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The LOGIQ e is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid.

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

LOGIQ e clinical application include: Ophthalmic, fetal/ob; abdominal (gyn & urology); pediatric; small organ (breast, testes, thyroid); neonatal and adult cephalic; cardiac (adult & pediatric); peripheral vascular; musculoskeletal conventional & superficial; transrectal; transvaginal; transesophageal; intraoperative (abdominal, thoracic and peripheral); thoracic/pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve block; vascular access). Mode 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/PWD, B/Color/PWD, B/Power/PWD.

The proposed LOGIQ e system is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement, display and analysis of the human body and fluid.

It is an ultrasound imaging & analysis system, consisting of a compact console with LCD, and control panel with new keyboard.

The system has digital acquisition, processing and display capability and operates from an integrated battery or AC/DC power adapter. It has one battery pack as standard configuration and also with an optional battery pack to be provided for additional power for longer scanning time.

The system also has an optional height-adjustable cart for comfortable standing and sitting positions. The cart is approx. 510mm length, 510mm width and adjustable height from 830 to 1130mm with optional battery box consisting of a charger box and 4pcs battery Packs to supply the system power from the cart.

LOGIQ e utilizes a variety of electronic array transducers operating in linear, curved, sector/phased array, TEE.

The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.

The system supports electronic delivery of software. The system allows the user, in addition to service personnel, to update the SW by logging into a GEHC website to download SW available to them and install it on the system. Download from the GEHC website requires an account.

The provided text does NOT contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document is a 510(k) premarket notification for a GE Medical Systems Ultrasound device, the LOGIQ e. It primarily focuses on demonstrating substantial equivalence to a predicate device and other reference devices, not on the performance of a new AI-powered feature with specific acceptance criteria.

The document discusses:

• Device Name: LOGIQ e
• Regulation Number/Name: 21 CFR 892.1550, Ultrasonic Pulsed Doppler Imaging System
• Regulatory Class: Class II
• Product Codes: IYN, IYO, ITX
• Indications for Use: General purpose diagnostic ultrasound for various clinical applications.
• Predicate Device: LOGIQ e (K151028)
• Reference Devices: Vivid iq (K221148), Versana Premier (K210438), Venue Go (K202233)
• Changes/Additions: New transducers, software features (AutoEF, Scan assistant, Strain Elastography, Probe check, Imaging Insights, Tricefy Uplink), hardware (new industrial design, secondary battery option, thermal solution), and accessories.
• Non-Clinical Tests: Acoustic output, biocompatibility, cleaning/disinfection, thermal, electromagnetic, and mechanical safety, compliance with various IEC, ISO, AAMI, and NEMA standards. Quality assurance measures like risk analysis, design reviews, and testing are mentioned.
• Clinical Tests: The document explicitly states: "The subject of this premarket submission, LOGIQ e, did not require clinical studies to support substantial equivalence."

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for the test and training sets, as these details are not present in the provided context. The submission is for a general diagnostic ultrasound system and not for a specific AI algorithm with performance metrics.

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The Voluson SWIFT, Voluson SWIFT+ is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals 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. Voluson SWIFT, Voluson SWIFT+ clinical applications include: Fetal Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatio; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal(including UrologyProstate) (TR); Transvaginal (TV).

Mode of operation include: B, M, AMM (Anatonical M-Mode), PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, HD-Flow (High Definition-Flow), Harmonic Imaging, Coded Pulse, 3D/4D Inaging mode, Elastography, B-Flow and Combined modes: BM, B/ Color, B/PWD, B/Power/PWD. The Voluson SWIFT / Voluson SWIFT+ are intended to be used in a hospital or medical clinic.

The subject device is a Track 3 device, primarily intended for general-purpose radiology evaluation and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. The Voluson SWIFT, Voluson SWIFT+ provide digital acquisition, processing and display capability. Voluson SWIFT, Voluson SWIFT+ consist of a mobile console with control panel, full touch monitor, optional image storage and printing devices. It provides high-performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. It utilizes a variety of linear, curved linear, matrix phased array transducer including mechanical and electronic scanning transducers which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for Auto-Caliper:

Study Details for Auto-Caliper Feature:

