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510(k) Data Aggregation
(167 days)
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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(154 days)
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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(146 days)
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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(137 days)
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.
| Acceptance Criteria Category | Reported Device Performance Summary (from document) |
|---|---|
| Acoustic Output | Complies with applicable medical device safety standards. |
| Biocompatibility | Complies with applicable medical device safety standards; Transducer material is biocompatible. |
| Cleaning and Disinfection Effectiveness | Complies with applicable medical device safety standards. |
| Thermal, Electrical, Electromagnetic, and Mechanical Safety | Complies with applicable medical device safety standards. |
| Voluntary Standards Compliance | Complies with: |
- 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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(121 days)
The LOGIQ Totus 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. LOGIQ Totus clinical applications include: Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac(Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal.
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging, Contrast Enhanced Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.
The system is intended to be used in Hospital or Clinical environments such as Intensive Care Unit(ICU, CVICU, CCU), Neonatal Intensive Care Unit(NICU), Pediatric Intensive Care Unit(PICU), Emergency Room, Operating Room, Outpatient Surgery Clinic, Radiology, Medical Office (Nurse Practitioner), Observational Units, Cath Lab, Clinic, Physician's Office, Labor/Deliver Unit and Oncology.
The LOGIQ Totus is full featured, Track 3 device, primarily intended for general purpose diagnostic ultrasound system which consists of a mobile console approximately 490mm wide(monitor width: 545mm), 835mm deep and 1415~1815mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls. 14-inch LCD touch screen and color 23.8-inch LCD & HDU image display.
The provided document contains information on two AI features: "Auto preset selection" and "Auto Abdominal Color Assistant". The acceptance criteria and study details for each are presented below.
Auto Preset Selection
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance (Summary Test Statistics) |
|---|---|
| The overall model success rate of the Abdomen, Air, Breast, Carotid, Leg, MSK, Scrotal, Thyroid and Carotid/Thyroid (Mixed) view suggestion is expected to be 80% or higher. | The document states, "The overall model success rate of the Abdomen, Air, Breast, Carotid, Leg, MSK, Scrotal, Thyroid and Carotid/Thyroid(Mixed) view suggestion is expected to be 80% or higher." This indicates the device met this criterion. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Number of individual patients' images collected from: 50+ patients
- Number of samples (images): 330+ images
- Data Provenance:
- Country of Origin: USA (57%) and Australia (43%)
- Retrospective/Prospective: Not explicitly stated, but the mention of "data collection protocol was standardized" suggests it might be retrospective collection of pre-existing data, or a controlled prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated how many individual sonographers/clinicians were involved.
- Qualifications of Experts: "Certified sonographer/clinician." No years of experience or specific board certifications are mentioned.
4. Adjudication method for the test set:
- Adjudication Method: "For the testing process, the results are generated by the AI software and the same are verified as Pass or Fail by a certified sonographer/clinician." This implies a single expert verification without explicit multi-reader adjudication (e.g., 2+1 or 3+1).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No MRMC comparative effectiveness study was explicitly mentioned for this AI feature. The testing method described focuses on the AI's success rate verified by experts, not on comparing human performance with and without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the "overall model success rate" refers to the algorithm's performance in suggesting views. The "verified as Pass or Fail by a certified sonographer/clinician" is likely a post-hoc verification of the algorithm's output, rather than an interactive human-in-the-loop study.
7. The type of ground truth used:
- Type of Ground Truth: Expert verification by certified sonographer/clinician, determining if the AI's view suggestion was a "Pass or Fail". This can be considered a form of "expert consensus" or "expert truth" (albeit with a single expert verification as mentioned in point 4).
8. The sample size for the training set:
- Not explicitly stated. The document only mentions that "The exams used for test/training validation purpose are separated from the ones used during training process and there is no overlap between the two." The sample size (330+ images from 50+ patients) is specified for the test set.
