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The Ultravision2™ System is indicated for use in surgery including laparoscopic surgery.

· The Ultravision2™ Generator is interface directly with the electrosurgical generator and serve as a passthrough for HF energy to HF electrosurgical instruments, to manage surgical smoke produced by energy-based instruments, and is indicated for use in surgery including laparoscopic surgery.

· The Ionwand™ Pack is intended to be used to manage surgical smoke and is indicated for use in surgery including laparoscopic surgery.

· The Ultravision™ 5mm Trocar is intended to be used to establish a path of entry for instruments and includes an Ionwand to manage surgical smoke, and is indicated for laparoscopic surgery.

· The Integrated Monopolar L-Hook (H/S)™ is intended to be used to facilitate the cutting and coagulation of soft tissue, to manage surgical smoke during laparoscopic surgical procedures, and is indicated for use in laparoscopic surgery.

· The IonPencil™ is intended to be used to facilitate the cutting and coagulation of soft tissue, to manage surgical smoke during general surgical procedures, and is indicated for use in surgery.

The Ultravision2™ System is a multifunctional system that synchronizes visual field clearing with the activation of smoke-producing electrosurgical devices. The system interfaces with commercially available electrosurgical instruments. The Ultravision2™ Generator connects directly to a commercially available electrosurgical generator (ESU) and passes the RF energy through to the desired electrosurgical instrument connected to the Utravision2™ Generator. The Ultravison2™ System is able to automate the activation of the Ionwand for visual field clearing to the electrosurgical device to synchronize visual field clearing with the generation of smoke.

The components of the overall system will be:

• Ultravision2TM system comprising: .
  • . Ultravision2TM generator
  • Link cables (x4)
  • . Power cable
  • Equipotential cable .
• . IonPencil™ accessory
• . Integrated Monopolar L-Hook(H/S)TM accessory
• Ionwand™ accessory
• . Ultravision™ 5mm Trocar accessory

The IonPencil™ is a bifunctional open surgery device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device. It's addition to the Ultravision 2 System adds the general open procedure capability to the Ultravision2™ indications of use along with the new single use accessory.

The IonPencil™ can only interface with the Ultravision2 generator which connects directly to a commercially available electrosurgical generator (ESU) for its HF monopolar energy source. The IonPencil™ provides two smoke clearing emitters that are automatically activated to clear the visual field when the device cutting function (HF) is activated. The mode of action of smoke management (visual field clearing) is electrostation as per the predicate Ultravision system. When the tissue cutting or coagulation is ceased, the visual field clearing signal is automatically switched off after a short delay period that is settable on the Ultravision2™ generator user interface.

Activation of the HF function of the IonPencil™ is via a yellow (Cut) or blue (Coag) button located on the handpiece, or via a footswitch if this connected to the parent electrosurgical generator which is connected to the Ultravision2™ system. The IonPencil™ itself is incompatible with the connectors of third-party electrosurgical generators. The IonPencil™ is provided with a 69mm long PTFE coated blade.

The following cleared accessories have not changed:

• The Integrated Monopolar L-Hook(H/S)™ is a bifunctional laparoscopic device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device.

· The Ionwand™ pack comprises a dedicated percutaneous 3mm trocar/catheter which accommodates the Ionwand™ cable that delivers low energy from the generator to the patient for smoke management.

• · The Ultravision™ 5mm Trocar includes a dedicated Ionwand™ cable.

The provided text describes the acceptance criteria and the results of non-clinical testing for the Ultravision2™ IonPencil. The study aims to demonstrate that the device is as safe, effective, and performs as well as or better than legally marketed predicate devices.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and the Reported Device Performance

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not contain the detailed methodology and results of a clinical study that would be used to prove novel device performance. The information outlines non-clinical testing and design validation under simulated use conditions.