2. Sample Size Used for the Test Set and Data Provenance:
* Test Set Sample Size: 67 volumes, with a total of 134 follicles evaluated (2 follicles per volume).
* Data Provenance: Data collected across multiple geographical sites: Germany, India, Spain, United Kingdom, USA. The data was collected from women examined in regular clinical practice. It was de-identified by external clinical partners.
* Retrospective/Prospective: The data appears to be retrospective, as it was "collected from patients from regular clinical practice" and then "de-identified."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
* Number of Experts: Not explicitly stated as a single number. The verification for the Auto-Caliper AI feature was performed by "clinical experts" following a specific protocol. The "truthing process" for training data mentions "clinical experts" and a "senior sonographer" reviewing a random subset. It is reasonable to infer that experts with similar qualifications were used for the test set ground truth.
* Qualifications: "Clinical experts" and a "senior sonographer." Specific experience levels (e.g., "10 years of experience") are not provided.

4. Adjudication Method for the Test Set:
* Method: The outputs were evaluated by the clinical expert and the assessment was documented as Pass/No result/Fail. This suggests a qualitative assessment by individual experts rather than a specific multi-reader consensus method like 2+1 or 3+1 for resolving discrepancies. However, the quantitative evaluation involved calculating the deviation from manual measurements, which likely served as the definitive ground truth for performance metrics.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
* Was one done? No. The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was compared.

6. Standalone (Algorithm Only) Performance Study:
* Was one done? Yes. The provided data is a standalone performance evaluation of the Auto-Caliper AI feature, comparing its predictions against ground truth (manual measurements by experts). The evaluation directly reports the deviation of the AI predictions from the manual measurements.

7. Type of Ground Truth Used:
* Type: Expert consensus / Manual measurements. The ground truth was established by "clinical experts" who manually placed calipers following a specific protocol. The "deviation of the measurements predicted by the Auto-Caliper tool from the manual measurements" confirms that expert manual measurements served as the reference.

8. Sample Size for the Training Set:
* Sample Size: 223 volumes.

9. How the Ground Truth for the Training Set Was Established:
* Method: A "curation protocol has been developed by clinical experts to be followed by curators." Additionally, "during and after the data curation process, a senior sonographer reviewed a random subset of the curated dataset for clinical accuracy." This indicates a structured process involving clinical expert input and review to establish the ground truth for the training data.

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The Vivid T8/Vivid T9 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by qualified and trained Healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab, and in private medical offices. The systems support the following clinical applications: Fetal/ Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Ceplalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculosketal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transesophageal, Transrectal, Transvaginal, Interventional guidance (including Biopsy, Fluid Drainage), Thoracic/Pleural, Intraoperative(Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color M, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD, B/Color/PWD, B/Power/PWD.

Vivid T9/Vivid T8 is a Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability.

The Vivid T9/Vivid T8 consists of a mobile console with control panel color LCD touch panel, LCD display monitor and optional image storage and printing devices. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, and dual array including dedicated CW transducers.

The user-interface includes an operator control panel, a 21.5-inch-wide screen LCD monitor (mounted on an arm for rotation and/or adjustment of height), a 10.1-inch touch panel with multi-touch capabilities and alpha-numeric keyboard.

The smart standby battery is an option to allow the system to not have to be powered down when moving from room to room. Imaging is not allowed when it is not plugged in.

The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.

Vivid T8 and Vivid T9 are based on the same SW platform and similar HW design. Each system may have different configurations available. The configurations may differ by available SW-options and transducers provided commercially. Vivid T9 has height-adjustable control panel, while Vivid T8's control panel can't be adjustable. Vivid T9 has monitor flexible arm, while Vivid T8 has a monitor fixed arm and monitor flexible arm as an option.

The product named Vivid T9 represents the system that has the full functionality and is offered with full support for transducers.

The GE Vivid T8/Vivid T9 ultrasound system includes AI algorithms named Easy Auto EF and Easy AFI LV. The acceptance criteria and the study proving the device meets these criteria are described below.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Number of Individual Patients' Images: 135 images
• Number of Exams: 45 exams (assumed 45 patients, exact number of patients unknown due to anonymization)
• Data Provenance:
  • Country of Origin: Europe, Asia, US
  • Retrospective/Prospective: Not explicitly stated, but implies retrospective collection from various clinical sites.

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

• Initial Ground Truth Establishment: Two certified cardiologists.
• Adjudication Panel: A panel of experienced experts. Specific number and years of experience not provided, beyond "experienced experts."

