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Ablation Confirmation™ (AC), is a Computed Tomography (CT) image processing software package available as an optional feature for use with the Certus® 140 2.45 GHz Ablation System. AC is controlled by the user via an independent user interface on a second monitor separate from the Certus 140 user interface. AC imports images from CT scanners and facility PACS systems for display and processing during ablation procedures. AC assists physicians in identifying ablation targets, assessing proper ablation probe placement and confirming ablation zones. The software is not intended for diagnosis.

AC is resident on the Certus® 140 system and is accessible to the physicians via a second, dedicated monitor with its own user interface separate from the ablation user interface. AC functions are controlled via a USB connected mouse. AC connects to a facility PACS system and CT scanner and receives and sends CT and MR images via the DICOM protocol.

AC contains a wide range of image processing tools, including:

• 2D image manipulation
• 3D image generation (from 2D images) ●
• 3D image manipulation
• Region of interest (ROI) identification, segmentation and measurement ●
• Automatic identification of ablation probes
• . Registration of multiple images into a single view

Prior to an ablation procedure, physicians can use AC to semi-automatically segment and visualize ablation target lesions in soft tissue including liver, lung and kidney. The physician initiates the segmentation with tools provided on the screen. AC then uses segmentation algorithms to construct a 2-D visualization of the target lesion selected. The physician can accept the initial segmentation results or use AC tools to manually adjust the defined target lesion. Once accepted, the identified target is rendered into a 3D image.

Upon the placement of ablation probes, taking and importing the CT scan, AC can process the image and identify up to three ablation probes. AC can then perform a registration of the initial CT scan, containing the identified target with the second scan containing the ablation probe(s) in place. The resulting image allows the physician to visualize the ablation probe(s) in relation to the identified target. This enables physicians to ensure proper probe(s) placement prior to starting the ablation. Following the ablation procedure and a post-procedure CT scan, AC allows the physician to semi-automatically segment and visualize the ablation zone using the same process as in the initial target segmentation. AC then performs a registration of the initial CT scan, containing the identified target, with the final CECT scan containing the segmented ablation zone. The physician also has the option to evaluate the effect of potential tissue contraction to help determine the technical success (ablation zone covers target lesion with desired amount of margin) of the ablation procedure.

All AC processing and viewing is accomplished at the Certus® 140 Ablation System without the physician having to leave the procedure area to utilize separate image processing tools.

Additionally, AC allows for the images to be viewed by a remote physician for time-saving clinical consultation on the current procedure.

The provided text describes the NeuWave Medical, Inc. Ablation Confirmation™ system and its 510(k) submission (K161285). However, it contains very limited direct information on acceptance criteria and the detailed study that proves the device meets specific acceptance criteria. The document states that "The system passed all pre-determined acceptance criteria identified in the test plan" and "Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing that fulfills the requirements of FDA "Guidance on Software Contained in Medical Devices"". It does not provide the specifics of these acceptance criteria or the study details.

Below is a summary of the information that is available in the provided text, and explicit statements about what information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

Not available directly in the provided text. The document states that "The system passed all pre-determined acceptance criteria identified in the test plan," but it does not list these criteria or report specific performance metrics against them.

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

Not available in the provided text. The document does not specify the sample size for the test set or the provenance of the data (e.g., country of origin, retrospective or prospective).

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

Not available in the provided text. The document does not mention the number of experts or their qualifications used to establish ground truth for any test set.

4. Adjudication Method for the Test Set

Not available in the provided text. The document does not describe any adjudication method used for a test set.

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

Not available in the provided text. The document does not mention an MRMC comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The device assists physicians, but no comparative study is described.

6. Standalone (Algorithm Only) Performance

Partially available, but not with specific performance metrics. The document implies that the software performs several functions (segmentation, identification of probes, registration) semi-automatically or automatically. However, it does not provide standalone performance metrics (e.g., accuracy, sensitivity, specificity) for these functions. It states that "AC uses segmentation algorithms to construct a 2-D visualization" and "AC can process the image and identify up to three ablation probes."

7. Type of Ground Truth Used

Not explicitly stated for performance evaluation. For segmentation purposes, the text states that "The physician can accept the initial segmentation results or use AC tools to manually adjust the defined target lesion," implying that physician judgment (expert input) forms the ultimate "ground truth" for the intended use of identifying and adjusting target/ablation zones. However, for formal performance evaluation against acceptance criteria, the specific type of ground truth (e.g., pathology, outcomes data, consensus) is not detailed.

