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510(k) Data Aggregation
(111 days)
Voluson Signature 18 / Voluson Signature 20 system are a general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson Signature 18 / Voluson Signature 20 system clinical applications include: Fetal/Obstetrics; Abdominal (including Renal and Gynecology/ Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic: Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (including Urology/Prostate) (TR); Transvaginal (TV).
Mode of operation include: B, M, AMM, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Tissue Doppler, HD-Flow, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shearwave Elastography, B-Flow, Contrast and Combined modes: B/M, B/Color, B/ PWD, B/Power/PWD. The Voluson Signature 18 / Voluson Signature 20 system are intended to be used in a hospital or medical clinic.
The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes.
The provided text is a 510(k) summary for the GE Voluson Signature 20 and Signature 18 diagnostic ultrasound systems. This document primarily focuses on demonstrating substantial equivalence to a predicate device, as required for FDA clearance. It does not describe an AI/software-as-a-medical-device (SaMD) study with specific acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, accuracy).
The document states: "The subject of this premarket submission, Voluson Signature 20/18 did not require clinical studies to support substantial equivalence." This indicates that no specific performance study, clinical or otherwise, was conducted to demonstrate the device meets acceptance criteria using test sets, expert ground truth, or MRMC studies that would be typical for an AI/SaMD product.
Instead, the summary emphasizes that the new device shares fundamental scientific technology with its predicate, has the same clinical intended use (with additional migrated features from other cleared devices like Shearwave Elastography, which is an imaging mode, not an AI algorithm performing diagnostic interpretation), and complies with relevant safety and performance standards for ultrasound systems.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details for an AI component from this document because it does not describe such a study. The "acceptance criteria" here are implicitly the regulatory requirements for showing substantial equivalence for an ultrasound system, focusing on safety, fundamental technology, and similar intended use.
In summary, based on the provided text, the device did not undergo the type of study described in your request for AI/SaMD products.
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(134 days)
Resona R9/Resona R9 Exp/Resona R9S/Nuewa R9/Nuewa R9/Nuewa R9 Pro/Nuewa R9 Pro/Nuewa R9S/Resona 7/ Resona 7CV/Resona 7EXP/Resona 7OB/Resona 7OB/Resona Y / Resona R9W/ Resona R9W/ Resona R7W/ Nuewa R9W/ Nuewa R7W Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel,urology exams.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healtheare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Modes of operation include: B, M, PWD(Pulse wave Doppler), CWD(Continuous wave Doppler), Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, 4D(Real-time 3D), iScape View, TDI(Tissue Doppler Imaging), Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO(Left Ventricular Opacification)), V Flow(Vector Flow), STE(Sound Touch Elastography), STQ(Sound Touch Quantification), Contrast imaging (Contrast agent for Liver).
The Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 70B, Resona 7PRO, Imagyn 7, Resona Y, Resona R9W, Resona R7W, Nuewa R9W. Nuewa R7W Diagnostic Ultrasound System is a general purpose. mobile, software controlled, ultrasonic diagnostic system.
This system is a Track 3 device that employs an array of probes that include linear array, Phased array, pencil phased and convex array.
The provided text describes a 510(k) premarket notification for the Resona R9 series Diagnostic Ultrasound System, which introduces modifications and new features to an already cleared predicate device (Resona R9, K202785). The submission focuses on demonstrating substantial equivalence to the predicate devices, rather than comprehensive clinical studies on the device's diagnostic performance for specific conditions.
The study presented here is a non-clinical validation of new features against predefined engineering performance criteria, primarily using phantom studies.
Here's the breakdown of the information requested, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria and reported device performance are specified for three new features: FH Tissue Tracking QA, UltraSound ATtenuation analysis, and HepatoRenal Index Plus. These are performance metrics related to the accuracy of quantitative measurements.
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| FH Tissue Tracking QA | Bias within ±20% | Evaluation Method: Obtained 10 fetal heart B-mode image samples. Compared manually obtained values with FH TTQA-obtained values. Calculated the deviation. (Implicitly, the results met the ±20% bias criteria as the device was cleared for market). |
| UltraSound ATtenuation analysis | Bias within ±5% | Evaluation Method: Selected four groups of phantoms with different acoustic attenuation values. Measured acoustic attenuation values and calculated the deviation between measured and calibrated phantom values. (Implicitly, the results met the ±5% bias criteria as the device was cleared for market). |
| HepatoRenal Index Plus | Bias within ±10% | Evaluation Method: Selected four groups of H/R-ROIs with different gray-scales in a phantom. Calculated the deviation between measured values and target values of the phantom. (Implicitly, the results met the ±10% bias criteria as the device was cleared for market). |
Additional Information on the Study:
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Sample size used for the test set and the data provenance:
- FH Tissue Tracking QA: 10 fetal heart B-mode image samples. Data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but the context of non-clinical testing with "image samples" suggests these were likely existing or specifically generated images, not new prospective patient data for this submission.