4. Adjudication Method for the Test Set

The adjudication method appears to be a 2 + 1 method (or similar consensus-based approach):

1. Two certified cardiologists performed manual delineation and reviewed each other's annotations.
2. A consensus reading was conducted where the two cardiologists discussed their agreement.
3. For annotations where the two cardiologists could not agree, a panel of experienced experts further reviewed and established the consensus.
4. The final ground truth comprised annotations agreed upon by the two cardiologists, and the consensus annotations from the expert panel review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not conducted. The document focuses on the standalone performance of the AI algorithm.

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

Yes, a standalone performance evaluation of the AI algorithm was conducted, specifically measuring the accuracy (Dice score) of the AI algorithm(s) against an established ground truth.

7. The Type of Ground Truth Used

The ground truth used was expert consensus. It was established through a multi-step process involving initial independent delineation by two certified cardiologists, their consensus discussions, and further review by a panel of experienced experts for disagreements.

8. The Sample Size for the Training Set

The document does not provide the sample size for the training set. It only states that the testing dataset was independent of the training data.

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

The document does not explicitly describe how the ground truth for the training set was established. It only mentions that the testing dataset was ensured to be independent from the training data by using datasets from "different clinical sites for testing as compared to the clinical sites for training."

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The Vivid iq is high-performance compact diagnostic ultrasound system designed for cardiovascular and shared services. It is intended for use by Healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Vivid iq clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy), Thoracic/Pleural, Intraoperative(Vascular), Intracardiac and Intraluminal. Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Real-Time (RT) 3D Mode (4D), Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power/PWD. The device is intended for use in an indoor hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab, in private medical offices, and in limited settings outside of professional Healthcare facilities.

The proposed Vivid ig system is a general-purpose, Track 3, diagnostic ultrasound device, primarily intended for cardiovascular diagnostic use and shared service imaging. It is an ultrasound imaging & analysis system, consisting of a compact console with control panel including a track pad, color LCD Touch Panel that includes an on-screen alfa-numeric keyboard. The system also has an optional height-adjustable cart for comfortable standing and sitting positions. An extended battery is integrated within the Vivid ig cart and provides additional power for longer scanning time.

There are options for image storage, USB wireless connectivity, cardiac signal input for cardiac gating and output capabilities to printing devices. Vivid ig utilizes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array, or dual array format, including dedicated CW transducers and real time 3D transducer. The system can also be used with compatible ICE transducers.

The system includes electronics for transmit and receive of ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.

Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The document describes the performance of the AI algorithms, "Easy Auto EF" and "Easy AFI LV," which are components of the Vivid iq system. The primary acceptance criterion appears to be the accuracy of the AI algorithm in terms of its Dice score.

Note: The document only provides performance metrics for the AI algorithms specifically, not for the entire Vivid iq system's overall clinical performance beyond safety and equivalence to predicates for its general ultrasound functions.

Study Details for AI Algorithms (Easy Auto EF and Easy AFI LV)

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

• Number of images: 135 images.
• Number of exams: 45 exams.
• Assumed number of patients: 45 patients (exact number unknown due to anonymization).
• Provenance: Retrospective data collected from different countries, including Europe, Asia, and the US. The document states that the testing dataset came from different clinical sites than the training data to ensure independence.

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

• Initial Experts: Two certified cardiologists.
• Adjudication Panel: An unspecified "panel of experienced experts" for cases where the initial two cardiologists did not agree. Specific qualifications for the panel are not provided beyond "experienced experts."

4. Adjudication method for the test set:

• Primary Method: Consensus reading between two certified cardiologists. They performed manual delineation and then reviewed each other's annotations. They discussed and agreed upon annotations.
• Secondary Method: For annotations where the two cardiologists could not agree, a "panel of experienced experts" further reviewed and established a consensus ground truth. This suggests a 2+1 (or 2+N) approach for disagreements.

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 MRMC comparative effectiveness study involving human readers with and without AI assistance is described in the provided text. The evaluation focuses solely on the standalone performance of the AI algorithm against expert-established ground truth.

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

• Yes, a standalone performance evaluation of the AI algorithm was conducted. The reported Dice scores (91-92% or higher) reflect the algorithm's accuracy in autonomously delineating structures.

7. The type of ground truth used:

• Expert consensus was used as the ground truth. This was derived from manual delineations by two certified cardiologists, with a panel of experienced experts resolving disagreements.