8. Sample Size for the Training Set

Not available in the provided text. The document does not mention any training set or its size.

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

Not available in the provided text. Given that the document does not mention a training set, the method for establishing its ground truth is also not provided.

Summary of what can be gleaned from the text regarding performance and validation:

The document indicates that:

• Ablation Confirmation™ "passed all pre-determined acceptance criteria identified in the test plan."
• "Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing that fulfills the requirements of FDA "Guidance on Software Contained in Medical Devices"."
• "Potential risks arising from the addition of the Tissue Contraction feature were analyzed and satisfactorily mitigated in the device design and labeling."

However, the specific details of these acceptance criteria, the performance metrics achieved, and the methodologies for the underlying studies (e.g., test set size, expert involvement, ground truth establishment) are not included in the provided 510(k) summary letter.

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The NeuWave Medical Certus 140™ 2.45 GHz Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings.

The Certus 140™ 2.45 GHz Ablation System is not indicated for use in cardiac procedures.

The system is designed for facility use and should only be used under the orders of a clinician.

The system has a single 2.45 GHz signal source generator and three (3) independent power amplifiers, each capable of producing up to 140W each. One, easy to use, touch-screen user interface controls the system. The User Interface can be set for either Ablation Mode or Surgical Mode. An optional footswitch can be connected to the system to control power delivery in Surgical Mode. Up to three (3) energy delivery accessories can be connected to and powered by the system at one time. An intermediate junction box or Power Distribution Module (PDM) reduces system set up complexity.

A variety of sterile, single-patient use energy delivery accessories (ablation probes and surgical tools) are available for use with the Certus 140. All are comprised of a sharp trocar on the end of a cannula, a handle, a cable and a connector assembly.

Models Certus", and Certus " ablation probes are available in either 17 gauge cannulas and are available in 15 cm and 20 cm lengths. These probes have a cable length of 1.4m.

Models Certus™ ablation probes are available only in 17 gauge cannulas and are available in 15 cm and 20 cm lengths. These probes have a cable length of 1.4m.

The model Certus® ablation probe has a 13 gauge cannula and is available in a 25 cm length only. Certus56 probes have a cable length of 1.4m.

Certusurged surgical tool is hand-held and has a 6cm, 17 gauge cannula designed specifically for surgical coagulation (including Planar Coagulation) in open surgical settings. This device has a finger-activated power delivery mechanism and a cable length of 2.9m.

Each energy delivery accessory contains temperature measurement sensors that help monitor performance and ensure patient and operator safety.

Additionally, the different percutaneous ablation probes have been designed to optimize the energy transfer efficiency from the probe into different types of tissue based on known electrical properties of each tissue.

Certus™ probes are designed to perform optimally, in terms of efficiently transferring energy into tissue, in liver and kidney tissue. Certus™ probes are designed to perform optimally, in terms of efficiently transferring energy into tissue, in lung tissue.

The antenna of the Certus® probe is designed to limit the length of the ablation for instances when a shorter ablation zone is desired. Certus® Probes were developed to provide physicians with an additional ablation probe designed specifically for ablating smaller lesions. The Certus® probes are designed to produce ablations that quickly encompass the tip of the probe while limiting the overall length of the ablation. Certus® probes will enable physicians to ablate smaller lesions while limiting necrosis of adjacent tissue when compared to other Certus probes.

The Certus® probes length and gauge size result in a sturdy probe ideal for use in laparoscopic applications.

The CertuSurg67 surgical tool is designed to produce focal, rapid coagulation of soft tissue in open surgical applications, including planar coagulation performed prior to tissue resection.

A CO2 based cooling system ensures the non-active portion of the probe does not exceed temperature requirements. Additionally, the CO2 enables the Tissu-Loc function, which can be used to adhere or stick the probe in place prior to starting ablation therapy. This function is similar in use to the stick function available on cryogenic ablation systems. The CertuSurg®T surgical tool does not have the Tissu-Loc function.

The system uses two (2) E-sized CO2 cylinders. When a tank in use empties, the system will automatically switch to using the other tank and notify the user to replace the empty tank.

An accessory, a small plastic probe clip that can hold two 17 gauge probes and allow the user to easily hold both while performing planar coagulation, is available.

Ablation Confirmation software (K150313) is available as an option on the Certus 140. When this option is supplied, a second monitor is provided with the system which hosts the Ablation Confirmation user interface.

