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The iQ3 Ultrasound System is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications:

Peripheral Vessel (including carotid, deep vein thrombosis and arterial studies). Small Organs (including thyroid, scrotum and breast), Cardiac, Abdominal, Lung, Procedural Guidance, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic.

Modes of operation include B-mode + M-mode, B-mode + Color Doppler, B-mode + Power Doppler, Spectral Pulsed Wave Doppler, Fetal Heart Sounds, B-mode + Biplane, B-mode + Needle Viz Tool, B-mode + Biplane + Needle Viz Tool, B-mode + Multi-Slice, and B-mode + Sweep.

The Butterfly iQ3 Ultrasound System's portability and user interface enables integration into professional healthcare facilities (e.g. Hospital, clinic. hospice, or medical office), home healthcare environment, ambulances and/or accident sites, and other environments where healthcare is provided. Users may also include medical students working under the supervision or authority of a physician during their education/training.

The Butterfly iQ3 Ultrasound System is a portable, hand-held, general-purpose diagnostic imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid on adult and pediatric patients. The system consists of a single transducer with broad imaging capabilities connected via a USB cable to a standard handheld commercial off the shelf (COTS) mobile device. In addition to M-mode and B-mode imaging the instrument also supports Color Flow Doppler imaging.

The user interface includes touch screen menus, buttons, controls, indication icons that allow the operator to control the system and to view and measure ultrasound imagerv.

The provided text is a 510(k) summary for the Butterfly iQ3 Ultrasound System. This document does not describe acceptance criteria for an AI/CADe device or a study proving that the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate ultrasound system (Butterfly iQ/iQ+ Ultrasound System, K220068) based on technological characteristics and non-clinical performance testing of the ultrasound system itself.

Here's why the requested information cannot be extracted from this document:

• No AI/CADe Acceptance Criteria: The document describes a general diagnostic ultrasound imaging system. While it mentions the "Bladder Volume and B-lines tools remain compatible with the images generated with the iQ3," these are presented as features of the ultrasound system's software compatibility, not as separate AI/CADe functions with specific performance acceptance criteria. There's no mention of a standalone AI algorithm, human-in-the-loop performance, or specific metrics like sensitivity, specificity, or AUC that would be associated with an AI/CADe device.
• No Clinical Study for Substantial Equivalence: The document explicitly states: "The Butterfly iQ3 Ultrasound System did not require clinical studies to support substantial equivalence for this premarket submission." This indicates that the substantial equivalence was demonstrated through non-clinical testing (e.g., electrical safety, biocompatibility, mechanical safety, software verification and validation) and comparison of technical specifications to the predicate device, not through a clinical performance study involving human readers or AI algorithms with associated ground truth.
• No Ground Truth Information: Since no clinical studies were performed, there is no discussion of how ground truth was established, the number of experts, their qualifications, or adjudication methods.
• No Training Set Information: Without a clinical performance study involving AI/CADe, there's no mention of a training set or how its ground truth was established.

Therefore, based on the provided text, it is not possible to fill out the requested table or answer the specific questions about acceptance criteria, clinical study details, sample sizes, expert involvement, or ground truth for an AI/CADe device.

The document primarily focuses on demonstrating that the Butterfly iQ3 Ultrasound System, as a whole, is safe and effective and substantially equivalent to its predecessor for various human body applications, based on its hardware and software functionalities for image acquisition and display, not on the performance of a specific AI algorithm designed to interpret those images for diagnostic purposes.

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The Butterfly iQ+ Ultrasound System is indicated for use by trained healthcare professionals in environments where healthcare is provided to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications: Peripheral Vessel (including carotid, deep ven thrombosis and arterial studies), Procedural Guidance, Small Organs (including thyroid, scrotum and breast), Cardiac, Abdominal, Lung, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic. Modes of operation include B-mode + M-mode, B-mode + Color Doppler, B-mode + Power Doppler, Spectral Pulsed Wave Doppler.

