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Voluson™ Performance 16 / Voluson™ Performance 18 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™ Performance 16 / Voluson™ Performance 18 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, HD-Flow, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Contrast and Combined modes: B/M, B/Color, B/PWD, B/Power/PWD. The Voluson™ Performance 16 / Voluson™ Performance 18 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.

Based on the provided FDA 510(k) clearance letter, the device in question, Voluson™ Performance 16/18, is a general-purpose diagnostic ultrasound system. The document explicitly states that "The subject of this premarket submission, Voluson™ Performance 16/18 did not require clinical studies to support substantial equivalence."

This means that no clinical study was conducted to prove the device meets specific acceptance criteria based on its performance in a clinical setting against a defined ground truth. Instead, the substantial equivalence determination relies on comparisons to predicate devices, non-clinical tests (acoustic output, biocompatibility, electrical/mechanical safety, etc.), and the migration of existing, already-cleared AI features.

Therefore, many of the requested details about acceptance criteria, study methodologies, and performance metrics (clinical study details, sample sizes, expert qualifications, ground truth, MRMC studies, standalone performance) are not available in this document because a clinical performance study was not deemed necessary for this 510(k) clearance.

Here's a breakdown of what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance:

Since no clinical performance study was conducted to establish new acceptance criteria for direct device performance in terms of diagnostic accuracy or reader improvement, a table of this nature cannot be provided from this document. The "acceptance criteria" here are related to non-clinical safety and performance standards for an ultrasound system, and the "reported device performance" is a statement of compliance with these standards and equivalence to predicates.

Regarding the Study That Proves the Device Meets Acceptance Criteria:

As noted, no clinical study was conducted for this specific 510(k) clearance. The basis for clearance is substantial equivalence to legally marketed predicate devices, supported by non-clinical testing and the migration of already-cleared AI features.

Therefore, for the remaining points (2-9), the answer is largely that this information is not applicable or not provided in this 510(k) summary because a de novo clinical performance study was not performed.

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used for a de novo performance study. The AI features were migrated from already-cleared devices (Voluson Expert 22/20/18, K242168), implying their original validation would have occurred with those previous clearances. Details of those previous validations are not in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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. No MRMC study was performed for this clearance. The AI features are already cleared on previous devices, and their performance improvement with AI assistance would have been part of those prior clearances, not described here.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly stated for this clearance. Given it's an ultrasound system, the AI features (SonoPelvicFloor 3.0, SonoAVCfollicle 2.0, Fibroid Mapping, SonoLyst Live) are typically integrated tools that assist the sonographer or physician, rather than standalone diagnostic algorithms. Their standalone performance would have been assessed during their original clearance (K242168).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for this specific clearance. For the migrated AI features, their original ground truth establishment would have been part of the K242168 submission.

8. The sample size for the training set: Not applicable, as no new training was described for this submission. The AI features are migrated and not undergoing new development or training for this device.

9. How the ground truth for the training set was established: Not applicable for this submission. This would pertain to the original development and clearance of the migrated AI features, information not provided in this document.

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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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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, Power Doppler, Power Doppler, 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 an analysis of the acceptance criteria and supporting studies for the device, based on the provided text:

Acceptance Criteria and Device Performance

The document describes several AI features: SonoAVC2.0, SonoPelvicFloor2.0, Fibroid Mapping, and SonoLyst/SonoLyst Live.

SonoAVC2.0 is explicitly stated to have migrated from a previously cleared device (K230346, Voluson SWIFT/SWIFT+) as "Auto Caliper," implying its performance has already met acceptance criteria in that context. No new specific acceptance criteria or performance metrics are provided for SonoAVC2.0 in this document.

