(102 days)
The FMS VUE™ Fluid Management and Tissue Debridement System is intended to provide controlled fluid distention and suction, controlled cutting, shaving and abrading of bone and tissue for use in arthroscopic surgery of the shoulder, knee, ankle, elbow, wrist and hip joints.
The FMS VUE Fluid Management and Tissue Debridement System is an arthroscopic pump system designed to provide optimal visibility of the surgical field by computer-controlled fluid regulation of intra-articular pressure, and flow during arthroscopic procedures. The system integrates a tissue debridement for controlled cutting, burring, shaving and abrading of bone and soft tissue.
The FMS VUE Fluid Management and Tissue Debridement System consists of irrigation pump, which controls joint pressure, and the suction pump, which controls the flow of saline and waste from the joint.
The FMS VUE Fluid Management and Tissue Debridement System includes an integrated shaver console, intended to provide controlled cutting, burring, shaving and abrading of bone and soft tissue.
The FMS VUE Fluid Management and Tissue Debridement System is designed to work with the existing FMS VUE platform accessories including: foot pedal, remote hand control, shaver handpieces, FMS connect cable, tubing sets, blades, and burrs.
The FMS VUE Fluid Management and Tissue Debridement System contains updates in the hardware, which include replaced near obsolescence components and new real panel connectors.
The FMS VUE Fluid Management and Tissue Debridement System software modification includes an additional shaver oscillation profile algorithm.
The provided document is a 510(k) summary for the DePuy Mitek, Inc. FMS VUE™ Fluid Management and Tissue Debridement System, seeking substantial equivalence to a previously cleared predicate device (K130169). The submission highlights hardware updates and a software modification (an additional shaver oscillation profile algorithm).
Crucially, this document is for a medical device (arthroscopic pump and debridement system) and not an AI/ML powered device that would typically have the acceptance criteria and study information you're asking for related to AI model performance (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts).
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are related to the hardware and software changes for a physical medical device, demonstrating that the modified device remains as safe and effective as its predicate.
Therefore, many of the requested points in your prompt are not applicable to the information contained in this 510(k) summary. I will address the applicable points based on the document's content.
Acceptance Criteria and Device Performance (Non-AI/ML Context)
The acceptance criteria here are focused on demonstrating that the updated FMS VUE system maintains its functional performance, electrical safety, electromagnetic compatibility, and software integrity, proving it is substantially equivalent to the predicate device despite hardware and minor software changes.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria (General Area) | Reported Device Performance (Summary from Document) |
|---|---|
| Functional Performance | - Pressure Transducer Test: Performed. Results not detailed but implied to be acceptable for intended use. |
- Pressure Security Test (Low & High Pressure Fault Checks): Performed. Results not detailed but implied to be acceptable.
- DUO (Inflow/Outflow) Performance: Performed. Results not detailed but implied to be acceptable.
- SOLO (Inflow) Performance: Performed. Results not detailed but implied to be acceptable.
- RFID Capability Functional Testing with existing electrical accessories (Foot Pedal, Remote Hand Control, Shaver Handpieces, FMS Connect Cable): Performed. Results not detailed but implied to be acceptable.
- Backflow-Prevention Valve Testing (Dye Leak Testing): Performed. Results not detailed but implied to be acceptable.
- Microbial and Viral Ingress Testing: Performed. Results not detailed but implied to be acceptable.
Overall: "Results of functional performance testing were compared to the predicate device and have demonstrated that the proposed device is suitable for its intended use." |
| Software Verification & Validation | - Software verification and validation (V&V) testing was conducted. Documentation provided as per FDA guidance "Content of Premarket Submission for Device Software Functions" (Basic Documentation level). - "The software development process for the subject FMS VUE Fluid Management and Tissue Debridement System software conforms to all clauses of IEC 62304 standard." (IEC 62304 is a standard for medical device software life cycle processes). |
| Electrical Safety & EMC | - "The subject FMS VUE Fluid Management and Tissue Debridement System complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC." (These are international standards for medical electrical equipment safety and electromagnetic compatibility). |
Study Information (as applicable to this non-AI/ML medical device submission)
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Sample size used for the test set and the data provenance:
- The document describes "functional performance testing" of the physical device. This doesn't involve "test sets" of patient data in the way an AI/ML model would. Instead, it refers to testing the physical device and its components (e.g., pressure transducers, pumps, software algorithms for fluid control, electrical safety tests).
- The provenance of data is from laboratory testing and verification conducted by the manufacturer, DePuy Mitek, Inc. (a Johnson & Johnson company). It is implicitly prospective testing for the design verification and validation of the modified device. No specific patient data or geographic origin is relevant here.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable. "Ground truth" in the context of an AI/ML model's diagnostic or predictive performance is not relevant for the functional performance testing of a fluid management and tissue debridement system. The "ground truth" here is the engineering specifications and performance requirements established by the manufacturer, verified through standard test methods and adherence to regulatory standards (e.g., IEC 60601-1, IEC 62304).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for establishing ground truth from multiple expert readers in imaging studies. This is a functional and safety verification of a physical device.
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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 question is not applicable. The device is a physical arthroscopic fluid management and tissue debridement system, not an AI/ML-powered diagnostic or assistive tool for human readers. No MRMC study was performed or required. The document explicitly states: "No human clinical testing was conducted to determine the safety and effectiveness of the FMS VUE Fluid Management and Tissue Debridement System."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device has an integrated shaver console with an "additional shaver oscillation profile algorithm." The software verification and validation would have tested this algorithm's performance within the system, which can be seen as a form of standalone testing for the algorithm's functional correctness. The document states: "Software verification and validation testing was conducted..." and "The software development process... conforms to all clauses of IEC 62304 standard." This implicitly covers testing of the algorithm without a human-in-the-loop, to ensure it performs as programmed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This question is not applicable in the typical sense for AI/ML. The "ground truth" for the device's functional performance are the engineering specifications, validated test methods, and compliance with recognized industry standards (e.g., pressure output accuracy, flow rates, software logic, electrical safety limits).
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The sample size for the training set:
- This question is not applicable. This is not an AI/ML system that requires a "training set" of data in the manner of deep learning models. The software algorithms are likely rule-based or control-loop algorithms, not learned from large datasets.
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How the ground truth for the training set was established:
- This question is not applicable for the same reason as point 7.
§ 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.