- UltraSound ATtenuation analysis: Four groups of phantoms.
- HepatoRenal Index Plus: Four groups of H/R-ROIs in a phantom.
- Data Provenance: For the quantitative features, the testing primarily involved phantoms or existing image samples rather than new prospective patient data. The document does not specify country of origin for any human data or the retrospective/prospective nature of image samples.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- FH Tissue Tracking QA: Ground truth was established by "manual-obtained values." The number of experts and their qualifications (e.g., "radiologist with 10 years of experience") are not specified.
- UltraSound ATtenuation analysis & HepatoRenal Index Plus: Ground truth was established by the "calibrated value of the phantom" or "target value of the phantom." This implies a reference standard from the phantom's known properties, not human experts.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- For the quantitative measurements using phantoms, adjudication is generally not applicable as the phantom itself provides the ground truth.
- For "FH Tissue Tracking QA" where "manual-obtained values" are compared, the adjudication method is not specified.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical Studies: Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." The studies described are non-clinical engineering performance assessments of new features.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The tests for "FH Tissue Tracking QA", "UltraSound ATtenuation analysis", and "HepatoRenal Index Plus" assessed the performance of the algorithm/system in extracting quantitative measurements, comparing them to ground truth (manual measurement or phantom values). This is essentially a standalone (algorithm only) performance evaluation for these specific features.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- FH Tissue Tracking QA: Manual-obtained values (presumably from an expert, though not detailed).
- UltraSound ATtenuation analysis & HepatoRenal Index Plus: Calibrated/target values of phantoms (physical reference standards).
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The sample size for the training set:
- The document does not provide information regarding the sample size for any training set. This submission is for a modification/upgrade to an existing device, and the focus is on the performance of added features rather than the development of the core algorithm from fresh training data.
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How the ground truth for the training set was established:
- Since information on a training set is not provided, how its ground truth was established is also not specified.
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(118 days)
The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Vascular; Transvaginal (including GYN); Transrectal
Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Color M Doppler, Power Doppier, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/ PWD, B/Elastography. The Voluson™ Expert 20, Voluson™ Expert 22 is intended to be used in a hospital or medical clinic.
The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate real-time three-dimensional imaging supporting all standard acquisition modes.
Here's a breakdown of the acceptance criteria and study details for the AI features of the Voluson Expert Series, based on the provided text:
Acceptance Criteria and Reported Device Performance
| AI Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| SonoPelvic Floor | Success rate of each AI component (MHD plane alignment, LH contour, and measurements) is expected to be 70% or higher on datasets marked as "Good Image Quality." Success rate of each AI component is expected to be 60% or higher on datasets marked as "Challenging Image Quality." | The document states "The success rate of each AI component of the feature (MHD plane alignment, LH contour and measurements) is expected to be 70% or higher. On datasets that are marked as challenging in image quality measure the success rate of each AI component of the feature should be 60% or higher." This implies that the device met these criteria, as there are no reported failures or instances where these thresholds were not achieved. The summary of testing states "Summary test statistics or other test results including acceptance criteria or other information supporting the appropriateness of the characterized performance." and then lists these as expectations. |
| SonoLyst | For SonoLystIR, sorting accuracy is higher than 80%. For SonoLystX, grading accuracy is higher than 80%. For SonoLystLive, accuracy is higher than 80%. | For SonoLystIR, the sorting accuracy is reported as "higher than 80%." For SonoLystX, the grading accuracy is reported as "higher than 80%." For SonoLystLive, the accuracy is reported as "higher than 80%." |
| FetalHS | The success rate of the 4CH view and 3VT view suggestion within cines is expected to be 70% or higher. The success rate of the suggested heart angle measurement is expected to be 80% or higher. | The document states "The success rate of the 4CH view and 3VT view suggestion within cines is expected to be 70% or higher. The success rate of the suggested heart angle measurement is expected to be 80% or higher." Similar to SonoPelvic Floor, this indicates that the device met these criteria. |
Study Details for AI Features
1. SonoPelvic Floor:
- Sample size for the test set: 110 3D/4D Volumes from 70+ individual patients.
