Search Results

Disposable Microwave Therapeutic Antennas is used with the Microwave Therapeutic System, which is indicated for the coagulation (ablation) of soft tissue. The Disposable Microwave Therapeutic Antennas is not intended for cardiac use.

Disposable Microwave Therapeutic Antennas is a puncture needle with microwave energy transmission. It is inserted into the human body through puncture, and the tissue is ablated by the thermal energy transformed by the needle tip.

Disposable Microwave Therapeutic Antennas is composed of radiator, handle, microwave cable with/without cooling tubes. The microwave cable connect the microwave ablation system to transmit microwaves to the ablation needle (radiator), a handle is set at the connection between the microwave cable and the ablation needle to facilitate the operator. The radiator is composed of a needle tip, a needle shaft, a cooling tube, and a coaxial cable. The metal parts are connected by a welding process, and the non-metal parts are connected by qlue. The needle and needle shaft are made of medical stainless steel, and the shape of the needle is a trianqular pyramid tip or pyramid type tip, which is mainly used for percutaneous puncture and microwave radiation; the handle is made of ABS material, the cooling tube is made of stainless steel to cool the needle bar all the way, the thermocouple is arranged in the handle to effectively monitor the temperature of the ablation needle not to exceed 45 degrees.

Disposable Microwave Therapeutic Antennas is provided sterile, for single use.

The provided text details the 510(k) summary for "Disposable Microwave Therapeutic Antennas" (K201265), comparing it to a predicate device (K183153) and a reference device (K133821). The core of the submission is to demonstrate substantial equivalence, focusing on technical performance and safety rather than on clinical effectiveness in a comparative sense (e.g., human-in-the-loop studies or ground truth established by experts interpreting images).

Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate device in terms of safety and functionality. The performance data provided is entirely non-clinical.

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

• Test Set Sample Size: Not applicable in the context of an AI/human-in-the-loop study. The "test set" here refers to non-clinical testing. For the in vitro tissue ablation studies, the sample size or details of the tissue models used are not explicitly stated. The type of data is non-clinical performance data from laboratory tests, including electrical safety, EMC, performance (IEC 60601-2-6), shelf life (accelerated aging), thermal effects, package verification, sterilization validation, and biocompatibility.
• Data Provenance: Not explicitly stated regarding the origin of the non-clinical data, but implied to be from internal testing by Nanjing ECO Microwave System Co., Ltd. The studies were not retrospective or prospective clinical studies but rather laboratory-based performance and safety evaluations.

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

• This information is not applicable as the device is not an AI diagnostic/interpretative device requiring expert-established ground truth from medical images. The ground truth for this device's performance is established through physical measurements, material science testing, and engineering standards compliance in a laboratory setting.

4. Adjudication Method for the Test Set

• Not applicable. There is no "adjudication" of expert opinions for a test set, as this is a non-AI hardware device approval. Performance is measured against engineering specifications and regulatory standards.

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

• No. An MRMC study was not conducted or required for this 510(k) submission. This is a device for physical ablation, not for interpretation of medical images or aiding human readers in diagnosis. The submission explicitly states: "Clinical testing is not required."

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

• Not applicable. This device is hardware; there is no standalone algorithm. Its performance is evaluated through physical and electrical tests, not as an algorithm's output.

7. The Type of Ground Truth Used

• The "ground truth" for this medical device is based on established engineering standards, material science properties, electrical safety parameters, and verified physical performance characteristics (e.g., achieving intended thermal effects/ablation in in vitro models). It is not expert consensus, pathology, or outcomes data in the clinical sense, as clinical testing was not required for this submission. The in vitro tissue ablation studies served as the proxy for functional ground truth related to the device's main purpose.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of an AI algorithm, as this is solely a hardware device.

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

• Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it.

Ask a specific question about this device

The Microwave Therapeutic System is indicated for the coagulation (ablation) of soft tissue. Therapeutic System is not intended for cardiac use.

The Microwave Therapeutic System is a host machine will be used together with Disposable Microwave Ablation Needle for ablation of soft tissue. The Microwave Therapeutic System consists of microwave source, control system, display system and temperature measurement system. It is a software-controlled microwave generator that deliver the microwave energy at a working frequency of 2450 MHz. The generator of the microwave therapeutic system is composed of a casinq, a power module, a control feedback unit, a display module, a microwave transmitting module, a water circulation module, and a temperature measurement module.

