(211 days)
The Vantage® Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
The Vantage® Total Ankle System is indicated for cemented use only.
The Vantage® Total Ankle System is a system of orthopedic implants intended for total ankle replacement. The system includes Tibial Plates, Tibial Inserts, Talar Components, and Locking Clips. This submission proposes three new components as line extensions of the Vantage Total Ankle System, which are modifications of their respective predicate components:
- 3D Tibial Plates
- 3D+ Tibial Plates ●
- 3D/3D+ Locking Clips ●
The proposed devices have the same indications for use and similar design characteristics as their predicate devices (cleared under K152217). The proposed tibial plates differ from the predicate in that they are additively manufactured, have minor geometrical modifications, and are offered in additional sizes. The proposed locking clips differ from the predicate in that they are offered in additional sizes.
The provided text describes the 510(k) summary for the Exactech® Vantage® Total Ankle System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study or a standalone algorithm performance study.
Therefore, many of the requested details, such as those pertaining to a multi-reader multi-case (MRMC) study, human reader improvement with AI assistance, standalone algorithm performance, or the sample size and ground truth establishment for training and test sets of an AI/ML device, are not applicable to this 510(k) submission.
This submission is for a traditional medical device (total ankle system implants and components), not an AI/ML-driven diagnostic or prognostic device that would typically involve the types of studies described in the prompt. The "acceptance criteria" here refer to the demonstration of substantial equivalence through non-clinical performance testing of mechanical properties and material characteristics, rather than diagnostic accuracy metrics.
Here's a breakdown of the available information based on your request, highlighting what is present and what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for a traditional medical device like this are primarily based on established ASTM standards and demonstrating mechanical equivalence to a predicate device. The performance is shown through passing these tests, rather than providing specific numerical thresholds for diagnostic accuracy.
| Acceptance Criteria (Type of Non-Clinical Testing) | Reported Device Performance |
|---|---|
| Tibial Plate Fatigue Testing per ASTM F2665 | Sufficient strength for intended use and substantially equivalent to legally marketed predicate devices. |
| Tibial Plate Fixation Stability Testing | Sufficient strength for intended use and substantially equivalent to legally marketed predicate devices. |
| Locking Mechanism Fatigue Testing | Sufficient strength for intended use and substantially equivalent to legally marketed predicate devices. |
| Residual Particulate Count Studies | (Not explicitly detailed, but implied to meet standards) |
| Porous Surface Characterization Testing: | |
| - Stereological Evaluation per ASTM F1854 | (Implied to meet standards) |
| - Static Shear Testing per ASTM F1044 | (Implied to meet standards) |
| - Tension Testing per ASTM F1147 | (Implied to meet standards) |
| - Abrasion Resistance Testing per ASTM F1978 | (Implied to meet standards) |
| - Shear Fatigue Testing per ASTM F1160 | (Implied to meet standards) |
| - Compression Testing | (Implied to meet standards) |
| Pyrogenicity Testing | Endotoxin limit is less than 20 EU/device. |
2. Sample size used for the test set and the data provenance
- Not Applicable: This is not a study involving a "test set" of clinical data or images for an AI/ML algorithm. The "testing" refers to mechanical and material performance testing of the device components themselves.
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 this context refers to the defined mechanical and material properties as per ASTM standards, not expert medical opinion on clinical cases.
4. Adjudication method for the test set
- Not Applicable: No adjudication method for a test set of clinical data is described. The "adjudication" would be related to the interpretation and validation of engineering test results, which is part of standard test protocols.
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 mechanical implant device, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This is a mechanical implant device, not a standalone AI algorithm.
7. The type of ground truth used
- For mechanical and material testing, the "ground truth" is based on established engineering principles and recognized consensus standards (e.g., ASTM F2665, ASTM F1044, ASTM F1147, ASTM F1978, ASTM F1160, ASTM F1854). These standards define the parameters and methodologies for evaluating the device's performance characteristics.
8. The sample size for the training set
- Not Applicable: This is not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established
- Not Applicable: As above, this is not an AI/ML device.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study described is a series of non-clinical engineering and material characterization tests designed to demonstrate the substantial equivalence of the Exactech® Vantage® Total Ankle System to a legally marketed predicate device (K152217).
- Objective: To show that the proposed new components (3D Tibial Plates, 3D+ Tibial Plates, and 3D/3D+ Locking Clips) have comparable safety and effectiveness to the predicate device, despite minor design and manufacturing differences (e.g., additive manufacturing, additional sizes).
- Methodology: A battery of tests was performed on the device components, adhering to recognized ASTM standards for total ankle replacement devices. These tests evaluated:
- Fatigue strength of tibial plates and locking mechanisms.
- Fixation stability of tibial plates.
- Characteristics of porous surfaces (stereological evaluation, shear, tension, abrasion resistance, compression).
- Residual particulate count.
- Pyrogenicity.
- Conclusion: The tests concluded that the strength of the new components is "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." The pyrogenicity test demonstrated endotoxin levels below the specified limit (
§ 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.