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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 surqical procedures in urology.

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 device is available with either sterile single use blades and non-sterile reusable blades.

The provided text is related to a medical device submission (K240831) for the MultiCut Solo Morcellator. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical study for a new device.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not available in the provided text.

The document states that the MultiCut Solo Morcellator is a modification of an already cleared device (K213597), with the specific modification being the addition of sterile single-use blades. The submission focuses on non-clinical performance data to support the substantial equivalence.

Here's what can be extracted from the text regarding the device's assessment:

1. A table of acceptance criteria and the reported device performance

• No specific acceptance criteria or performance metrics related to diagnostic accuracy or clinical outcomes are provided. The submission focuses on product safety and function rather than a software algorithm's diagnostic performance.
• The document mentions that the device "successfully passed the following testing" and "is in compliance with all applicable sections of the above-mentioned performance standards." These relate to the safety and functionality of the device and its components, particularly the new sterile single-use blades. The "performance" in this context refers to meeting engineering and safety standards, not clinical diagnostic accuracy.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. The document describes non-clinical performance data (e.g., sterilization validation, biocompatibility) rather than a test set for diagnostic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. There is no mention of expert-established ground truth for a diagnostic test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set requiring adjudication is described.

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

• Not applicable. The MultiCut Solo is a mechanical morcellator, not an AI diagnostic device, and thus no MRMC study would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. The assessments made (e.g., sterilization effectiveness, biocompatibility) are based on established scientific methods and standards (e.g., EN/ISO 10993, IEC 60601 series) rather than a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set

• Not applicable. The device is not based on machine learning or AI that would require a training set.

9. How the ground truth for the training set was established

• Not applicable.

In summary, the provided FDA 510(k) summary focuses on the technical safety and performance of a medical device (a morcellator) and its components, specifically regarding modifications and substantial equivalence to a predicate device, rather than on the diagnostic accuracy or clinical efficacy that would involve the type of acceptance criteria and study designs typically associated with AI/software-as-a-medical-device (SaMD) clearances.

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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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