The MAVEN™ Patient-Specific Instrumentation System 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 MAVEN™ Patient- Specific Instrumentation System is intended for use with the Paragon 28® APEX 3D™ Total Ankle Replacement System and its cleared indications for use, provided that anatomic landment and positioning of the implant are identifiable on patient imaging CT scans. The MAVEN™ Patient- Specific Instrumentation System 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® MAVEN™ Patient Specific Instrumentation (PSI) system is intended to assist a surgeon with pre-operative planning and transfer of the pre-operative plan to the surgery in total ankle replacement procedures. The system contains several physical and digital outputs including patient-specific anatomical models and guides (physical outputs); and a patient-specific case report (digital or documentation output).

The MAVEN™ PSI System is for use with the APEX 3D™ Total Ankle Replacement System.

AI/ML Overview

This document describes a 510(k) premarket notification for the MAVEN™ Patient-Specific Instrumentation system. The notification seeks to demonstrate substantial equivalence to a previously cleared device, not to introduce a new device requiring extensive clinical trials to prove its performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, and MRMC studies is not applicable to this specific submission.

The core of this 510(k) is a Special 510(k), which signifies a modification to an already cleared device. The purpose is not to prove the device meets pre-defined performance metrics for a new claim, but rather to demonstrate that specific minor changes (material and supplier) to an existing device do not alter its safety or effectiveness.

Here's an analysis of the provided text in relation to your request:

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

Not Applicable. This 510(k) is a Special 510(k) for a modification (material and supplier), not a submission for a novel device that requires establishing new performance acceptance criteria and then proving the device meets them through clinical or comprehensive performance studies for initial market clearance. The company conducted an internal "design and manufacturing process validation" to ensure the changes did not alter "the creation of a patient specific instrument," but no specific numerical performance metrics or acceptance criteria are reported in this summary for the altered device.

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

Not Applicable in the context of a clinical test set. The document states: "The company conducted a design and manufacturing process validation, to demonstrate that the changes presented within this premarket submission, did not change the outputs, which is the creation of a patient specific instrument." This suggests internal engineering or manufacturing validation, not a patient-based test set from a clinical study. Therefore, no information on sample size, origin, or retrospective/prospective nature is provided for a "test set" in the sense of clinical performance evaluation.

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. As no clinical "test set" for performance evaluation against a specific clinical claim is described, there's no mention of experts establishing ground truth for such a set.

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

Not Applicable. No clinical test set.

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. The MAVEN™ Patient-Specific Instrumentation system is described as assisting in positioning and guiding bone marking, it's not described as an AI-powered diagnostic or assistive tool for human readers (like radiologists interpreting images). An MRMC study would be irrelevant for this device's described function and the nature of this 510(k) submission.

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

Not Applicable. The device is patient-specific instrumentation intended to assist surgeons (human-in-the-loop) in the operating room. It's not a standalone algorithm performing a task without human intervention for which performance would be evaluated in isolation.

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

Not Applicable. No clinical ground truth is established or reported for this Special 510(k). The "ground truth" relevant to this submission would be internal engineering specifications or manufacturing quality controls, ensuring the changed materials/suppliers still result in instruments that meet original design parameters, but this is not detailed.

8. The sample size for the training set

Not Applicable. The MAVEN™ System creates patient-specific instruments based on imaging (CT scans) of individual patients. It's not an AI model that undergoes a "training set" in the machine learning sense. The device is customized for each patient, not trained on a general dataset.

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

Not Applicable. As there is no training set in the AI sense, there is no ground truth established for it. The "ground truth" for the device's function relies on the accuracy of the patient's CT scan and the accuracy of the surgical planning software to generate the instrument.

Summary specific to this document:

This 510(k) is a Special 510(k). Its purpose is to demonstrate that a minor modification (change in material grade of nylon and OTS design software) to an already cleared device (K202019) does not raise new questions of safety or effectiveness. The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...".

The "Performance Data" section of the 510(k) summary only states: "The company conducted a design and manufacturing process validation, to demonstrate that the changes presented within this premarket submission, did not change the outputs, which is the creation of a patient specific instrument. The validation successfully demonstrated the minor changes made to the subject device are substantially equivalent to the predicate." This refers to internal validation of manufacturing processes and design outputs, not a clinical study to meet acceptance criteria for a new device.

