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510(k) Data Aggregation
(103 days)
HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
The Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients.
Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan+™ Mode, Combined modes, Multi-Image modes (Dual, Quad), 3D/4D modes.
The HERA W9/ HERA W10 are general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as Bmode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S- Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes.
The HERA W9/HERA W10 also give the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HERA W9/HERA W10 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The provided FDA 510(k) summary (K242444) describes the acceptance criteria and study proving the device meets these criteria for three AI-powered features: HeartAssist, BiometryAssist, and ViewAssist, as well as a non-AI feature, SonoSync.
Here's a breakdown of the requested information for each AI feature:
HeartAssist
1. Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| View recognition accuracy | 89% | 96.07% |
| Segmentation dice-score | 0.8 | 0.88 |
| Size measurement (area) error rate | 8% or less | 8% or less |
| Size measurement (angle) error rate | 4% or less | 4% or less |
| Size measurement (circumference) error rate | 11% or less | 11% or less |
| Size measurement (diameter) error rate | 11% or less | 11% or less |
2. Sample size used for the test set and data provenance
- Individuals: 69
- Static Images: 315 (at least 1 static image per view location per individual)
- Provenance: Data collected at two hospitals in the United States and South Korea. Mixed retrospective and prospective data collection.
3. Number of experts used to establish the ground truth for the test set and their qualifications
- Number of Experts: Three active participating experts for initial classification and manual drawing, supervised by one additional expert.
- Qualifications:
- One obstetrician with more than 20 years of experience (primary classification/drawing).
- Two sonographers with more than 10 years of experience in fetal cardiology (primary classification/drawing).
- One obstetrician with more than 25 years of experience (supervising the entire process).
4. Adjudication method for the test set
Not explicitly stated. The process mentions "All acquired images for training, tuning and validation were first classified into the correct views by three participating experts. Afterwards, corresponding anatomy areas were manually drawn for each of the images." It doesn't specify if there was a consensus mechanism or independent review and adjudication if the experts disagreed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This study focuses on the standalone performance of the AI algorithm.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the provided data describes the standalone performance of the HeartAssist algorithm against established ground truth.
7. The type of ground truth used
Expert consensus based on manual classification of views and manual drawing of corresponding anatomy areas.
8. The sample size for the training set
Not explicitly stated for HeartAssist, but it is mentioned that "Data used for training, tuning and validation purpose are completely separated from the ones during training process and there is no overlap among the three."
9. How the ground truth for the training set was established
Not explicitly detailed for the training set, but it is implied to be the same method as for the validation set: "All acquired images for training, tuning and validation were first classified into the correct views by three participating experts. Afterwards, corresponding anatomy areas were manually drawn for each of the images."
BiometryAssist
1. Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Segmentation dice-score | 0.8 | 0.91 |
| Size measurement (circumference) error rate | 8% or less | 8% or less |
| Size measurement (distance) error rate | 4% or less | 4% or less |
| Size measurement (NT, NB, IT) error rate | 1mm or less | 1mm or less |
2. Sample size used for the test set and data provenance
- Individuals: 33
- Static Images: 360 (at least 1 static image per view location per individual)
- Provenance: Data collected at two hospitals in South Korea and the United States. Mixed retrospective and prospective data collection.
3. Number of experts used to establish the ground truth for the test set and their qualifications
- Number of Experts: Three active participating experts for initial classification and manual drawing, supervised by one additional expert.
- Qualifications:
- One obstetrician with more than 20 years of experience (primary classification/drawing).
- Two sonographers with more than 10 years of experience in fetal cardiology (primary classification/drawing).
- One obstetrician with more than 25 years of experience (supervising the entire process).
4. Adjudication method for the test set
Not explicitly stated. The process mentions "All acquired images for training, tuning and validation were first classified into the correct views by three participating experts. Afterwards, corresponding anatomy areas were manually drawn for each of the image." It doesn't specify if there was a consensus mechanism or independent review and adjudication if the experts disagreed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This study focuses on the standalone performance of the AI algorithm.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the provided data describes the standalone performance of the BiometryAssist algorithm against established ground truth.
