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The Acessa Pro Vu System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.

The Acessa ProVu System includes optional electromagnetic guidance for enhancing the ultrasonic image of the Acessa ProVu Handpiece and for predicting its future path on a computer monitor screen which also shows the ultrasound B-scan image.

The Acessa ProVu System provides radiofrequency (RF) ablation, ultrasound visualization and guidance within a single console and includes additional accessories. The Acessa ProVu System consists of a console with push buttons to control menu functionality. The console contains the following hardware and electronic components:

• RF Ablation System
• Ultrasound Visualization System
• Guidance System

The following accessories connect to the console:

• Dual Foot pedal (one for RF ablation and one for coagulation)
• Video Cable
• Power Cord
• Acessa Pads and Acessa Pad Cable
• Acessa ProVu Handpiece and Acessa ProVu Handpiece Cable
• Acessa Transducer, either:
  • Acessa ProVu Transducer used with Acessa ProVu Transducer Sleeve (embedded with sensor), or
  • Acessa ProVu Transducer with (embedded) sensor
• Acessa Table Top Field Generator or Acessa ProVu Planar Field Generator
• Monitor (hospital-owned accessory monitor, not provided by Acessa)

The Acessa ProVu System is designed to deliver up to 200 W of RF power at 460 kHz in three operational modes: Temperature Control, Power Control and Coagulation Mode. The graphical user interface (GUI) is displayed on a hospital-owned monitor. The system enables selection of operational parameters such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the Acessa ProVu Handpiece placed in the tissue to be ablated and its electrodes deployed, RF power can be turned on. The system parameters are continuously monitored and displayed on the monitor. If the measured parameters are outside the acceptable limits, the RF energy delivery automatically stops and a message appears on the graphical user interface. RF energy during an ablation or coagulation can also be stopped at any time by the user by pressing the foot pedal.

The Acessa ProVu System uses electromagnetic tracking technology to track the positions of the Acessa ProVu Transducer used with Acessa ProVu Transducer Sleeve (or the Acessa ProVu Transducer with embedded sensor) and the Acessa ProVu Handpiece shaft and draws virtual representations of them in their spatial relationship, so that a physician can predict the Acessa ProVu Handpiece shaft's future path in relation to the features in the ultrasound slice. The use of the guidance functionality is considered an optional accessory to procedures where ultrasound is currently used for visualization, such as the Acessa System procedure.

The provided text describes the Acessa ProVu System and its premarket notification to the FDA. However, it does not contain a study to prove the device meets acceptance criteria, nor does it define specific acceptance criteria with quantitative performance metrics for the device. The document primarily focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and a summary of non-clinical bench testing.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, sample size used for the test set, data provenance, number of experts for ground truth, adjudication methods, MRMC study details, standalone performance, type of ground truth, training set sample size, and how training ground truth was established. This information is not present in the provided text.

The closest relevant information is a general statement that "The performance data demonstrate that the subject device is substantially equivalent to the predicate devices" and a list of non-clinical bench tests performed:

• Biocompatibility Testing
• Use Life Testing of Transducers
• Electrical Safety and Electromagnetic Compatibility testing per various IEC/ANSI standards
• Software Validation and Verification Testing per FDA guidance (software considered "major" level of concern)
• Acessa ProVu Console and Guidance System Level Testing
• Benchtop Ablation Testing to validate substantial equivalence to the predicate
• Acessa ProVu Handpiece Performance Testing
• Acessa Pads Performance Testing
• Acessa ProVu Transducer Performance Testing (Acoustical and Thermal Measurement, in conformance with IEC 60601-2-37)
• Acessa ProVu Transducer Sleeve Testing

The document states that the Acessa ProVu System includes optional electromagnetic guidance with an accuracy of ±10 mm. This is the only quantitative performance metric mentioned in relation to the device's functionality. It does not, however, present this as an "acceptance criterion" that was tested in a "study" with specific results.

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The Acessa Guidance System is indicated for enhancing the ultrasonic image of the Acessa Handpiece and for predicting its future path on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended as an optional accessory for use during the Acessa System procedure.

