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510(k) Data Aggregation
(30 days)
The OrthAlign Plus® system is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instructures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® system facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length discrepancy in Total Hip Arthroplasty.
Example orthopedic surgical procedures include but are not limited to:
- Total Knee Arthroplasty
- · Total Hip Arthroplasty: Anterior/Posterior
- · Unicompartmental Knee Arthroplasty: Tibial transverse resection
The OrthAlign HipAlign® Sterile Pin Pack is indicated for use with the OrthAlign Plus® System.
Intended Use: The OrthAlign® HipAlign® Sterile Pin Pack is intended to be used with the OrthAlign Plus® system specific to Total Hip Arthroplasty.
The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display anqular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes,
The OrthAlign HipAliqn® Sterile Pin Pack is a set of sterile, single use pins used in conjunction with the OrthAlign Plus® system of instruments and electronics. The OrthAlign® HipAlign® Pin Pack includes:
- . Pelvic Fixation pins: 4.0mm in diameter and 90mm to 140mm in length
- Pelvic Fixation pins: 5mm in diameter and 170mm in length
- . Femoral registration markers: 4.0mm to 4.5mm in diameter and 16mm to 25mm in length
This document describes a Special 510(k) Premarket Notification for the OrthAlign HipAlign® Sterile Pin Pack, which is a modification to the previously cleared OrthAlign Plus® System (K171780). The focus of this notification is on the sterility and packaging of the pins and markers used with the system, rather than a a comprehensive AI/ML device. Therefore, the details requested in the prompt regarding AI/ML device performance, such as MRMC studies, training set ground truth establishment, and expert adjudication, are not applicable or available in this document.
However, based on the provided text, we can describe the acceptance criteria and study that proves the device meets the acceptance criteria as it relates to the modification of the device (sterility and packaging).
Device: OrthAlign HipAlign® Sterile Pin Pack, used with the OrthAlign Plus® System.
Purpose of this Submission: To demonstrate substantial equivalence of the modified sterile, single-use pins and markers to the previously cleared non-sterile, reusable pins and markers.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this submission is for a modification primarily related to sterility and packaging, the acceptance criteria and performance are focused on these aspects, ensuring the modified components are as safe and effective as the predicate.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from document) | Reported Device Performance |
|---|---|---|
| Packaging Integrity | Packaging materials confirm intended use; verified and validated per procedures. | Confirmed: "Performance testing of the packaging materials confirm that the OrthAlign® Sterile Pin Packs can be used according to its intended use. The packaging has been verified and validated according to OrthAlign's procedures for product design and development." |
| Sterilization Efficacy | Sterilization of the product is validated. | Validated: "The sterilization of the product has been validated." |
| Environmental Robustness | Ability to withstand environmental conditioning and distribution simulation. | Demonstrated: "Performance testing included: Environmental conditioning and distribution simulation." |
| Package Seal Integrity | Maintain integrity during visual inspection, dye penetration test, and peel strength testing. | Demonstrated: "Package integrity testing (visual, dye penetration test, and peel strength testing)." |
| Safety & Effectiveness Equivalence | Modified pins and markers are as safe and effective as the predicate device. | Demonstrated: "This testing demonstrates that the pins and markers are as safe and effective as the predicate device." |
| Substantial Equivalence | Modified device is substantially equivalent to the legally marketed predicate device for its intended use. | Confirmed: "This testing regime demonstrates that the modified device is substantially equivalent to the legally marketed predicate device, for its intended use in detecting, measuring, and displaying angular and positional measurement changes in a triaxial format. The information provided by OrthAlign in this 510(k) notification confirms that the modified OrthAlign Plus® instruments are substantially equivalent to the predicate device, the OrthAlign Plus® System (K171780)." |
| Shelf Life | Establish a defined shelf life for the sterile product. | Established: "7-year shelf life" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the performance testing (e.g., number of packages tested for integrity, number of sterilization cycles validated). The testing described relates to device components (packaging and sterilization), not patient data or clinical performance studies.
- Sample Size: Not explicitly stated as numerical values for packaging and sterilization tests. It is implied that sufficient samples were used to meet validation standards for these types of tests.
- Data Provenance: The data is generated from in-house laboratory performance testing conducted by OrthAlign, Inc., as part of their design and development procedures. This is neither retrospective nor prospective patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The "ground truth" here is compliance with engineering and quality standards for sterile medical devices (e.g., package integrity, sterilization efficacy). These are established through validated test methods and industry standards, not typically through human expert adjudication of medical images or diagnoses.
4. Adjudication Method for the Test Set
Not applicable. This type of submission does not involve adjudication of clinical data or expert consensus. It relies on objective engineering and microbiological test results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for AI/ML diagnostic or assistive devices where human reader performance (e.g., radiologists interpreting images) is being augmented by AI. This submission is for surgical instrumentation components (pins and markers) and their sterility/packaging.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical surgical instrument set. It is not an algorithm, and therefore, standalone performance in the context of AI is irrelevant. The OrthAlign Plus® System itself is a "computer-controlled system intended to assist the surgeon," implying a human-in-the-loop system, but this specific submission focuses on the sterile pins and markers, not the performance of the computer-controlled system's algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this specific submission's performance evaluation is based on:
- Engineering Standards and Test Methods: For packaging integrity (e.g., ASTM standards for dye penetration, peel strength), and environmental conditioning.
- Sterilization Validation Standards: For demonstrating the effectiveness of the sterilization process (e.g., ISO, AAMI standards for EtO sterilization).
- Biocompatibility Standards: Implicit in the use of standard medical-grade materials.
These are objective, quantitative criteria, not subjective expert consensus or clinical outcomes data in the traditional sense of diagnostic AI.
8. The Sample Size for the Training Set
Not applicable. There is no software algorithm or AI model being "trained" in this submission. The device is a physical product (sterile pins and markers).
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model.
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