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The Ultrasound Imaging System is a software-based imaging system and accessories intended for use by qualified physicians and 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:

LX Series:
Ophthalmic,Fetal,General abdominal imaging,Pediatric,Small organ (Nerve, prostate, scrotum, breast),Neonatal cephalic,Trans-rectal,Trans-vaginal,Urology,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,Other (Carotid),Pulmonary,Nerve

128 Series:
Ophthalmic,Fetal,General abdominal imaging,Pediatric,Small organ (Nerve, prostate, scrotum, breast),Neonatal cephalic,Trans-rectal,Trans-vaginal,Urology,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

LU700 Series:
Ophthalmic,Fetal,General abdominal imaging,Pediatric,Small organ (Nerve, prostate, scrotum, breast),Neonatal cephalic,Trans-rectal,Trans-vaginal,Urology,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

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

The Ultrasound Imaging System 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

A complete list of all the probes and indications including:

Dual headed probe

LX Series:

LX128LC
Linear transducer: Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

Convex transducer: Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

LX128LP
Linear transducer: Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

Phased Array transducer: ,Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric),Pulmonary,FAST/EFAST,Nerve

LX192LC
Linear transducer: Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superf-dotorial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

Convex transducer: ,Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

Single headed probe

128 Series:

LK128C
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

LK128L
Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

LK128LH
Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

LK128M
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter)

LK128PA
Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric),Pulmonary,FAST/EFAST,Nerve

LK128E
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Trans-rectal,Trans-vaginal,Urology,OB/Gyn,interventional guidance (free hand needle/ catheter)

LU700 Series:

LU700L
General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

LU710L
Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

LU710LH
Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

LU700C
General abdominal imaging,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

LU710C
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

LU710M
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter)

LU710PA
Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric),Pulmonary,FAST/EFAST,Nerve

LU710E
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Trans-rectal,Trans-vaginal,Urology,OB/Gyn,interventional guidance (free hand needle/ catheter)

The provided FDA 510(k) clearance letter and summary for Leltek Inc.'s Ultrasound Imaging Systems (K243226) address the addition of new dual-headed probes (LX series) to existing cleared devices. While it asserts that the new models meet safety and performance standards, the document does not provide specific acceptance criteria or detailed study results for device performance in the format requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K241161) and compliance with various recognized standards (e.g., IEC 60601 series, ISO 10993 series). It states that "No additional clinical testing is required" due to the nature of the changes being additions of transducers with established technologies.

Therefore, the requested information cannot be fully extracted directly from this document. However, I can reconstruct what parts are mentioned or implied.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

Request for Acceptance Criteria and Study Details

The provided document (FDA 510(k) Clearance Letter - Leltek Inc. Ultrasound Imaging Systems, K243226) details a submission for adding new dual-headed probes (LX series) to an already cleared Ultrasound Imaging System. It asserts that the new models meet safety and performance standards equivalent to the predicate device, thereby requiring no additional clinical testing.

The document does not provide specific acceptance criteria or detailed study results for device performance in the format of a comparative table or a comprehensive study description as requested for a new AI/software-based medical device. Instead, it relies on the principle of substantial equivalence and compliance with recognized standards for hardware modifications.

However, it does provide information on the safety and performance evaluations conducted to support the substantial equivalence.

Requested Information Breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided as clear, quantifiable acceptance criteria or reported device performance metrics in the given document.
The document states that the devices comply with various standards, which inherently means they meet the performance requirements within those standards. It mentions:

• "full compliance with acoustic output, biocompatibility, cleaning, and disinfection effectiveness"
• "maximum acoustic output level is under the FDA recommended limit"
• "All the safety and performance tests of the device meet the essential requirements."

Without specific numerical targets for metrics like accuracy, sensitivity, or specificity (which are common for AI/software devices, but not the primary focus here for a hardware add-on to an imaging system), a table cannot be constructed. The performance is assessed against the established safety and performance of the predicate device and relevant industry standards.

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

Not applicable in the context of this 510(k) submission for new transducers.
The submission focuses on the safety and performance of the hardware (new transducers) and their integration with existing software. It explicitly states, "No additional clinical testing is required." Therefore, there is no mention of a clinical "test set" with patient data or its provenance. The testing would be on the physical device's characteristics (e.g., acoustic output, EMC, biocompatibility).

