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The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, and Aplio i700 Model TUS-AI700 are indicated for the visualization of structures, and dynamic processes with 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.

In addition to the aforementioned indications for use, when EUS transducer GF-UCT180 and BF-UC190F are connected, Aplio i800 Model TUS-AI800/E3 provides image information for diagnosis of the upper gastrointestinal tract and surrounding organs, airways, tracheobronchial tree and esophagus.

The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700, V9.0 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 33MHz.

This FDA 510(k) clearance letter details the substantial equivalence of the Aplio i900, Aplio i800, and Aplio i700 Software V9.0 Diagnostic Ultrasound System to its predicate device. The information provided specifically focuses on the validation of new and improved features, with particular attention to the 3rd Harmonic Imaging (3-HI), a new deep learning (DL) enabled filtering process.

Acceptance Criteria and Device Performance for 3rd Harmonic Imaging (3-HI)

Detailed Study Information

1. Acceptance Criteria and Reported Device Performance

(See table above)

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

• 3rd Harmonic Imaging (3-HI) Clinical Evaluation:
  • Sample Size: 30 patients.
  • Data Provenance: Previously acquired data from a U.S. clinical site (retrospective). Patients were selected to ensure diverse demographic characteristics representative of the intended U.S. patient population, including a wide range of body mass indices (18.5-36.3 kg/m²), roughly equivalent numbers of males and females, and ages ranging from 23-89 years old.
• 3rd Harmonic Imaging (3-HI) Phantom Study:
  • Sample Size: Five abdominal phantoms.
  • Data Provenance: Phantom data.

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

• 3rd Harmonic Imaging (3-HI) Clinical Evaluation:
  • Number of Experts: Three (3).
  • Qualifications: U.S. board-certified radiologists.

4. Adjudication Method for the Test Set

• 3rd Harmonic Imaging (3-HI) Clinical Evaluation:
  • Adjudication Method: Blinded observer study. The three radiologists compared images with 3-HI to images without 3-HI (predicate functionality) using a 5-point ordinal scale. The median score was then compared with the middle score of 3.

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

• Yes, a MRMC-like comparative effectiveness study was done for 3-HI's clinical evaluation.
• Effect Size: The statistical analysis demonstrated that scores for 3-HI were higher than the middle score of 3 for spatial resolution, contrast resolution, and artifact suppression. This indicates that human readers (radiologists) rated images with 3-HI as improved compared to those without.

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

• Yes, a standalone study was performed for 3-HI in the phantom study. The phantom studies objectively examined lateral and axial resolution, slice resolution, contrast-to-noise ratio (CNR), reverberation artifact suppression, and frequency spectra without human interpretation.

7. The Type of Ground Truth Used

• 3rd Harmonic Imaging (3-HI) Clinical Evaluation:
  • Type of Ground Truth: Expert consensus (from the three board-certified radiologists) on image quality metrics (spatial resolution, contrast resolution, artifact suppression) through a blinded comparison against predicate functionality. The initial selection of patient images included "representative focal pathologies" suggesting clinical relevance in the images themselves.
• 3rd Harmonic Imaging (3-HI) Phantom Study:
  • Type of Ground Truth: Objective measurements against known physical properties and targets within the phantoms.

8. The Sample Size for the Training Set (for 3-HI)

• The document explicitly states that the "The validation data set [30 patients] was entirely independent of the data set used to train the algorithm during its development." However, the actual sample size for the training set is not provided in the given text.

9. How the Ground Truth for the Training Set Was Established (for 3-HI)

• This information is not provided in the given text, beyond the statement that the algorithm was "locked upon completion of development" and had "no post-market, continuous learning capability."

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LOGIQ E10 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; Tranesophageal 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 E10 is intended to be used in a hospital or medical clinic.

The LOGIQ E10 is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 991 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 12-inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor.

