Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
Previous tibial condyle or plateau fractures with loss of anatomy or function.
Varus or valgus deformities.
Revision of previous arthroplasty procedures.
These devices are indicated for cemented use only.

Device Description

The STRIDE Unicondylar Knee device is a unicompartmental prosthetic implant that resurfaces one femoral condyle, and one side of the tibial plateau. The femoral component is made of cobalt chrome and the tibial component is. made of titanium with a UHMWPE insert that snaps into place. The device is nonconstrained; the articulating surface of the UHMWPE insert is flat and joint stability is maintained by ligaments and other soft tissue surrounding the knee.

AI/ML Overview

The provided text describes the 510(k) summary for the STRIDE Unicondylar Knee, a unicompartmental prosthetic implant. The submission primarily focuses on demonstrating substantial equivalence to predicate devices through engineering analysis and non-clinical bench testing. It does not include information about clinical studies with human subjects or AI/algorithm-based performance.

Here's a breakdown of the requested information based on the provided text:

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

Test/Analysis	Acceptance Criteria	Reported Device Performance
Finite Element Analysis (FEA)	Not explicitly stated as "acceptance criteria," but implied to demonstrate similar load stresses to predicate devices.	Compared load stresses at 0, 15, 20, 60, 90, 120, and 155 degrees of flexion. FEA Stress Analysis Comparison at +/- 10 degrees of varus/valgus and 0, 15, and 60 degrees of flexion.
Contact pressure bench testing	Follows ASTM F2083-10 standards.	Contact pressure bench testing performed to ASTM F2083-10 for Stride.
Tibial component fatigue	Not explicitly stated as "acceptance criteria," but implied to meet design specifications.	Engineering analysis for Stride tibial component fatigue.
Tibial trav and insert interlocking strength/force	Not explicitly stated as "acceptance criteria," but implied to meet design specifications.	Tibial trav and insert interlocking strength and force analysis.
Range of motion analysis	Not explicitly stated as "acceptance criteria," but implied to meet design specifications.	Range of motion analysis.
Biocompatibility	Per ISO 10993 standards.	Biocompatibility of materials analysis per ISO 10993.
Sterilization	Sterilization to a Sterility Assurance Level (SAL) of 10-6.	Sterilization to SAL of 10-6.
Packaging and shelf life	Not explicitly stated as "acceptance criteria," but implied to demonstrate double sealed containers, double sterile barriers, and a shelf life of 2 years (as per predicate device description).	Packaging and shelf life analysis.
Overall conclusion	Device meets its design specifications; no new issues of safety or effectiveness compared to predicates.	Analysis and testing results demonstrated that the subject device meets its design specifications. Test results and comparative performance data indicate that differences do not present any new issues of safety or effectiveness.

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

This information is not applicable as the submission describes engineering analysis and non-clinical (bench) testing, not a clinical study on a test set of data.

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 the submission describes engineering analysis and non-clinical (bench) testing, not a clinical study requiring expert ground truth.

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

This information is not applicable as the submission describes engineering analysis and non-clinical (bench) testing, not a clinical study requiring adjudication.

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

This information is not applicable. The device is a physical knee implant, not an AI or imaging diagnostic tool, and therefore no MRMC study, human readers, or AI assistance is relevant.

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

This information is not applicable as the device is a physical knee implant, not an algorithm.

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

This information is not applicable as the device is a physical knee implant and the testing focused on engineering and material performance rather than diagnostic accuracy against a ground truth. The "ground truth" here is implied to be engineering specifications and predicate device performance.

8. The sample size for the training set

This information is not applicable as the submission pertains to a physical medical device and its engineering analysis, not a machine learning model requiring a training set.

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

This information is not applicable as the submission pertains to a physical medical device and its engineering analysis, not a machine learning model requiring a training set and its associated ground truth.

Summary

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Traditional 510(K) 510(K) Summary Rev 4-17-2013 STRIDE™

K123380 (1/4)

MAY 3 1 2013

Image /page/0/Picture/4 description: The image shows a black and white logo. The logo features a central oval shape surrounded by swirling lines. The lines create a sense of motion around the oval. The overall design is abstract and modern.