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

Not applicable. As no clinical "test set" or diagnostic performance study is described, there's no mention of experts establishing ground truth for such a test.

4. Adjudication method for the test set

Not applicable. As no clinical "test set" or diagnostic performance study is described, there's no mention of an adjudication method.

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

No. This is not an AI/Software as a Medical Device (SaMD) submission focused on aiding diagnosis, but rather a submission for a new hardware component (ultrasound transducers) to an imaging system. Therefore, no MRMC study or AI assistance effect size is mentioned.

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

No. This is not an AI/SaMD submission.

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

Not applicable. For this type of submission, the "ground truth" for demonstrating safety and performance relates to engineering specifications, physical measurements (e.g., acoustic output, electrical safety), and material properties (e.g., biocompatibility testing results), rather than clinical diagnostic accuracy against pathology or expert consensus.

8. The sample size for the training set

Not applicable. This submission is for hardware. There is no mention of a "training set" in the context of an algorithm or AI.

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

Not applicable. As there is no training set mentioned, this information is not available.

Summary of Device Safety and Performance Assessment (from the Document):

The document indicates that the substantial equivalence is established based on the following:

• Compliance with recognized standards: A comprehensive list of IEC and ISO standards for medical electrical equipment, usability, software lifecycle, biological evaluation (biocompatibility), risk management, and quality management is provided (Pages 14-15).
• Acoustic Output: The device is tested and determined to be in "full compliance with acoustic output" and the "maximum acoustic output level is under the FDA recommended limit" (Page 16).
• Biocompatibility: The new models are deemed to have "biosafety equivalence" and passed "biocompatibility" tests (Page 16).
• Cleaning and Disinfection: Demonstrated "cleaning, and disinfection effectiveness" (Page 16).
• Software and Hardware Equivalence: The new LX Series probes "utilizes the same software, cover material, and transducer specifications as the 128 Series but replaces a similar PCBA with a dual-headed probe, maintaining the same block diagram." (Page 16)
• No Pragmatic Detriments: The changes "have no pragmatic detriments" (Page 16).

In essence, Leltek Inc. demonstrated that the new LX series transducers behave similarly to their predicate devices and comply with relevant safety standards, thus no further clinical performance studies were deemed necessary for this specific 510(k) submission.

Ask a specific question about this device

The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals. Specific clinical applications remain the same as previously cleared: Fetall OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Vascular; Transvaginal (including GYN); Transrectal

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 and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/ PWD, B/ Elastography. The Voluson™ Expert 18, Voluson™ Expert 20, Voluson™ Expert 22 is intended to be used in a hospital or medical clinic.

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate real-time three-dimensional imaging supporting all standard acquisition modes.

The provided document describes the predicate devices as the Voluson Expert 18, Voluson Expert 20, Voluson Expert 22. The K-number for the primary predicate device is K231965. The document does NOT describe the acceptance criteria or study that proves the device meets the acceptance criteria for those predicate devices. Instead, it details the testing and acceptance criteria for new or updated AI software features introduced with the new Voluson Expert Series devices (K242168).

Here's a breakdown of the requested information based on the AI testing summaries provided for the new/updated features: Sono Pelvic Floor 3.0 (MHD and Anal Sphincter), SonoAVC Follicle 2.0, and 1st/2nd Trimester SonoLyst/SonoLystlive.