SonoPelvicFloor2.0

Fibroid Mapping

Fibroid Mapping (Quantitative Evaluation - DICE Scores when successful)

SonoLyst/SonoLyst Live (2nd Trimester Features)

Study Details

SonoPelvicFloor2.0

1. Sample Size and Data Provenance (Test Set):

   • Total Volumes: 94
   • Distribution by Systems: Voluson Expert 22 (82), Voluson E8 (8), Voluson E6 (4)
   • Distribution by Probes: RAB6-D (41), RIC5-9-D (21), RM7C (32)
   • Distribution by Countries: Austria (36), U.S.A (47), South Africa (4), Czech Republic (7)
   • Data Provenance: Retrospective. Data is "provided by external clinical partners who de-identified the data before sharing it with us." Original data is collected in the form of 4D volume Cines, preserving flexibility for retrospective re-processing. The data covers multiple geographical sites.

2. Number and Qualifications of Experts for Ground Truth (Test Set):

   • The verification was "performed by clinical experts" and involved an "internal clinical expert" for assessment.
   • Specific numbers or qualifications (e.g., years of experience, specialty) of these experts are not explicitly stated in the provided text.

3. Adjudication Method (Test Set):

   • Not explicitly described as a formal adjudication method (e.g., 2+1). The "internal clinical expert" documents the assessment.

4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study is mentioned for this feature. Performance is reported as standalone accuracy.

5. Standalone Performance:

   • Yes, the reported accuracy (96% on good IQ, 93% on challenging IQ) is for the algorithm's standalone performance.

6. Type of Ground Truth:

   • "Internal clinical expert" assessment based on a specific workflow (observing automated placement of MHD plane and assessing success/failure). This would constitute expert consensus/judgment on the algorithm's output.

7. Sample Size for Training Set:

   • Volumes: 983 distinct volumes
   • Patients: 616 individual patients
   • Images (generated): 8847 images (3 slices from each volume with three rotation angles per image)
   • Distribution by Systems: V730 (116), Voluson E10 (482), Voluson E6 (21), Voluson E8 (90), Voluson P8 (274)
   • Distribution by Probes: RAB 4-8L (116), RAB2-6-RS (38), RAB6-D (111), RIC5-9A-RS (236), RIC5-9-D (8), RM6C (474)
   • Distribution by Countries: Australia (116), Austria (8), Belgium (465), Czech Republic (100), Japan (236), Italy (37), South Africa (21)

8. How Ground Truth for Training Set was Established:

   • Not explicitly detailed for the training set within the provided text. However, it states that "Data used for both training and validation has been collected across multiple geographical sites" and "Data is provided by external clinical partners who de-identified the data." This implies that clinical experts or medical professionals initially generated the data, which was then de-identified. The process of labeling or establishing "ground truth" (e.g., manual annotations of pelvic floor structures) on these 983 volumes for training is not described.

Fibroid Mapping

1. Sample Size and Data Provenance (Test Set/Verification):

   • Primary Verification:
     • Total Volumes: 78
     • Systems: Voluson Expert Series
     • Probes: RIC5-9-D, RIC6-12-D
     • Countries: Egypt, Greece, Korea, Philippines, Romania, USA.
   • Secondary Evaluation (Qualitative and Quantitative):
     • Total Volumes: 74
     • Systems: Voluson Expert Series
     • Probes: RIC5-9-D, RIC10-D
     • Countries: Austria, Egypt, Germany, Greece, Korea, Philippines, Romania, USA.
   • Data Provenance: Retrospective. Data "provided by external clinical partners who de-identified the data before sharing it with us." Original data is collected in 3D/4D volumes.

2. Number and Qualifications of Experts for Ground Truth (Test Set):

   • Verification "performed by clinical experts."
   • "Independent clinical experts" for qualitative assessment and correlation with DICE scores.
   • "Internal and external clinical experts" were consulted for defining requirements for success rates.
   • Specific numbers or qualifications (e.g., years of experience, specialty) of these experts are not explicitly stated in the provided text.

