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The Venue, Venue Go, Venue Fit and Venue Sprint are general purpose diagnostic ultrasound systems 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.

Venue, Venue Go and Venue Fit are intended to be used in a hospital or medical clinic. Venue, Venue Go and Venue Fit 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), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.

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 and non-vascular access). Modes of operation include: B, M, PW Doppler, Color Doppler and Harmonic Imaging.

Venue, Venue Go, Venue Fit and Venue Sprint are general-purpose diagnostic ultrasound systems intended for use by qualified and trained healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis.

The systems utilize a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes.

The systems have a small footprint that easily fits into tight spaces and positioned to accommodate the sometimes-awkward work settings of the point of care user.

The Venue is a mobile system, the Venue Go and Venue Fit are compact, portable systems that can be hand carried using an integrated handle, placed on a horizontal surface, attached to a mobile cart or mounted on the wall. Venue, Venue Go and Venue Fit have a high-resolution color LCD monitor, with a simple, multi-touch user interface that makes the systems intuitive.

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.

The Venue, Venue Go, Venue Fit and Venue Sprint systems can be powered through an electrical wall outlet for long term use or from an internal battery for a short time with full functionality and scanning. A barcode reader and RFID scanner are available as additional input devices. The systems meet DICOM requirements to support users image storage and archiving needs and allows for output to printing devices.

The Venue, Venue Go and Venue Fit systems are capable of displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal which is used as an input for gating during scanning. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis. Compatible biopsy kits can be used for needle-guidance procedures.

The provided document, a 510(k) Clearance Letter and Submission Summary, primarily focuses on the substantial equivalence of the GE Healthcare Venue series of diagnostic ultrasound systems to previously cleared predicate devices. It specifically details the "Auto Bladder Volume (ABV)" feature as an AI-powered component and provides a summary of its testing.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (for Auto Bladder Volume - ABV)

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

• Test Set (Verification Dataset) Sample Size: 1874 images from 101 individuals.
• Data Provenance:
  • Country of Origin: USA and Israel.
  • Retrospective or Prospective: Not explicitly stated as either retrospective or prospective. However, the description of "data collected from several different Console variants" for training and verification suggests pre-existing data, which often leans towards a retrospective collection.

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

• Number of Experts: Not explicitly stated. The document refers to "annotators" who performed manual annotation.
• Qualifications of Experts: Not explicitly stated. The annotators are described as performing "manual annotation," implying they are skilled in this task, but specific qualifications (e.g., radiologists, sonographers, years of experience) are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The document mentions "annotators performed manual annotation," but does not detail if multiple annotators were used for each case or any specific adjudication process (e.g., 2+1, 3+1 consensus).

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

• Was an MRMC study done? No. The document states: "The subjects of this premarket submission, Venue, Venue Go, Venue Fit and Venue Sprint, did not require clinical studies to support substantial equivalence." The testing described for ABV is a standalone algorithm performance validation against established ground truth, not a comparative human-AI study.
• Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes. The "AI Summary of Testing" section describes a study for the Auto Bladder Volume (ABV) feature, which assesses the algorithm's "automatic caliper placement success rate" against manually established ground truth. This is a standalone performance evaluation of the algorithm.

7. Type of Ground Truth Used (for ABV Test Set)

• Ground Truth Type: Expert consensus/manual annotation. The document states: "Ground truth annotations of the verification dataset were obtained as follows: In all Training/Validation and Verification datasets, annotators performed manual annotation on images converted from DICOM files." They identified "landmarks, which represent the bladder edges," corresponding to standard measurement locations.

8. Sample Size for the Training Set (for ABV)

• Training Set Sample Size: Total dataset included 8,392 images from 496 individuals. Of these, 1,874 were used for the verification dataset, and "the rest" were used for training/validation. This implies the training/validation set would be 8392 - 1874 = 6518 images from the remaining individuals not included in the verification set.

9. How the Ground Truth for the Training Set Was Established (for ABV)

• Ground Truth Establishment: Similar to the verification dataset, "annotators performed manual annotation on images converted from DICOM files" for both Training/Validation and Verification datasets. They chose "4-6 images that represent different bladder volume status" for each individual and annotated "4 different landmarks" per view (transverse and longitudinal) representing bladder edges.

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PIUR tUS inside System is a computer-aided detection device intended to assist and support medical professionals in the diagnostic workflow of thyroid and thyroid nodules acquired from FDA-cleared ultrasound systems, including image documentation, analysis, and reporting. The device supports the physician with additional information during image review, including quantification and visualization of sonographic characteristics of thyroid nodules.

PIUR tUS inside System may be used on any adult patient aged 22 and older, independent of gender, linguistic and cultural background, or health status, unless any of the contraindications apply.

The PIUR tUS inside System acts as part of the diagnostic chain and must not be used as a sole source for treatment decisions, but as an add-on solution to regular 2D ultrasound imaging.

The PIUR tUS inside System is not intended for body contact (including skin, mucosal membrane, breached or compromised surfaces, blood path indirect, tissues, bones, dentin, or circulation blood).

PIUR tUS inside is a medical device which enhances standard ultrasound devices with a three-dimensional (3D) tomographic imaging method for a 3D analysis of ultrasound volumes. With PIUR tUS inside, examining physicians can make diagnostic decisions based on standard 2D as well as 3D image data integrated in an ultrasound device environment. This 3D data provides information which previously could have only been generated using other 3D imaging technologies like CT or MRI.