The Acessa Guidance System consists of the following components: Guidance Controller (Model Number 5100), Guidance Ultrasound Transducer Sleeve (Model Number 5500), Guidance Field Generator (Model Number 5200), Guidance Handpiece Cable (Model Number 5400), and Power Cord (Model Number 4110). The Acessa Guidance System uses electromagnetic tracking technology to track the positions of the Guidance Ultrasound Transducer Sleeve and the Guidance Handpiece shaft and draws virtual representations of them in their spatial relationship, so that a physician can predict the Guidance Handpiece shaft's future path in relation to the features in the ultrasound slice. The Acessa Guidance System is considered an optional accessory to procedures where ultrasound is currently used for visualization, such as the Acessa System procedure.

The Acessa Guidance System includes the following performance testing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify sample sizes for any of the listed performance tests.
• The provenance of the data (e.g., country of origin, retrospective or prospective) is not provided for any of the tests.

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

• This information is not provided in the document. The tests described are primarily engineering, biocompatibility, and simulated environment tests, rather than clinical studies requiring expert ground truth for interpretation of patient data.

4. Adjudication Method for the Test Set:

• This information is not applicable as the provided testing is not a clinical study involving human reader interpretation requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not conducted or described in this document. The device is a guidance system, and the testing focuses on its engineering and functional performance rather than its impact on human reader performance in a diagnostic context.

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

• The document describes performance testing that largely functions as "standalone" performance for the device's components (electrical, safety, biocompatibility, mechanical). The "system worse-case accuracy comparison testing in a simulated clinical environment" evaluates the algorithm's accuracy in a controlled setting without explicit mention of human-in-the-loop performance influencing the measurement. However, the device is an "optional accessory" for use during a procedure and is meant to enhance ultrasonic images and predict tool paths, implying human interaction during its intended use. Therefore, while some tests are algorithmic/system performance, it's not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used:

• Electrical and Safety Testing: Ground truth is established by the specified international standards (e.g., ANSI/AAMI ES 60601-1).
• Biocompatibility Testing: Ground truth is established by the specified international standards (e.g., ISO 10993 series).
• Mechanical (Guidance Sleeve end cap tensile testing): Ground truth would be engineered specifications or established industry standards for material strength.
• Accuracy (System worse-case accuracy comparison): Ground truth would be defined reference points or known positional values within the simulated clinical environment.
• Software Validation: Ground truth would be the software requirements specifications and expected functional behavior.

8. The Sample Size for the Training Set:

• The document does not mention a "training set" in the context of machine learning or AI models. The software is noted to be from the manufacturer of the predicate device and based on their cleared device, implying reuse or adaptation of existing software rather than a de novo development requiring a distinct training phase.

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

• This information is not applicable as no training set for an AI model is described.

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The Acessa Guidance Handpiece is indicated for use in percutaneous laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.

Acessa Guidance Handpiece (Model Number 5300):

The Acessa Guidance Handpiece, when used with the tracking system, is meant to guide the tip of the Handpiece up to the uterine serosa. Once the device is advanced into the uterus, standard ultrasound views are used to guide the tip to the fibroid. Ultrasound visualization for fibroid penetration and treatment remain unchanged.

The Acessa Guidance Handpiece is a single-use only, sterile, radiofrequency (RF) applicator that connects to the Acessa Generator by a custom Cable. The Handpiece consists of a handle with a trocar shaft, active needle tip, and seven deployable needle electrodes each with embedded thermocouple sensors for real-time temperature feedback. The Acessa Guidance Handpiece also has control buttons that allow the user to access the User Interface.

This Acessa Guidance Handpiece also contains the magnetic guidance sensor used to determine spatial location. The embedded sensor and SROM can be used with the electromagnetic tracking technologies to track the positions of an Ultrasound Transducer and the Handpiece shaft, and draws virtual representations of them in their spatial relationship, so that a physician can predict the Handpiece shaft's future path in relation to the features in the ultrasound slice. These electromagnetic tracking technologies are considered optional accessories to Acessa System procedure.