8. The sample size for the training set:

• The sample size for the training set is not specified in the provided document. It only mentions that datasets from different clinical sites were used for training compared to the test set.

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

• The document does not explicitly describe how the ground truth for the training set was established. However, given the description for the test set, it is highly probable that a similar expert-driven delineation and consensus process was used.

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The Venue Fit is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue Fit is intended to be used in a hospital or medical clinical applications include: abdominal (GYN and Urology), thoracic pleural, ophthalmic. Fetal/OB. Small Organ (including breast, testes, thyroid), VascularPeripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatic), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid dramage, 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: BM, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.

Venue Fit 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 analvsis. The Venue Fit is a compact, portable system with a small footprint. The system can be hand carried using the integrated handle, placed on a horizontal surface (if kickstand is attached), attached to a mobile cart or mounted on the wall. 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 Fit 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 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 Fit is capable of wired or wireless internet connection. The system meets DICOM requirements to support users image storage and archiving needs (local PACS or products such as Q-Path) and allows for output to printing devices. The user documentation is available electronically.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (cNerve feature)

Note: The document does not provide specific performance percentages against the 70% and 80% thresholds. It states that success criteria were based on conformance to ground truth and that preliminary surveys identified appropriate thresholds for pixel and frame accuracy for the intended use.

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

• Sample Size:
  • Sequences: 124 sequences
  • Frames: 3776 frames
  • Individuals: 44 individuals
• Data Provenance: USA, Japan, Israel (Retrospective, as it was a pre-existing dataset used for verification)

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

• Number of Experts: A single clinical expert.
• Qualifications of Experts: "clinical expert" - further specific qualifications (e.g., years of experience, specialty) are not provided in the document.

4. Adjudication Method for the Test Set

• Adjudication Method: None explicitly stated. Ground truth annotations were performed by a single clinical expert.

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 MRMC comparative effectiveness study was done to evaluate human reader improvement with AI assistance. The testing focused on the standalone performance of the cNerve feature.

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

• Yes, a standalone study was performed. The "AI Summary of Testing" directly addresses the performance of the cNerve algorithm against ground truth annotations.

7. The Type of Ground Truth Used

• Type of Ground Truth: Expert consensus (from a single clinical expert) on anatomical areas of nerve bundles within individual frames.

8. The Sample Size for the Training Set

• The document does not specify the sample size for the training set. It only states that the data used for verification is "completely distinct" from the training data.

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

• The document does not specify how the ground truth for the training set was established. It only ensures that the verification data was distinct from the training data.

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The Venue is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. 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 pediatic), 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, Color Doppler, Color M Doppler, Power Doppler, Harnonic 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. 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. The Venue has a battery that allows for scanning without the need to plug in to an electrical outlet. The system is capable of wireless communication. 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 provided document describes the FDA 510(k) premarket notification for the GE Medical Systems Venue diagnostic ultrasound system. While the primary focus of the document is on establishing substantial equivalence to a predicate device, it also includes an "AI Summary of Testing" specifically for a feature called "cNerve." This summary provides some details about the cNerve feature's acceptance criteria and performance evaluation.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text, focusing on the cNerve feature.

Acceptance Criteria and Study for cNerve Feature

The cNerve feature is designed to "detect and track nerves during the scouting stage of a nerve block procedure, prior to inserting the needle to inject the anesthetic material."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size:
  • Individuals: A total of 44 individuals.
  • Sequences: 124 sequences. Each individual contributed up to 2 sequences per view location, often from both laterals (left and right).
  • Frames: 3776 frames.
• Data Provenance: Retrospective, collected from "USA, Japan, Israel."

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

• Number of Experts: A single clinical expert.
• Qualifications: "A single clinical expert" - specific qualifications (e.g., years of experience, specialty) are not detailed in the provided text.

4. Adjudication Method for the Test Set

• Adjudication Method: "None" explicitly mentioned. Ground truth annotations were "obtained as follows: Frames from scouting sequences were annotated by a single clinical expert, where the anatomical area of the nerves was marked in each frame." This indicates a single-expert annotation without a specified adjudication process.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or performed for the cNerve feature in this summary. The AI testing described focuses on standalone algorithm performance against a single expert's ground truth.

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

• Standalone Performance: Yes. The "AI Summary of Testing" describes the evaluation of the cNerve feature's "accuracy" based on its detections conforming to ground truth annotations. The acceptance criteria heavily focus on the algorithm's ability to meaningfully and successfully detect nerves in sequences and frames, suggesting a standalone performance evaluation.