Here's an analysis of the acceptance criteria and supporting studies for the LOGIQ E10 ultrasound system, derived from the provided FDA 510(k) Clearance Letter:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Auto Abdominal Color Assistant 2.0:
  • Test Set Sample Size: 49 individual subjects, 1186 annotation images.
  • Data Provenance: Retrospective, all data from the USA.
• Auto Aorta Measure Assistant:
  • Test Set Sample Size:
    • Long View Aorta: 36 subjects (11 Male, 25 Female).
    • Short View Aorta: 35 subjects (11 Male, 24 Female).
  • Data Provenance: Retrospective, from Japan (15-16 subjects) and USA (20 subjects).
• Auto Common Bile Duct (CBD) Measure Assistant:
  • Test Set Sample Size: 25 subjects (11 Male, 14 Female).
  • Data Provenance: Retrospective, from USA (40%) and Japan (60%).
• Ultrasound Guided Fat Fraction (UGFF):
  • Test Set Sample Size (Primary Study): 582 participants.
  • Data Provenance (Primary Study): Retrospective, Japan.
  • Test Set Sample Size (Confirmatory Study 1): 15 US patients + 5 EU patients (total 20).
  • Data Provenance (Confirmatory Study 1): Retrospective, USA and EU.
  • Test Set Sample Size (Confirmatory Study 2): 24 EU patients.
  • Data Provenance (Confirmatory Study 2): Retrospective, EU.

3. Number of Experts and Qualifications for Ground Truth

• Auto Abdominal Color Assistant 2.0: Not explicitly stated, but implies multiple "readers" to ground truth anatomical visibility. No specific qualifications are mentioned beyond "readers."
• Auto Aorta Measure Assistant: Not explicitly stated, but implies multiple "readers" for measurements and an "arbitrator" to select the most accurate measurement. No specific qualifications are mentioned beyond "readers" and "arbitrator."
• Auto Common Bile Duct (CBD) Measure Assistant: Not explicitly stated, but implies multiple "readers" for measurements and an "arbitrator" to select the most accurate measurement. No specific qualifications are mentioned beyond "readers" and "arbitrator."
• Ultrasound Guided Fat Fraction (UGFF): Ground truth for the primary study was MRI Proton Density Fat Fraction (MRI-PDFF %). No human experts were involved in establishing the ground truth for UGFF, as it relies on MRI-PDFF as the reference. The correlation between UGFF and UDFF also used UDFF as a reference, not human experts.

4. Adjudication Method for the Test Set

• Auto Abdominal Color Assistant 2.0: Not explicitly mentioned, however, the process described as "Readers to ground truth the 'anatomy' visible in static B-Mode image. (Before running AI)" and then comparing to AI predictions does not suggest an adjudication process for the ground truth generation itself beyond initial reader input. Confusion matrices were generated later.
• Auto Aorta Measure Assistant: An "Arbitrator" was used to "select most accurate measurement among all readers" for the initial ground truth, which was then compared to AI baseline. This implies a 1 (arbitrator) + N (readers) adjudication method for measurement accuracy. For keystroke comparison, readers measured with and without AI.
• Auto Common Bile Duct (CBD) Measure Assistant: An "Arbitrator" was used to "select most accurate measurement among all readers" for the initial ground truth, which was then compared to AI baseline. This implies a 1 (arbitrator) + N (readers) adjudication method for measurement accuracy. For keystroke comparison, readers measured with and without AI.
• Ultrasound Guided Fat Fraction (UGFF): Ground truth was established by MRI-PDFF or comparison to UDFF. No human adjudication method was described for these.

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

• Auto Aorta Measure Assistant: Yes, a comparative study was performed by comparing keystroke counts with and without AI assistance for human readers.
  • Effect Size:
    • Long View Aorta AP Measurement: Average reduction from $4.132 \pm 0.291$ keystrokes (without AI) to $1.236 \pm 0.340$ keystrokes (with AI).
    • Short View Aorta AP and Trans Measurement: Average reduction from $7.05 \pm 0.158$ keystrokes (without AI) to $2.307 \pm 1.0678$ keystrokes (with AI).
• Auto Common Bile Duct (CBD) Measure Assistant: Yes, a comparative study was performed by comparing keystroke counts with and without AI assistance for human readers.
  • Effect Size: Average reduction of $1.62 \pm 0.375$ keystrokes (mean and standard deviation) from manual to AI-assisted measurements.
• Other features (Auto Abdominal Color Assistant 2.0, UGFF): The documentation does not describe a MRMC study for improved human reader performance with AI assistance for these features.

6. Standalone (Algorithm Only) Performance Study

• Auto Abdominal Color Assistant 2.0: Yes, the model's accuracy (detection accuracy, sensitivity, specificity, DICE score) was evaluated in a standalone manner against the human-annotated ground truth.
• Ultrasound Guided Fat Fraction (UGFF): Yes, the correlation and agreement of the UGFF algorithm's values were tested directly against an established reference standard (MRI-PDFF) and another device's derived fat fraction (UDFF).

