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

This document is an FDA 510(k) summary for the AngioDynamics Solero Microwave Tissue Ablation (MTA) System and Accessories. It details the device, its intended use, comparison to a predicate device, and the testing performed to demonstrate substantial equivalence.

The document does not describe a study related to an AI/ML device, nor does it provide acceptance criteria and performance metrics for such a device. The changes described are software updates to reduce a specific error ("Error 0001") related to NAND flash memory errors, not the introduction of new AI/ML functionality.

Therefore, I cannot provide the information requested in the prompt, as the provided text does not contain any details about:

1. A table of acceptance criteria and the reported device performance for an AI/ML device.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study or human reader improvement.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on:

• Identical design, materials, manufacturing, specifications, dimensions, and indication for use.
• Software updates not introducing new risks or affecting biocompatibility, electrical safety, or sterilization.
• Software verification and validation testing to ensure the changes did not create unintended issues.

The performance data section (L) explicitly states: "Software correction verification and validation testing was conducted based on the impact of the software changes. Results from the following tests ensure that the changes did not create any unintended issues in the operation of the system overall: Unit Verification Testing, BSP Verification Testing, Integration Testing, System Integration Testing, Validation Testing, Language Validation and Regression Testing. All testing completed successfully. Additionally, software testing was conducted in compliance with IEC 62304:2006+A1:2015 Medical Device Software – Software Life-cycle Processes."

This is standard software testing for a medical device firmware update, not an AI/ML performance study.

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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 Solero Microwave Tissue Ablation (MTA) System and Accessories is a software-controlled, microwave generator with an integrated peristaltic pump that surgically ablates soft tissue through sterile applicators. It is used to deliver microwave energy into soft tissue for the purpose of microwave ablation.

The Solero MTA Generator is distributed with a main power cable and a footswitch, which may be used as an alternate means of controlling microwave activation in place of the microwave button on the front of the generator. Power is delivered through the disposable Solero Applicator which are provided separately. The Solero Applicator is a surgically invasive, sterile single patient use device used to thermally ablate targeted soft tissue. The probe is specifically designed to deliver microwave energy at a frequency of 2.45 GHz from its distal end into soft tissue. A chilled saline source is required to maintain the Solero Applicators at an appropriate temperature.

The Solero MTA System includes an optional accessory, the Solero MTA Cart, that is used to assist transport of the Solero Generator, and to provide a resting surface during operation and storage.

The provided text describes a 510(k) premarket notification for the Solero Microwave Tissue Ablation (MTA) System and Accessories. This notification seeks to demonstrate substantial equivalence to an existing predicate device, primarily due to manufacturing improvements and minor accessory additions, rather than a new clinical indication or significant technological change requiring extensive new performance studies against clinical endpoints.

Therefore, the information typically found in a clinical study evaluating a diagnostic AI device is largely absent here. This document pertains to an electrosurgical cutting and coagulation device, not an AI or diagnostic device that would have acceptance criteria based on classifications (sensitivity, specificity, AUROC, etc.). The "performance data" discussed relates to engineering and bench testing, as well as an animal study for ablation size comparison.

However, I can extract and structure the information that is present, aligning it as closely as possible to your requested format, and explicitly noting where the requested information is not applicable or not provided in the document.

Explanation of Applicability:
The questions asked (1 through 9) are highly specific to the evaluation of AI-powered diagnostic devices, often involving complex statistical analysis of classification performance, human reader studies, and ground truth establishment from medical experts or pathology. The Solero MTA System is a surgical device for tissue ablation, and its evaluation strategy focuses on safety, electrical compatibility, biocompatibility, and demonstration of equivalent physical performance (like ablation size) to a predicate device after minor design changes. Therefore, many of your requested points are not directly addressed or are not relevant to this type of device submission.