The PIUR tUS inside runs on a compatible GE Healthcare ultrasound system. The PIUR tUS inside takes as an input a sequence of 2D ultrasound images that are transmitted through a software interface from the ultrasound to the PIUR tUS inside. In addition, the PIUR Sensor must be clipped onto the ultrasound transducer using individually designed PIUR Brackets. For image acquisition, the user moves the 2D ultrasound transducer perpendicular to the structure to be imaged over the region of interest of the patient's body. An inertial measurement unit (IMU), which is built into the PIUR Sensor, tracks the orientation of the transducer during the scan and sends this information to the ultrasound via Bluetooth.

The PIUR tUS inside combines image information and sensor information to generate tomographic 3D ultrasound volumes on which image analysis can be performed. An important property of this method is the unlimited length of the acquired volume. PIUR tUS inside therefore allows recording and analyzing a complete thyroid lobe.

The PIUR tUS inside and the PIUR tUS Infinity Predicate Device share most hardware and software components and algorithms. On the hardware side, both systems use the same PIUR Sensor to track probe movement during a freehand ultrasound acquisition. The data from the PIUR Sensor is transferred wirelessly through a Bluetooth connection to the software where it is being used to generate ultrasound volumes from the freehand sweep. Both systems also share the same volume compounding software algorithms, semi-automatic lobe and nodule segmentation algorithms, and volume calculation algorithms. The performance for image compounding and volume calculations are therefore the same for both systems.

The main difference between the PIUR tUS inside System and the Predicate Device is the interface for image retrieval. While the Predicate Device uses the Infinity Box to transfer digital ultrasound images from a third-party ultrasound system to the software through a Wi-Fi connection, the PIUR tUS inside has direct access to the image stream through a software interface. It runs directly on the compatible ultrasound scanners: GE Healthcare LOGIQ E10 (K231966) and GE Healthcare LOGIQ E10s/Fortis (K231989). This, however, is not performance relevant as the image data remains the same. It only reduces the number of compatible ultrasound systems as a close collaboration with the ultrasound manufacturer is required.

The PIUR tUS inside System acts as part of the diagnostic chain only and must not be used as a sole source for diagnostic or treatment decisions.

The solution is intended to be used on patients aged 22 and older, independent of gender, linguistic and cultural background, or health status, unless any of the contraindications apply, in a non-sterile environment. The solution is not intended to be used on patients with open wounds or irritated skin or during surgery.

The provided FDA 510(k) clearance letter and summary for PIUR tUS inside (K250484) does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study that proves the device meets them.

The document primarily focuses on establishing substantial equivalence to a predicate device (PIUR tUS Infinity, K240036) by demonstrating similar intended use, technological characteristics, and principles of operation, rather than providing a detailed clinical performance study with specific acceptance criteria, sample sizes, expert qualifications, or comparative effectiveness.

However, based on the information available in the document, here's what can be extracted and inferred:

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

The document does not explicitly state acceptance criteria in a quantitative manner as one might find in a clinical study report. Instead, the "Performance Data" section indicates that software performance, verification, and validation testing demonstrated that the PIUR tUS inside System met all design requirements and specifications.

It also states that the device was tested for electrical safety, EMC, and a white-noise test was conducted to verify that the wireless equipment does not induce additional white noise or degrade ultrasound image quality. These are performance aspects, but not specific clinical or diagnostic accuracy acceptance metrics.

2. Sample size used for the test set and the data provenance:

The document mentions "performance validation testing" and "software verification and validation testing," but it does not specify the sample size used for these tests. It also does not provide details on the data provenance (e.g., country of origin, retrospective or prospective nature) for any datasets used in these tests. The only clue is that the device assists in diagnosing thyroid and thyroid nodules acquired from FDA-cleared ultrasound systems.

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):

The document states under "Ground Truth Establishment" in the Substantial Equivalence Comparison Table:
"The ground truth to be established for performance studies of the device are annotated data sets labeled by medical specialists."

However, it does not specify the number of experts used, their qualifications (e.g., specific specialties, years of experience), or their accreditation.

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

The document does not describe any adjudication method used for establishing the ground truth for the test set.

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:

The document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. The device is described as a "computer-aided detection device intended to assist and support medical professionals" and an "add-on solution to regular 2D ultrasound imaging," implying a human-in-the-loop scenario. However, no study demonstrating the improvement of human readers with AI assistance is detailed.

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

The document states under "Performance Testing Data to Support SE Determination" in the Substantial Equivalence Comparison Table:
"Results from standalone performance testing of machine learning algorithm suggested ROIs of user-selected nodules."

This indicates that some form of standalone performance testing was conducted specifically for the segmentation ("suggested ROIs") of user-selected nodules. However, the details of this standalone performance (e.g., accuracy metrics, specific results) are not provided in this summary.

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

As mentioned above, the ground truth for performance studies is described as "annotated data sets labeled by medical specialists." This suggests an expert consensus or expert labeling approach, rather than pathology or outcomes data specifically.

8. The sample size for the training set:

The document does not specify the sample size used for the training set of the machine learning algorithms.

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

Similar to the test set, the document states generally: "The ground truth to be established for performance studies of the device are annotated data sets labeled by medical specialists." This implies the training set ground truth would also be established through expert labeling, but no further details are provided.

Summary of what is present vs. what is missing:

The provided 510(k) summary focuses heavily on demonstrating substantial equivalence through shared technological characteristics and general compliance with standards. It explicitly states that the device met "all design requirements and specifications" but lacks specific quantitative performance metrics (e.g., sensitivity, specificity, F1-score) or detailed clinical study results often found in AI/CAD device submissions. The information regarding ground truth establishment, sample sizes for training and testing, expert qualifications, and specific study designs (like MRMC or detailed standalone performance) is either very limited or entirely absent from this summary.

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