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The Canady Flex RoboWrist is intended for grasping, mobilization, transection, suturing, and/or electrocautery of tissue under direct and endoscopic visualization.

The Canady Flex RoboWrist is a motorized, hand-held laparoscopic surgery instrument available with hook, scissors, or needle holder end-effectors. The device includes a connector for an electrosurgical generator, which allows the option of using the mono scissors or hook for electrosurgery. The Canady Flex RoboWrist primarily intended for dissection, and/or suturing of tissue under direct and endoscopic visualization in minimally invasive surgical procedures for interventions such as laparoscopic (urologic, gynecologic) or thoracic surgeries.

The Canady Flex RoboWrist is composed of an instrument (with end-effectors) and a control unit, which provides power to the instrument. Three models of instruments are available: needle-holder, monopolar hook and monopolar scissors. An electrical cable is provided to connect the instrument to the control unit. It is also provided with a sterilization tray.

The provided text is a 510(k) summary for the Canady Flex RoboWrist, an endoscopic instrument. This document describes the device, its intended use, and how it demonstrates substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria or a study that evaluates the device's performance against specific clinical or diagnostic metrics, as would be expected for an AI/ML-driven device with performance claims.

Instead, the document focuses on non-clinical performance data to demonstrate safety and effectiveness for a surgical instrument. The key takeaway is that this is not an AI/ML device and therefore the questions about AI-specific performance criteria, ground truth, expert adjudication, and MRMC studies are not applicable.

Here's an analysis based on the provided text, highlighting what is present and what is not:

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

The document does not specify quantitative acceptance criteria in the typical sense for a medical device with performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it lists various non-clinical tests that were performed to evaluate conformance to product specifications.

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 "test set" here refers to physical components of the device and its performance in a lab setting, not a dataset of patient images or clinical outcomes.

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. This device is an endoscopic surgical instrument, not an AI/ML diagnostic or prognostic tool. "Ground truth" for this device would relate to engineering specifications, material properties, and functionality demonstrations performed by engineers and technicians, not clinical experts establishing diagnostic accuracy.

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

Not applicable. There is no clinical test set requiring adjudication in the context of an AI/ML device.

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

No. This is not an AI/ML-assisted device.

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

No. This is a surgical instrument operated by a human.

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

For the non-clinical tests, the "ground truth" is defined by the requirements and specifications of the referenced ISO and IEC standards (e.g., a material is cytotoxic or not based on ISO 10993-5 criteria; electrical safety is met if measurements are within IEC 60601-1 limits). For functionality, it's whether the device can successfully manipulate, cut, and suture tissue as intended.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML device.

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

Not applicable. No training set is involved.

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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 BLUNTPORT™ Blunt Trocar with Threaded Anchor is intended for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry.

The Bluntport™ with Threaded Anchor 5mm-12mm is a sterile. single use device used for abdominal access during laparoscopic procedures. The device consists of a cannula assembly, blunttipped obturator component and an anchoring assembly. The cannula assembly accommodates various size laparoscopic devices ranging from 5mm to 12mm in diameter while still maintaining pneumoperitoneum. The anchoring device provides stability of the cannula at the access site.

The provided document is a 510(k) summary for the Covidien Bluntport™ Blunt Trocar with Threaded Anchor 5mm-12mm. It outlines the device description, intended use, and a comparison with a predicate device. However, it does not provide detailed acceptance criteria and specific performance results in a quantifiable manner from a study.

The document states that "Design verification studies were conducted to demonstrate that the Bluntport™ with Threaded Anchor 5mm-12mm is safe and effective and performs as intended." It then lists the types of tests performed. For this type of device (a surgical trocar), the "acceptance criteria" are typically related to the functional performance of the device (e.g., maintaining pneumoperitoneum, anchoring strength, biocompatibility), and the "study" would involve testing the device against these performance requirements.

Based on the provided text, I can infer the general categories of acceptance criteria and the types of studies conducted, but I cannot give specific numerical acceptance thresholds or the detailed performance data that would "prove" the device meets them. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with specific statistical outcomes.

Here's an attempt to structure the information based on what is available and what is typically expected for such devices, while acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Limitations: The document only lists the types of tests performed. It does not provide specific numerical acceptance criteria (e.g., "leak rate less than X mL/min") or the quantitative results of these tests. The statement "implies satisfactory performance" is an interpretation based on the conclusion that the device is safe, effective, and substantially equivalent.

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

The document does not specify the sample sizes used for any of the listed tests (pneumoperitoneum leak rate, anchoring strength, etc.).
The data provenance is not explicitly stated (e.g., country of origin). The studies appear to be retrospective in the sense that they are design verification studies performed by the manufacturer, rather than prospective clinical trials.

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

For a device like a surgical trocar, "ground truth" and "experts" as typically understood in diagnostic AI/image analysis studies are not directly applicable in the same way. The performance of the device (e.g., leak rate, anchoring strength) is typically measured using engineering and biological testing methods against established standards or internal specifications, not by expert consensus on clinical findings. Therefore, this information is not provided and is likely not relevant in the context of this device's verification.

4. Adjudication Method for the Test Set

As explained above, "adjudication method" is not applicable here, as these are technical performance and biocompatibility tests rather than assessments requiring human interpretation of data for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is designed for evaluating diagnostic devices or AI algorithms where human readers interpret medical data. This type of study is not applicable to a surgical tool like a trocar, and therefore, no such study or its effect size is mentioned.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This question refers to the performance of an AI algorithm independent of human interaction. The Covidien Bluntport™ Blunt Trocar is a physical surgical device, not an AI algorithm. Therefore, a standalone performance study in this context is not applicable.

7. Type of Ground Truth Used

The "ground truth" for the performance tests (e.g., pneumatic leak rate, anchoring strength) would be objective physical measurements obtained through standardized engineering and laboratory testing protocols. For biocompatibility, the ground truth would be established by the results of standardized biological assays (e.g., cell viability, immune response indicators) interpreted against established ISO standards (ISO 10993-1).

8. Sample Size for the Training Set

Not Applicable. The device is a physical surgical tool, not an AI algorithm that requires a "training set" of data.

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

Not Applicable. As there is no training set for a physical surgical device, this question is not relevant.

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