Search Results

The NanoKnife System with six outputs is indicated for surgical ablation of soft tissue, including prostate tissue.

The NanoKnife System is a device used for tissue ablation using irreversible electroporation (IRE), a method of focal ablation which uses high voltage electrical pulses to change the permeability of the cell membrane leading to cell death. During the procedure, electrical pulses between probe pairs produce an electric field which induces electroporation of cells within the targeted abation area. The NanoKnife System with six outputs is currently indicated for the surgical ablation of soft tissue by the United States Food and Drug Administration (FDA).

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: A total of 121 subjects were enrolled and subsequently treated with the NanoKnife System.
• Data Provenance: The study was a prospective, nonrandomized pivotal study. The document does not explicitly state the country of origin of the data, but the submission is to the U.S. FDA, implying the study was conducted to support a U.S. market application.

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

• This information is not provided in the given text. The ground truth for effectiveness was based on biopsy results, which are pathological findings, not subjective expert readings of images.

4. Adjudication Method for the Test Set:

• This information is not applicable as the primary effectiveness endpoint was based on objective biopsy results ("negative in-field biopsy"), not subjective assessments requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This study evaluated the performance of the NanoKnife system itself for tissue ablation, not how human readers' performance improved with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

• Not applicable. The NanoKnife System is a medical device for surgical ablation, not an AI algorithm. The study assessed the device's clinical effectiveness directly.

7. The Type of Ground Truth Used:

• The primary effectiveness ground truth was based on pathology, specifically the result of an "in-field biopsy at 12 months" (negative or positive). Safety ground truth was based on the incidence and grading of adverse events (AEs) using CTCAE v5.0.

8. The Sample Size for the Training Set:

• Not applicable. The NanoKnife System is a physical medical device, not an AI model that requires a "training set" in the machine learning sense. The "PRESERVE" study was a clinical trial to evaluate the device's performance.

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

• Not applicable. As stated above, this is a physical medical device, not an AI model. Therefore, there is no "training set" or ground truth establishment in this context.

Ask a specific question about this device

The Cannula is indicated for:
· the non-surgical removal of thrombi or emboli from the vasculature
· aspiration of contrast media and other fluids from the vasculature

The Cannula is intended for use in the venous system and for the treatment of pulmonary embolism.

The Handle is indicated as a vacuum source for the AlphaVac Multipurpose Mechanical Aspiration System.

The AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System is a single use-overwire catheter-based system that facilitates the removal of thrombus, embolus, or clot during minimally invasive percutaneous procedures. The AlphaVac MMA F186 System is comprised of six main components packaged together:

• . a flexible AlphaVac Cannula with self-expandable, nitinol reinforced, angled funnel shaped distal tip (18F)
• AlphaVac Sheath (22F)
• AlphaVac Obturator (17F) ●
• AlphaVac Handle .
• . Waste Bag and Tubing

The AlphaVac Cannula is placed within target vasculature using standard percutaneous vascular access techniques (i.e., Seldinger) and commonly available vascular access tools (e.g., guidewire, vascular introducers, etc.). Once the cannula is in place, the AlphaVac Handle and waste bag is connected and primed. The AlphaVac Cannula is advanced out of the sheath and the nitinol basket automatically expands into a funnel, aiding in the removal of thrombus, emboli, and clot. The aspiration handle is pulled back creating suction and pulling the material into the catheter, removing it from the vasculature. The aspirated material is captured and contained within the waste bag for disposal. Target vessels include, but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC), Right Heart (Atrium (RA)), and Pulmonary Artery Vasculature. The device is provided in ~85° (AlphaVac F1885) angled configuration.

The provided text describes the 510(k) summary for the AngioDynamics AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System. While it details the device and its intended use, it does not explicitly provide information on acceptance criteria for an AI/ML-based medical device, nor does it present a study proving the device meets AI/ML specific acceptance criteria. This document describes a traditional medical device (a catheter system) and its performance through bench testing and a clinical trial.

