(126 days)
The Multi4 System is intended for use by trained urologists for endoscopically controlled tissue resection and coagulation, and removal of bladder tumors (TURBT) via suction channel under controlled flow conditions following resection using a monopolar resectoscope. The Multi4 System is also intended to deliver injectable materials into the urinary bladder wall during transurethral endoscopic procedures.
The Multi4 System is an electrosurgical system used during urethral resection procedures of adult patients. The system, intended to remove and collect tissue from the bladder, includes a single-use electrosurgical instrument, known as the Multi4 B, as well as the reuseable Multi4 Pump. The Multi4 Pump administers energy from an external electrosurgical unit to the handheld Multi4 B instrument, which has electrosurgical functions and allows for fluid transport and tissue sample collection. The Multi4 B instrument accesses the bladder through the working channel of a commercially available cystoscope. The Multi4 System is a prescription device intended for use in professional healthcare facilities by healthcare professionals (HCPs).
The Multi4 System consists of the following components:
• Multi4 Pump (with Integrated Fluid Control)
o Footswitch
• Multi4 B
o Resectoscope & Needle
o Simple4tainer (For collection of gross resected tissue pieces for pathology)
The provided FDA 510(k) clearance letter and summary for the Multi4 System primarily focuses on demonstrating substantial equivalence to predicate devices through design similarity, material composition, intended use, and technological characteristics. The document details extensive non-clinical testing performed to ensure safety and effectiveness.
However, the provided text does not contain details about acceptance criteria, the study design, or performance metrics in a way that allows for the construction of a table comparing acceptance criteria with reported data, nor does it provide information on sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
The document does mention:
- Non-Clinical Testing: Software Verification and Validation Testing, Sterility Testing, Packaging Testing, Shelf-life Testing, Biocompatibility Testing (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Pyrogenicity), Electrical Safety & EMC (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-2-2), Integrity Testing, Functional Testing (Cut and coagulation, aspiration, irrigation, injection), Dimensional Inspection and Testing, Simulated Use Testing.
- Lack of Clinical Study: The "SUMMARY OF NON-CLINICAL TESTING" section and the overall context strongly suggest that the clearance was based on non-clinical data demonstrating equivalence to predicate devices, rather than a clinical study evaluating specific performance metrics against acceptance criteria for a new AI/algorithm. There is no mention of "ground truth" as it would apply to an AI study (e.g., expert consensus, pathology, outcomes data).
Therefore, I must state that the requested information regarding acceptance criteria, study data for AI performance, sample sizes for AI test/training sets, expert roles, adjudication, and MRMC studies is not present in the provided text. The document focuses on demonstrating substantial equivalence via engineering and bench testing, not clinical performance or AI/algorithm validation with a test set and ground truth in the manner typically required for AI-driven devices.
Without this specific information from the provided text, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI-driven device with performance metrics.
If this were an AI device, the missing information would be crucial for understanding its validation. For this specific device and the information provided, the "acceptance criteria" were met by demonstrating that the Multi4 System performs as safely and effectively as its predicate devices through rigorous non-clinical testing.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).