9. How the ground truth for the training set was established:
- Not explicitly stated. The document mentions that the test data was independent of the training data but doesn't detail the ground truth establishment for the training set. It's generally assumed that ground truth for training data in such AI applications would also be established by experts.
Auto Abdominal Color Assistant
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance (Summary Test Statistics) |
|---|---|
| The overall model success rate of the Aorta, Kidney, Liver, GB and Pancreas view suggestion is expected to be 80% or higher. | The document states, "The overall model success rate of the Aorta, Kidney, Liver, GB and Pancreas view suggestion is expected to be 80% or higher." This indicates the device met this criterion. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Number of individual patients' images collected from: 40 patients
- Number of samples (images): 280+ images
- Data Provenance:
- Country of Origin: USA (35%) and Australia (65%)
- Retrospective/Prospective: Similar to "Auto preset selection", not explicitly stated, but a "standardized data collection protocol" is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated how many individual sonographers/clinicians were involved.
- Qualifications of Experts: "Certified sonographer / clinician." No years of experience or specific board certifications are mentioned.
4. Adjudication method for the test set:
- Adjudication Method: "For the testing process, the results are generated by the AI software and the same are verified a Pass or Fail by a certified sonographer / clinician." This implies a single expert verification without explicit multi-reader adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No MRMC comparative effectiveness study was explicitly mentioned for this AI feature.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the "overall model success rate" refers to the algorithm's performance. The "verified as Pass or Fail by a certified sonographer / clinician" is likely a post-hoc verification of the algorithm's output.
7. The type of ground truth used:
- Type of Ground Truth: Expert verification by certified sonographer/clinician, determining if the AI's view suggestion was a "Pass or Fail".
8. The sample size for the training set:
- Not explicitly stated. The document only mentions that "The exams used for test/training validation purpose are separated from the ones used during training process and there is no overlap between the two." The sample size (280+ images from 40 patients) is specified for the test set.
9. How the ground truth for the training set was established:
- Not explicitly stated. Similar to the "Auto preset selection" feature, it's assumed expert input would have been used for training data ground truth, but no details are provided.
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(127 days)
LOGIQ E10 is intended for use by a qualified physician for ultrasound evaluation of Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIQ E10 is intended to be used in a hospital or medical clinic.
The LOGIQ E10 is a full featured, track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 991 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 12-inch highresolution color touch screen and 23.8-inch High Contrast LED LCD monitor.
Here's a breakdown of the acceptance criteria and study details for the "Auto Renal Measure Assistant" and "Auto Abdominal Color Assistant" features of the GE LOGIQ E10, based on the provided FDA 510(k) summary:
The document provides information for two distinct AI features: "Auto Renal Measure Assistant" and "Auto Abdominal Color Assistant". I will detail the information for each separately.
Auto Renal Measure Assistant
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Longitudinal Model: | |
| Accuracy > 80% | 96.45% accuracy with 95% CI of ±1.26% |
| Transverse Model (Width Measurements): | |
| Accuracy > 70% | 92.94% accuracy with 95% CI of ±3.02% |
| Transverse Model (Height Measurements): | |
| Accuracy > 70% | 93.13% accuracy with 95% CI of ±3.63% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 30 patients, resulting in 60 images (30 Longitudinal views and 30 Transverse views).
- Data Provenance:
- Country of Origin: USA (58%) and Japan (42%).
- Retrospective/Prospective: Prospectively collected.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: 2 Readers (certified sonographer/Clinician) and 1 Board Certified Nephrologist.
- Qualifications: "Certified sonographer/Clinician" for the initial readers; "Board Certified Nephrologist" for the arbitrator. Specific years of experience are not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: A Board Certified Nephrologist arbitrated the ground truth between the two initial readers to establish the reference standard. This resembles a "2+1" or "tie-breaker" adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a "Multi-Reader Multi-Case (MRMC) comparative effectiveness study" comparing human readers with and without AI assistance was not specified for this feature. The study focused on the algorithm's performance against expert-established ground truth.
