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Vivid E80 / Vivid E90 / Vivid E95 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrios; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate), Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

Vivid E80 / Vivid E90 / Vivid E95 systems are Track 3 diagnostic ultrasound systems primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E80 / Vivid E90 / Vivid E95 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers. Vivid E80 will support 2D imaging, while Vivid E90 and Vivid E95 will support real time 3D imaging in addition to 2D, and incorporate several real-time 3D transducers. Vivid E80 / Vivid E90 / Vivid 95 consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, an OLED or LCD color video display, DVI connector for optional external video display, and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.

This document is a 510(k) Premarket Notification submission for the GE Vivid E80, Vivid E90, and Vivid E95 diagnostic ultrasound systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices and does not describe a study to establish new acceptance criteria or performance metrics for the core ultrasound imaging functionalities.

Instead, the submission highlights updates and new features compared to the predicate devices and confirms adherence to established safety and performance standards. Therefore, the device doesn't "meet acceptance criteria" in the sense of a novel clinical efficacy study, but rather demonstrates that changes and new features do not negatively impact safety or effectiveness, and that the device continues to conform to existing regulatory and voluntary standards.

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

1. Table of acceptance criteria and the reported device performance:

Since this is a submission for substantial equivalence based on updates to a previously cleared device (K173341) and new features, the "acceptance criteria" discussed are primarily compliance with general safety and performance standards and demonstrating that the new features do not compromise this. There are no specific numerical performance metrics for clinical efficacy presented for the overall device in this document, as the core diagnostic ultrasound functionality has been cleared previously.

The document lists compliance with several voluntary standards:

For the new features, the "acceptance criteria" are implied to be that they perform as intended and are substantially equivalent to existing functionalities or enhance workflow without impacting safety or effectiveness. The document asserts this by stating:

• CT Fusion: "substantially equivalent to the V Nav feature with Fusion on LOGIQ E9 (K082185)."
• 4D Marker: "an extension of existing image annotation capabilities on the predicate Vivid E90 / Vivid E95 (K173341)."
• 4D Auto LAO: "substantially equivalent to the 4D Auto RVQ already present on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K173341)."
• AutoEF 2.0 & AFI 2.0: "workflow improvement of functionality already available on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K173341)." and "expanded ... for pediatric use."
• Automatic View Recognition: "workflow improvement to AFI 2.0 and Auto EF 2.0 and provides an automated alternative to manual image selection already available on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K173341)."
• "Whitelisting", "Texture", "Hybrid Filter", 24" LCD monitor, reduced weight: Explicitly state "no impact on the safety or effectiveness of the clinical functionality" or device.

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 does not detail specific sample sizes or data provenance for a test set in the context of a clinical study for performance evaluation. The submission relies on non-clinical tests and demonstrations of substantial equivalence for feature updates rather than a new clinical performance study.

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)

No information provided. Clinical studies with expert ground truth establishment are not described for this submission.

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

No information provided, as clinical studies with adjudication methods are not 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

No MRMC comparative effectiveness study is mentioned in this document. The "Automatic View Recognition" feature uses a deep neural network, but its performance is described as an "automated alternative to manual image selection" and a "workflow improvement" to existing functionalities, rather than a comparative effectiveness study showing human reader improvement with AI assistance.

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

The document mentions "Automatic View Recognition" which is "new functionality based on deep neural network embedded into the software." While this suggests a standalone algorithm, no standalone performance metrics (e.g., sensitivity, specificity) are provided for this feature. Its role is described as a "workflow improvement" and "automated alternative" to manual processes.

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

For the new AI/software features, the "ground truth" seems to be implicitly the functionality of the predicate device or a clinical outcome (e.g., left atrium volumes as measured by the device for "4D Auto LAO"). However, the explicit method of establishing this ground truth (e.g., expert consensus on specific cases for validation) is not detailed in this summary.

8. The sample size for the training set

The document states that "Automatic View Recognition" is "new functionality based on deep neural network." However, it does not provide any information regarding the sample size of the training set used for this deep neural network.

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

The document does not provide any information regarding how the ground truth for the training set was established for the deep neural network used in "Automatic View Recognition."

