The Parcus Synd-EZ SS 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 SS 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 SS 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 Synd-EZ Ti, the Synd-EZ SS is easily adjusted for length and resists elongation without requiring knots to secure the fixation. The device is made from medical grade titanium, stainless steel and UHMWPE suture and is provided sterile.

AI/ML Overview

The provided text describes the Parcus Synd-EZ SS, a medical device intended for fracture repair and syndesmotic fixation. However, the document does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving the device meets them, especially in the context of AI/algorithm performance.

Here's what can be extracted and what is missing:

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

The document provides a general statement about performance testing but does not offer a table of specific acceptance criteria or quantitative performance metrics.

Acceptance Criteria	Reported Device Performance
Not explicit. The document states "Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions." The specific numerical thresholds for these evaluations are not provided.	"Results were compared with test data for the predicate device and demonstrated substantial equivalency." This indicates the device performed comparably to a predicate device, but specific performance numbers are absent.

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

This information is not available in the provided text. The document mentions "Devices were assembled to test blocks," implying laboratory testing, but does not specify the sample size or any data provenance related to human subjects or clinical data.

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 available in the provided text. The device described is a physical implant, not an AI or diagnostic tool that would typically involve expert-established ground truth for performance evaluation in the way you've framed the question. The "testing" referred to is mechanical.

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

This information is not available in the provided text. Adjudication methods are typically used in clinical trials or studies involving expert interpretation, which is not described here for this mechanical device.

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

This information is not available in the provided text. The device is a surgical implant and does not involve AI assistance for human readers. Therefore, an MRMC study related to AI effectiveness is not relevant to this device.

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

This information is not available in the provided text. The device is a physical implant and does not involve an algorithm.

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

The "ground truth" for this device's performance would be established through mechanical test standards and material properties. The document states that "Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions." This implies engineering and biomechanical testing, where the "ground truth" is defined by established engineering principles and benchmarks for such implants. It's not clinical "ground truth" in the sense of diagnosis or pathology.

8. The sample size for the training set

This information is not available in the provided text. The document describes a physical medical device, not an AI/machine learning model that would have a "training set."

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

This information is not available in the provided text. This question is not applicable as there is no mention of a training set or AI model.

Summary of what the document does indicate about performance:

Type of Study: Laboratory performance testing ("side by side with the predicate device").
Parameters Evaluated: Strength and elongation under cyclic loading and ultimate failure conditions.
Conclusion: The device "demonstrated substantial equivalency" to the predicate device (Parcus Synd-EZ Ti, K191783).
Other Testing: LAL (Limulus Amebocyte Lysate) testing for pyrogenicity and a biocompatibility assessment in alignment with ISO 10993-1 were also conducted.

This document focuses on the regulatory clearance for a physical medical device based on substantial equivalence to a predicate device, primarily through mechanical testing and biocompatibility assessments. It does not pertain to the evaluation of AI systems or diagnostic performance as implied by many of your questions.

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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K192964

Trade/Device Name: Parcus Synd-EZ SS Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: October 22, 2019 Received: October 23, 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

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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 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 (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 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. Acting Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality 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.

PSC Publishing Services (301) 443-6740

510(k) Number (if known)

Device Name

Parcus Synd-EZ SS

FORM FDA 3881 (7/17)

Indications for Use (Describe)

The Parcus Synd-EZ SS 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)


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	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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Surgical Innovation | Customer Driven

	510(k) Summary
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:	November 15, 2019
Device Trade Name:	Synd-EZ SS
Common Name:	Fastener, Fixation, Non-Degradable, Soft Tissue
Device Class:	Class II
Classification Name:	21 CFR 888.3040 - Product Code MBI
Predicate Device:	Parcus Synd-EZ Ti, K191783, October 9, 2019.

Device Description:

Intended Use:

Substantial Equivalence Summary:

The Synd-EZ SS is very similar to the predicate Parcus Medical Synd-EZ Ti in that they both utilize titanium and UHMWPE suture, are intended for the same indications and both utilize the same design. LAL testing was conducted on a representative device comprised of similar materials and it was concluded that the Synd-EZ SS does not raise any additional concerns regarding pyrogenicity. A biocompatibility assessment was

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Surgical Innovation | Customer Driven

conducted in alignment with FDA guidance regarding the use of ISO 10993-1. Based on this biocompatibility assessment, side by side performance testing, and further comparison with the predicate device, it is our determination that the Synd-EZ is substantially equivalent to the predicate device.

Summary Performance Data:

The Synd-EZ SS was evaluated and testing was conducted side by side with the predicate device. 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.