The Cetus system is a 1064nm. pulsed, Nd: YAG Q-switched laser system used together with a sterile, single use laser probe and a Phaco machine. The system console has a digital touch screen and it is used in conjunction with the Cetus probe and a Phacoemulsification machine in the operating room. The probe converts the laser light energy into acoustic energy which is used to perform the fragmentation of the the crystalline lens and has integrated aspiration and irrigation functions.

AI/ML Overview

The provided text is a 510(k) summary for the Cetus System, a laser system for phacofragmentation of cataractous crystalline lenses. It focuses on demonstrating substantial equivalence to a predicate device through comparison of technical specifications and non-clinical performance data.

However, the document does not contain information related to acceptance criteria, clinical studies, or performance metrics in the way your prompt describes for AI/medical device performance evaluation. Such information would typically include:

Acceptance Criteria for Device Performance: Specific numerical thresholds for metrics like accuracy, sensitivity, specificity, etc.
Reported Device Performance: Actual results from tests against these criteria.
Sample Sizes, Data Provenance, Ground Truth: For clinical or simulated clinical studies demonstrating performance.
Expert Review/Adjudication: Details on how ground truth was established, especially in diagnostic/imaging devices.
MRMC or Standalone Studies: Type of clinical efficacy study.

Therefore, based solely on the provided text, I cannot complete the table or answer the questions related to clinical performance, acceptance criteria, or studies proving the device meets them because this information is not present.

The document explicitly states: "Clinical Performance Data: None".

The "performance data" referred to in the document is non-clinical and focuses on compliance with various safety, sterilization, packaging, and risk management standards, rather than the device's clinical efficacy or output performance as measured by typical diagnostic/treatment metrics.

Here's what I can extract from the provided text relevant to the device and its testing, but it does not address your specific request for acceptance criteria and clinical performance study details:

1. Table of Acceptance Criteria and Reported Device Performance:

None provided for clinical performance. The document only lists non-clinical compliance standards.

2. Sample size used for the test set and the data provenance:

Not applicable / Not provided. No clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided. No clinical test set.

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

Not applicable / Not provided. No clinical test set.

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:

No. The document explicitly states "Clinical Performance Data: None." This device is a surgical tool, not an AI diagnostic tool, so an MRMC study is not relevant in the context of this submission.

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

No. The document explicitly states "Clinical Performance Data: None."

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

Not applicable / Not provided. No clinical test set.

8. The sample size for the training set:

Not applicable / Not provided. No training set for an AI algorithm is mentioned as this is a physical medical device.

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

Not applicable / Not provided. No training set for an AI algorithm is mentioned.

Summary of Non-Clinical Performance Data from the document:

The device's safety and effectiveness were demonstrated through compliance with various non-clinical standards:

Electrical Safety: AAMI ANSI ES60601-1:2005(R) 2012 and A1:2012
Laser Safety: IEC 60825-1:2007
Electromagnetic Compatibility: IEC 60601-1-2:2007
Sterilization: DIN EN ISO 11135-1:2014
Packaging Integrity: ASTM F1886/ F1886M-09:2013
Accelerated Ageing of Sterile Barrier: ASTM F1980-07:2011
Sterile Packaging: DIN EN 868-5:2009
Microbial Ranking of Porous Packaging Materials: ASTM F1608-00:2009
Biological Evaluation of EO Residuals: DIN ISO 10993-7:2009
Risk Management: ISO 14971: 2007 + Am 2010

The document concludes based on these non-clinical tests that the Cetus system is "as safe and effective as the predicate device."

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

September 27, 2017

A.R.C. Laser GmbH % Angela Thyzel General Manager Bessemer St. 14 Nurnberg, 90411 DE

Re: K170183

Trade/Device Name: Cetus System, Cetus Probe Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous Aspiration and Cutting Instrument Regulatory Class: Class II Product Code: HQE Dated: August 24, 2017 Received: August 24, 2017

Dear Angela Thyzel:

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

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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 (DICE) 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 Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) 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,

Bradley S. Cunningham -S

for Malvina Eydelman, M.D. 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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Indications for Use

510(k) Number (if known) K170183

Device Name Cetus System

Indications for Use (Describe)

The Cetus Laser System is indicated for use in phacofragmentation of the cataractous crystalline lens.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/1 description: The image is a logo for A.R.C. Laser. The logo is set against a blue background. The text "A.R.C." is in large, bold, white letters. Below that, the word "LASER" is in a white box. Underneath the box, the phrase "enlighten your surgery" is written in a smaller, cursive font.

