(244 days)
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.
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.
"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.
| 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 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.
§ 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.