The Butterfly iQ/Butterfly iQ+ Ultrasound System is a hand-held general-purpose diagnostic imaging system for use by trained healthcare professionals in environments where healthcare is provided to enable visualization and measurement of anatomical structures and fluid of adult and pediatric patients. The system consists of a single transducer with broad imaging capabilities connected to a standard handheld commercial off the shelf (COTS) mobile device compatible with the Butterfly iO/iO+ mobile application (app). The subject device introduces the Auto B-line Counter, a software application backed by an image analysis algorithm. The purpose of the Auto B-line Counter is to provide automated detection and automatic calculation of the number of B-lines to a user in a given rib space and also provides the users the capabilities of reviewing the detected B-lines (via visual overlays). The overlay of B-lines does not mark images for detection of specific pathologies. The Auto B-line Counter enables the automated identification and count of B-lines during a lung scan and is integrated into the existing Butterfly iQ/iQ+ mobile application for use with the Butterfly iQ or iQ+ transducers.

The provided text describes the Butterfly iQ/iQ+ Ultrasound System, which introduces an "Auto B-line Counter" software application. The information below summarizes the acceptance criteria and the study that proves the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Auto B-line Counter algorithm's performance are primarily established through analytical validation and clinical performance evaluation.

• Intraclass Correlation Coefficient (ICC) between annotators for Quality Indicator.
• Dice Coefficient Score (DSC) for conformance of automatic B-line segmentation to ground truth.
  (Specific numerical thresholds for ICC and DSC for acceptance are not provided in the text, but the claim is that criteria were met.) |
  | Clinical Performance Evaluation | Algorithm performance non-inferior to clinician annotator ground truth | Demonstrated non-inferiority. Performance assessed by calculating the Intraclass Correlation Coefficient (ICC) between the tool and the ground truth. Algorithm's performance was consistent among clinically meaningful subgroups: age, gender, and BMI. (Specific numerical thresholds for ICC for acceptance are not provided, but the claim is that non-inferiority was shown). |

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

• Analytical Testing Test Set:
  • Sample Size: 6000 de-identified cines.
  • Data Provenance: Acquired from 253 sites. The datasets spanned many demographic variables including gender (male, female, and unidentified), age (20-90 years), and ethnicity via collection from a multitude of clinical sites with diverse and distinct racial patient populations. The data included various clinical subgroups and confounders such as congestive heart failure, heart failure with reduced ejection fraction, diabetes (with and without chronic complications), myocardial infarction, peripheral vascular disease, and renal disease. This suggests a retrospective, multi-center, multi-national (implied by "diverse and distinct racial patient populations") data provenance, although explicit country of origin is not stated.
• Clinical Performance Evaluation Test Set:
  • Sample Size: 99 subjects.
  • Data Provenance: Not explicitly detailed beyond being used for clinical performance evaluation. Given the context, it is likely also retrospective data from a similar pool as the analytical test set, or specifically collected for this evaluation.

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

• Number of Experts: The text refers to "expert annotators" (plural) for determining ground truth locations of B-lines and for establishing ICC. While a specific number isn't provided, the use of "annotators" and "experts" in plural implies a group.
• Qualifications of Experts: The text states, "The ground truthing for B-line counts was determined by the ICC among expert annotators presented with lung cines and instructions to determine the maximum number of B-Lines using the instant percent method. The ground truth locations of B-lines were then determined by expert annotator segmentations." The exact qualifications (e.g., number of years of experience, specialty like radiologist or emergency physician) are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: The ground truthing involved assessing the "Intraclass Correlation Coefficient (ICC) among expert annotators." This suggests that multiple experts independently provided assessments, and their agreement (measured by ICC) was used to establish the ground truth or validate its reliability. It doesn't explicitly state a specific adjudication method like 2+1 or 3+1 for resolving discrepancies, but rather implies consensus or high agreement as the basis for ground truth.

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

• The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study where human readers' performance with and without AI assistance is compared. The studies described focus on the standalone performance of the AI algorithm against human annotator ground truth.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, standalone performance was done. The analytical validation and clinical performance evaluation sections explicitly describe testing the "Auto B-line Counter algorithm performance" as being "non-inferior to clinician annotators (Ground Truth)" and calculating the ICC between "the tool and the ground truth." This indicates a direct comparison of the algorithm's output against established ground truth, representing standalone performance.

7. Type of Ground Truth Used

• Expert Consensus / Expert Annotation: The ground truth for B-line counts was determined by the "ICC among expert annotators" and by "expert annotator segmentations" for the locations of B-lines. This strongly indicates an expert consensus or expert annotation approach, where human experts interpret the images to establish the reference standard.