6. If a Standalone (Algorithm Only) Performance Study Was Done
- Yes, the reported accuracies (96.45%, 92.94%, 93.13%) represent the standalone performance of the algorithm in measuring renal dimensions against the established ground truth.
7. The Type of Ground Truth Used
- Type of Ground Truth: Expert consensus (between two sonographers/clinicians, arbitrated by a nephrologist).
8. The Sample Size for the Training Set
- The document states that the verification data was acquired independently during validation after the development of the model. The sample size for the training set is not provided in this summary.
9. How the Ground Truth for the Training Set Was Established
- The method for establishing ground truth for the training set is not specified in this summary. Only the method for the independent verification (test) set is described.
Auto Abdominal Color Assistant / Auto Preset Assistant
(Note: The document lists "Auto Abdominal Color Assistant" and then immediately below it, and seemingly as a continuation or related feature, "Auto Preset Assistant" with similar testing information. I will treat them as two related or broadly similar features based on the provided structure.)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Auto Abdominal Color Assistant: | |
| Overall model success rate of Aorta, Kidney, Liver, GB, and Pancreas view suggestion is expected to be 80% or higher. | Not explicitly stated in a single number, but implied to meet criteria given context of a 510(k) summary. |
| Auto Preset Assistant: | |
| Overall model success rate of Abdomen, Air, Breast, Carotid, Leg, MSK, Scrotal, Thyroid and Carotid/Thyroid (Mixed) view suggestion is expected to be 80% or higher. | Not explicitly stated in a single number, but implied to meet criteria given context of a 510(k) summary. |
2. Sample Size Used for the Test Set and Data Provenance
- Auto Abdominal Color Assistant:
- Sample Size: 50+ patients, resulting in 1100+ images.
- Data Provenance:
- Country of Origin: USA (77%) and Australia (23%).
- Retrospective/Prospective: Not explicitly stated, but "collected from:" implies existing data or a mix.
- Auto Preset Assistant:
- Sample Size: 110+ patients, resulting in 2600+ images.
- Data Provenance:
- Country of Origin: USA (41.2%), Austria (3.8%), Australia (1.1%), Japan (41.3%), Italy (0.7%), and Greece (12%).
- Retrospective/Prospective: Not explicitly stated, but "collected from:" implies existing data or a mix.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Unspecified number of "Readers (certified sonographer/Clinician)".
- Qualifications: "Certified sonographer/Clinician". Specific years of experience or precise number of experts not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The summary states, "Readers (certified sonographer/Clinician) to ground truth the "anatomy" visible in static B-Mode image." It doesn't mention multiple readers for the same image or an adjudication process if there were discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not specified for these features. The testing described is for the standalone algorithm's accuracy in view suggestion.
6. If a Standalone (Algorithm Only) Performance Study Was Done
- Yes. The core of the testing involved running the AI and comparing its predictions to the ground truth to calculate the accuracy of the algorithm against each class. This represents standalone performance.
7. The Type of Ground Truth Used
- Type of Ground Truth: Expert annotation by "certified sonographer/Clinician" on B-mode images ("anatomy visible").
8. The Sample Size for the Training Set
- The document states that exams used for test/training validation were separated with no overlap. However, the specific sample size for the training set is not provided.
9. How the Ground Truth for the Training Set Was Established
- The method for establishing ground truth for the training set is not specified. Only the method for the independent test set is described.
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(125 days)
The LOGIQ E10s and LOGIQ Fortis are intended for use by a qualified physician for ultrasound evaluation.
Specific clinical applications and exam types include: Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal, Vascular).
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.
The LOGIQ E10s and LOGIQ Fortis are intended to be used in a hospital or medical clinic.
The LOGIQ E10s is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 991 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 12-inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor.
The LOGIQ Fortis is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 575 mm wide (keyboard). 925 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a digital keyboard (physical keyboard as an option), specialized controls, 12inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor (or 23.8inch High Resolution LED LCD monitor as an option).