Here's a summary of the acceptance criteria and study information for the Acessa Guidance Handpiece 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

The provided document describes performance testing of the device itself (electrical, safety, biocompatibility, mechanical, and compatibility with a tracking system), not a clinical study on patient data. Therefore, there isn't a "test set" in the context of patient data, nor is there data provenance in terms of country of origin or retrospective/prospective nature for such a clinical study. The testing was technical in nature, conducted on the device hardware and materials.

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

Not applicable. As noted above, this was not a study evaluating performance against a clinical ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable. This was not a study involving expert adjudication of clinical cases.

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 the 510(k) submission for a medical device (Acessa Guidance Handpiece) which is a physical instrument, not an AI or software algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant here.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing was based on:

• Established national and international standards for electrical safety (EN/IEC 60601 series).
• Established national and international standards for biocompatibility (ISO 10993 series).
• Internal criteria for flexural strength and compatibility with the electromagnetic tracking system.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

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The Acessa System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.

The Acessa System includes the following system components: Generator (Model Number 1000): Provides RF energy to the Handpiece through the Handpiece Cable. Handpiece (Model Number 2000): Consisting of a disposable handle with a trocar-pointed shaft and 7 deployable needle electrodes. For use only disposable electrosurgical devices provided by Halt Medical, Inc. Handpiece Cable (Model Number 4200): Connects Handpiece to the Generator. This extension cable is provided with the Generator. Pads (Model Number 3000): A disposable set of 2 units, providing the return path for the RF energy applied by the Handpiece. Use only the Pads provided by Halt Medical, Inc. Pad Cable (Model Number 4300): Connects the Pads to the Generator. This extension cable is provided with the RF Generator. Power Cord (Model Number 4110): A medical grade power cord that provides AC power to the Generator. The Power cord is provided with the Generator. Foot Pedal (Model Number 4100): Pneumatic foot pedal with tubing used to turn RF energy on and off. The Foot Pedal with tubing is provided with the Generator. The Acessa System is designed to deliver up to 200 W of RF power at 460 kHz in three operational modes: Temperature Control, Manual Control and Coagulation Mode. A touch screen with a graphical user interface (GUI) enables selection of operational parameters such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the Handpiece placed in the tissue to be ablated and its electrodes deployed, RF power can be turned on. The system parameters are continuously monitored and displayed on the Generator. If the measured parameters are outside the acceptable limits, the RF energy delivery automatically stops and a message appears on the graphical user interface. RF energy during an ablation or coagulation can also be stopped at any time by the user by pressing the foot pedal. NOTE: The Acessa System must be used under laparoscopic ultrasound guidance. Laparoscopic ultrasound equipment is not included with the Acessa System.

The provided document describes the Acessa System, a device for laparoscopic coagulation and ablation of soft tissue, specifically for symptomatic uterine fibroids. Here's a breakdown of the acceptance criteria and the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabulated format with specific thresholds. Instead, it describes various performance testing and clinical study outcomes that demonstrate the device's safety and effectiveness. Based on the provided information, the closest approximation of acceptance criteria and reported performance is:

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The MicroMed PD-8K system is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation integrity of electrosurgical instruments.

The MicroMed PD-8K system (MMPD-8K) is comprised of a reusable hand-held instrument probe, a detector or control/base unit, a ground wire and a high voltage wire in which the appropriate electrode (instrument probe) is control with and a fight vone in a mich in appropriate electrode housed at the end of the detector (control/base) unit The battery adaptor (recharger) is provided with the system for recharging the battery. The MicroMed PD-8K electrodes are reusable.

MicroMed PD-8K System includes:

• Detector (base unit)
• Battery with Charging adaptor
• Probe handle with 2m (6ft) lead-Red HV Wire
• 2m (6ft) lead ground wire with clamp-Green Wire
• Brush electrode 8mm (0.31inch) wide brass wires
• Ring Electrode with brass wires
• Carrying case
• Standard Operating Instruction manuals. CD With additional information.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroMed PD-8K device:

Based on the provided 510(k) summary, the device is an insulation tester, and the documentation focuses on its substantial equivalence to predicate devices rather than reporting a detailed clinical study with specific acceptance criteria in the traditional sense of diagnostic or therapeutic devices.