Therefore, I cannot extract the requested information about AI/ML acceptance criteria and a study proving the device meets them from the provided text.

Here's why and what information is available:

• Device Type: The AlphaVac MMA F1885 System is described as a "single use-overwire catheter-based system that facilitates the removal of thrombus, embolus, or clot." This is a physical, mechanical medical device, not an AI/ML software device.
• Performance Data (K): This section refers to "Comprehensive bench testing (integrity and functional performance)" and lists various engineering and mechanical tests (Dimensional Testing, Tensile Testing, Fluid Volume Removal, etc.). These are typical tests for a physical medical device.
• Clinical Testing (L): This section describes the APEX-AV trial, a multicenter pivotal study to assess the use of the device in subjects with acute intermediate-risk pulmonary embolism. The primary safety endpoint was the rate of major adverse events (MAEs), and the primary effectiveness endpoint was the reduction in RV/LV ratio. These are standard clinical trial endpoints for a physical medical device.

To answer your request, if this were an AI/ML device, the information would typically include:

1. AI/ML Specific Acceptance Criteria: Metrics like sensitivity, specificity, AUC, F1 score, precision, recall, positive predictive value (PPV), negative predictive value (NPV), often with specific thresholds (e.g., "Sensitivity must be >= 90%").
2. Study Design for AI/ML Evaluation:
   • Test Set Details: Sample size, data provenance (e.g., patient demographics, imaging modalities, data type like CT scans, X-rays), and whether it was retrospective or prospective.
   • Ground Truth Establishment: Number and qualifications of experts, the adjudication method (e.g., 2+1, 3+1 for consensus), and the nature of the ground truth (e.g., expert consensus, pathology, clinical outcomes).
   • MRMC Study: Whether a multi-reader multi-case study was performed, and its findings on human reader improvement with AI assistance.
   • Standalone Performance: Specific metrics for the algorithm-only performance.
   • Training Set Details: Sample size and how ground truth was established for the training data.

Since this document pertains to a mechanical medical device, none of the above AI/ML specific details are present.

Ask a specific question about this device

VenaCure EVLT NeverTouch Procedure Kit: The AngioDynamics VenaCure EVLT NeverTouch Procedure Kits are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

VenaCure EVLT NeverTouch Direct Introducer Sheath: The AngioDynamics, Inc. VenaCure EVLT NeverTouch Direct Introducer Sheath is indicated for use with the VenaCure EVLT NeverTouch Direct Procedure Kit to introduce the laser fiber into the peripheral vasculature.

VenaCure EVLT NeverTouch Direct Procedure Kit: The AngioDynamics, Inc. VenaCure EVLT NeverTouch Direct Procedure Kits are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of variose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

VenaCure EVLT NeverTouch and NeverTouch Direct Fiber Procedure Kits should be used only with lasers cleared for use in the treatment of varicose veins, varicosities with superficial reflux of the GSV, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower extremity.

VenaCure EVLT NeverTouch Procedure Kit: The VenaCure EVLT Fiber Procedure Kits include single use disposable devices for use with a laser for the treatment of varicose veins. In addition, the Trè-Sheath Introducer is available both in the kits and provided individually. The main components of the NeverTouch Procedure Kit are identified below:

• 600μ VenaCure EVLT NeverTouch Fiber
• 4Fr Tre' Sheath Introducer
• 0.035" Guidewire
• 19 Gauge or 21 Gauge Entry Needle

VenaCure EVLT NeverTouch Direct Fiber Procedure Kit: The VenaCure EVLT NeverTouch Direct Procedure Kits is comprised of single use disposable devices for use with a laser for the treatment of varicose veins. The VenaCure EVLT NeverTouch Direct Fiber Procedure Kits are comprised of

• 21 Gauge Entry Needle
• 0.018" Guidewire
• Introducer Sheath/Dilator Assembly
• Fiber

This document is a 510(k) Pre-market Notification for the AngioDynamics VenaCure EVLT NeverTouch Procedure Kits and NeverTouch Direct Procedure Kits. It seeks to establish substantial equivalence to a predicate device.