The provided text describes three AI features of the LOGIQ E10s and LOGIQ Fortis systems: Auto Renal Measure Assistant, Auto Abdominal Color Assistant, and Auto Preset Assistant. The information provided for each feature allows for a detailed breakdown of their acceptance criteria and the studies conducted to prove they meet these criteria.
Here's the requested information structured for clarity:
1. Table of Acceptance Criteria and Reported Device Performance
| AI Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Auto Renal Measure Assistant | Longitudinal model accuracy for length measurements expected to be > 80%. Transverse model accuracy for width measurements expected to be > 70%. | Longitudinal model for length measurements: Average accuracy of 96.45% (95% CI: ±1.26%), average absolute error of 0.35cm (95% CI: ±0.12 cm). |
| Transverse model for width measurements (first mention): Average accuracy of 92.94% (95% CI: ±3.02%), average absolute error of 0.38cm (95% CI: ±0.14 cm). | ||
| Transverse model for width measurements (second mention, likely a typo/repetition): Average accuracy of 93.13% (95% CI: ±3.63%), average absolute error of 0.37cm (95% CI: ±0.14 cm). | ||
| Auto Abdominal Color Assistant | Overall model success rate for Aorta, Kidney, Liver, GB, and Pancreas view suggestion expected to be 80% or higher. | Specific accuracy percentages for each view are not individually reported in the summary, but the success rate is implied to have met or exceeded the 80% threshold, as the device is deemed substantially equivalent. The summary states "Calculated the accuracies of the algorithm against each class," which suggests these were evaluated. |
| Auto Preset Assistant | Overall model success rate for Abdomen, Air, Breast, Carotid, Leg, MSK, Scrotal, Thyroid, and Carotid/Thyroid (Mixed) view suggestion expected to be 80% or higher. | Specific accuracy percentages for each view are not individually reported in the summary, but the success rate is implied to have met or exceeded the 80% threshold, as the device is deemed substantially equivalent. The summary states "Calculated the accuracies of the algorithm against each class," which suggests these were evaluated. |
2. Sample Sizes and Data Provenance for Test Sets
- Auto Renal Measure Assistant:
- Test Set Sample Size: 30 patients, resulting in 60 samples (30 longitudinal views, 30 transverse views).
- Data Provenance: Prospective collection. Data from USA (58%) and Japan (42%).
- Auto Abdominal Color Assistant:
- Test Set Sample Size: 50+ patients, resulting in 1100+ images.
- Data Provenance: Not explicitly stated as retrospective or prospective, but collected from USA (77%) and Australia (23%).
- Auto Preset Assistant:
- Test Set Sample Size: 110+ patients, resulting in 2600+ images.
- Data Provenance: Not explicitly stated as retrospective or prospective, but collected from USA (41.2%), Austria (3.8%), Australia (1.1%), Japan (41.3%), Italy (0.7%), and Greece (12%).
3. Number of Experts and Qualifications for Ground Truth
- Auto Renal Measure Assistant:
- Number of Experts: 2 "Readers" and 1 "Board Certified Nephrologist" for arbitration.
- Qualifications: "certified sonographer/Clinician" for the two readers. "Board Certified Nephrologist" for the arbitrator.
- Auto Abdominal Color Assistant:
- Number of Experts: Unspecified number of "Readers".
- Qualifications: "certified sonographer/Clinician" for the readers.
- Auto Preset Assistant:
- Number of Experts: Unspecified number of "Readers".
- Qualifications: "certified sonographer/Clinician" for the readers.
4. Adjudication Method for Test Sets
- Auto Renal Measure Assistant:
- Method: A "Board Certified Nephrologist arbitrated the ground truth between the above two readers to establish the reference standard". This implies a 2+1 (two readers, one arbitrator) method.
- Auto Abdominal Color Assistant & Auto Preset Assistant:
- Method: The text states, "Readers (certified sonographer/Clinician) to ground truth the 'anatomy' visible in static B-Mode image." There is no mention of multiple readers or an arbitration process, implying no explicit inter-reader adjudication method was described beyond individual expert annotation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was explicitly described in the provided text. The studies focus on the standalone performance of the AI algorithms against a derived ground truth, rather than comparing human reader performance with and without AI assistance. Therefore, no effect size for human readers' improvement with AI assistance is reported.
