The SPR is a pulsed light device intended for providing light therapy to the body and specifically indicated for treatment of pigmented and vascular lesions.

Device Description

The SPR is a pulsed light device intended for providing light therapy to the body and specifically indicated for treatment of pigmented and vascular lesions. The SPR has the same intended use, with similar indications for use, and is technologically identical to the cleared SkinStation with respect to the operation and function of the SkinStation's pigmented and vascular lesions module.

AI/ML Overview

The provided text is a 510(k) summary for the Radiancy (Israel) Ltd.'s SPR System.
A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than presenting detailed studies demonstrating device performance against specific acceptance criteria in the manner one might find for novel device approvals or software algorithms.

Based on the information provided in the text, it is not possible to complete the requested table and answer the questions related to acceptance criteria, study details, sample sizes, expert involvement, and ground truth.

Here's why and what information is available:

Key Takeaways from the document:

Device Type: The SPR System is a pulsed light device.
Intended Use: Providing light therapy to the body, specifically indicated for treatment of pigmented and vascular lesions.
Substantial Equivalence: The submission asserts substantial equivalence to Radiancy's SkinStation® System (K030897). Crucially, the document states: "The SPR has the same intended use, with similar indications for use, and is technologically identical to the cleared SkinStation with respect to the operation and function of the SkinStation's pigmented and vascular lesions module."
No Performance Data Presented: The document focuses on regulatory classification, contact information, and the claim of substantial equivalence. It does not contain any performance data, clinical study results, or specific acceptance criteria for treatment efficacy or safety.

Why the requested information cannot be found in the provided text:

510(k)s often rely on existing predicate devices and technological characteristics, especially for devices like light therapy systems where the mechanism of action is well-established and previous devices have cleared the regulatory hurdles. They typically do not involve the same level of detailed performance study reporting as a PMA (Pre-Market Approval) or a software as a medical device (SaMD) submission that requires extensive clinical validation metrics like sensitivity, specificity, or AUC against ground truth.
The questions posed (e.g., sample size for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth) are highly relevant for diagnostic AI algorithms or novel therapeutic devices requiring extensive clinical trials to prove efficacy and safety. This document is for a pulsed light therapy device and demonstrates substantial equivalence to an already cleared device.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details because that information is not present in the provided 510(k) summary.

The document states the device is "technologically identical" to its predicate for the relevant functions, suggesting that the basis for approval is primarily this equivalence rather than new performance data against numerical acceptance criteria.

Summary

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OCT 2 4 2003

Kossia I of 2

510(k) SUMMARY

Radiancy (Israel) Ltd.'s SPR System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Radiancy (Israel) Ltd. 9 Gan Ravve Street Industrial Park Yavne lsrael Telephone: +972-8-9438010 Facsimile: +972-8-9438020 Jonathan S. Kahan, Esq. Contact Person:

Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109 Telephone: (202) 637-5794 Facsimile: (202) 637-5910 Email: JSKahan@HHLaw.com

Date Prepared:

Name of Device and Name/Address of Sponsor

Trade/Proprietary Name:	SPR™ System
Common Name:	Pulsed Light System
Classification Name:	Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR § 878.4810)
Address of Manufacturing Facility:	Radiancy (Israel) Ltd.9 Gan Ravve StreetIndustrial ParkYavne, Israel

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K031891 2 of 2

Establishment Registration Number: Owner/operator number:

9616256 9040071

Predicate Devices

Radiancy's SkinStation® System (K030897)

Intended Use / Indications for Use

The SPR is a pulsed light device intended for providing light therapy to the body and specifically indicated for treatment of pigmented and vascular lesions.

Technological Characteristics and Substantial Equivalence

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

OCT 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Radiancy (Israel) Ltd. c/o Mr. Jonathan S. Kahan Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109

Re: K033181

Trade/Device Name: SPR™ System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: September 30, 2003 Received: October 1, 2003

Dear Mr. Kahan:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Jonathan S. Kahan

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1 Indications for Use Form

510(k) Number (if known):

K033181

SPR™ System Device Name:

Indications for Use:

The SPR is a pulsed light device intended for providing light therapy to the body and specifically indicated for treatment of pigmented and vascular lesions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use_ (Per 21 C.F.R. 801.109)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

(Optional Format 1-2-96)

510(k) Number K033181

\\PH - 69039/0002 - 13460 v1

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.