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The HandX is intended to assist in the control of Human Xtensions laparoscopic instruments including needle holder, grasper and monopolar instruments, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, cutting and/or coagulation, during laparoscopic surgical procedures.

The HandX monopolar instruments are connected by a standard electrosurgical power source. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use.

The Monopolar Hook is a single use sterile electrosurgical electrode for use with the HandX™ device. The Monopolar Hook is connected to the HandX device and transmits the HandX device motors' rotation in order to articulate the movement of the end effector of the Monopolar Hook. It is designed to address surgeons' needs relating to the application of monopolar diathermy for various surgical purposes.

The Monopolar Hook is connected to a standard electrosurgical unit via a standard generator cable.

The provided text is a 510(k) Premarket Notification Summary for the "Monopolar Hook" device by Human Xtensions Ltd. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than describing a study proving the device meets acceptance criteria for an AI/algorithm-driven, diagnostic, or prognostic medical device.

Therefore, much of the requested information (acceptance criteria for an AI model, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) is not present in the provided document, because the Monopolar Hook is a physical surgical instrument, not an AI or algorithm-based device.

The "Performance Data" section describes validation for a physical medical device, not an AI system. It mentions:

• Biocompatibility testing: Catheterized as an externally communicating device in limited contact (≤24 hours) with tissue or bone. Endpoints considered: cytotoxicity, sensitization, acute systemic toxicity, and material mediated pyrogenicity.
• Electrical Safety and ElectroMagnetic Compatibility (EMC): Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-18, and IEC 60601-1-6.
• Bench Testing: Evaluated device performance against design inputs, demonstrating safety and effectiveness.
  • Tests included: Physical/Dimensional Inspection and Tip Measurements, Functional Test, Impedance Test, DC Hipot-Ramp to Failure, Generator Cable Pull Test, Seal Test, Sterile Barrier, Mechanical Strength – Pull to Failure, Passivation Verification Corrosion Test, Shaft's Insulation Integrity Test.
  • Acceptance Criteria & Performance: "All tests met the predefined acceptance criteria." Specific quantitative criteria and detailed performance values are not provided in this summary document, only the statement of compliance.
• Animal Study (Pre-clinical): Tested in a porcine model to evaluate safety, functional performance, and usability.
  • Safety assessed via histopathology evaluation of slits performed by the Monopolar Hook compared to the predicate device.
  • Performance: "The Monopolar Hook performed similarly when compared to the predicate device."

Based on the provided document, here's what can be extracted and what cannot:

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

   Acceptance Criteria Description	Reported Device Performance (Summary)	Quantifiable Performance Data Provided?
   Biocompatibility	Compliance with ISO 10993-1 for cytotoxicity, sensitization, acute systemic toxicity, material mediated pyrogenicity.	No specific data, only "considered".
   Electrical Safety / EMC	Full compliance with IEC 60601 series standards (IEC 60601-1, -1-2, -2-2, -2-18, -1-6).	No specific data, only "fully comply."
   Bench Testing (Multiple aspects)	All predefined acceptance criteria were met for: - Physical/Dimensional Inspection & Tip Measurements - Functional Test - Impedance Test - DC Hipot-Ramp to Failure - Generator Cable Pull Test - Seal Test - Sterile Barrier - Mechanical Strength – Pull to Failure - Passivation Verification Corrosion Test - Shaft's Insulation Integrity Test	No specific quantitative acceptance criteria or performance values are detailed in this summary.
   Animal Study (Safety/Similarity)	Device safety (histopathology of slits) and functional performance were evaluated. Performed similarly to the predicate device.	No specific histopathology results or quantitative performance metrics for "similarly."

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

   • Test Set Sample Size: Not specified for any of the tests. The animal study mentions a "porcine model" but not the number of animals used.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This is a medical device clearance, not a clinical trial or AI validation study.

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/Not mentioned. The device is a surgical instrument, not an AI diagnostic tool requiring expert ground truth for image interpretation. The histopathology in the animal study would presumably be conducted by a pathologist, but details are not provided.

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

   • Not applicable/Not mentioned.

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. This is not an AI-assisted diagnostic device.

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

   • Not applicable.

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

   • For the animal study, safety was assessed by a "histopathology evaluation" of lesions. This implies pathological assessment served as a form of ground truth for safety comparison.

8. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI model.

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

   • Not applicable. This is a physical device, not an AI model.

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