Summary

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November 17, 2022

Paragon 28, Inc. % Jan Triani Regulatory Affairs Consultant Triani Consulting, LLC 14445 Grasslands Drive Englewood, Colorado 80112

Re: K223227

Trade/Device Name: 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: October 17, 2022 Received: October 18, 2022

Dear Jan Triani:

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

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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 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 medical devices and radiation-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 -S

Ting Song, Ph.D. 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) K223227

Device Name MAVEN™ Patient Specific Instrumentation

Indications for Use (Describe)

The MAVEN™ Patient-Specific Instrumentation System 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 MAVEN™ Patient- Specific Instrumentation System is intended for use with the Paragon 28® APEX 3D™ Total Ankle Replacement System and its cleared indications for use, provided that anatomic landment and positioning of the implant are identifiable on patient imaging CT scans. The MAVEN™ Patient-Specific Instrumentation System 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.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

Paragon 28, Inc. MAVEN Patient Specific Instrumentation

Manufacturer:	Paragon 28, Inc14445 Grasslands, Dr.Englewood, CO 80112Phone: 855-786-2525
Official Contact:	Jan TrianiRegulatory ConsultantPatient Specific, Paragon 28, Inc.
Date Prepared:	October 11 ,2022
Device Trade Name:	Paragon 28 MAVEN™ Patient-Specific Instrumentation
Device Common Name:	Patient Specific Guide
Classification:	21 CFR 888.3110
Product Code:	HSN, OYK

Purpose of the Special 510(k) notice:

The modification to the subject device is to allow an additional material and supplier to make the subject device.

Intended Use

The intended use and indication are the same as the main predicate device. K202019. Indications are:

The MAVEN™ Patient-Specific Instrumentation System 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 MAVEN™ marking of bone before cutting. The Patient-Specific Instrumentation System is intended for use with the Paragon 28® APEX 3D™ Replacement System indications Total Ankle and its cleared for use, provided that anatomic landmarks necessary for alignment and positioning of the MAVEN™ implant are identifiable on patient imaging CT scans. The Patient-Specific Instrumentation System is intended for single use only. The 286 TAR Patient-Specific Case Reports are intended Paragon for use with the Paragon 28® APEX 3D™ Total Ankle Replacement System and its that anatomic landmarks necessary cleared indications for use, provided for alignment and positioning of the implant are identifiable on patient imaging CT scans.

Device Description

The Paragon 28® MAVEN™ Patient Specific Instrumentation (PSI) system is intended to assist a surgeon with pre-operative planning and transfer of the pre-operative plan to the surgery in total

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ankle replacement procedures. The system contains several physical and digital outputs including patient-specific anatomical models and guides (physical outputs); and a patient-specific case report (digital or documentation output).

The MAVEN™ PSI System is for use with the APEX 3D™ Total Ankle Replacement System.

Performance Data

The company conducted a design and manufacturing process validation, to demonstrate that the changes presented within this premarket submission, did not change the outputs, which is the creation of a patient specific instrument. The validation successfully demonstrated the minor changes made to the subject device are substantially equivalent to the predicate.

Substantial Equivalence

The modification made to the MAVEN Patient Specific Instrumentation are minor. The subject device has the same intended use and same indications, and principles of operation, as the primary predicate (K202019). The minor differences in the grade of nylon and OTS design software do not raise any new questions of safety or effectiveness. The subject device is made by the same supplier, from the same nylon material and manufacturing methods, and uses the same software as the secondary predicate (K211076). Performance data demonstrates that the subject device is as safe and effective as the predicate devices. Thus, the subject device is substantially equivalent to its predicate devices.

Conclusions

In summary, the company's modified MAVEN Patient Specific Instrumentation has the same intended use as all of the previously cleared MAVEN Patient Specific Instrumentation (K202019). In addition, the modified device has the same indications, technological characteristics, and principles of operation as its primary predicate. Although there are minor differences between the subject and its primary predicate device, namely the grade of nylon material and the OTS software used by the design engineers, those differences do not raise new questions of safety or efficacy, and data provided in this and previous 510(k)s establish equivalence. Thus, the subject device is substantially equivalent.

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.