Search Results
Found 7 results
510(k) Data Aggregation
(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.
Ask a specific question about this device
(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.
Ask a specific question about this device
(85 days)
The LOGIQ P10, LOGIQ P9, LOGIQ P8 are general purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The LOGIO P10, LOGIO P9 and LOGIO P8 clinical applications include: evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectar, Transvaginal; Transesophageal and Intraoperative (abdominal, vascular).
Modes of operation include: B, M, PW, Doppler, CW Doppler, Color M Doppler, Power Doppler, 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 P10, LOGIQ P9 and LOGIQ P8 are intended to be used in a hospital or medical clinic.
The LOGIQ P10, LOGIQ P9 and LOGIQ P8 are full featured, Track 3 device, primarily intended for general purpose diagnostic ultrasound system which consists of a mobile console approximately 55 cm wide, 74 cm deep and 160 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.4-inch LCD touch screen and color 23.8-inch LCD image display.
The provided text describes a 510(k) premarket notification for the LOGIQ P10, LOGIQ P9, and LOGIQ P8 diagnostic ultrasound systems. It details the device's intended use, comparison to predicate devices, and a summary of non-clinical tests. However, the document explicitly states in "Summary of Clinical Tests" that "The subject of this premarket submission, LOGIQ P10, LOGIQ P9 and LOGIQ P8, did not require clinical studies to support substantial equivalence."
Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria, as no such clinical study was conducted or reported in this 510(k) submission.
The document focuses on demonstrating substantial equivalence through:
- Comparison to Predicate Devices: Showing the new devices use the same fundamental scientific technology, have the same clinical intended uses (with minor additions), similar imaging modes (with some new modes migrated from other cleared devices like UGAP), and similar capabilities for measurements, image capture, review, and reporting.
- Non-Clinical Tests: Verifying acoustic output, biocompatibility, cleaning and disinfection effectiveness, and compliance with thermal, electrical, electromagnetic, and mechanical safety standards (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, ISO14971, NEMA PS 3.1 - 3.20 (2016) DICOM Set, IEC 62359).
- Quality Assurance Measures: Including risk analysis, requirements reviews, design reviews, unit level testing, integration testing, performance testing, and safety testing.
There is no mention of acceptance criteria based on performance metrics that would typically arise from a clinical study (e.g., sensitivity, specificity, AUC) or any study that evaluated human reader performance with or without AI assistance, as these are not AI/ML-enabled devices described here, but rather general diagnostic ultrasound systems.
Ask a specific question about this device
(86 days)
LOGIQ E10 is intended for use by a qualified physician for ultrasound evaluation of Fetal / Obstetrics; Abdominal (including Renal, GynecologyPelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vasculo-skeletal Conventional and Superficial; Urology (including Prostate); Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).
The LOGIQ E10 is a full featured, track 3, general purpose diagnostic ultrasound system which consists of a mobile console that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, LCD touch screen and color widescreen monitor. The system utilizes a variety of linear, curved, phased, dual, and matrix array transducers to support the broad imaging capabilities.
The provided FDA submission for the GE LOGIQ E10 does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML component or performance metrics for diagnostic accuracy beyond general equivalence claims.
The document primarily focuses on establishing substantial equivalence of the LOGIQ E10 ultrasound system to predicate devices based on:
- Intended Use: Similar clinical applications.
- Technology: Same fundamental scientific technology (ultrasound imaging).
- Components: Similar transducers and system capabilities (measurements, digital imaging, reporting).
- Safety Standards: Compliance with electrical, thermal, electromagnetic safety, and biocompatibility.
- Software Features: Identical software features with some migrations from other GE systems (Voluson E10, LOGIQ E9, LOGIQ S8) and a new feature (UGAP) similar to one on another predicate.
The document explicitly states: "The subject of this premarket submission, LOGIQ E10, did not require clinical studies to support substantial equivalence." This means no specific performance metrics comparing the LOGIQ E10 to a gold standard or human readers were presented for this submission.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or any details about MRMC or standalone AI studies, as this information is not present in the provided text.
The information provided only demonstrates that the device is an ultrasound system with various imaging capabilities, and its submission for FDA clearance relies on substantial equivalence to existing predicate devices, rather than a de novo clinical performance study showcasing specific diagnostic accuracy metrics.
Ask a specific question about this device
(71 days)
The LOGIQ E10s 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 E10s clinical applications include : Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transvaginal; Transesophageal and Intraoperative (Vascular).
Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M. B/Color. B/Color/PWD. B/Power/PWD. The LOG10 E10s is 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 that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, high resolution color touch screen, and color widescreen monitor. The system utilizes a variety of linear, curved, phased and matrix array transducers to support the broad imaging capabilities.
The provided text states that the LOGIQ E10s did not require clinical studies to support substantial equivalence. Therefore, there is no information available in the document regarding acceptance criteria or a study proving the device meets acceptance criteria through clinical trials.
The document focuses on non-clinical tests and comparisons to predicate devices to establish substantial equivalence.