Regarding the remaining questions, the provided text does not contain the requested information:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The text mentions "non-clinical testing" and "design validation under simulated use conditions" but does not specify sample sizes for these tests or the provenance of any data. These are likely bench tests and not human subject studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as the tests described are non-clinical, primarily focused on device specifications and performance rather than diagnostic accuracy involving human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical testing.
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 document describes a surgical smoke precipitator, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical tests, "ground truth" is typically defined by engineering specifications, standard test methods, and comparison to predicate device performance. For biocompatibility, it's defined by the specific criteria of the ISO standards.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

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The Ultravision2™ System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.

The Ultravision2™ 5mm Trocar component establishes a path of entry for instruments used in laparoscopic surgery.

The Ultravision2™ Generator interfaces directly with the electrosurgical generator and serves as a pass-through for RF energy to RF electrosurgical instruments.

The Ultravision2™ System is a multifunctional system that synchronizes visual field clearing with the activation of smoke-producing electrosurgical devices. The system interfaces with commercially available electrosurgical instruments. The Ultravision2™ Generator connects directly to a commercially available electrosurgical generator (ESU) and passes the RF energy through to the desired electrosurgical instrument connected to the Utravision2™ Generator. The Ultravison2™ System is able to automate the activation of the Ionwand for visual field clearing to the activation of the electrosurgical device to synchronize visual field clearing with the generation of smoke. The Ionwand™ pack comprises a dedicated percutaneous 3mm trocar/catheter which accommodates the Ionwand™ cable that delivers low energy from the generator to the patient. The Ultravision™ 5mm Trocar includes a dedicated Ionwand™ cable. This device is for prescription use only.

The information provided does not contain a study that proves the device meets the acceptance criteria. It presents a summary of non-clinical testing performed, including acceptance criteria and results (all "Pass"), but does not detail the methodology, sample sizes, or ground truth establishment for these tests in a way that aligns with a typical performance study.

Based on the provided text, here's what can be extracted:

1. Table of acceptance criteria and the reported device performance:

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

The document summarizes "non-clinical testing" and lists various tests, but it does not specify sample sizes for any of these tests. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective nature) as these are non-clinical engineering and performance characterization tests, not studies involving patient data.

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

This information is not provided as the disclosed tests appear to be engineering and design validation tests rather than clinical studies requiring expert ground truth for interpretation (e.g., image analysis by radiologists).

4. Adjudication method for the test set:

This information is not provided for the same reasons as above. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple expert readers.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in the provided text. The device is a "Surgical Smoke Precipitator" and an "Ultravision2™ System" which focuses on clearing smoke during laparoscopic surgery, not an AI diagnostic or assistive device for human readers. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not applicable.

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

The Ultravision2™ System is a medical device for surgical smoke clearance, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The device's function is physical and mechanical/electrical in nature for smoke precipitation synchronization.

7. The type of ground truth used:

The "ground truth" for the reported tests appears to be engineering specifications and established standards (e.g., ASTM, IEC, internal standards). For example, for "Dimensional and physical verification," the ground truth is "dimensional specification and physical specifications as per internal standards." For "Electrical safety," it's "the requirements of the applicable clauses in the standards."

8. The sample size for the training set:

This information is not applicable as the device is not an AI/machine learning system that requires a training set in the typical sense.

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

This information is not applicable for the same reason as above.

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The Ultravision 2™ Integrated Monopolar L-Hook (H/S)™ is intended to be used with applications in surgical procedures to facilitate cutting, coagulating of tissue, in combination with the clearance of smoke and other particulate matter that is created during laparoscopic surgery.

