The Arthrosurface Total Wrist Arthroplasty System is indicated for replacement of the painful wrist joint due to rheumatoid arthritis, oseto-arthritis, or post-traumatic arthritis.

The device is a single-use implant intended to be used with bone cement.

Device Description

The Arthrosurface Total Wrist Arthroplasty (TWA) System is a modular joint restoration system that consists of both a radial implant assembly and carpal implant assembly. The radial implant assembly is comprised of a metallic stemmed tray component and Ultra-High-Molecular-Weight-Polyethylene (UHMWPE) articular component. The carpal implant assembly consists of a taper post component, a carpal plate, an articular component and two auxiliary bone screw components, all of which are metallic. The system is designed to replace the radiocarpal joint (distal radius and proximal row of carpal bones) and is intended to alleviate pain while restoring functionality and mobility of the joint.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Arthrosurface WristMotion Total Wrist Arthroplasty System. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a study proving the device meets specific performance criteria as would be found for a novel device.

Therefore, many of the requested details, particularly regarding acceptance criteria with reported performance, sample sizes for test and training sets, expert qualifications, and specific AI-related comparative effectiveness or standalone studies, are not applicable or not explicitly provided in this type of regulatory document.

However, based on the information given, here's what can be extracted and inferred:

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

This information is not explicitly provided in a quantified table format in the document. The submission focuses on demonstrating substantial equivalence through non-clinical tests. The "Conclusion" states: "The results have demonstrated the safety and effectiveness of the Arthrosurface Total Wrist Arthroplasty System along with substantial equivalence to the predicate devices." This implies that the device met the performance expectations for these tests, but the specific acceptance criteria (e.g., maximum torque, minimum cycles) and the reported values are not detailed.

Specific Non-Clinical Tests Conducted (without acceptance criteria or reported performance):

Test Name	Acceptance Criteria (Not Provided)	Reported Performance (Not Provided)
Bone Screws – insertion & removal	N/A	N/A
Bone Screws – torsion to failure	N/A	N/A
Bone Screws – axial pullout	N/A	N/A
Assembly / Disassembly	N/A	N/A
Resistance to Torque	N/A	N/A
Static & Cyclic Edge Testing	N/A	N/A
Fretting Corrosion	N/A	N/A
Constraint testing (Subluxation)	N/A	N/A
Comparative Engineering Analyses (ROM, Contact Area etc.)	N/A	N/A
Kinetic Chromogenic LAL Test for Devices	Meets standard limit of 0.5 EU/mL or 20 EU/ Device per USP Chapter Bacterial Endotoxins Test, USP Chapter Transfusion and Infusion Assemblies and Similar Medical Devices, and AAMI ST72:2002/R2010, Bacterial Endotoxins-Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing.	N/A (implied met)

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: Not specified. The document mentions "non-clinical tests and/or analysis" but does not detail the number of samples used for each test.
Data Provenance: The tests are non-clinical, likely performed in a laboratory setting, so country of origin or retrospective/prospective nature of patient data is not applicable.

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 applicable as this submission is for a medical implant (arthroplasty system), not an AI/software device that requires expert-established ground truth for image interpretation or diagnosis. The "ground truth" for non-clinical device testing refers to engineering standards and physical measurements.

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

Not applicable for this type of non-clinical device testing. Adjudication methods are typically used in clinical studies or for interpreting ambiguous cases in AI/software performance evaluations by humans.

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 submission is for a medical implant, not an AI-assisted diagnostic or therapeutic device.

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

Not applicable. This submission is for a medical implant.

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

The "ground truth" for the non-clinical tests listed would be based on engineering standards, material properties, and physical measurements performed in a laboratory. For example, for "torsion to failure," the ground truth would be the objectively measured torque at which the screw failed, compared against a pre-defined standard or predicate device performance. For the LAL test, the ground truth is whether the endotoxin level meets the specified USP and AAMI standards.

8. The sample size for the training set:

Not applicable. This submission is for a physical medical implant, not a machine learning model that requires a training set.

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

Not applicable. As above, this is for a physical implant, not an AI/ML device.

Summary

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October 15, 2020

Arthrosurface, Inc. Dawn Wilson VP, Quality & Regulatory 28 Forge Parkway Franklin, Massachusetts 02038

Re: K200718

Trade/Device Name: Arthrosurface WristMotion Total Wrist Arthroplasty System Regulation Number: 21 CFR 888.3800 Regulation Name: Wrist Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWJ Dated: September 11, 2020 Received: September 14, 2020

Dear Dawn Wilson:

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

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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,

Vesa Vuniqi 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) K200718

Device Name

Arthrosurface Total Wrist Arthroplasty System

Indications for Use (Describe)

The Arthrosurface Total Wrist Arthroplasty System is indicated for replacement of the painful wrist joint due to rheumatoid arthritis, oseto-arthritis, or post-traumatic arthritis.

The device is a single-use implant intended to be used with bone cement.

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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510(k) Summary

510(k) Owner:	Arthrosurface28 Forge ParkwayFranklin, MA 02038Tel: 508.520.3003Fax: 508.528.4604
Contact:	Dawn WilsonVP, Quality & Regulatory
Date of Preparation:	March 17, 2020
Trade Name:	Arthrosurface WristMotion™ Wrist Arthroplasty System
Common Name:	Total Wrist Arthroplasty System
Device:	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation Semi-Constrained
Classification Regulation:	Wrist joint metal/polymer semi-constrained cementedprosthesis
Device Class:Review Panel:Product Code:	Class IIOrthopedicJWJ

Device Description

Indications for Use

The Arthrosurface Total Wrist Arthroplasty System Indicated for replacement of the painful wrist joint due to rheumatoid arthritis, osteoarthritis, or post-traumatic arthritis.

The device is a single-use implant intended to be used with bone cement.

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Substantial Equivalence

Arthrosurface has demonstrated that for the purposes of the FDA's regulation of medical devices, the Arthrosurface Total Wrist Arthroplasty System is substantially equivalent in indications for use and design principles to the following predicate devices, which have been previously cleared by the FDA:

Primary Predicate	Avanta Orthopaedics Inc. Total Wrist (K021859)Now Stryker ReMotion
Reference Predicate Devices	Biomet Maestro Total Wrist System (K042032)Arthrosurface HemiCAP Wrist (K141920)

The fundamental scientific technology of the proposed device has not changed relative to the predicate device.

Total arthroplasty implant for the wrist joint ●
Same indications for use
Same implant materials
Same radial stem fixation and central carpal fixation with 2 auxiliary screws

Support

In support of this submission, the following non-clinical tests and/or analysis were performed for the Subject Device:

Bone Screws – insertion & removal, torsion to failure, axial pullout
Assembly / Disassembly
Resistance to Torque
Static & Cyclic Edge Testing
Fretting Corrosion
Constraint testing (Subluxation)
Comparative Engineering Analyses (ROM, Contact Area etc.)
. A Kinetic Chromogenic LAL Test for Devices which meets the standard limit of 0.5 EU/mL or 20 EU/ Device per United States Pharmacopeia (USP) Chapter Bacterial Endoxins Test, USP Chapter Transfusion and Infusion Assemblies and Similar Medical Devices, and AAMI ST72:2002/R2010, Bacterial Endotoxins-Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing.

Conclusion

The results have demonstrated the safety and effectiveness of the Arthrosurface Total Wrist Arthroplasty System along with substantial equivalence to the predicate devices.

Regulation Number and Section

§ 888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.