The restor3d MTP Implant is intended for use as a hemi-arthroplasty implant for the first metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The device is a single use implant intended to be press fit with optional use of bone cement.

Device Description

The restor3d MTP Implant is a sterile, single use implant grade metal device, available in varied articulating surface coverages. The restor3d MTP implant is designed to replace damaged articulating surface of the first metatarsal distal head. The device is intended for the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head. This implant can also be used in the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The implant is a single use product intended to be press fit, with optional use of bone cement.

The restor3d MTP Implant is comprised of a single laser powder bed fusion (LPBF) printed cobalt-chromium alloy (Co28Cr6Mo) part. The external surface of the implant that is intended to be in contact with the phalanx is mirror polished.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "restor3d MTP Implant". It focuses on establishing substantial equivalence to a predicate device rather than describing an AI/ML powered device or a comparative effectiveness study involving human readers. Therefore, much of the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes for test/training sets, expert involvement, and ground truth establishment is not present in this document.

However, I can extract the information related to the device's performance testing to support its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a typical "Pass/Fail" format. Instead, it describes a set of performance tests conducted to demonstrate substantial equivalence to a predicate device. The implied acceptance is that the restor3d MTP Implant performs similarly to or meets the standards demonstrated by the predicate device for the specified tests.

Acceptance Criteria (Implied)	Reported Device Performance
Comparable performance to predicate device in monotonic compression-subsidence	Performance was sufficient to support the assertion of substantial equivalence.
Comparable performance to predicate device in monotonic compression	Performance was sufficient to support the assertion of substantial equivalence.
Comparable performance to predicate device in monotonic bending-pullout	Performance was sufficient to support the assertion of substantial equivalence.
No significant difference from predicate device in monotonic bending	Performance was sufficient to support the assertion of substantial equivalence.
Acceptable surface roughness characteristics	Analysis was conducted, and performance was sufficient to support the assertion of substantial equivalence.
Acceptable performance in monotonic shear, shear fatigue, and abrasion for modified metallic surfaces	Tests were conducted, and performance was sufficient to support the assertion of substantial equivalence.
Acceptable performance in gravimetric and comparative particulate analysis	Tests were conducted, and performance was sufficient to support the assertion of substantial equivalence.
No new questions of safety or effectiveness identified during testing.	No new questions of safety or effectiveness were identified.

2. Sample size used for the test set and the data provenance

This document does not describe tests related to AI/ML or diagnostic performance based on data sets. The tests mentioned are mechanical and material property tests of the physical implant. Therefore, "sample size for the test set" in the context of image data or patient data, and "data provenance" (country of origin, retrospective/prospective) are not applicable or mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as this is a physical medical device (implant) and the document describes mechanical/material testing, not diagnostic performance evaluated by experts.

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

Not applicable. Adjudication methods are typically used for reconciling expert opinions in diagnostic studies, which is not the subject of this submission.

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 document is for a physical orthopedic implant, not an AI/ML-powered diagnostic tool.

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

Not applicable. This document is for a physical orthopedic implant, not an AI/ML algorithm.

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

For the mechanical and material tests described, the "ground truth" would be established by adherence to recognized engineering standards and test methods. For example, material properties are verified against industry standards for cobalt-chromium alloys, and mechanical tests (compression, bending, shear, fatigue, abrasion) would be assessed against benchmarks derived from the predicate device's performance or industry-accepted performance criteria for such implants. The document does not specify these detailed standards but implies compliance with generally accepted testing methodologies for orthopedic implants.

8. The sample size for the training set

Not applicable. There is no mention of an AI/ML component or a training set.

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

Not applicable. There is no mention of an AI/ML component or a training set.

Summary

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May 25, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Restor3d, Inc. Jillian Udell Product Manager 311 W Corporation St Durham, North Carolina 27701

Re: K201393

Trade/Device Name: restor3d MTP Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe Joint Phalangeal (Hemi-Toe) Polymer Prosthesis Regulatory Class: Class II Product Code: KWD Dated: May 16, 2022 Received: May 18, 2022

Dear Nathan Evans:

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 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, 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) K201393

Device Name restor3d MTP Implant

Indications for Use (Describe)

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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Prescription Use (Part 21 CFR 801 Subpart D)

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

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Traditional 510(k) Page 5-1 of 3

510(k) Summary

510(k) Number: K201393

Date Prepared: May 16, 2022

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

A. Submitter: restor3d, inc., 311 W Corporation St Durham, NC 27701 (984) 888-0593
B. Company Contact: Jillian Udell Product Manager 984-888-0593 jillian@restor3d.com

C.	Device Information:
	Trade Name:	restor3d MTP Implant
	Common Name:	MTP Arthroplasty Implant
D.	Classification:	MTP Arthroplasty Implant
		21 CFR 888.3730

E. Predicate Device(s): Metatarsal Decompression Implant™, K090127

F. Physical Description:

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Indications for Use: G.

The restor3d MTP Implant is intended for use as a hemi-arthroplasty implant for the first metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The device is a single use implant intended to be press fit, with optional use of bone cement.

Comparison of Characteristics / Performance Testing / Substantial H. Equivalence:

The restor3d MTP Implant is substantially equivalent to the predicate device (Metatarsal Decompression Implant™, K090127) in intended use and important physical and performance specifications. The devices have similar design / physical characteristics (i.e., similar articulating surface, presence of stem) and similar indications for use. The proposed restor3d device was subjected to the following performance tests to support the assertion of substantial equivalence:

Comparative monotonic compression-subsidence test
Monotonic compression test
Comparative monotonic bending-pullout test
Monotonic bending test
Surface roughness analysis
Monotonic shear, shear fatigue, and abrasion tests for modified metallic surfaces
Gravimetric and comparative particulate analysis tests

No new questions of safety or effectiveness were identified during device testing; therefore, the restor3d MTP Implant is considered substantially equivalent to the predicate device.

Piliin Udell 05/16/2021

Jillian Udell Product Manager

311 W Corporation St Durham, NC 27701 984-888-0593

restor3d, inc.

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K201393 Page 3 of 3

Traditional 510(k) Page 5-3 of 3

984-888-0593 jillian@restor3d.com

311 W Corporation St Durham, NC 27701 984-888-0593

Regulation Number and Section

§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.

(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.