6. Standalone (Algorithm Only) Performance Study
- Yes, standalone (algorithm only) performance studies were done for all three AI features listed. The studies evaluate the accuracy or success rate of the AI algorithms in performing their intended functions (measurement, view suggestion) against an established ground truth, without a human-in-the-loop component being explicitly tested or reported.
7. Type of Ground Truth Used
- Auto Renal Measure Assistant: Expert Consensus, as it involved two readers and an arbitrator to establish the reference standard for measurements.
- Auto Abdominal Color Assistant & Auto Preset Assistant: Expert Annotation/Consensus, established by "Readers (certified sonographer/Clinician) to ground truth the 'anatomy'visible in static B-Mode image." While not explicitly stated as consensus among multiple readers, it is established by qualified experts.
8. Sample Size for Training Sets
- The training set sample sizes are not explicitly provided in the summaries for any of the AI features. The document only mentions that the "verification data was acquired independently during validation process after the development of the model," and "The exams used for test/training validation purpose are separated from the ones used during training process." This implies training data existed but its size is not detailed.
9. How Ground Truth for Training Sets Was Established
- The document does not explicitly describe how the ground truth for the training sets was established. It focuses primarily on the process for the test/validation sets. However, it can be inferred that a similar process involving expert clinicians/sonographers would have been used to establish ground truth for training data, as is common practice in medical imaging AI development.
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(82 days)
The Leltek Ultrasound Imaging System (Model: LU700 Series) 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, 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:
LU700L
General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic, Musculoskeletal (conventional),Musculosketal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter)
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)
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)
LU700C
General abdominal imaging,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Peripheral vessel ,interventional guidance (free hand needle/ catheter)
LU710C
Fetal.General abdominal imaging.Small organ (thyroid, prostate, scrotum, breast).Urology.Musculoskeletal (conventional),OB/Gyn,Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter)
LU710M
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic. Urology. Musculoskeletal (conventional), OB/Gyn. Cardiac (pediatric), Peripheral vessel ,interventional guidance (free hand needle/ catheter)
LU710PA
Fetal, General abdominal imaging, Pediatric, Cardiac (adult), Cardiac (pediatric), Pulmonary
LU710E
Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Transvaginal,Urology,OB/Gyn,interventional guidance (free hand needle/ catheter)
The clinical environments where the system can be used include physician offices, clinics, and clinical point-of-care for diagnosis of patients.
The Leltek Ultrasound Imaging System (Model: LU700 Series) is a portable, software controlled, handheld ultrasound system used to acquire and display hi-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) mobile device.
- I. The imaging system software runs as an app on a mobile device.
- II. The imaging system software can be download to a commercial off-the-shelf (COTS) mobile device and utilizes an icon touch-based user interface.
- III. The imaging system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range portable personal device.
- IV. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components
The provided text describes the Leltek Ultrasound Imaging System (Model: LU700 Series) seeking 510(k) clearance from the FDA. Based on the document, here's a breakdown of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of quantitative acceptance criteria and reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance criteria are generally based on compliance with international safety and performance standards for medical electrical equipment and the device demonstrating "substantially equivalent" safety and effectiveness to predicate devices.
