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Venue Sprint is a general-purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country. state or other local municipality in which he or she practices, for ultrasound imaging, measurement. display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training.

The Venue Sprint is intended to be used in a hospital, medical clinic, home environment and road/air ambulance.

Venue Sprint clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric, 40 kg and above) and interventional guidance (includes free hand tissue biopsy, fluid drainage, vascular access). Modes of operation include: B. M. PW Doppler, Color Doppler and Harmonic Imaging.

Venue Sprint is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis. The Venue Sprint is used together with the Vscan Air probes and provides the user interface for control of the probes and the needed software functionality for analysis of the ultrasound images and saving/storage of the related images and videos.

This document describes the Venue Sprint diagnostic ultrasound system (K240206). Based on the provided text, the device is an ultrasound system and does not appear to have AI/ML functionality that requires specific performance metrics beyond general safety and effectiveness. The document explicitly states that clinical studies were not required to support substantial equivalence.

Therefore, most of the requested information regarding acceptance criteria, specific performance tables, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not present in this 510(k) summary for the Venue Sprint.

Here's an attempt to answer the questions based only on the provided text:

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

The provided document does not contain a specific table of acceptance criteria or performance metrics for an AI/ML component. The "acceptance criteria" for this device appear to be compliance with various safety and performance standards for diagnostic ultrasound systems.

• Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Guidance
• AAMI/ANSI ES60601-1
• IEC 60601-1-2
• IEC 60601-2-37
• IEC 62359
• ISO 10993-1
• ISO 14971
• NEMA PS 3.1-3.20e (DICOM)
• AAMI TIR69
• IEC 60601-1-11
• IEC 60601-1-12 |
  | Quality Assurance Measures | Risk Analysis, Requirements Reviews, Design Reviews, Testing (unit, integration, performance, safety) |

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

The document explicitly states: "The subject of this premarket submission, Venue Sprint, did not require clinical studies to support substantial equivalence." Therefore, there is no mention of a test set, its sample size, or data provenance from clinical studies within this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical studies requiring ground truth establishment for a test set were conducted or described.

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

Not applicable, as no clinical studies requiring ground truth establishment for a test set were conducted or described.

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. The document does not describe any AI-assisted features or MRMC studies. The device is described as a "general-purpose diagnostic ultrasound system." The phrase "expanding cleared Auto Inferior Vena Cava (IVC), Auto B-Lines, Real Time ejection fraction (RT-EF) and cNerve" refers to features already cleared on other predicate devices and their expansion to new probes on this system; it does not constitute a new AI feature with its own performance study described here.

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

Not applicable, as no standalone algorithm performance study is described.

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

Not applicable, as no clinical studies requiring ground truth were conducted or described.

8. The sample size for the training set

Not applicable, as no machine learning model training is described in this submission.

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

Not applicable, as no machine learning model training is described in this submission.

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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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