Here's a breakdown of the available information based on your requested points, highlighting the absence of clinical study data:
-
A table of acceptance criteria and the reported device performance
- Not available. The document does not provide a table of acceptance criteria or reported device performance from a clinical study. It discusses non-clinical compliance with safety standards and similarity to predicate devices.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical test set information is provided as clinical studies were not required.
-
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. No clinical test set information is provided.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set information is provided.
-
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. No MRMC comparative effectiveness study was done or reported. This device is a diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool as described in the question.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to AI algorithms. While the device connects to "Koios DS for Breast" (K190442), which is an AI-based system, the document refers to the LOGIQ E10s as a diagnostic ultrasound system, not an AI algorithm itself. No standalone performance of an algorithm is reported for the LOGIQ E10s.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No clinical test set information is provided.
-
The sample size for the training set
- Not applicable. No clinical test information or AI training set information is provided for the LOGIQ E10s itself.
-
How the ground truth for the training set was established
- Not applicable. No clinical test information or AI training set information is provided.
Instead of clinical studies, the submission relies on documentation of compliance with safety standards and a comparison to predicate devices, stating: "The subject of this premarket submission, LOGIQ E10s, did not require clinical studies to support substantial equivalence." The conclusion is that the LOGIQ E10s is considered "as safe, as effective, and performance is substantially equivalent to the predicate device(s)."
The non-clinical tests performed included:
- Acoustic output
- Biocompatibility
- Cleaning and disinfection effectiveness
- Thermal, electrical, electromagnetic, and mechanical safety
The device was found to conform with applicable medical device safety standards, including:
- AAMI/ANSI ES60601-1
- IEC 60601-1-2
- IEC 60601-2-37
- ISO 10993-1
- ISO 14971
- NEMA PS 3.1-3.20 (DICOM Set)
- IEC 62359
Quality assurance measures applied during development included:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
Ask a specific question about this device
(79 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; 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, thoracic, vascular).
When Pinpoint™ GT Technology, from C.R. Bard, Inc., is included with the system, the Indications for Use include: Pinpoint GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.
The LOGIQ P9; LOGIQ P7 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 53 cm wide, 74 cm deep and 157 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.4 inch LCD touch screen and color 21.5 inch LCD image display.
This document is a 510(k) Premarket Notification from GE Healthcare for their LOGIQ P9 and LOGIQ P7 diagnostic ultrasound systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a de novo clinical study with detailed performance metrics against specific acceptance criteria. Therefore, the information typically found in an AI/Software as a Medical Device (SaMD) study for performance reporting (such as ROC curves, sensitivity/specificity, sample sizes for test/training sets, or expert ground truth adjudication) is not present.
However, based on the provided text, we can infer and extracting relevant safety and effectiveness information as follows:
1. Table of Acceptance Criteria (Inferred from Compliance and Testing) and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance and Compliance |
|---|---|
| Safety and Effectiveness (General Equivalence) | The LOGIQ P9; LOGIQ P7 systems are substantially equivalent to predicate devices with regard to intended use, imaging capabilities, technological characteristics, safety, and effectiveness. |
| Clinical Intended Uses | The LOGIQ P9; LOGIQ P7 systems have the same clinical intended uses as their predicate devices, with the addition of Transesophageal exams. The device is intended for use for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ; Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular). |
| Imaging Modes | The LOGIQ P9; LOGIQ P7 systems have the same imaging modes as their predicate devices, except for the addition of Shear wave elastography (migrated from LOGIQ S8) and enhancement of B-flow/B-flow color mode with high definition color. HDlive®, Tricefy, and LOGIQ P Apps features have also been migrated from other GE Ultrasound systems. |
| Transducer Compatibility | Transducers are identical to predicate devices, with the addition of L3-12-RS, 6Tc-RS, P2D, and IC9-RS transducers. |
| Biocompatibility | Manufactured with materials evaluated and found to be safe; transducer materials and patient contact materials are biocompatible. |
| Acoustic Output Levels | Acoustic power levels are below applicable FDA limits and conform to NEMA UD 2 (2004). |
| Electrical, Electromagnetic, and Mechanical Safety | Designed in compliance with approved electrical and physical safety standards, including AAMI/ANSI ES60601-1, IEC60601-1-2, and IEC60601-2-37. |
| Risk Management | Application of risk management to medical devices (ISO14971:2007). |
| Measurements, Digital Imaging, Reviewing, and Reporting | Similar capability to predicate devices for performing measurements, capturing digital images, reviewing, and reporting studies. Can recall non-ultrasound DICOM images. |
| Compliance with FDA Ultrasound Specific Guidance | Complies with "Guidance for Industry and FDA Staff - Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 9, 2008)". |
| Quality Assurance Measures | Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification). |
2. Sample Sizes and Data Provenance for Test Set
The document explicitly states: "The subject of this premarket submission, LOGIQ P9; LOGIQ P7, did not require clinical studies to support substantial equivalence."
This means there wasn't a separate "test set" in the context of a prospective clinical trial or performance study against pre-defined metrics. The submission relies on bench testing, compliance with standards, and comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical performance study with patient data.