7. The type of ground truth used
Expert consensus based on manual classification of views and manual drawing of corresponding anatomy areas.
8. The sample size for the training set
Not explicitly stated for BiometryAssist, but it is mentioned that "Data used for training, tuning and validation purpose are completely separated from the ones during training process and there is no overlap between the three."
9. How the ground truth for the training set was established
Not explicitly detailed for the training set, but it is implied to be the same method as for the validation set: "All acquired images for training, tuning and validation were first classified into the correct views by three participating experts. Afterwards, corresponding anatomy areas were manually drawn for each of the image."
ViewAssist
1. Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| View recognition accuracy | 89% | 94.92% |
| Anatomy annotation (segmentation) dice-score | 0.8 | 0.89 |
2. Sample size used for the test set and data provenance
- Individuals: 98
- Static Images: 1,485 (at least 1 static image per view location per individual)
- Provenance: Data collected at two hospitals in South Korea and the United States. Mixed retrospective and prospective data collection.
3. Number of experts used to establish the ground truth for the test set and their qualifications
- Number of Experts: Three active participating experts for initial classification and manual drawing, supervised by one additional expert.
- Qualifications:
- One obstetrician with more than 20 years of experience (primary classification/drawing).
- Two sonographers with more than 10 years of experience in fetal cardiology (primary classification/drawing).
- One obstetrician with more than 25 years of experience (supervising the entire process).
4. Adjudication method for the test set
Not explicitly stated. The process mentions "All acquired images for training, tuning and validation were first classified into the correct views by three participating experts. Afterwards, corresponding anatomy areas were manually drawn for each of the image." It doesn't specify if there was a consensus mechanism or independent review and adjudication if the experts disagreed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This study focuses on the standalone performance of the AI algorithm.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the provided data describes the standalone performance of the ViewAssist algorithm against established ground truth.
7. The type of ground truth used
Expert consensus based on manual classification of views and manual drawing of corresponding anatomy areas.
8. The sample size for the training set
Not explicitly stated for ViewAssist, but it is mentioned that "Data used for training, tuning and validation purpose are completely separated from the ones during training process and there is no overlap between the three."
9. How the ground truth for the training set was established
Not explicitly detailed for the training set, but it is implied to be the same method as for the validation set: "All acquired images for training, tuning and validation were first classified into the correct views by three participating experts. Afterwards, corresponding anatomy areas were manually drawn for each of the image."
General Notes applicable to all AI features:
- No Multi-Reader Multi-Case (MRMC) Study: The document explicitly states that "The subject of this premarket submission, HERA W9/ HERA W10, did not require clinical studies to demonstrate the substantial equivalence." The studies described are technical performance evaluations of the AI algorithms, not comparative effectiveness studies with human readers.
- Ground Truth Consistency: For all three AI features, the ground truth establishment process is described identically, relying on a small panel of experienced experts.
- Independence of Data: For all three AI features, it is stated that "Data used for training, tuning and validation purpose are completely separated from the ones during training process and there is no overlap among the three."
- Demographics: For all three AI features, the demographic distribution of the validation dataset indicates Female Gender, Reproductive age (specific age not collected), and Ethnicity/Country as Not Available / United States and South Korea. ICUOG and AIUM guidelines were used to divide fetal ultrasound images into views. BMI and Gestational Age distributions are also provided.
- Equipment: Data was acquired with SAMSUNG MEDISON's ultrasound systems (HERA W9/HERA W10) to secure diversity.
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(100 days)
HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
The Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients.
Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan+TM Mode, Combined modes, Multi-Image modes (Dual, Quad), 3D/4D modes.
The HERA W9/ HERA W10 are general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as Bmode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S- Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes.
