(251 days)
The Quantum® total ankle prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Note: In the United States, the ankle prosthesis is intended for cement use only.
The QUANTUM® Total Ankle Prosthesis is a fixed-bearing total ankle replacement device. The prosthesis is composed of a tibial implant, a tibial inlay, and a talar implant. Both the tibial implant and talar implant are secured to patient anatomy via bone cement; the intermediate inlay is rigidly fixed to the tibial implant intra-operatively. When all three components are implanted, the intermediate inlay acts as a bearing along the talar implant, enabling movements at the replaced joint. Components are available in a variety of sizes and design configurations to accommodate the various anatomical needs of a patient's ankle joint, and intended for both primary and revision applications. QUANTUM® Total Ankle Prosthesis is accompanied by a complete instrumentation set including trial and drill/cutting guide to assist surgeons in implantation of the device.
The In2Bones QUANTUM® Total Ankle Prosthesis underwent performance testing to demonstrate substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method (Reference Standard) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Bench Testing (ASTM F2665) | The specific quantitative acceptance criteria are not detailed in the provided text, but generally, for total ankle prostheses tested to ASTM F2665, criteria would involve demonstrating sufficient: |
- Range of Motion: Allowable physiological range of motion without impingement or abnormal articulation.
- Contact Pressure and Constraint: Acceptable contact stress distributions on articulating surfaces and adequate constraint against abnormal translations/rotations.
- Component Fatigue: Resistance to fracture or failure under cyclic loading representative of physiological conditions for a specified number of cycles.
- Insert Locking Mechanism: Secure engagement and retention of the insert within the tibial component under relevant forces. | The results indicate that the QUANTUM® total ankle prosthesis met the acceptance criteria for:
- Range of Motion study
- Contact pressure and constraint evaluation
- Component Fatigue analysis
- Insert Locking mechanism |
| Wear Evaluation (ISO 22622) | The specific quantitative acceptance criteria for wear are not detailed in the provided text, but generally, for total ankle prostheses tested to ISO 22622, criteria would involve demonstrating that the wear rate of the articulating components (specifically the polyethylene insert) is within acceptable limits to ensure long-term device function and minimize wear debris generation. | The results indicate that the QUANTUM® total ankle prosthesis met the acceptance criteria for wear evaluation. |
| Pyrogen Testing (ANSI/AAMI ST72:2011) | The device must meet the pyrogen limit specification according to ANSI/AAMI ST72:2011. This typically involves demonstrating that the endotoxin level is below a specified threshold. | The device meets pyrogen limit specification as determined by the Limulus Amebocyte Lysate (LAL) test. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text does not specify the sample sizes used for the mechanical bench testing, wear evaluation, or pyrogen testing. It also does not mention the data provenance (e.g., country of origin, retrospective/prospective) for these tests, as these are in vitro and in silico studies, not human subject data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The performance data for this medical device (a total ankle prosthesis) is based on mechanical bench testing, finite element analysis, and laboratory pyrogen testing, not on human expert interpretation of images or clinical data. Therefore, there is no "ground truth" established by experts in the context of a test set, nor are there experts "qualifications" relevant to this type of testing.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, the testing performed is mechanical and laboratory-based, not involving human interpretation or adjudication processes typical of clinical studies or image-based AI evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not done. The provided information pertains to the mechanical and biological safety performance of the device itself, not to a diagnostic or interpretive AI system that would assist human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This is not an AI algorithm but a physical medical device. The "performance" described is the standalone performance of the implant under various simulated physiological conditions.
7. The Type of Ground Truth Used:
The "ground truth" for the performance testing is based on:
- Engineering principles and material science standards: For mechanical bench testing (ASTM F2665), wear evaluation (ISO 22622), and finite element analysis, the "ground truth" is adherence to established industry-recognized performance metrics and models that predict in-vivo behavior.
- Biological safety standards: For pyrogen testing (ANSI/AAMI ST72:2011), the "ground truth" is the absence of pyrogens above a defined safe limit.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no AI training set for this device.
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.