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The intended use of EPIQ Ultrasound Diagnostic Series is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:

Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.

Modes of operation include: B Mode(3D/4D), M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler and Harmonic Imaging.

The clinical environments where EPIQ Series Diagnostic ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.

The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

The intended use of Affiniti Series Diagnostic Ultrasound System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:

Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.

Modes of operation include: B Mode (3D/4D), M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler and Harmonic Imaging.

The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information.

Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the addition of the Artificial Intelligence (AI) Auto Measure Abdomen feature software application onto the EPIQ Series Diagnostic Ultrasound Systems and Affiniti Series Diagnostic Ultrasound Systems.

The Auto Measure Abdomen feature on Philips EPIQ and Affiniti Series Diagnostic Ultrasound System aims to improve workflow efficiency by automating selected measurements required for routine abdominal and renal exams. The Auto Measure feature is designed to provide semi-automated and editable measures of abdominal organs such as kidney and spleen. The software provides a semi‑automated measurement capability. Users may adjust the position of the caliper end points for measurement refinement or perform additional manual measurements. The Auto Measure Abdomen feature is available in C5-1 and C9-2 transducers only.

The software applications are supported by all EPIQ and Affiniti models running software version 14.0 or higher.

Here's a breakdown of the acceptance criteria and the study details for the Auto Measure Abdomen feature, based on the provided FDA 510(k) clearance letter (K253595):

1. Table of Acceptance Criteria and Reported Device Performance

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

• Number of subjects: 150 subjects (i.e., 150 ultrasound exams).
• Number of images (samples):
  • 292 images for kidney longitudinal view (for kidney length measurement).
  • 271 images for kidney transverse view (for kidney width and height measurement).
  • 145 images for spleen sagittal view (for spleen length measurement).
• Data Provenance: Images were collected from adults (≥18 years) enrolled at three clinical sites. The data included both patients referred for abdominal or renal ultrasound and healthy volunteers. The letter does not explicitly state the country of origin, but "three clinical sites" implies a multi-site collection, likely within the US, given the FDA context. The data appears to be previously collected ("ultrasound images previously collected"). It's a retrospective study for the AI evaluation, using prospectively collected patient data.

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

• Number of experts: 3 clinical experts.
• Qualifications of experts: All three experts are registered clinical sonographers with ten or more years of experience in general imaging and abdominal imaging, and each holds active certification by the American Registry for Diagnostic Medical Sonography (ARDMS).

4. Adjudication Method for the Test Set

• Method: The three clinical experts independently carried out manual measurements. The average values obtained from their measurements served as the ground truth. This is a form of expert consensus (averaging), without a specific 2+1 or 3+1 rule mentioned beyond averaging the three independent measurements. The experts also reviewed the AI algorithm-generated measurements to either accept or edit them, implying an expert-in-the-loop validation process for the AI output against their manual measurements.

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

• No, a formal MRMC comparative effectiveness study comparing human readers with and without AI assistance to measure a specific improvement effect size was not explicitly described in this document. The study focused on comparing the AI's measurements directly against expert ground truth. While experts were involved in generating ground truth and reviewing AI output, the study's primary endpoint was the concordance between AI measurements and expert measurements, not the increase in human reader performance with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, the primary evaluation was a standalone performance test of the AI algorithm. The study evaluated the "AI algorithm performance" by comparing its "algorithm-generated measurements" to the expert-derived ground truth. Although experts could edit the AI measurements, the core evaluation reported in the tables (AI Auto Measure (cm) Mean ± SD (Min, Max)) represents the algorithm's raw output before any human modification.

7. The Type of Ground Truth Used

• Type: Expert consensus (average values of measurements from three experienced clinical sonographers).

8. The Sample Size for the Training Set

• The document states, "The datasets used in the validation study and for regulatory clearance were distinct from those employed during algorithm training." However, the exact sample size for the training set is not provided in this document.

