The Optimotion Implants Porous Metal-Backed Patella is intended or cementless applications when resurfacing the surgically prepared patella as part of primary Total Knee Arthroplasty (TKR). The Optimotion Implants Metal-Backed Patella is compatible for use with components of the Optimotion™ Blue Total Knee System components (K191084).

General Total Knee Arthroplasty (TKR) Indications:

· Painful, disabling joint disease of the knee resulting from; noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic loss of knee joint configurations and function.

· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

· Revision of previous unsuccessful knee replacement or other procedure.

· Fracture of the distal femur and/or proximal tibia that cannot be standard fracture-management techniques.

· Optimotion porous tibial tray and porous CR femoral components are indicated for cemented or cementless use.
· Optimotion cemented CR Femoral and cemented tibial tray components are indicated for cemented use only.

Device Description

The Optimotion Implants Porous Metal-Backed Patella is an extension of The Optimotion™ Blue Total Knee System (K191084) product line for use in primary Total Knee arthroplasty. The Optimotion Porous Metal-Backed Patella will come in two variations Onset styles. It is a sterile, single use, non-modular porous metal-backed patella that is manufactured from UHMWPE (ASTM F648) and commercially pure titanium (ASTM F1580). The device is offered in a symmetric design that is available in multiple sizes. The metal backing features an additive manufactured porous posterior surface and three additive manufactured porous pegs to provide cemented or cementless fixation to bone.

AI/ML Overview

The provided document is a 510(k) summary for the Optimotion Implants Porous Metal-Backed Patella. It describes the device and its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information regarding acceptance criteria, study details, sample sizes, expert qualifications, or adjudication methods that would typically be found in a clinical study report for an AI/ML medical device.

The "Performance Testing" section (6.8) states that the device utilizes the performance testing of a previously cleared device (Optimotion™ Blue Total Knee System K191084) and refers to Appendix E-1 for the completed testing. It mentions tests for "Additive Titanium Porous Structure" including "Percent Porosity and Average Pore Size" and "Shear Static and Fatigue." These are engineering and material performance tests, not clinical or AI/ML performance studies.

Therefore, many of the requested items cannot be extracted from this document, as the device is a medical implant (patella) and not an AI/ML-based diagnostic or prognostic tool.

Here's a breakdown based on the information available in the document:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria Category	Specific Criteria (if available)	Reported Device Performance / Assessment
Material Properties	Percent Porosity	Tested (details in Appendix E-1)
	Average Pore Size	Tested (details in Appendix E-1)
Mechanical Properties	Shear Static	Tested (details in Appendix E-1)
	Shear Fatigue	Tested (details in Appendix E-1)
Substantial Equivalence	Design	Similar to predicate
	Materials	Similar to predicate
	Indications	Similar to predicate
	Performance Characteristics	Similar to predicate
	Operational Principles	Similar to predicate

Note: The document states that the device "utilizes the Performance testing of the Optimotion™ Blue Total Knee System (K191084)." To see the detailed acceptance criteria and reported performance for these mechanical and material tests, one would need to refer to Appendix E-1 of the original submission or the 510(k) for K191084. The current document only lists the types of tests performed.

2. Sample size used for the test set and the data provenance: Not applicable. This device is a physical implant, not an AI/ML diagnostic. The performance testing mentioned refers to material and mechanical property tests, not a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML device requiring expert ground truth for classification or diagnosis. "Consultations with professionals at testing centers, Optimotion™ Implants' surgeon advisors, and engineering consultants" are mentioned in general for the previous device's testing, but not for establishing ground truth in an AI/ML context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 device is a physical implant, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the physical properties of the implant, the "ground truth" would be the established engineering standards for parameters like porosity, pore size, and shear strength.

8. The sample size for the training set: Not applicable. This device is a physical implant, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary

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March 14, 2022

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle and text encircling it. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Optimotion Implants, LLC Andy Rynearson CEO 6052 Turkey Lake Road Orlando, Florida 32819

Re: K220049

Trade/Device Name: Optimotion Implants Porous Metal-Backed Patella Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH, JWH, OIY Dated: January 4, 2022 Received: January 6, 2022

Dear Andy Rynearson:

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. 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) K220049

Device Name

Optimotion Implants Porous Metal-Backed Patella

Indications for Use (Describe)

General Total Knee Arthroplasty (TKR) Indications:

· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

· Revision of previous unsuccessful knee replacement or other procedure.