Based on the provided text, the submission does not describe any new studies or performance tests as the device itself hasn't changed. The submission explicitly states:

"The proposed VenaCure EVLT NeverTouch and NeverTouch Direct Procedure Kits and the predicate VenaCure EVLT NeverTouch and NeverTouch Direct Procedure Kits are identical to one another (and therefore substantially equivalent) in all aspects, not limited to design, materials, manufacturing, specifications, dimensions, and indication for use. The difference is the proposed VenaCure EVLT NeverTouch and NeverTouch Direct Procedure Kits is an update to the labeling." (Page 5, Section G)

And, "Modifications made to the VenaCure EVLT NeverTouch and NeverTouch Direct Procedure Kits were limited to updating the labeling." (Page 5, Section H)

Therefore, the submission is not presenting new acceptance criteria or a study to prove the device meets new criteria. Instead, it leverages the previous testing and substantial equivalence determination for the predicate device (K171921) and reference devices (K170695 and K112600) because the changes are limited to labeling, and do not affect the device's technical characteristics, functionality, or performance.

Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such new study or criteria are presented in this 510(k) submission.

The document implies that the original predicate device (K171921) and reference devices (K170695 and K112600) met their acceptance criteria through non-clinical testing. However, the details of those past studies (sample size, experts, ground truth, etc.) are not included in this document.

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 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.

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 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.

Ask a specific question about this device

The Cannula is indicated for
- · the non-surgical removal of thrombi or emboli from venous vasculature.
- · aspiration of contrast media and other fluids from venous vasculature.

The Cannula is intended for use in the venous system.

The Handle is indicated as a vacuum source for the AlphaVac MMA System.

The AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System is a single use-overwire catheter-based system that facilitates the removal of thrombus, embolus, or clot during minimally invasive percutaneous procedures. The AlphaVac MMA F186 System is comprised of six main components packaged together:

• . a flexible AlphaVac Cannula with self-expandable, nitinol reinforced, angled funnel shaped distal tip (18F)
• AlphaVac Sheath (22F)
• AlphaVac Obturator (17F) ●
• AlphaVac Handle .
• . Waste Bag and Tubing

The AlphaVac Cannula is placed within target vasculature using standard percutaneous vascular access techniques (i.e., Seldinger) and commonly available vascular access tools (e.g., guidewire, vascular introducers, etc.). Once the cannula is in place, the AlphaVac Handle and waste bag is connected and primed. The AlphaVac Cannula is advanced out of the sheath and the nitinol basket automatically expands into a funnel, aiding in the removal of thrombus, emboli, and clot. The aspiration handle is pulled back creating suction and pulling the material into the catheter, removing it from the vasculature. The aspirated material is captured and contained within the waste bag for disposal. Target vessels include, but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC), and Right Heart (Atrium (RA)). The device is provided in ~85° (AlphaVac F1885) angled configuration.

The provided document is a 510(k) Premarket Notification from the FDA for the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System. It describes the device, its indications for use, and the studies performed to demonstrate its substantial equivalence to a predicate device.

There is no information in this document related to any AI/ML model, ground truth, expert readers, or retrospective/prospective studies on patient data. This document focuses on the mechanical and functional performance of a medical device (aspiration catheter) and its substantial equivalence to a predicate device.

Therefore, I cannot provide a response that includes information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device. The request specifically asks for details pertinent to AI/ML device evaluation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, etc.), which are not present in this document.

The document outlines the following performance data to support substantial equivalence for the device itself (not an AI/ML component):

Acceptance Criteria and Device Performance (Mechanical/Functional Device)

The document states that "Comprehensive bench testing (integrity and functional performance) was performed to support substantial equivalence of the specified predicate device. The AlphaVac MMA F1885 System met all specified design and performance requirements below."