The Integrated Monopolar L-Hook (H/S)™ is a bifunctional device that combines proprietary visual field clearing and monopolar HF tissue and coagulation in a single device. The Integrated Monopolar L-Hook (H/S)™ can only interface with the Ultravision2 generator which connects directly to a commercially available electrosurgical generator (ESU) for its HF monopolar energy source. The Integrated Monopolar L-Hook (H/S)™ provides two recessed smoke clearing emitters that are automatically activated to clear the visual field when the device cutting function (HF) is activated. The mode of action of visual field clearing is electrostation as per the predicate Ultravision system. When the tissue cutting is ceased, the visual field clearing signal is automatically switched off after a short delay period that is settable on the Ultravision 2 generator user interface. Activation of the HF function of the Integrated Monopolar L-Hook (H/S)™ is via a yellow (Cut) or blue (Coag) button located on the handpiece, or via a footswitch if this connected to the parent electrosurgical generator which is connected to the Ultravision 2 system. The Integrated Monopolar L-Hook (H/S)™ itself is incompatible with the connectors of third party electrosurgical generators. On demand visual field clearing only can also be applied by activation of a third grey button on the handle. This clearing field action is stopped immediately after release of the grey button. The Integrated Monopolar L-Hook (H/S)™ is available with of 32cm. It is intended to be introduced via standard 5mm surgical trocars as long as their internal diameter is 5.70mm or greater. The device is for prescription use only.

The provided text is a 510(k) summary for the Ultravision2™ System Integrated Monopolar L-Hook (H/S)™. It details the device's characteristics, comparison to predicate devices, and a summary of non-clinical testing.

However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of a software-driven AI device. The device described is a surgical instrument that combines visual field clearing and monopolar HF tissue cutting/coagulation. The "visual field clearing" mechanism is stated as "electrostatic precipitation," which is a physical principle, not an AI algorithm.

Therefore, many parts of your request, specifically those related to AI/software performance, ground truth establishment, expert adjudication, MRMC studies, or training sets, cannot be answered from the provided text.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics comparison and non-clinical bench testing for safety and performance of the surgical instrument itself.

Here is what can be extracted from the provided text regarding device acceptance and performance through non-AI related testing:

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

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

• The document does not specify sample sizes for the various tests.
• Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned as the testing relates to the physical device and its biocompatibility/electrical safety, not clinical study data for AI.

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):

• This is not applicable as the device is not an AI/software device requiring expert interpretation of medical images or data. Ground truth for the described tests would be established by validated measurement techniques and laboratory protocols based on the specified ISO and ASTM standards.

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

• Not applicable for the type of testing described (bench testing, biocompatibility).

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. The device is a surgical instrument, not an AI-assisted diagnostic tool.

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 biocompatibility tests, ground truth is established by the specific chemical and biological reactions/observations as defined by the ISO and USP standards (e.g., cell viability for cytotoxicity, skin reaction for irritation, hemolysis levels).
• For electrical safety and mechanical tests, ground truth is established by direct physical measurements against engineering specifications and international standards (IEC, EN, ASTM).
• For "Visual field clearing" and "Design validation under simulated use conditions," the ground truth is against internal performance specifications, aiming for equivalence to predicate devices, implying practical demonstration of effectiveness.

8. The sample size for the training set:

• Not applicable as this is not an AI/machine learning device.

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

• Not applicable as this is not an AI/machine learning device.

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The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter that is created during surgery, including laparoscopic surgery. The Ultravision™ 5mm Trocar component establishes a path of entry for instruments used in laparoscopic surgery.

The Ultravision™ Visual Clearing System removes surgical smoke and particulates from the visual field by means of electrostatic precipitation. The System consists of the Ultravision Generator, the Ionwand Sterile Pack, and the Ultravision 5mm Trocar. The Ionwand is connected to the energy source and is then introduced into the body cavity near the smoke generating electrosurgical device. The Ultravision™ 5mm Trocar is intended for use only with the Ultravision™M Visual Field Clearing System to introduce the Ionwand while providing a pathway for laparoscopic instruments through one 5 mm trocar incision. The trocar may be used with or without the Ionwand component of the system. The system is powered using a rechargeable battery or through mains power. Accessories include the rechargeable battery, battery recharging station, mains converter power supply, mains converter, power supply unit, and patient return adaptor.