7. Type of Ground Truth Used

• Auto Abdominal Color Assistant 2.0: Expert consensus/annotations on B-Mode images, followed by comparison to AI predictions.
• Auto Aorta Measure Assistant: Expert consensus on measurements (human readers with arbitrator selection) and keystroke counts from these manual measurements and AI-assisted measurements.
• Auto Common Bile Duct (CBD) Measure Assistant: Expert consensus on measurements (human readers with arbitrator selection) and keystroke counts from these manual measurements and AI-assisted measurements.
• Ultrasound Guided Fat Fraction (UGFF): Established clinical reference standard: MRI Proton Density Fat Fraction (MRI-PDFF %). For one confirmatory study, another cleared device's derived fat fraction (UDFF) was used as a comparative reference.

8. Sample Size for the Training Set

• The document states that "The exams used for test/training validation purpose are separated from the ones used during training process" but does not provide the sample size for the training set itself for any of the AI features.

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

• The document implies that the ground truth for training data would have been established similarly to the test data ground truth (e.g., expert annotation for Auto Abdominal Color Assistant, expert measurements for Auto Aorta/CBD Measure Assistants). However, the specific methodology for the training set's ground truth establishment (e.g., number of experts, adjudication, qualifications) is not detailed in the provided text. It only explicitly states that "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" for annotation. Independence of test and training data by exam site origin or overall separation is mentioned, but not the process for creating the training set ground truth.

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The LOGIQ E10s is intended for use by a qualified physician for ultrasound evaluation.

Specific clinical applications and exam types include: 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 E10s is intended to be used in a hospital or medical clinic.

The LOGIQ E10s is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 991 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 12-inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor.

The provided text describes three AI features: Auto Abdominal Color Assistant 2.0, Auto Aorta Measure Assistant, and Auto Common Bile Duct (CBD) Measure Assistant, along with a UGFF Clinical Study.

Here's an analysis of the acceptance criteria and study details for each, where available:

1. Table of Acceptance Criteria and Reported Device Performance

For Auto Abdominal Color Assistant 2.0

For Auto Aorta Measure Assistant

For Auto Common Bile Duct (CBD) Measure Assistant

For UGFF Clinical Study

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

Auto Abdominal Color Assistant 2.0:

• Sample Size: 49 individual subjects (1186 annotation images)
• Data Provenance: Retrospective, from the USA (100%).

Auto Aorta Measure Assistant:

• Sample Size:
  • Long View Aorta: 36 subjects
  • Short View Aorta: 35 subjects
• Data Provenance: Retrospective, from Japan and USA.

Auto Common Bile Duct (CBD) Measure Assistant:

• Sample Size: 25 subjects
• Data Provenance: Retrospective, from USA (40%) and Japan (60%).

UGFF Clinical Study:

• Sample Size:
  • Original study: 582 participants
  • Confirmatory study (US/EU): 15 US patients and 5 EU patients (total 20)
  • Confirmatory study (UGFF vs UDFF): 24 EU patients
• Data Provenance: Retrospective and Prospective implicitly (clinical study implies data collection).
  • Original Study: Japan (Asian population)
  • Confirmatory Study (US/EU): US and EU (demographic info unavailable for EU patients, US patients: BMI 21.0-37.5, SCD 13.9-26.9)
  • Confirmatory Study (UGFF vs UDFF): EU

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

Auto Abdominal Color Assistant 2.0:

• Number of Experts: Not specified. The text mentions "Readers to ground truth the 'anatomy'".
• Qualifications of Experts: Not specified.

Auto Aorta Measure Assistant:

• Number of Experts: Not specified. The text mentions "Readers to ground truth the AP measurement..." and an "Arbitrator to select most accurate measurement among all readers." This implies multiple readers and a single arbitrator.
• Qualifications of Experts: Not specified.

Auto Common Bile Duct (CBD) Measure Assistant:

• Number of Experts: Not specified. The text mentions "Readers to ground truth the diameter..." and an "Arbitrator to select most accurate measurement among all readers." This implies multiple readers and a single arbitrator.
• Qualifications of Experts: Not specified.