Acceptance Criteria and Device Performance for New/Updated AI Features

1. Table of Acceptance Criteria and Reported Device Performance

• On datasets marked as "Good Image Quality": success rate should be 70% or higher.
• On datasets marked as "Challenging Image Quality": success rate should be 60% or higher.
  Overall MHD:
• On "Good IQ" datasets: 70% or higher.
• On "Challenging Quality" datasets: 60% or higher. | MHD Tracking:
• Good Image Quality: 89.3%
• Challenging Image Quality: 77.7%
  Minimum MHD Frame Detection:
• Good Image Quality: 89.3%
• Challenging Image Quality: 83.3%
  Maximum MHD Frame Detection:
• Good Image Quality: 90.66%
• Challenging Image Quality: 77.7%
  Overall MHD:
• On Good IQ datasets: 81.9%
• On Challenging quality datasets: 60.9% |
  | Sono Pelvic Floor 3.0 (Anal Sphincter)| - On datasets marked as "Good Image Quality": success rate should be 70% or higher.
• On datasets marked as "Challenging Image Quality": success rate should be 60% or higher. | The document states "Verification results on actual verification data is as follows" but then the table structure is missing the actual performance metrics for Anal Sphincter. It only lists "On Good IQ datasets: 81.9%" and "On Challenging quality datasets: 60.9%" under the MHD section, implying those might be overall success rates for the entire Sono Pelvic Floor 3.0 feature across both components, but it's not explicitly clear. Therefore, the specific reported device performance for "Anal Sphincter" is not clearly presented in the provided text. |
  | SonoAVC Follicle 2.0 | - The success rate for the AI feature should be 70% or higher. (This appears to be an overall accuracy criterion). | Accuracy:
• On test data acquired together with train cohort: 94.73%
• On test data acquired consecutively post model development: 92.8%
• Overall Accuracy: 93.6%

Dice Coefficient by Size Range:

• 3-5 mm: 0.937619
• 5-10 mm: 0.946289
• 10-15 mm: 0.962315

• 15 mm: 0.93206 |
  | 1st Trimester SonoLyst/SonoLystLive | - The average success rate of SonoLyst 1st Trimester IR, X and SonoBiometry CRL and overall traffic light accuracy is 80% or higher. | The document states "The average success rate...is 80% or higher" as the acceptance criteria and then mentions "Data used for both training and validation has been collected across multiple geographical sites..." but it does not explicitly provide the numerically reported device performance value that met or exceeded the 80% criterion. |
  | 2nd Trimester SonoLyst/SonoLystLive | - Acceptance criteria are met for both subgroups (variety of ultrasound systems/data formats vs. target platform). (The specific numerical criteria for acceptance are not explicitly stated, but rather that the performance met them for demonstration of generalization.) | The document states "For both subgroups the acceptance criteria are met." but does not explicitly provide the numerically reported device performance values. |

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

• Sono Pelvic Floor 3.0 (MHD & Anal Sphincter):

  • Test Set Sample Size: 93 volumes for MHD, 106 volumes for Anal Sphincter.
  • Data Provenance: Data is provided by external clinical partners who de-identified the data. Original data collected in 4D volume Cines (*.vol5 or *.4dv6) or 4D/3D volume acquisitions (*.vol2 or *.4dv3).
  • Countries: A diverse range of countries contributed to the test data including Italy, U.S.A, Australia, Germany, Czech Republic, France, India (for MHD); and Italy, U.S.A, France, Germany, India (for Anal Sphincter).
  • Retrospective/Prospective: The data collection method ("re-process data to our needs retrospectively during scan conversion") suggests a retrospective approach to assembling the dataset, although a "standardized data collection protocol was followed for all acquisitions." New data was also acquired post-model development from previously unseen sites to test robustness.

• SonoAVC Follicle 2.0:

  • Test Set Sample Size: 138 datasets, with a total follicle count of 2708 across all volumes.
  • Data Provenance: External clinical partners provided de-identified data in 3D volumes (*.vol or *.4dv).
  • Countries: Germany, India, Spain, United Kingdom, USA.
  • Retrospective/Prospective: The data was split into train/validation/test at the start of model development (suggesting retrospective). Additionally, consecutive data was acquired post-model development from previously unseen systems and probes to test robustness (suggesting some prospective element for this later test set).

• 2nd Trimester SonoLyst/SonoLystLive:

  • Test Set Sample Size: "Total number of images: 2.2M", "Total number of cine loops: 3595". It's not explicitly stated how much of this was test data vs. training data, but it implies a large dataset for evaluation.
  • Data Provenance: Systems used for data collection included GEHC Voluson V730, E6, E8, E10, Siemens S2000, and Hitachi Aloka. Formats included DICOM & JPEG for still images and RAW data for cine loops.
  • Countries: UK, Austria, India, and USA.
  • Retrospective/Prospective: Not explicitly stated, but "All training data is independent from the test data at a patient level" implies a pre-existing dataset split rather than newly acquired prospective data solely for testing.