Acceptance Criteria and Device Performance (Solero Microwave Tissue Ablation (MTA) System and Accessories)

Given the nature of the device (a surgical tissue ablation system) and the 510(k) submission which focuses on substantial equivalence due to manufacturing changes, the "acceptance criteria" and "reported device performance" are primarily related to engineering specifications, safety standards, and comparative performance to the predicate device in an ex-vivo model. There are no clinical performance metrics like sensitivity, specificity, or AUROC for this type of device as it's not a diagnostic AI.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Description: The primary "test set" for performance evaluation was an ex-vivo bovine liver model.
• Sample Size: For the ex-vivo animal study, ablations were performed at three energy settings (minimum, medium, maximum). Each setting was performed a minimum of three (3) separate times. This means a minimum of 9 ablations in total for both the test device and the predicate device for comparison.
• Data Provenance: The study was conducted by AngioDynamics, presumably in the USA. The data is prospective for this ex-vivo study.

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

• This question is not applicable in the context of this device submission. For a tissue ablation device, "ground truth" for the ex-vivo study would typically involve direct physical measurement of the ablated tissue, not expert interpretation or consensus on diagnostic findings. The document does not specify who performed the measurements or their qualifications, as it's an engineering and animal model study rather than a clinical expert study.

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

• Not applicable. This specific type of adjudication method is used in diagnostic studies (especially AI-assisted ones) to resolve discrepancies in expert interpretation of medical images or data. For an ex-vivo physical measurement study, such a method is not relevant.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC study was done. This device is a surgical tool, not a diagnostic AI system or an AI-assisted diagnostic tool. Therefore, a study on human reader improvement with AI assistance is not relevant or applicable.

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

• Not applicable. The Solero MTA System is not a standalone algorithm. It is a physical device operated by a human surgeon. While it has software controls, its "performance" is the physical ablation of tissue, not an algorithmic output like a diagnostic reading.

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

• For the ex-vivo animal study: The "ground truth" was direct physical measurement of ablation size (length, width, and volume) in the bovine liver tissue. This is objective measurement rather than expert consensus, pathology, or outcomes data, which are typically found in clinical studies or diagnostic evaluations.
• For engineering/safety tests: Ground truth is defined by the objective pass/fail criteria of the respective engineering and safety standards (e.g., specific voltage/current ranges, leak rates, resistance to tensile forces, biological responses in biocompatibility tests).

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm that undergoes a "training phase" with a dataset in the way a machine learning model does. The device's design is based on engineering principles and validated through testing, not iterative learning from a training set.

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

• Not applicable. As there is no "training set" for an AI algorithm, the concept of establishing ground truth for it does not apply here.

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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 Solero Microwave Tissue Ablation (MTA) System and Accessories is a software-controlled, microwave generator with an integrated peristaltic pump that surgically ablates soft tissue when connected with sterile applicators. It is used to deliver microwave energy into soft tissue for the purpose of microwave ablation.

The Solero MTA Generator is distributed with a main power cable and a footswitch, which may be used as an alternate means of controlling microwave activation in place of the microwave button on the front of the generator. Power is delivered through the disposable Solero Applicator which are provided separately. The Solero Applicator is a surgically invasive, sterile single patient use device used to thermally ablate targeted soft tissue. The probe is specifically designed to deliver microwave energy at a frequency of 2.45 GHz from its distal end into soft tissue. A chilled saline source is required to maintain the Solero Applicators at an appropriate temperature.

The Solero MTA System includes an optional accessory, the Solero MTA Cart, that is used to assist transport of the Solero Generator, and to provide a resting surface during operation and storage.

The provided text describes a 510(k) premarket notification for a medical device (Solero Microwave Tissue Ablation (MTA) System and Accessories) that underwent a software modification. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the validation of these software changes, rather than a clinical study evaluating the device's efficacy in ablating tissue.

Here's an analysis of the acceptance criteria and the study that proves the device meets these criteria, based on the provided text:

Nature of the Device Modification and its Impact on the Study:

The core of this 510(k) submission is a software modification. The text explicitly states:

• "The purpose of this submission is to introduce into commercial distribution a modification to the Solero MTA System software..."
• "The primary purpose of the software update is to mitigate risk of boot up failure."
• "The results of this Risk Analysis activity determined the proposed software correction did not present any new risks or modify an existing risk."
• "These changes did not affect the materials, manufacturing, design, biocompatibility/sterilization, technical characteristics, functionality, performance, usability, or indication for use of the previously cleared device (K162449)."