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

• The document states, "The datasets used in the validation study and for regulatory clearance were distinct from those employed during algorithm training." However, the method for establishing ground truth for the training set is not provided in this document. It only confirms independence from the validation set's ground truth.

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EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System and transducers are designed to obtain ultrasound images and analyze body fluids.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Dermatology, Trans-esophageal (Cardiac) and Peripheral vessel.

It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals (including emergency rooms), private practices, clinics and similar care environment for clinical diagnosis of patients.

Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, MV-Flow mode, Multi-Image mode(Dual, Quad), 3D/4D mode.

EVO Q30, EVO Q20, EVO Q10, EVO XQ30, EVO XQ20, EVO XQ10, EVO QH30, EVO QH20, EVO QH10 Diagnostic Ultrasound System are general purpose, portable (without cart)/mobile (with cart), software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, MV-Flow mode, Multi-Image mode(Dual, Quad), 3D/4D mode.

EVO Q30, EVO Q20, EVO Q10, EVO XQ30, EVO XQ20, EVO XQ10, EVO QH30, EVO QH20, EVO QH10 Diagnostic Ultrasound System also give the operator the ability to measure anatomical structures and offer analysis packages that provide information that is used to make a diagnosis by competent health care professionals.

EVO Q30, EVO Q20, EVO Q10, EVO XQ30, EVO XQ20, EVO XQ10, EVO QH30, EVO QH20, EVO QH10 Diagnostic Ultrasound System have a real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

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The Butterfly Gestational Age Tool is indicated to provide an output of gestational age (GA) of a singleton intrauterine pregnancy presumed to be between 16-37 weeks gestation. It is for use by qualified and trained healthcare professionals in environments where healthcare is provided. This adjunctive information is not intended to be used for prenatal management and/or delivery planning. The Butterfly Gestational Age Tool is to be used with Butterfly's ultrasound systems (iQ+ or iQ3).

The Butterfly Gestational Age Tool (GA Tool) is a software application that guides trained healthcare professionals through measuring fundal height and obtaining ultrasound cines of a patient's gravid abdomen, using a Butterfly ultrasound probe (iQ+ or iQ3) connected to a tablet. Users launch the tool as a calculation tool within the iQ App's OB scan presets (OB 1/GYN or OB 2/3). Users first measure the fundal height in centimeters, which determines the number of ultrasound videos or "sweeps" needed. These sweeps are short cines captured by moving the probe across the abdomen in specific orientations without relying on the live B-mode. The system presents users with animations for each sweep to communicate the intended path and probe orientation, rather than relying on a live B-mode scan.

The collected sweeps are input into a deep-learning model within the GA Tool. The model then outputs an estimated gestational age. Users can delete the measurement or add additional documentation like patient details or notes. When performing the sweeps, the ultrasound probe makes direct contact with the patient's skin using a coupling medium such as an ultrasound gel.

Once complete, users have the options to delete the measurement or add additional documentation before uploading the results securely to Butterfly's cloud for storage and access by medical professionals. The GA Tool aims to standardize and simplify the process of estimating gestational age using ultrasound technology.

The subject device contains the exact same hardware technology as the previously cleared subject device and no accessories are required to use the GA Tool. The GA Tool is compatible with both the Butterfly iQ3 (primary predicate) and Butterfly iQ/iQ+ Ultrasound Systems. The only change is the new GA Tool, which does not alter the intended use of the device, nor does it affect the safety and effectiveness of the device relative to the predicate.

Here's a breakdown of the acceptance criteria and study details based on the provided FDA 510(k) clearance letter for the Butterfly Gestational Age Tool:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria itself (e.g., "+/- 10 days") is explicitly mentioned in the document as "pre-defined established clinical acceptable error of ultrasound measured gestational age." The reported results (LOA) for both iQ+ and iQ3 fall within these acceptable errors.

