(86 days)
The Storz Millennium™ Viscous Fluid System is intended for the injection and aspiration of viscous fluids into and out of the eye during posterior ophthalmic vitreoretinal surgery. The system is designed to inject and aspirate viscous fluids, such as silicone oil which act as a tamponade in fixating large retinal tears and detachments.
The Storz Millennium™ Viscous Fluid System is intended for the injection and aspiration of viscous fluids into and out of the eye during posterior ophthalmic vitreoretinal surgery. The system is designed to inject and aspirate viscous fluids, such as silicone oil which act as a tamponade in fixating large retinal tears and detachments. The Storz viscous fluid system consists of the Storz CX5700 Millennium™ Viscous Fluid System Module and the Storz CX5710 Viscous Fluid Injection Pack. The Storz CX5700 module is a self-contained pump system used as an individual module with the Storz Millennium™ Microsurgical System for the injection and aspiration of viscous fluids. The Storz CX5710 is the disposable accessory pack intended for single use to be used with the Storz viscous fluid module.
The provided text is a 510(k) premarket notification for the Storz Millennium™ Viscous Fluid System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a clinical trial or performance study report would for an AI/ML device.
Therefore, many of the requested points regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission.
The document primarily relies on predicate comparison to establish substantial equivalence.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not define explicit "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) typically associated with AI/ML devices. Instead, the acceptance is based on demonstrating substantial equivalence to existing legally marketed predicate devices. The "performance" is implied by demonstrating similar design, intended use, and operational characteristics to these predicates.
| Feature | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Storz CX5700 Viscous Fluid System) |
|---|---|---|
| Intended Use | Posterior segment ophthalmic surgery - injection & aspiration of viscous fluids (matching predicates like Escalon and Richard James) | Posterior segment ophthalmic surgery - injection & aspiration of viscous fluids |
| Modular Design | Yes (matching Storz Millennium™ Microsurgical System, different from some other predicates) | Yes |
| Ophthalmic Features | Viscous fluid injection/aspiration (matching Escalon, Richard James) | Viscous fluid injection/aspiration |
| Programmable For Multiple Surgeons | Yes (matching Storz Millennium™ Microsurgical System, Alcon Accurus™) | Yes |
| Disposable Accessories | Yes (matching all predicates listed) | Yes |
| Viscous Fluid User Interface | Foot pedal & touch screen (matching Storz Millennium™, Alcon Accurus™) | Foot pedal & touch screen |
| Foot Controller - Dual Linear | Yes (matching Storz Millennium™ Microsurgical System, different from some other predicates) | Yes |
| Viscous Fluid Injection, Pressure Range | 0 - 70 PSI (matching Escalon, Richard James; similar to Alcon Accurus™ at 0-80 PSI) | 0 - 70 PSI |
| Viscous Fluid Aspiration, Range | 0 - 600 mmHg (matching Escalon; similar to Alcon Accurus™ at 0-600 mmHg and Richard James at 0-650 mmHg) | 0 - 600 mmHg |
2. Sample Size Used for the Test Set and Data Provenance:
This is a premarket notification for a medical device (a pump system for ophthalmic surgery), not an AI/ML diagnostic or prognostic tool. Therefore, there is no "test set" or "data provenance" in the context of evaluating algorithm performance on a dataset of patient cases. The evaluation is based on comparing the device's design and functional specifications to legally marketed predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. There is no "ground truth" establishment in the context of a dataset for an AI/ML device. The "truth" for this submission is based on the established safety and effectiveness of the predicate devices.
4. Adjudication Method for the Test Set:
Not applicable. No test set or adjudication method as described for AI/ML performance evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, this is not an AI/ML device requiring an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML algorithm. It's a medical pump system.
7. The Type of Ground Truth Used:
The "ground truth" in this context is the regulatory acceptance and established safety/effectiveness of the predicate devices. The submission essentially argues that the new device is sufficiently similar to these predicates that it can be considered equally safe and effective.
8. The Sample Size for the Training Set:
Not applicable. As this is not an AI/ML device, there is no training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable. There is no training set or ground truth in the context of AI/ML for this device.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).