UGFF Clinical Study:

• Number of Experts: Not applicable, as ground truth was established by MRI-PDFF measurements, not expert consensus on images.

4. Adjudication method for the test set

Auto Abdominal Color Assistant 2.0:

• Adjudication Method: Not explicitly described as a specific method (e.g., 2+1). The process mentions "Readers to ground truth" and then comparison to AI predictions, but no specific adjudication among multiple readers' initial ground truths.

Auto Aorta Measure Assistant:

• Adjudication Method: Implies an arbitrator-based method. "Arbitrator to select most accurate measurement among all readers." This suggests multiple readers provide measurements, and a single arbitrator makes the final ground truth selection.

Auto Common Bile Duct (CBD) Measure Assistant:

• Adjudication Method: Implies an arbitrator-based method. "Arbitrator to select most accurate measurement among all readers." Similar to the Aorta assistant.

UGFF Clinical Study:

• Adjudication Method: Not applicable. Ground truth was established by MRI-PDFF measurements.

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

Auto Abdominal Color Assistant 2.0:

• MRMC Study: Not explicitly stated as a comparative effectiveness study showing human improvement. The study focuses on the algorithm's performance against ground truth.
• Effect Size (Human Improvement with AI): Not reported.

Auto Aorta Measure Assistant:

• MRMC Study: Yes, an implicit MRMC study comparing human performance with and without AI. Readers performed measurements with and without AI assistance.
• Effect Size (Human Improvement with AI):
  • Long View Aorta (Keystrokes): Average keystrokes reduced from 4.132 (without AI) to 1.236 (with AI).
  • Short View Aorta (Keystrokes): Average keystrokes reduced from 7.05 (without AI) to 2.307 (with AI).
  • (No specific improvement in diagnostic accuracy for human readers with AI is stated, primarily focuses on efficiency via keystrokes).

Auto Common Bile Duct (CBD) Measure Assistant:

• MRMC Study: Yes, an implicit MRMC study comparing human performance with and without AI. Readers performed measurements with and without AI assistance.
• Effect Size (Human Improvement with AI):
  • Porta Hepatis CBD (Keystrokes): Average reduction in keystrokes for measurements with AI vs. manually is 1.62 +/- 0.375.
  • (No specific improvement in diagnostic accuracy for human readers with AI is stated, primarily focuses on efficiency via keystrokes).

UGFF Clinical Study:

• MRMC Study: No, this was a standalone algorithm performance study compared to a reference standard (MRI-PDFF) and a predicate device (UDFF). It did not involve human readers using the AI tool.

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

Auto Abdominal Color Assistant 2.0:

• Standalone Performance: Yes. The reported accuracy, sensitivity, specificity, and DICE score are for the algorithm's performance.

Auto Aorta Measure Assistant:

• Standalone Performance: Yes, implicitly. The "AI baseline measurement" was compared for accuracy against the arbitrator-selected ground truth. While keystrokes involved human interaction to use the AI, the measurement accuracy is an algorithm output.

Auto Common Bile Duct (CBD) Measure Assistant:

• Standalone Performance: Yes, implicitly. The "AI baseline measurement" was compared for accuracy against the arbitrator-selected ground truth.

UGFF Clinical Study:

• Standalone Performance: Yes. The study directly assesses the correlation and agreement of the UGFF algorithm's output with MRI-PDFF and another ultrasound-derived fat fraction algorithm.

7. The type of ground truth used

Auto Abdominal Color Assistant 2.0:

• Ground Truth Type: Expert consensus for anatomical visibility ("Readers to ground truth the 'anatomy' visible in static B-Mode image.")

Auto Aorta Measure Assistant:

• Ground Truth Type: Expert consensus from multiple readers, adjudicated by an arbitrator, for specific measurements ("Arbitrator to select most accurate measurement among all readers.")

Auto Common Bile Duct (CBD) Measure Assistant:

• Ground Truth Type: Expert consensus from multiple readers, adjudicated by an arbitrator, for specific measurements ("Arbitrator to select most accurate measurement among all readers.")

UGFF Clinical Study:

• Ground Truth Type: Outcomes data / Quantitative Reference Standard: MRI Proton Density Fat Fraction (MRI-PDFF %).

8. The sample size for the training set

Auto Abdominal Color Assistant 2.0:

• Training Set Sample Size: Not specified beyond "The exams used for test/training validation purpose are separated from the ones used during training process".

