Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.
Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.
Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.
Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.
Joint instability resulting from excessive bone resection.

For Femoral component, Hinged/ Tibial baseplate, Hinged/ Cemented tibial stem/ Cemented Straight stem, RHS, non coated/ Cemented Curved stem, RHS, non coated/ Cemented Straight stem, RHS/ Cemented Curved stem, RHS/ Tibial Augment: These devices are single use implant and intended for cemented use only.

For Distal Femoral Component, RHS/ Proximal Tibial Component, RHS/ Tibial stem/ Segment Part, RHS/ Segment Part, RHS, Bridge: These devices are single use implant and intended for cementless use only.

USTAR II Knee System, Stem

Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) resulting from trauma where massive resection and transplantation are needed.
Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.
Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.
Correction for revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement.
Joint instability resulting from excessive bone resection.

Cemented Tibial Stem is a single use implant and intended for cemented use only. Tibial Stem is a single use implant and intended for cementless use only.

USTAR II Hip System

Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.
Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.
Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.
Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.
Joint instability resulting from excessive bone resection.

This device is a single use implant and intended for cementless use only.

Device Description

"United" USTAR II System is used for patients who need a special prosthesis for their particular indication, which may present large quantity of bone loss and deformity associated with previous failed arthroplasty, ligament deficiencies, one tumors resection, or trauma and may require a further operation or reconstruction.

USTAR II System includes two sub-systems, which is "USTAR II Knee System" and "USTAR II Hip System". USTAR II Knee System is designed as modular combinations. It offers a variety of component options for treatment of patients that require femoral component, tibial baseplate and tibial insert. The tibial augment, segment part and stem are provided for patient with more bone resection. USTAR II Hip System is designed as a modular system which is composed Proximal femoral component, Trochanteric claw, and Press-fit, RHS straight/curved stem.

AI/ML Overview

This document is a 510(k) premarket notification for the "USTAR II System" by United Orthopedic Corporation. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the context of an AI/ML device.

Therefore, the requested information for an AI/ML device (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, standalone performance) is not applicable to this document.

The document describes a medical device (a knee and hip prosthesis system) and its non-clinical performance testing. It states that "Performance data demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices."

Here's what can be extracted regarding the device performance and testing for this non-AI/ML medical device:

1. Acceptance Criteria and Reported Device Performance (Non-AI/ML)

The document does not explicitly state quantitative acceptance criteria in a table format for diagnostic performance, as it's not a diagnostic AI/ML device. Instead, it lists non-clinical performance tests conducted to demonstrate safety and effectiveness and substantial equivalence to predicate devices. The reported performance is that the device "met" or "demonstrates" parity with predicate devices.

Acceptance Criterion (Implicit)	Reported Device Performance (Implicit)
Device functions safely and effectively under mechanical stress	Pass: Hyperextension fatigue test, Internal and external rotation, Stem fatigue test, Neck fatigue test, Disassembly Force and Fretting Corrosion completed.
Device exhibits acceptable wear and corrosion properties	Pass: Wear and corrosion test completed.
Device has acceptable range of motion	Pass: Range of Motion test completed.
Modified surface treatment is acceptable	Pass: Evaluation of Modified Surface Treatment completed.
Device meets biocompatibility requirements	Pass: Bacterial endotoxin testing conducted and met USP <161> limits.
Overall performance is substantially equivalent to predicate devices	Pass: "Performance data demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices."

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

Not applicable. This pertains to a physical medical device (prosthesis), not an AI/ML diagnostic algorithm that uses a "test set" of data in the common sense. The testing performed involves mechanical and material properties.

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

Not applicable. Ground truth establishment by experts is relevant for diagnostic AI/ML systems where human interpretation is the gold standard. For a physical device, performance is evaluated against engineering standards and validated test methods.

4. Adjudication method for the test set

Not applicable. This concept belongs to the evaluation of human judgment in diagnostic AI/ML studies.

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. MRMC studies are for evaluating how AI assistance impacts human reader performance in diagnostic tasks.

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

Not applicable. This refers to a diagnostic algorithm's performance in isolation. The USTAR II System is a physical implant.

7. The type of ground truth used

For the non-clinical tests (e.g., fatigue, wear, endotoxin), the "ground truth" is defined by established engineering and biological standards (e.g., ISO standards, USP pharmacopeial limits). The device is tested against these predefined performance benchmarks.

8. The sample size for the training set

Not applicable. This device is not an AI/ML system that requires a "training set."

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

Not applicable.

Summary

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September 23, 2019

United Orthopedic Corporation Lois Ho Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu, 30075 TAIWAN

Re: K190100

Trade/Device Name: USTAR II System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee Joint Femorotibial Metal/Polymer Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRO, LPH, LWJ, KWL Dated: August 14, 2019 Received: August 22, 2019

Dear Lois Ho:

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.

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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 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 Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K190100

Device Name USTAR II System

Indications for Use (Describe)

USTAR II Knee System

Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.

1. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.
1. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.
1. Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.

Joint instability resulting from excessive bone resection.

For Femoral component, Hinged/ Tibial baseplate, Hinged/ Cemented Straight stem, RHS, non coated/ Cemented Curved stem, RHS, non coated/ Cemented Straight stem, RHS/ Cemented Curved stem, RHS/ Tibial Augment: These devices are single use implant and intended for cemented use only.

For Distal Femoral Component. RHS/ Proximal Tibial Component. RHS/ Tibial stem/ Segment Part. RHS, Bridge: These devices are single use implant and intended for cementless use only.

USTAR II Knee System, Stem

Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) resulting from trauma where massive resection and transplantation are needed.

1. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.
1. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.

Correction for revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement.

1. Joint instability resulting from excessive bone resection.
  Cemented Tibial Stem is a single use implant and intended for cemented use only. Tibial Stem is a single use implant and intended for cementless use only.

USTAR II Hip System

Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.

1. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.
1. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.
1. Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.
1. Joint instability resulting from excessive bone resection.

This device is a single use implant and intended for cementless use only.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/1 description: The image contains the logo for United Orthopedic Corporation. The logo features a green circular icon with a white circle inside, resembling the letter 'U'. To the right of the icon, the word "United" is written in a bold, dark gray font. Below "United", the words "Orthopedic Corporation" are written in a smaller, lighter gray font.

510(k) Summary of K190100

Submitter Information
Name	United Orthopedic Corporation
Address	No.57, Park Ave. 2, Science Park, Hsinchu City 30075,
	Taiwan.
Phone Number	+886-3-5773351 ext. 2220
Fax Number	+886-3-577156
Name of Contact Person	Lois Ho, Regulatory Affairs Manager
Date prepared	January 08, 2019
Device Information
Trade Name	USTAR II System
Common Name	Total Knee Prosthesis / Total Hip Prosthesis
Classification Panel	Orthopedics
Regulation Name andNumber	Knee joint femorotibial metal/polymer constrainedcemented prosthesis (21CFR 888.3510);Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis (21 CFR 888.3358)
Regulatory Class	Class II
Product Code(s)	KRO, LPH, LWJ, KWL
Predicate Device(s)	1. “United” U2 Total Knee System – PSA Type (K082424,K100981, K122183)
	2. “Zimmer” NexGen® Complete Knee Solution RotatingHinge Knee (K013385)
	3. “Zimmer” Zimmer® Segmental System (K070978,K110940)

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Image /page/5/Picture/1 description: The image shows the logo for United Orthopedic Corporation. The logo consists of a green circular symbol with a white dot in the center, followed by the word "United" in a bold, gray font. Below the word "United" is the phrase "Orthopedic Corporation" in a smaller, lighter gray font.

Orthopaedic Salvage System (K002757, 4. "Biomet" K052685) 5. "Zimmer" Arcos Modular Femoral Revision System (K130063) 1. "United" UTF Stem, reduced, Ti plasma spray (K123550) "United" UCP Stem (K152530) 2. 3. "United" U2 Hip stem, cemented (K111546) "Stryker" Global Modular Replacement 4. System (K023087)

1. "Zimmer" Vanguard™ DCM tibial insert (K100048)

Reference Device(s)

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Image /page/6/Picture/1 description: The image shows the logo for United Orthopedic Corporation. The logo consists of a green stylized "U" shape with a white circle inside, followed by the word "United" in a bold, dark gray font. Below "United" is the text "Orthopedic Corporation" in a smaller, lighter gray font.

Device Description:

Indications for Use:

USTAR II Knee System

Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.

Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.

Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.

Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.

Joint instability resulting from excessive bone resection.

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Image /page/7/Picture/1 description: The image shows the logo for United Orthopedic Corporation. The logo consists of a green circle with a white dot inside, followed by the word "United" in gray, and the words "Orthopedic Corporation" in a smaller font below it. The logo is simple and modern, and the colors are eye-catching.

devices are single use implant and intended for cemented use only.

USTAR II Knee System, Stem

Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) resulting from trauma where massive resection and transplantation are needed.

Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.

Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.

Correction for revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement.

Joint instability resulting from excessive bone resection.

Cemented Tibial Stem is a single use implant and intended for cemented use only. Tibial Stem is a single use implant and intended for cementless use only.

USTAR II Hip System

Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.

Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.

Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.

Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.

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Image /page/8/Picture/1 description: The image shows the logo for United Orthopedic Corporation. The logo features a green stylized "U" with a white circle inside, followed by the word "United" in a bold, dark gray font. Below "United" is the text "Orthopedic Corporation" in a smaller, lighter gray font.

Joint instability resulting from excessive bone resection.

This device is a single use implant and intended for uncemented use only.

Comparison of Technological Characteristics with the Predicate Device:

The features of the subject device are comparable to the predicates mentioned above in terms of the indication for use, design rationale, materials, coating and sterilization method. The differences have been validated by several testing to demonstrate that the performance of subject device is substantially equivalent to that of the predicate devices.

Performance Data:

● Non-clinical Performance

Tests as follows were conducted to evaluate the safety and effectiveness of the subject device:

a. Hyperextension fatigue test
b. Internal and external rotation
c. Wear and corrosion test
d. Stem fatigue test
e. Neck fatigue test
f. Range of Motion
g. Disassembly Force and Fretting Corrosion
h. Evaluation of Modified Surface Treatment
i. Bacterial endotoxin testing was conducted and met the endotoxin limit as specified in USP <161>.

Performance data demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.

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Image /page/9/Picture/1 description: The image contains the logo for United Orthopedic Corporation. The logo consists of a green circular symbol with a white circle inside, resembling the letter 'U'. To the right of the symbol, the word "United" is written in a bold, dark gray font. Below "United", the words "Orthopedic Corporation" are written in a smaller, lighter gray font.

● Clinical Performance Data/Information

None provided as a basis for substantial equivalence.

● Substantial Equivalence Conclusion:

The subject device has the same intended use, materials, coating, sterilization method, and similar design features to the predicates mentioned above. The performance results demonstrate that the subject device is as safe and effective as the legally marketed predicate devices. Based on the information provided, "United" USTAR II System is considered substantially equivalence to that of predicate devices.

Regulation Number and Section

§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.