The provided text describes a 510(k) summary for the Microwave Therapeutic System (K201262) and compares it to a predicate device (K183153). While it discusses device performance and testing, it explicitly states that clinical testing is not required and does not present data from a study that proves the device meets specific acceptance criteria based on a clinical outcome or a comparison to human performance with or without AI assistance. Instead, the submission relies on non-clinical data to demonstrate substantial equivalence to a legally marketed predicate device.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them cannot be found in the provided text, as this type of study was not performed or required for this particular regulatory submission.

Here's a breakdown of what can be extracted or inferred from the text, and what is not present:

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

The document does not provide a table for acceptance criteria of clinical or human performance, as no such study was conducted. It implicitly relies on the device meeting established electrical safety, EMC, and performance standards for microwave therapy equipment, and software validation guidance.

The "performance" criteria are based on compliance with standards rather than clinical outcomes. The text states:

• Electrical Safety: ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
• Electromagnetic Compatibility: IEC 60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances --Requirements and tests
• Performance (General): IEC 60601-2-6 Medical electrical equipment Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
• Software validation: In compliance with FDA guidance for software contained in Medical devices.
• Shelf Life: "Accelerated aging tests were conducted to confirm the validity of the 8 years shelf life for 1 machine." (No specific acceptance criteria or results are given beyond "confirm the validity").
• Thermal Effects test and Temperature monitoring test: Referencing "FDA Guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for General Surgery." The text mentions "the test result prove that single needle ablation can also achieve the intended use, the performance meet the requirements of IEC 60601-2-6, the temperature measurement accuracy meet the requirements of intended use". Again, no specific quantitative criteria or results are provided.

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

• Test set sample size: Not applicable/provided. No clinical test set data is described. The non-clinical tests were conducted on the device itself.
• Data provenance: Not applicable/provided. No human data for a test set is listed.

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

• Number of experts: Not applicable. No human expert review was part of the reported performance evaluation.
• Qualifications of experts: Not applicable.

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

• Adjudication method: Not applicable. No human review or adjudication process is mentioned as part of the submission's performance evaluation.

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

• MRMC study: No. The device is a Microwave Therapeutic System for ablation of soft tissue, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant to this device type and was not performed.

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

• Standalone performance: The "performance" described pertains to the standalone operation of the microwave therapy device itself, based on engineering tests against established standards. This is not an AI algorithm's standalone performance, but the device's functional performance. The text indicates that these tests found the device to meet the respective standards, such as IEC 60601-2-6.

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

• Ground truth: For the device's performance, the "ground truth" is defined by compliance with established international and FDA-recognized standards for electrical safety, EMC, and microwave therapy equipment (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-6), as well as FDA guidance for software validation and specific thermal effects testing. These are engineering and regulatory benchmarks, not clinical ground truth derived from patients or expert consensus on clinical outcomes.

8. The sample size for the training set

• Training set sample size: Not applicable. This is a medical device, not an AI/ML algorithm that requires a training set of data for its primary function.

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

• Ground truth for training set: Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The Emprint™ Ablation System is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation on nonresectable liver tumors.

The Emprint™ Ablation System is not intended for use in cardiac procedures

The Emprint™ Ablation System with Thermosphere™ Technology, Covidien's microwave ablation system, was released for commercial distribution in the United States in April 2014.

The 510(k) Cleared Emprint™ Ablation System consists of the following components:

• 1. Emprint™ Ablation Generator (2450 MHz)
• 2. Emprint™ Percutaneous Antenna (sterile, single use)
• 3. Emprint™ Ablation Reusable Cable
• 4. Emprint™ Ablation Pump

The system also includes the following optional equipment/accessories:

• 5. Emprint™ Ablation Cart (with Isolation Transformer)
• 6. Ablation Footswitch
• 7. Remote Temperature Probe (sterile, single use)

The current Emprint™ Ablation System utilizes a 2450 MHz 100W generator (CAGEN1) to deliver power to a dedicated single microwave ablation antenna. The optional cart, Emprint™ Ablation Cart is intended to be used with the Emprint™ Ablation Generator.