• 1st Trimester SonoLyst/SonoLystLive:

  • Test Set Sample Size: SonoLyst 1st Trim IR: 5271 images, SonoLyst 1st Trim X: 2400 images, SonoLyst 1st Trim Live: 6000 images, SonoBiometry CRL: 110 images.
  • Data Provenance: Systems included GE Voluson V730, P8, S6/S8, E6, E8, E10, Expert 22, Philips Epiq 7G. Formats included DICOM & JPEG for still images and RAW data for cine loops.
  • Countries: UK, Austria, India, and USA.
  • Retrospective/Prospective: "All training data is independent from the test data at a patient level." "A statistically significant subset of the test data is independent from the training data at a site level, with no test data collected at the site being used in training." This indicates a retrospective collection with careful splitting, and some test data from unseen sites.

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

• Sono Pelvic Floor 3.0 (MHD & Anal Sphincter), SonoAVC Follicle 2.0, 2nd Trimester SonoLyst/SonoLystLive, 1st Trimester SonoLyst/SonoLystLive:

  • Number of Experts: Three independent reviewers.
  • Qualifications: "at least two being US Certified sonographers, with extensive clinical experience."

• Additional for 2nd Trimester SonoLyst/SonoLystLive & 1st Trimester SonoLyst/SonoLystLive:

  • For sorting/grading accuracy review, a "5-sonographer review panel" was used. Qualifications are not specified beyond being sonographers.

4. Adjudication Method for the Test Set

• Sono Pelvic Floor 3.0 (MHD & Anal Sphincter), SonoAVC Follicle 2.0, 2nd Trimester SonoLyst/SonoLystLive, 1st Trimester SonoLyst/SonoLystLive:
  • The evaluation was "based on interpretation of the AI output by reviewing clinicians." The evaluation was "conducted by three independent reviewers."
  • For 2nd and 1st Trimester SonoLyst/SonoLystLive, where sorting/grading accuracy was determined, if initial sorting/grading differed from the ground truth (established by a single sonographer then refined), a 5-sonographer review panel was used, and reclassification was based upon the "majority view of the panel." This implies a form of majority vote adjudication for these specific sub-tasks.
  • The general approach for the three reviewers, especially when evaluating AI output, implies an independent review, and while not explicitly stated, differences would likely lead to discussion or a form of consensus/adjudication. However, a strict 'X+Y' model (like 2+1 or 3+1) is not explicitly detailed.

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

• The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study designed to measure how human readers improve with AI vs. without AI assistance. The studies described are primarily aimed at assessing the standalone performance or workflow utility of the AI features.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, standalone performance was assessed for all described AI features. The "Summary test Statistics" and "Verification Results" sections for each feature (Sono Pelvic Floor 3.0, SonoAVC Follicle 2.0, 1st/2nd Trimester SonoLyst/SonoLystLive) report the algorithm's direct performance (e.g., success rates, accuracy, Dice coefficient) against the established ground truth, indicating standalone evaluation. The "interpretation of the AI output by reviewing clinicians" method primarily focuses on validating the AI's direct result rather than a comparative human performance study.

7. The Type of Ground Truth Used

• Expert Consensus/Annotation:
  • Sono Pelvic Floor 3.0 (MHD): Ground truth was established through a "two-stage curation process." Curators identified the MHD plane and marked anatomical structures. These curated datasets were then "reviewed by expert arbitrators."
  • Sono Pelvic Floor 3.0 (Anal Sphincter): Ground truth involved "3D segmentation of the Anal Canal using VOCAL tool in the 4D View5 Software." Each volume was "reviewed by a skilled arbitrator for correctness."
  • SonoAVC Follicle 2.0: The "Truthing process for training dataset" indicates a "detailed curation protocol (developed by clinical experts)" and a "two-step approach" with an arbitrator reviewing all datasets for clinical accuracy.
  • 2nd Trimester SonoLyst/SonoLystLive & 1st Trimester SonoLyst/SonoLystLive: Ground truth for sorting/grading was initially done by a single sonographer, then reviewed by a "5-sonographer review panel" for accuracy, with reclassification based on majority view if needed.

