(107 days)
The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only.
The proposed Optetrak Logic Porous Femoral Component devices represent modifications to existing Optetrak Logic Total Knee System (K093360) and Optetrak Logic CR Knee System femoral components (K111400 and K121307) used in total knee arthroplasty. The only difference between proposed Optetrak Logic Porous Femoral Components and predicate Optetrak Logic femoral components is the addition of a beaded, sintered cobalt-chrome coating to specific non-articulating areas of the subject devices, similar to the coating added to predicate Optetrak Porous Coated Cruciate Retaining Femoral Component devices cleared per 510(k) K935726 and predicate Exactech Posterior Stabilized Porous Femoral Component devices cleared per 510(k) K935773.
Both predicate and proposed devices share the following similarities:
- the same indications for use .
- . the same materials
- . the same basic fundamental scientific technology
- . the same device compatibility
- the same materials and processes used for packaging and sterilization .
Here's an analysis of the provided text regarding the acceptance criteria and study for the Exactech® Optetrak Logic® Porous Femoral Component:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from FDA guidance) | Reported Device Performance (from Summary of Testing) |
|---|---|
| Porous Coating Characteristics: | |
| Volume porosity: 30% to 70% | Mean porosity: 65.8% |
| Average pore size: 100 to 1,000 microns | Mean pore size: 339.9 μm |
| Coating thickness: 500 to 1,500 microns | Mean tissue-interface coating thickness: 766.9 μm |
| Mechanical Properties: | |
| Minimum Shear Strength: 20 MPa | Mean shear strength: 40.6 MPa (All samples exceeded 20 MPa) |
| Minimum Tensile Strength: 20 MPa (Implied, often similar to shear for porous coatings) | Mean tensile strength: 46.9 MPa (All samples exceeded 20 MPa) |
| Fatigue Performance: | |
| Withstand load cycles (specific criteria not explicitly stated, but common in medical device testing to demonstrate durability) | Specimen 1.3 withstood 10 million load cycles at max shear stress of 22.5 MPa. Specimens 1.4 and 1.5 failed after 2.4 million and 7.5 million cycles respectively (at higher stresses or adhesive interface). Other specimens also tested at higher stresses and failed at adhesive/coating interfaces. |
| Abrasion Resistance: | |
| No visible abrasion marks or particle shedding (goal) | No visible abrasion marks or particle shedding. Average material change after 100 abrasion cycles = 11.3 ± 13.4 mg. |
| Chemical Composition & Microstructure: | |
| Equivalent to predicates (goal) | Modified substrate equivalent to predicates per chemical composition, grain size, grain distribution, and microstructure. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes material and mechanical testing, not a clinical study with patients. Therefore, the concept of "test set" in terms of patient data or clinical outcomes doesn't directly apply here.
- Mechanical Testing (e.g., Shear fatigue testing): Sample size of n=5 was used for shear fatigue testing per ASTM F1160-05.
- Other Mechanical Tests (Shear strength, Tensile strength): The document states "All test samples exceeded..." for shear and tensile strength, implying multiple samples were tested, but the exact count isn't specified beyond "all test samples."
- Data Provenance: The tests are reported as "engineering studies" and "cadaver lab evaluation," indicating laboratory-based data and potentially pre-clinical/bench testing. There is no mention of country of origin for this data or if it's retrospective or prospective in a clinical sense. The cadaver lab evaluation is a type of prospective pre-clinical test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Cadaver Lab Evaluation: A "surgeon" determined the prototype was implanted without difficulty. The number of surgeons and their specific qualifications (e.g., years of experience, specialization) are not specified. This 'ground truth' is subjective, based on surgical ease of use.
- Other Tests: For the material and mechanical tests, the "ground truth" is established by the ASTM standards themselves (e.g., ASTM F1854-09, ASTM F1044-05). These standards define the test methods and performance metrics, and the measurements are objective laboratory results. There is no mention of human experts establishing ground truth for these quantitative measurements beyond the technicians conducting the tests according to standard protocols.
4. Adjudication Method for the Test Set:
Not applicable in the context of these engineering and cadaver lab tests. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for ambiguous cases or diagnostic disagreement between multiple human readers or between human readers and AI. The tests performed are objective measurements against defined standards or surgeon's subjective assessment of implantability.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This submission focuses on material and mechanical equivalence for a modified medical device, not on assessing the diagnostic or clinical effectiveness of an AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This submission is for a physical medical device (femoral component for knee replacement), not an algorithm or AI system.
7. The Type of Ground Truth Used:
- Material and Mechanical Tests: The ground truth is objective, quantitative measurements derived from standardized laboratory tests (e.g., ASTM standards) and compared against pre-defined performance acceptance criteria suggested by FDA guidance.
- Cadaver Lab Evaluation: The ground truth is a subjective expert assessment by a surgeon regarding the ease of implantation.
8. The Sample Size for the Training Set:
Not applicable. There is no "training set" as this is not an AI/machine learning device. The device's design is based on existing predicate devices and engineering principles, not statistical learning from a dataset.
9. How the Ground Truth for the Training Set was Established:
Not applicable. No training set exists for this device.
§ 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.