Given this context, the "acceptance criteria" and "study" are focused on verifying that the software changes are effective, do not introduce new risks, and maintain the existing performance of the device. There is no large-scale clinical efficacy study described, as the changes are deemed not to impact the fundamental therapeutic function.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, the acceptance criteria relate to the proper functioning of the software changes and the continued safe and effective operation of the device as previously cleared.

• IEC-60601-1: 2006/03/09 (R2012), Ed 3.0 (Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance)
• IEC 60601-1-2:2014/02/25 Ed.4 (Medical Electrical Equipment - Electromagnetic Compatibility)
• IEC 60601-1-6 2013/10/29 Ed: 3.1 (Medical Electrical Equipment - Usability)
  (Implied successful testing, as submission was cleared). |
  | Compliance with Relevant Standards (Software Lifecycle)| Software development and testing must comply with medical device software lifecycle standards. | "software testing was conducted in compliance with IEC 62304 2006/05/09 Ed: 1 Medical Device Software - Software Lifecycle Process." |
  | No Impact on Core Device Characteristics | The software changes should not impact materials, manufacturing, design, biocompatibility/sterilization, technical characteristics, functionality, usability, or indications for use. | "The changes did not affect the materials, manufacturing, design, biocompatibility/sterilization, technical characteristics, functionality, performance, usability, or indication for use of the previously cleared device (K162449)." (Stated explicitly, supported by focused testing on software and power output). Biocompatibility and Sterilization specifically mentioned as "no impact" due to changes being solely software related. |

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

• Sample Size: The document does not specify a numerical sample size for "tests" or "test sets" in the context of clinical data. The testing described is verification and validation (V&V) of software changes and system performance, not a clinical trial with patient data. It refers to "executing tests" and "regression testing." It's likely that these tests involved a sufficient number of runs or configurations to cover the changed software functions and ensure no adverse effects on power output.
• Data Provenance: Not applicable in the context of clinical data for this submission. The "data" refers to the results of internal engineering and software V&V testing. The document does not mention the country of origin of data or whether it was retrospective or prospective, as it's not a clinical study.

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

• Number of Experts: Not applicable. The "ground truth" for the software modifications and performance checks is based on engineering specifications, software requirements, and established performance parameters (e.g., power output specifications defined during the original device development). There is no mention of human experts establishing ground truth in the context of interpreting medical images or clinical outcomes for this specific submission, as it's a software update to an existing device.
• Qualifications of Experts: N/A, as above.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies for resolving discrepancies in expert interpretations of medical data. For software verification and validation, test results are compared against defined acceptance criteria (pass/fail for specific tests) rather than adjudicated by multiple human readers.

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

• MRMC Study: No. An MRMC study is a clinical study design often used for evaluating the effectiveness of AI systems in diagnostic imaging by comparing performance with and without AI assistance across multiple readers and cases. This submission is for a software update to a microwave tissue ablation system, not a diagnostic imaging AI, and the changes are not related to diagnostic utility.
• Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was conducted.

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

• Standalone Performance: Not applicable in the context of typical AI diagnostic algorithms. The device itself is an electrosurgical device; its "performance" is about delivering microwave energy. The software enables the function of the device. The "standalone performance" was evaluated through the various verification and validation tests to ensure the software properly controls the hardware and that the power output remains as specified.

7. The type of ground truth used:

• Type of Ground Truth: The ground truth for this software modification related to boot-up, language, and power output was based on:
  • Defined software requirements and specifications: For the boot-up process (e.g., successful boot, automatic switch to backup), and language display.
  • Engineering specifications and regulatory standards: For power output (i.e., the power output must remain within specified tolerances as per the original device's cleared performance) and compliance with electrical safety and software lifecycle standards.
  • Risk Analysis: To confirm no new risks were introduced.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This is not a machine learning/AI model that requires training data in the traditional sense. The software changes are programming fixes and additions, not an algorithm learned from data.

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for a machine learning algorithm. The "ground truth" for the software development refers to the defined functional requirements and design specifications that the software was programmed to meet.

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