Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
Previously failed hip surgery.
Proximal femoral neck fractures or dislocation.
Idiopathic avascular necrosis of the femoral head.
Non-union of proximal femoral neck fractures.
Treatment of fractures that are unmanageable using other forms of therapy.
Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Device Description

Trivictal is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) and sintered bead commercially pure (Cp) Titanium coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Trivicta is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating and porous sintered bead coating. The stem has a variety of sizes to accommodate most patients encountered: lengths (101-119mm), horizontal offsets (38-53mm), vertical offsets (29-36mm), resection angle of 41°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar. Trivicta™ is compatible with the following Ortho Development devices: CoCr Femoral Heads, Biolox Delta Ceramic Femoral Heads, Solitude™ Unipolar Head, Escalade Acetabular Cup System, Legend® Acetabular Liner, Escalade Legend® Acetabular Shell, and Tri-plus™ DCM Liner.

AI/ML Overview

This looks like a 510(k) summary for a medical device (Trivicta Hip Stem), not an AI/ML powered device. Therefore, the questions related to AI/ML performance criteria, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," training set information, and adjudication methods for ground truth, are not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through design, materials, indications for use, and performance testing related to the physical characteristics and safety of the hip stem, not software performance.

Here's an analysis of the provided information, focusing on the available details:

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

The document does not present acceptance criteria in a structured, quantitative table with specific target values for performance attributes, as would be typical for an AI/ML device. Instead, it outlines the types of non-clinical mechanical tests performed and states that the device was found to be "safe for its intended use" and "performs as well as the legally marketed predicates" based on these tests.

However, based on the categories of testing performed, we can infer some general "acceptance criteria" and "reported performance":

Category	Implied Acceptance Criteria	Reported Device Performance
Sterilization	Achieve a Sterility Assurance Level (SAL) of 10^-6 in accordance with ISO 11137.	"validated to a sterility assurance level of 10^-6 in accordance with the ISO 11137."
Shelf Life	Packaging validated to maintain integrity and sterility over the defined shelf life (Implied).	"packaging for Trivicta was validated in accordance with ISO 11607."
Biocompatibility	Meet requirements of ISO 10993-1, ensuring no adverse biological reactions.	"biocompatibility was established according to the requirements of ISO 10993-1 and found to be safe for its intended use."
Mechanical Testing	Meet specified performance standards for hip prostheses as outlined in relevant ISO/ASTM standards (e.g., adequate range of motion, resistance to shear fatigue, neck fatigue, distal stem fatigue, and impingement performance).	"The following non-clinical mechanical tests and analyses were conducted...- Range of Motion Test (ISO 21535:2023)- Shear Fatigue Test (ASTM F1160-14)- Neck Fatigue Test (ISO 7206-6:2013)- Distal Stem Fatigue Test (ISO 7206-4:2010)- Engineering analysis of impingement performance (ASTM F2582-20)"The overall conclusion states: "The results of verification and validation activities demonstrate that Trivicta performs as well as the legally marketed predicates." This implies that the device met the performance requirements of these tests relative to the predicate devices and applicable standards.

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

This document details tests on the physical medical device (hip stem), not a data-driven AI/ML model. Therefore, "sample size for the test set" typically refers to the number of physical device units or test specimens used in mechanical testing. The document does not specify the exact number of samples for each mechanical test, nor does it refer to "data provenance" in the context of patient data. The tests are in vitro (laboratory) tests on the device itself.

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 question is not applicable. "Ground truth" in the context of AI/ML refers to expert labels on data. For a physical medical device like a hip stem, ground truth is established by objective engineering and scientific measurements and adherence to established material and mechanical standards. There are no human "experts" establishing ground truth in the AI/ML sense for these in vitro physical tests.

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

This question is not applicable as it relates to expert review for AI/ML ground truth, which is not relevant to the physical testing of a hip stem.

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 question is not applicable. MRMC studies are used to evaluate the diagnostic performance of AI-assisted systems compared to human readers. This document describes a physical medical device, not an AI system.

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

This question is not applicable as it pertains to AI/ML algorithm performance.

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

For the physical device, the "ground truth" for its performance is based on:

Adherence to recognized international and national standards (e.g., ISO 11137 for sterilization, ISO 11607 for shelf life/packaging, ISO 10993-1 for biocompatibility, ISO 21535, ASTM F1160, ISO 7206-6, ISO 7206-4, ASTM F2582 for mechanical testing).
Objective physical and chemical measurements obtained during laboratory testing.
Comparison to predicate devices that have established safety and effectiveness.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device.