The provided text describes a medical device, the NeuWave Medical Certus 140 2.45 GHz Ablation System, and its accessories. It details its indications for use, device description, modifications, and performance data from a 510(k) summary. However, it does not contain explicit "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the format typically requested for AI/ML device evaluation.

The document discusses performance data in the context of substantial equivalence to predicate devices and compliance with international standards for electrical safety, electromagnetic compatibility, and biocompatibility.

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

Missing Information:
The document does not provide:

• A table of explicit acceptance criteria with reported device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC).
• Sample sizes used for a "test set" or data provenance for a diagnostic/AI study.
• Number of experts, their qualifications, or adjudication methods for ground truth establishment specific to a diagnostic study.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or an effect size for human readers with and without AI assistance.
• Whether a standalone (algorithm only) performance study was done for AI.
• Details on the sample size for a "training set" or how ground truth for a "training set" was established, as these terms are relevant to AI/ML development, which is not the focus of this 510(k) summary for a microwave ablation system.

Information Extracted from the Document:

1. A table of acceptance criteria and the reported device performance:
   The document states: "The system passed all pre-determined acceptance criteria identified in the test plan." It also mentions "Ablation sizes for 15 gauge probe variants were deemed to be substantially equivalent to the predicate devices."
   However, specific numerical acceptance criteria and their corresponding reported performance values are not detailed in this summary. The criteria are general for compliance and functional equivalence.

   Acceptance Criteria (Implied)	Reported Device Performance
   Compliance with IEC 60601-1:2005 (Electrical Safety)	Passed applicable portions
   Compliance with IEC 60601-2-2:2006 (High Frequency Surgical Equipment)	Passed applicable portions
   Compliance with IEC 60601-2-6:1984 (Microwave Therapy Equipment)	Passed applicable portions
   Compliance with IEC 60601-1-2:2007 (Electromagnetic Compatibility)	Passed applicable portions
   Compliance with EN ISO 11607-1:2009 (Sterilization Packaging)	Passed applicable portions
   Compliance with ISO 10993-1: 2009 (Biocompatibility)	Passed applicable portions
   Ablation size equivalence for 15 gauge probe variants	Deemed substantially equivalent to predicate devices (ex-vivo)
   System passed all pre-determined acceptance criteria	System passed all pre-determined acceptance criteria identified in the test plan.
   Verification and Validation Testing	Completed in accordance with company's Design Control process (21 CFR Part 820.30) and FDA Guidance on Software Contained in Medical Devices. Potential risks analyzed and mitigation.

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

   • Sample Size (Test Set): Not specified in terms of patient/case count. Testing involved ex-vivo studies.
   • Data Provenance: Ex-vivo testing in bovine liver and lung and porcine kidney. This implies laboratory-controlled experiments rather than human clinical data from a specific country or retrospective/prospective human study.
   • The document also mentions "Ablation Confirmation software (K150313) is available as an option on the Certus 140." This suggests an AI/ML component might exist, but the performance data section describes testing for the ablation system itself, not specifically the "Ablation Confirmation software." If this software were to be evaluated as an AI/ML device, the detailed information requested would be critical. However, this 510(k) is not for the AI software, but rather for the overall ablation system and its hardware modifications.

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 to the type of ex-vivo performance testing described. Ground truth was likely established through direct measurement of ablation zones in the ex-vivo tissue rather than expert consensus on diagnostic images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   No. This type of study is not mentioned as this document is for an ablation device, not an AI diagnostic/assessment tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. The performance testing is for the ablation system's physical effects.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For the ex-vivo studies, the ground truth would have been direct physical measurement of the ablation zone size in the tissue samples.

8. The sample size for the training set:
   Not applicable, as this is not an AI/ML device approval focusing on a training set. The "design concepts, technologies and materials" were evaluated against predicate devices.

9. How the ground truth for the training set was established:
   Not applicable.

Summary of what this document actually provides:
This document is a 510(k) summary for a microwave ablation system, focusing on its substantial equivalence to previously cleared predicate devices and its compliance with relevant medical device standards. The "performance data" section primarily discusses engineering and basic functional testing (e.g., electrical safety, electromagnetic compatibility, biocompatibility, and ex-vivo ablation size equivalence). It is not a document evaluating an AI/ML diagnostic or prognostic device, and thus many of the questions related to AI/ML study design are not addressed.

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