(172 days)
The Pipeline Knee System is indicated for skeletally mature 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 otherwise be obtained at the time of surgery..
Pipeline Knee System components are indicated for use only with cement, and are single use devices.
The Pipeline Knee System is a patellofemorotibial polymer/metal/polymer semiconstrained cemented knee joint prosthesis. The system includes femoral components, tibial trays, biomimetic cruciate retaining (CR) tibial inserts, patellar components, and associated instrumentation. The tibial trays are manufactured from highly crosslinked vitamin E polyethylene. The patellar components are manufactured from vitamin E polyethylene. The CR inserts are designed for use when the posterior cruciate ligament is intact.
The Pipeline Total Knee System femoral component, when used with the Pipeline Knee System articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.
The document is a 510(k) summary for the Pipeline Knee System, which is a knee joint prosthesis. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria for device performance.
Therefore, the provided text does not contain acceptance criteria for device performance in the way one would expect for a diagnostic or AI-driven decision support system (e.g., sensitivity, specificity, accuracy thresholds). Similarly, it doesn't describe a study that "proves" the device meets such criteria through statistical analysis of clinical outcomes.
Instead, the document details non-clinical performance testing to support the substantial equivalence of the new Pipeline Knee System to existing predicate devices.
Given this context, I will address the requested information based on what is available in the provided text, while also noting what is not present due to the nature of this type of submission.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Proxy) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|
| Mechanical Performance: Ability to withstand anticipated physiologic loading. (Implicit within the submission's goal of demonstrating substantial equivalence to legally marketed devices for the same indications for use and material/design characteristics.) | Evaluated through non-clinical performance testing for: |
- Tibial tray fatigue strength
- Insert locking mechanism strength
- Femorotibial range of motion
- Femorotibial range of constraint
- Patellofemoral range of constraint
- Femorotibial contact areas/contact stress
- Patellofemoral contact area and contact stress
- Wear simulation. |
| Material Properties: Highly crosslinked Vitamin E polyethylene material properties are comparable to legally marketed devices, ensuring safety and performance. (Implicit within the submission's goal of demonstrating substantial equivalence to legally marketed devices for the same indications for use and material/design characteristics.) | Testing provided to support the substantial equivalence of the highly cross-linked Vitamin E polyethylene for the following properties: - Tensile strength
- Yield strength
- Elongation
- Density
- Crystallinity
- Wear resistance and particle size characterization
- Free radical concentration
- Thermal properties
- Impact strength
- Small punch strength
- Oxidation resistance
- Trans vinylene index
- Biocompatibility testing. |
| Indications for Use: The device is suitable for the stated indications and is comparable to predicate devices in this regard. | The Pipeline Knee System's indications for use are similar to legally marketed predicate devices, for skeletally mature patients with severe knee pain and disability due to various conditions (e.g., rheumatoid arthritis, osteoarthritis, traumatic arthritis, collagen disorders, avascular necrosis, post-traumatic loss of joint configuration, deformities, salvage of failed attempts). |
Additional Requested Information:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes non-clinical performance testing of a physical medical device (knee prosthesis), not a software device or AI algorithm with a 'test set' of data. The testing involves mechanical and material property assessments on device components or prototypes. There is no mention of patient data or clinical data utilized as a 'test set'.
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)
- Not Applicable. As this is non-clinical testing of a physical device, there is no 'ground truth' established by medical experts in the context of imaging or clinical diagnoses. The "truth" for mechanical and material properties is determined by engineering standards and measurement techniques.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. There is no 'test set' or adjudication process involving human experts for establishing ground truth in this non-clinical testing context.
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 a 510(k) submission for a physical knee prosthesis, not an AI or imaging diagnostic device. Therefore, no MRMC study or AI-assisted performance evaluation was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This filing pertains to a physical orthopedic implant. There is no algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For the non-clinical performance data, the 'ground truth' is based on established engineering and material science principles, standardized test methods (likely ASTM or ISO standards), and physical measurements of the device's mechanical and material properties. It is not an expert consensus on clinical cases, pathology, or outcomes data, as these are not relevant for demonstrating substantial equivalence of a device's physical and material characteristics.
8. The sample size for the training set
- Not Applicable. This is not a machine learning or AI algorithm; therefore, there is no concept of a 'training set'.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not applicable.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.