Search Results

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:

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.

Ask a specific question about this device

The Prophecy® Surgical Planning System is intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The Prophecy® Surgical Planning Guides and Reports are intended for use with the Inbone®. Infinity® and Invision® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (e.g. CT scans and X-rays). The Prophecy® Surgical Planning guides are intended for single use only.

The Prophecy® Surgical Planning System is composed of three components:

• Prophecy® patient-specific guides
• Prophecy® 3D Planner
• Prophecy® Preoperative report

The Prophecy® Surgical Planning System is compatible with the Inbone®, Infinity®, and Invision® Total Ankle Systems.

The provided text describes a 510(k) premarket notification for the Prophecy® Surgical Planning System. The submission focuses on modifications to the Prophecy® 3D Planner software. The information available details non-clinical testing performed to demonstrate substantial equivalence, but it does not provide specific acceptance criteria or an explicit study proving performance against those criteria in a format you requested for a device that involves performance against defined metrics (e.g., accuracy, sensitivity, specificity).

Here's a breakdown of the available information based on your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states, "All test results met the acceptance criteria, demonstrating the subject device performs as intended and is substantially equivalent to the predicate device." However, the text does not explicitly list the specific acceptance criteria or the reported device performance metrics in a quantitative manner.

2. Sample size used for the test set and the data provenance

The document mentions "Software verification testing," "Software validation," "Usability test," and "Cybersecurity testing." These are general descriptions of testing types. No specific sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective) are provided in the given text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states, "Clinical testing was not necessary for the determination of substantial equivalence." This implies that the validation did not rely on expert-established ground truth in a clinical context for performance metrics as you typically find for AI diagnostic devices. For the usability testing, the number and qualifications of intended users (surgeons or engineers) involved in establishing ground truth are not specified.

4. Adjudication method for the test set

Since specific acceptance criteria involving expert-reviewed ground truth are not detailed, no adjudication method is mentioned or implied in the provided text.

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

The document explicitly states, "Clinical testing was not necessary for the determination of substantial equivalence." Therefore, no MRMC comparative effectiveness study was performed or is referenced.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The Prophecy® Surgical Planning System is described as a tool that "assists in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning," and involves "user interface software intended to be used by orthopedic surgeons" and "trained employees/engineers." This suggests a human-in-the-loop process. While software verification and validation would test the algorithm's performance, the context implies it's not a standalone diagnostic AI, but rather a planning and guidance tool. The text does not explicitly detail a standalone algorithm-only performance study in the manner of a diagnostic AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given that clinical testing was not performed for substantial equivalence, the "ground truth" for the software's performance would likely be based on engineering specifications, design requirements, and possibly simulated or phantom data for accuracy of measurements and guide design. For usability, it would relate to user feedback and completion of tasks as per the system's design. The document mentions "software verification testing to ensure all design outputs meet all specified requirements" and "software validation to ensure software specifications conform to user needs and intended uses," which aligns with this interpretation.

8. The sample size for the training set

The document refers to a "Prophecy® 3D Planner" software update. It does not mention any machine learning or AI model training. Therefore, a training set size is not applicable or provided in this context.

9. How the ground truth for the training set was established

As there's no mention of a traditional machine learning training set, this question is not applicable. The "ground truth" for the software's development (not training) would have been established through engineering design processes and requirements.

Ask a specific question about this device