- Data provenance: Images collected from Europe, Asia, and South Africa.
- Number of experts used to establish ground truth & qualifications: The results generated by the AI software were verified as "Pass or Fail" by a "certified sonographer/Clinician." The number of such sonographers/clinicians is not specified, but it implies at least one. Specific qualifications beyond "certified sonographer/Clinician" are not detailed.
- Adjudication method: Not explicitly stated, but the process involves a single expert verifying the AI output. There is no mention of multiple experts or a specific consensus method beyond single expert review.
- MRMC comparative effectiveness study: No. This was a standalone AI performance evaluation.
- Standalone (algorithm only) performance: Yes, the study evaluates the performance of the AI algorithm in generating results.
- Type of ground truth used: Expert verification by a "certified sonographer/Clinician."
- Sample size for the training set: Not specified, but it's stated that the volumes used for testing were "completely distinct from the ones used during training process and there is no overlap between the two."
- How the ground truth for the training set was established: Not specified.
2. SonoLyst:
- Sample size for the test set: 40,000+ images derived from 5,000+ exams (individual patients).
- Data provenance: Exams from the United Kingdom, Austria, India, USA. A mix of retrospective and prospective data collection from GE and non-GE scanners.
- Number of experts used to establish ground truth & qualifications:
- Initial curation (sorting and grading) by a "single Sonographer."
- Review panel of "5-sonographer[s]" for instances where SonoLyst differed from the initial ground truth, to determine sorting and grading accuracy. Qualifications beyond "sonographer" are not detailed.
- Adjudication method:
- Initial ground truth established by a single sonographer.
- Discrepancies between the AI and initial ground truth were reviewed by a "5-sonographer review panel." The sorting ground truth was reclassified based on the "majority view of the panel." This implies a form of 5-sonographer consensus, where the majority dictates the revised ground truth.
- MRMC comparative effectiveness study: No. This was a standalone AI performance evaluation.
- Standalone (algorithm only) performance: Yes, the study evaluates the performance of the AI algorithm in sorting and grading images.
- Type of ground truth used: Expert consensus, specifically from a panel of 5 sonographers for ambiguous cases, following initial assessment by a single sonographer.
- Sample size for the training set: Not specified, but it's stated that the exams used for testing were "separated from the ones used during training process and there is no overlap between the two."
- How the ground truth for the training set was established: Not specified.
3. FetalHS:
- Sample size for the test set: 400+ cines from 250+ patients.
- Data provenance: USA, India, Japan, Germany, Austria.
- Number of experts used to establish ground truth & qualifications: The AI software's results were verified as "Pass or Fail" by "certified sonographers/clinicians." The number of such sonographers/clinicians is not specified, but it implies at least one. Specific qualifications beyond "certified sonographers/clinicians" are not detailed.
- Adjudication method: Not explicitly stated, but the process involves a single expert verifying the AI output. There is no mention of multiple experts or specific consensus beyond single expert review.
- MRMC comparative effectiveness study: No. This was a standalone AI performance evaluation.
- Standalone (algorithm only) performance: Yes, the study evaluates the performance of the AI algorithm in suggesting views and measuring heart angles.
- Type of ground truth used: Expert verification by "certified sonographers/clinicians."
- Sample size for the training set: Not specified, but it's stated that the datasets used for testing were "completely distinct from the ones used during training process and there is no overlap between the two."
- How the ground truth for the training set was established: Not specified.
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(101 days)
The Voluson SWIFT, Voluson SWIFT+ 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. Voluson SWIFT, Voluson SWIFT+ clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatric; Small Organ (Breast, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic; Cardiaς (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal(including Urology/ Prostate) (TR): Transvaginal (TV).
Mode of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography and Combined modes: B/M, B/Color, B/PWD, B/ Power/PWD. The Voluson SWIFT / Voluson™ SWIFT+ are intended to be used in a hospital or medical clinic.
The subject device is a Track 3 device, primarily intended for general-purpose radiology evaluation and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. The Voluson SWIFT, Voluson SWIFT+ provide digital acquisition, processing and display capability. Voluson SWIFT, Voluson SWIFT+ consist of a mobile console with control panel, full touch monitor, optional image storage and printing devices. It provides high-performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. It utilizes a variety of linear, curved linear, matrix phased array transducer including mechanical and electronic scanning transducers which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes.
