(163 days)
Intended Use: The Incompass Total Ankle System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
Indications for Use: The Incompass Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The Incompass Total Ankle is additionally indicated for patients with a failed previous ankle surgery.
Incompass™ Total Ankle System is a total ankle replacement system consisting of implants and instruments.
Incompass™ Total Ankle System will harmonize the Infinity™ and Inbone™ Total Ankle Systems into one comprehensive system consisting of modular stemmed and low-profile pegged tibial trays, tibial inserts, and talar domes. The harmonized system is facilitated by sharing the same tibial resection geometry between the pegged and the stemmed tibial tray designs.
The provided text is a 510(k) clearance letter for the Incompass Total Ankle System. It outlines the device's indications for use, its classification, and declares its substantial equivalence to predicate devices based on non-clinical evidence.
However, the clearance letter explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."
This means that the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment (which are typical for studies proving a device meets acceptance criteria, especially for AI/ML-based devices or those requiring clinical trials) is not included in this document. The clearance was based on non-clinical performance bench testing to demonstrate substantial equivalence in wear, articular stability, lock detail, manufacturing processes, static strength, fatigue strength, fretting, corrosion, and MRI safety, rather than clinical efficacy studies.
Therefore, I cannot provide the requested information from this document. If this were a submission for a device that required clinical performance data to demonstrate safety and effectiveness (e.g., an AI/ML device), this section would typically contain summaries of those studies.
Based on the provided document, here's what can be inferred or explicitly stated regarding the acceptance criteria and study proving adherence to them:
The device in question is a Total Ankle System, a type of orthopedic implant, not an AI/ML-based device or one that underwent a clinical efficacy study for its 510(k) clearance.
The "study" that proves the device meets acceptance criteria, in this context, refers to non-clinical performance bench testing.
1. A table of acceptance criteria and the reported device performance:
Since no clinical efficacy study was conducted for this 510(k) clearance, there's no data to populate such a table detailing clinical performance metrics (like sensitivity, specificity, or human reader improvement).
The acceptance criteria for this device were related to substantial equivalence through bench testing. The document states:
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (from Non-Clinical Bench Testing) |
|---|---|
| Demonstrate wear performance comparable to predicate. | Testing performed to demonstrate substantial equivalence in wear. |
| Demonstrate articular stability comparable to predicate. | Testing performed to demonstrate substantial equivalence in articular stability. |
| Demonstrate lock detail comparable to predicate. | Testing performed to demonstrate substantial equivalence in lock detail. |
| Adherence to manufacturing processes. | Testing performed to demonstrate substantial equivalence in manufacturing processes. |
| Demonstrate static strength comparable to predicate. | Testing performed to demonstrate substantial equivalence in static strength. |
| Demonstrate fatigue strength comparable to predicate. | Testing performed to demonstrate substantial equivalence in fatigue strength. |
| Demonstrate fretting performance comparable to predicate. | Testing performed to demonstrate substantial equivalence in fretting. |
| Demonstrate corrosion resistance comparable to predicate. | Testing performed to demonstrate substantial equivalence in corrosion. |
| Demonstrate MRI safety. | Testing performed to demonstrate substantial equivalence in MRI safety. |
| Overall, no new questions of safety or effectiveness raised compared to predicates. | "The differences in design specifications do not raise any new questions of safety and effectiveness over the predicate, which is demonstrated in the performance testing and process validation." |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified in the document, as it refers to engineering and materials testing (bench testing) rather than a dataset of patient cases. For bench testing, "samples" would refer to the number of devices or components tested.
- Data Provenance: Not applicable in the context of clinical patient data (e.g., country of origin, retrospective/prospective), as the evidence was non-clinical bench testing. The testing would have been conducted in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically defined for AI/ML or clinical studies (e.g., expert consensus on medical images) was not established. The "ground truth" for bench testing is determined by engineering standards, material science principles, and established testing methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is relevant for studies involving human reviewers or AI output, not for materials and mechanical bench 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 type of study is specifically for AI/ML-assisted diagnostic devices. The Incompass Total Ankle System is a physical medical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is relevant for AI/ML algorithms.
7. The type of ground truth used:
- The "ground truth" for this clearance was established through engineering standards, material specifications, and validated bench testing protocols comparing the device's physical and mechanical properties against those of legally marketed predicate devices. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI/ML algorithm.
§ 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.