The reported device performance is primarily described as:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Safety and Performance Standards Compliance | The device has been designed, manufactured, tested, and certified to comply with the following internationally recognized standards: |
| - AAMI/ANSI ES60601-1 (2009 & 2012): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | |
| - IEC 60601-1-2 (2014): Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | |
| - IEC 60601-1-6 (2013): Medical electrical equipment Part 1-6 General requirements for basic safety and essential performance Collateral standard Usability | |
| - IEC 60601-2-37/AMD1 (2008 & 2015): Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment | |
| - IEC 62133 (2012): Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications | |
| - IEC 62304 (2014): Medical device software - Software life-cycle processes | |
| - IEC 62366-1 (2015): Medical devices -- Part 1: Application of usability engineering to medical devices | |
| - ISO 10993-1 (2009 & 2018): Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process | |
| - ISO 10993-5 (2009): Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity | |
| - ISO 10993-10 (2010): Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization | |
| - ISO 13485 (2016): Medical devices - Quality management systems - Requirements for regulatory purposes | |
| - ISO 14971 (2019): Medical devices - Application of risk management to medical devices | |
| - ISO 15223-1 (2016): Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements | |
| Device Performance Specifics (as mentioned for new models/changes) | - Acoustic output: The new models (LU710L, LU710LH) were tested and determined to be in full compliance. The maximum acoustic output level is under the FDA recommended limit, and the power level is displayed all the time. |
| - Biocompatibility: The new models were tested and determined to be in full compliance. | |
| - Cleaning and disinfection effectiveness: The new models were tested and determined to be in full compliance. | |
| - Wireless, thermal, electrical, electromagnetic and mechanical safety: The system has been evaluated and found to conform with applicable medical device safety standards. | |
| Substantial Equivalence | The device is deemed "substantially equivalent" to predicate devices, meaning it has "no pragmatic detriments" compared to the cleared device (K210432) and other reference devices (K202035). All safety and performance tests meet essential requirements. |
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 Leltek Ultrasound Imaging System did not require clinical testing to establish substantial equivalence." This indicates that no test set involving patient data was used for a clinical performance study. The evaluation was based on compliance with performance standards and comparison with predicate devices.
Therefore, information regarding sample size, country of origin, and retrospective/prospective nature of a test set is not applicable as no clinical test set was used.
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 test set was used and therefore no ground truth needed to be established by experts for a performance evaluation study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
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 states "The Leltek Ultrasound Imaging System did not require clinical testing to establish substantial equivalence." This implies no clinical performance study, including an MRMC study with AI assistance, was conducted or required for this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Leltek Ultrasound Imaging System is an ultrasound imaging system, not an AI algorithm. It provides imaging data for qualified physicians and healthcare professionals to conduct ultrasound scans and fluid flow analysis. Therefore, a "standalone algorithm only" performance study is not applicable to this device. Its performance is evaluated on its ability to produce safe and effective ultrasound images, not on an AI's diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of a clinical performance study for an AI algorithm. The device itself is an imaging tool. Its "ground truth" for regulatory purposes revolves around its technical specifications, safety, and ability to generate images comparable to legally marketed predicate devices, as demonstrated through engineering tests and adherence to standards.
8. The sample size for the training set
Not applicable. The Leltek Ultrasound Imaging System is an imaging device, not an AI algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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(531 days)
The Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type CT, Type CL) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging. The part of this device to contact with the patient is the probe head.
The Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) is a wireless ultrasound system that uses pulsed-echo technology to transmit ultrasound images via wireless communication to a mobile device that utilizes the iOS operating system.
The Wireless Probe Type Ultrasound Scanner is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS mobile device, (ii) the Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device, (iii) the battery-operated, hand-held Wireless Probe Type Ultrasound Scanner transducer that communicates wirelessly with iOS mobile devices, and (iv) the instructions for use manual, USB Cable for Charging.
The Wireless Probe Type Ultrasound Scanner utilizes pulsed-echo technology to determine the depth and location of tissue interfaces, and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Ultrasound waves are emitted from the transducer, propagate through tissues, and return to the transducer as reflected echoes. The returned echoes are then converted into electrical impulses by transducer crystals and further processed in order to form the ultrasound image presented on the screen.
The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria, as it relates to AI performance metrics. This document is a 510(k) summary for a medical device (Wireless Probe Type Ultrasound Scanner) seeking market clearance from the FDA.
The summary focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Intended Use: The device has the same diagnostic ultrasound echo imaging, measurement, and analysis indications for general clinical applications (OB, GY, abdominal imaging) as the primary predicate device.