The Ultravision Visual Field Clearing System is a surgical smoke precipitator. The study described in the provided text focuses on demonstrating the substantial equivalence of the updated Ultravision system to its predicate device, particularly concerning the addition of a new indication for use in open surgical procedures.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Biocompatibility Tests (Cytotoxicity, Intracutaneous Irritation, Systemic Toxicity, Maximization Sensitization): The sample sizes for these tests are not explicitly stated in the provided text. These are typically standard tests conducted according to ISO 10993 guidelines, which would specify the number of samples/animals required. The provenance is likely laboratory-based testing.
• Performance Test 1 (Simulated Use): The text states a "human factors evaluation was also conducted during simulated surgery by actual users (surgeons)." The number of surgeons or simulated cases is not specified. The data provenance is from simulated surgical conditions.
• Performance Test 2 (Risk Assessment/Ozone Generation): This involved "empirical testing on ozone generation" in a "worst-case model." The specific sample size for these empirical tests (e.g., number of test runs, duration of tests) is not provided. The data provenance is laboratory testing.

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

• Biocompatibility Tests: Ground truth for these tests is established by standardized laboratory procedures and scientific assessment against predefined biological endpoints. No "experts" in the sense of clinical specialists establishing ground truth are mentioned.
• Performance Test 1 (Simulated Use): "Actual users (surgeons)" provided feedback to compare the Ultravision device to reference devices. The number of surgeons is not specified, nor are their specific qualifications (e.g., years of experience, subspecialty), beyond being "surgeons." Their feedback likely served as the "ground truth" for perceived performance metrics like workflow, ease of use, and risks in the simulated environment.
• Performance Test 2 (Risk Assessment): The ground truth for ozone generation is established by analytical measurements against regulatory limits (implied by "21 CFR"). The risk assessment for tissue damage risks was conducted internally by the manufacturer, comparing risks across different environments. The specific experts involved in designing or executing this risk assessment are not detailed, but it would involve experts in medical device safety, engineering, and possibly toxicology.

4. Adjudication Method for the Test Set

• Biocompatibility Tests: Adjudication is based on objective measurements and adherence to ISO 10993 standards and criteria.
• Performance Test 1 (Simulated Use): Feedback from "actual users (surgeons)" was synthesized to conclude equivalence. The method of synthesizing this feedback (e.g., individual reports, consensus meeting, voting) is not specified. It's unclear if a formal adjudication process beyond simple aggregation of feedback was used.
• Performance Test 2 (Risk Assessment): The risk assessment involves internal evaluation against predefined criteria and regulatory standards (for ozone). This is typically an internal process, so a specific external adjudication method is unlikely to have been used in the sense of a clinical read.

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 MRMC comparative effectiveness study was done. This device is a surgical smoke precipitator, not an AI diagnostic tool. The "Performance Test 1" involved human factors evaluation by surgeons, but it was not an MRMC study and did not involve AI.

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

• This device is a physical medical device (surgical smoke precipitator) and not an algorithm or AI-powered tool. Therefore, a standalone algorithm performance study is not applicable. The device's performance is intrinsically linked to its physical operation.

7. The Type of Ground Truth Used

• Biocompatibility Tests: Ground truth is established by standardized laboratory test results adhering to ISO 10993, which provide objective measurements of biological response (e.g., cell viability, irritation scores, systemic effects, sensitization).
• Performance Test 1 (Simulated Use): Ground truth is based on subjective feedback and comparative assessment from "actual users (surgeons)" regarding workflow, ease of use, and perceived risks in a simulated environment.
• Performance Test 2 (Risk Assessment): Ground truth for ozone generation is based on empirical measurement data compared against regulatory limits (21 CFR). For tissue damage assessment, it's based on an internal risk assessment methodology comparing scenarios.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set. The device was previously cleared (K182053), and the current submission is for an expanded indication, so the "development" or "training" of the device happened prior to or as part of the predicate device's clearance.

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

• Not applicable, as no training set for an AI/ML model is involved.

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The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.

