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

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

• Primary Study (UGFF vs. MRI-PDFF):

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

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

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

• Second Confirmatory Study (UGFF vs. UDFF):

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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

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

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

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

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

AI Features Analyzed:

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

1. Auto Abdominal Color Assistant 2.0

1.1. Acceptance Criteria and Reported Device Performance:

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

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

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

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

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

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

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

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

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

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

2. Auto Aorta Measure Assistant

2.1. Acceptance Criteria and Reported Device Performance:

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

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

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

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

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

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

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

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

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

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

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

3. Auto Common Bile Duct (CBD) Measure Assistant

3.1. Acceptance Criteria and Reported Device Performance:

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

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

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

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

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

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

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

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

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

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

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

4. Ultrasound Guided Fat Fraction (UGFF)

4.1. Acceptance Criteria and Reported Device Performance:

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

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

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

• Second Confirmatory Study:

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

• Third Confirmatory Study (Comparison with Predicate):

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

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

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

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

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

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

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

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

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

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HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System and probes 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, Trans-esophageal (Cardiac), Peripheral vessel and Ophthalmic.

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, private practices, clinics and similar care environment for clinical diagnosis of patients.

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

HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System are a general purpose, mobile, software controlled, diagnostic ultrasound system. Their 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.

HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 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. HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 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.

Here's a breakdown of the acceptance criteria and the study details for each AI-ML based software feature described in the FDA 510(k) summary:

Overview of Acceptance Criteria and Device Performance (AI-ML Features)

The provided document details the testing and performance for several new and updated AI-ML based software features. The information given for each feature constitutes the acceptance criteria and the device's reported performance against those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

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

4. Adjudication Method for the Test Set

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI vs. without AI assistance for any of the features described. The studies focused on the standalone performance of the AI algorithms.

6. Standalone (Algorithm Only) Performance

Yes, standalone (algorithm only without human-in-the-loop performance) was done for all the AI/ML features described.

• AbdomenAssist: Evaluated success rate and Bland-Altman agreement of the algorithm's measurements.
• BladderAssist: Evaluated success rate and Bland-Altman agreement of the algorithm's measurements.
• QualityCheck: Evaluated sensitivity, specificity, PPV, and NPV of the algorithm's view classification and structure detection.
• PelvicAssist: Evaluated acceptance rate for volume alignment and ICC/Bland-Altman for LH measurement of the algorithm.
• EzVolume: Evaluated error rate, bias, and LoA for the algorithm's measurements based on its segmentation results.
• UterineAssist: Evaluated Dice-score for segmentation, average error range for feature point extraction, and error range/Bland-Altman for size measurements of the algorithm.
• NerveTrack: Evaluated localization accuracy success rate and processing speed of the algorithm's detection.

7. Type of Ground Truth Used

8. Sample Size for the Training Set

The document explicitly states for each feature that "Data used for test and training/tuning purpose are completely separated from the ones during training process and there is no overlap between the two." or "Data used for training, tuning and validation purpose are completely separated from the ones during training process and there is no overlap between the three."

However, the specific sample sizes for the training sets are not provided in this FDA 510(k) summary document.

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

Similar to the training set size, the document does not explicitly describe how the ground truth for the training set was established. It only details the process for establishing the ground truth for the test/validation sets. The inference is that a similar expert-driven annotation process would have been used for training data, but the specifics are absent from this document.

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BioticsAI is intended to analyze fetal ultrasound images and frames (DICOM instances) using machine learning techniques to automatically detect views, detect anatomical structures within the views and to facilitate quality criteria verification and characteristics of the views.

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

BioticsAI is a software used by OB/GYN care centers for prenatal ultrasound review and reporting. BioticsAI uses artificial intelligence (A.I.) to automatically annotate ultrasound images with fetal anatomical planes and structures to facilitate ultrasound review and report generation for fetal ultrasound anatomical scans. It serves as concurrent reading aid for ultrasound images both during and after a fetal anatomical ultrasound examination.

BioticsAI is a Software as a Service (SaaS) solution that aims at helping sonographers, OB/GYNs, MFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCP) to perform their routine fetal ultrasound examinations in real-time.

BioticsAI can be used by Healthcare Professionals HCPs during fetal ultrasound exams for Trimester 2 of the fetus, during which a fetal anatomy exam is typically captured (typically conducted between 18-22 weeks but can be captured on gestational ages ranging from 18 up to 39 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

BioticsAI requires the following SaaS accessibility from internet browser.

