Search Results

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal (includes infertility monitoring of follicle development), Abdominal, Pediatric, Small Organ, Adult Cephalic, Cardiac (Adult, Pediatric), Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, and Muscular-Skeletal (conventional, superficial). Typical examinations performed using the system are: General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies. Study of small parts including breasts, shoulders, thyroid, and the abdominal wall. Pediatric scans of organs and bony structures. Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Prostate, prostate biopsy guidance, and rectal wall studies. Trans-cranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. Cardiac studies in adults and children. Biopsy guidance for tissue or fluid sampling. Conventional podiatry scans.

The SA-9900PLUS scanner is a 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, Color-Flow Doppler, Continuous (CW) Doppler, Pulsed (PW) Doppler and Power Doppler, or as a combination of these modes. The SA-9900PLUS 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 SA-9900PLUS has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. Thirteen different models of transducers are available and any four may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. The SA-9900PLUS uses digital beamforming technology, and supports a variety of Linear, Convex, Phased Array and Static probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the expected date of delivery by using GS (Gestational Sac), CRL (Crown-Rump Length), YS (Yolk Sac), BPD (Biparietal Diameter), OFD (Occipital-Frontal Diameter), HC (Head Circumference), APD (Anterior-Posterior), Abdominal Diameter, TAD (Transverse Abdominal Diameter), AC (Abdominal Circumference), FTA (Fetal Trunk Area), FL (Femur Length), TTD (Transverse Trunk/Thorax Diameter), APTD (AnteroPosterior TrunkThorax Diameter), HUM (Humerus Length), ULNA (Ulna Length), TIB (Tibia Length), RAD (Radius Length), FIB (Fibula Length), CLAV (Clavicle Length), LV (Lateral Ventricle), CEREB ( Cerebellum Diameter), OOD (Outer Ocular Distance), IOD (Inner Ocular Distance), CM (Cisterna Magna), NF (Nuchal Fold), FOOT (Foot Length), EAR (Ear Length), MP (Middle Phalenix), AFI (Amniotic Fluid Index), Cardiac Analysis (volume by area/length, Simpson biplane and single plane, M-mode analysis, Doppler: peak and mean gradients, pressure half time, E/A ratio and continuity equation) and Vascular Analysis (resistive index, pulsatility index, % stenosis, ICA/CCA ratio, Volume flow). Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. M-mode uses the scroll display method, which has its images flow from the right to the left on the monitor. The SA-9900PLUS supports the Cine function (capable of storing up to 256 sequential images) and real-time zoom function to the region-of-interest. The system provides the ability to perform remote viewing of images, without compression, via a DICOM 3.0 compatible output. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

The provided text is a 510(k) Premarket Notification for the SA-9900PLUS Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices (SA 9900 - K002185 and SA8000 - K013627) rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

For a diagnostic ultrasound system like the SA-9900PLUS, acceptance criteria typically involve demonstrating that the new device performs as intended and is as safe and effective as the predicate device. This is primarily achieved by showing that its technological characteristics and intended uses are the same or very similar to the predicate devices, and that any differences do not raise new questions of safety or effectiveness.

Therefore, the "study" demonstrating criteria fulfillment is primarily a comparison of specifications and intended uses against the predicate devices. The document does not contain information about a traditional clinical study with a test set, ground truth established by experts, sample sizes for training or testing, adjudication methods, or MRMC studies.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• The document does not describe a specific "test set" or a formal clinical study with patient data to evaluate the device's performance against predefined acceptance criteria in the way a new, novel device might.
• The data provenance is implicitly from the specifications and performance of the predicate devices (SA 9900 - K002185 and SA8000 - K013627), which would have been cleared based on their own performance data. The SA-9900PLUS is stated to operate "identical to the predicate devices."
• This is a retrospective comparison against existing device specifications rather than a prospective study on new data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. There is no mention of a test set with ground truth established by experts in this 510(k) summary. The submission relies on substantial equivalence to predicate devices.

4. Adjudication method for the test set:

• Not applicable. No test set or expert adjudication is described.

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:

• No MRMC study mentioned. This device predates widespread AI integration in diagnostic ultrasound and is being cleared based on substantial equivalence, not a comparative effectiveness study involving human readers and AI.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a diagnostic ultrasound system, not an AI algorithm, and therefore a "standalone" performance study in the context of AI is not relevant. The device requires a human operator.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. No explicit ground truth is mentioned as part of this submission for the SA-9900PLUS itself. The "ground truth" for showing equivalence relies on the established safety and effectiveness of the predicate ultrasound systems.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that undergoes a training phase as described in the context of modern AI devices.

9. How the ground truth for the training set was established:

• Not applicable. As above, this is not an AI/ML device with a training set.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal (includes infertility monitoring of follicle development), Abdominal, Pediatric, Small Organ, Cardiac (Adult), Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, Muscular-Skeletal (conventional, superficial). Typical examinations performed using the system are: General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies. Study of small parts including breasts, shoulders, thyroid, and the abdominal wall. Pediatric scans of organs and bony structures. Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Prostate, prostate biopsy guidance, and rectal wall studies. Trans-cranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. Cardiac studies in adults. Biopsy guidance for tissue or fluid sampling. Conventional podiatry scans.