7. The Type of Ground Truth Used

• Type of Ground Truth: Expert consensus (from a single expert). The ground truth was established by "a single clinical expert, where the anatomical area of the nerves was marked in each frame."

8. The Sample Size for the Training Set

• Training Set Sample Size: Not specified in the provided document. The summary only mentions that the "data used for verification is completely distinct from that used during training process and there is no overlap between the two."

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

• Training Set Ground Truth Establishment: Not specified in the provided document. The summary only states that the training data and verification data are distinct.

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The Venue Go is a general purpose diagnostic ultuse by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. 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, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatic), 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 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. The Venue Go utilizes a varietv 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 builtin 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 user documentation is available electronically.

The provided document is a 510(k) Premarket Notification Submission for the GE Venue Go ultrasound system. It includes a specific section detailing the AI feature cNerve. Based on this information, here's a description of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance (cNerve AI Feature)

Important Note: The document outlines the acceptance criteria for cNerve but does not explicitly provide the measured numerical performance results of the device against these criteria. It states that the "cNerve performance requirements" are listed but does not follow up with a section detailing the actual tested performance numbers.

2. Sample Size and Data Provenance for the Test Set

• Sample Size (Individuals): A total of 44 individuals contributed to the verification dataset.
• Sample Size (Sequences/Frames): The test dataset included 124 sequences and 3776 frames.
• Relationship between Samples: Each individual contributed up to 2 sequences per view location (often both left and right laterals were scanned).
• Demographic Distribution:
  • Gender: Male and Female
  • Age: 18-82 years
  • Ethnicity/Country: USA, Japan, Israel
• Subgroups Tested: The algorithm performance was verified via frame accuracy on all demographic subgroups: Gender (M/F), Age (=60), BMI (25). It was also tested for all supported nerve block locations and supported probe types.
• Data Provenance: The document implies the data was collected from a mix of clinical settings (implied by "USA, Japan, Israel" for ethnicity/country) and clinical scenarios ("all supported nerve block locations and all supported probe types"). The study type (retrospective or prospective) is not explicitly stated, but the process of collecting and annotating an existing dataset suggests a retrospective approach for the dataset creation for validation.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: A single clinical expert annotated the frames from scouting sequences.
• Qualifications of Experts: The specific qualifications (e.g., years of experience, specific specialty like "radiologist") of the "single clinical expert" are not detailed in the provided text.

4. Adjudication Method for the Test Set

• The ground truth was established by a single clinical expert. Therefore, there was no adjudication method described (e.g., 2+1, 3+1 concensus), as only one expert was involved in marking the ground truth.

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

• The document does not indicate that an MRMC comparative effectiveness study was done to evaluate how much human readers improve with AI vs without AI assistance. The study focuses solely on the standalone performance measurement of the cNerve algorithm against defined ground truth.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done. The "AI Summary of Testing" section describes the evaluation of the cNerve algorithm's accuracy, focusing on its ability to detect and track nerve bundles independently. The acceptance criteria ("Sequence accuracy requirement - for testing overall cNerve performance") explicitly relate to the algorithm's performance.

7. Type of Ground Truth Used

• The ground truth used was expert annotation/consensus (from a single expert). The frames were "annotated by a single clinical expert, where the anatomical area of the nerves was marked in each frame."

8. Sample Size for the Training Set

• The sample size for the training set is not provided in the document. The document explicitly states: "The data used for verification is completely distinct from that used during training process and there is no overlap between the two." However, it does not disclose details about the training data itself.

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

• The document does not describe how the ground truth for the training set was established. It only mentions that the test data was distinct from the training data.

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The Versana Balance 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. Versana Balance clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Parts (includes breast, testes, thyroid), Cardiac Adult, Cardiac Pediatric, Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Transcranial, Transrectal, Transvaginal, 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, Power Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, and Combined modes: B/M, B/Color, B/PWD, B/ Color/PWD, B/Power/PWD, B Flow/B Flow Color.

Versana Balance is intended to be used in a hospital or medical clinic.

The Versana Balance is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The system is a mobile console that includes an operator control panel, display monitor and transducers.

The console provides digital acquisition, processing and display capability. The system has an internal battery to allow for acquisition while the system is not plugged into a power source. Acquisition can also be done while the system is connected to an AC power source.