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

This question is not applicable as this is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 8, 2024

Ortho Development Corp. Drew Weaver Director of Regulatory Affairs 12187 S. Business Park Drive Draper, Utah 84020

Re: K233758

Trade/Device Name: Trivicta™ Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: MEH, LPH, LZO, KWL Dated: February 12, 2024 Received: February 12, 2024

Dear Drew Weaver:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Limin Sun -S

Limin Sun, 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K233758

Device Name

Trivicta™ Hip Stem

Indications for Use (Describe)

This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
1. Previously failed hip surgery.
1. Proximal femoral neck fractures or dislocation.
1. Idiopathic avascular necrosis of the femoral head.
1. Non-union of proximal femoral neck fractures.

Treatment of fractures that are unmanageable using other forms of therapy.
Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

Name of the Sponsor:	Ortho Development® Corporation12187 South Business Park DriveDraper, Utah 84020
510(k) Contact:	Name:	Drew Weaver
	Position:	Director of Regulatory Affairs
	Address:	12187 S. Business Park DriveDraper, UT 84020 USA
	Telephone:	(801) 553-9991
	Email:	dweaver@orthodevelopment.com
Date Prepared:	March 7, 2024
Submission Type:	Traditional
Proprietary Name:	Trivicta™ Hip Stem
Common Name:	Uncemented Hip Prosthesis
Product Code /Classification:	MEH	21 CFR 888.3353: Hip joint metal/ceramic/polymersemi-constrained cemented or nonporous uncementedprosthesis
Associated ProductCode(s) / Classification:	LPH	21 CFR 888.3358: Hip joint metal/polymer/metalsemi-constrained porous-coated uncementedprosthesis
	LZO	21 CFR 888.3353: Hip joint metal/ceramic/polymersemi-constrained cemented or nonporous uncementedprosthesis
	KWL	21 CFR 888.3360: Hip joint femoral (hemi-hip)metallic cemented or uncemented prosthesis
Device Class:	Class II
Primary PredicateDevice:	DepuySynthes Actis DuoFix Hip Prosthesis (K150862)
Reference PredicateDevice:	DepuySynthes Actis DuoFix Hip Prosthesis (K210581)Entrada™ Hip Stem (K171249)

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1.0 Device Description:

Trivicta is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating and porous sintered bead coating.

The stem has a variety of sizes to accommodate most patients encountered: lengths (101-119mm), horizontal offsets (38-53mm), vertical offsets (29-36mm), resection angle of 41°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar.

Trivicta™ is compatible with the following Ortho Development devices: CoCr Femoral Heads, Biolox Delta Ceramic Femoral Heads, Solitude™ Unipolar Head, Escalade Acetabular Cup System, Legend® Acetabular Liner, Escalade Legend® Acetabular Shell, and Tri-plus™ DCM Liner.

2.0 Indication for Use:

This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or posttraumatic arthritis.
Previously failed hip surgery. 2.
1. Proximal femoral neck fractures or dislocation.
1. Idiopathic avascular necrosis of the femoral head.
1. Non-union of proximal femoral neck fractures.
Treatment of fractures that are unmanageable using other forms of therapy. 6.
1. Benign or malignant bone tumors. congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

3.0 Comparison of Technological Characteristic:

Trivicta is the same as the previously cleared predicate device DepuySynthes Actis (K150862, K210581) in terms of materials, fixation, taper/trunnion, offsets, collar/collarless, and sterilization, and is similar to Actis in terms of indications for use, stem sizes and lengths, neck angle, and packaging.

Trivicta is technologically the same as the already cleared predicate device Entrada (K171249) in terms of indications for use, taper/trunnion, neck angle, offsets, collar/collarless, sterilization method, and shelf life. Trivicta is similar to Entrada in terms of packaging.

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4.0 Performance Data:

Sterilization

Trivicta is gamma radiation sterilized and was validated to a sterility assurance level of 10th in accordance with the ISO 11137.

Shelf Life

The packaging for Trivicta was validated in accordance with ISO 11607.

Biocompatibility

Trivicta's biocompatibility was established according to the requirements of ISO 10993-1 and found to be safe for its intended use.

Mechanical Testing

The following non-clinical mechanical tests and analyses were conducted on the subject device.

Range of Motion Test (ISO 21535:2023) ●
Shear Fatigue Test (ASTM F1160-14) ●
Neck Fatigue Test (ISO 7206-6:2013) ●
Distal Stem Fatigue Test (ISO 7206-4:2010)
Engineering analysis of impingement performance (ASTM F2582-20) ●

Clinical Testing

No clinical testing is required to establish the safety and effectiveness of Trivicta.

5.0 Substantial Equivalence Conclusion:

Verification and validation activities were conducted to establish the performance of Trivicta. The results of verification and validation activities demonstrate that Trivicta performs as well as the legally marketed predicates.

Based on similarities in indication for use/intended use, technological characteristic, basic design, device material, and principle of operation, Trivicta is considered substantially equivalent to the previously cleared predicate devices.

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.