(59 days)
The Duracon® Total Knee System components are for use in total knee arthroplasty to relieve pain and restore knee function for indications such as: noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and, irreparable fracture of the knee. These products are intended to achieve fixation with and without the use of bone cement.
The device includes femoral, tibial and patellar components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the distal femur, proximal tibia to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.
The provided text describes the Duracon® Total Knee System and its regulatory submission (K032163) for an additional indication for use without bone cement. The study described focuses on demonstrating equivalence to predicate devices rather than a typical clinical study with acceptance criteria for device performance in patients.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative "acceptance criteria" in terms of clinical performance (e.g., pain reduction, range of motion improvement) that a new device would need to meet through a clinical study. Instead, the "acceptance criteria" are related to established engineering and material standards for knee prostheses. The "reported device performance" refers to the results of testing demonstrating compliance with these standards.
| Acceptance Criteria (Related to "Study") | Reported Device Performance |
|---|---|
| Requirements outlined in the "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA," dated January 16, 2003, for: |
- Porous coating characterization
- Baseplate fatigue testing
- Contact area / stress analyses
- Range of motion / range of constraint testing
- Locking mechanism testing
- UHMWPe material properties | The results demonstrate that the Duracon Total Knee System meets the requirements of this document. |
| Equivalence of the proposed products to the predicate devices. | Demonstrated through risk analysis and research and development testing. |
2. Sample Size Used for the Test Set and Data Provenance:
The document discusses "research and development testing" on the components of the Duracon Total Knee System. This implies in-vitro or bench testing on a sample of the manufactured devices or their materials.
- Sample Size: Not explicitly stated. The testing would have been conducted on a representative sample of device components (e.g., a certain number of porous coatings, baseplates, UHMWPe samples).
- Data Provenance: The testing was likely conducted in a laboratory setting by Howmedica Osteonics Corp. (the manufacturer) or a contracted lab. It is not clinical data from patients, therefore concepts like "country of origin" or "retrospective/prospective" don't apply in the human data sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the "study" described is not a clinical study involving human patients, and therefore, there is no "ground truth" to be established by experts in a clinical context (e.g., radiologists, pathologists). The "ground truth" in this context is the physical and mechanical properties of the device components as measured by scientific instruments and methods, compared against engineering specifications.
4. Adjudication Method for the Test Set:
This is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for expert review of clinical cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The study described is a benchtop engineering and materials testing study, not a clinical study involving human readers or patients.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This concept is not applicable. The device is a physical knee implant, not a software algorithm or AI-driven system.
7. The Type of Ground Truth Used:
The "ground truth" used for this type of submission is:
- Engineering Specifications and Standardized Test Methods: Compliance with established industry standards and guidance documents (e.g., from the FDA) for mechanical strength, material properties, porous coating characteristics, etc.
- Predicate Device Performance: Documentation that the proposed device performs equivalently to the legally marketed predicate devices, particularly regarding its mechanical and material aspects.
8. The Sample Size for the Training Set:
This concept is not applicable. There is no "training set" in the context of an engineering and materials testing study for a physical medical device. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set was Established:
This concept is not applicable for the same reasons as point 8.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.