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The MultiCut Solo Morcellator is intended for use under endoscopic visualization for the transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surgical procedures in urology.

The MultiCut Solo consists of a special endoscopic handpiece in which a blade is inserted which mechanically shreds the tissue. The blade is driven by a dc motor, which is integrated in the handpiece. The motor itself is driven by a motor driver PCB. The blade can rotate at different speeds and thereby change the direction of rotation periodically (so called oscillation). The morcellator handpiece is also connected by an aspiration tube set to a peristaltic aspiration pump. By this pump the crushed tissue can be transported through a hollow channel in the handpiece to a waste container.

The provided text describes a 510(k) submission for a medical device called "MultiCut Solo Morcellator." This document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance standards. Itdoes not contain information about a clinical study involving a dataset, human readers, or AI assistance. Therefore, I am unable to describe the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML-based medical device.

The information provided is typical for a traditional medical device 510(k) submission, detailing:

• Device Description: MultiCut Solo Morcellator, an endoscopic handpiece with a motor-driven blade for mechanical tissue shredding and aspiration.
• Intended Use: Transurethral mechanical morcellation and removal of prostate adenoma after enucleation during endoscopic surgical procedures in urology.
• Nonclinical Performance Data:
  • Compliance with various IEC/EN/ISO standards for electrical safety, EMC, software lifecycle, risk management, and biocompatibility.
  • "Comparative bench testing has been performed to show the performance equivalence of the subject device to its predicate."
• Comparison to Predicate Devices: A detailed table comparing the MultiCut Solo to two predicate devices (VersaCut + Morcellator and MORCE SCOPE SET 8970) across various characteristics like principle of operation, intended use, speed regulation, dimensions, materials, power supply, rotation speed, aspiration, electrical requirements, suction pump, and reusability.

Based on the provided document, the following items CANNOT be addressed as they are not present in the text:

• A table of acceptance criteria and reported device performance related to a data-driven or AI/ML study. The "acceptance criteria" discussed are primarily compliance with safety and performance standards for a mechanical device.
• Sample size used for the test set and data provenance. No test set of data (like images or patient records) is mentioned.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

The document concludes that "The non-clinical performance testing conducted supports that the device can be used safely and effectively. The differences in the indications for use and technological characteristics between the subject and predicate device do not raise new types of questions regarding safety and effectiveness, and the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices." This statement refers to bench testing, compliance with design standards, and similarity to existing devices, not a study proving performance on a clinical dataset.

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