The acceptance criteria are implied to be the successful demonstration that the device performs according to its design and functional requirements. The reported device performance is that it "met all specified design and performance requirements."

Non-Applicable AI-Specific Information from the Document:

The following points are not addressed or are not applicable based only on the provided text, as the document describes a mechanical medical device, not an AI/ML system:

• Sample size used for the test set and data provenance: No information on patient data test sets as it's a mechanical device.
• Number of experts used to establish the ground truth for the test set and qualifications: Not applicable for a mechanical device.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes the regulatory clearance for a physical medical device (aspiration catheter) based on a demonstration of substantial equivalence through bench testing, biocompatibility, and sterilization validation, not an AI/ML product.

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 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.

Ask a specific question about this device

The AngioVac F18 85 is indicated as a venous drainage cannula for the non-surgical removal of thrombi or emboli during extracorporeal bypass for up to 6 hours.

The AngioVacF1886 is a venovenous cannula with a nitinol basket reinforced, self-expandable funnel shaped distal tip collapsed using an over-sheath that can be advanced through a 22 Fr sheath and over a guidewire into the venous system percutaneously or via a surgical cut-down. During use, the cannula is connected to an extracorporeal circuit, an AngioVac Circuit, a commercially available centrifugal pump and bubble trap. A commercially available reinfusion cannula is placed for venous return (tvpically within internal jugular or one of the common femoral veins) and connected to the extracorporeal circuit. The funnel tip is actuated by advancing the AngioVac F188 out of the sheath deploying the self-expanding nitinol reinforced funnel shaped tip angle. Once optimal flow rate is achieved, the AngioVac F1885 is advanced under image guidance towards the undesirable intravascular (i.e. thrombus or emboli) until it is engaged, suctioned into the cannula and removed from the vasculature. The blood is then circulated though the filter and returned to the venous return cannula. A benefit of the AngioVac F1805 is that it allows for removal of thrombus and embolic material, while minimizing blood loss via recirculation of blood through a standard extracorporeal (venovenous) bypass circuit. Target vessels for the thrombus/embolus extraction include but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC) and Right Heart. The device is provided in an ~85° (AngioVac F1885) angled configuration.

Here's an analysis of the provided text regarding acceptance criteria and the study:

The provided FDA 510(k) summary (K212386 for AngioVac F18 85) does not describe a study involving an AI/Machine Learning device or a human-in-the-loop performance evaluation. Instead, it focuses on demonstrating substantial equivalence to a predicate device (AngioVac Cannula C20 and C180, K190594) through non-clinical bench testing and biocompatibility assessments.

Therefore, most of the requested information regarding AI device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment in that context is not applicable to this document.

However, I can extract information related to the device's performance based on the bench testing conducted.

Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing)

The document describes various performance tests conducted to support the substantial equivalence of the AngioVac F18 85. For these types of medical devices, "acceptance criteria" are generally that the device performs as intended and meets established engineering specifications, often validated against the predicate device's performance or industry standards. The text states that the device "met all specified design and performance requirements."

Here's a table summarizing the areas of performance evaluated:

Addressing Other Requested Information (and why some are not applicable):

1. Sample size used for the test set and the data provenance: Information is not provided in a way that relates to an "AI test set." The performance data refers to bench testing of the physical medical device. The exact number of samples for each specific bench test (e.g., how many cannulas were tested for tensile strength) is not stipulated, but the nature of bench testing implies multiple physical units were subjected to these tests. No separate "test set" in the context of data for an algorithm is described.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study where human experts established ground truth for an algorithm. Device performance was assessed against engineering specifications and industry standards during bench testing.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as there is no "test set" in the context of an algorithm requiring expert adjudication.
4. 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 a physical medical device, not an AI-assisted diagnostic tool or system that would involve human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is about a physical medical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench testing, the "ground truth" would be engineering specifications, validated test methods, and industry standards (e.g., ISO 10993 for biocompatibility) that define acceptable performance. For the substantial equivalence, the predicate device served as the primary reference.
7. The sample size for the training set: Not applicable. There is no AI/ML training set described.
8. How the ground truth for the training set was established: Not applicable. There is no AI/ML training set described.

