(211 days)
The Sovereign Compact Phacoemulsification System is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.
The Sovereign Compact Phacoemulsification System) is a modular ophthalmic microsurgical system that facilitates anterior segment (cataract) surgery for the disruption and extraction of a cataractous lens. As with other phacofragmentation systems, The System is identified in 21 CFR 886.4670 as a "phacofragmentation system that is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract."
The main performance functions of The System include ultrasonic phacoemulsification, diathermy, irrigation and aspiration, and vitrectomy. Ultrasonic phacoemulsification provides vibration at an ultrasonic frequency when used in conjunction with a compatible AMO ultrasonic handpiece. The System is controlled and powered by The System console, which includes an active color graphic user interface and receptacles for an automated IV pole, footpedal, remote control, and drainage packs.
This document describes the regulatory submission for the "Sovereign Compact Phacoemulsification System," which is an upgrade to an existing medical device. As such, the submission focuses on proving substantial equivalence to predicate devices rather than establishing novel acceptance criteria through extensive clinical studies.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria with specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) are provided in this regulatory submission for the "Sovereign Compact Phacoemulsification System." This is typical for submissions focused on substantial equivalence to existing, already cleared devices, especially when the changes are primarily software or minor hardware enhancements.
Instead of defining new "acceptance criteria," the submission argues that the device meets the safety and effectiveness profile of its predicate devices through non-clinical testing. The "reported device performance" is implicitly that it performs "equivalently" to the predicate devices in the described modes of surgery.
| Feature/Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Overall Safety and Effectiveness | Equivalent to predicate devices (Sovereign Compact K003638, AMO Ophthalmic Surgical System K060366, Sovereign Phaco Handpiece K981116) | "The subject device was found to perform equivalently to the predicate device during the following modes of anterior segment ophthalmic surgery: phacoemulsification, irrigation, diathermy and vitrectomy." |
| Compliance with Safety Standards | Compliance with applicable safety standards | "The System and Handpiece 690880 have undergone testing and are in compliance with applicable safety standards." |
| Functional Equivalence | Functional requirements and specifications met | "Validation and verification demonstrates that the functional requirements and specifications have been met prior to commercial release." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical trials or AI/algorithm validation for performance metrics. The evaluation relies on non-clinical testing. Therefore, information regarding sample size and data provenance in this context is not applicable. The "test" here refers to engineering and functional verification and validation.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This is not applicable as the submission did not involve clinical studies requiring expert ground truth establishment for a test set of data. The "ground truth" for the device's functionality and safety is based on engineering specifications, regulatory standards, and comparison to existing predicate devices.
4. Adjudication Method for the Test Set
Not applicable, as there was no test set requiring expert adjudication for performance measurement.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. This device is a surgical system, not an AI or imaging diagnostic tool where MRMC studies are typically performed. The comparison is against predicate devices in terms of function and safety, not an evaluation of human reader improvement with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a medical device, a phacoemulsification system, which by its nature is used with a human surgeon (human-in-the-loop). There is no "algorithm only" performance study in the context of diagnostic or AI systems for this type of device.
7. Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Engineering specifications and regulatory standards: The device was tested to ensure it met its defined functional and safety requirements, which are derived from engineering principles and relevant standards.
- Performance of predicate devices: The primary ground truth for demonstrating substantial equivalence is the established safety and effectiveness profile of the legally marketed predicate devices (Mojave Cataract Extraction System (K003638), AMO Ophthalmic Surgical System (K060366), and Sovereign Phaco Handpiece (K981116)). The new device is asserted to perform "equivalently" in the same surgical modes.
8. Sample Size for the Training Set
Not applicable. This device is a physical surgical system, not an AI or machine learning algorithm that requires a "training set" of data in the conventional sense. The "development" or "training" involves engineering design, prototyping, and testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of AI/ML for this device. The "ground truth" for the device's development and validation came from established engineering principles, design specifications, and the performance characteristics of previously cleared predicate devices.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.