The PHAKOS Disposable Retinal Cryo Probe and Accessories is for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, and cryo destruction of lash follicles for trichiasis.

Device Description

The cryoprobe adapter is a mechanical accessory used to adapt the PHAKOS Disposable Retinal Cryo Probe to different cryosurgery generators found on the market; it is connected to the cryoprobe connector on the generator. The rear end piece receiving the cryoprobe is the same for all adapters; the body varies according to the generator used. The adapter is fitted on the generator in the place of the original cryoprobe, and remains in position, while the PHAKOS Disposable Retinal Cryo Probe is plugged into the universal rear end piece.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Frigitronics Adapter." It describes the device, its intended use, and demonstrates its substantial equivalence to previously marketed predicate devices.

Based on the provided text, there is no information about a study proving the device meets acceptance criteria related to AI/algorithm performance.

The document states: "No clinical studies were performed" and the "Non-clinical Test Summary" only mentions "creation of the ice ball" and that "The results of these evaluations indicate that the Frigitronics Adapter is equivalent to predicate devices."

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-powered device, as this document pertains to a mechanical adapter and not an AI/algorithm-driven device.

To directly answer your prompt based on the provided text, the following points are relevant:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document assesses substantial equivalence based on intended use, design, materials, mechanical safety, and performance (evidenced by ice ball creation), not specific performance metrics against pre-defined quantitative acceptance criteria in the context of an AI/algorithmic output.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set for an AI/algorithm is described.
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 ground truth for an AI/algorithm test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. No multi-reader study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary

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March 16, 2018

Phakos % J D Webb Authorized Contact Person The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681

Re: K180195

Trade/Device Name: Frigitronics adapter Regulation Number: 21 CFR 886.4170 Regulation Name: Cryophthalmic unit Regulatory Class: Class II Product Code: HRN Dated: January 19, 2018 Received: January 24, 2018

Dear J D Webb:

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.

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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 devicerelated 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.

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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) 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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bradley S. Cunningham -S

for Malvina B. 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) K180195

Device Name Frigitronics Adapter

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary: Frigitronics Adapter

Date Prepared	March 09, 2018
Submitted By	PHAKOS62 Rue Kléber93100 MontreuilFRANCEo.aumaitre@phakos.com
Primary Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Telee-mail: jdwebb@orthomedix.net
Trade Name	Frigitronics Adapter
Common Name	cryomatic probe adapter
Classification Name	Unit, Cryophthalmic, Ac-powered
Class	II
Product Code	HRN
CFR Section	21 CFR section 886.4170
Device Panel	Ophthalmic
Primary PredicateDevice	PHAKOS Disposable Retinal Cryo Probe (K162756)
Device Description	The cryoprobe adapter is a mechanical accessory used to adapt the PHAKOS DisposableRetinal Cryo Probe to different cryosurgery generators found on the market; it is connectedto the cryoprobe connector on the generator. The rear end piece receiving the cryoprobeis the same for all adapters; the body varies according to the generator used.The adapter is fitted on the generator in the place of the original cryoprobe, and remainsin position, while the PHAKOS Disposable Retinal Cryo Probe is plugged into the universalrear end piece.
Materials	Stainless steel per ASTM F899Polyoxymethylene (acetal) per ASTM D6778
SubstantialEquivalence Claimedto Predicate Devices	The Frigitronics Adapter is substantially equivalent to the predicate devices in terms ofintended use, design, materials used, mechanical safety and performances.
Summary of thetechnologicalcharacteristicscompared topredicate	Criteria	Demonstration of Equivalency
	Intended Use	The intended use of the Frigitronics Adapter is the same as the other Phakos adapters.
	Material	The PHAKOS Frigitronics Adapter uses the same material as the other PHAKOS adapters.
	Design	The Frigitronics Adapter and the other PHAKOS adapters are equivalent in terms of shape,
	Disposable probeconnection	The disposable cryo probes are connected to the console via the Frigitronics Adapter and the other PHAKOS adapters.
Non-clinical TestSummary	The following analyses were conducted:• creation of the ice ball
	The results of these evaluations indicate that the Frigitronics Adapter is equivalent to predicate devices.
Clinical TestSummary	No clinical studies were performed
Conclusions: Non-clinical and Clinical	PHAKOS considers the Frigitronics Adapter to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

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Regulation Number and Section

§ 886.4170 Cryophthalmic unit.

(a)
Identification. A cryophthalmic unit is a device that is a probe with a small tip that becomes extremely cold through the controlled use of a refrigerant or gas. The device may be AC-powered. The device is intended to remove cataracts by the formation of an adherent ice ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumors.(b)
Classification. Class II.