Search Results

The Klassic Knee System is intended for prosthetic replacement in treatment of the following:

· Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis

• · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
• · Patients with failed previous surgery where pain, deformity, or dysfunction persists
• · Correctable varus-valgus deformity and moderate flexion contracture
• · Revision of a previously failed knee arthroplasty
• · Patients who require a total knee replacement

The Klassic Knee System is indicated for cemented use only, except for the Klassic Femur with Cobalt 3D™, and the Klassic Tibial Baseplate with Ti-Coat®, which are indicated for cementless use.

The purpose of this 510(k) is to add Klassic® Knee CR/Congruent Tibial Inserts and Ultra-PS® Tibial Inserts, which are fabricated with E^X Poly, to the Klassic® Knee System. E^X Poly is a crosslinked UHMWPE containing alpha-tocopherol. The subject Klassic® Knee CR/Congruent and Ultra-PS® Tibial Inserts are available in various sizes and thicknesses to match patient anatomy.

The provided text is a 510(k) summary for the Klassic Knee System, focusing on the addition of new tibial inserts. It outlines the device description, indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML or diagnostic performance.

The document primarily describes the regulatory submission for a physical medical device (knee implants) and its substantial equivalence to previously cleared devices based on bench testing and engineering analyses for wear, stability, stress, range of motion, and modular disassembly. It does not mention any AI/ML components, digital image analysis, or diagnostic performance evaluation studies that would typically involve acceptance criteria for metrics like sensitivity, specificity, or AUC, or require a test set with ground truth established by experts.

Therefore, I cannot extract the requested information (1-9) from the provided text. The document is about a mechanical orthopedic implant, not a diagnostic AI/ML device.

Ask a specific question about this device

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.

Ask a specific question about this device

This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
  Porous coated tibial baseplate components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplates and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.

The Zimmer® Persona™ Personalized Knee System is a semi-constrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Knee System utilizes a modular design between the tibial plates and articular surfaces.

This submission describes the Zimmer Persona Personalized Knee System. The device is a modular knee prosthesis for resurfacing the articulating surfaces of the femoral, tibial, and patellar bones. The submission focuses on non-clinical performance and a comparison of the device's material characteristics to its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: The document does not specify exact sample sizes for each test. However, it indicates that "bench testing outlined below was conducted according to FDA guidance documents," which implies that appropriate sample sizes were used as per relevant standards (e.g., ISO 14243 for wear testing).
• Data Provenance: The data is from non-clinical bench testing performed by Zimmer, Inc., a company located in Warsaw, IN, USA. This is prospective data generated specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable. This submission relies on non-clinical bench testing, not expert-derived ground truth from human data. The "ground truth" for these tests comes from established engineering and biocompatibility standards and predicate device performance.

4. Adjudication Method:

• Not applicable. Adjudication methods are typically used in clinical studies or studies involving human readers/experts to resolve discrepancies in interpretation. This submission focuses on objective bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This submission describes the clearance of a medical device based on non-clinical performance data and substantial equivalence to predicate devices, not a comparative effectiveness study involving human readers or AI.

6. Standalone Performance (Algorithm Only):

• Not applicable. This device is a physical knee prosthesis, not an AI algorithm. Its "performance" is assessed through its mechanical, wear, and material characteristics, not through algorithmic accuracy.

7. Type of Ground Truth Used:

• The "ground truth" for the non-clinical tests is derived from:
  • Established engineering standards: Such as ISO 14243 for wear testing.
  • FDA guidance documents: Which outline appropriate test methodologies and performance expectations for orthopedic implants.
  • Predicate device characteristics: The Vivacit-E material characteristics for the Persona Knee System are stated to be "identical to the predicate Zimmer Vivacit-E Acetabular Polyethylene Liners (K120370)," and other performance metrics are compared to "Persona Conventional UHMWPE articular surfaces."

8. Sample Size for Training Set:

• Not applicable. This submission describes a physical medical device, not an AI system that requires a "training set."

9. How Ground Truth for Training Set was Established:

• Not applicable. As above, there is no AI training set involved.

Ask a specific question about this device