Auto Aorta Measure Assistant:

• Training Set Sample Size: Not specified beyond "The exams used for regulatory validation purpose are separated from the ones used during model development process".

Auto Common Bile Duct (CBD) Measure Assistant:

• Training Set Sample Size: Not specified beyond "The exams used for regulatory validation purpose are separated from the ones used during model development process".

UGFF Clinical Study:

• Training Set Sample Size: Not specified. The study describes validation but not the training phase.

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

Auto Abdominal Color Assistant 2.0:

• Training Set Ground Truth: Not explicitly detailed, but implied to be similar to the test set ground truthing process: "Information extracted purely from Ultrasound B-mode images" and "Readers to ground truth the 'anatomy'".

Auto Aorta Measure Assistant:

• Training Set Ground Truth: Not explicitly detailed, but implied to be similar to the test set ground truthing process: "Information extracted purely from Ultrasound B-mode images" and "Readers to ground truth the AP measurement...".

Auto Common Bile Duct (CBD) Measure Assistant:

• Training Set Ground Truth: Not explicitly detailed, but implied to be similar to the test set ground truthing process: "Information extracted purely from Ultrasound B-mode images" and "Readers to ground truth the diameter...".

UGFF Clinical Study:

• Training Set Ground Truth: Not specified for the training set, but for the validation set, the ground truth was MRI-PDFF measurements.

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The X9 Ultrasound System is intended for ultrasound imaging of validated vascular accesses for hemodialysis during the preliminary stage of a cannulation procedure, prior to inserting the needle. The device is intended to be used by qualified healthcare professionals in a medical setting. The device is not intended to be used to diagnose the position of the vascular access without confirming position per standard of care. The X9 Ultrasound System is not for use in pediatric patients.

The X9 Ultrasound System is intended for guidance in accessing arteriovenous fistulas and grafts (AVF/G). The X9 Ultrasound System consists of a Handpiece and Software. The Handpiece is a handheld device with an ultrasound transducer and is attached via a cable to a user-supplied Computer. The Handpiece is covered by a compatible probe cover and is placed on the patient's limb and positioned (translated/rotated) by the user to align with the AVF/G. The Handpiece contains a physical button for the user to activate/deactivate the system and an alignment marking to assist the user with positioning the Handpiece over the vessel. The software, which runs on a standard operating system platform installed on the Computer, provides the Graphical User Interface (GUI). The GUI will indicate when the Handpiece is aligned with the AVF/G. The information given from the system is intended to guide the user so that they can efficiently proceed with the standard of care assessment prior to cannulation.

Here's a detailed breakdown of the acceptance criteria and the study that proves the X9 Ultrasound System meets those criteria, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) summary explicitly states that the Machine Learning Model (and therefore the X9 Ultrasound System) met the ML Model Validation acceptance criteria for the primary analyses.

Study Details

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

• Sample Size for Test Set: 378 B-mode ultrasound images collected from 63 participants.
• Data Provenance: The study involved participants known to have an arteriovenous fistula or graft (AVF/G). Clinic locations for ML model validation were selected to obtain a sample of participants. The patient demographics provided (31 females, 32 males, 34 Black/African American, 27 White, 1 Asian, 1 Unknown/Not Reported, 4 Hispanic or Latino, and 59 Not Hispanic or Latino, aged 18 to 75+ years old) suggest a diverse, likely multi-center, prospective collection of data within a clinical setting, although specific countries are not mentioned. Given the FDA submission, the data is most likely from the United States or a country adhering to similar clinical trial standards.

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

• Number of Experts: Three (3) independent sonographers.
• Qualifications of Experts: The document states they used their "clinical expertise" to determine if an access vessel was visible and to annotate its location. This implies they are trained and experienced medical professionals in ultrasound imaging, specifically sonographers.

4. Adjudication Method for the Test Set

• The ground truth for Access Presence was established when the "majority of independent reviewers determined that an access vessel was present in the image." This indicates a 2 out of 3 consensus (or "2+1") method for access presence.
• For the True Location of the access vessel, it was established by calculating the average of the locations annotated by each of the independent reviewers. This is an averaging adjudication method for continuous metrics.

