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The VersaCut + Tissue Morcellator is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparascopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.

The VersaCut + Tissue Morcellator system is a multiple-use electrosurgical cutting and aspiration device that provides rapid and efficient morcellation and removal of dissected tissue under direct or endoscopic visualization. The cutting action of the VersaCut + Tissue Morcellator is driven by the motor in the handpiece and the treatment site is accessed through the sheath of a nephroscope using the endoscope adapter as needed to keep the cutting blades in the field of view. The VersaCut + Tissue Morcellator is comprised of a main component as listed below:

• · Control unit with aspiration pump
• · Limited reuse, steam sterilizable handpieces (motor-body unit) with power cable
• · Limited reuse, steam sterilizable cutting blade sets
• · Reusable, steam sterilizable endoscope adapters
• · Drainage tube, single use
• · Reusable, multi-position, multi-staged footswitch with power cable
• · Sterile, single use aspiration tubing
• · Tissue collection kit components, single use
• · Reusable sterilization tray, including cleaning brushes
  The VersaCut + Tissue Morcellator is provided cleaned and non sterile. Before use, the handpiece, blades set and the endoscope adapters are to be cleaned and sterilized.

Here's an analysis of the provided text regarding the VersaCut + Tissue Morcellator, focusing on the acceptance criteria and the study used to prove it:

Summary of Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • No specific test set sample size is mentioned for the performance bench testing.
   • No information on data provenance (e.g., country of origin, retrospective/prospective) is provided, as the studies conducted were bench tests, not clinical studies involving patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The "ground truth" for this device's performance was established by adherence to recognized technical standards and comparison to a predicate device through bench testing, not through expert review of clinical cases.

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

   • Not applicable. No clinical test set requiring adjudication was used.

4. 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:

   • No. This device is a surgical instrument (tissue morcellator), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI-related effect sizes are not applicable.

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

   • Not applicable. This device is a mechanical/electrical surgical tool and does not involve an algorithm or AI.

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

   • The "ground truth" for demonstrating safety and efficacy was established by compliance with recognized industry standards (listed above) and direct comparison of performance characteristics through bench testing against a legally marketed predicate device, demonstrating functional equivalence.

7. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or AI, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set.

Conclusion of the Study:

The primary study conducted was performance bench testing. This testing aimed to demonstrate that the VersaCut + Tissue Morcellator is as safe and effective as its predicate device (Lumenis VersaCut Tissue Morcellator System, K050639). The document explicitly states:

• "Performance testing demonstrated that the VersaCut + Tissue Morcellator is as safe and effective as the cleared predicate device."
• "Lumenis believes that clinical studies are not needed to claim safety and efficacy of the device."

The study design was a comparative bench test focusing on functional equivalence and compliance with established standards, rather than a clinical trial. The justification for substantial equivalence was based on:

• Identical intended use.
• Identical structures, materials, and dimensions.
• Minor differences (inverted handpiece, disposable tissue collector with one-way valve, manual updates) that were addressed and shown not to negatively impact safety or effectiveness, and in some cases, improved safety (preventing reverse aspiration).

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