The new system component, Emprint™ HP Ablation Generator (CAGENHP) [subject device] is similar to the device, Emprint™ Ablation Generator (CAGEN1) [predicate device] as described in K193232 with two exceptions. The new system component, Emprint™ HP Ablation Generator (CAGENHP), will extend the power setting range from 5 to 100W (Emprint™ Ablation Generator - CAGEN1) to 5 to 150W. The increased power will allow clinicians to create larger ablation zones when ablating soft tissue lesions, compared to use of the system with the existing 100-watt microwave generator (CAGEN1). Further the Emprint™ HP Ablation Generator (CAGENHP) is composed of analog and digital circuits with software whereas the predicate Emprint™ Ablation Generator (CAGEN1), is composed of analog and digital circuits with no software or firmware. The Emprint™ HP Generator will be compatible with all current Emprint™ ablation system components and accessories except the cart. The new optional Emprint™ HP Cart (CARTHP) has been added to the system and is compatible with the Emprint™ HP Ablation Generator (CAGENHP).

The optional cart holds the Emprint™ HP Generator (CAGENHP) and the Emprint™ Ablation Pump (CAPUMP1) securely in one location. The optional footswitch can be placed on the cart's lower shelf. There are hooks on both sides of the cart which are meant to hold either the normal saline bag during a procedure, or to loop (and store) the reusable cable over while not in use.

Emprint™ HP Ablation Cart (CARTHP) is similar to the previously cleared (K193232) Emprint™ Ablation Cart (CART1), which holds the Emprint™ Generator (CAGEN1) and the Emprint™ Ablation Pump (CAPUMP1) securely in one location.

The provided document is a 510(k) summary for the Covidien Emprint™ Ablation System with Thermosphere™ Technology. It describes a submission for new components, specifically the Emprint™ HP Ablation Generator (CAGENHP) and its optional accessory, the Emprint™ HP Ablation Cart (CARTHP).

This document does not describe an AI medical device or a study proving its performance against acceptance criteria for an AI or imaging-based diagnostic device. Instead, it focuses on demonstrating substantial equivalence of a microwave ablation system (a physical medical device used for soft tissue coagulation) to a predicate device.

Therefore, many of the questions asked in the prompt, such as those related to AI-specific performance criteria (e.g., sample size for training/test sets, expert consensus, MRMC studies, effect size of AI assistance), are not applicable to the content of this document.

However, I can extract information relevant to the device's acceptance criteria and the studies performed to prove its substantial equivalence as described in the document.

Analysis of Device Acceptance Criteria and Performance (Based on the provided non-AI device document):

Since the document describes a microwave ablation system and not an AI/imaging diagnostic device, the acceptance criteria and supporting studies are focused on the safety and effectiveness of the physical device and its new components, primarily demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal "acceptance criteria" table in the way one might for an AI device's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by the various tests and verification activities conducted to demonstrate the new components are safe and effective and do not alter the system's fundamental performance compared to the predicate.

The following points are not applicable as the document describes a physical medical device, not an AI/imaging diagnostic device. I'll explicitly state "Not Applicable" or "Not Provided/Relevant" for these.

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

• Sample Size for Test Set: Not explicitly specified for discrete tests. For the animal study, it mentions "an in vivo porcine model" but doesn't give a specific number of animals. For bench testing, typical engineering verification involves numerous tests without a "sample size" in the clinical trial sense.
• Data Provenance (Country of origin, retrospective/prospective): Not specified. The animal study is stated as "GLP-compliant pivotal study," suggesting a prospective, controlled experimental design, but location is not mentioned.

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

• Not Applicable. This is not an AI/diagnostic device where human expert "ground truth" for image interpretation would be established. The ground truth for this device is based on physical measurements (e.g., ablation zone dimensions), engineering specifications, and safety standards.

4. Adjudication Method for the Test Set:

• Not Applicable. No human interpretation for "ground truth" to be adjudicated.

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

• No. This is not a diagnostic device involving human readers.
• Effect size of human readers improve with AI vs. without AI assistance: Not Applicable.

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

• Not Applicable. This is a hardware device, not an algorithm.

7. The Type of Ground Truth Used:

• For the ablation performance, the "ground truth" appears to be physical measurements of ablation zone dimensions (compared directly between the subject and predicate devices under identical power settings) and compliance with engineering design requirements, international safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-6), and preclinical (animal) study results demonstrating equivalent therapeutic effect and safety.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI device trained on a dataset.

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

• Not Applicable.

Ask a specific question about this device

The Emprint™ Visualization Application is a stand-alone software product that allows physicians to visualize and compare CT and MRI imaging data. The display, annotation, and volume rendering of medical images aids in ablation procedures conducted using Emprint™ ablation systems. The software is not intended for diagnosis.

