(266 days)
The FMS VUE II Fluid Management and Tissue Debridement System is intended to provide controlled fluid distention and suction, controlled cutting, burring, 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™ II 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 during arthroscopic procedures.
The FMS VUE™ II 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™ II 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.
I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request. Specifically, the document is a 510(k) summary for a medical device (FMS VUE II Fluid Management and Tissue Debridement System) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study description with acceptance criteria and performance data in the format you requested.
Here's what I can extract and what's missing:
What is available in the document:
- Device Name: FMS VUE™ II Fluid Management and Tissue Debridement System
- Intended Use: "The FMS VUE™ II Fluid Management and Tissue Debridement System is intended to provide controlled fluid distention and suction, controlled cutting, burring, shaving and abrading of bone and tissue for use in arthroscopic surgery of the shoulder, knee, ankle, elbow, wrist and hip joints."
- Predicate Device: The FMS VUE™ Fluid Management and Tissue Debridement System (K130169) (DePuy Mitek)
- Testing Mentioned: The document generally states that testing included "functional performance, joint pressure estimation and control, software verification and validation and testing per IEC 60601-1 and IEC 60601-1-2 standards." It also mentions "dye leak testing, and microbial and viral ingress testing" for a re-usable tubing accessory.
- Conclusion: The device has been shown to be substantially equivalent to the predicate device based on similarities in intended use, technological characteristics, IEC 60601-1/IEC 60601-2 compliance, and functional performance.
What is NOT available in the document (and therefore cannot be provided in the table or detailed answers):
- Specific Acceptance Criteria: The document mentions "functional performance" and "joint pressure estimation and control" but does not explicitly state numerical acceptance criteria (e.g., specific pressure ranges, flow rates, debridement efficacy metrics).
- Reported Device Performance: While it states that results "have demonstrated that the proposed device is suitable for its intended use," it does not provide the actual performance metrics or data against any criteria.
- Sample Size for Test Set: Not specified.
- Data Provenance (country, retrospective/prospective): Not specified.
- Number of Experts and Qualifications: Not applicable as this is a fluid management and tissue debridement system, not an AI diagnostic device requiring expert interpretation for ground truth.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable to this type of device.
- Standalone Performance: Not applicable in the context of an AI algorithm. The device's "standalone" performance would be its functional performance, which is generally described but not quantified.
- Type of Ground Truth Used: Not applicable in the context of expert consensus or pathology for a fluid management system. Ground truth would be based on engineering specifications and performance testing.
- Sample Size for Training Set: Not applicable as this is not an AI/machine learning device with a training set.
- How Ground Truth for Training Set was Established: Not applicable.
Based on the provided text, I cannot complete your request in the specified format for acceptance criteria and study details. The document is a regulatory submission summary that attests to equivalence and suitability for intended use, rather than a detailed scientific study report.
If this were an AI/ML device, the regulatory submission would typically include a separate section with a detailed clinical validation study that addresses these points.
§ 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.