The Ultravision™ 5mm Trocar component also establishes a path of entry for instruments used in laparoscopic surgery.

The Ultravision™ Visual Clearing System removes surgical smoke from the visual field during laparoscopic surgery by means of electrostatic precipitation. The System consists of the Ultravision™ Generator, the Ionwand Sterile Pack, and the Ionwand 5mm Trocar. The Ionwand is connected to the energy source and is then introduced into the body cavity near the smoke generating electrosurgical device. The Ultravision™ 5mm Trocar is intended for use only with the Ultravision™ Visual Field Clearing System to introduce the Ionwand while providing a pathway for laparoscopic instruments through one 5 mm trocar incision. The Ultravision™ 5mm Trocar provides an alternative to the currently available Ultravision™ Visual Field Clearing System Ionwand™ Sterile Pack for introduction of the Ionwand. The trocar may be used with or without the Ionwand component of the system. The system is powered using a rechargeable battery or through mains power. Accessories include the rechargeable battery, battery recharging station, mains converter power supply, mains converter, power supply unit, and patient return adaptor.

This request is about a medical device called the "Ultravision™ Visual Field Clearing System," which is a surgical smoke precipitator. The provided text is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than detailed clinical performance studies or acceptance criteria for AI/ML performance.

Therefore, based on the provided document, the device does not employ Artificial Intelligence or Machine Learning, and thus, none of the requested information regarding AI/ML acceptance criteria and performance evaluation is available.

The document describes a modification to an existing mechanical device (adding a mains power option), and the safety and effectiveness are established by comparing it to a previously cleared version of the same device. The "Nonclinical Performance Data" section mentions electromagnetic compatibility and electrical safety standards, which are typical for medical devices but distinct from AI/ML performance evaluation.

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The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.

The Ultravision 5mm Trocar component also establishes a path of entry for instruments used in laparoscopic surgery.

The Ultravision™ Visual Clearing System removes surgical smoke from the visual field during laparoscopic surgery by means of electrostatic precipitation. The System consists of the Ultravision Generator, the Ionwand Sterile Pack, and the Ionwand 5mm Trocar. The Ionwand is connected to the energy source and is then introduced into the body cavity near the smoke generating electrosurgical device. The Ultravision™ 5mm Trocar is a new accessory device intended for use only with the Ultravision™ Visual Field Clearing System to introduce the Ionwand while providing a pathway for laparoscopic instruments through one 5 mm trocar incision. The Ultravision™ 5mm Trocar provides an alternative to the currently available Ultravision™ Visual Field Clearing System Ionwand™ Sterile Pack for introduction of the Ionwand. The Ultravision™ 5mm Trocar is a standard dilating laparoscopic trocar compatible for use with 5mm instruments. The trocar design includes a discrete lumen that is positioned separate from the main trocar channel and which accepts the Ionwand component of the system. The trocar design allows the distal tip of the Ionwand to exit the trocar some 12mm from its distal point and at an angle to the trocar body that positions the Ionwand at a point close to but not interfering with the 5mm energy instruments that are intended to be accommodated by the trocar. The Ultravision™ 5mm trocar and Ionwand are provided packaged together in the same sterile barrier packaging. The trocar may be used with or without the Ionwand component of the system.

The provided text describes the regulatory clearance (510(k) submission) for the Ultravision™ Visual Field Clearing System, specifically focusing on the new 5mm Trocar component. It details the device's function, comparison to predicate devices, and the nonclinical testing performed to demonstrate substantial equivalence.

Based on the provided information, the device is not an AI/ML medical device. It's a surgical device for clearing smoke during laparoscopic surgery. Therefore, many of the typical acceptance criteria and study components associated with AI/ML devices (like MRMC studies, expert consensus for ground truth on training data, etc.) are not applicable here.

However, I can extract the acceptance criteria and the study (nonclinical testing) that proves the device meets them from the provided text, interpreting them in the context of a physical medical device.

