The Parcus Synd-EZ Ti is intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

The Parcus Synd-EZ Ti is intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of the syndesmosis (syndesmosis disruptions) in connection with Weber B and Weber C ankle fractures.

Device Description

The Parcus Synd-EZ Ti consists of two buttons with suture connecting them and are designed to be used for stabilizing the syndesmosis during healing. Building upon the technology of the Parcus GFS Ultimate, the Synd-EZ Ti is easily adjusted for length and resists elongation without requiring knots to secure the fixation. The device is made from medical grade titanium and UHMWPE suture and is provided sterile.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Parcus Synd-EZ Ti device:

Based on the provided FDA 510(k) summary (K191783), there are no mentions of AI assistance, expert readers, or ground truth establishment in a medical imaging context. This document describes a medical device, the Parcus Synd-EZ Ti, which is a hardware implant for syndesmosis fixation, and not a software device or an AI/ML algorithm.

Therefore, many of the requested criteria related to AI/ML software performance are not applicable to this submission. The 510(k) summary focuses on the physical and mechanical properties of the device.

Here's the information that can be extracted from the provided text, adapted to the closest relevant categories:

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

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Mechanical Strength	Resist elongation under cyclic loading conditions.	Evaluated for strength and elongation under cycle loading and ultimate failure conditions. Results "demonstrated substantial equivalency" to the predicate device.
Ultimate Failure	Withstand ultimate failure conditions.	Evaluated for strength and elongation under cycle loading and ultimate failure conditions. Results "demonstrated substantial equivalency" to the predicate device.
Material Biocompatibility	Made from medical grade materials.	Made from medical grade titanium and UHMWPE suture.
Pyrogenicity	Non-pyrogenic.	LAL testing conducted on a representative device concluded that the Synd-EZ Ti "does not raise any additional concerns regarding pyrogenicity."

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

Sample Size: The document states "Devices were assembled to test blocks" and "testing was conducted on the worst case configurations." It does not specify a numerical sample size (e.g., number of devices tested).
Data Provenance: Not explicitly stated, but it's implied that the testing was conducted by the manufacturer, Parcus Medical, LLC, which is based in Sarasota, Florida, USA. The testing is prospective for the purpose of demonstrating substantial equivalence to the predicate.

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. This device is a mechanical implant, not a diagnostic imaging aid. Ground truth was established by direct physical measurement and material testing, not expert interpretation of medical images.

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

Not applicable. This is not a study involving human readers or interpretation. The performance data is derived from mechanical testing.

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. This is not an AI-assisted device, nor does the document describe any human reader effectiveness studies.

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

Not applicable. This device is not an algorithm. Performance refers to the physical characteristics of the implant.

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

The "ground truth" for this device's performance would be the direct physical and mechanical properties measured during the testing (e.g., actual tensile strength, elongation, pyrogenicity test results). These are objective, quantifiable measurements from material science and engineering, not medical interpretation categories.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. There is no training set for this type of device.

Summary

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Parcus Medical, LLC Paul Vagts Director of Regulatory Affairs 6423 Parkland Drive Sarasota, Florida 34243

Re: K191783

Trade/Device Name: Parcus Synd-EZ Ti Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HTN Dated: September 9, 2019 Received: September 10, 2019

Dear Mr. Vagts:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Laurence D. Coyne, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K191783

Device Name

Parcus Synd-EZ Ti

Indications for Use (Describe)

The Parcus Synd-EZ Ti is intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of the syndesmosis disruptions) in connection with Weber B and Weber C ankle fractures.

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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Image /page/3/Picture/0 description: The image shows the logo for PARCUS MEDICAL, LLC. The word "PARCUS" is in large, blue, sans-serif font, with a red square to the left of the word. Below the word "PARCUS" is the phrase "MEDICAL, LLC." in a smaller, blue, sans-serif font.

Surgical Innovation | Customer Driven

510(k) Summary – K191783
510(k) Owner & Submitter:	Parcus Medical, LLC
	6423 Parkland Dr
	Sarasota, FL 34243
Company Contact:	Paul Vagts
	Phone: (941)755-7965
	Fax: (941)755-6543
Date Prepared:	September 9th, 2019
Device Trade Name:	Synd_EZ Ti
Common Name:	Fastener, Fixation, Non-Degradable, Soft Tissue
Device Class:	Class II
Classification Name:	21 CFR 888.3040 - Product Code MBI
Predicate Device:	Parcus GFS Ultimate, K162198, cleared 11/18/16,Arthrex Tightrope™ Syndesmosis Device, K043248,2/16/2005

Device Description:

Intended Use:

Substantial Equivalence Summary:

The Synd-EZ Ti is very similar to the predicate Parcus Medical GFS Ultimate in that it is comprised of the same materials, intended for the same indications and utilizes similar designs. LAL testing was conducted on a representative device and it was concluded that the Synd-EZ Ti does not raise any additional concerns regarding pyrogenicity.

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Image /page/4/Picture/0 description: The image shows the logo for "PARCUS MEDICAL, LLC.". The word "PARCUS" is in large, bold, blue font. To the left of the word is a red square with a white line running through it. Below the word "PARCUS" is the phrase "MEDICAL, LLC." in a smaller, blue font.

Surgical Innovation | Customer Driven

Summary Performance Data:

The Synd-EZ Ti was evaluated and testing was conducted on the worst case configurations. Devices were assembled to test blocks and placed in a test fixture. Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions. Results were compared with test data for the predicate device and demonstrated substantial equivalency.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.