BioticsAI receives DICOM instances, which consist of still fetal ultrasound images (in the form still image captures or individual frames from a multi-frame instance) from the ultrasound machine, which are submitted by the performing healthcare professional from the clinic's network, either during the screening or post-screening and performs the following:

• Automatically detect fetal anatomical planes (2D ultrasound views).
• Automatically flag high-level anatomical features (e.g., "head", "thorax", "limb detected in image", etc).
• Automatically detect specific anatomical structures within supported planes/views (i.e. "cerebellum, csp, and cisterna magna found in transcerebellar plane image").
• Facilitate quality verification of supported planes by determining whether the expected anatomical structures, as informed by the latest ISUOG and AIUM guidelines, are present in the ultrasound image. The quality assessment focuses on the presence or absence of these anatomical structures.

BioticsAI automatically identifies fetal anatomical views and anatomical structures captured during the screening. It uses green highlights to indicate successfully detected planes and structures. Red highlights are used to flag instances where the model could not detect an expected anatomical view or structure, even though it is a supported feature. Yellow highlights indicate views or structures that require manual verification (when the AI cannot determine whether anatomical features are present or absent because it is not yet supported by our product).

The end user can interact with the software to override BioticsAI's outputs. Specifically, users can unassign or assign an image to a plane or high level anatomical feature, and update the status of quality criteria for structures by changing it from "found" to "not found" or vice versa. Users have the flexibility to review and edit these assignments at any point during or after the exam.

The end user then has the ability to include the information gathered during quality and image review automatically in a final report via a button called "Confirm Screening Results", automatically filling out a report template with identified planes and structures. The report can then be further exported to the clinic's PACS over DIMSE via a populated DICOM SR.

BioticsAI also provides a standard DICOM Viewer for viewing DICOM instances, and obstetrics ultrasound report templates for manually creating ultrasound reports without the AI based functionality as described above.

To further explain the AI-driven outputs provided by the device, we describe the three primary AI components below:

• AI-1: High-Level Anatomy Classification

  Provides a multi-label classification of the general anatomical region depicted in the image (e.g., head/brain, face, thorax/chest, abdomen, limbs). These categories correspond to standard high-level anatomy groupings used in fetal ultrasound interpretation.

• AI-2: Per-Class Top-1 Fetal Plane Classification

  Provides fetal anatomical plane classifications using a per-class Top-1 approach. A fetal "plane" refers to a standardized cross-sectional view defined by ISUOG and aligned with AIUM guidance for mid-trimester fetal anatomy scans. For each anatomical plane category, the model outputs the image with the single highest-confidence prediction (Top-1) associated with that class.

• AI-3: Fetal Anatomical Structure Classification

  Provides multi-label identification of fetal anatomical structures (e.g., cerebellum, cisterna magna, cerebral peduncles), generated from the model's segmentation head and refined through post-processing filters that enforce plane-structure consistency and remove non-intended labels.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter for BioticsAI:

Please note that the document primarily provides the results of standalone performance testing and verification/validation activities. It does not detail specific acceptance criteria values that were established prior to testing for each metric (e.g., "The device must achieve a sensitivity of at least X"). Instead, the tables present the achieved performance of the device from its standalone testing. Based on the clearance letter, it is implied that these reported performance metrics were deemed acceptable by the FDA for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 11,186 fetal ultrasound images across 296 patients.
• Data Provenance:
  • Country of Origin: United States.
  • Retrospective or Prospective: Not explicitly stated as retrospective or prospective, but described as "independent of the data used during model development" and collected "from a single site (across multiple ultrasound screening units and machine instances) in the United States." This typically implies a retrospective collection for model validation.
  • Diversity: Data represented varying ethnicities, patient BMIs, patient ages (18-44 years), gestational ages (18-39 weeks), twin pregnancies, and presence of abnormalities, designed to be "representative of the intended use population."

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

The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the test set. It only states that the ground truth was "independent of the data used during model development."

4. Adjudication method for the test set

The document does not specify the adjudication method (e.g., 2+1, 3+1, none) used for establishing the ground truth of the test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A MRMC comparative effectiveness study was not explicitly mentioned or detailed in the provided document. The performance data presented is for standalone device performance.

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

Yes, a standalone performance testing (algorithm only without human-in-the-loop performance) was done. The document states: "BioticsAI conducted a standalone performance testing on a dataset of 11,186 fetal ultrasound images..." The tables present the Sensitivity and Specificity of the AI model.

