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

The VersaCut™ Tissue Morcellator System is a multiple-use clectrosurgical cutting and aspiration device that is intended for the morcellation and removal of dissected tissue under direct or endoscopic visualization. The cutting action of the VersaCut™ Tissue Morcellator System 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 System is comprised of main components as listed below. These main components are available separately when replacements are needed.

• Reusable, steam sterilizable handpiece (motor-body unit) with power cable .
• Limited reuse, steam sterilizable cutting blade sets .
• Reusable, steam sterilizable endoscope adapters .
• Reusable aspiration pump-control unit combination with main power cable and fuses
• Reusable, multi-position, multi-staged footswitch with power cable .
• Sterile, single use aspiration tubing ◆
• Reusable sterilization tray, including cleaning brushes .

The VersaCut™ Tissue Morcellator System is provided as a production-cleaned, non-sterile device. Before use in a sterile procedure, the handpiece, blade set(s), and endoscope adapter(s) are to be enzymatically-cleaned and steam-sterilized. Sterile aspiration tubing is provided with the device.

This document is a 510(k) Summary for the Lumenis VersaCut™ Tissue Morcellator System, which is a medical device. As such, it does not describe a study involving an AI/Machine Learning device or outline acceptance criteria and performance of such a device in the way a clinical trial for diagnostic tools would.

Instead, this submission is centered on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway focused on showing that a new device is as safe and effective as a legally marketed device, rather than proving a specific performance metric against a set acceptance criteria.

Therefore, many of the requested categories for AI/ML device studies (like expert adjudication, MRMC studies, training set details, etc.) are not applicable to this document.

However, I can extract the relevant information regarding the device's performance demonstration.

Acceptance Criteria and Device Performance for Lumenis VersaCut™ Tissue Morcellator System

The Lumenis VersaCut™ Tissue Morcellator System is a medical device seeking 510(k) clearance based on substantial equivalence. The "acceptance criteria" in this context refers to demonstrating that the device meets its product specifications and performs comparably to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated as a "test set" in the context of an AI/ML model. The evaluation involved "physical testing" and "in vitro bench testing." The specific number of tests or samples used for these physical and bench tests is not detailed in this summary.
• Data Provenance: The testing was "in vitro bench testing," meaning it was conducted in a laboratory setting. No country of origin for patient data (as it's not a clinical study involving patients) or retrospective/prospective nature is applicable here. The data originates from internal company testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

• Not Applicable. This is a device performance test, not a diagnostic accuracy study requiring expert ground truth for classification. Performance was assessed against predefined engineering specifications and safety standards.

4. Adjudication Method for the Test Set

• Not Applicable. No ground truth adjudication by experts for a test set is relevant for this type of device submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is not relevant for this type of device. This device is a surgical tool, not a diagnostic imaging or AI system intended to be used by multiple human readers for interpretation.

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

• Not Applicable. This is a physical electrosurgical device, not an algorithm. Its performance is inherent to its physical operation and design, and while it's used by a human, it does not have a "human-in-the-loop" interaction in the sense of an AI interpreting inputs for a human.

7. The Type of Ground Truth Used

• Engineering Specifications and Safety Standards. The ground truth for performance was defined by the device's product specifications (e.g., cutting capability, motor function, material strength, electrical safety parameters) and established biocompatibility and sterilization standards.

8. The Sample Size for the Training Set

• Not Applicable. This refers to an AI/ML model's training data. This document describes a physical medical device. Device design and development typically involve iterative prototyping and testing, which could be considered an analogous "training" phase for the physical design, but it's not a data-driven training set.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. See point 8.

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