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510(k) Data Aggregation
(86 days)
The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended for cemented use only.
The Paragon 28 Laser Alignment Guide is a line extension to the APEX 3D Total Ankle Replacement System instrumentation (K192994). The Paragon 28® APEX 3D™ Total Ankle Replacement System Laser Alignment Guide is designed to provide a visual guide to verify alignment of the instrumentation associated with the APEX 3D™ Total Ankle Replacement System. Once inserted into the proper instrumentation, the Laser projects a line onto the patient to be used by surgeons as a visual reference for alignment. The Laser Alignment Guide is a singleuse electrical device.
This document describes the APEX 3D Total Ankle Replacement System Laser Alignment Guide, a line extension to the APEX 3D Total Ankle Replacement System instrumentation. The information provided is sufficient to answer some, but not all, of your questions regarding acceptance criteria and the study proving device performance, especially concerning clinical study details, as this submission primarily focuses on substantial equivalence based on non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on the Laser Alignment Guide specifically and its substantial equivalence to predicate devices, rather than establishing new performance criteria or providing a direct table of acceptance criteria and performance for the overall APEX 3D Total Ankle Replacement System itself. The "acceptance criteria" for the Laser Alignment Guide are inferred from the non-clinical tests performed to demonstrate its intended function and safety.
| Acceptance Criteria (Inferred for Laser Alignment Guide) | Reported Device Performance (Summary from Non-Clinical Testing) |
|---|---|
| Laser line projection efficacy (e.g., clear, visible, accurate projection of a line onto the patient for alignment) | Cadaveric design evaluation of the Laser line demonstrated it performs as intended. |
| Stability of the Laser Alignment Guide (e.g., secure attachment to instrumentation, does not obstruct procedures) | Stability assessment demonstrated it performs as intended. |
| Electrical Safety (e.g., compliance with electrical safety standards, safe operation as an electrical device) | Electrical safety testing demonstrated it performs as intended. |
| Material/Chemical Composition/Energy Source Similarities to Predicate Devices | The Laser Alignment Guide possesses similar technological characteristics as the predicate devices, including design, material, chemical composition, and energy source. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "a cadaveric design evaluation" and "stability assessment" but does not specify the sample size (e.g., number of cadavers, number of stability tests).
- Data Provenance: The cadaveric study would imply human anatomical data. The provenance (e.g., country of origin) is not specified.
- Retrospective or Prospective: These non-clinical tests would be considered prospective in nature, as they were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The cadaveric design evaluation and stability assessment would likely involve technical and possibly surgical experts, but their numbers and qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the non-clinical tests (cadaveric evaluation, stability, electrical safety), a formal "adjudication method" in the sense of consensus among multiple human readers of medical images is unlikely to apply directly. The "assessment" mentioned suggests an evaluation against pre-defined criteria, but the specific method is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission for the Laser Alignment Guide is based on substantial equivalence demonstrated through non-clinical testing. It does not involve a study comparing human reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The Laser Alignment Guide is a physical medical device that provides a visual guide for human surgeons. It is not an algorithm or an AI system, so the concept of "standalone performance" for an algorithm does not apply. Its function is inherently "human-in-the-loop" as it assists a surgeon.
7. The Type of Ground Truth Used
For the non-clinical tests mentioned:
- Cadaveric Design Evaluation: The "ground truth" would be the anatomical landmarks and the intended alignment as determined by surgical principles. The laser's projection would be evaluated against this anatomical reality.
- Stability Assessment: The "ground truth" would be the engineering specifications for stability and secure attachment.
- Electrical Safety Testing: The "ground truth" would be the applicable electrical safety standards and regulations.
8. The Sample Size for the Training Set
The Laser Alignment Guide is a hardware device, not an AI/ML system that utilizes a "training set." Therefore, discussions of a training set sample size are not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for this hardware device, this question is not applicable.
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