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

• Sample Size for Clinical Performance Evaluation (Test Set): 111 unique subjects (110 for iQ+ data analysis due to one exclusion).
• Data Provenance:
  • Country of Origin: United States.
  • Locations: 4 sites within the USA: Butterfly offices in Burlington, MA; Thomas Jefferson University in Philadelphia, PA; Remedy Direct Primary Care in Flagstaff, AZ; and Butterfly offices in NYC, NY.
  • Retrospective/Prospective: Prospective study, conducted between March 2025 to February 2026. This dataset was stated to be "totally independent from that of the Butterfly GA tool development."

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

• Number of Healthcare Practitioners for Data Collection: 13 trained healthcare practitioners.
  • 7 Physicians
  • 6 Sonographers
• Ground Truth Establishment for Clinical Performance Evaluation:
  • Biometry was performed by the 6 sonographers.
  • Gestational Age from the subject reported Last Menstrual Period (LMP) was recorded.
  • The primary ground truth for evaluating the device was the Gestational Age calculation from Last Menstrual Period (LMP). Biometry was also performed by sonographers and used for comparison.

4. Adjudication method for the test set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for establishing the ground truth from LMP or biometry for the clinical performance test set. The LMP was "subject reported," and biometry was "performed by the 6 sonographers." It implies that LMP was taken as reported, and sonographer biometry measurements were used directly for comparison.

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

• A formal MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance is not explicitly reported in this document.
• The clinical performance study compares the device's standalone performance (Butterfly GA Tool) against LMP and against biometry performed by sonographers. It also compares biometry against LMP. It does not evaluate how human performance changes when using the AI tool as an assistant.

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

• Yes, a standalone performance evaluation was done. The clinical performance evaluation directly assessed the "Butterfly GA Tool error in reference to the Gestational Age calculation from Last Menstrual Period (LMP)" and also compared the Butterfly GA Tool against biometry measurements. The device is described as "outputting an estimated gestational age" from collected sweeps, indicating a standalone algorithmic output.

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

• For the Clinical Performance Evaluation (Test Set):

  • Primary Ground Truth: Gestational Age calculation from Last Menstrual Period (LMP).
  • Secondary Reference: Biometry performed by sonographers.

• For the Training Set:

  • Previously established gestational age, against which the model's performance was assessed.
  • Standard fetal biometry performed by sonographers from the gathered cine loops.

8. The sample size for the training set

• Training Set Sample Size: Over 100,000 cine loops comprising millions of image frames from thousands of patients.

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

• The training data (cine loops) were obtained by POCUS users.
• Ground Truth for Training: This data was accompanied by "standard fetal biometry performed by sonographers" and assessed "against previously established gestational age" (likely from LMP or other clinical methods) as described in the FAMLI protocol. The model aimed to "estimate gestational age from the sweeps" based on this ground truth.

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The LOGIQ Vita / S20 Series are intended for use by a qualified physician for ultrasound evaluation of Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo- skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).

Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.

The LOGIQ Vita / S20 Series are intended to be used in a hospital or medical clinic.

The LOGIQ Vita / S20 Series are full featured, Track 3, general purpose diagnostic ultrasound systems which consists of a mobile console approximately 530 mm wide (Caster), 835 mm deep (front and back handle) and 1314 mm high that provides digital acquisition, processing and display capability. The user interface includes a digital keyboard (physical keyboard as an option), specialized controls, 14-inch high-resolution color touch screen and 23.8-inch Wide screen High-Resolution HDU monitor and 23.8-inch Wide screen High-Resolution LCD monitor.

The provided FDA 510(k) clearance letter and summary do not contain detailed information about specific acceptance criteria, reported device performance metrics, or a study specifically designed to prove that the device meets those criteria.

The submission is for a new diagnostic ultrasound system (LOGIQ Vita / S20 Series) that leverages the design and clinical data of a predicate device (LOGIQ Fortis K253366). The core argument for substantial equivalence is that the new device has "no changes to the features, accessories, or components that require new clinical studies to support substantial equivalence."

This means that the provided document does not describe a new study that proves the device meets acceptance criteria in the way you've requested. Instead, it asserts that because the new device is substantially equivalent to a previously cleared device, the existing evidence for the predicate device's safety and effectiveness applies.