The Emprint™ Visualization Application is a software product that achieves its medical purpose without being part of the hardware of a medical device (SaMD). The Emprint™ Visualization Application is used to support Emprint ™-system ablation procedures by displaying patient CT and MRI images with modeled ablation zones / volumes. The application is a Windows™ desktop program that is installed on a hospital computer with local storage and a network connection. The software receives CT and MRI images by supporting DICOM connections with CT/MRI scanners and hospital PACS. The software's DICOM image viewer does not in any way alter the medical images. The device is designed to meet the procedure planning and evaluation needs of physicians conducting soft tissue ablation procedures using Emprint ™-branded systems only.

Based on the provided text, the Emprint™ Visualization Application is a standalone software product (Software as a Medical Device - SaMD) that allows physicians to visualize and compare CT and MRI imaging data to aid in ablation procedures. It is not intended for diagnosis. The performance testing described focuses on various aspects of software quality and usability rather than a comparative effectiveness study with human readers or a standalone AI performance evaluation for diagnostic purposes.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, according to the provided document:

Acceptance Criteria and Reported Device Performance

The document describes performance testing that focused on software verification and human factors engineering. Explicit quantitative acceptance criteria are not presented in a table format with corresponding performance metrics for features like sensitivity, specificity, or accuracy in a diagnostic sense. Instead, the performance is described in terms of compliance with standards and functional verification.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

1. Sample sizes used for the test set and data provenance:

   • The document does not specify a sample size for a "test set" in the context of image data for diagnostic performance.
   • It mentions "extensive software verification testing" including "software subsystem and system-level verification" and "simulated-use, validation testing" for human factors.
   • The data provenance of the images used in these tests (e.g., country of origin, retrospective or prospective) is not explicitly stated. The device uses patient CT and MRI images, which would be from clinical practice, implicitly retrospective for testing purposes if not generated specifically for the study.

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

   • This information is not provided. Since the device is "not intended for diagnosis" and the testing focused on functional verification and usability (measurement accuracy, workflow), the concept of "ground truth" established by experts for diagnostic performance (e.g., presence/absence of disease) is not applicable or described in this submission summary. The "ground truth" for the measurement accuracy test (e.g., +/- 2 voxels) would likely be based on known geometric properties of test objects or simulated environments rather than expert interpretation of pathology.

3. Adjudication method for the test set:

   • Not applicable/described as there's no mention of a diagnostic performance study requiring expert adjudication of cases.

4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

   • No, a MRMC comparative effectiveness study was not done.
   • The device is a visualization and planning tool, not an AI for diagnosis or a system designed to directly improve human reader performance in interpreting images for diagnostic tasks. Its purpose is to aid in ablation procedures by displaying, annotating, and volume rendering medical images.

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

   • The document doesn't describe a standalone performance evaluation in the typical sense of an AI algorithm making a diagnostic decision. The device itself is a "stand-alone software product" (SaMD), but its function is visualization and planning aid, not autonomous decision-making. Its "standalone" nature refers to it being a software app distinct from a hardware device. Performance testing focused on software functions, DICOM compliance, and measurement accuracy, which are "algorithm-only" in the sense that the software correctly performs its programmed tasks.

6. The type of ground truth used:

   • For measurement accuracy: The document states "system-level testing was conducted to verify the application's measurement accuracy (+/- 2 voxels)". The ground truth for this would likely be an engineered or known value within test objects or simulated datasets, not expert consensus or pathological findings from real patients.
   • For functional correctness: The ground truth is the expected behavior and output of the software as per its design specifications and standard compliance (e.g., DICOM standard conformance, correct display of images, faithful representation of ablation zones based on look-up tables).
   • For usability: The ground truth is user needs and expectations, assessed through human factors engineering and simulated-use validation testing.

7. The sample size for the training set:

   • The document does not mention a "training set" in the context of machine learning or AI models that learn from data. The device's description suggests it primarily uses rule-based logic (e.g., referencing "zone charts (look-up tables)" for ablation zones) and established imaging principles rather than a deep learning model requiring a large training dataset.

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

   • Not applicable, as no training set for a machine learning model is described. The "zone charts" mentioned for ablation zone prediction are likely derived from preclinical studies or physical principles of the ablation systems, not from ground truth established by experts interpreting images.