- Technological Characteristics: The device employs the same basic operating principles (pulsed-echo ultrasound, B, BM, Color Doppler, PDI, PW modes) and similar features (biopsy guideline, harmonic function) as the predicate devices. Differences mentioned (e.g., image display unit size, specific frequency ranges) are deemed not to affect core usage or substantial equivalence.
- Safety and Effectiveness: Compliance with recognized international standards for biocompatibility (ISO 10993), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance safety (IEC 60601-2-37), as well as FCC radio frequency testing.
Crucially, the document explicitly states: "Clinical testing was not performed for Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) as part of the submission." This means there is no performance study evaluating the device's diagnostic accuracy or comparing it with other methods (human readers, AI assistance, etc.) presented in this document.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, test set details, expert ground truth adjudication, MRMC studies, standalone performance, or training set details as these are not discussed in the provided text.
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(31 days)
Kosmos is intended to be used by qualified and trained healthcare professionals in the clinical assessment for the following clinical applications by acquiring, processing, displaying, measuring, and storing ultrasound images, or synchronized ultrasound images, electrocardiogram (ECG) rhythms, and digital auscultation (DA) sounds and waveforms.
With respect to its ultrasound imaging capabilities, Kosmos is a general purpose diagnostic ultrasound system used in the following clinical applications and modes of operation:
· Clinical Applications: Cardiac, Thoracic/Lung, Abdominal, Vascular, Musculoskeletal, and interventional guidance (includes needle/catheter placement, fluid drainage, and nerve block) · Modes of Operation: B-mode, Color Doppler, Pulsed-Wave (PW) Doppler, Continuous-Wave (CW) Doppler, Combined Modes of B+M. and B+CD. B+PW. B+CW. and Harmonic Imaging
Kosmos is intended to be used in clinical care and medical education settings on adult and pediations.
The device is non-invasive, reusable, and intended to be used on one patient at a time.
Kosmos consists of a tablet (i.e., Kosmos Bridge or supported Off-The-Shelf Android tablet provided by the user) and probe (i.e., Kosmos Torso, Torso-One, or Lexsa), which connects to the tablet via a cable. Additional components include the ECG Patient Cable and Binaural Headset for use with Kosmos Torso only. Kosmos can operate on battery or while connected to mains, when used as either handheld device or mounted to the mobile stand (i.e., AI Station 2).
The probe face houses an ultrasound transducer and sealed microphones for auscultation (Kosmos Torso only).
The tablet (i.e., Kosmos Bridge or supported Off-The-Shelf Android tablet provided by the customer) displays clinical and patient data information including the display of ultrasound images, auscultation and ECG waveforms (when connected to Kosmos Torso), and patient data/reports. The tablet also includes speakers for sounds associated with system control and feedback. Additionally, the tablet offers a means of user control with its touchscreen display and buttons.
Although its intended operation is not dependent on Wi-Fi, Kosmos supports Wi-Fi connectivity for:
- patient data archival,
- updating the embedded Kosmos Software (Kosmos Bridge configurations only), or ●
- downloading or updating the Kosmos Software Application from the Google Play Store ● (Kosmos On Android configuration only)
Kosmos' ECG capability provides a timing reference with respect to the cardiac cycle as compared with both ultrasound imaging and digital auscultation. Ultrasound imaging, ECG, and DA are all integrated into Kosmos Torso in a time-synchronized manner.
Kosmos' 3-lead single-channel ECG allows for the acquisition and display of a single ECG waveform (lead), which can be any one of the Lead I, or Lead III waveforms. One end of Kosmos' ECG cable connects to the probe via a custom-designed magnetic connector. The other end has three (3) RA/LA/LL leadwires to be connected to user-supplied clip-style electrodes affixed to the patient using the standard RA/LA/LL configuration.
Kosmos is an FDA-cleared medical device: however, the new AI-assisted EF Workflow and Trio tool are not yet cleared by the FDA. Instead, EchoNous is following the Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, Guidance for Industry and Food and Drug Administration Staff, April 2020 for this new feature.