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

• No, a MRMC comparative effectiveness study was not explicitly done or reported. The study focused on the standalone performance of the machine learning model against expert-annotated ground truth. There is no mention of comparing human readers with AI assistance versus human readers without AI assistance, nor any effect sizes of human reader improvement.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance study was done. The "Machine Learning Model Validation" directly assesses the performance of the algorithm (X9 Ultrasound System's ML model) in determining access vessel presence and location against expert-established ground truth. The reported metrics (Access Presence Sensitivity, Average Lateral Error, and Average Dice Similarity Coefficient) are all measures of the algorithm's performance alone.

7. Type of Ground Truth Used

• The ground truth used was expert consensus and expert annotation.
  • For "Access Presence," it was based on the majority decision of three independent sonographers.
  • For the "True Location" of the access vessel, it was the average of the locations annotated by the three independent sonographers.

8. Sample Size for the Training Set

• The document states, "The training dataset was collected at dialysis clinics not included in the ML model validation and was used exclusively for model training." However, the specific sample size (number of images or participants) for the training set is not provided in this document.

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

• The document states, "Separate test datasets were reserved for performance validation against expert-annotated ground truth." This implies that the training data also likely utilized expert-annotated ground truth, similar to the test set, but this is not explicitly detailed for the training set. It's standard practice for machine learning models to be trained on data with established ground truth, often through expert labeling or external verified sources.

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EPIQ:

The intended use of EPIQ Ultrasound Diagnostic 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), 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, 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.

Affiniti:

The intended use of Affiniti Series Diagnostic Ultrasound Systems 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, 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 special 510(k) Pre-Market Notification is to introduce EPIQ and Affiniti Series Diagnostic Ultrasound Systems with Custom Electromagnetic Interference (EMI) filter. The proposed EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound Systems with new Custom EMI filter spare part, will reduce the electrical interferences induced by the external environments and feed the clean electrical signals to the ultrasound device, equivalent to predicate device, K250177.

Ultrasound systems are very sensitive in nature. These electrical interference couplings result in Image distortions or artifacts in Images, using this Custom EMI filter will reduce such artifact effects appearing on Ultrasound systems.

N/A

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deepLive is intended to be used as a non-invasive imaging tool in the evaluation of external human tissue microstructure by providing three-dimensional, cross-sectional and en-face real-time depth visualization for assessment by physicians to support in forming a clinical judgment.

The deepLive device is an update to the previously cleared deepLive device (K240610). The update includes the addition of a hand-held Dermoscope (DMS).

deepLive was designed for an easy integration into clinical practices. The device is composed of:

• A mobile cart, allowing the user to move the whole device and including a cart tablet for accessories.
• A touchscreen, fixed on the cart mast, displaying the software interfaces to the user.
• A first hand-held probe (LC-OCT), integrating the LC-OCT imaging system (interferometric microscope, OCT camera). The probe is connected to the CPU front panel by a sheathed cable bundle, and stored in a dedicated probe-holder fixed on the cart tablet.
• A second hand-held probe (DMS), complementary to the LC-OCT, integrating a dermoscope and providing wide-field surface color images. The probe is connected to the CPU by a USB cable, and stored in a dedicated probe-holder fixed on the cart tablet.
• A central power unit (CPU), mounted on the cart, integrating various imaging and electronic peripherals (laser, computer, electronic cards, drivers, power supplies, etc.), driving and powering the imaging probe.
• A software running on the device's computer, which controls the components of the system, acquires and processes images, and provides user interfaces for performing examinations and managing data.

deepLive hardware interfaces are located on the front-panel of the CPU. Input/output connections include:

• 1 Display port to connect the screen
• 3 USB ports to connect external drives (Wifi key, hard drive disk, etc.)

deepLive software runs on a computer embedded in the CPU of the device. The computer uses Windows Enterprise LTSC operating system. The software executable and all dynamic libraries needed for program execution are deployed at a specific location in the file system.

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Shear Wave Quantificational Ultrasound Diagnostic System, Transient Elastography based device, is intended to provide 50 Hz shear wave speed measurements and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body.

Shear Wave Quantificational Ultrasound Diagnostic System, Transient Elastography based device is intended to provide 100Hz shear wave speed measurements and estimates of tissue stiffness in spleen.

Shear Wave Quantificational Ultrasound Diagnostic System is indicated as a non-invasive aid for the clinical management, diagnosis, and monitoring of adult and pediatric patients with confirmed or suspected liver disease, as part of an overall assessment of the liver. Results in the pediatric population should be interpreted while considering the clinical condition and the overall patient profile.