Here's the information as requested, with "N/A" for sections not applicable to this type of device or not explicitly mentioned in the document:

Acceptance Criteria and Device Performance for Ultravision™ Visual Field Clearing System (K170178)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful results of the specified nonclinical tests, demonstrating equivalence to predicate devices. The reported device performance is that it "Pass"-ed all these tests and was found "Equivalent" to the predicate.

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

• Sample Size:
  • The document does not explicitly state the numerical sample sizes for each nonclinical test (e.g., how many units were tested for strength, how many cycles for reinsertion). It describes the type of tests performed.
• Data Provenance:
  • Country of Origin: Not specified, but the applicant (Alesi Surgical Ltd) is based in Cardiff, GB (United Kingdom). The tests were presumably conducted internally or by a contracted lab.
  • Retrospective or Prospective: These are laboratory/benchtop tests and simulated use conditions, not clinical studies on patients. Therefore, the terms "retrospective" or "prospective" as typically applied to patient data are not directly applicable. These were newly conducted tests to support the 510(k) submission.

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

• Number of Experts: N/A. Ground truth in this context (performance of a physical device) typically relies on engineering specifications, physical measurements, and standardized testing protocols rather than expert consensus on subjective interpretations.
• Qualifications of Experts: N/A. The qualification of personnel performing the tests would be governed by internal quality systems and standards for medical device manufacturing and testing, but not explicitly stated as "experts" for ground truth establishment in the way it's done for AI models interpreting medical images.

4. Adjudication Method for the Test Set

• Adjudication Method: N/A. Adjudication methods (like 2+1 or 3+1) are typically used for establishing ground truth from multiple human readers in image interpretation tasks. For physical device testing, results are typically objective measurements against predefined acceptance criteria.

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

• MRMC Study: No. This device is not an AI/ML system or diagnostic imaging tool that would benefit from an MRMC study. Its function is direct surgical smoke clearance and trocar access, not interpretation by human readers.
• Effect Size of Human Readers Improvement: N/A, as no MRMC study was conducted or relevant for this device.

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

• Standalone Performance: N/A. This is a physical medical device, not an algorithm. Its "performance" is its physical and functional operation.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device's performance is established by:
  • Predicate Device Performance: Demonstrating "equivalence" to the legally marketed predicate device (Ultravision™ Visual Field Clearing System, DEN150022) under simulated use conditions.
  • Industry Standards and Specifications: Adherence to standards like ISO 10993 for biocompatibility, industry standards for luer fittings, and general engineering principles for strength, sealing, etc.
  • Established Methods for Sterilization and Shelf-Life Validation: Following recognized protocols for these critical aspects.
  • Objective Measurements: Dimensional verification, pressure tests, electrical safety measurements provide objective data points.

8. The Sample Size for the Training Set

• Sample Size for Training Set: N/A. This device is not an AI/ML system that requires a "training set" in the computational sense. Device design and development are based on engineering principles and iterative testing, not statistical training on a data set.

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

• Ground Truth for Training Set Establishment: N/A. As there is no training set as understood in AI/ML, there is no method for establishing ground truth for it. The development and refinement of the device would involve engineering design, prototyping, and testing against functional requirements and safety standards.

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The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.

The Ultravision™ Visual Field Clearing System is a device that precipitates surgical smoke generated during laparoscopic procedures to clear the visual field. The device components are summarized briefly in Table 1, below.

Acceptance Criteria and Device Performance for ULTRAVISION™ Visual Field Clearing System

The ULTRAVISION™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter created during laparoscopic surgery. The acceptance criteria address various aspects of the device's safety, performance, and usability.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device as a "surgical smoke precipitator," the acceptance criteria were primarily qualitative and focused on safety, usability, and the ability to maintain a clear visual field.

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

• Test Set (Clinical Study): 30 patients were enrolled. Follow-up data was available for 25/30 enrolled patients.
• Data Provenance: The clinical study was a randomized, double-blinded, controlled, prospective trial conducted at a "single site." The location of this single site (e.g., country of origin) is not explicitly stated in the provided text.