However, based on the information provided, we can infer some details:

1. Table of acceptance criteria and reported device performance:

The document explicitly states: "The subject of this premarket submission, the LOGIQ Vita / S20 Series, leverages the same clinical data as the predicate and no changes to the features, accessories, or components that require new clinical studies to support substantial equivalence."

This implies that the acceptance criteria and reported device performance are identical to those established for the predicate device, LOGIQ Fortis (K253366). Since the details of that predicate device's performance study are not included in this document, we cannot populate this table with specific quantitative metrics.

Regarding the study proving the device meets acceptance criteria:

The document explicitly states: "The subject of this premarket submission, the LOGIQ Vita / S20 Series, leverages the same clinical data as the predicate and no changes to the features, accessories, or components that require new clinical studies to support substantial equivalence."

This means there was no new, independent clinical study conducted for the LOGIQ Vita / S20 Series to demonstrate it meets acceptance criteria beyond what was established for the predicate device (LOGIQ Fortis K253366). The substantial equivalence argument relies on the fact that the changes are minor and do not impact the core safety and effectiveness established by the predicate.

Given this, the subsequent questions, which would typically describe such a study, cannot be answered directly from the provided text for the LOGIQ Vita / S20 Series. If such information exists, it would be found in the 510(k) submission for the LOGIQ Fortis (K253366) predicate device.

Based on the provided document, here's what we can state:

• 2. Sample size used for the test set and the data provenance: Not applicable for a new study. The device "leverages the same clinical data as the predicate," meaning no new test set was used for this 510(k).
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a new study.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for a new study.
• 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 mentions "AI algorithms" in the context of UGAP/UGFF features being identical to the predicate, but it does not describe an MRMC comparative effectiveness study to measure human reader improvement.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The document states that the liver assessment features (UGAP/UGFF) utilize AI algorithms, and these are identical to the predicate device. However, it does not describe a standalone performance study specifically for the AI components in this submission. The assertion is that these features have not changed since the predicate.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a new study.
• 8. The sample size for the training set: Not applicable for a new study.
• 9. How the ground truth for the training set was established: Not applicable for a new study.

In conclusion, the clearance for the LOGIQ Vita / S20 Series is based on its substantial equivalence to the predicate LOGIQ Fortis (K253366), rather than a new, dedicated study demonstrating its performance against new acceptance criteria. The performance and safety data are derived from the predicate device.

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The Sonosite iLOOK Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:

• Pediatric
• Peripheral vessel
• Needle Guidance

Modes of operation include: B Mode (B), Color Power Doppler, Color Velocity Doppler, Multi-beam imaging, and combined modes, including duplex imaging: B+C.

This device is indicated for Prescription Use Only.

The Sonosite iLOOK system is intended to be used in medical practices, clinical environments, including healthcare facilities, hospitals, clinics, and clinical point-of-care for diagnosis of patients. The system includes a transducer and a display connected together wirelessly. The transducer is powered by battery, while the display is powered either by battery or by AC electrical power. The clinician is positioned next to the patient and places the transducer onto the patient's body where needed to obtain the desired ultrasound image.

The Sonosite iLOOK Ultrasound System is a fully featured, general-purpose, software-controlled diagnostic ultrasound system utilizing an all-digital architecture. The system is a portable ultrasound device consisting of a display, adjustment handle, wireless L15-5 linear ultrasound transducer, and a transducer holder with a built-in wireless charger.

The system is designed to acquire and display high-resolution, real-time ultrasound data in 2D, Color Power Doppler (CPD), Color Velocity Doppler (CVD), or a combination of these modes. It provides measurement capabilities for anatomical structures and pediatric biometry, offering information for clinical diagnostic purposes.

The system includes a variety of accessories, including an optional stand. Additionally, it features Digital Imaging and Communications in Medicine (DICOM) capabilities, along with general computer communication functionalities, including wireless networking. These capabilities enable the acceptance, transfer, display, storage, and digital processing of ultrasound images and loops.