8. The Sample Size for the Training Set

• Sono Pelvic Floor 3.0 (MHD): Total Volumes: 983
• Sono Pelvic Floor 3.0 (Anal Sphincter): Total Volumes: 828
• SonoAVC Follicle 2.0: Total Volumes: 249
• 2nd Trimester SonoLyst/SonoLystLive: "Total number of images: 2.2M", "Total number of cine loops: 3595". (The precise breakdown of training vs. test from this total isn't given for this feature, but it's a large overall dataset).
• 1st Trimester SonoLyst/SonoLystLive: 122,711 labelled source images from 35,861 patients.

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

• Sono Pelvic Floor 3.0 (MHD): A two-stage curation process. First, curators identify the MHD plane and then mark anatomical structures. These curated datasets are then reviewed by expert arbitrators and "changes/edits made if necessary to maintain correctness and consistency in curations."
• Sono Pelvic Floor 3.0 (Anal Sphincter): "3D segmentation of the Anal Canal using VOCAL tool in the 4D View5 Software." Curation protocol involved aligning the volume and segmenting the Anal Canal. Each volume was "reviewed by a skilled arbitrator for correctness."
• SonoAVC Follicle 2.0: A "two-step approach" was followed. First, curators were trained on a "detailed curation protocol (developed by clinical experts)." Second, an automated quality control step confirmed mask/marking availability, and an arbitrator reviewed all datasets from each curator's completed data pool for clinical accuracy, with inconsistencies discussed by the curation team.
• 2nd Trimester SonoLyst/SonoLystLive & 1st Trimester SonoLyst/SonoLystLive: The images were initially "curated (sorted and graded) by a single sonographer." If these differed from the ground truth (which implies a higher standard or previous ground truth for comparison), a "5-sonographer review panel" reviewed them and reclassified based on majority view to achieve the final ground truth.

Ask a specific question about this device

The Venue Fit is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices, for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training. Venue Fit is intended to be used in a hospital or medical clinic. Venue Fit clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Color M Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD, B/CWD. B/Color/CWD.

The Venue Fit is a general purpose diagnostic ultrasound system. It is a portable system with a touch screen interface. It can be powered through an electrical wall outlet or an internal battery. It utilizes linear, convex, and phased array transducers and supports standard acquisition modes. Compatible biopsy kits can be used for needle-guidance procedures. The system can display the patient's ECG trace synchronized to the scanned image. A barcode reader and RFID scanner are available as additional input devices. A roller bag is available for transport. It is capable of wired or wireless internet connection and meets DICOM requirements for image storage and archiving.

The provided text describes specific features and functionalities of the GE Venue Fit ultrasound system but does not contain information about acceptance criteria, reported device performance, or a specific study proving it meets acceptance criteria as typically outlined for AI/CADe devices.

The document is a 510(k) Premarket Notification Submission for the Venue Fit ultrasound system. It primarily focuses on demonstrating substantial equivalence to a predicate device (K220848 Venue Fit) regarding general imaging capabilities, technological characteristics, safety, and effectiveness.

Here's what can be extracted and what is explicitly stated as not applicable:

1. A table of acceptance criteria and the reported device performance
Not provided in the document. The document focuses on performance testing in the context of safety and effectiveness, rather than specific diagnostic accuracy metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document states, "The subject of this premarket submission, Venue Fit, did not require clinical studies to support substantial equivalence." Therefore, there is no test set in the context of a clinical study for diagnostic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical studies were required.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies were required.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document does not describe an AI/CADe device that assists human readers, nor does it present results from an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Venue Fit is a diagnostic ultrasound system, not a standalone algorithm. Its capabilities, like "Auto Volume Flow (AVF)" or "Bladder Volume Tool", are functionalities of the ultrasound system itself, not standalone AI algorithms with reported diagnostic performance metrics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no clinical studies requiring ground truth establishment were mentioned.

8. The sample size for the training set
Not applicable. The document does not describe a machine learning algorithm that would have a training set. The "Venue Fit" is a general-purpose diagnostic ultrasound system. While it has "semi-automated tools," the document does not detail their development or any AI-specific training sets.

9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI algorithm.

