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510(k) Data Aggregation
(103 days)
ACUSON Sequoia and ACUSON Sequoia Select
The ACUSON Sequoia and Sequoia Select ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic, structures), Cardiac, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.
The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis.
The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
ACUSON Origin
The ACUSON Origin ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Pediatric, OB/ GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Intracardiac, Vascular, Adult Cephalic, and Peripheral Vascular applications.
The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
The ACUSON Sequoia, Sequoia Select, and Origin Diagnostic Ultrasound Systems are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an onscreen display of thermal and mechanical indices related to potential bio-effect mechanisms. The ultrasound system function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes. Panoramic Imaging. Contrast agent Imaging. Virtual Touch Strain Imaging (except Origin), Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging or Harmonic Imaging on a Display and provide cardiac anatomical and quantitative function software applications.
The provided FDA 510(k) summary describes the Siemens ACUSON Sequoia, ACUSON Sequoia Select, and ACUSON Origin Diagnostic Ultrasound Systems, focusing on new software applications (AI Measure, AI Assist, 2D HeartAI, 4D HeartAI) that incorporate Machine Learning algorithms for cardiac imaging.
The document includes summaries of validation testing for each of these AI features.
1. Table of Acceptance Criteria and Reported Device Performance
| AI Feature | Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|---|
| AI Assist | Overall Success Rate: Percentage of placements requiring no adjustment or only minor adjustment by the user. | 99.3% overall successful placement across all cardiac views and placement locations. For any single placement location, success is 92% or higher. |
| 2D HeartAI | Pearson Correlation Coefficient: With user edits compared to reference standard ground truth. | 0.81 or higher |
| Bland-Altman Bias: With user edits compared to reference standard ground truth. | less than 5.2 (minimal bias) | |
| Performance for Normal BMI subjects ( 25 kg/m2): Pearson Correlation Coefficient. | greater than 0.82 | |
| 4D HeartAI | Pearson Correlation Coefficient: With user edits compared to reference standard ground truth. | 0.87 or higher |
| Bland-Altman Bias: With user edits compared to reference standard ground truth. | less than 13.3 (minimal bias) | |
| Performance for Normal BMI subjects ( 25 kg/m2): Pearson Correlation Coefficient. | greater than 0.81 | |
| AI Measure | Overall Success Rate: Percentage of measurements deemed clinically acceptable (Pass or Pass with/Edit). | 89.6% overall successful performance. For any single acquisition mode, success is 88.1% or higher. |
2. Sample Sizes Used for the Test Set and Data Provenance
| AI Feature | Test Set Sample Size (Patients/Exams/Samples) | Data Provenance |
|---|---|---|
| AI Assist | 12 patients; 14 exams (12 patients, with 2 having additional data); 168 samples (16 frames x 12 cardiac views x 14 exams). | US; Retrospective (collected by a cardiac sonographer who scanned 12 cardiac views included in an Adult Echocardiogram examination). |
| 2D HeartAI | 45 exams; 90 images extracted. | US, Mexico; From 5 different institutions; Retrospective. |
| 4D HeartAI | 32 patients; 64 volumes extracted. | US, Mexico; From 5 different institutions; Retrospective (for 5Z1 (17 TTE) and 6ZT (15 TEE) transducers, with Volume rates > 13.4vps). |
| AI Measure | 32 individual patients; 1354 samples (from 392 images). | US, Mexico; From 5 institutions; Retrospective (the dataset consists of exams from across five institutions, five probes (5V1, 5Z1, 8V3, 10V4, Z6T) and different Sequoia CV Systems. The data collection protocol was standardized across all data collection sites). |
3. Number of Experts and Qualifications for Ground Truth
| AI Feature | Number of Experts | Qualifications |
|---|---|---|
| AI Assist | 3 sonographers | Expert cardiac sonographers (implied by context). |
| 2D HeartAI | 3 examiners | "Examiners" performed all manual contouring and measurements. No specific years of experience mentioned, but expertise is implied for establishing reference standard. |
| 4D HeartAI | 3 examiners | "Examiners" performed all manual contouring and measurements. No specific years of experience mentioned, but expertise is implied for establishing reference standard. |
| AI Measure | At least 3 sonographers | Expert cardiac sonographers (implied by context). |
4. Adjudication Method for the Test Set
| AI Feature | Adjudication Method |