The system features a single USB port, allowing the use of compatible storage devices, such as memory sticks and hard drives. An AC adapter is included in the stand module, enabling manual connection to AC power.

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The QT Scanner 2000 Model A is for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient's breast. The QT Scanner 2000 Model A software also calculates the breast fibroglandular tissue volume (FGV) value and the ratio of FGV to total breast volume (TBV) value as determined from reflection-mode and transmission-mode ultrasound images of a patient's breast. The device is not intended to be used as a replacement for screening mammography.

The QT Scanner 2000 Model A is indicated for use by trained healthcare professionals in environments where healthcare is provided to enable breast imaging in adult patients.

The subject QT Scanner 2000 Model A ("QT Scanner") is an automated, software-controlled ultrasound imaging system which performs a standardized scan of the whole breast without the use of ionizing radiation, compression, or contrast injection; and generates both reflection-mode and transmission-mode breast images. The QT Scanner consists of a Patient Scanning System, an Operator Console, an optional offboard image processor, and the QTviewer software.

The Patient Scanning System contains the necessary electronics which perform acquisition and initial processing of the breast images and further provides a support table which allows the patient to rest comfortably while the scanning takes place. The scan tank is centered below a patient's breast and contains the ultrasound transducer arrays. The transducer arrays include a set of three reflection transducers that transmit pulsed ultrasound waves into targeted tissues using the water bath in the scan tank as a coupling medium. An additional transmitter and receiver array pair collect the ultrasound energy to generate images that provide speed of sound values.

During scanning, a patient lies prone on the examination table with the breast suspended in a warm water bath maintained near skin temperature. Images are automatically acquired on a pendant breast positioned with the nipple as a point of reference. The transducer arrays rotate about a vertical axis to circle the breast in the coronal plane. The array is then translated vertically, and the scanning process is repeated until the entire breast is scanned, allowing B-scan images to be constructively combined into tomographic, speed of sound and reflection ultrasound images.

The QT Scanner outputs the images to a server which allows the images to be stored until they are reviewed on a Viewer Console running the QTviewer™ software. Alternatively, raw data files can be output to a server and remotely constructively combined into tomographic, speed of sound and reflection ultrasound images. Coronal, axial and sagittal images are generated for review by the radiologist. The QTviewer software also provides a number of analytics capabilities, such as biometric measurement, manual segmentation, and Region of Interest calculations. The QTviewer software also provides the "Fibroglandular Volume" (FGV) which is display of calculated fibroglandular tissue volume within a breast, expressed in dimensions of volume, as well as a ratio of the volume of fibroglandular tissue within the breast volume to the total breast volume, from QT Scanner breast images.

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This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), GYN/Pelvic, urology, adult and pediatric cardiac, and peripheral vessel exams.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Power Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape View, Color M, TDI, V Flow, Smart 3D, 4D(Real-time 3D), Strain Elastography, STE, STQ, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver), Contrast imaging (Contrast agent for Pediatric application in Cardiac, Liver and Urinary Tract).

The Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD, Color Doppler, Power Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape View, Color M, TDI, V Flow, Smart 3D, 4D(Real-time 3D), Strain Elastography, STE, STQ, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver), Contrast imaging (Contrast agent for Pediatric application in Cardiac, Liver and Urinary Tract).

The Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

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The Diagnostic Ultrasound System Aplio beyond Model CUS-ABE00, Aplio me Model CUS-AME00 are indicated for the visualization of structures, and dynamic processes within the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs (thyroid, breast and testicle), trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and thoracic/pleural.

This system provides high-quality ultrasound images in the following modes: B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler, Power Doppler and Combination Doppler, as well as Speckle-tracking, Tissue Harmonic Imaging, Combined Modes, Shear wave, Elastography, and Acoustic attenuation mapping.

This system is suitable for use in hospital and clinical settings by physicians or appropriately trained healthcare professionals.