Ask a specific question about this device

The Cannula is indicated for
· the non-surgical removal of thrombi or emboli from vasculature.
· aspiration of contrast media and other fluids from vasculature.
The Cannula is intended for use in the venous system.
The Handle is indicated as a vacuum source for the AlphaVac MMA System.

The AlphaVac Multipurpose Mechanical Aspiration (MMA) System is a single use-over-wire catheter- based system that facilitates the removal of thrombus, or clot during minimally invasive percutaneous procedures. The AlphaVac MMA System is comprised of six main components packaged together:

• a flexible AlphaVac Cannula with self-expandable, nitinol reinforced, angled funnel shaped distal tip
• . AlphaVac Sheath
• . AlphaVac Obturator
• AlphaVac Handle
• Waste Bag and Tubing
  The AlphaVac Cannula is placed within target vasculature using standard percutaneous vascular access techniques (i.e. Seldinger) and commonly available vascular access tools (e.g., guidewire, vascular introducers, etc.). Once the cannula is in place, the AlphaVac Handle and waste bag is connected and primed. The AlphaVac Cannula is advanced out of the sheath and the nitinol basket automatically expands into a funnel, aiding in the removal of thrombus, emboli, and clot. The aspiration handle is pulled back creating suction and pulling the material into the catheter, removing it from the vasculature. The aspirated material is captured within the waste bag for disposal. Target vessels for include, but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC), and Right Heart (Atrium (RA)). The device is provided in ~20° (AlphaVac 25F/C20) and ~180° (AlphaVac 25F/C180) angled configurations.

The provided text is a 510(k) summary for the AlphaVac Multipurpose Mechanical Aspiration (MMA) System. It details information typically included in a regulatory submission for medical devices to prove substantial equivalence to a predicate device. However, it does not include specific information regarding acceptance criteria for device performance studies, nor does it describe a study that explicitly demonstrates the device "meets" those acceptance criteria in the way a clinical trial or a performance study with defined endpoints would.

Instead, the document focuses on demonstrating substantial equivalence through bench testing, biocompatibility, sterilization, and a comparison of technological characteristics with a predicate device. It briefly mentions "Previous animal studies also contributed to demonstrating substantial equivalence," but no details on the study design, acceptance criteria, or results are provided.

Therefore, many of the requested pieces of information cannot be extracted from the provided text. I will address the points that can be inferred or explicitly stated.

Acceptance Criteria and Device Performance for AlphaVac Multipurpose Mechanical Aspiration (MMA) System

The provided 510(k) summary does not explicitly list acceptance criteria in terms of specific performance thresholds for a study designed to prove the device meets those criteria. Instead, it outlines a series of tests performed to support substantial equivalence to a predicate device (FlowTriever Retrieval/Aspiration System). The "reported device performance" is described as successfully meeting "all specified design and performance requirements" for these non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria are not provided, this table will summarize the types of tests performed and the general outcome as stated in the document.

2. Sample size used for the test set and the data provenance:
The document refers to "comprehensive bench testing" and "previous animal studies." However, no specific sample sizes for these tests are provided. Data provenance is not explicitly stated beyond "performed by AngioDynamics and independent test houses" for sterilization/shelf life and biocompatibility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The document describes non-clinical engineering and biological tests, not a clinical study with expert-established ground truth. Human Factors/Usability Evaluation was performed, which would typically involve users, but the details are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a diagnostic device requiring adjudication of interpretations.

