(26 days)
The Smith & Nephew 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 25 Fluid Management System is a microprocessor controlled arthroscopic fluid management system that is designed for controlled delivery of irrigation fluids during intra-articular surgery. The system controls joint pressure independently of aspiration rate over a wide range of flow rates. The system will maintain control of intra-articular pressure regardless of varying outflow rates and may be used with any arthroscopic inflow cannula.
The provided text describes a 510(k) premarket notification for the "Smith & Nephew 25 Fluid Management System." It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth cannot be extracted from this document.
Here's an analysis of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document implies the acceptance criterion is "substantial equivalence" to predicate devices without introducing new issues of safety or efficacy.
- Reported Device Performance: The document states that "performance testing and the software verification and validation conducted on the Smith & Nephew 25 Fluid Management System demonstrates substantial equivalence." However, it does not provide specific performance data (e.g., accuracy, precision, reliability figures) in a quantifiable manner against predefined acceptance criteria.
Therefore, a table cannot be fully constructed with specific acceptance criteria and performance numbers from this document.
2. Sample size used for the test set and the data provenance:
- The document mentions "performance testing" but does not specify any sample size for a test set (e.g., number of cases, images, or test runs), nor does it provide data provenance (country of origin, retrospective/prospective). This is typically a preclinical engineering test, not a clinical study with a "test set" in the sense of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Since a clinical "test set" with ground truth established by experts is not described, this information is not applicable and not present in the document.
4. Adjudication method for the test set:
- As no expert-established ground truth for a test set is described, an adjudication method is not applicable and not present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This device is a fluid management system, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that "performance testing and the software verification and validation" were conducted on the device itself. This would be considered "standalone" performance for the device, but it's not an "algorithm only" in the sense of a diagnostic AI. No specific performance metrics for this standalone testing are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this type of device (fluid management system), "ground truth" would likely be established through engineering specifications and measurements (e.g., fluid pressure accuracy, flow rate stability, software functionality against requirements). The document doesn't explicitly state the methodology for establishing this "ground truth."
8. The sample size for the training set:
- Training sets typically refer to data used for machine learning models. This device is described as a "microprocessor controlled arthroscopic fluid management system," not an AI/ML device in the modern sense. Therefore, a "training set" with a specified sample size is not applicable and not mentioned.
9. How the ground truth for the training set was established:
- As there is no described training set, this information is not applicable and not present.
Summary of what is available from the document:
- Device: Smith & Nephew 25 Fluid Management System
- Purpose of the study/testing: To demonstrate substantial equivalence to predicate devices (Smith & Nephew InteliJET™ HERMES-Ready (K031605) and Smith & Nephew InteliJET™ Fluid Management Systems (K050580)).
- Method of demonstrating equivalence: "Performance testing and the software verification and validation."
- Conclusion: The testing "demonstrates substantial equivalence" and that "the differences in the new device and the predicate device do not raise any new issues of safety and efficacy."
This document is a regulatory submission focused on comparing a new device to existing legally marketed predicate devices, not on proving de novo performance against a set of clinical acceptance criteria using a typical clinical study design with human readers or AI algorithms.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.