3. Adjudication Method (Test Set):

   • Not explicitly described as a formal adjudication method. Clinical experts perform the qualitative assessment and judge if segmentation is "satisfying." If not, they may return to an earlier step or activate manual segmentation.

4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study is mentioned for this feature. Performance is reported as a standalone success rate and DICE scores.

5. Standalone Performance:

   • Yes, the reported success rates and DICE scores are for the algorithm's standalone performance in segmentation.

6. Type of Ground Truth:

   • Qualitative: "Clinical expert" assessment of whether the segmentation is "satisfying."
   • Quantitative: DICE scores calculated against what is presumably expert-annotated ground truth segmentations, which are then correlated with the qualitative expert assessment. The explicit method for defining this precise quantitative ground truth (e.g., expert manual segmentation per pixel) is not detailed for the test set.

7. Sample Size for Training Set:

   • Unique Volumes: 779
   • Augmented Volumes: 7790

8. How Ground Truth for Training Set was Established:

   • "We collected training data of the following types from hospital centers as well as private practices. We provided a dedicated data collection protocol explaining the required data needs to each provider." This implies a structured collection, but the actual process of defining the ground truth for segmentation (e.g., manual outlining of fibroids, uterus, endometrium by experts on each training image) is not explicitly described.

SonoLyst/SonoLyst Live (2nd Trimester Features) Improvement

1. Sample Size and Data Provenance (Test Set):

   • Quantitative Evaluation for SonoLyst 2nd Trimester IR: 42102 images
   • Quantitative Evaluation for SonoLyst 2nd Trimester X: 10424 images
   • Quantitative Evaluation for SonoLystLive 2nd Trimester: 5666 images
   • Data Provenance: Retrospective. Data collected from routine clinical practice in hospitals and private practice during mid-trimester examinations. Countries include UK, Austria, India, and USA.

2. Number and Qualifications of Experts for Ground Truth (Test Set):

   • Sonographer Panel: 5 sonographers were used to review sorted and graded images for accuracy.
   • Initial Curation: A "single sonographer" initially curated (sorted and graded) the images.
   • Specific qualifications (e.g., years of experience) for these sonographers are not explicitly stated.

3. Adjudication Method (Test Set):

   • Majority View: For images where the initial sonographer's sorting differed from the algorithm's initial classification, a 5-sonographer review panel determined the sorting accuracy, resulting in reclassification based on the "majority view of the panel."
   • For graded images, the 5-sonographer panel reviewed where they differed from the initial ground truth to determine grading accuracy. This is a form of 5-reader consensus/adjudication.

4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

   • The verification of SonoLystLive 2nd Trimester features is based on "the average agreement between a sonographer panel and the output of the algorithm regarding Traffic light quality." While this involves multiple readers assessing the algorithm's output, it's described more as a validation of the algorithm's performance against human judgment rather than a comparative effectiveness study showing human reader improvement with AI assistance. No effect size of human improvement with AI vs. without is provided.

5. Standalone Performance:

   • Yes, the reported average success rate of 80% or higher for SonoLyst 2nd Trimester IR and X and overall traffic light accuracy is a standalone measure of the algorithm's performance in sorting and grading.

6. Type of Ground Truth:

   • Expert Consensus: A "sonographer review panel" (5 sonographers) provided the ground truth for both sorting and grading accuracy, based on a majority view where discrepancies arose with an initial sonographer's assessment.

7. Sample Size for Training Set:

   • Total Images: 2.2 million
   • Total Cine Loops: 2570
   • Data collected across multiple geographical sites using different systems (GE Voluson V730, E6, E8, E10, Siemens Acuson S2000 and Hitachi Aloka).

8. How Ground Truth for Training Set was Established:

   • Not explicitly described for the training set in this section. General statement that "Data used for both training and validation has been collected across multiple geographical sites." The detailed "truthing process" mentioned focuses on the verification data, not the much larger training set. It's common for training data to be annotated by experts, but the specifics are not provided here.

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