8. Sample Size for the Training Set

• The document does not specify the sample size for the training set. It only states that the "data used for verification is completely distinct from that used during the training process and there is no overlap between the two."

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

• The document does not explicitly describe how the ground truth for the training set was established. It only ensures the independence of training and testing data and mentions the process for establishing ground truth for the verification/test sets.

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The Butterfly iQ Ultrasound System is indicated for use by trained healthcare professionals in environments where healthcare is provided to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications: Peripheral Vessel (including carotid, deep vein thrombosis and arterial studies), Procedural Guidance, Small Organs (including thyroid, scrotum and breast), Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic. Modes of operation include B- mode + M-mode, B-mode + Color Doppler, B-mode + Power Doppler.

The Butterfly iQ Ultrasound System is a general-purpose diagnostic imaging system for use by qualified and trained healthcare professionals in environments where healthcare is provided to enable visualization and measurement of anatomical structures and fluid of adult and pediatric patients. The system consists of a single transducer with broad imaging capabilities connected to a standard handheld commercial off the shelf (COTS) mobile device. In addition to M-mode imaging the instrument also supports Color Doppler and Power Doppler imaging. The user interface includes touchscreen menus, buttons, controls, indicators and navigation icons that allow the operator to control the system and to view and measure ultrasound imagery.

The provided text describes the Butterfly iQ Ultrasound System and establishes its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria or an analytical study proving that the device meets those criteria.

The document discusses:

• Indications for Use: The system is for diagnostic ultrasound imaging and measurement of anatomical structures and fluids in adult and pediatric patients for various clinical applications (Peripheral Vessel, Procedural Guidance, Small Organs, Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal, Ophthalmic).
• Technological Characteristics: It's a general-purpose diagnostic imaging system consisting of a single transducer connected to a mobile device, supporting B-mode, M-mode, Color Doppler, and Power Doppler.
• Comparison to Predicate Devices: It highlights similarities and differences with the Butterfly Poseidon Ultrasound System (K163510) and GE Venue (K170714) regarding intended use, general device description, clinical applications, target population, usage environment, energy output, regulatory classification, portability, biocompatibility, sterility, electrical and mechanical safety, product codes, transducer type, and display.
• Summary of Safety and Performance: It states that verification and validation activities were performed to demonstrate that the device meets predetermined performance specifications and lists various IEC, ISO, and NEMA standards used for evaluation (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993, NEMA UD-2).
• Conclusion of Substantial Equivalence: It concludes that the Butterfly iQ Ultrasound System is as safe and effective as the predicate, with similar intended uses, indications, technological characteristics, and principles of operation, and that minor technological differences raise no new issues of safety or effectiveness. Performance data, including software verification and validation and performance testing, are mentioned as demonstrating safety and effectiveness.

However, the document does not provide the following specific information:

1. A table of acceptance criteria and the reported device performance. While it mentions "predetermined performance specifications" and "performance data," it doesn't quantify what those specifications were or the results achieved.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of human reader improvement with AI assistance. The device is an ultrasound system, not explicitly an AI-assisted diagnostic tool as described in the prompt.
6. If a standalone (algorithm only without human-in-the-loop performance) was done. Again, the prompt describes AI/algorithm performance, which is not the focus of this 510(k) for an ultrasound system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

In summary, the provided text confirms the general safety and performance evaluation undertaken for the Butterfly iQ Ultrasound System to establish substantial equivalence but lacks the detailed metrics, study design, and results typically found in a clinical study report for specific acceptance criteria.

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The Butterfly Auto 3D Bladder Volume Tool is a software application package. It is designed to view, quantify and report results acquired on Butterfly Network ultrasound systems for noninvasive volume measurements of the bladder, to support physician diagnosis. Indicated for use in adult populations.

The Butterfly Auto 3D Bladder Volume Tool is a software application used on Butterfly iQ Ultrasound Systems to provide a non-invasive measurement of bladder volume. The system calculates the bladder volume using proprietary artificial intelligence automatic segmentation and volume measurement algorithms on Butterfly Network ultrasound systems.

The Auto 3D Bladder Volume Tool allows the clinician to calculate bladder volume when using the Bladder preset in B-mode. The tool is used to acquire 25, 2D images of the bladder. Once acquired, a volume estimate is calculated and presented back to the clinician. The clinician can then exit, restart the tool or save the acquisition to the study roll. The information presented is intended as additional input to standard diagnostic pathways and is only to be used by qualified clinicians.