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

• Number of Experts: The text refers to "The surgeons and reviewing panel" rating the treatment group's visibility. The specific number of surgeons or members of the reviewing panel is not provided.
• Qualifications of Experts: The qualifications of the "surgeons" are implied by their role in performing and assessing laparoscopic cholecystectomy. The qualifications of the "reviewing panel" are not specified beyond their role in judging visual field effectiveness.

4. Adjudication Method

The text indicates that "The surgeons and reviewing panel rated the treatment group to have a higher mean proportion of procedures with effective visibility than the control group." This suggests some form of consensus or independent rating was used, but a specific adjudication method (e.g., 2+1, 3+1) is not explicitly detailed. The blinding of the surgeon to the device's activation status suggests an effort to reduce bias in assessment.

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

A formal MRMC comparative effectiveness study, as typically described in imaging, was not conducted. However, a controlled clinical trial was performed where surgeons served as "readers" of the visual field.

• Effect size of human readers with AI vs. without AI assistance: The device is not an AI-assisted diagnostic tool but a physical device that clears the visual field. Therefore, the "effect size" isn't about human reader improvement with AI, but rather the improvement in the surgical environment (visual field clarity) provided by the device.
  • Visual Field Clarity: The treatment group (with device active) had a "higher mean proportion of procedures with effective visibility" compared to the control group (device deactivated).
  • Procedure Interruptions: In the treatment group, 8 procedures had no interruptions, while in the control group, no cases were completed without interruptions due to visual field impairment.
  • Camera Cleaning: 85% of procedures with the active device required no camera cleaning, compared to only 35% in the control group.

These results indicate a substantial positive impact of the device on the surgeon's ability to maintain a clear visual field and proceed without interruptions.

6. Standalone Performance Study

Yes, a standalone performance (algorithm only without human-in-the-loop performance) was implicitly done for several aspects, though not for visual field assessment.

• Biocompatibility Testing (Table 2): These are laboratory tests evaluating material properties directly, independent of human interaction.
• Chemical Characterization: This study assessed the effect of the device on surgical smoke chemistry, independent of human observers.
• Sterilization and Shelf Life Validation: These studies verify the effectiveness of the sterilization process and integrity of the packaging over time, independent of human application.
• Electrical Safety and EMC Testing: These are objective engineering tests demonstrating compliance with safety standards, not requiring human interpretation of the device's primary function.
• Software Verification and Validation: These analyze the software's functionality independently.
• Animal Simulated-Use Testing: While involving an animal subject, the assessment of functionality, visual field clearance, and non-damaging effects were objectively observed and recorded, serving as a standalone performance validation in a controlled environment prior to human clinical use.

7. Type of Ground Truth Used

• Clinical Study: The primary endpoint, "maintenance of a clear visual field," was established by the subjective assessment and consensus of the surgeons performing the procedures and a "reviewing panel." Secondary endpoints like adverse events and physiological measurements (CO, MetHb) were objective data (lab results) but visual field was assessed by human observation.
• Animal Study: The "acceptance criteria for the study were qualitative verification of performance and usability, through observed clearance of the visual field and an absence of observed clinical chemistry or histology concerns." This indicates a combination of expert observation/assessment (for visual field and usability) and objective laboratory results (clinical chemistry and histology).
• Other Studies (Biocompatibility, Chemical Characterization, Electrical Safety, etc.): These rely on objective test results against established standards and scientific methodologies (e.g., ISO standards, spectrographic analysis, electrical measurements).

8. Sample Size for the Training Set

The provided document describes a medical device, not an AI/ML algorithm that requires a "training set" in the conventional sense for model development. Therefore, there is no explicit training set sample size mentioned for an AI/ML model for this device. The clinical trial and animal studies serve as validation, not training.

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

As stated above, this device is not an AI/ML algorithm that uses a "training set." Therefore, this question is not applicable in the context of the provided information.

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