The PHOTON EX is a table-top, xenon lamp lightsource used for intraocular illumination during vitreoretinal surgery. The lightsource employs two channels from a single lamp. The channels terminate with entry ports on the unit's front panel. Each channel has a dedicated filter wheel; the filter wheels include the following band pass filters with an upper cut-off at 650 nm and lower cut-offs at 435nm, 475nm, 475nm, and 515nm respectively. The user inputs are controlled by membrane switches on the front panel.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called PHOTON EX, an ophthalmic light source. The document focuses on establishing substantial equivalence to a predicate device (Synerlight) rather than providing detailed acceptance criteria and a comprehensive study for de novo approval.

Therefore, the requested information for acceptance criteria and a study proving the device meets them, especially with specific details like ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, cannot be found in this document.

This type of submission (510(k)) primarily demonstrates that a new device is as safe and effective as a legally marketed predicate device. The information provided is generally a comparison of technological characteristics and a summary of non-clinical tests to show equivalence.

However, I can extract the information that is present in the document which relates to performance and testing:

Device: Synergetics PHOTON EX
Predicate Device: Synergetics Synerlight FiberOptic Lightsource, K032598
Intended Use: The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery.

Here's an attempt to answer the questions based on the available information, noting where information is explicitly not present in the document:

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

The document does not explicitly state acceptance criteria in a quantitative manner for specific performance metrics (e.g., "illumination intensity must be > X lumens with a tolerance of Y%"). Instead, it focuses on demonstrating equivalence to the predicate device.

Acceptance Criteria (Implied by equivalence)	Reported Device Performance (Summary of Non-clinical Tests)
Safety: Complies with applicable requirements of safety standards.	The PHOTON EX has undergone testing and complies with the applicable requirements of safety standards.
Effectiveness: Similar performance profile to the predicate device.	The subject device performed equivalently to the predicate device in a comparative bench test. The device is as safe and effective as the predicate device.
Technological Characteristics: Similar to or improved upon predicate.	Many characteristics are directly compared and are either identical or represent an improvement (e.g., digital control vs. analog, more filter options).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document mentions "comparative bench test" but does not detail the sample size (e.g., number of units tested, number of test cycles), data provenance, or study design.

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)

This information is not provided in the document. For a physical device like an ophthalmic light source, "ground truth" as it applies to diagnostic interpretation or clinical outcomes (which would involve experts) is not typically the focus of a 510(k) submission. Performance is usually assessed through engineering benchmarks and comparative tests against the predicate.

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

This information is not provided in the document.

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

An MRMC study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. The PHOTON EX is an ophthalmic light source, a non-diagnostic device used for illumination during surgery. Therefore, an MRMC study is not applicable and was not performed for this device in the context of this 510(k) submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A "standalone" performance evaluation typically refers to the performance of an algorithm or an automated system without human intervention, again common in AI-driven diagnostic devices. Since the PHOTON EX is a surgical light source, this concept is not applicable and was not performed. Its performance is assessed through its physical characteristics and functionality.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a physical light source, "ground truth" would relate to measurable physical parameters (e.g., light output intensity, spectral purity, color temperature, beam uniformity, operational safety). The document states "The PHOTON EX has undergone testing and complies with the applicable requirements of safety standards." and "The subject device performed equivalently to the predicate device in a comparative bench test." This implies that the ground truth for performance was established through engineering specifications, safety standards, and direct comparative measurements against the predicate device's measured performance. Details of these specific ground truths (e.g., the exact safety standards, detailed performance metrics) are not provided.

8. The sample size for the training set

This information is not provided in the document. The concept of a "training set" is typically associated with machine learning or AI models, which are not described as part of this device.

9. How the ground truth for the training set was established

As the concept of a "training set" is not applicable or discussed for this device, information on how its ground truth was established is not provided.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines connecting them.

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

February 24, 2015

Synergetics™ Mr. Mark Job Reviewer Regulatory Technology Services 1394 25th Street NW Buffalo, MN 55313

Re: K143123

Trade/Device Name: PHOTON EXTM Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: MPA Dated: February 5, 2015 Received: February 9, 2015

Dear Mr. Job:

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 (reporting of medical

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Post market Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Kesia Y. Alexander -S

for Malvina B. Eydelman, MD Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for "Synergetics". The logo consists of a geometric shape on the left, resembling a diamond made up of smaller squares. To the right of the shape is the word "Synergetics" in a bold, sans-serif font. There is a superscript "TM" symbol next to the word.

