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510(k) Data Aggregation
(27 days)
The Smith & Nephew InteliJET™ Fluid Management System (FMS) is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids through the joint to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.
The Smith & Nephew InteliJETTM Fluid Management System Hermes-Ready™ is a microprocessor-based system designed for controlled delivery of irrigation fluid during intra-articular surgery. This controlled delivery is accomplished via an electronic pressure control loop between the control unit and the tube casssette. The addition of the Hermes Ready™ feature will enable voice and pendant control of the pressure, mode, suction, and on/off functions when used in conjunction with a Hermes™ Digital O.R. Center.
This document describes the Smith & Nephew InteliJET™ Fluid Management System Hermes-Ready™, an arthroscopic fluid management system. It's important to note that this device is a hardware system, not an AI/ML-driven software device. Therefore, several of the requested categories related to AI/ML studies are not applicable.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it makes a general statement about the device's efficacy and safety.
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Overall Performance | Not explicitly stated as a quantitative criterion. | "All verification and validation data demonstrates that the device is safe and effective and performs as intended." |
| Intended Use | The system should regulate flow of irrigation fluids during arthroscopic joint surgery to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site. | The device's technological characteristics and intended use are considered substantially equivalent to the predicate device, which presumably met its intended use. The addition of the Hermes Ready™ feature enabling voice/pendant control does not change the intended use or features. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a hardware device. The "test set" would refer to engineering verification and validation testing, not a clinical data set. The document does not provide details on the sample sizes of devices tested during internal verification and validation, nor does it specify the provenance of such engineering test data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device does not generate an "output" that requires expert ground truth establishment in the manner of an AI/ML diagnostic tool. Its performance is evaluated through engineering and functional testing.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is a hardware device and does not involve clinical "test sets" or "adjudication" in the context of diagnostic performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This is a hardware device and not an AI/ML software. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is a hardware device. The concept of "standalone algorithm performance" is not applicable. The device functions as part of a surgical system with a human operator.
7. The Type of Ground Truth Used
Not applicable. The "ground truth" for a device like this would be its ability to consistently and accurately maintain fluid pressure and flow rates as designed, as measured by internal sensors and validated through engineering tests. It's not about diagnostic accuracy against pathology or expert consensus.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device. It does not utilize a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth to be established for it.
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