The HERA W9/HERA W10 also give the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HERA W9/HERA W10 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Here's an analysis of the acceptance criteria and study details for the BiometryAssist and ViewAssist features of the HERA W9/HERA W10 Diagnostic Ultrasound System, based on the provided document:
BiometryAssist
1. Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria | Reported Performance |
|---|---|---|
| Segmentation Test | Average Dice-score ≥ 0.8 | 0.91 (threshold 0.8) |
| Size Measurement | Circumference error rate ≤ 8% | 8% or less |
| Distance measured value error rate ≤ 4% | 4% or less | |
| NT measured value error rate ≤ 1mm | 1mm or less |
2. Sample Size and Data Provenance
- Test Set Sample Size: 320 fetal biometry images.
- Data Provenance: Images collected retrospectively and prospectively at two hospitals in South Korea and the United States.
3. Number of Experts and Qualifications
- Experts for Test Set Ground Truth: Three participating experts and one supervising obstetrician.
- Qualifications:
- One obstetrician with more than 20 years of experience (supervisor).
- Two sonographers with more than 10 years of experience, all specializing in fetal cardiology.
- One obstetrician with more than 25 years of experience (supervisor).
4. Adjudication Method
- The document implies a consensus-based approach among the three experts for classifying images and manually drawing anatomy areas, supervised by a fourth obstetrician. No specific "2+1" or "3+1" adjudication method is explicitly stated, but the process involves multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not explicitly mentioned or described for comparing human readers with and without AI assistance. The study focuses on the standalone performance of the AI algorithm.
6. Standalone Performance
- Yes, the study describes the standalone performance of the algorithm for segmentation and size measurement without human intervention after the initial image acquisition and ground truthing.
7. Type of Ground Truth Used
- Expert consensus. All acquired images for training, tuning, and validation were classified into correct views by experts, and corresponding anatomy areas were manually drawn by them.
8. Training Set Sample Size
- Not explicitly stated, but the document mentions that a dataset was acquired for training, tuning, and validation.
9. How Ground Truth for Training Set Was Established
- All acquired images for training, tuning, and validation were first classified into the correct views by three participating experts. Afterwards, corresponding anatomy areas were manually drawn for each image. The participating experts were composed of an obstetrician with more than 20 years of experience and two sonographers with more than 10 years of experience, all in fetal cardiology, and the entire process was supervised by another obstetrician with more than 25 years of experience.
ViewAssist
1. Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria | Reported Performance |
|---|---|---|
| View Recognition Test | Average recognition accuracy ≥ 89% | 94.70% (threshold 89%) |
| Anatomy Annotation (Segmentation) Test | Average Dice-score ≥ 0.8 | 0.875 (threshold 0.8) |
2. Sample Size and Data Provenance
- Test Set Sample Size: 1,320 fetal heart and fetal biometry images.
- Data Provenance: Images collected retrospectively and prospectively at two hospitals in South Korea and the United States.
3. Number of Experts and Qualifications
- Experts for Test Set Ground Truth: Three participating experts and one supervising obstetrician.
- Qualifications:
- One obstetrician with more than 20 years of experience (supervisor).
- Two sonographers with more than 10 years of experience, all specializing in fetal cardiology.
- One obstetrician with more than 25 years of experience (supervisor).
4. Adjudication Method
- Similar to BiometryAssist, the document implies a consensus-based approach among the three experts for classifying images and manually drawing anatomy areas, supervised by a fourth obstetrician. No specific "2+1" or "3+1" adjudication method is explicitly stated, but the process involves multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not explicitly mentioned or described for comparing human readers with and without AI assistance. The study focuses on the standalone performance of the AI algorithm.
6. Standalone Performance
- Yes, the study describes the standalone performance of the algorithm for view recognition and anatomy annotation (segmentation) without human intervention after the initial image acquisition and ground truthing.
7. Type of Ground Truth Used
- Expert consensus. All acquired images for training, tuning, and validation were classified into correct views by experts, and corresponding anatomy areas were manually drawn by them.
8. Training Set Sample Size
- Not explicitly stated, but the document mentions that a dataset was acquired for training, tuning, and validation.
