(241 days)
The ANATOMIC® Total Knee System is indicated for use in total knee arthroplasty as a result of:
- 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 ANATOMIC® Total Knee System is for single use only and is intended for implantation with bone cement only.
The ANATOMIC® Total Knee System belongs to the category of sliding posterior-stabilized total knee prostheses (PS, posterior-cruciate substituting).
The ANATOMIC® Total Knee System is intended for use as a semi-constrained replacement system. It consists of a femoral implant, a tibial implant and a patellar implant. The tibial implant consists of two components: tibial insert and tibial baseplate. The patellofemoral joint may be preserved or resurfaced with the patellar resurfacing implant.
The femoral implant comes in right and left versions and in various sizes. The tibial baseplate and tibial insert are symmetrical and can be used both for right and left sides. The tibial baseplate comes in various sizes. The tibial insert is available in various sizes and thicknesses.
The nominal size of the insert includes the thickness of the tibial baseplate. The standard keel (supplied in the tibial baseplate packaging) must be mounted and blocked on the implant by the surgeon before implantation.
The components are for cemented used only.
The selection of the appropriate implants can be made by using the recommendations of the surgical technique and by using the x-ray templates and trial implants supplied with the instrumentation.
Please note: The provided document describes the ANATOMIC® Total Knee System, which is a medical device (knee prosthesis). The request asks for information relevant to "AI/ML powered device" or "software" performance criteria. Since this document is for a mechanical implant and not an AI/ML powered device, many of the requested fields (like "AI vs without AI assistance," "number of experts for ground truth," "adjudication method," "sample size for training set," etc.) are not applicable and thus couldn't be extracted from the provided text.
Based on the provided document, here's an analysis of the acceptance criteria and study information for the ANATOMIC® Total Knee System:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results in the format typically used for software or AI/ML devices. Instead, it refers to a "substantial equivalence" conclusion based on a comparison to predicate devices and adherence to relevant standards through non-clinical testing.
The comparison table (Table 1 on pages 4-6) lists numerous characteristics and states "YES" under the "Substantial equivalence?" column for each feature, indicating that the device's characteristics are considered equivalent to the predicate devices.
Key areas covered by the non-clinical testing for substantial equivalence:
| Acceptance Criteria Category (Derived from Testing Type) | Reported Device Performance (as implied by "Substantial Equivalence") |
|---|---|
| Tibial Baseplate Fatigue | Met required fatigue strength per FDA guidance. |
| Insert (post) Fatigue | Met required fatigue strength per FDA guidance. |
| Wear | Demonstrated acceptable wear characteristics. |
| Range of Motion | Achieved intended range of motion (High flexion = 130° max). |
| Constraints Femoro-Tibial | Demonstrated appropriate femoro-tibial constraints. |
| Constraints Patello-Femoral | Demonstrated appropriate patello-femoral constraints. |
| Contact Area/Stress Femoro-Tibial | Exhibited acceptable contact area and stress distribution. |
| Contact Area/Stress Patello-Femoral | Exhibited acceptable contact area and stress distribution. |
| Interlock Strength insert/Baseplate | Demonstrated sufficient interlock strength. |
| UHMWPE Material Properties | Conformed to test standards (ISO 5834-2, ASTM F648 for predicates). |
| Galvanic Effect on Corrosion | Assessed and demonstrated conformity to relevant standard. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical laboratory testing, not human patient data. Therefore, concepts like "test set sample size" (in terms of patients) and "data provenance" (country of origin, retrospective/prospective) are not applicable in the context of this device. The tests are performed on physical samples of the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of this document, refers to physical measurements and engineering standards, not expert evaluation of clinical data.
4. Adjudication method for the test set
Not applicable. This concept applies to human reader studies or clinical trials, not non-clinical laboratory testing of a mechanical implant.
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 is a mechanical implant, not an AI/ML powered device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical implant, not an AI/ML powered device.
7. The type of ground truth used
The ground truth for the non-clinical tests is based on established engineering standards and regulatory guidance (e.g., FDA Guidance Class II/Special Controls Guidance Document Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA, issued January 16, 2003, and test standards for materials like ISO 5832-4, ASTM F75, ISO 5834-2, ASTM F648).
8. The sample size for the training set
Not applicable. This is a mechanical implant; there is no "training set" in the AI/ML sense. The "training" in manufacturing would refer to design, material selection, and process validation, which are not typically quantified by a "sample size" in this context.
9. How the ground truth for the training set was established
Not applicable, for the same reasons as point 8.
§ 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.