Summary of what is present:

The document establishes substantial equivalence through a comparison to a predicate device (K220848 Venue Fit) and a list of reference devices (K231301 Vscan Air, K161047 LOGIQ P9 and LOGIQ P7, K231989 LOGIQ E10s/LOGIQ Fortis, K180374 Voluson S8/ S10/ S10 Expert, K202035 Vscan Air).

It outlines several non-clinical tests performed to ensure safety and compliance with standards:

• Acoustic output evaluation
• Biocompatibility
• Cleaning and disinfection effectiveness
• Thermal, electrical, electromagnetic, and mechanical safety

The system states compliance with various voluntary standards including:

• Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Guidance for Industry and Food and Drug Administration Staff (February 21, 2023)
• AAMI/ANSI ES60601-1 (Medical Electrical Equipment - Part 1: General Requirements for Safety)
• IEC 60601-1-2 (Electromagnetic Compatibility Requirements and Tests)
• IEC 60601-2-37 (Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment)
• IEC 62359 (Ultrasonics Field characterization Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields)
• ISO 10993-1 (Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process)
• ISO 14971 (Application of risk management to medical devices)
• NEMA PS 3.1 3.20e (Digital Imaging and Communications in Medicine (DICOM) Set)
• AAMI TIR69 (Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems)

Quality assurance measures applied during development include:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification & Validation)
• Safety testing (Verification)

The conclusion states that based on equipment design similarities, conformance to recognized performance standards, and performance testing, the proposed Venue Fit is considered substantially equivalent in safety, effectiveness, and performance to the predicate device.

Crucially, the document explicitly states: "The subject of this premarket submission, Venue Fit, did not require clinical studies to support substantial equivalence." This means that the information requested regarding acceptance criteria, device performance, sample sizes, ground truth, experts, adjudication, and MRMC/standalone studies in a diagnostic performance context is not available within this document.

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The Venue Go is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices, for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training. Venue Go is intended to be used in a hospital or medical clinic. Venue Go clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.

Venue Go is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis.

The Venue Go is a compact, portable system with a small footprint. The system can be hand carried using an integrated handle, placed on a horizontal surface, attached to a mobile cart or wall mounted. It has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The system can be powered through an electrical wall outlet for long term use or from an internal battery for a short time with full functionality and scanning.

The Venue Go utilizes a variety of linear, convex, and phased array transducers which provide high imaging performance and support standard acquisition modes. Compatible biopsy kits can be used for needle-guidance procedures.

The system is capable of displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal which is used as an input for gating during scanning. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis.

A barcode reader and RFID scanner are available as additional input devices. A roller bag will also be available for the customer to use when transporting the system.
Venue Go is capable of wireless communication through a built-in Wireless LAN device. The system meets DICOM requirements to support image storage and archiving (local PACS or products such as Q-Path) and allows for output to printing devices.

The provided FDA 510(k) summary for the GE Venue Go ultrasound system does not include acceptance criteria for artificial intelligence (AI) performance or the study details to prove the device meets such criteria.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Venue Go K220800) and other reference devices, based on:

• Identical fundamental scientific technology.
• Similar imaging capabilities, technological characteristics, safety, and effectiveness.
• Minor updates to the Indications for Use statement for clarity regarding operator qualifications.
• Addition of new transducers already cleared on other GE devices.
• New features/functionality such as Auto Volume Flow (AVF), Bladder Volume Tool, expanded MSK diagrams, Venue Coach, electronic software delivery, expanded Auto Inferior Vena Cava (IVC), Auto B-Lines, Real-Time ejection fraction (RT-EF), cNerve for Vscan Air CL and SL probes (which are already cleared with these AI features on predicate Vscan Air K231301 and reference LOGIQ E10s/LOGIQ Fortis K231989), and AppAPI functionality.
• Conformity to recognized performance standards for acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety.
• Quality assurance measures like risk analysis, requirements/design reviews, and various levels of testing.

Specifically, the document states: "The subject of this premarket submission, Venue Go, did not require clinical studies to support substantial equivalence." This indicates that any evaluation of "AI performance" as typically understood (e.g., using a test set with ground truth, performance metrics, and acceptance criteria) was not part of this 510(k) submission.