Ask a specific question about this device

The Solero Microwave Tissue Ablation (MTA) System is indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not indicated for cardiac use.

The device description of the Solero MTA System from the previous cleared K162449, has not been modified with the exception of the addition of the Solero MTA Cart as an optional accessory to the Solero MTA System.

The Solero MTA Cart is an optional accessory, that allows for transport, storage, and maneuverability of the system pre- and post-use. The Solero MTA Cart provides a shelf that is designed to securely hold the Solero MTA Generator in place. Once on the cart, the Solero MTA Generator is at an appropriate working height. The Solero MTA Cart has an incorporated IV pole for holding the chilled saline source used for maintaining the Solero Applicator at an appropriate temperature. There is a cable management system built into the Solero MTA Cart that allows for the mains power cable and footswitch to be stored for transporting the device or storage. The Solero MTA System can be transported using the handle on the cart. There is a tray on the stand of the cart intended to hold Directions for Use and Operators Manual. The Solero MTA Cart sits on four rotating casters that can all be locked into place during use, storage, or as appropriate during transit.

The provided text describes a 510(k) premarket notification for the Solero MTA Cart, an accessory to the Solero Microwave Tissue Ablation (MTA) System. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.

The document is a regulatory submission for a physical accessory (a cart) for an existing medical device, not a software or AI-driven device. Therefore, the questions related to AI performance metrics (like sample size for test/training sets, expert consensus, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this submission.

Here's a breakdown of what is available in the document, which pertains to the physical accessory:

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

The document doesn't present a formal table of acceptance criteria with corresponding performance data. Instead, it describes general safety and functional requirements.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a hardware accessory; testing was likely bench testing and functional evaluations rather than clinical studies with patient data.

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. Ground truth and expert consensus are irrelevant for a physical cart accessory.

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

Not applicable.

5. If a multi reader mult-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 AI-driven.

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

Not applicable. This device is not an algorithm.

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

Not applicable.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary of the study that proves the device meets the acceptance criteria:

The document states that the following performance testing was used to substantiate safety and effectiveness:

• IEC 60601-1: General Requirements for Basic Safety and Essential Performance: This likely involved electrical safety, mechanical stability, and general design integrity testing according to international standards for medical electrical equipment.
• Packaging Testing: Ensures the device can be transported without damage.
• Functional Testing including (e.g. electromagnetic compatibility and coexistence in a simulated use environment): This would involve testing the cart's ability to perform its intended functions (transport, hold generator, provide IV pole), as well as ensuring it doesn't interfere with other electronic devices and operates correctly in a typical medical environment. Specific mention is made of the casters' durability: "The Solero MTA Cart's casters have successfully completed 5,000 full "on" and "off" cycles without failure of the locking holding power, wear or permanent deformation that would adversely affect the locking performance of the casters."

The document concludes that "The results of comparison of technology similarities and the non-clinical performance testing demonstrates that the subject device (cart accessory), when used as an accessory for the predicate device (Solero MTA System), is substantially equivalent to the predicate device when used without it." This suggests that the performed non-clinical tests (bench testing, functional evaluations, and comparison to a legally marketed predicate device's cart) were sufficient to demonstrate the safety and effectiveness for a 510(k) clearance for this type of accessory. No clinical studies are mentioned for the cart itself, as it has no direct patient contact and its function is primarily transport and support.

Ask a specific question about this device

The Emprint™ Ablation Visualization is a stand-alone software product that allows physicians to visualize and compare CT imaging data. The display, annotation, and volume rendering of medical images aids in ablation procedures conducted using Emprint™ ablation systems. The software is not intended for diagnosis.

The Emprint™ Ablation Visualization Application is a software product that achieves its medical purpose without being part of the hardware of a medical device (SaMD). The visualization application is a DICOM image viewer that allows surgeons and interventionists to utilize a health care facility's PACS (Picture Archiving and Communications System) server (or other digital media transfer process) to view and interact with CT images. Using preprocedure, intra-procedure and post-procedure CT images, physicians can both plan and evaluate soft-tissue ablation procedures conducted with the Emprint™ Ablation System (K133821) and the Emprint™ SX Ablation Platform (K171358). The application is designed to streamline and enhance the procedure planning, execution and evaluation process; it is not required for the safe and effective conduct of an Emprint™ ablation procedure.