- Sample Size for Test Set: Not applicable as a clinical test set was not used for this 510(k) submission.
- Data Provenance: Not applicable for clinical performance data. The data provenance discussed is related to compliance with engineering standards and existing clearances for predicate and reference devices (e.g., K163596, K170445, K160162, K173555).
3. Number of Experts and Qualifications for Ground Truth for the Test Set
- Not applicable, as a clinical test set requiring expert ground truth establishment for a performance study was not performed. The evaluation relies on technical performance and safety testing, and substantial equivalence to existing devices cleared through other means.
4. Adjudication Method for the Test Set
- Not applicable, as a clinical test set requiring adjudication was not utilized.
5. MRMC Comparative Effectiveness Study
- Not applicable. This submission is for a diagnostic ultrasound system, not an AI or imaging assistance device that would typically undergo an MRMC study to show human reader improvement with AI assistance. The focus is on the device's inherent safety and performance for imaging.
6. Standalone Performance (Algorithm Only)
- Not applicable in the context of an "algorithm only" performance typical for AI/SaMD. The device itself is an ultrasound imaging system. Its performance relates to its ability to generate diagnostic ultrasound images and fluid flow analysis, which is demonstrated through engineering and safety evaluations and comparison to predicate devices.
- While new features like "Shear wave elastography" involve processing, their performance is demonstrated via technical validation and substantial equivalence, not a standalone algorithm efficacy study in the typical AI sense.
7. Type of Ground Truth Used
- Not applicable in the sense of 'ground truth' defined by expert consensus or pathology for a clinical performance study. The "ground truth" here is compliance with established engineering and safety standards, and the capabilities of the already cleared predicate devices.
8. Sample Size for the Training Set
- Not applicable. This is a hardware/software system, and the submission does not describe a machine learning model that was "trained" on a dataset in the way an AI/SaMD product would be. The "training" here refers to the device's design and engineering based on established physics and medical imaging principles.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as no external "training set" with established ground truth was utilized for a machine learning model. The device's design and functionality are based on long-standing principles of ultrasound imaging and adherence to regulatory standards.
Ask a specific question about this device
(33 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (vascular).
The LOGIQ E10 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 900 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 LCD touch screen and color widescreen monitor.
Here's an analysis of the provided text regarding the acceptance criteria and study for the LOGIQ E10 device:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel performance claims. The document explicitly states that "The subject of this premarket submission, LOGIQ E10, did not require clinical studies to support substantial equivalence." Therefore, the information regarding acceptance criteria and a study proving the device meets those criteria will be limited, primarily referencing the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a diagnostic ultrasound system, the "acceptance criteria" are implied to be that the new device performs "as safe, as effective, and its performance is substantially equivalent to the predicate device(s)" (as stated in the conclusion). Specific quantitative acceptance criteria for image quality or diagnostic accuracy are not provided in this document, as clinical studies were not required. The performance is assessed by comparison to the established performance of the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety equivalent to predicate devices | Conforms to applicable medical device safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, ISO14971, NEMA UD 2). Acoustic power levels are below FDA limits. Transducer materials are biocompatible. |
| Effectiveness equivalent to predicate devices | Employs the same fundamental scientific technology as predicate device(s). Has the same clinical intended use and imaging modes as the predicate LOGIQ E9. Similar capability in terms of measurements, digital image capture, review, and reporting studies. |
| Substantial Equivalence to predicate devices | The new platform (LOGIQ E10) is substantially equivalent to the predicate devices (K163077 LOGIQ E9, K170445 LOGIQ S8, K172342 Voluson E6/E8/E10). This equivalence is based on similar technology, intended use, imaging modes, safety, and performance characteristics. Specific probes and features were migrated from other cleared GE devices. |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or associated sample size is mentioned for a clinical performance study since none was required. The "testing" referred to in the document is primarily non-clinical, focusing on engineering verification and validation against technical standards and comparisons to existing predicate devices.
- Sample Size for Test Set: Not applicable, as no clinical test set was used/required for performance evaluation.
- Data Provenance: Not applicable for clinical test data. Non-clinical data would originate from internal GE Healthcare testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical test set was required, and thus no ground truth established by experts for such a set.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. The device described, LOGIQ E10, is a diagnostic ultrasound system, not an AI/CADe (Computer-Aided Detection/Diagnosis) device for image interpretation that would typically necessitate an MRMC study comparing human reader performance with and without AI assistance. The document focuses on the capabilities of the ultrasound system itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not applicable. The LOGIQ E10 is a diagnostic ultrasound imaging system; its "performance" is inherently tied to image acquisition and display, which is then interpreted by a human physician. It is not an algorithm designed for standalone diagnostic output.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Not applicable for clinical performance studies. For non-clinical (engineering) verification, ground truth would be established through defined engineering specifications, phantom measurements (for acoustic output), and compliance with recognized standards.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/Machine Learning device that requires a training set for algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/Machine Learning device.
Ask a specific question about this device
Page 1 of 1