K170183

510(k) SUMMARY

Title:	A.R.C. Cetus System
Submitter:	A.R.C. Laser GmbHBessemer St. 1490411, NurnbergGermany
Contact :	Angela Thyzel
Tittle :	General Manager
Phone :	0911-21779-0
Fax :	0911-21779-99
E-Mail:	a.thyzel@arclaser.de
Address:	Bessemer St. 1490411, NurnbergGermany
DatePrepared:	September 26, 2017
Device TradeName:	Cetus System
CommonName:	Phacofragmentation System
ClassificationName:	Vitreous aspiration and cutting instrument, ophthalmic
Device productcode:	HQE
DeviceClassification	21 CFR 886.4150
PredicateDevice:	Laser Photolysis System, K993154

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Image /page/4/Picture/1 description: The image features a logo for A.R.C. Laser, set against a vibrant blue background. The acronym "A.R.C." is prominently displayed in large, bold white letters, with the word "LASER" directly beneath it in a smaller, yet still noticeable, white font. Below the word "LASER" is a tagline in a cursive font that reads "enjoyed in your surgery".

Device Description:

Intended Use:

The Cetus Laser System is indicated for use in for phacofragmentation of the cataractous crystalline lens.

Substantial Equivalence:

The Cetus system have the same mechanism of action, same intended use and the same technological characteristics as the predicate device, the Laser Photolysis System (K993154). and that the minor differences should not raise concerns regarding safety and/ or effectiveness.

Specification lasersystem	Subject Device	Predicate
510(k) #	K170183	K993154
Manufacturer	A.R.C. Laser	A.R.C. Laser
Indications for Use	Intended for use inphacofragmentation of thecataractous crystalline lens	Intended for use inphacofragmentation of thecataractous crystalline lens
Submission includes	Cetus laser system & Cetus probeonly	Laser photolysis system, probe &phaco machine
Laser media	Nd: YAG	Nd: YAG
Mode of operation	Pulsed, Q-Switch	Pulsed, Q-Switch
Wavelength	1064 nm	1064 nm
Used in combination	with a probe and a Phaco machine	with a probe and a Phaco machine
Laser mechanism	Shockwave	Shockwave
Repetition rate	Max. 20Hz	Max. 20Hz
Laser Class	I	I
Pulse length	< 10 ns	< 10 ns
Mains supply	100V to 240V – 50/60 Hz	100V to 240V – 50/60 Hz
Cooling	Air, internal	Water, internal
Software	Integrated in system	From Phaco machine

Comparison Table - Cetus system & Laser Photolysis System

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Image /page/5/Picture/1 description: The image shows the logo for A.R.C. Laser. The logo is set against a blue background. The text "A.R.C." is in large, bold, white letters, with the word "LASER" directly underneath in a smaller font. Below that, the tagline "enjoy laser surgery" is written in a cursive font.

K170183

Specification	Subject Device	Predicate
Laser beam delivery	Quartz optical fiber 300um with laser probe	Quartz optical fiber 300um with laser probe
Dimensions system	H 13,5 cm. (5,31 in.) X W 47,8 cm.(18,8 in.) X L 42,1 cm. (16,5 in.)	H 16 cm. (6,3 in.) X W 47 cm.(18,5 in.) X L 56 cm. (22 in.)
Display	Digital touch screen	External in Phaco machine
Weight	12 Kg. (26.4 pounds)	18 Kg. (39.6 pounds)

Comparison Table - Cetus system & Laser Photolysis System (Continuation)

The Cetus system is a further development of its predicate (A.R.C. Laser Photolysis System, K993154). The predicate device (K993154) includes a laser system, a probe and a phaco machine. The current submission includes the laser system and the probe only. Additional minor differences between the subject and predicate systems include the cooling system (air vs. water), software (integrated vs. external), display, dimensions and weight as shown in the table above.

Non clinical Performance Data: Performance testing was conducted in order to demonstrate that the A.R.C. Cetus System is as safe and as effective as the cleared predicate device.

The Cetus system has been tested for Electrical Safety compliance to AAMI ANSI ES60601-1:2005(R) 2012 and A1:2012, for Laser Safety to IEC 60825-1:2007, for Electromagnetic Compatibility to IEC 60601-1-2:2007, Sterilization to DIN EN ISO 11135-1:2014, Packaging Integrity to ASTM F1886/ F1886M-09:2013, Accelerated ageing of sterile barrier to ASTM F1980-07:2011, Sterile Packaging to DIN EN 868-5:2009, Microbial ranking of porous packaging materials to ASTM F1608-00:2009, Biological evaluation of EO residuals to DIN ISO 10993-7:2009 and Risk Management been conducted according to ISO 14971: 2007 + Am 2010.

According to the test results provided in this submission, we conclude that the Cetus system is as safe and effective as the predicate device.

Clinical Performance Data: None

Regulation Number and Section

§ 886.4150 Vitreous aspiration and cutting instrument.

(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.