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

The document does not explicitly state the precise type of ground truth used (e.g., expert consensus, pathology, outcomes data). However, for image analysis tasks like detecting planes and structures in ultrasound images, ground truth is typically established by expert annotation or consensus by qualified medical professionals (e.g., sonographers, OB/GYN, MFMs, Fetal surgeons, or radiologists) interpreting the images. The context describes the device as verifying guidelines and determining presence/absence of structures, implying a gold standard based on established medical interpretation.

8. The sample size for the training set

The document does not provide the exact sample size for the training set. It only mentions that the test set was "independent of the data used during model development (training/fine tuning/internal validation) and establishment of device operating points."

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

The document does not provide details on how the ground truth for the training set was established. It only mentions the data was used for "model development (training/fine tuning/internal validation)." Typically, similar to the test set, this would involve expert annotation and labeling.

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The Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), Pulsed Wave Doppler (PWD), and M-modes.

It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac, Lung.

The Lumify system is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

The Lung Application 3 is intended to assist healthcare professionals by providing automated image processing to analyze ultrasound images for lung-related conditions. Specifically, it evaluates the adequacy of ultrasound frames for clinical interpretation and assesses the appearance of pleural lines as normal or irregular.

The Lung Application 3 is a software-only functionality integrated into the Philips Lumify Diagnostic Ultrasound System, designed to support lung ultrasound examinations. It introduces two key features: pleural line assessment and lung image view quality assessment. The Pleural Line feature identifies and assesses the appearance of pleural lines as normal or irregular (defined as thickened, interrupted, fragmented, jagged, uneven, or otherwise non-smooth appearance on ultrasound). The lung view quality tool assesses the adequacy of ultrasound frames based on overall image appearance and the presence of any pleural lines. The application operates on a compatible Android-based commercial off-the-shelf device (e.g., tablet or smartphone) connected to Lumify transducers (C5-2, S4-1, and L12-4 models). It utilizes machine learning algorithms trained on a large dataset of expert-annotated lung ultrasound images to ensure accurate analysis. The workflow includes zone selection, image acquisition, navigation, review, and editing of results, with real-time feedback provided via visual indicators for image quality and pleural line analysis. The Lung Application 3 is intended for use by trained professionals in clinical settings to assist in evaluations of adult patients (18 years and older) with various pulmonary conditions. It does not introduce any new contraindications and is designed to comply with existing safety and operational standards.

Key Features:

• Software-based functionality for lung ultrasound enhancement.
• Pleural line classification as normal or irregular appearance.
• Lung view quality assessment for diagnostic adequacy.
• Real-time feedback via visual indicators.
• Machine learning-based algorithms for accurate image analysis.
• Compatibility with existing Lumify transducers and Android devices.

The Philips Lumify Diagnostic Ultrasound System (Lumify) is a mobile, durable, and reusable, software-controlled medical device, which is intended to acquire high-resolution ultrasound data and to display the data in B mode (2D), Pulsed Wave Doppler, Color Doppler, Combined (B+ Color), and M modes. The Lumify system is compatible with iOS and Android operating systems.

The Lumify Diagnostic Ultrasound System (iOS) utilizes:

1. A commercial off-the-shelf (COTS) iOS mobile item (smart phone or tablet)
2. The Philips Ultrasound Lumify software running as a medical device application on the COTS device
3. The Philips C5-2 Curved array USB transducer
4. The Philips L12-4 Linear array USB transducer
5. The Philips S4-1 Sector array USB transducer
6. Lumify Micro B Transducer Cable
7. Lumify Micro C Transducer Cable
8. Lumify USB-C to USB-C Transducer Cable
9. Lumify Power Module

Here's a breakdown of the acceptance criteria and the study proving the device's adherence, based on the provided FDA 510(k) clearance letter for the Philips Lumify Diagnostic Ultrasound System with Lung Application 3:

Acceptance Criteria and Reported Device Performance

Study Details

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

• Test Set Sample Size: The document does not explicitly state the exact numerical sample size for the test set. It mentions that the machine learning algorithms were trained on a "large dataset of expert-annotated lung ultrasound images" and that the retrospective data analysis evaluated the performance on a set of images to assess agreement with ground truth. More specific numbers for the test set are not provided.
• Data Provenance: The data was described as "retrospective data analysis study evaluated the performance of two artificial intelligence algorithms integrated into the Philips Lumify Diagnostic Ultrasound System for automated classification of lung view quality and pleural line appearance during clinical LUS examinations." The country of origin for the data is not specified.

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

• Number of Experts: The document does not explicitly state the number of experts used to establish ground truth. It refers to "expert-annotated lung ultrasound images" and "qualified clinical experts" when establishing acceptance criteria based on inter-rater agreement.
• Qualifications of Experts: The experts are referred to as "qualified clinical experts." Specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.