Shear Wave Quantificational Ultrasound Diagnostic System is intended for general purpose pulse echo ultrasound imaging and Doppler flow analysis in the human body (including abdominal applications) in B, M, CFM, PWD, B/B, 4B, B+M, B+CFM, B+PWD, and B+CFM+PWD modes.

The system must be operated by qualified and appropriately trained medical professionals in a professional healthcare facility environment.

The subject system is a general purpose, software-controlled, diagnostic ultrasound system. It is composed of a complex probe, an imaging probe, a main unit, a power cord, a foot switch, two fuses and a protective earth wire. The complex probe is a convex array probe used for elasticity measurement and ultrasound imaging, and the imaging probe is also a convex array probe used for ultrasound imaging. The system uses transient elastography to measure shear wave speed non-invasively and estimate tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body. A mechanical vibrator in the complex probe produces low-frequency shear waves at 50 Hz or 100HZ that travel through the skin and intercostal space into the liver or spleen respectively. The propagation speed of the shear wave is captured by complex probe using ultrasound at 2.5 MHz. Under imaging mode, the system acquires and displays ultrasound images in B, M, CFM, PWD modes. The system uses imaging probe and complex probe with a frequency range of 2.5MHz to 5.0 MHz on abdomen for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. The ultrasonic imaging also helps to find a proper location for the Transient Elastography examination.

There are a total of 6 models in this product, all of which share the same intended use, physical design and principle of technology. The only differences among these models are software functions configuration and availability of imaging probe.

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The "Astrasono A3Pro Bladder Scanner" is B-mode pulsed-echo ultrasound device. It is intended as a handheld battery-operated device. The device projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder volume noninvasively. It is intended to be used only by qualified medical professionals.

Environments of intended use: Professional medical environments

The intended patient population: Adult patients who require bladder volume measurement (not applicable to pediatric patients).

The "Astrasono A3Pro Bladder Scanner" is a hand-held battery-operated device, it provides non-invasive bladder volume measurement utilizing real-time ultrasound imaging.

The "Astrasono A3Pro Bladder Scanner" measures the bladder volume in the range of 0 – 999 mL.

There are three scanning modes (all B-modes): Easy Mode, Expert Mode, and Empower Mode:

• Easy Mode: Under this mode, the screen displays a real-time image of bladder silhouette.
• Expert Mode: Under this mode, the screen displays a real-time image of bladder.
• Empower Mode: Under this mode, the screen displays a real-time image of bladder projection.

This device consists of a console (including a rechargeable Li-ion battery pack and built-in printer), a probe, and a medical switching power supply.

The obtained ultrasound images and calculated bladder volume results can be downloaded to USB drive as encrypted Data.

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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.

The ultrasound system is intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac), and vascular); Intra-operative (Neuro); Laparoscopic; Pediatric; Small organ (thyroid, breast, testes, etc); Neonatal cephalic; Adult Cephalic/Transcranial; Trans-rectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal (Conventional); Musculoskeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac); Intra-cardiac; Peripheral vessel.

Modes of operation include: B (Includes B-Mode and Harmonic (Contrast) imaging (HI)), M, PWD (Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)), CWD, Color Doppler (Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)), Combined Modes (Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)), Color M-Mode (CM), 3D/4D, CEUS (Contrast agent for Liver), ARFI, 2D SWI, Freehand tissue elasticity, CEUS (Contrast agent for LVO).

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.

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The Sonosite LX and Sonosite PX ultrasound systems are general purpose ultrasound systems 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:

• Abdominal
• Adult Cephalic
• Neonatal Cephalic
• Cardiac Adult
• Cardiac Pediatric
• Fetal - OB/GYN
• Musculo-skeletal (Conventional)
• Musculo-skeletal (Superficial)
• Ophthalmic
• Pediatric
• Peripheral vessel
• Small Organ (breast, thyroid, testicles, prostate)
• Transesophageal (cardiac)
• Transrectal
• Transvaginal
• Needle Guidance

Modes of operation include: B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M-M-Mode), PW Doppler (PWD) (including High Pulse Repetition Frequency (HPRF) and simultaneous PWD for certain exam types), Tissue Doppler Imaging (TDI), Continuous Wave Doppler (CWD), Color Power Doppler, Velocity Color Doppler, Color Variance, Tissue Harmonic Imaging (THI), Multi-beam imaging, Steep Needle Profiling, Trapezoid, and combined modes, including duplex and triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD.