The "acceptance criteria" here are met through demonstrating that the device has the same indications for use, similar design, and comparable performance to legally marketed predicate devices. The study proving this is primarily a comparison to predicate devices and an internal assessment of the device's technical specifications.

1. Table of Acceptance Criteria and Reported Device Performance

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The InsulScan™ Insulation Testing System is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation of electrosurgical instruments.

The InsulScan™ system is comprised of a disposable hand-held instrument probe, a control unit, a cable adapter, and a ten-foot long connection cable. The InsulScan™ system is powered by a rechargeable battery housed in the control unit. A battery recharger unit and battery charger cable are provided for recharging. The InsulScan™ probe is provided sterile, single use and may not be resterilized.

The provided document describes the InsulScan™ Insulation Testing System, which is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation of electrosurgical instruments.

The document does not include specific acceptance criteria or a detailed study proving the device meets those criteria. It focuses on the regulatory submission (510(k) summary) rather than performance validation. Therefore, the requested information cannot be fully provided from the given text.

However, based on the available information, here's what can be extracted and how the missing pieces would typically be presented:

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

The document provides "Device Specifications" which can be interpreted as design specifications or performance targets. However, it does not explicitly state acceptance criteria or show actual measured performance against those criteria.

2. Sample size used for the test set and the data provenance

The document does not provide details on a specific test set, its sample size, or data provenance. This type of information would typically be found in a detailed validation study report, which is not included here. This 510(k) summary refers to the device as being substantially equivalent to a predicate device (LIT Insulation Testing System K952889), which implies that the substantial equivalence was demonstrated through comparison to the predicate's established performance, but specific test data for the InsulScan™ is not presented.

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

Not applicable. The document does not describe a clinical study or a study involving expert assessment to establish ground truth for a test set. This device is an insulation tester, not a diagnostic or imaging device that would typically rely on expert ground truth.

4. Adjudication method for the test set

Not applicable. There is no mention of a test set that would require an adjudication method.

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 device is not an AI-assisted diagnostic tool.

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

Not applicable. This device is a hardware testing instrument, not an algorithm. Its performance is inherent in its design and function. The "standalone" performance would typically refer to its ability to accurately detect insulation breaches as designed, but specific testing details are not provided.

7. The type of ground truth used

For an insulation testing device, the "ground truth" would typically be established by:

• Known defective insulation: Electrosurgical instruments with pre-engineered or confirmed insulation failures.
• Known intact insulation: Electrosurgical instruments with confirmed, undamaged insulation.
• Reference standard measurement: Using highly accurate and calibrated laboratory equipment to determine the actual insulation integrity (e.g., breakdown voltage, leakage current) against which the device's measurements are compared.

The document does not detail how the ground truth was established for any internal testing or validation studies.

8. The sample size for the training set

Not applicable. This device is a physical instrument, not a machine learning model that requires a training set.

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

Not applicable. This device is a physical instrument, not a machine learning model that requires a training set.

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The Laparoscopic Unipolar Tips will serve as accessories to the Endo-Tech, Ltd, Inc.,Endo-Aid, which is an Aspiration- Irrigation Device. These tips will thread into the laparoscopic irrigation and aspiration control handle. The tips will be used during laparoscopic procedures and electrosurgical procedures.

The Laparoscopic Unipolar Tips will be threaded into the Endo-Tech, Ltd., Inc. Endo-Aid (K#930756) and will be used during Laparoscopic procedures. These tips will be used by a range of surgeons for various abdominal procedures in a hospital operating room environment. The Laparoscopic Unipolar Tips consist of the following components: Threaded adapter (Male), Thread on probe and stainless tip (Female:Spatula, L Hook, J Hook, and Needle), Insulation Sheath for Electrosurgical Tips (Ratcheting).

This 510(k) submission (K961695) is for a medical device that does not involve AI/ML. There is no information in the provided text regarding acceptance criteria, device performance, sample sizes, expert involvement, or any studies related to AI/ML performance.

Therefore, I cannot provide a response with the requested information based on the provided text. The document describes a comparison to a predicate device based on physical and functional characteristics, not performance metrics usually associated with AI/ML systems.

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