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LIPOCONTROL is indicated for: Laser assisted lipolysis. LIPOCONTROL should be used to melt small amount of fat from small areas only such as chins or upper arms. LIPOCONTROL should not be used to melt larger volumes or areas of fat and on areas such as thighs, buttocks, or abdomen.

The medical device LIPOCONTROL is based on the use of a laser module allowing the emission of a beam of coherent light at 970nm ±10nm at a maximum power of 25W. The laser module consists of laser diodes assembled in series and optically aligned in order to focus in an optical fibre of 200um or more. The optical fibre is screwed onto the SMA 905 connector of the laser module. LipoControl contains a localisation system. This localisation system is based on a magnetic sensor (LipoBird), positioned on the handpiece and a field transmitter. With this localization system, an informative function and a safety function are built-in: The informative function is a 2D map (display on the device screen) which indicates the area where the energy is deposited and the total amount of energy delivered. The safety function is on the delivered power. Maximum output power and output fiber speed displacement are chosen by physician and delivered when footswitch is pressed and the output fiber speed displacement is over the pre-defined limit. If it the output fiber speed displacement is below the pre-defined limit then the delivered power is diminished. The 2D map can be displayed only if the treatment surfaces are inclined less than 35 decree relative to the observation plane defined by the user. The user can divide the treated area in adiacent areas with an andle less than 35 degree or use the device without these optional functions. The LipoControl includes the power supplies necessary to supply the laser and to ensure its temperature control using Peltier elements built on a ventilated radiator. In addition, the LIPOCONTROL includes the whole of electronics and the functions allowing the parameter setting of the laser and the safe functioning of the device. The adjustments of the parameters are done using a LCD (Liquid Crystal Display) screen and a touch screen controlled by a PC.

{
  "acceptance_criteria_study": {
    "1_acceptance_criteria_and_performance": {
      "table": [
        {
          "criteria": "Accuracy of the localization system in normal and worst-case situations (electrical noise, magnetic distortion)",
          "reported_performance": "In good agreement with theoretical accuracy claimed by the supplier of the localization module."
        },
        {
          "criteria": "Accuracy of the energy mapping display",
          "reported_performance": "Complies with the mathematical model of projection in 2D plan of 3D data and to the energy pattern defined by OSYRIS MEDICAL."
        },
        {
          "criteria": "Power regulation according to speed displacement (power diminished if speed below pre-defined limit, full power if speed above)",
          "reported_performance": "When the speed is below the set value, the power is regulated linearly depending on the speed. When the speed is above the set value, the power set is delivered."
        },
        {
          "criteria": "Stop of power delivery if the probe is outside the screen monitoring area",
          "reported_performance": "Checked and confirmed."
        },
        {
          "criteria": "Feasibility of defining Region of Interest (ROI) using Lipocontrol",
          "reported_performance": "Investigator was able to define the ROI using the Lipocontrol, and the ROI recorded by the system matched the one plotted on transparencies."
        },
        {
          "criteria": "Safety and efficacy (subject recovery time, pain/heat sensation, adverse events, subject satisfaction)",
          "reported_performance": "Recovery time less than 1 week. Minor and transitional pain or heat sensation observed. No serious adverse event occurred. Minor and transitional side effects occurred. On average, subjects very satisfied with both the procedure and clinical result."
        }
      ]
    },
    "2_sample_size_and_data_provenance": {
      "sample_size_test_set": "4 subjects (2 treated on the chin, 2 treated on the upper arms).",
      "data_provenance": "Prospective clinical feasibility study."
    },
    "3_number_and_qualifications_of_experts_for_ground_truth": {
      "number_of_experts": "Not explicitly stated. The study involved an 'investigator' who defined the ROI and assessed feasibility. It does not mention multiple experts for ground truth establishment for the device's technical functions but does refer to clinical assessment by 'investigator' and subject questionnaires.",
      "qualifications_of_experts": "Not specified beyond 'investigator'."
    },
    "4_adjudication_method": "Not explicitly stated. The document mentions the 'investigator' defining ROI and assessing feasibility. It does not describe an adjudication process for conflicting interpretations, implying a single assessment method or the details are not provided.",
    "5_mrmc_comparative_effectiveness_study": "No. This study was a feasibility study for a medical device (laser lipolysis system) itself, not an AI-assisted diagnostic device, and thus no MRMC study or human reader improvement effect size is relevant or reported.",
    "6_standalone_performance": "The performance data described for the localization system, energy mapping display, and power regulation are for the algorithm/device's standalone function (bench tests). The clinical feasibility study also assesses the device's function and safety in human use but doesn't compare it directly to unaided human performance in an 'AI vs. human' context.",
    "7_type_of_ground_truth": {
      "technical_functions": "Internal specifications, mathematical models, and supplier claims for the localization module for bench tests.",
      "clinical_feasibility": "Investigator-defined Region of Interest (ROI), comparison of recorded ROI to plotted transparencies, video review, subject questionnaires, and assessment of side effects for clinical tests."
    },
    "8_sample_size_training_set": "Not applicable for this device. This is a medical device (laser system) with a localization and energy regulation system, not an AI/ML model that requires a 'training set' in the traditional sense.",
    "9_ground_truth_for_training_set_establishment": "Not applicable as there is no traditional 'training set' for an AI/ML model for this device."
  }
}