The Auto 3D Bladder Volume Tool is based on the image segmentation method, U-Net', and the volume calculation is computed using the process of integration over binary images.

Here's a breakdown of the acceptance criteria and study information for the Butterfly Network Auto 3D Bladder Volume Tool, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

Note: The document states that the "primary endpoint was met" but does not explicitly provide the specific numerical results of the device performance against the acceptance criteria within this summary section. It only lists the target performance (which matches the predicate's stated performance).

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

The document states, "A non-interventional validation study was conducted, where bladder volume was calculated." It mentions that "The patient dataset was constructed to provide a representative range of volume values, in a patient population with a balanced gender proportion and clinically typical age."

• Sample Size: The exact sample size for the test set is not explicitly stated in the provided text.
• Data Provenance: The document does not specify the country of origin of the data. It indicates the study was "non-interventional" and used a "patient dataset," suggesting it was retrospective data, but this is not explicitly confirmed.

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

Not explicitly stated. The document mentions that the primary endpoint was met and that inter and intra-operator variability was assessed, implying the involvement of operators/experts, but provides no details on their number or qualifications, nor how they established ground truth for the test set.

4. Adjudication Method for the Test Set

Not explicitly stated. No information is provided regarding an adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance. The study focuses on the performance of the algorithm itself.

6. Standalone (Algorithm Only) Performance Study

Yes. The validation study described appears to be a standalone performance study. The document states, "A non-interventional validation study was conducted, where bladder volume was calculated." It also mentions "Inter and intra-operator variability was assessed between operators processing the same images," which suggests the algorithm's output was part of the assessment, but the primary focus is on the device's ability to calculate bladder volume using its AI algorithm. The statement "Test datasets were strictly segregated from algorithm training datasets" further supports this.

7. Type of Ground Truth Used

The document does not explicitly state the method used to establish the ground truth volume for the test set. Given the context of bladder volume measurement, common methods for ground truth could include:

• Catheterization (direct measurement): This is often considered the gold standard for bladder volume.
• Manual ultrasound tracing by experts: Expert consensus on manual tracing of the bladder in 2D or 3D ultrasound could also be used as a reference.
• Phantom studies: Controlled experiments with known volumes.

However, the provided text does not specify which type of ground truth was used.

8. Sample Size for the Training Set

Not explicitly stated. The document mentions "Test datasets were strictly segregated from algorithm training datasets," confirming that a training set was used, but its size is not provided.

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

Not explicitly stated. The document mentions the use of "proprietary artificial intelligence automatic segmentation and volume measurement algorithms" and references the U-Net convolutional network for biomedical image segmentation, which implies that the training set would have included images with corresponding ground truth segmentations. However, the exact method or the qualifications of those who established this ground truth for the training data are not detailed.

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The Poseidon Ultrasound System is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediativ for the following clinical applications: Peripheral Vessel (including carotid and arterial studies), Procedural Guidance, Small Organs (including thyroid), Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional) and Musculoskeletal (superficial).

The Poseidon Ultrasound System is a general-purpose diagnostic imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid on adult and pediatric patients. The system consists of a single transducer with broad imaging capabilities connected via a USB cable to a standard handheld commercial off the shelf (COTS) mobile device. In addition to M-mode and B-mode imaging the instrument also supports Color Flow Doppler imaging.

The user interface includes touchscreen menus, buttons, controls, indicators and navigation icons that allow the operator to control the system and to view and measure ultrasound imagery.

The provided text is a 510(k) summary for the Butterfly Network Poseidon Ultrasound System. It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance.

This document focuses on the mechanical, electrical, and physical safety and performance of the ultrasound system itself, and its substantial equivalence to a previously cleared device (Philips Healthcare, Lumify Ultrasound System). It cites compliance with standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993:2009, and NEMA UD-2.

There is no mention of an AI/ML component in the Poseidon Ultrasound System, nor any data or study design related to algorithmic performance as would be required for an AI/ML-driven medical device. Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI component meets those criteria.

The information you asked for (acceptance criteria for an AI component, sample sizes, expert qualifications, ground truth, etc.) is typically found in submissions for AI/ML-enabled devices, which this document does not appear to describe.

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