Salto Talaris Total Ankle Prosthesis : The Salto Total Ankle Prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatic, or degenerative arthritis. Components are intended for cemented use only.

Integra XT Revision Ankle Replacement System: The Integra XT Revision Ankle Replacement System is indicated as a total ankle replacement in revision surgeries only for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. Components are intended for cemented use only.

Device Description

The Integra Salto Total Ankle System (Salto Talaris Total Ankle Prosthesis and the Integra XT Revision Ankle Replacement System) is a semi-constrained anatomical design. Both subsystems consist of two mating components: a metal tibial base in association with a conforming polyethylene articulating insert, and a metal talar resurfacing component.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA for a medical device called the "Integra Salto Total Ankle System." It's a clearance letter, not a study report. Therefore, it does not contain the detailed information necessary to describe acceptance criteria and a study proving device performance in the context of an AI-powered diagnostic device, as the prompt requests.

The document discusses the substantial equivalence of the Integra Salto Total Ankle System to a predicate device, based on material, intended use, fundamental scientific technology, and functional/technological characteristics.

Specifically, it states:

"Nonclinical Performance Data": The Salto Talaris Total Ankle Prosthesis and Integra XT Revision Ankle Replacement System were subjected to verification per standard ASTM F2665 to establish equivalent performance in comparison to the predicate device, covering tests like Tibial Tray Fatigue, Tibial Tray/Insert Locking, Tibial Tray Bone Fixation, Talar Dome Bone Fixation, and Talar Dome Fatigue.
"Clinical Performance Data": "Clinical performance data is not required to demonstrate substantial equivalence to the predicate device."

Since this is a mechanical orthopedic device clearance and not an AI/diagnostic device, the concepts of acceptance criteria for AI performance (like sensitivity, specificity, AUC), sample sizes for test sets (in the context of images), expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable or present in this document.

Therefore, I cannot provide the requested information based on the provided text.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 18, 2018

Ascension Orthopedics, Inc. Divya Savant Regulatory Affairs Specialist 311 Enterprise Drive Plainsboro, NJ 08536

Re: K182878

Trade/Device Name: Integra Salto Total Ankle System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSN Dated: November 20, 2018 Received: November 27, 2018

Dear Divya Savant:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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,

Peter G.
Allen -S
Digitally signed by Peter
G. Allen -S
Date: 2018.12.18
12:57:01 -05'00'

FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K182878

Device Name Integra Salto Total Ankle System

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the Integra logo. The word "INTEGRA" is written in gray, with the tagline "LIMIT UNCERTAINTY" underneath. To the right of the text is a column of green squares of varying sizes.

510(k) Summary

Sponsor	Ascension Orthopedics11101 Metric BlvdAustin, Texas 78758
EstablishmentNumber	3014207283
Point of Contact	Divya SavantSpecialist, Regulatory Affairs609-936-6968311 Enterprise DrivePlainsboro, NJ 08536
Date	12/7/2018

Trade Name (s)	Integra Salto Total Ankle System: Salto Talaris Total AnkleProsthesis & Integra XT Revision Ankle Replacement System
Common Name	Total Ankle Prosthesis
Classification Panel	Orthopedic
Classification	Class II
Classification Name	Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis
Regulation	21 CFR 888.3110
Product Code	HSN
Predicate Device	K153452: Salto Talaris, Salto XT
Reference Device	K151459: Integra Cadence Total Ankle Replacement System

Device Description The Integra Salto Total Ankle System (Salto Talaris Total Ankle Prosthesis and the Integra XT Revision Ankle Replacement System) is a semi-constrained anatomical design. Both subsystems consist of two mating components: a metal tibial base in association with a conforming polyethylene articulating insert, and a metal talar resurfacing component.
Salto Talaris Total Ankle Prosthesis: The Salto Talaris Total Ankle Intended Use Prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Components are intended for cemented use only.

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Image /page/4/Picture/1 description: The image shows the Integra logo. The word "INTEGRA" is written in gray, and below it, in smaller letters, is the phrase "LIMIT UNCERTAINTY". To the right of the word "INTEGRA" are four green squares of varying sizes, arranged in a descending order.

	Integra XT Revision Ankle Replacement System: The Integra XTRevision Ankle Replacement System is indicated as a total anklereplacement in revision surgeries only for patients with ankle jointsdamaged by severe rheumatoid, post-traumatic, or degenerative arthritis.Components are intended for cemented use only.
NonclinicalPerformance Data	The Salto Talaris Total Ankle Prosthesis and Integra XT RevisionAnkle Replacement System were subjected to verification per standardASTM F2665 to establish equivalent performance in comparison to thepredicate device.1. Tibial Tray Fatigue2. Tibial Tray/Insert Locking3. Tibial Tray Bone Fixation4. Talar Dome Bone Fixation5. Talar Dome Fatigue
ClinicalPerformance Data	Clinical performance data is not required to demonstrate substantialequivalence to the predicate device.
SubstantialEquivalenceConclusion	Substantial equivalence of the subject device and predicate device isbased on the following:The modified device and predicate device have the same material. The modified devices and predicated devices have the same intended use. The devices operate using the same fundamental scientific technology. The devices share the same functional and technological characteristics via the same operational principles. There are no new questions of safety or effectiveness.In conclusion, the modified device and predicate device are both semi-constrained, total ankle arthroplasty systems that have the same intended use, fundamental scientific technology, and materials of construction.

Regulation Number and Section

§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.