BLUE BELT TECHNOLOGIES, INC

510(k) Summary

510(k) SPONSOR:

Blue Belt Technologies, Incorporated 2828 Liberty Avenue, Suite 100 Pittsburgh, PA 15222

DATE 510(K) Summary was Prepared: 4-9-13

CONTACT PERSON:

Company Representative:	Richard Confer
Title:	Vice President of Regulatory Affairs and Quality Assurance
Phone Number:	412-860-3768 ext. 106
Fax Number:	412 683-6447
E-mail address:	rconfer@bluebelttech.com
TRADE NAME:	STRIDE Unicondylar Knee
COMMON NAME:	Unicompartmental Knee, Unicondylar Knee
CLASSIFICATION:	21 CFR 888.3520
CLASS:	Class II
PRODUCT CODE:	HSX
PANEL:	Orthopedic
PREDICATE DEVICES:	The predicate devices for the STRIDE Unicondylar Knee are the Zimmer® Unicompartmental Knee System, K033363 (cleared 1/16/2004); and the MAKO Surgical Corporation Unicondylar Knee Implant System III, K082081 (cleared 8/15/2008).

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DEVICE DESCRIPTION: The STRIDE Unicondylar Knee device is a unicompartmental prosthetic implant that resurfaces one femoral condyle, and one side of the tibial plateau. The femoral component is made of cobalt chrome and the tibial component is. made of titanium with a UHMWPE insert that snaps into place. The device is nonconstrained; the articulating surface of the UHMWPE insert is flat and joint stability is maintained by ligaments and other soft tissue surrounding the knee.

INDICATIONS FOR USE: The STRIDE Unicondylar Knee devices are indicated for patients with:

-Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
Previous tibial condyle or plateau fractures with loss of anatomy or function. -
Varus or valqus deformities. -
Revision of previous arthroplasty procedures. -

These devices are indicated for cemented use only.

BASIS FOR SUBSTANTIAL EQUIVALENCE:

The STRIDE Unicondylar Knee is substantially equivalent to the Zimmer Unicompartmental Knee System and the MAKO Surgical Corporation Unicondylar Knee Implant System III. All three of these devices are non-constrained unicondylar knee prostheses made of similar materials. The manufacturing and sterilization methods are equivalent. These devices are approximately the same geometrically, and indications for use are equivalent. Each of these devices is indicated for cemented use only. A comparison of the STRIDE Unicondylar Knee to the Zimmer Unicompartmental Knee and the MAKO Surgical Corporation Unicondylar Knee Implant System III indicates that the subject device is substantially equivalent to the predicate devices:

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Traditional 510(K) Tab 6 – 510(K) Summary Rev 2

STRIDE™

K123380 (3/4)

Characteristics	STRIDE UnicondylarKnee(Subject Device)	ZimmerUnicompartmental Knee(ZUK)	MAKO Unicondylar KneeImplant System III
Intended Use	These devices are intendedto be used in unicondylarknee patients meeting theindications for use.	These devices are intendedfor patients with [see theindications for use below]:	Mako Surgical Corp.Unicondylar Knee ImplantSystem III components areintended for use inunicompartmental kneearthroplasty as a result of[see the indications for usebelow]:
Indications	Painful and/or disabling kneejoints due to osteoarthritis ortraumatic arthritis.	Painful and/or disabling kneejoints due to osteoarthritis ortraumatic arthritis.	Moderately disabling jointdisease of the knee resultingfrom painful osteo- or post-traumatic arthritis.
	Previous tibial condyle orplateau fractures with loss ofanatomy or function.	Previous tibial condyle orplateau fractures with loss ofanatomy or function.	As an alternative to tibialosteotomy in patients withunicompartmentalOsteoarthritis.
	Varus or valgus deformities.	Varus or valgus deformities.
	Revision of previousarthroplasty procedures.	Revision of previousarthroplasty procedures.	Revision of previousunsuccessfulunicompartmental kneereplacement.
	These devices are indicatedfor cemented use only.	These devices are indicatedfor cemented use only.	These devices are intendedfor cemented use only.
		The ZUK unicompartmentalknee is designed for usewhen load bearing ROM isexpected to be less than orequal to 155 degrees.
Materials	Femoral: CoCrMoTibial Plate: TitaniumTibial Insert: UHMWPE	Femoral: CoCrMoTibial Plate: TitaniumTibial Insert: UHMWPE	Femoral: CoCrMoTibial Plate: TitaniumTibial Insert: UHMWPE
Sterilization andPackaging	Gamma, metal components;Gamma (UHMWPE);All components are suppliedin double sealed containersmaintaining double sterilebarriers. Sterilizationparameters are designed tomeet SAL 10-6, and a shelflife of 2 years	Gamma, metal components;Gamma, (UHMWPE);All components are suppliedin double sealed containersmaintaining double sterilebarriers	Gamma, metal components;Gamma, (UHMWPE)All components are suppliedin double sealed containersmaintaining double sterilebarriers
Designs	Curved back femoralcomponent, 1 posterior facetOnlay tibial plate	Faceted back femoral.Onlay tibial plate	Curved back femoral.component, 1 posterior facetOnlay and inlay tibial plates

