(91 days)
The Cadence Total Ankle System is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint.
The Cadence Total Ankle System is indicated for use to treat:
- systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis)
- primary arthritis (e.g. degenerative disease)
- secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved)
The Cadence Total Ankle System is also indicated for revision surgeries following failed total ankle replacement and non-union/mal-union of ankle arthrodesis, provided sufficient bone stock is present.
Note: In the United States, this device is intended for cemented use only.
The Integra® Total Ankle Replacement System is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint.
The prosthesis is composed of a tibial component, a talar component and an insert. Both the tibial component and talar component are secured to patient anatomy via bone cement; the intermediate insert is rigidly fixed to the tibial component intra-operatively. When all three components are implanted, the intermediate insert acts as a bearing along the talar component, enabling flexion and extension movement at the replaced joint.
Components are available in a variety of sizes and design configurations intended for both primary and revision applications.
For marketing purposes the Integra Total Ankle Replacement System will be released to market as the Cadence Total Ankle System.
The provided text describes a 510(k) premarket notification for the Integra Total Ankle Replacement System (also referred to as Cadence Total Ankle System), which is an ankle joint metal/polymer semi-constrained cemented prosthesis.
Based on the information provided, here's a breakdown of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Objective | Reported Device Performance | Conclusion |
|---|---|---|
| Mechanical Stiffness | The stiffness of the Integra Total Ankle Replacement System was statistically equivalent to the predicate device. | Device met acceptance criteria. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size (number of devices/constructs) used for the test set in the mechanical testing. It only mentions that "the predicate construct and Integra Total Ankle Replacement System construct were tested both dynamically and statically." The data provenance is not specified beyond being part of a 510(k) submission, implying it's from the manufacturer's internal testing. It is a prospective test, as it was conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" for the test set here refers to mechanical performance, not expert-derived clinical outcomes or interpretations. The acceptance criteria are based on engineering standards and comparison to a predicate device's mechanical properties.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for establishing ground truth in clinical studies involving multiple expert readers, not for mechanical performance testing.
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
No. This is a medical device (prosthesis) submission, not an AI/software as a medical device (SaMD) submission. An MRMC study or AI-related effectiveness analysis is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is not an AI/SaMD.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the mechanical testing, the "ground truth" is established by the measured mechanical properties (specifically stiffness) of the devices under controlled dynamic and static conditions, compared to the predicate device. It's an engineering "ground truth."
8. The sample size for the training set
This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described is for physical device performance.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of device submission.
§ 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.