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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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The DEX device laparoscopic instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, suturing, transection and electro-cauterization of tissues.

The DEX Device consists of an electro-mechanical system designed for surgeon to perform minimal invasive surgeries: laparoscopic surgery. The surgeon will use the system in a similar way than any laparoscopic instruments and remains in contact with the patient. The surgeon will positioned himself like in any classic laparoscopic procedure, standing in the sterile field close to the patient: Same installation, trocars, endoscopic camera, suction, ESU for monopolar, needles, operating table, instruments, procedure. The device consists of a Control handle and different Arms (instruments); and accessories. The Console hosts the software and the power unit. The control handle is comprised of an ergonomic hand piece that can turn on its own axis thanks to the comfort joint. The control handle has command buttons that activate the different degrees of freedom or the Arm. Different arms can be connected on the control handle. Arms consists in a distal articulation that allows the tip (scissors, needle holder, forceps or Hook) to tilt, rotate and open-close. The arms and the control handle are reusable and autoclavable. The scissors, the dissector (Maryland) and the hook supports electrocautery monopolar energy after connecting the standard monopolar cable between DEX device and an ESU compliant with IEC 60601-2-2; After installed the neutral electrode; The user can control the cautery effect by pressing on the foot pedal switch provided with the ESU. Associated acessories includes : sleeves

Here's a breakdown of the acceptance criteria and study information for the DEX Device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Biocompatibility: Not explicitly stated as a separate "test set" sample size. The testing involves materials of the device.
• Electrical Safety & EMC: Not explicitly stated as a numerical sample size of devices. Implies testing performed on "DEX device."
• Bench Test (Reliability): Not explicitly stated as a numerical sample size per specific test (e.g., how many needle holders were evaluated).
• Thermal Spread: Not explicitly stated as a numerical sample size. Mentions "different types of tissues" and "fresh tissues."
• Simulated Use: 40 simulated uses for DEX invasive parts.
• Data Provenance: Not explicitly stated (e.g., country of origin) for each test. Most tests were conducted by independent laboratories. The "System testing: monopolar energy (animal test)" clearly indicates animal data. "Thermal spread... Histomorphometric analysis on fresh tissues" also implies animal or cadaveric tissue. Overall, the studies are likely prospective for the specific device testing.

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

• This information is not provided in the document. The studies listed are primarily engineering, laboratory, and animal-based performance tests, not clinical studies involving expert interpretation of patient data.

4. Adjudication Method for the Test Set:

• This information is not applicable/provided. The studies focus on device performance parameters rather than diagnostic accuracy or clinical outcomes requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• No, an MRMC comparative effectiveness study was not done.
• The DEX Device is an electromechanical surgical instrument, not an AI-powered diagnostic or assistive tool for human readers/interpreters in the context of radiology or pathology. Therefore, this type of study is not relevant to this device.

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

• This concept is not applicable to the DEX Device as it is a physical surgical instrument, not a software algorithm providing standalone diagnostic or assistive output. While it contains software, the relevant "performance" is the instrument's function in the hands of a surgeon.

7. The Type of Ground Truth Used:

• Biocompatibility: Standardized biological test results (e.g., cytotoxicity assays, irritation indices).
• Electrical Safety & EMC: Compliance with international safety standards (e.g., IEC 60601 series).
• Bench Testing (Reliability): Engineering specifications and performance metrics for mechanical function and durability (e.g., number of cycles without failure, functional operation).
• Thermal Spread: Histomorphometric analysis on fresh tissues, comparing lesion characteristics to a predicate device. This is a scientific measurement based on tissue effects.
• Cleaning & Sterilization: Microbiological test results (e.g., sterility assurance level) and validated cleaning efficacy against contaminants, measured against ISO and AAMI standards.
• Software Validation: Adherence to software development lifecycle processes and requirements as outlined in FDA guidance and IEC standards.
• Usability: Assessment against usability standards and guidelines (IEC 60601-1-6, EN 60601-1-6) suggesting an evaluation of user interface and interaction.
• Simulated Use: Physical inspection for damage, cracks, corrosion after repeated operational cycles.

8. The Sample Size for the Training Set:

• This information is not applicable/provided. The DEX Device is a physical medical device, not a machine learning model that requires a "training set" in the conventional sense. The "training" for such a device occurs during its design, development, and engineering validation processes, which are informed by scientific principles and engineering best practices, not a dataset in the AI sense.

9. How the Ground Truth for the Training Set Was Established:

• This information is not applicable/provided for the same reasons as in item 8.

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