The AI-related features mentioned (Auto IVC, Auto B-Lines, RT-EF, cNerve) are noted as being "expanded" or already "cleared" on predicate/reference devices (K231301 Vscan Air, K231989 LOGIQ E10s/LOGIQ Fortis). This implies their performance was likely evaluated as part of those previous 510(k) submissions, and the current submission is leveraging that prior clearance for their inclusion in the Venue Go system when used with the particular probes.

Therefore, since this 510(k) does not present new AI performance study data for the Venue Go, I cannot extract the requested information. The document focuses on demonstrating that the Venue Go, with its included features, is substantially equivalent to existing cleared devices, rather than proving novel AI algorithm performance.

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The Venue is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country. state or other local municipality in which he or she practices, for ultrasound imaging, measurement. display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training.

Venue is intended to be used in a hospital or medical clinic. Venue clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic. Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B. M. PW Doppler, CW Doppler, Color M Doppler, Color M Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD,B/CWD, B/Color/CWD.

The proposed Venue system is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities. Venue can be used in offices, clinics and hospitals.

The Venue is a mobile system with a small footprint that easily fits into tight spaces and positioned to accommodate the sometimes-awkward work settings of the point of care user.

The Venue has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The single surface screen provides easy cleanability. Articulated monitor arm enables flexible display positions in order to be accessible and clearly visible in both user-standing and sitting positions.

The system is capable of displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal which is used as an input for gating during scanning. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis.

Barcode reader and RFID scanner are available as additional input devices.

The Venue has a battery that allows for scanning without the need to plug in to an electrical outlet.

System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices.

The Venue utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Compatible biopsy kits can be used for needle-guidance procedures.

The system includes several automated tools designed to simplify and shorten the workflow time of the healthcare professional for some common assessments.

The provided document is a 510(k) Summary for a diagnostic ultrasound system (Venue). It does not contain information about acceptance criteria and a study that proves the device meets those criteria for software performance.

The document states:

• "The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence." (Page 10)
• The comparison is primarily focused on hardware, transducers, and general features, and states that the Venue system is substantially equivalent to a predicate device regarding "imaging capabilities, technological characteristics and safety and effectiveness." (Page 6)

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies because this document does not present such a study. The submission focuses on demonstrating substantial equivalence to a predicate device, which often relies on non-clinical tests and comparisons rather than new clinical performance studies.

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Venue Sprint is a general-purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country. state or other local municipality in which he or she practices, for ultrasound imaging, measurement. display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training.

The Venue Sprint is intended to be used in a hospital, medical clinic, home environment and road/air ambulance.

Venue Sprint clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric, 40 kg and above) and interventional guidance (includes free hand tissue biopsy, fluid drainage, vascular access). Modes of operation include: B. M. PW Doppler, Color Doppler and Harmonic Imaging.

Venue Sprint is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis. The Venue Sprint is used together with the Vscan Air probes and provides the user interface for control of the probes and the needed software functionality for analysis of the ultrasound images and saving/storage of the related images and videos.

This document describes the Venue Sprint diagnostic ultrasound system (K240206). Based on the provided text, the device is an ultrasound system and does not appear to have AI/ML functionality that requires specific performance metrics beyond general safety and effectiveness. The document explicitly states that clinical studies were not required to support substantial equivalence.

Therefore, most of the requested information regarding acceptance criteria, specific performance tables, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not present in this 510(k) summary for the Venue Sprint.

Here's an attempt to answer the questions based only on the provided text:

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

The provided document does not contain a specific table of acceptance criteria or performance metrics for an AI/ML component. The "acceptance criteria" for this device appear to be compliance with various safety and performance standards for diagnostic ultrasound systems.

• Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Guidance
• AAMI/ANSI ES60601-1
• IEC 60601-1-2
• IEC 60601-2-37
• IEC 62359
• ISO 10993-1
• ISO 14971
• NEMA PS 3.1-3.20e (DICOM)
• AAMI TIR69
• IEC 60601-1-11
• IEC 60601-1-12 |
  | Quality Assurance Measures | Risk Analysis, Requirements Reviews, Design Reviews, Testing (unit, integration, performance, safety) |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "The subject of this premarket submission, Venue Sprint, did not require clinical studies to support substantial equivalence." Therefore, there is no mention of a test set, its sample size, or data provenance from clinical studies within this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical studies requiring ground truth establishment for a test set were conducted or described.