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

• The document does not specify the adjudication method used for establishing ground truth for the test set. It mentions "expert-annotated," implying multiple experts, but the process for resolving disagreements (if any) is not detailed.

4. 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 MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not explicitly described in this document as part of the performance evaluation for this 510(k) clearance. The study focused on the standalone performance of the AI algorithms against expert-established ground truth.

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

• Yes, a standalone study was done. The performance evaluation described in Section 8, "Non-Clinical Performance Data," is a standalone assessment of the AI algorithms. It evaluated "algorithm agreement with ground truth labels." The results presented for PABAK, concordance, and Kappa are all measures of the algorithm's performance independent of real-time human interaction.

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

• The ground truth was established by expert annotation/consensus. The document states, "machine learning algorithms trained on a large dataset of expert-annotated lung ultrasound images" and "evaluated algorithm agreement with ground truth labels." The acceptance criteria were also "established based on published inter-rater agreement ranges for lung view quality and pleural line irregularity among qualified clinical experts."

7. The sample size for the training set:

• The document states, "It utilizes machine learning algorithms trained on a large dataset of expert-annotated lung ultrasound images." A specific numerical sample size for the training set is not provided.

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

• The ground truth for the training set was established through expert annotation. The document explicitly mentions "machine learning algorithms trained on a large dataset of expert-annotated lung ultrasound images."

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The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic imaging system intended for use by sufficiently trained healthcare professionals for ultrasound imaging, measurement, and analysis of the human body, which is intended to be used in a hospital or medical clinic.

The system is intended for use in the following clinical applications: Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), OB/Gyn and Urology.

Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Directional Power Doppler, Tissue Harmonic Imaging, Tissue Doppler Imaging, 3D/4D Imaging mode, Strain Elastography, Contrast imaging and Combined modes: B/M, B/PWD, B/THI, M/Color M, B/Color Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD.

This X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/SU11C CU Digital Color Doppler Ultrasound System (hereafter as "X11 Exp Series Digital Color Doppler Ultrasound System") is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array phased array and etc.

This system consists of a console with touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes.

This system is a portable, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, contrast, 3D/4D.

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The ASUS Ultrasound Imaging System (Model: LU800 Series) is a software-based imaging system and accessories intended for use by qualified and trained healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body.

The modes of operation include B mode, M mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD). Specific clinical applications and exam types including:

LU800L
General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic, Musculoskeletal (conventional), Musculoskeletal (superficial), Peripheral vessel, Other(Carotid), Pulmonary, interventional guidance(includes free hand needle/ catheter)

LU800C
Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Urology, Musculoskeletal (conventional), OB/Gyn, Cardiac (adult), Cardiac(pediatric), Peripheral vessel, interventional guidance(includes free hand needle/ catheter)

LU800M
Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic, Urology, Musculoskeletal (conventional), OB/Gyn, Cardiac(adult), Cardiac (pediatric), Peripheral vessel

LU800PA
Fetal, General abdominal imaging, Pediatric, Cardiac (adult), Cardiac (pediatric), Pulmonary

LU800E
Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Trans-rectal, Trans-vaginal, Urology, OB/Gyn, interventional guidance(includes free hand needle/ catheter)

The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients.

The ASUS Ultrasound Imaging System (Model: LU800 Series) is a portable, software controlled, handheld ultrasound system used to acquire and display hi-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) mobile device.

I. The imaging system software runs as an app on a mobile device.

II. The imaging system software can be download to a commercial off-the-shelf (COTS) mobile device and utilizes an icon touch-based user interface.

III. The imaging system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range portable personal device.

IV. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components

The device is intended for use in environments where healthcare is provided by qualified and trained healthcare professionals, but not intended for use in emergency medical service, ambulance, or aircraft.

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Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Pediatric, small organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, musculo-skeletal (conventional), musculo- skeletal (superficial), thoracic/pleural, Cardiac Adult, Cardiac Pediatric and Peripheral vessel exams.

It is intended to provide 50Hz shear wave speed measurements (ViTE: Visual Transient Elastography) and estimates of tissue stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (LiSA: Liver Ultra-Sound Attenuation) in internal structures of the body.

It is also intended to measure spleen stiffness using ViTE at 100 Hz shear wave frequency.

The liver stiffness measurement by ViTE may aid the physician in determining the likelihood of cirrhosis and may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of liver fibrosis.

The coefficient of attenuation measurement by LiSA may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of hepatic steatosis.

ViTE and LiSA is indicated as a non-invasive aid for the clinical management, diagnosis, and monitoring of patients with liver disease, as part of an overall assessment of liver.

