(158 days)
The Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components are intended to articulate with any commercially available Osteonics® Scorpio™ Total Knee Femoral Component, any commercially available Osteonics® Series 7000 Total Knee Femoral Component, and any commercially available Osteonics® Omnifit® Total Knee Femoral Component. The subject patellar components are single use devices, intended for cemented application onto the surgically prepared posterior patella. These components replace the patellar articulating surface of the knee joint and simulate the natural function of the indications for the use of the Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components in conjunction with a total knee replacement. in keeping with those of other legally marketed Class II patellar components, are as follows:
Indications:
- Painful, disabling joint disease of the knee resulting from: degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis.
- . Post-traumatic loss of knee joint configuration and function.
- . Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
- Revision of previous unsuccessful knee replacement or other procedure. .
The Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components are fabricated from ultra-high molecular weight polyethylene (UHMWPE). The articular geometry is designed with a round dome topography. The overall geometry essentially consists of a circular patellar button configuration with three fixation pegs on the anterior surface of the component. The anterior surface of the components also features circular grooves and pockets for cement interdigitation. Each patellar component is available in 8mm and 10mm dome thicknesses.
This document, K972967, is a 510(k) Premarket Notification for the Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components. It is a submission to the FDA for market clearance, not an independent study report with detailed device performance data against acceptance criteria. Therefore, the information requested cannot be fully provided from this document.
Specifically, this document does not include:
- A table of acceptance criteria and reported device performance (in terms of specific metrics like sensitivity, specificity, accuracy, etc., which are common for AI/diagnostic devices). This product is a physical medical device (knee implant components), and its "performance" is typically assessed through mechanical testing and comparison to predicate devices, not through statistical metrics derived from AI model outputs.
- Sample sizes for test sets, training sets, or data provenance in the context of an AI study.
- Information on experts used to establish ground truth or adjudication methods, as these are related to clinical study design for diagnostics, not mechanical component equivalence.
- Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or standalone algorithm performance.
- Specific ground truth types (pathology, outcomes data, etc.) for an AI model.
The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, as required for a 510(k) submission.
Here's what can be inferred or directly stated from the provided text, related to the nature of this submission:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) for a physical medical device (knee implant components), the "acceptance criteria" are implicitly regulatory requirements for demonstrating substantial equivalence to predicate devices, rather than performance metrics for an AI algorithm. The document states:
| Criterion | Reported Performance / Statement |
|---|---|
| Predicate Device Identification | The Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components are substantially equivalent to other legally marketed, Class II, patellar components, including the Osteonics® Scorpio™ Total Knee All-Polyethylene Patellar Components - concentric dome design, and the Johnson and Johnson® P.F.C.® Cruciate Sacrificing Patellar Component. |
| Materials | Shares the same materials (ultra-high molecular weight polyethylene (UHMWPE)) as predicate devices. |
| Intended Use | Shares the same intended use as predicate devices: to articulate with specific Osteonics femoral components; single-use, cemented application; replaces patellar articulating surface; simulates natural knee function. |
| Basic Surgical Techniques | Shares basic surgical techniques with predicate devices. |
| Basic Design Features | Shares basic design features (circular patellar button, three fixation pegs, circular grooves/pockets for cement interdigitation) with predicate devices. |
| Performance Testing | "Applicable performance testing demonstrates that the subject devices perform at least as well as, if not better than, commercially available designs." (Specific test results are not detailed in this summary, but would have been part of the full 510(k) submission). |
| Indications for Use | Indications for use are consistent with those of other legally marketed Class II patellar components (e.g., painful disabling joint disease, post-traumatic loss of function, moderate deformity, revision surgery). |
| Specific FDA Limitations | Device may not be labeled or promoted for non-cemented use. Labeling must prominently state intended for cemented use only. Non-cemented fixation is considered investigational. |
2. Sample sized used for the test set and the data provenance:
Not applicable in the context of an AI-specific "test set." The "test" for this device involved mechanical performance testing and comparison to predicate devices, not evaluation of an AI model. The document does not specify sample sizes for mechanical testing, nor does it refer to data provenance in the context of an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a medical device clearance, not an AI diagnostic study requiring expert ground truth establishment for an algorithm's output.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of device submission.
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 device is a physical knee implant component, and therefore an MRMC study comparing human readers with AI assistance is irrelevant to its purpose.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical knee implant component, not an AI algorithm.
7. The type of ground truth used:
For this type of device, the "ground truth" implicitly refers to established engineering standards, biomechanical principles, and the safety and effectiveness of the predicate devices. The "study" proving it meets criteria largely involves mechanical testing and engineering analysis to ensure it performs comparably (or better) than existing devices in terms of mechanical properties, wear, and fixation, consistent with its intended use.
8. The sample size for the training set:
Not applicable, as this is not an AI algorithm.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI algorithm.
§ 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.