Using the application's three ablation workflows (Liver, Lung and Kidney Ablation), physicians can prepare for or evaluate an Emprint™ system ablation procedure by viewing and annotating patient-specific anatomy. The visualization's Compare Workflow facilitates the comparison of images across patients, or the comparison of images from the same patient before and after an ablation procedure. Physicians can use the software to perform the following, key, workflow-based tasks:

• Import standard DICOM images and render them in 3-dimensions
• Select and view specific anatomical features (e.g., soft-tissue lesions, anatomical landmarks)
• Measure and mark critical anatomical features / areas of interest
• Overlay and position virtual images of the Emprint ablation antenna and the anticipated thermal ablation zone onto the medical image
• Add textual annotations to images
• Save annotated plans for future viewing
• Export annotated plans for the patient's medical record or for use in a radiology or operating suite
• View and compare any 2 of the imported DICOM datasets, simultaneously

The visualization application is designed for installation and use on Windows™-based computers (Windows™ 7 or 10) and is compatible with procedure plans that were generated with the predicate device (Emprint™ Procedure Planning Application, K142048).

The provided text describes a software device called "Emprint™ Ablation Visualization Application" and its performance testing to demonstrate substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or detailed results of a study that proves the device meets those criteria, especially in terms of metrics like sensitivity, specificity, accuracy, or comparative performance with human readers if it were an AI-driven diagnostic aid.

The information provided focuses on the device's function as a DICOM image viewer, its intended use for visualizing and comparing CT images for ablation procedures, and general software verification testing. It explicitly states, "The software is not intended for diagnosis." This is crucial. Since it's not a diagnostic AI, the typical performance metrics associated with AI devices (like sensitivity, specificity, or MRMC studies) are not pertinent or captured in this submission.

Therefore, many of the requested points regarding acceptance criteria and performance against those criteria cannot be directly extracted from the provided text. I will address the points that can be inferred or explicitly stated.

Here's an analysis based on the provided text:

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

The document does not provide a table of performance-based acceptance criteria beyond general statements about software functioning and measurement accuracy.

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

The document does not specify a "test set sample size" in the context of a dataset of patient images for diagnostic performance evaluation, as the device is not for diagnosis. The testing seems to be functional and human factors related.

• Data Provenance: Not specified, but given it's a visualization tool and not a diagnostic AI, the provenance of "data" in the typical sense (e.g., patient cases) is not detailed. It mentions using "preprocedure, intra-procedure and post-procedure CT images".

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

Not applicable. Since the device is a visualization tool and not a diagnostic AI, there is no mention of establishing ground truth using experts for diagnostic purposes. The ground truth for its functional performance would be self-evident (e.g., does it display the image correctly, does it measure accurately within a defined tolerance).

4. Adjudication method for the test set

Not applicable. No diagnostic ground truth was established by experts requiring adjudication.

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. The document explicitly states: "The software is not intended for diagnosis." Therefore, a comparative effectiveness study assessing human reader improvement with AI assistance would not be relevant or performed for this type of device.

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

The device itself is standalone software ("SaMD"). Its performance was evaluated through "software subsystem and system-level verification" and "simulated-use, validation testing." These are essentially "algorithm only" tests in the sense that they evaluate the software's inherent functions (e.g., display, annotation, measurement accuracy) rather than its interaction within a diagnostic human-in-the-loop workflow.

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

For the measurement accuracy, the "ground truth" would likely be the known voxel dimensions or a calibrated phantom. For other functional aspects (display, annotation, saving), the "ground truth" is simply whether the software performs the intended action correctly according to its specifications. It is not a diagnostic ground truth based on clinical findings or pathology.

8. The sample size for the training set

Not applicable. This is not an AI/Machine Learning device that undergoes a "training set" in the conventional sense (i.e., learning from data to make predictions or classifications). It's a DICOM viewer with visualization and measurement tools.

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

Not applicable, as there is no "training set."

Ask a specific question about this device

The MedWaves AveCure™ Ablation System is intended for use in percutaneous, laparoscopic, and intraoperative coagulation-ablation of soft tissue.

The MedWaves AveCure™ Ablation System is not intended for use in cardiac procedures.

The MedWaves AveCure® Ablation System is designed to deliver ultrahigh radiofrequency (RF) through an antenna placed next to or embedded into soft-tissue for coagulating a volume of that tissue.

The MedWaves AveCure® Ablation System is composed of a durable generator-controller, and single-patient-use sterile accessories consisting of four antenna sizes and extension cable sets.

