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The Smith & Nephew DYONICS 25 Fluid Management System is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip, and small joints to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site.

The Smith & Nephew DYONICS 25 Fluid Management System is a centrifugal fluid management pump used in arthroscopic surgery to regulate the flow of irrigation fluids through the joint to maintain intra-articular pressure for distension and visualization of the surgical site. This is accomplished using an electronic pressure control feedback loop between the control unit and the tube set cassettes.

The Smith & Nephew DYONICS 25 Fluid Management System includes -

• . control unit
• . inflow tube set
• . inflow /outflow tube set
• inflow/outflow tube set with forked suction lines
• . day-tube set
• . patient tube set
• . wired/wireless (IR) remote control (optional)
• . Luer to colder Connector (optional)

Additionally, the Smith & Nephew LEVELERT II Fluid Level Sensors (K060123) as well as a shaver system interface cable, U.S. and international power cords can be used with the Smith & Nephew DYONICS 25 Fluid Management System (DYONICS 25).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew DYONICS 25 Fluid Management System:

This document is a 510(k) Summary of Safety and Effectiveness Information for a medical device. It's important to understand that a 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials as might be required for a novel device. The "acceptance criteria" here refer to meeting performance specifications and relevant standards to demonstrate equivalence, not necessarily clinical outcome measures.

Description of Acceptance Criteria and Study to Prove Device Meets Them

The Smith & Nephew DYONICS 25 Fluid Management System is a centrifugal fluid management pump used in arthroscopic surgery. The current submission (K171794) is for a modified version of a previously cleared device (K051326). The "acceptance criteria" for this submission are primarily that the modified device performs comparably to the predicate device and meets relevant performance specifications and recognized consensus standards, without raising new questions of safety or effectiveness due to the design changes.

The study proving the device meets these criteria is a series of bench and engineering tests and software verification and validation.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This document does not specify a "sample size" in the context of patient data or a test set of clinical images. The testing described (Package/Performance, Environmental, Fluids, EMC, Safety, Software V&V) are bench and engineering tests, performed on the device itself or its components. Therefore, terms like "test set," "data provenance," or "country of origin for data" are not applicable in the typical sense of a clinical study or AI model evaluation.

• Sample size: Not applicable as it's not a clinical or image-based study. The "sample" would be the device units or components tested.
• Data provenance: Not applicable. The data is from internal engineering and bench testing.
• Retrospective/Prospective: Not applicable.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This is not a study requiring expert readers or consensus to establish ground truth. The "ground truth" for the engineering and performance tests is defined by the technical specifications, international standards (e.g., IEC), and the functional requirements of the device.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process for bench and engineering tests. The results are typically pass/fail based on predefined technical criteria and standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is common for evaluating diagnostic imaging devices or AI systems, especially when comparing human performance with and without AI assistance. This device is a fluid management pump, not a diagnostic or AI-powered imaging device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device does not feature an "algorithm only" component in the sense of an AI/ML system that would operate autonomously. While it has software and a feedback loop for pressure control, its operation is an integral part of an arthroscopic surgical procedure that always involves a human surgeon. The "software verification & validation" conducted is the closest equivalent to testing the "standalone" performance of its control logic.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Technical specifications derived from the intended function of the device (e.g., maintaining pressure, regulating flow).
• International consensus standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 62304) which define safety and performance requirements.
• Comparison to the predicate device's established performance.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a "training set" of data in the common sense. The software development process involves coding, verification, and validation, but not training on a dataset to learn patterns.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted in point 8, there is no "training set" for this device.

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