The provided document is a 510(k) Premarket Notification for the EchoNous Kosmos device. It specifically states that "An assessment of clinical performance data for Kosmos was not required to support a determination of substantial equivalence."
Therefore, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria from a clinical perspective. It only reports compliance with non-clinical performance standards.
As requested, I will provide the information that is available in the document, acknowledging the absence of clinical performance data.
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical performance criteria are provided, this table will reflect compliance with non-clinical performance standards.
| Acceptance Criteria Category | Standard Designation Number and Date | Title of Standard | Reported Device Performance |
|---|---|---|---|
| Non-Clinical Performance Standards | |||
| Electromagnetic Compatibility | CISPR 11:2015+AMD1:2016+AMD2:2019 CSV Consolidated version | Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Basic Safety and Essential Performance | ANSI AAMI IEC ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Electromagnetic Disturbances | ANSI AAMI IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Usability | IEC 60601-1-6 Edition 3.1 2013-10 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Diagnostic Ultrasound Equipment | IEC 60601-2-37 Edition 2.1 2015 | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Biological Evaluation | ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management proce (Note: Document lists "proce", likely "process") | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Risk Management | ISO 14971:2019 | Medical devices - Application of risk management to medical devices | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Software Life Cycle | IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION | Medical device software - Software life cycle processes | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Usability Engineering | IEC 62366-1 Edition 1.0 2015-02 (Including CORRIGENDUM 1 (2016)) | Medical devices - Part 1: Application of usability engineering to medical devices | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Symbols for Medical Devices | ISO 15223-1 Third Edition 2016-11-01 | Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Ultrasonics Field Characterization | IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION and AIM Standard 7351731 Rev. 2.00 2017-02-23 | Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Acoustic Output Measurement | NEMA UD 2-2004 (R2009) | Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| ECG Trunk Cables & Leadwires | ANSI AAMI EC53:2013 | ECG trunk cables and patient leadwires | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Medical Device Security | AAMI TIR57:2016 | Principles for medical device security - Risk management. | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Cleaning Reusable Medical Devices | AAMI TIR 30:2011 | A Compendium Of Processes, Materials, Test Methods, And Acceptance Criteria For Cleaning Reusable Medical Devices | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable for clinical data. The document focuses on compliance with non-clinical performance standards. For these standards, "All verification and validation testing" was conducted, implying that the device itself underwent testing to confirm its specifications were met, rather than using a separate "test set" of clinical data.
- Data Provenance: Not applicable for clinical data. The focus is on the device's adherence to engineering and safety standards.
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 with ground truth established by experts is described for this submission. The "ground truth" for the non-clinical tests would be the specifications outlined in the various standards.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication is 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
The document explicitly states: "Kosmos is an FDA-cleared medical device: however, the new AI-assisted EF Workflow and Trio tool are not yet cleared by the FDA. Instead, EchoNous is following the Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, Guidance for Industry and Food and Drug Administration Staff, April 2020 for this new feature."
Therefore, no MRMC comparative effectiveness study was done for AI-assisted features for this 510(k) submission, as these features were not part of the current clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document does not describe standalone algorithm performance studies for The Kosmos device. The mention of "AI-assisted EF Workflow and Trio tool" indicates potential future AI capabilities, but these are specifically noted as "not yet cleared by the FDA" in this submission.
7. The type of ground truth used
For the non-clinical performance data, the "ground truth" is implied to be the requirements and specifications within the listed FDA-recognized consensus standards (e.g., IEC 60601 series, ISO 10993, NEMA UD 2). The device's performance was evaluated against these established benchmarks.
8. The sample size for the training set
Not applicable. This document is a 510(k) for a diagnostic ultrasound system and its integrated components, focusing on substantial equivalence to predicate devices and compliance with non-clinical performance standards. It does not describe the development or training of AI algorithms.
9. How the ground truth for the training set was established
Not applicable, as no AI training set is described in this submission.
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