(101 days)
The Freedom® Cementless Femoral Components are designed to be used as a part of the Freedom® Total Knee System, and is indicated for the following:
- Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Correction of functional deformities.
- Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
- Moderate valgus, varus, or flexion trauma.
- Knee fractures untreatable by other methods
- Revision surgery where sufficient bone stock and soft tissue integrity are present. ●
The Freedom Total Knee System, Freedom Stemmed Tibial Components and Freedom PCK Components are indicated for cemented fixation. Only Cementless Femoral (CR and PS) components with porous coating are additionally indicated for cementless biological fixation application.
The Cementless Femoral Components ("Components") are intended for use with the currently available Freedom Total Knee System as part of total knee replacement (TKR) surgery. Total knee replacement surgery is a procedure where worn, diseased, or damaged surfaces of the knee joint are removed and replaced with artificial surfaces.
The Components will be prescription products consisting of single use only, implantable devices for implanting into patients in an operating theatre by a qualified surgeon.
This document is a 510(k) premarket notification for the "Freedom® Cementless Femoral Components," a knee joint prosthesis. It outlines the device's indications for use, its similarity to predicate devices, and the performance testing conducted to demonstrate its substantial equivalence.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define specific numeric acceptance criteria for each test in a table format with corresponding performance results. Instead, it broadly states that the evaluations were performed in accordance with a specific FDA guidance document and that the "results were found to be equivalent to the legally marketed predicate device."
| Test Name | Acceptance Criteria (Stated) | Reported Device Performance (Stated) |
|---|---|---|
| Stereological Evaluation | Determine (1) percent porosity, (2) pore size (line length intercept), and (3) coating thickness of CoCr coupons. Examine interconnection of porosity. (As per TR-15-01 objective) | "results were found to be equivalent to the legally marketed predicate device." |
| Static Shear and Tensile | Not explicitly detailed in the objective section, but referenced as "Performance Testing: TR-15-02" | "results were found to be equivalent to the legally marketed predicate device." |
| Abrasion Testing | Not explicitly detailed in the objective section, but referenced as "Performance Testing: TR-15-03" | "results were found to be equivalent to the legally marketed predicate device." |
| Shear fatigue testing | Determine shear fatigue strength of ASTM F75 CoCr coupons coated and sintered with three layers of -40/+60 mesh CoCr powder. (As per TR-15-04 objective) The coating technique utilized is identical to that used for specified medical implants. | "results were found to be equivalent to the legally marketed predicate device." |
| General Performance (Overall) | Evaluations performed in accordance with the Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Cementless Prostheses; Guidance for Industry and FDA. | "The Freedom® Cementless Components are mechanically and functionally equivalent to the parent Freedom® Total Knee System." and "The results were found to be equivalent to the legally marketed predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify the exact sample sizes (e.g., number of coupons or test specimens) used for each mechanical test (Stereological Evaluation, Static Shear and Tensile, Abrasion Testing, Shear Fatigue Testing).
- Data Provenance: The document does not provide details about the country of origin of the data or whether the tests were retrospective or prospective. It describes laboratory mechanical testing, which is generally performed in a controlled environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This document describes mechanical and functional performance testing of a medical device (femoral components for knee replacement), not a diagnostic or screening device that requires expert interpretation for ground truth. Therefore, the concept of "experts establishing ground truth for a test set" in the context of human interpretation is not relevant here. The ground truth for these tests would be the physical properties derived from standardized mechanical testing methods.
4. Adjudication Method for the Test Set:
- Not Applicable. As explained above, this is mechanical testing, not a study involving human interpretation of data where adjudication methods (like 2+1, 3+1) would be used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC study is relevant for diagnostic or screening devices evaluated by multiple human readers. This document describes mechanical performance testing of a physical implant.
6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Yes, in spirit, but not in the AI sense. The performance testing described is "standalone" in the sense that it evaluates the device's mechanical properties independently. It does not involve any algorithm or AI in the common understanding of an "algorithm-only" study. It's a direct evaluation of the physical product's mechanical characteristics.
7. The Type of Ground Truth Used:
- The "ground truth" for the mechanical testing would be defined by established engineering standards and material properties. For example, in stereological evaluation, the "ground truth" would be the actual measurable porosity, pore size, and coating thickness. For shear fatigue testing, it would be the fatigue strength determined experimentally according to a standard. These are objective physical measurements rather than expert consensus, pathology, or outcomes data, which are typically associated with clinical or diagnostic studies.
8. The Sample Size for the Training Set:
- Not Applicable. The device is a physical implant, not an AI or algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As explained above, there is no training set for this type of device.
§ 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.