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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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Sonio Detect is intended to analyze fetal ultrasound images and clips using machine learning techniques to automatically detect views, detect anatomical structures within the views and verify quality criteria and characteristics of the views.

The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images.

Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN MFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCP in the following) to perform their routine fetal ultrasound examinations in real-time. Sonio Detect can be used by Healthcare Professionals HCPs during fetal ultrasound exams for Trimester 1, Trimester 2 and Trimester 3 of the fetus (GA: from 11 weeks to 41 weeks). The software is intended to assist HCPs in assuring during and after their examination that the examination is complete and all images were collected according to their protocol.

Sonio Detect requires the following:

• Edge Software (described below) to install on a server on the same network as the Ultrasound Machine;
• SaaS accessibility from any internet browser (recommended browser: Google Chrome).

Sonio's Edge Software is a light-weight application that runs on a server (computer) connected to the same network as the Ultrasound Machine. Sonio Edge Software is installed on the HCP server (computer) and network and the main purpose is to receive DICOM instances from the Ultrasound Machine and upload them to Sonio's Cloud to be used by Sonio Detect.

Sonio Detect receives fetal ultrasound images and clips from the ultrasound machine, that are submitted through the edge software by the performing healthcare professional, in real-time and performs the following:

• Automatically detect views;
• Automatically detect anatomical structures within the supported views;
• Automatically verify quality criteria and characteristics of the supported views by checking whether they conform to standardized quality criteria
• Automatically output bounding box for views and structures

Quality criteria are related to:

• The presence of an anatomical structure;
• The absence of an anatomical structure;

Characteristics are related to other items than quality criteria:

• Location of the placenta
• Fetus sex

Sonio Detect then automatically associates the image to its detected view. It also highlights in yellow the view and/or the corresponding quality criteria or characteristics if there are unverified items: quality criteria or characteristics not verified or view not detected.

The end user can interact with the software to override the Sonio Detect's outputs (reassign the image to another view or unassign it or assign it if it was not assigned, changes the status of a quality criteria from verified to unverified or from unverified to verified) and manually set the characteristics of the views. The user has the ability to review and edit/override the matching at any time during or at the end of the exam.

The list of views, anatomical structures, quality criteria and characteristics that can be automatically detected and verified by the software are detailed in tables 1, 2, 3 and 4 below.

Here's a breakdown of the acceptance criteria and the study that proves Sonio Detect (v3) meets them, based on the provided FDA 510(k) clearance letter:

Sonio Detect (v3) - Acceptance Criteria and Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter does not explicitly state pre-defined acceptance criteria for each metric (e.g., "Sensitivity must be > X"). Instead, it presents the reported performance values from a standalone bench study. The "acceptance" is implied by the FDA's substantial equivalence determination based on these reported results.

However, to create a table highlighting what was reported as acceptable performance, we can extract the sensitivity and specificity values for various detection tasks, and mIoU for localization tasks.

2. Sample Size and Data Provenance for the Test Set

• Sample Size (Test Set): 22,496 fetal ultrasound images.
• Data Provenance (Test Set):
  • Country of Origin: Not explicitly stated in the provided document.
  • Retrospective or Prospective: Not explicitly stated in the provided document.
  • Independence: The dataset was "independent of the data used during model development (training/fine tuning/internal validation) and establishment of device operating points."
  • Subgroup Validation: Performance was also validated for subgroups including: Ultrasound machine manufacturer (GE, Canon, Philips, Samsung were specified as supported manufacturers), BMI, maternal age, confounding cases, Image quality, geography, gestational age and race/ethnicity (when appropriate).

3. Number of Experts and Qualifications for Test Set Ground Truth

The document does not explicitly state the number of experts used to establish the ground truth for the test set, nor their specific qualifications (e.g., "radiologist with 10 years of experience"). It mentions "ground truth" and "independent of the data used during model development," implying expert labeling, but the details are missing from this executive summary.

4. Adjudication Method for the Test Set

The adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the test set is not explicitly stated in the provided document.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical Study: Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device." This means there is no information on how human readers improve with AI vs. without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was done. The document states: "Sonio conducted a standalone performance testing on a dataset of 22496 fetal ultrasound images." The results presented in Table 6 are all for the algorithm's standalone performance (sensitivity, specificity for detection tasks, and mIoU for localization tasks).

7. Type of Ground Truth Used

The specific type of ground truth (e.g., expert consensus, pathology, outcomes data) for the test set is not explicitly detailed. However, given the nature of fetal ultrasound image analysis and the listed performance metrics (sensitivity, specificity, mIoU), it is highly probable that the ground truth was established by expert consensus or individual expert annotations on the images, which were then compared against the device's output. The document itself doesn't provide this specific detail.

8. Sample Size for the Training Set

The sample size for the training set is not explicitly stated in the provided document. The document refers to "data used during model development (training/fine tuning/internal validation)," but does not provide the specific numbers of images or cases.

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

The method for establishing the ground truth for the training set is not explicitly stated in the provided document. Similar to the test set, it is inferred to be through expert annotation, but no details regarding the number or qualifications of experts or the adjudication process are given.

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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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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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ROSA Knee System with USIP for use with ROSA RECON platform, is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. The robotic arm placement is performed relative to the position and orientation of the femur and tibia as tracked by the ultrasound and optical systems. It is also based on the surgical plan specified by the surgeon intra-operatively on the robot user interface. To be able to perform this tracking, a virtual 3D bone model of the patient's femur and tibia are generated pre-operatively from a CT-scan of their leg.

The ROSA Knee System with USIP is designed for use on skeletally mature patient population. It includes an ultrasound imaging system, a robotic arm, an optical sensor navigation system and accessories, surgical instruments, and a software system. It does not include a pre-operative planning feature.

The ROSA Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: Persona® CR, Persona PS, Persona Ti-Nidium® CR, Persona Ti-Nidium PS and Persona IQ® The Smart Knee™.

The ROSA® Knee System with USIP (Ultrasound Imaging Platform) is used to assist surgeons in performing Total Knee Arthroplasty (TKA) with features to assist with the bone resections. The USIP device is to be used with the Zimmer Biomet ROSA Knee System to perform TKA. The USIP device provides an ultrasound-based location solution for tibia and femur replacing the use of fluted pins placed in the femur and tibia. The USIP is composed of the ultrasound acquisition box, which connects to the ROSA Knee System and two belts; femur and tibia, which contain the ultrasound transducers. NavitrackERs are mounted on the femur and tibia belts and calibrated to locate the bone relative to the robot. The belts wrap or partially wrap the thigh (femur belt) and the calf (tibia belt) of the patient. The belts image the patient's bone via the ultrasound transducers contained in the belts.

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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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