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USTAR II Knee System

1. Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.
2. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.
3. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.
4. Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.
5. 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

1. Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) resulting from trauma where massive resection and transplantation are needed.
2. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.
3. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.
4. Correction for revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement.
5. 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

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

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

"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.

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.

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.

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This device is indicated for use in total hip replacement undergoing primary and revision surgery for the following conditions:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.

2. Inflammatory degenerative joint disease such as rheumatoid arthritis.

3. Correction of functional deformity.

4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

5. Revision procedures where other treatments or devices have failed.

This device is designed for cementless use.

This subject device is a size extension of the cleared "UNITED" UTF Stem - reduced (K123550, K132207). The indications, materials, design of this subject device are identical to the cleared "UNITED" UTF Stem - reduced (K123550, K132207) except for size distribution. "UNITED" UTF Stem - reduced is a modular, wedge-shaped stem with 12/14 neck taper and 130° neck angle, which is indicated for use in primary or revision hip arthroplasty. UTF Stem - reduced is available with standard offset and high offset options to restore hip biomechanics.

The provided document is a 510(k) premarket notification for a medical device, specifically a hip joint prosthesis. It addresses a size extension for an already cleared device. As such, the document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device through a new comprehensive study.

Therefore, much of the information requested in your prompt regarding specific acceptance criteria, detailed study design for proving device performance, sample sizes for test/training sets, expert adjudication methods, and MRMC studies, is not present in this type of regulatory submission. This document highlights that the new device shares the same indications, materials, and design (with minor modifications) as previously cleared devices.

Here's an analysis based on the information available:

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

The document does not provide a table of acceptance criteria with numerical targets and reported performance in the way one might expect for a new device study. Instead, it relies on demonstrating that the new size extension performs "as safe and effective as the predicates" by conducting specific mechanical tests required for orthopedic implants.

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 for Test Set: Not explicitly stated as a "test set" in the context of a clinical or image-based AI study. The "test set" here refers to the actual physical devices (UTF Stem, reduced, #0, #00) subjected to mechanical and biocompatibility testing. The exact number of units tested for each mechanical test is not specified in this summary.
• Data Provenance: The document does not specify the country of origin for the mechanical testing data. The manufacturer, United Orthopedic Corporation, is based in Hsinchu, Taiwan. The type of testing is non-clinical (laboratory-based mechanical and biocompatibility tests). These are prospective tests performed on the device.

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 is not applicable to the type of device and submission. This is a mechanical/biocompatibility evaluation of a physical orthopedic implant, not an AI or image analysis device that requires expert ground truth labeling.

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

Not applicable. There is no human adjudication process described for the mechanical and biocompatibility tests performed on the physical device. The tests have predefined pass/fail criteria based on engineering standards and regulatory guidelines (e.g., USP for endotoxin limits), not expert consensus.

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 is not an AI-assisted device or an imaging diagnostic device.

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

Not applicable. This is not an AI-driven algorithm.

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

The "ground truth" for this device's performance relies on established engineering principles, international standards for mechanical testing of implants, and biological safety standards (e.g., USP for endotoxins). Performance is measured against these objective standards and comparison to the predicate device's known performance, not against expert consensus, pathology, or outcomes data in the way an AI diagnostic device would.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no training set in that context.

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

Not applicable. There is no training set.

Summary of what the document does communicate:

• Purpose of Submission: This 510(k) is for a "size extension" of an already cleared hip stem (UTF Stem, reduced, #0, #00).
• Demonstration of Safety and Effectiveness: The primary method is demonstrating substantial equivalence to previously cleared predicate devices (K123550, K132207, K110245).
• Key Argument for Equivalence: The subject device shares identical indications for use, materials, and design (except for size distribution and minor design modifications that "do not change the intended use or fundamental scientific technology") with the predicates.
• Non-Clinical Performance Data: To support equivalence, the following tests were conducted:
  • Stem Fatigue Test
  • Neck Fatigue Test
  • Range of Motion
  • Bacterial Endotoxin Testing (met USP limits)
• Clinical Performance Data: "None provided as a basis for substantial equivalence." This is common for minor modifications or size extensions of already cleared devices, as new human clinical trials are typically not required if substantial equivalence can be demonstrated through non-clinical means.

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