・

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Traditional 510(K) Tab 6 - 510(K) Summary Rev 2

The engineering analysis and non-clinical (bench) testing of the Stride Unicondylar Knee and the predicate included:

Finite element analysis (FEA) comparing load stresses at 0, 15, 20, 60, 90 and . 120 and 155 degrees of flexion
FEA Stress Analysis Comparison at .+/- 10 degrees of varus/valgus and 0, 15 ● and 60 degrees of flexion
Contact pressure bench testing to ASTM F2083-10 for Stride .
Engineering analysis for Stride tibial component fatique ●
Tibial trav and insert interlocking strength and force analysis .
Range of motion analysis .
Biocompatibility of materials analysis per ISO 10993 .
Sterilization to SAL of 10-6 .
Packaging and shelf life analysis .

Analysis and testing results demonstrated that the subject device meets its design specifications.

SUMMARY AND CONCLUSIONS:

The STRIDE Unicondylar Knee was designed to utilize materials, geometry, and manufacturing methods similar to the predicate devices and which are currently used in clinical practice. The similarity between the subject device and the predicate devices with respect to indications, design, materials, packaging and sterilization methods, combined with FEA and bench test results, and an FMEA hazard analysis, identified no new hazards associated with the STRIDE Unicondylar Knee.

The primary differences are:

The STRIDE Unicondylar Knee tibial plate is offered in more sizes than the . individual predicates, but covers the same ranges as the combined predicate tibial plate offering.
. The Stride has differences in femoral component rear surface geometry than the predicate devices.

Test results and comparative performance data for the STRIDE and its predicate unicondylar implants indicate that these differences do not present any new issues of safety of effectiveness as compared to the predicates.

Therefore, based on the above analysis and data presented in this submission, a finding of substantial equivalence with the predicate devices is justified.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 31, 2013

Blue Belt Technologies, Incorporated % Mr. Richard Confer Vice President of Regulatory Affairs and Ouality Assurance 2828 Liberty Avenue, Suite 100 Pittsburgh, Pennsylvania 15222

Re: K123380

Trade/Device Name: Stride Unicondylar Knee System Regulation Number: 21 CFR 888:3520 Regulation Name: Knee Joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX Dated: May 21, 2013 Received: May 28, 2013

Dear Mr. Confer:

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. 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 (reporting of medical

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Page 2 - Mr. Richard Confer

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin I. Keith

For

Mark N. Melkerson
Director
Division of Orthopedic Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Cinaceal - Louds

Enclosure

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510(k) Number (if known): N/A K123380

Device Name: The STRIDE Unicondylar Knee

Indications For Use:

The STRIDE Unicondylar Knee devices are indicated for patients with:

Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. -
Previous tibial condyle or plateau fractures with loss of anatomy or function.
Previous tibial condyle or plateau fractures with loss of anatomy or function.
Varus or valgus
Varus or valgus deformities.
Revision of previous arthroplasty procedures.

These devices are indicated for cemented use only.

Prescription Use X Over-The-Counter Use (Part 21 CFR 801 Subpart D) AND/OR (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

Blue Belt Technologies, Inc.

10/31/2012

Regulation Number and Section

§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.