Each antenna-probe assembly is composed of one of the four antennas mounted at the distal end of one of many shaft configurations that are stiff, flexible or combination of both. The extension cable set is used to connect antennas to the generator controller. The material compositions of antennas and extension cables are nonmagnetic in nature and MRI safe. Therefore, the devices can be used in intraoperative, laparoscopic and percutaneous methods with CT, MR and Ultrasound imaging techniques to positions the antenna for ablation of softtissues.

The MedWaves AveCure® Ablation System is very efficient in transmitting RF power from the generator-controller to the antenna. With the low-power loss, the system does not need cooling pump, CO- or other mechanism to irrigate the antenna shaft and RF transmission lines for patient and user safety.

The provided document does not contain acceptance criteria for device performance based on a study, nor does it describe a study that proves the device meets specific performance criteria.

Instead, the document is a 510(k) summary for the MedWaves AveCure™ Ablation System, indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. The "Performance Data" section primarily discusses compliance with design specifications, risk analysis, and medical device standards (electrical safety-EMC, biocompatibility, sterility, and packaging shelf-life). It makes a general statement about mechanical and coagulation-ablation performance:

"The mechanical and coagulation-ablation performance ex-vivo and in-vivo meets the intended design and shows to be similar to the predicated devices."

This statement does not provide specific acceptance criteria or detailed study results. Therefore, I cannot generate the requested table and information.

To answer your request, I would need a document that explicitly details:

• Specific, quantifiable acceptance criteria (e.g., minimum ablation zone diameter, maximum ablation time for a certain volume, specific temperature achieved).
• The methodology and results of a study designed to test these criteria.

Ask a specific question about this device

The Emprint™ Procedure Planning Application is a stand-alone software product that allows physicians to visualize and compare CT imaging data. The display, annotation, and volume rendering of medical images aids intervention planning for video-assisted thoracoscopic surgery (VATS) and ablation procedures using the Emprint Ablation System. The software is not intended for diagnosis.

The Emprint™ Procedure Planning Application is a stand-alone software product that is intended to be used to view and compare CT image sets. The system is composed of image review and planning software and a Windows-based computer. The system includes tools that provide 3-D rendering of the image sets, pre-procedure planning of interventional thermal ablation procedures, and post-procedure review of interventional thermal ablation procedures. The Emprint™ Procedure Planning Application does not prescribe therapy and is not intended for the diagnosis or treatment of any disease. It does not control or alter the functions or parameters of any medical device and has no direct patient contact.

The provided text is a 510(k) Summary for the Emprint™ Procedure Planning Application. This document describes the device's intended use and technological characteristics but does not contain the detailed performance study results, acceptance criteria, or sample sizes typically found in a full validation study report.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment cannot be extracted from this document.

Here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: Specific quantitative acceptance criteria (e.g., accuracy, precision targets for measurements, rendering display fidelity) are not provided. The document only states that the system "passed all criteria." No reported metrics (e.g., specific accuracy values, error rates) are given.

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

• Sample Size for Test Set: Not mentioned.
• Data Provenance: Not mentioned. (e.g., country of origin, retrospective/prospective)

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.
• Role of Experts: It's unclear if "experts" were formally used to establish ground truth or if it was based on engineering design specifications.

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

• Adjudication Method: 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:

• MRMC Study: Not mentioned. The device is described as a "procedure planning application" that "aids in the intervention planning." It's a visualization and measurement tool, not primarily an AI-driven diagnostic aid that would typically undergo MRMC studies to compare human reader performance with and without AI. It explicitly states, "The software is not intended for diagnosis."

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

• Standalone Performance: The document states, "The Emprint™ Procedure Planning Application was tested in accordance with a test plan to evaluate all functions performed by the software as configured on the computer workstation." This implies standalone testing of the software's functionality, though specific quantitative results are not provided.

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

• Type of Ground Truth: Not explicitly stated. Given the description of testing "all functions performed by the software as configured," the ground truth likely refers to the expected output according to the software's design specifications for measurement accuracy, rendering fidelity, and data import/display. It's not based on external medical ground truth like pathology or outcomes.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable/not mentioned. This device is described as software for viewing, rendering, and planning, not a machine learning model that would have a "training set" in the traditional sense. It processes DICOM data from CT scanners.

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

• Ground Truth for Training Set: Not applicable/not mentioned, as it's not described as a device that uses a training set in the machine learning context.

Ask a specific question about this device