The operator control panel includes function keys, trackball, an alfa-numeric keyboard and a touch panel as input sources of the device.

The variety of transducers include convex, linear, sector, and mechanical 4D transducers. The access types include trans- body surface, transrectal, transvaginal and transcranial.

Data can be imported or exported by DVD, USB, LAN or WiFi if the USB wireless adapter is connected to the system. An external ECG module has been verified to use as input for gating/triggering during scanning. The system has a HDMI port, VGA connection port, Audio out port, S-Video port, and a Composite Out port connection. The system has an external AC outlet to allow connection of a printer box of the console and an option for external Printer USB Isolator for other printers to connect. The system supports one way, Bluetooth communication capability from the system to a personal device to allow for sharing of the patient's data/images when the external Bluetooth USB adapter is connected to the system.

The provided text is a 510(k) summary from the FDA for a diagnostic ultrasound system (Versana Balance). While it details the device, its intended use, and comparisons to predicate devices, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria for AI features.

The document states: "The subject of this premarket submission, Versana Balance, did not require clinical studies to support substantial equivalence." This means that the device's clearance was based on its similarity to previously cleared devices, rather than a new clinical study demonstrating specific performance metrics for AI in humans.

The document mentions an "Artificial Intelligence (AI) feature that identifies key anatomies/organs", namely "Whizz Label". It also states that "Whizz Label was first cleared with Versana Premier (K210438)". This implies that any performance data or acceptance criteria for this AI feature would have been part of the K210438 submission, not K220446.

Therefore,Based on the provided text, I cannot extract the information required to populate the table or answer the questions related to the acceptance criteria and the study proving the device meets those criteria for the AI features requested. This document focuses on the substantial equivalence of the overall ultrasound system to predicate devices, rather than detailed performance metrics of its AI components.

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The LOGIQ P&P9/P10 is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ(Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac(adult and pediatric); Peripheral Vascular; Musculo-skeletal Converticial; Urology(including Prostate); Transrectar, Transvaginal; Transesophageal and Intraoperative(Abdominal, Vascular).

Modes of operation include: B, M, PW, Doppler, CW 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 P8/P9/P10 is intended to be used in a hospital or medical clinic.

The LOGIQ P10, LOGIQ P9 and LOGIQ P8 are full featured, Track 3 device, primarily intended for general purpose diagnostic ultrasound system which consists of a mobile console approximately 55 cm wide, 74 cm deep and 160 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.4-inch LCD touch screen and color 23.8-inch LCD image display with HDMI audio function. All probes on the subject device have been previously cleared on the predicate K203114 with the exception of the E7C8L-RS which was previously cleared on predicate K210438. All probes available as accessories for the subject systems LOGIQ P Series uses are unchanged from the cleared predicates. They are made of the same materials and their shape is unchanged.

The provided FDA 510(k) premarket notification for the GE LOGIQ P10, LOGIQ P9, and LOGIQ P8 ultrasound systems does not contain information about acceptance criteria or a study proving the device meets specific performance criteria for an AI/CAD product.

This document is primarily concerned with demonstrating substantial equivalence to previously cleared predicate devices (K203114 LOGIQ P10/P9/P8 Diagnostic Ultrasound System and K210438 Versana Premier). The focus is on the general diagnostic ultrasound system and its various imaging modes, not a specific AI or computer-aided detection (CAD) application with distinct performance metrics.

The "modifications" mentioned, such as the addition of the E7C8L-RS transducer, Stepper Volume Measurement support, "EZ DICOM Viewer," "Probe Health Test," and the KOIOS SW (KOIOS Breast) connectivity, are described as either hardware additions, software features for workflow/data management, or connectivity to a separate cleared CAD system (KOIOS DS for Breast, K190442).

Therefore, it is explicitly stated in the "Summary of Clinical Tests" section:

"The subject of this premarket submission, LOGIQ P10, LOGIQ P9 and LOGIQ P8, did not require clinical studies to support substantial equivalence."

Without a specific clinical study detailed in this document to demonstrate the performance of an AI/CAD component against acceptance criteria, I cannot provide the requested information. The document focuses on demonstrating safety and effectiveness through compliance with standards and comparing the new device's features to those of cleared predicate devices.

If this were a submission for a new AI/CAD specific algorithm, the information you requested would typically be required and detailed within the 510(k) submission, often in sections dedicated to performance testing, clinical validation, or human factors studies.

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