The Paragon 28 MAVEN™ Patient-Specific Instrumentation is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. The Paragon 28 MAVENTM Patient-Specific Instrumentation is intended for use with the Paragon 28 APEX 3D Total Ankle Replacement System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans. The Paragon 28 MAVEN™ Patient-Specific Instrumentation is intended for single use only. The Paragon 28 TAR Patient-Specific Case Reports are intended for use with the Paragon 28 APEX 3D Total Ankle Replacement System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.

Device Description

The Paragon 28 MAVENTM Patient-Specific Instrumentation is used in conjunction with the APEX 3D Total Ankle Replacement System instrumentation (K192994). The guides are created to fit the anatomy of the patient's distal tibia and proximal talus, and when used in combination with the APEX 3D instruments, facilitate positioning of the APEX 3D implants.

AI/ML Overview

The provided text is a 510(k) Summary for the Paragon 28 MAVEN™ Patient-Specific Instrumentation. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance data. However, the document does not contain the detailed acceptance criteria or the specifics of the study that proves the device meets those criteria in the format requested.

Here's a breakdown of what is and is not available in the provided text:

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

Not available. The document states that "The device performance was characterized via Guide Design Process Validation, Pre-operative vs Post-Operative Analysis of Implant Placement and Resection Location, and Software Validation." However, it does not provide specific acceptance criteria (e.g., maximum allowable deviation for implant placement) or the quantitative results of these performance characterizations.

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

Not available. The document mentions "Pre-operative vs Post-Operative Analysis of Implant Placement and Resection Location" but does not specify the sample size of patients or images used for this analysis, nor does it describe the data provenance.

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 available. The document does not describe any expert-based ground truth establishment or the involvement of experts in the performance characterization studies.

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

Not available. Since no explicit ground truth establishment process involving experts is described, there is no mention of an adjudication method.

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 available. The document describes a "Patient-Specific Instrumentation" (PSI) system, which is a physical guide to assist surgeons, not an AI-assisted diagnostic or interpretation tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device type.

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

Not applicable/Not explicitly stated. The device is "Patient-Specific Instrumentation" intended to be used intraoperatively by surgeons. While there is a "Software Validation" mentioned, the performance characterization seems to be related to the accuracy of the physical guides and the resulting implant placement, rather than a standalone algorithm's diagnostic performance. The document itself focuses on the instrument's ability to facilitate positioning, inherently a human-in-the-loop process.

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

Inferred, but not explicitly stated. For "Pre-operative vs Post-Operative Analysis of Implant Placement and Resection Location," the ground truth would likely be the intended implant placement/resection location based on the surgical plan (pre-operative) compared to the actual post-operative placement, possibly verified by post-operative imaging. However, the document does not explicitly define how this "ground truth" was established or measured.

8. The sample size for the training set

Not applicable/Not available. As this device is a patient-specific surgical instrumentation system rather than a machine learning model that requires a training set, the concept of a training set sample size is not relevant in the context usually meant for AI/ML devices. The "Guide Design Process Validation" implies internal software validation, but not a training set for an AI model.

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

Not applicable/Not available. See point 8.

In summary, the provided document offers a high-level overview of the device and its claimed equivalence but lacks the granular details of performance criteria and study results requested. It indicates that "Clinical data are not needed to support the safety and effectiveness of the subject device," suggesting that the performance data presented (Guide Design Process Validation, Pre-operative vs Post-Operative Analysis, Software Validation) were considered sufficient without specific clinical trials.

Summary

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January 14, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image 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.

Paragon 28, Inc. % Dave McGurl Director, Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW. Suite 1000 Washington, District of Columbia 20001

Re: K202019

Trade/Device Name: Paragon 28 MAVENTM Patient-Specific Instrumentation Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSN, OYK Dated: December 8, 2020 Received: December 9, 2020

Dear Dave McGurl:

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,

Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202019

Device Name

Paragon 28 MAVEN™ Patient-Specific Instrumentation

Indications for Use (Describe)

The Paragon 28 MAVEN™ Patient-Specific Instrumentation is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. The Paragon 28 MAVEN™ Patient-Specific Instrumentation is intended for use with the Paragon 28 APEX 3D Total Ankle Replacement System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans. The Paragon 28 MAVEN™ Patient-Specific Instrumentation is intended for single use only. The Paragon 28 TAR Patient-Specific Case Reports are intended for use with the Paragon 28 APEX 3D Total Ankle Replacement System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Paragon 28 MAVEN™ Patient-Specific Instrumentation - Traditional 510(k)

510(k) Summary

Manufacturer:	Paragon 28, Inc.14445 Grasslands Dr.,Englewood, CO 80112
Contact:	Ms. Haylie HertzRegulatory Affairs SpecialistPhone: 855-786-2828hhertz@paragon28.com
Correspondent:	Musculoskeletal Clinical Regulatory Advisers, LLC1050 K Street, NW, Suite 1000Washington, DC 20001Phone: 202.552.5800
Date Prepared:	January 14, 2021
510(k) Number:	K202019
Device Trade Name:	Paragon 28 MAVEN™ Patient-Specific Instrumentation
Device Common Name:	Total Ankle Prosthesis
Classification:	21 CFR 888.3110Class II
Product Code:	HSN, OYK

Indications for Use:

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K202019 Page 2 of 2

Paragon 28 MAVEN™ Patient-Specific Instrumentation – Traditional 510(k)

anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.

Device Description:

Predicate Devices:

The Paragon 28 MAVEN™ Patient-Specific Instrumentation is substantially equivalent to the PROPEHCY INFINITY Pre-Operative Navigation System (K170968). The APEX 3D Total Ankle Replacement System (K192994) is an additional predicate device and VSP Orthopedics System (K190044) is considered a reference device.

Technological Characteristics:

The subject Paragon 28 MAVEN Patient-Specific Instrumentation components possess the same technological characteristics as the predicate devices. These include:

. performance,
basic design, .
material, manufacturing and ●
sizes (dimensions are comparable to those offered by the predicate systems). ●

Differences between the MAVEN Patient-Specific Instrumentation and the predicate devices were shown not to raise new questions of safety and effectiveness. Therefore, the fundamental scientific technology of the subject Paragon 28 MAVEN Patient-Specific Instrumentation is similar to previously cleared devices.

Performance Data:

All necessary testing has been performed on representative Paratrooper™ Plantar Plate Repair System components to assure substantial equivalence to its predicate and demonstrate the subject device performs as intended. All testing was performed on finished devices.

The device performance was characterized via Guide Design Process Validation, Pre-operative vs Post-Operative Analysis of Implant Placement and Resection Location, and Software Validation. Clinical data are not needed to support the safety and effectiveness of the subject device.

Conclusion:

Performance testing demonstrates the substantial equivalence of the Paragon 28 MAVEN Patient-Specific Instrumentation to the Wright Medical PROPEHCY INFINITY Pre-Operative Navigation System. Therefore, the MAVEN PSI System is substantially equivalent to the predicate devices with respect to their indications for use, technical characteristics, and function.

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.