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 is not an AI-assisted diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a mechanical aspiration device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the bench tests, the "ground truth" would be established engineering specifications, material standards, and regulatory requirements (e.g., ISO, FDA guidance). For biocompatibility, it's ISO 10993 standards. For animal studies, the ground truth would be based on physiological observations and post-mortem analysis.

8. The sample size for the training set:
Not applicable. This refers to a medical device's non-clinical performance and substantial equivalence, not a machine learning model.

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

Ask a specific question about this device

The UNIFUSE Infusion System with Cooper Wire is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral and pulmonary artery vasculature.

The proposed UNIFUSE Infusion System with Cooper Wire devices are single-lumen, nylon catheters with longitudinal slits located at 90° intervals around the distal end of the catheter for fluid delivery. An occluding ball wire (or occlusion guidewire) provides end-hole occlusion during fluid delivery. The catheters are available in 4F and 5F diameters and overall lengths of 90cm and 135cm. Additionally, they are available in multiple infusion segment lengths, including 2cm, 5cm, 10cm, and 15cm lengths – the latter two of which are the subject of this proposal. It is also worth noting that the overall length of each catheter remains the same no matter the length of the infusion segment. The active infusion area can be identified under imaging by means of radiopague markers on the catheter shaft at the distal and proximal ends of the infusion segment.

The provided text describes the UNIFUSE Infusion System with Cooper Wire and the study conducted to demonstrate that proposed longer infusion segment lengths (10cm and 15cm) are substantially equivalent to previously cleared shorter lengths (2cm and 5cm) for use in the pulmonary artery vasculature.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: The document states that "multiple practicing physicians" participated in the human factors study. It does not specify the exact number of physicians or the number of tests performed.
• Data Provenance: The study was a "simulated-use vascular model" study. The provenance is internal testing performed by AngioDynamics, Inc. It does not specify the country of origin of the data beyond the company's address in Massachusetts, USA. The study is prospective in the sense that it was conducted specifically to evaluate the new configurations.

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

• Number of Experts: "multiple practicing physicians experienced in the use and placement of infusion catheters." The exact number is not provided.
• Qualifications of Experts: They were "practicing physicians experienced in the use and placement of infusion catheters." No further specific details like years of experience or sub-specialty (e.g., interventional radiology, cardiology) are given.

4. Adjudication Method for the Test Set:

• The document implies that the observed performance of the device by the physicians in the simulated environment was directly assessed against the criteria. There is no mention of a formal adjudication method (like 2+1 or 3+1 consensus) being used to establish a "ground truth" for the test results themselves. The "ground truth" (or the desired outcome) was the ability of the device to perform as intended and for the DFU to be adequate, which was observed and concluded by the study conductors.

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, an MRMC comparative effectiveness study was not done. This study is for a medical device (infusion system), not an AI-assisted diagnostic tool. The "human factors" testing involved physicians using the device on a simulated model, not "reading" cases with or without AI assistance.

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

• No, a standalone (algorithm only) performance study was not done. The device is a physical medical device (catheter system), not an algorithm. The human factors testing necessarily involved human operation of the device.

7. The Type of Ground Truth Used:

• The ground truth for the human factors study was essentially expert observation and assessment in a simulated environment. The "truth" being confirmed was the device's functional performance in the intended use environment (pulmonary artery vasculature) by experienced users (physicians). This includes the ability to navigate, place, use, and image the device.

8. The Sample Size for the Training Set:

• The concept of a "training set" is not directly applicable here as this is a physical medical device and a human factors study, not a machine learning model. Therefore, no training set was used in the context of the study described for the K202347 submission. The study aimed to demonstrate the performance characteristics of the physical device.

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

• Given that there was no training set in the context of machine learning, this question is not applicable. The "ground truth" for the device's design and previous iterations (predicate device K192864) was established through a series of performance tests (listed in Table 2) covering various physical and functional aspects, along with human factors testing. For the current submission, the "ground truth" was established by comparing the performance of the new configurations to the established performance characteristics of the predicate device through the human factors study.

Ask a specific question about this device