The mycolor 202 scanner (marketed under the name SonoAce PICO) is a 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, Color-Flow Doppler, Pulsed (PW) Doppler and Power Doppler, or as a combination of these modes. The mycolor 202 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 mycolor 202 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. Seven different models of transducers are available and only one can be connected. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. The mycolor 202 uses digital beamforming technology, and supports a variety of Linear, Convex, Phased Array and Static probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the expected date of delivery by using BPD (Biparietal Diameter), HC (Head Circumference), OFD (Occipital Frontal Diameter), FL (Femur Length), AC (Abdominal Circumference), FTA (Fetal Trunk Area), APTD (Anterior Posterior Thoracic Diameter), TTD (Transverse Thoracic Diameter), TAD (Transverse Abdominal Diameter), CRL (Crown Rump Length). GS (Gestational Sac), APD (Anterior-Posterior Abdominal Diameter), AF1 (Amniotic Fluid Index), APD (Anterior-Posterior Abdominal Diameter), Cerebellum, CLAV(Clavicle), CM (Cisterna Magna), Ear, FIB (Fibular), Foot, HUM (Humerus), IOD (Inner Ocular Distance), LV (Lateral Ventricle). Mid Cerebral Artery. MP (Middle Phalanx), NF (Nuchal Fold), OOD (Outer Ocular Distance), RAD (Radius Length), TIB (Tibia), ULNA (Ulna Length), Umbilical Artery, YS- Yolk Sac, Cardiac Analysis (volume by area/length, Simpson biplane and single plane, M-mode analysis, Doppler: peak and mean gradients, pressure half time, E/A ratio and continuity equation) and Vascular Analysis (resistive index, pulsatility index, % stenosis, ICA/CCA ratio. Volume flow). Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. M-mode uses the scroll display method, which has its images flow from the right to the left on the monitor. The mycolor 202 supports the Cine function (capable of storing up to 256 sequential images) and real-time zoom function to the region-of-interest. The system provides the ability to perform remote viewing of images, without compression, via a DICOM 3.0 compatible output. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

The provided document is a 510(k) Premarket Notification for the mycolor 202 Ultrasound System, dated May 30, 2003. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than a detailed performance study with acceptance criteria in the context of AI/ML.

Therefore, many of the requested elements (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth for test/training sets, and training set sample size) are not applicable or not detailed in this type of submission. This document is a regulatory filing for a traditional, non-AI ultrasound system.

However, based on the information provided, here's what can be extracted:

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

This document does not present "acceptance criteria" and "reported device performance" in the way one would typically expect for an AI/ML device (e.g., target specificity, sensitivity, or AUC values). Instead, it focuses on the device's technical specifications and adherence to safety and regulatory standards, and its substantial equivalence to predicate devices for specific clinical applications and modes of operation.

The key "acceptance criteria" implicitly addressed are:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. This is a regulatory submission for a conventional ultrasound device based on substantial equivalence, not an AI/ML performance study utilizing test datasets.

3. 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)

This information is not provided as this is not an AI/ML study involving ground truth experts for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as this is not an AI/ML study involving expert adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed for this submission. This device is a diagnostic ultrasound system and does not incorporate AI for assistance to human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone algorithm performance study was not performed. This is a hardware and software system for direct human operation, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

"Ground truth" in the context of an AI/ML algorithm's performance is not applicable to this submission. The "truth" here is related to the device's ability to accurately acquire and display ultrasound data, perform measurements, and conform to safety and technical standards as expected of a diagnostic ultrasound system. Compliance with established safety standards and verification of technical specifications serve as the "ground truth" for this type of device.

8. The sample size for the training set

This information is not provided as this is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as this is not an AI/ML device that requires a training set and associated ground truth.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal (includes infertility monitoring of follicle development), Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac (Adult, Pediatric), Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, Muscular-Skeletal (conventional, superficial), Intra-Operative (Neurological, Abdominal, Peripheral vascular). Typical examinations performed using the system are: General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies. Study of small parts including breasts, shoulders, thyroid, and the abdominal wall. Pediatric scans of organs and bony structures. Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Prostate, prostate biopsy guidance, and rectal wall studies. Neonatal head studies. Trans-cranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. Cardiac studies in adults and children. Biopsy guidance for tissue or fluid sampling. Conventional podiatry scans.