9. How Ground Truth for Training Set Was Established
- All acquired images for training, tuning, and validation were first classified into the correct views by three participating experts. Afterwards, corresponding anatomy areas were manually drawn for each image. The participating experts were composed of an obstetrician with more than 20 years of experience and two sonographers with more than 10 years of experience, all in fetal cardiology, and the entire process was supervised by another obstetrician with more than 25 years of experience.
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(90 days)
HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System
The diagnostic ultrasound system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients.
Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan+™ Mode, Combined modes, Multi-Image modes (Dual, Quad), 3D/4D modes.
The HERA W9/ HERA W10 are general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDD), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes.
The HERA W9/HERA W10 also give the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HERA W10 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
This document is a 510(k) summary for the HERA W9/W10 Diagnostic Ultrasound System, which explicitly states that clinical studies were not required to support substantial equivalence. Therefore, the document does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study designs (MRMC, standalone) in the context of proving device performance against acceptance criteria.
The submission focuses on demonstrating substantial equivalence to a predicate device (HERA W9/W10, K211824) primarily through technological characteristics, intended use, and compliance with non-clinical safety and performance standards.
The "Summary of Clinical Tests" section on page 7 explicitly states: "The subject of this premarket submission, HERA W9/ HERA W10, did not require clinical studies to support substantial equivalence."
Therefore, I cannot provide the requested information from the provided document.
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(87 days)
HERA W9, HERA W10 Diagnostic Ultrasound System
The diagnostic ultrasound system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, clinics and similar care environment for clinical diagnosis of patients.
Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan+™ Mode, Combined modes, Multi-Image modes (Dual, Quad), 3D/4D modes.
The HERA W9/ HERA W10 are general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes.
The HERA W9/HERA W10 also give the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HERA W10 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Here's a summary of the acceptance criteria and the study details for the SAMSUNG MEDISON CO., LTD. HERA W9/HERA W10 Diagnostic Ultrasound System, specifically focusing on the AI-based features mentioned in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria for the AI-based features. Instead, it states that "Performance testing was successfully completed for the new software functions (artificial intelligence based features HeartAssist, ViewAssist and Slice A) to show passing results for predefined testing criteria," and that for BiometryAssist, "measurement accuracy requirements were met."
Therefore, based on the provided text, the table would look like this:
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied) | Reported Device Performance |
|---|---|---|
| HeartAssist | Meeting "predefined testing criteria" for classification of ultrasound images into measurement views, caliper placement, and measurement results. | "Performance testing was successfully completed... to show passing results for predefined testing criteria." |
| ViewAssist | Meeting "predefined testing criteria" for classification of ultrasound images into key scanning views and providing annotations. | "Performance testing was successfully completed... to show passing results for predefined testing criteria." |
| Slice A | Meeting "predefined testing criteria" for functionality similar to VCIA. | "Performance testing was successfully completed... to show passing results for predefined testing criteria." |
| BiometryAssist (AI version) | Meeting "measurement accuracy requirements" for automatic biometric measurement of fetal growth parameters. | "validated through performance testing to confirm the measurement accuracy requirements were met." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on:
- The specific sample size used for the test set for any of the AI features.
- The data provenance (e.g., country of origin of the data, retrospective or prospective) for the test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide details on:
- The number of experts used to establish the ground truth for the test set.
- The qualifications of those experts.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set. It mentions that clinical studies were not required for substantial equivalence and focuses on performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
The document does not indicate that an MRMC comparative effectiveness study was done. It focuses on the performance of the AI features themselves rather than comparing human reader performance with and without AI assistance. The text explicitly states: "The subject of this premarket submission, HERA W9/ HERA W10, did not require clinical studies to support substantial equivalence."
