Not Provided) in this 510(k) summary for a laser surgical instrument, as they pertain to AI/diagnostic model validation:

2. Sample size used for the test set and the data provenance: N/A. No test set of patient data (images, etc.) is mentioned as this is not an AI diagnostic device. The "tests" mentioned are non-clinical engineering and safety compliance tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. No "ground truth" derived from expert review of patient data is relevant for this type of device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.

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: N/A. This is a surgical laser, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. There is no algorithm mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A. The "ground truth" for this device would be its adherence to established engineering, electrical, and laser safety standards, and its consistent output of specified laser parameters.

8. The sample size for the training set: N/A. No AI model or training set is mentioned.

9. How the ground truth for the training set was established: N/A.

In summary, this 510(k) document is for a medical laser, not an AI or diagnostic device. Therefore, the detailed questions about AI model validation, test/training sets, and expert ground truth are not relevant to the information presented in this regulatory submission. The "study" proving the device meets criteria consists of non-clinical, engineering, and safety compliance tests against recognized international standards.

Summary

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November 17, 2017

ELEN Electronic Engineering Spa Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, 50041 Italy

Re: K172363

Trade/Device Name: Deka Smartxide Ultraspeed 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: GEX Dated: August 22, 2017 Received: August 24, 2017

Dear Paolo Peruzzi:

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 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):

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@Ida.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Jennifer R. Stevenson -$3

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

K172363

Device Name

SmartXide UltraSpeed

Indications for Use (Describe)

Also, the SmartXide UltraSpeed laser is indicated for periodontal applications such as, but not limited to:

· Removal of diseased or Inflamed soft tissue in the periodontal pocket (sulcular debridement)
· Biopsies
Frenectomy, Frenum release
Gingivoplasty
Papillectomy
· Vestibuloplasty
· Hyperplasia
Operculectomy
· Drainage (abscess)
· Flap surgerv
· Fibroma (nonmalignant tumor, mucosa, tongue)
Epulis
· Aphthous ulcers
· Removal of soft tissue, cysts, and tumors

· Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long iunctional enithelium).

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary

DEKA SmartXide UltraSpeed

Submitter:

El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI), Italy

Contact:

Paolo Peruzzi Regulatory Affairs Manager & Official Correspondent Phone: +39.055.8826807 E-mail: p.peruzzi@elen.it

Date Summary Prepared:

August 02, 2017

Device Trade Name:

DEKA SmartXide UltraSpeed

Common Name:

Medical Laser system

Classification Name:

Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology (GEX)

Classification Number:

21 CFR 878.4810

Equivalent Devices:

DEKA Smart US 20D/UltraSpeed and Smart Clinic laser (K081181).

Device Description:

Intended Use:

SmartXide UltraSpeed laser is indicated for the incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic/laproscopic general surgery, gastroenterology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications. Also, the SmartXide UltraSpeed laser is indicated for periodontal applications such as, but not limited to:

· Removal of diseased or Inflamed soft tissue in the periodontal pocket (sulcular debridement)

· Biopsies

Frenectomy, Frenum release

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K172363 Page 2 of 3

Gingivoplasty
Papillectomy
Vestibuloplasty
· Hyperplasia
· Operculectomy
· Drainage (abscess)
· Flap surgery
· Fibroma (nonmalignant tumor, mucosa, tongue)
Epulis
· Aphthous ulcers
· Removal of soft tissue, cysts, and tumors
· Laser assisted new attachment procedure (cementum-mediated periodontal ligament newattachment to the root surface in the absence of long junctional epithelium).

Substantial equivalence discussion:

The DEKA SmartXide UltraSpeed is substantially equivalent to the Smart US 20D/UltraSpeed and Smart Clinic laser (K081181).

Device Trade Name	DEKA SmartXide UltraSpeed	Predicate DeviceK081181Smart US 20D/UltraSpeedand Smart Clinic lasers
Laser Type	CO2	CO2
Wavelength (nm)	10600	10600
Power (Watts)	40	Smart US20D/Ultraspeed: 25Smart Clinic: 50
Spot Sizes(mm)	0.2; 0.4	0.2; 0.4
Exposure	Continuous, single and repeatedpulse	Continuous, single andrepeated pulse
Pulse width (ms)	0.02-70	0.2-80
Repetition rate (Hz)	5-100	5-100
Aiming beam	Diode laser, 4.0 mW	Diode laser, 1.0 mW

The DEKA SmartXide UltraSpeed has the same indications for use as the abovementioned predicate device, with same principle of operation and essentially the same performances.

Clinical Performance Data:

None

Non-Clinical Performance Data:

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K172363 Page 3 of 3

Non clinical Performance Tests according to the following standards have been performed:

ISO 10993-1 Fourth edition 2009-10-15 biological evaluation of medical devices - part 1: evaluation and testing within a risk management process
IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment part 1-2: general . requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
IEC 60601-2-22 Edition 3.1 2012-10, medical electrical equipment part 2-22: particular ● requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
IEC 60825-1 Edition 2.0 2007-03, safety of laser products part 1: equipment classification, ● and requirements.

Tests results demonstrated compliance to related standards.

Conclusion:

Base on substantially equivalence discussion and on non Clinical Performance data, we can conclude that the DEKA SmartXide UltraSpeed laser system is substantially equivalent to the predicate device .

Additional Information:

None

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.