The Aplio beyond, Model CUS-ABE00 and Aplio me, Model CUS-AME00, V2.0 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex, and sector array with frequency ranges between approximately 2MHz to 20MHz.

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LOGIQ Totus is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal(including Renal, Gynecology/Pelvic), Pediatric; Small organ(Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac(Adult and Pediatric), Peripheral Vascular, Musculo-skeletal Conventional and Superficial; Urology(including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative(Abdominal and Vascular).

Modes of operation includes: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.

The LOGIQ Totus is intended to be used in a hospital or medical clinic.

The LOGIQ Totus is full featured, Track 3 device, primarily intended for general purpose diagnostic ultrasound system which consists of a mobile console approximately 490mm wide (monitor width: 545mm), 835mm deep and 1415~1815mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 14-inch LCD touch screen and color 23.8-inch LCD & HDU image display.

The provided FDA 510(k) clearance letter and summary for the LOGIQ Totus Ultrasound System (K253370) describes the acceptance criteria and the study for the Ultrasound Guided Fat Fraction for adult imaging (UGFF) software feature. This feature is being added to the LOGIQ Totus and is similar to a previously cleared Siemens UDFF feature.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the performance of the UGFF feature by comparing it to MRI Proton Density Fat Fraction (MRI-PDFF) and, in a separate confirmatory study, to a predicate UDFF device. The "acceptance criteria" are implied by the reported strong correlations and limits of agreement with these reference standards.

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

• Primary Study (UGFF vs. MRI-PDFF):

  • Sample Size: 582 participants
  • Data Provenance: External clinical study in Japan (Population: Asian). The study was retrospective or prospective is not specified, but the phrase "obtained from the liver of five hundred and eighty-two (582) participants" suggests a data collection event rather than a purely retrospective analysis of existing medical records. The study is described as an "external clinical study," further suggesting a dedicated data collection.

• First Confirmatory Study (UGFF vs. MRI-PDFF):

  • Sample Size: 15 US patients and 5 EU patients (total 20 patients)
  • Data Provenance: US and EU patients. Demographic information on the 5 EU patients was unavailable. This was conducted as a "confirmatory study."

• Second Confirmatory Study (UGFF vs. UDFF):

  • Sample Size: 24 EU patients
  • Data Provenance: EU patients. This was conducted as a "confirmatory study."

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

The document does not specify the number of experts or their qualifications for establishing the ground truth.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. For the UGFF feature, the "ground truth" was objective measurements (MRI-PDFF or a predicate device's UDFF), which typically do not require adjudication by human experts in the same way an image diagnosis might.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done for the UGFF feature as described. The studies focused on comparing the device's output (UGFF index) to an objective reference standard (MRI-PDFF or another device's UDFF), not on how human readers' performance improved with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was done. The UGFF index, based on acoustic property measurements, is compared directly to MRI-PDFF and UDFF. This indicates the algorithm's performance independent of human interpretation or intervention in the final measurement calculation. While a technologist operates the ultrasound system, the UGFF index calculation itself is an algorithmic output.

7. The Type of Ground Truth Used

The type of ground truth used is MRI Proton Density Fat Fraction (MRI-PDFF) measurements, which are quantitative and objective reference standards for liver fat quantification. Additionally, for one confirmatory study, the ground truth was the Ultrasound-Derived Fat Fraction (UDFF) from a Siemens Acuson S3000/S2000, functioning as a predicate device's output. These are akin to "outcomes data" or "established reference standard measurements."

8. The Sample Size for the Training Set

The document states: "During the migration of the AI software feature from LOGIQ E10s (K231989), the algorithm was not retrained and there were no changes to the algorithmic flow or the AI components performing the inferencing." This implies the training set was associated with the original clearance of the Auto Renal Measure Assistant on the LOGIQ E10s (K231989) but the sample size for the training set is not provided in this document.

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

Similarly, since the algorithm was not retrained and the document pertains to the migration of an existing AI feature, the method for establishing the ground truth for the original training set is not provided in this document.

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LOGIQ Fortis is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).

Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.

The LOGIQ Fortis is intended to be used in a hospital or medical clinic.

The LOGIQ Fortis is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 575 mm wide (keyboard), 925 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a digital keyboard (physical keyboard as an option), specialized controls, 12-inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor (or 23.8-inch High Resolution LED LCD monitor as an option).

Here's a breakdown of the acceptance criteria and study details for the AI features of the LOGIQ Fortis Ultrasound System, based on the provided FDA 510(k) clearance letter:

AI Features Analyzed:

1. Auto Abdominal Color Assistant 2.0
2. Auto Aorta Measure Assistant
3. Auto Common Bile Duct (CBD) Measure Assistant
4. Ultrasound Guided Fat Fraction (UGFF)

1. Auto Abdominal Color Assistant 2.0

1.1. Acceptance Criteria and Reported Device Performance:

1.2. Sample Size and Data Provenance (Test Set):

• Number of individual subjects: 49
• Number of annotation images: 1186
• Country: USA (100%)
• Retrospective/Prospective: Not explicitly stated, but the description "Before the process of data annotation, all information displayed on the device is removed and performed on information extracted purely from Ultrasound B-mode images" and "Readers to ground truth the 'anatomy' visible in static B-Mode image" suggests retrospective analysis of collected images.

1.3. Number and Qualifications of Experts for Ground Truth (Test Set):

• Number of Experts: Not specified ("Readers to ground truth the 'anatomy'").
• Qualifications: Not specified (generally, these would be qualified ultrasonographers or radiologists).

1.4. Adjudication Method (Test Set): Not specified.

1.5. MRMC Comparative Effectiveness Study: No, this study evaluates the standalone performance of the AI model.

1.6. Standalone Performance: Yes, this study was done to evaluate the algorithm's performance in detecting abdominal structures.

1.7. Type of Ground Truth Used: Expert consensus on "anatomy" visible in static B-Mode images.

1.8. Sample Size for Training Set: Not explicitly stated, but implied to be separate from the test set.

1.9. How Ground Truth for Training Set Was Established: Not explicitly stated, but implied to be similar to the test set, with experts annotating B-mode images.

2. Auto Aorta Measure Assistant

2.1. Acceptance Criteria and Reported Device Performance:

2.2. Sample Size and Data Provenance (Test Set):

• Long View Aorta:
  • Subjects: 36 (11 Male, 25 Female)
  • Country: 16 Japan, 20 USA
• Short View Aorta:
  • Subjects: 35 (11 Male, 24 Female)
  • Country: 15 Japan, 20 USA
• Retrospective/Prospective: Not explicitly stated, but "Validation images were collected on LOGIQ Fortis" and the truthing process suggests retrospective analysis of collected images.

2.3. Number and Qualifications of Experts for Ground Truth (Test Set):

• Number of Experts: Not specified ("Readers to ground truth...").
• Qualifications: Not specified.

2.4. Adjudication Method (Test Set): An "arbitrator to select most accurate measurement among all readers" was used. This suggests a form of adjudication, possibly 2+1 or similar, where the arbitrator acts as the tie-breaker/final decision-maker.

2.5. MRMC Comparative Effectiveness Study: Yes, this study directly compares human performance with and without AI assistance by measuring keystrokes and accuracy.

• Effect Size (Keystrokes):
  • Long View Aorta: Reduction of ~2.896 keystrokes (4.132 - 1.236)
  • Short View Aorta: Reduction of ~4.743 keystrokes (7.05 - 2.307)
    (While not a traditional effect size like AUC improvement, this quantifies human workflow improvement).

2.6. Standalone Performance: Partially. The accuracy measurements compare AI baseline against an arbitrator's selected measurement, indicating standalone algorithm accuracy, but the primary focus is on human-in-the-loop efficiency.

2.7. Type of Ground Truth Used: Expert consensus on measurements, with an arbitrator for final selection.

2.8. Sample Size for Training Set: Not explicitly stated, but independence from the test set is ensured by "exam site origin."