The provided text is a 510(k) summary for the GE Voluson SWIFT, Voluson SWIFT+ diagnostic ultrasound system. It outlines the device's technical characteristics, intended use, and comparison to predicate devices to establish substantial equivalence.
However, the document explicitly states that clinical studies were NOT required or performed to support the substantial equivalence of the Voluson SWIFT, Voluson SWIFT+.
Therefore, I cannot provide the detailed information requested regarding acceptance criteria and performance studies, including:
- A table of acceptance criteria and reported device performance.
- Sample sizes and data provenance for test sets.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- Method for establishing ground truth for the training set.
The submission focuses entirely on non-clinical tests to demonstrate safety and effectiveness, based on compliance with electrical, mechanical, and safety standards, and by showing substantial equivalence to previously cleared predicate devices through similar technology, intended use, imaging modes, and acoustic power levels.
The relevant section in the document states:
"Summary of Clinical Tests: The subject of this premarket submission. Voluson SWIFT, Voluson SWIFT+, did not require clinical studies to support substantial equivalence."
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(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.
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(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:
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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.
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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.
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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.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set information is provided.
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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.
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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.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No clinical test set information is provided.
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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.
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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)
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(83 days)
ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images, and generation of medical reports primarily for diagnostic ultrasound.
ViewPoint 6 provides the user the ability to include images, drawings, and charts into medical reports. ViewPoint 6 is designed to accept, transfer, display, calculate, store, and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint 6 displays to the user, can be used for diagnostic purposes.
ViewPoint 6 is intended for professional use only. ViewPoint 6 is not intended to be used as an automated diagnosis system.
ViewPoint 6 is not intended to operate medical devices in surgery related procedures.
ViewPoint 6 is an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data. It provides different calculations and tools to allow for the assessment of the images and data.
ViewPoint 6 is for professional use only and enables quick diagnostic reporting with standardized terminology. It has an intuitive graphical user interface (GUI) and is based on Microsoft Windows® with defined hardware requirements for the user to install on their computer.
ViewPoint 6 provides exam type specific reporting forms for various medical care areas. Forms are composed of different sections with data entry fields. The documentation can include measurements, exam findings, images, and graphs. All data is saved in the ViewPoint 6 database and can be compiled to a professional report. Images and image sequences can be reviewed in the ViewPoint 6 display area based on user preference.
ViewPoint 6 supports both a single workstation and a client - server setup. The number of user licenses determines how many workstations in the network have concurrent access to the database. Access can be limited to read - only functionality.
This FDA 510(k) summary for GE Healthcare's ViewPoint 6 software does not contain the detailed information necessary to complete the requested table and answer the study-related questions. The document states that no clinical studies were required to support substantial equivalence (Page 6).
Therefore, I cannot provide:
- A table of acceptance criteria and the reported device performance: This information is derived from clinical studies, which were not performed.
- Sample size used for the test set and the data provenance: No clinical test set was described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth for a test set was established as no clinical test was conducted.
- Adjudication method for the test set: Not applicable as no test set was used.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, the document explicitly states no clinical studies were required.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as no algorithm performance study was described. ViewPoint 6 is described as an image archiving and reporting software, not an automated diagnostic algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Based on the provided document, the ViewPoint 6 device is a Picture Archiving and Communication System (PACS) software tool. The 510(k) submission for ViewPoint 6 relied primarily on non-clinical tests and a comparison to predicate devices, rather than clinical performance studies, to demonstrate substantial equivalence.
The document states:
- "The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence." (Page 6)
- "GE Healthcare considers the ViewPoint 6 to be as safe, as effective, and performance is substantially equivalent to the predicate devices." (Page 6)
- The determination of substantial equivalence was based on "intended use, capabilities, technological characteristics, safety and effectiveness" compared to predicate devices (ViewPoint 6, K173456, and reference devices Voluson E10, K192159 and Versana Balance, K191792). (Page 5)
- The summary focuses on "Non-Clinical Tests" such as compliance with voluntary standards (IEC 62366-1, IEC 62304, NEMA PS 3.1-3.20 DICOM, ISO 14971, IEC 82304-1) and quality assurance measures (Risk Analysis, Requirements Reviews, Design Reviews, various levels of testing). (Pages 5-6)
Therefore, the requested information regarding acceptance criteria and performance data from a clinical study cannot be extracted from this document, as no such study was conducted or presented in this 510(k) summary.
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