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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 Halt 2000GI™ Electrosurgical Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of soft tissue.

The Halt 2000GI™ Electrosurgical Radiofrequency Ablation System includes the following system components:
• Halt 2000GI Radiofrequency Generator (RF Generator): that provides RF energy to the RF Probe
• Disposable RF Probe (Tulip™, TU 1000), a hand piece with a trocar-pointed shaft and 7 deployable RF needle electrodes.
• RF Probe Extension Cable that connects the RF Probe to the RF Generator.
• Dispersive Electrode Pads (TSP 115) Set that provides the return path for the RF energy applied by the RF Probe. (Use only Dispersive Electrode Pads provided by Halt Medical, Inc.)
• Dispersive Electrode Pad Set Extension Cable (TSPCBL) that connects the Dispersive Electrode Pad Set to the RF Generator.
• Power Cord that is a medical grade power cord providing AC power to the RF Generator.
• Foot Pedal that is a pneumatic foot pedal with tubing used to turn RF energy on and off.

The Halt 2000GI™ Electrosurgical Radiofrequency Ablation 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 RF probe 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 RF 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.

The provided text is a 510(k) Summary for the Halt 2000GI™ Electrosurgical Radiofrequency Ablation System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as would be found for a novel device. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods, is not explicitly available in the provided text.

However, I can extract and infer some information based on the content.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of clinical or image-based studies. The testing mentioned includes:

• Electrical, mechanical, and software validation.
• Animal testing.
• Bench testing.
• Biocompatibility testing.

The size of these "test sets" (e.g., number of animals, number of bench tests) is not provided. Data provenance (country of origin, retrospective/prospective) is also not specified for these types of engineering and pre-clinical tests.

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. The ground truth for the performance testing appears to be based on the outcomes of engineering tests (e.g., meeting electrical safety standards) and observations from animal and bench studies (e.g., "reproducible, discretely demarcated zone of tissue necrosis"). There is no mention of expert consensus for establishing ground truth in the context of a diagnostic or interpretive device.

4. Adjudication method for the test set

Not applicable to the types of testing described. Adjudication methods are typically relevant for human-in-the-loop studies or clinical trials involving subjective assessment, which are not detailed here.

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

An MRMC comparative effectiveness study was not conducted. This device is an electrosurgical ablation system, not a diagnostic imaging device utilizing AI that would involve human readers.

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

This device does not involve an "algorithm only" component in the sense of AI or image interpretation. Its performance is related to its ability to deliver RF energy and achieve tissue ablation, which was evaluated through animal and bench testing, as well as engineering validation.

7. The type of ground truth used

The ground truth used for performance validation appears to be:

• Engineering specifications and regulatory standards for electrical, mechanical, and software validation.
• Histopathological or visual assessment of tissue necrosis in animal and bench testing.
• Biocompatibility standards (ISO 10993 series) for material safety.

8. The sample size for the training set

Not applicable. This document describes an electrosurgical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

Not applicable, as no training set is mentioned for this type of device.

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