2.9. How Ground Truth for Training Set Was Established: Not explicitly stated, but implied to be similar to the test set, with experts performing measurements.

3. Auto Common Bile Duct (CBD) Measure Assistant

3.1. Acceptance Criteria and Reported Device Performance:

3.2. Sample Size and Data Provenance (Test Set):

• Subjects: 25 (11 Male, 14 Female)
• Countries: USA (40%), Japan (60%)
• Retrospective/Prospective: Not explicitly stated, but "Validation images were collected on LOGIQ Fortis" and the truthing process suggests retrospective analysis of collected images.

3.3. Number and Qualifications of Experts for Ground Truth (Test Set):

• Number of Experts: Not specified ("Readers to ground truth...").
• Qualifications: Not specified.

3.4. Adjudication Method (Test Set): An "arbitrator to select most accurate measurement among all readers" was used.

3.5. MRMC Comparative Effectiveness Study: Yes, this study directly compares human performance with and without AI assistance by measuring keystrokes and accuracy (specifically, accuracy with and without segmentation scroll edit, which implies human interaction with AI).

• Effect Size (Keystrokes): Average reduction of 1.62 keystrokes.

3.6. Standalone Performance: Partially. The measurement accuracy with and without segmentation scroll edit provides insight into the algorithm's performance and the benefit of human refinement, but the primary focus is on human-in-the-loop efficiency and accuracy.

3.7. Type of Ground Truth Used: Expert consensus on measurements, with an arbitrator for final selection.

3.8. Sample Size for Training Set: Not explicitly stated, but independence from the test set is ensured by "exam site origin."

3.9. How Ground Truth for Training Set Was Established: Not explicitly stated, but implied to be similar to the test set, with experts performing measurements.

4. Ultrasound Guided Fat Fraction (UGFF)

4.1. Acceptance Criteria and Reported Device Performance:

4.2. Sample Size and Data Provenance (Test Set): This section describes the clinical studies used for validation of the UGFF index, rather than a traditional AI test set.

• Primary Study (Development/Validation of UGFF Index):

  • Subjects: 582 participants
  • Country: Japan
  • Retrospective/Prospective: "external clinical study in Japan" implies prospective data collection, with subsequent analysis.

• Second Confirmatory Study:

  • Subjects: 15 US patients, 5 EU patients (Total 20)
  • Country: US and EU
  • Retrospective/Prospective: Not specified.

• Third Confirmatory Study (Comparison with Predicate):

  • Subjects: 24 EU patients
  • Country: EU
  • Retrospective/Prospective: Not specified.

4.3. Number and Qualifications of Experts for Ground Truth (Test Set):

• UGFF Study: The ground truth is established by a reference imaging modality (MRI-PDFF) and a comparison device (UDFF), not directly by human experts interpreting ultrasound images for the purpose of the study. The study involves acoustic property measurements.

4.4. Adjudication Method (Test Set): Not applicable, as the ground truth is based on MRI-PDFF and UDFF, not human interpretation requiring adjudication.

4.5. MRMC Comparative Effectiveness Study: No, this is a clinical validation against a reference standard and a comparative study against a predicate device.

4.6. Standalone Performance: Yes, the UGFF index is an algorithm-generated value based on acoustic properties, and its performance is evaluated in a standalone manner against established reference methods (MRI-PDFF) and a legally marketed predicate (UDFF).

4.7. Type of Ground Truth Used: Quantitative measurements from a reference imaging modality (MRI Proton Density Fat Fraction - MRI-PDFF %) and a comparative device (Ultrasound-Derived Fat Fraction (UDFF, Siemens)).

4.8. Sample Size for Training Set: The UGFF index is based on a least squares fit (estimation) between acoustic property measurements and MRI-PDFF measurements from the primary 582-subject study. This study effectively serves as the "training" dataset for establishing the correlation and the estimation model.

4.9. How Ground Truth for Training Set Was Established: MRI-PDFF measurements were obtained from the liver of these 582 participants.

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