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

Not applicable, as no clinical studies requiring ground truth establishment for a test set were conducted or described.

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

Not applicable. The document does not describe any AI-assisted features or MRMC studies. The device is described as a "general-purpose diagnostic ultrasound system." The phrase "expanding cleared Auto Inferior Vena Cava (IVC), Auto B-Lines, Real Time ejection fraction (RT-EF) and cNerve" refers to features already cleared on other predicate devices and their expansion to new probes on this system; it does not constitute a new AI feature with its own performance study described here.

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

Not applicable, as no standalone algorithm performance study is described.

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

Not applicable, as no clinical studies requiring ground truth were conducted or described.

8. The sample size for the training set

Not applicable, as no machine learning model training is described in this submission.

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

Not applicable, as no machine learning model training is described in this submission.

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U-Lite PRO is a Handheld Ultrasound system intended for use in environments where healthcare is provided by qualified and trained healthcare professionals.

It can therefore be used in different configurations, especially:

• In medical offices (general practitioner's office)
• In clinics & hospitals (incl. in emergency and critical care units)
• In a field hospital

It is used in imaging or examinations rooms.

It can be used at the bedside. It is not intended for direct use in a sterile environment.

The U-Lite PRO is not compatible with the use of the HF surgery device or in an MRI system.

U-Lite PRO is indicated for the visualization of structures and dynamic processes in the human body using ultrasound imaging and fluid flow analysis for diagnosis in the following clinical applications:

• ophthalmic
• fetal/obstetric,
• gynecological,
• abdominal,
• pediatric,
• neonatal cephalic
• adult cephalic
• small organ,
• trans-vaginal,
• trans-rectal,
• cardiac adult & pediatric
• peripheral vascular,
• urology (including prostate)
• musculoskeletal (both conventional and superficial)

Note : The application fields are dependent on the selected probes and the modes of operations.

Modes of operations include:

• B-Mode (B)
• M-Mode (M)
• Color Doppler (CD)
• Power Doppler (PD)
• Spectral Pulsed-Wave Doppler (PWD)
• Continous Wave Doppler (CWD)
• Combined :(B+M; B+CD; B+ PD; B+PWD)

U-Lite PRO is a compact, ultralight battery powered general purpose diagnostic ultrasound scanner. The U-Lite PRO is a notebook-size, battery-operated, generalpurpose track 3 diagnostic ultrasound system. The U-Lite PRO can be handheld measuring 180mm x 115mm x 20mm and weighing 0.7 kg (approximately 1.54 lbs.). The unit is a handheld ultrasound (HHU) imaging system with interchangeable probes with optional stand.

The U-Lite PRO is used to acquire and display high-resolution LED screen images, realtime ultrasound data and display the data as B Mode, M Mode, PWD Mode, CWD Mode, Color Doppler Mode, Power Doppler, Tissue Harmonic Imaging Mode, and Combined (B +M; B+CD; B+PD; B+PWD).

The provided text is a 510(k) summary for the U-Lite PRO ultrasonic pulsed Doppler imaging system. It focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with various standards, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics for an AI/CADe (Computer-Aided Detection/Diagnosis) component.

Therefore, the document does not contain the information required to populate a table of acceptance criteria for AI performance, nor does it describe a study proving an AI/CADe device meets such criteria. Specifically:

• No acceptance criteria for AI were provided. The document describes acoustic output limits and measurement accuracy for the ultrasound system itself, but not for any AI/CADe features.
• No specific study proving AI performance was described. The document states, "No clinical studies were conducted," and the "Non-clinical Performance Testing" sections focus on electrical safety, EMC, usability, biocompatibility, and software verification/validation, along with acoustic output and measurement range/accuracy of the ultrasound hardware. There is no mention of a study to assess the performance of an AI algorithm in detection, diagnosis, or reader assistance.

Given the information provided in the document, it is not possible to complete the requested table or describe a study proving the device meets AI/CADe acceptance criteria, as the submission does not detail any AI component or its performance evaluation. The device described appears to be an ultrasound imaging device, not explicitly an AI/CADe system for image analysis.

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