(21 days)
The Klassic™ Knee System is intended for prosthetic replacement with the use of bone cement in treatment of the following:
- · Patient conditions of non-inflammatory degenerative joint disease (NIDID): 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 a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component. The purpose of this Special 510(k) is to add 18mm Ultra-PS and 18mm CR/Congruent tibial inserts to the Klassic™ Knee System. These components are manufactured from ultrahigh molecular weight polyethylene and each is available in 6 sizes.
This 510(k) pertains to adding new tibial inserts (18mm Ultra-PS and 18mm CR/Congruent) to an existing Klassic™ Knee System. The document focuses on demonstrating that these new components are substantially equivalent to the previously cleared components and meet the required performance criteria. Therefore, the information provided isn't a typical study demonstrating a device's clinical performance, but rather an engineering evaluation for new component additions.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The information summarized in the Design Control Activities Summary demonstrates that the 18mm Ultra-PS and 18mm CR/Congruent tibial insert met the pre-determined acceptance criteria for the verification activities." However, the specific acceptance criteria and detailed performance results are not provided in this summary document. The summary only generally states that engineering analyses were performed to evaluate "resistance to modular disassembly and stability characteristics."
| Acceptance Criteria (Not Detailed) | Reported Device Performance (Not Detailed) |
|---|---|
| Resistance to modular disassembly criteria (Specific values not provided) | Met pre-determined acceptance criteria |
| Stability characteristics criteria (Specific values not provided) | Met pre-determined acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "engineering analyses" performed on the new tibial inserts. This implies a laboratory-based, in-vitro testing scenario, not a study involving human subjects or real-world clinical data.
- Sample Size for Test Set: Not explicitly stated as a numerical value for "samples". It refers to "the 18mm Ultra-PS and 18mm CR/Congruent tibial inserts" and "the previously cleared tibial inserts." This suggests that the analyses were performed on representative physical components or their digital models.
- Data Provenance: Not applicable in the context of clinical data. The analyses are engineering-based, likely performed in a controlled laboratory environment by the manufacturer or a contracted lab. The document does not specify a country of origin for the data beyond the manufacturer's location in Salt Lake City, UT, USA.
- Retrospective or Prospective: Not applicable as this is an engineering analysis, not a clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. Ground truth in this context would be defined by engineering specifications, material properties, and biomechanical principles, not expert clinical consensus.
- Qualifications of Experts: Not applicable. The analyses are based on engineering principles.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is an engineering verification, not a clinical study requiring adjudication of observations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This is not a clinical imaging or diagnostic device requiring an MRMC study. It's an orthopedic implant.
- Effect Size: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This device is a physical orthopedic implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Type of Ground Truth: Engineering specifications, material science principles, biomechanical testing standards, and previously established performance benchmarks for the predicate devices. The "ground truth" is defined by the physical and mechanical properties required for a safe and effective knee implant component.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no mention of machine learning or an "algorithm" being trained in this 510(k). The evaluation is based on engineering analyses of physical components.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set mentioned in this context.
§ 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.