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.

Modes of operation include: B, M, PW Doppler, CWD, Color Doppler, Amplitude Doppler, Tissue Harmonic Imaging, Biopsy guidance, Color M, Contrast imaging (Contrast agent for Liver), ViTE, LiSA and Combined mode: B+M, PW+M, Color+B, Power+B, PW+Color+B, Power+PW+B, iScape View, TDI.

The Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 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, PW Doppler, CWD, Color Doppler, Amplitude Doppler, Tissue Harmonic Imaging, Biopsy guidance, Color M, Contrast imaging (Contrast agent for Liver), ViTE, LiSA and Combined mode: B+M, PW+M, Color+B, Power+B, PW+Color+B, Power+PW+B, iScape View, TDI.

The Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 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.

Compared to the predicate device Hepatus 7 (K200643), the new features of the subject device are listed in the table below.

Items: Indications for uses, New features: small organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, musculo-skeletal (conventional), musculo-skeletal (superficial), thoracic/pleural, Cardiac Adult, Cardiac Pediatric.
Items: Indications for uses, New features: Spleen stiffness measurement using ViTE at 100 Hz.

The liver stiffness measurement by ViTE may aid the physician in determining the likelihood of cirrhosis and may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of liver fibrosis.

The coefficient of attenuation measurement by LiSA may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of hepatic steatosis.

ViTE and LiSA is indicated as a non-invasive aid for the clinical management, diagnosis, and monitoring of patients with liver disease, as part of an overall assessment of liver.

Probes: LFC5-1s, L9-3s, L15-3RCs, P4-2s
Needle-guided brackets: NGB-034, NGB-011, NGB-043
Functions: iScape View, CW, Tissue Doppler Imaging, Spleen ViTE, Small Parts Package, Pediatrics Package, Nerve Package, Cardiology Package, Emergency&Critical Package

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The multifunctional ultrasound scanner is used to collect, display, and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes.

Main applications

• Cardiac
  • Districts: Cardiac Adult, Cardiac Pediatric (including newborns)
  • Invasive access: Transesophageal
• Vascular
  • Districts: Neonatal, Adult Cephalic, Vascular
  • Invasive access: Not applicable
• General Imaging
  • Districts: Abdominal, Musculo-skeletal, Neonatal, Pediatric, Small Organ (Testicles, Breast, Thyroid), Urologic
  • Invasive access: Intraoperative (Abdominal), Laparoscopic, Transrectal
• Women Health
  • Districts: OB/Fetal, Gynecology
  • Invasive access: Transrectal, Transvaginal

The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Power Doppler, Tissue Velocity Mapping (TVM), Combined modes, Elastosonography, 3D/4D and CnTI.

The ultrasound scanner is suitable for use in health institutions and is designed for ultrasound practitioners.

7600 Ultrasound System is a portable based ultrasound device used to perform diagnostic general ultrasound studies.

7600 Ultrasound System is equipped with two LCD Color Displays. The first LCD Color Display is the main output device used to display the acquisition image, the acquisition configuration and the exam results. The second LCD is provided with Touch panel and is used as a flexible input control device because its easy configurability.

The device uses the physical properties of the ultrasound (i.e. sound waves with frequency above 20 kHz and that are not audible to the human ear) for the visualization of deep structures of the body by recording the reflections or echoes of ultrasonic pulses directed into the tissues and of the Doppler effect, i.e. the frequency-shifted ultrasound reflections produced by moving targets (usually red blood cells) in the bloodstream, to determine both direction and velocity of blood flow in the target organs.

The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Power Doppler, Tissue Velocity Mapping (TVM), Combined modes. 7600 Ultrasound System also manages Elastosonography, 3D/4D and CnTI.

Several types of probes are used to cover different needs in terms of geometrical shape and frequency range.

7600 Ultrasound System can drive Phased array, Convex array, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes).

7600 Ultrasound System is equipped with wireless capability.

7600 Ultrasound System will be available on the market in two models with the following commercial names: MyLabC25, MyLabC30.

The difference between MyLabC25 and MyLabC30 models is only in the licenses configuration.

7600 Ultrasound System, defined herein, is a new portable version of the cart-based 6600 Ultrasound System previously cleared under K243253.

The proposed 7600 Ultrasound System includes a new software version that combines features FDA-cleared and already available in the predicate and reference devices (K243253 and K241671). No new functionalities have been introduced in the current software release compared to the version previously cleared.

7600 Ultrasound System employs the same fundamental technological characteristics as its predicate device cleared via K243253.

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