· Fracture of the distal femur and/or proximal tibia that cannot be standard fracture-management techniques.

· Optimotion porous tibial tray and porous CR femoral components are indicated for cemented or cementless use.
· Optimotion cemented CR Femoral and cemented tibial tray components are indicated for cemented use only.

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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Premarket Notification:

Optimotion Implants Porous Metal-Backed Patella

510(k) Summary 6.

The following 510(k) Summary is provided in accordance with 21 CFR 807.92.

6.1 510(k) Owner and Registration

Owner's Name:	Optimotion Implants, LLC.
Address:	6052 Turkey Lake Rd, Suite 170Orlando, FL 32819
Phone Number:	(321) 316-2601
Fax Number:	N/A
Date Summary Prepared:	January 4, 2022
Establishment Registration Number:	N/A

6.2 510(k) Contact

Contact:	Andy Rynearson
Address:	6052 Turkey Lake Rd, Suite 170Orlando, FL 32819
Phone Number:	(321) 316-2601
Fax Number:	N/A
Contact Person:	Andy Rynearson

Device Name and Classification 6.3

Device Trade Name:	Optimotion Implants Porous Metal-Backed Patella
Device Common Name:	Total Knee Joint Replacement
Regulation Number and Description:	21 CFR 888.3560, 21 CFR 888.3565
Device Class:	Class II
Product Codes:	MBH, JWH, OIY
Advisory Panel:	87 (Orthopedic)

Legally Marketed Predicate 6.4

Optimotion Implants is utilizing the Stryker Triathlon™ Metal-Backed Patella (K132624) as the predicate device. The Optimotion Implants Porous Metal-Backed Patella features component designs, materials, indications, and manufacturing methods that are similar to the Stryker Triathlon™ Metal-Backed Patella.

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Premarket Notification:

Optimotion Implants Porous Metal-Backed Patella

6.5 Device Description

6.6 Intended Use

The Optimotion Implants Porous Metal-Backed Patella is intended for cemented or cementless applications when resurfacing the surgically prepared patella as part of primary Total Knee Arthroplasty (TKR). The Optimotion Implants Metal-Backed Patella is compatible for use with components of the Optimotion™ Blue Total Knee System components (K191084).

General Total Knee Arthroplasty (TKR) Indications:

0 Painful, disabling joint disease of the knee resulting from; noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis, Post-traumatic loss of knee joint configurations and function.
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
Revision of previous unsuccessful knee replacement or other procedure.
Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracturemanagement techniques.
Optimotion porous tibial tray and porous CR femoral components are indicated for cemented or cementless use.
. Optimotion cemented CR Femoral and cemented tibial tray components are indicated for cemented use only.

6.7 Summary of Technological Characteristics

Device comparisons and performance testing show that the Optimotion Implants Porous Metal-Backed Patella is substantially equivalent to its predicates in terms of intended use, indications, design, materials, performance characteristics and operational principles.

6.8 Performance Testing

Optimotion Implants Porous Metal-Backed Patella utilizes the Performance testing of the Optimotion™ Blue Total Knee System (K191084) which was performed per the FDA "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA", consultations with professionals at testing centers, Optimotion™ Implants' surgeon advisors, and engineering consultants as follows. Optimotion Implants Porous Metal-Backed Patella utilizes the same additive manufacture and processes as the currently cleared Optimotion™ Blue Total Knee System (K191084). The completed testing can be found in Appendix E-1. The following is what was tested.

Additive Titanium Porous Structure
- O Percent Porosity and Average Pore Size
- Shear Static and Fatigue O

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Premarket Notification:

Optimotion Implants Porous Metal-Backed Patella

6.9 Conclusions

The subject device has similiar design features, materials, and indications for use as the predicate devices. The testing performed for the predicate device indicates that the Optimotion Implants Porous Metal-Backed Patella is safe for clinical use.

The Optimotion Implants Porous Metal Backed Patella is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.