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510(k) Data Aggregation
(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.
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(90 days)
The INBONE Total Ankle System and INFINITY Total Ankle System are indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INBONE Total Ankle System and INFINITY Total Ankle System are additionally indicated for patients with a failed previous ankle surgery.
CAUTION: In the United States, the ankle prosthesis is intended for cement use only.
The subject INBONE™ and INFINITY™ Total Ankle Systems are fixed-bearing, bone-sparing ankle replacement prostheses that restore mobility to a failing ankle joint. Both the INFINITY and INBONE systems include three components (tibial trays with or without stems, poly inserts, and talar domes) that are assembled together to create the two-piece prosthesis.
This is a 510(k) premarket notification for a medical device (INFINITY and INBONE Total Ankle Systems) and does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria in the context of AI/ML or diagnostic performance. Instead, it demonstrates substantial equivalence to predicate devices, focusing on design, materials, and non-clinical performance.
Therefore, many of the requested points cannot be answered from the provided text. I will address the points that can be inferred or directly stated.
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria or reported device performance in the form of a table with numerical values for metrics like sensitivity, specificity, or image quality, as would be expected for a diagnostic or AI-driven device. Instead, it lists non-clinical tests performed to demonstrate substantial equivalence to predicate devices.
| Acceptance Criteria (Non-Clinical Tests) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Chemical Analysis | Demonstrated equivalence to predicate devices |
| Compressive Strength | Demonstrated equivalence to predicate devices |
| Shear and Tensile Strength | Demonstrated equivalence to predicate devices |
| MRI Safety Analysis | Minimal risk to patients in an MR environment (MR Conditional) |
| Direct Metal Laser Sintering (DMLS) Process Validation | Demonstrated equivalence to predicate devices (Performance Qualification, Mechanical validation, Microstructure, Powder Bed Position Validation) |
| Endotoxin ( |
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(57 days)
The INFINITY Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. The INFINITY Total Ankle System is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: In the United States, the ankle prosthesis is intended for cement use only.
The subject INFINITY™ Total Ankle System is a fixed-bearing, bone-sparing ankle replacement prosthesis that restores mobility to a failing ankle joint. The system includes three components (i.e., tibial tray, poly insert, and talar dome) that are assembled together to create the two-piece prosthesis. The tibial tray is manufactured using additive manufacturing technology.
The provided document is a 510(k) summary for the INFINITY Total Ankle System. It focuses on demonstrating substantial equivalence to predicate devices and outlines non-clinical bench testing. It explicitly states that "Clinical Studies were not required to demonstrate substantial equivalence between the subject device and the predicate devices." Therefore, the document does not contain information regarding acceptance criteria, device performance from a clinical study, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on clinical data.
Based on the information provided, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
Not applicable. The document discusses non-clinical bench testing for a medical device (Total Ankle System) rather than an AI/ML-driven device with clinical performance metrics. The listed non-clinical tests (e.g., Chemical Analysis, Abrasion Resistance, Fatigue Testing) are intended to show substantial equivalence to predicate devices, not to meet specific clinical performance acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set was used as clinical studies were not required. The document refers to non-clinical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical test set or human expert review for ground truth was involved since clinical studies were not required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication process was involved.
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. A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "Clinical Studies were not required to demonstrate substantial equivalence between the subject device and the predicate devices." This device is a total ankle system, not an AI/ML diagnostic tool for which MRMC studies are typically conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical medical implant (Total Ankle System), not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. Since no clinical studies were performed and clinical performance was not assessed in this submission, there is no discussion of ground truth based on clinical data. The "ground truth" for the non-clinical tests would be defined by engineering specifications and material standards, which are not detailed in this summary.
8. The sample size for the training set
Not applicable. This document pertains to a physical medical device. There is no mention of a training set as would be relevant for an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned for an AI/ML device, the establishment of ground truth for a training set is not discussed.
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