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Yes, the descriptions of HeartAssist, ViewAssist, Slice A, and BiometryAssist (AI version) focus on their automated capabilities ("classification," "proposes caliper placements," "proposes corresponding anatomy annotations," "automatic technology for biometric measurement"). While it mentions user editing, the performance testing appears to validate the algorithm's standalone capabilities against "predefined testing criteria" and "measurement accuracy requirements."
7. The Type of Ground Truth Used
The document states that BiometryAssist's accuracy requirements were met for "biometric measurement," implying that quantitative measurement values (likely manually obtained or from established references) were used as ground truth. For HeartAssist, ViewAssist, and Slice A, the ground truth would likely involve expert-defined "measurement views," "key scanning views," and "anatomy annotations," respectively, but the precise nature (e.g., expert consensus) is not detailed.
8. The Sample Size for the Training Set
The document does not provide details on the sample size used for the training set for any of the AI features.
9. How the Ground Truth for the Training Set was Established
The document does not provide details on how the ground truth for the training set was established. It only generally refers to these features as "deep learning based functions" which implies a training process with labeled data.
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(106 days)
HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System
The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
The HERA W9/ HERA W10 are general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound dasta and to display the data as B-mode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes.
The HERA W9/HERA W10 also give the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HERA W9/HERA W10 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
As compared with predicate device(HERA W10, K182595), the subject device has added new three transducers(EV2-10A, EA2-11AV and EA2-11AR) and nine biopsy kits (BP-KIT-079, BP-KIT-080, BP-KIT-081, BP-KIT-082, BP-KIT-085, BP-KIT-086, BP-KIT-089 and BP-KIT-089 and BP-KIT-090) and the product name of HERA W9. There are no change and new software features from the predicate device. The HERA ultrasound system is supported by software and the software is not modified for the subject system.
The provided FDA 510(k) summary for the HERA W9/HERA W10 Diagnostic Ultrasound System does not contain information about acceptance criteria or a study proving that the device meets such criteria.
This is because the submission is for a 510(k) pathway, specifically claiming substantial equivalence to a predicate device (HERA W10, K182595). In such cases, the primary goal is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a novel technology.
The document explicitly states:
"The subject of this premarket submission, HERA W9/ HERA W10, did not require clinical studies to support substantial equivalence."
Instead, the submission focuses on demonstrating:
- Technological equivalence: "The HERA W9/ HERA W10 employ the same fundamental scientific technology as its predicate device."
- Feature similarity: A detailed table comparing features, clinical applications, scanhead types, modes of operation, etc., between the new device and the predicate. The differences noted are primarily hardware variations (DVD, caster size, monitor size, active probe ports) and the addition of new transducers and biopsy kits. Critically, it states, "There are no change and new software features from the predicate device. The HERA ultrasound system is supported by software and the software is not modified for the subject system."
- Compliance with safety standards: The document lists several IEC, ISO, and NEMA standards that the device conforms to for acoustic output, biocompatibility, cleaning/disinfection, thermal, electromagnetic, and mechanical safety.
Therefore, since no clinical study was required or performed to prove specific performance metrics against acceptance criteria for the new device itself, I cannot provide the requested information. The device's "performance" is implicitly deemed equivalent to the predicate device through the demonstration of similar technology, intended use, and safety characteristics.
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(89 days)
HERA W10 Diagnostic Ultrasound System
The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
The HERA W10 is general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound dasta and to display the data as B-mode. M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes. The HERA W10 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HERA W10 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
I am sorry, but the provided text does not contain sufficient information to answer your request. The document is a 510(k) summary for the HERA W10 Diagnostic Ultrasound System, which primarily focuses on establishing substantial equivalence to predicate devices and detailing the device's intended uses and compliance with safety standards.
Specifically, the text does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes used for test sets, data provenance, number or qualifications of experts for ground truth, or adjudication methods for test sets.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Information about a standalone (algorithm only) performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set or how its ground truth was established.
In fact, section 11 explicitly states: "The subject of this premarket submission, HERA W10, did not require clinical studies to support substantial equivalence." This indicates that detailed performance studies as you've requested were not part of this specific FDA submission.
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