This device is indicated for Prescription Use Only.

The Sonosite LX and Sonosite PX ultrasound systems are intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics, and clinical point-of-care for diagnosis of patients.

The systems are used with a transducers attached and they are 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 LX and Sonosite PX Ultrasound Systems are full featured, general purpose, software controlled diagnostic ultrasound systems used to acquire and display high-resolution, real-time ultrasound data in 2D, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler (CPD), and Color Doppler (Color) or in a combination of these modes.

The systems include a variety of accessories including needle guide starter kits. The systems include USB host support for peripherals such as input devices, storage devices and Ethernet port. Input devices include wired and wireless devices. The systems also include an ECG-specific port to support the ECG feature. The non-diagnostic ECG module provides ECG tracing of the cardiac signal synchronized with the ultrasound image.

The provided document details the 510(k) clearance for the Sonosite LX and Sonosite PX Ultrasound Systems, specifically focusing on the addition of the PIV Assist AI feature. Here's a breakdown of the acceptance criteria and the study proving the device meets them:

Acceptance Criteria and Reported Device Performance

The document presents performance metrics for the PIV Assist AI algorithm, which serve as the acceptance criteria for its functionality. Specifically, the metrics cover "Vessel Precision," "Vessel Recall," "Vein Classification Accuracy," and "Artery Classification Accuracy" for two different transducers (L19-5 and L12-3). Additionally, average depth and diameter errors are reported.

Here's a table summarizing the reported device performance against implicitly defined acceptance criteria (as these are the results presented to demonstrate performance). No explicit "desired" or "threshold" values are given for acceptance criteria; rather, the reported performance is the demonstration of meeting the criteria.

Note: While specific acceptance thresholds are not explicitly stated, the reported high percentages and low error margins demonstrate the device's acceptable performance for its intended use.

Study Details for PIV Assist AI Algorithm Performance Testing

Here's a breakdown of the study details as provided in the document:

1. Sample Size used for the test set and the data provenance:

   • Sample Size: 584 ultrasound clips from 292 subjects.
   • Data Provenance: The data was collected prospectively from 3 hospitals within the United States. The document explicitly states that the validation dataset was collected at a "much later timeframe" and at "different sites from the training and tuning data" to ensure independence.

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

   • The document states that "certified Clinical Sonographers" independently labeled the data.
   • For adjudication, an "Interventional Radiologist" evaluated the labeled data.
   • Specific numbers of sonographers or the interventional radiologist are not provided. Their general qualifications (certified Clinical Sonographers, Interventional Radiologist) are mentioned, but specific experience (e.g., "10 years of experience") is not detailed.

3. Adjudication method for the test set:

   • An adjudication process took place "in cases where there was disagreement between the images."
   • The adjudication was performed by an "Interventional Radiologist" who evaluated the labeled data to establish the final ground truth. This suggests a form of expert consensus with a tie-breaker, though specific methods like "2+1" or "3+1" are not explicitly stated. It implies a process where disagreements among sonographers were resolved by a higher-level expert.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. The document focuses solely on the "AI algorithm performance testing" in a standalone manner, evaluating its accuracy against ground truth. There is no mention of comparing human reader performance with and without AI assistance, nor any effect size.

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

   • Yes, a standalone study was done. The "Summary of PIV Assist AI Algorithm Performance Testing" section details metrics like precision, recall, and classification accuracy, which are inherent to the algorithm's performance when processing and interpreting ultrasound data. There's no indication of human interaction during the measurement of these performance metrics.

6. The type of ground truth used:

   • The ground truth was established through expert consensus and adjudication of ultrasound clips and frames. "Certified Clinical Sonographers" independently labeled the data, and an "Interventional Radiologist" adjudicated disagreements to establish the "final ground truth."

7. The sample size for the training set:

   • The document states that the validation dataset was collected independently from the "training and tuning data," but it does not provide the sample size of the training set.

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

   • The document mentions "training and tuning data" but does not explicitly detail how the ground truth for the training set was established. It can be inferred that a similar process of expert labeling, potentially with adjudication, was used given the rigorous approach for the validation set, but this is not explicitly stated.

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