|---|---|
| AI Assist | Consensus-based scoring: Three sonographers scored the results for each placement made by the algorithm. Success was defined as "no adjustment or minor adjustment needed," while "failure" meant a "major adjustment needed." This implies a form of expert consensus without explicit mention of conflict resolution, but rather individual scoring that collectively determined the success rate. |
| 2D HeartAI | Mean value from multiple examiners: Three examiners performed all manual contouring and measurements. Reference standard for each measurement was established by calculating the mean value from the three examiners. Variability was assessed by intraclass correlation (ICC) and inter-reader variability by Pearson correlation and Bland-Altman. This is a form of 3-expert consensus by averaging. |
| 4D HeartAI | Mean value from multiple examiners: Identical to 2D HeartAI. Three examiners performed all manual contouring and measurements. Reference standard for each measurement was established by calculating the mean value from the three examiners. Variability was assessed by intraclass correlation (ICC) and inter-reader variability by Pearson correlation and Bland-Altman. This is a form of 3-expert consensus by averaging. |
| AI Measure | Consensus-based scoring: At least three sonographers scored the results for each measurement made by the algorithm to assess success ("measurements were deemed clinically acceptable"). Similar to AI Assist, this implies a form of expert consensus without explicit mention of conflict resolution. |
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study to measure the effect size of human readers improving with AI vs. without AI assistance. The studies performed focus on the standalone performance of the AI algorithms, often with user edits being factored in, but not a direct comparison of human performance with and without AI.
6. Standalone Performance Study
Yes, standalone performance studies were done for each AI feature:
- AI Assist: Evaluated the algorithm's ability to successfully place Color Box and Doppler Gate based on expert sonographer scoring of its output (99.3% success). This is a standalone assessment of the algorithm's initial placement accuracy.
- 2D HeartAI: Evaluated the accuracy of the 2D HeartAI "as measured by comparison of 2D HeartAI with user edits compared to a reference standard ground truth." While user edits are mentioned, the reported correlation coefficient and bias (0.81 or higher, bias
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(29 days)
For ACUSON Maple Diagnostic Ultrasound System
The ACUSON Maple ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Neonatal, Vascular, Urology, Echocardiography, and Musculoskeletal applications using different ultrasound transducers for different applications. The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system.
For ACUSON Maple Select Diagnostic Ultrasound System
The ACUSON Maple Select ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediat, Urology, Echocardiography and Musculoskeletal applications using different ultrasound transducers for different applications. The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system.
The ACUSON Maple Diagnostic Ultrasound System and ACUSON Maple Select Diagnostic Ultrasound System are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an onscreen display for thermal and mechanical indices related to potential bio-effect mechanisms. Their function is to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Doppler Tissue Image mode, Amplitude Doppler Mode, combination modes, Harmonic Imaging and 3D Imaging modes, or Harmonic Imaging and 4D imaging modes on a flat panel display for diagnostic ultrasound imaging.
The provided document is a 510(k) summary for the ACUSON Maple Diagnostic Ultrasound System and ACUSON Maple Select Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a detailed study with acceptance criteria.
Therefore, the document does not contain the requested information regarding acceptance criteria, reported device performance, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.
The document explicitly states:
"The proposed ACUSON Maple and ACUSON Maple Select did not require any clinical studies to support substantial equivalence."
This means that the device was cleared based on its similarity to previously cleared devices (ACUSON Juniper and Juniper Select (K230207), ACUSON NX2 and NX2 Elite (K173981), ACUSON SC2000 (K211726)) and non-clinical data demonstrating safety and adherence to voluntary standards.
Consequently, I cannot provide the requested table or describe a study that proves the device meets specific acceptance criteria based on the input text.
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