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The Sonix Ultrasound Imaging System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial.

The system also provides the ability to measure anatomical structures (fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peribheral vessel, musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Sonix Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed(PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Morde, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console.

The system has an electrocardiography (ECG) display feature and support for a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording, capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage.

The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes.

The biopsy kits are accessories to the Sonix Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle guides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle guides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.

I am sorry, but the provided text does not contain specific acceptance criteria, study details, or performance metrics for the Sonix Ultrasound Scanner as you requested. The document is primarily a 510(k) summary for premarket notification, focusing on:

• Device Description: General features and function of the ultrasound system and its accessories.
• Intended Uses: A broad list of clinical applications for the system and various transducers.
• Comparison to Predicate Devices: Establishing substantial equivalence based on intended use, principles of operation, and technological characteristics.
• Safety Considerations: Compliance with general safety standards and acoustic output limits.
• Transducer Specifications: Detailed tables outlining the modes of operation and new/previously cleared indications for each transducer.

There is no mention of:

• Specific acceptance criteria (numerical thresholds for performance).
• Any particular study (e.g., clinical trial, bench study with performance data) to prove device meets acceptance criteria.
• Sample sizes used for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications to establish ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth was established for the training set.

The document highlights the device's compliance with general safety and acoustic output standards, but these are not presented as performance acceptance criteria in the context of clinical efficacy or diagnostic accuracy.

Therefore, I cannot populate the table or answer the specific questions you've posed based on the provided text.

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The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.

Electromagnetic tracking tool kit works in conjunction with images gathered by OEM imaging devices to provide physicians with a tool for image registration and/or tracking of instruments. This is accomplished by utilizing attachment brackets, needle guides, adhesive skin markers or fiducial markers, needles and other housings that are specially configured to contain an electromagnetic sensor. The electromagnetic sensor in the tracked instrument is used within an EM field introduced by OEM equipment. The position and orientation can be thus detected and combined with the acquired imaging to assist with navigating a tracked instrument. The system also utilizes accessories in conjunction with the system to allow the users additional options for protecting the equipment from contamination, needle guidance, and image registration.

The provided text describes a 510(k) summary for an Electromagnetic Tracking System. However, it does not contain any information regarding specific acceptance criteria, a study that proves the device meets those criteria, or performance data.

The document primarily focuses on:

• Intended Use: Electromagnetic tracking of instruments with respect to image data.
• Device Description: EM sensor within tracked instruments, used with OEM imaging devices, and various accessories (EMT sensor covers, EMT slot guide, skin markers).
• Predicate Devices: A list of previously cleared devices to which the current device claims substantial equivalence.
• Substantial Equivalence Claim: Based on equivalent intended uses, manufacturing materials, operating principles, and physical/operational specifications compared to predicate devices, with the only noted difference being qualification with the GE Logiq E9 system.
• FDA Clearance Letter: Confirming the 510(k) clearance and regulatory details.
• Indications for Use: Reiterating the intended use.

Therefore, I cannot provide the requested table and study details as they are not present in the input text. The document states that "There are no significant differences between the proposed and predicate devices except that they have now been qualified with the GE Logiq E9 system," which implies that the substantial equivalence argument, rather than a new performance study against specific acceptance criteria, was the primary basis for clearance.

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