Section 4 - Indications for Use

510(k) Number (if known):
Device Name:	Synergetics PHOTON EX
Indications for Use:	The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery.

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

Over-The-Counter Use _ (21 CFR 801 Subpart

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the word "Synergetics" in a bold, sans-serif font. To the left of the word is a geometric logo that looks like a diamond made up of smaller squares and triangles. The letters are all black, and there is a small "TM" symbol in the upper right corner of the word.

Section 5 - 510(k) Summary

Submitted in accordance with the requirements of 21 CFR 807.92

I. SUBMITTER

Applicant's Name	Synergetics
and Address:	3845 Corporate Centre DriveO'Fallon, MO 63368

Contact Person: Dan Regan, Regulatory Affairs Director

Date Prepared: September 16, 2014

II. DEVICE

Device Trade Name: PHOTON EX

Common Name: Ophthalmic Light Source
Device Classification: Class II

Class Name: Endoscope and Accessories (21 CFR 876.1500)

Product Code: MPA

FDA Panel: Ophthalmic

III. PREDICATE DEVICE

Predicate Device: Synergetics Synerlight FiberOptic Lightsource, K032598

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Image /page/4/Picture/0 description: The image shows the word "Synergetics" in a bold, sans-serif font. To the left of the word is a geometric design composed of several squares arranged to form a larger diamond shape. To the right of the word, there is a superscript "TM" symbol, indicating a trademark.

Section 5 - 510(k) Summary

Submitted in accordance with the requirements of 21 CFR 807.92

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery.

	Subject Device	Predicate Device
Element	PHOTON EX	Synerlight (PHOTON)
510(k) Number	To be assigned	K032598
Product Code	MPA	MPA, GEX
Lamp	75 Watt Xenon	75 Watt Xenon
ConsumableConnectors	Generic MultiportTubing Cut-off	Generic MultiportTubing Cut-off
Multiport Connector Location	Internal, Front Panel	External, Front & SidePanel

VI. COMPARISION OF TEHCNOLOGICAL CHARACTERISITICS WITH THE PREDICATE DEVICE:

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Image /page/5/Picture/0 description: The image contains the logo for "Synergetics™". To the left of the word Synergetics is a geometric shape that is made up of 4 squares. The letters of the word Synergetics are in bold font. The letters TM are in superscript.

Section 5 - 510(k) Summary

Submitted in accordance with the requirements of 21 CFR 807.92

VI. COMPARISION OF TEHCNOLOGICAL CHARACTERISITICS WITH THE PREDICATE DEVICE:

	Subject Device	Predicate Device
Element	PHOTON EX	Synerlight (PHOTON)
Method of Control	Digital	Analog
User Interface	Membrane Switches on frontpanel	Analog dial adjacent tomultiport connection
Filter Selection	Selectable filter wheel with650nm upper cut off andlower cut offs of 435nm,455nm, 475nm, and 515nm	Fixed filter wheel with650nm upper cut offand a lower cut-off of435nm
Unit Height x Width x Depth	8.1" x 13.2" X 12.6"	9" x 9.5"x 6.8"
Unit weight	18.5 pounds	13.28 pounds
Electrical power specifications	100-120V	100-120V
	220-240V	220-240V
	50/60 Hz	50/60 Hz
Consumables provided sterile(sold independent of device)	Yes	Yes
Consumables method ofsterilization	ETO	ETO
Consumables SterilityAssurance Level	$10^{-6}$	$10^{-6}$

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Image /page/6/Picture/0 description: The image shows the word "Synergetics" in a bold, sans-serif font. To the left of the word is a geometric design made up of squares and lines. A superscripted "TM" appears to the right of the word, indicating a trademark.

Section 5 - 510(k) Summary

Submitted in accordance with the requirements of 21 CFR 807.92

VII. Summary of Non-clinical tests:

The PHOTON EX has undergone testing and complies with the applicable requirements of safety standards. The subject device performed equivalently to the predicate device in a comparative bench test. Therefore, the subject device and the predicate device have similar safety, effectiveness, and performance profiles.

VIII. Substantial Equivalence Basis:

The conclusions performed by independent laboratories and internal comparative bench testing provide objective evidence to substantiate the Synergetics PHOTON EX is as safe and effective as the predicate device, the Synergetics Synerlight.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.