The SA8000 scanner is a 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, Color-Flow Doppler, Continuous (CW) Doppler, Pulsed (PW) Doppler and Power Doppler, or as a combination of these modes. The SA8000 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 SA8000 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. Seventeen different models of transducers are available and any three may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. The SA8000 uses digital beamforming technology, and supports a variety of Linear, Convex, Phased Array and Static probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the expected date of delivery by using BPD (biparietal diameter), OFD (occipitofrontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), LMP (last menstural period.), Cardiac Analysis (volume by area/length, Simpson biplane and single plane, M-mode analysis, Doppler: peak and mean gradients, pressure half time, E/A ratio and continuity equation) and Vascular Analysis (resistive index, pulsatility index. % stenosis, ICA/CCA ratio, Volume flow). Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. M-mode uses the scroll display method which has its images flow from the right to the left on the monitor. The SA8000 supports the Cine function (capable of storing up to 256 sequential images) and real-time zoom function to the region-of-interest. The system provides the ability to perform remote viewing of images, without compression, via a DICOM 3.0 compatible output. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

The Medison America, Inc. SA8000 Diagnostic Ultrasound System and its associated transducers are general purpose diagnostic ultrasound systems. The provided documentation primarily focuses on establishing substantial equivalence to previously cleared predicate devices (SA 9900 - K002185 and SA8800/HDI1500 - K974269) by demonstrating equivalent technological characteristics and intended uses.

Based on the provided information, typical "acceptance criteria" for this type of device are related to its technical specifications and intended uses being substantially equivalent to legally marketed predicate devices, as well as meeting safety standards. The study described is a submission for 510(k) clearance, which is a regulatory pathway to demonstrate substantial equivalence, rather than a clinical trial with specific performance metrics against a defined ground truth.

Here's an analysis of the provided information relative to your requested points:

Acceptance Criteria and Device Performance

The core "acceptance criteria" for a 510(k) submission like this often revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved by showing substantially equivalent technological characteristics and intended uses.

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices primarily through technical specifications and intended uses, rather than a clinical performance study with a "test set" in the typical sense of AI/algorithm evaluation. Therefore, information about a specific sample size for a test set, data provenance (country of origin, retrospective/prospective), etc., is not available in this document. The "study" here is the regulatory submission itself, comparing the new device's specifications to existing ones.

3. 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)
As there is no described clinical performance study with a test set requiring expert-established ground truth, this information is not applicable/not provided in the document. The regulatory review process involves FDA experts evaluating the submission against established standards and predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since there's no defined "test set" for performance evaluation, an adjudication method is not applicable/not provided.

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
This submission predates the widespread use of AI in medical imaging devices and focuses on foundational ultrasound technology. No MRMC study involving AI assistance for human readers was conducted or reported in this document. This information is not applicable/not provided.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is a diagnostic ultrasound system, which inherently requires a human operator for image acquisition and interpretation. It is not a standalone algorithm in the sense of AI. Therefore, a standalone algorithm performance study is not applicable/not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given that this is a 510(k) submission for a general-purpose ultrasound system based on substantial equivalence, there isn't a "ground truth" for disease detection or diagnosis that would typically be established in a clinical trial for an AI-powered diagnostic device. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices and compliance with recognized safety standards. This information is not applicable/not provided.

8. The sample size for the training set
This document does not describe a machine learning algorithm or AI component that would typically require a "training set." Therefore, information on a training set size is not applicable/not provided.

9. How the ground truth for the training set was established
As there is no described training set, this information is not applicable/not provided.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal (including infertility monitoring of follicle development), Abdominal, Intra-operative (Abdominal, Vascular), Intra-operative (Neurological), Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (Non cardiac, Cardiac), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Cardiac (Adult, Pediatric), Peripheral-vascular.
Typical examinations performed using the system are: General abdominal and pelvic studies including organ surveys, assessment, and retro-peritoneal cavity studies. Study of small parts including breasts, shoulders, thyroid, and the abdominal wall. Pediatric scans of organs and bony structures. Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Prostate, prostate biopsy guidance, and rectal wall studies. Neonatal head studies. Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. Cardiac studies in adults and children. Biopsy guidance for tissue or fluid sampling. Conventional podiatry scans. Intra-operative application including soft tissue structures.

The SA 9900 scanner is a 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, Continuous (CW) Doppler, Pulsed (PW) Doppler, Power Doppler, and 3D imaging or as a combination of these modes. The SA 9900 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. All modes of operation have been previously cleared in 510(k) K002185. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals. The control panel has not changed from the description in the SA9900 Ultrasound System Operator's Manual, submitted in the 510(k) Special Report, Add-to-File for K002185. Various different models of transducers are available and any four may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. The SA-9900 uses digital beamforming technology, and supports a variety of Linear, Convex, Phased Array and Static probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. These probes can be applied to a variety of clinical applications such as fetal, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-rectal, trans-vaginal, peripheral-vascular, muscular-skeletal. The same clinical uses were cleared for the predicate device, SA8800/HD11500 (K974269). The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the expected date of delivery by using BPD (biparietal diameter), OFD (occipitofrontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), LMP (last menstural period.), Cardiac Analysis (volume by area/length, Simpson biplane and single plane, M-mode analysis, Doppler: peak and mean gradients, pressure half time, E/A ratio and continuity equation) and Vascular Analysis (resistive index, pulsatility index, % stenosis, ICA/CCA ratio, Volume flow). Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. M-mode uses the scroll display method which has its images flow from the right to the left on the monitor. The SA9900 supports the Cine function (capable of storing up to 256 sequential images) and real-time zoom function to the region-ofinterest. The system provides the ability to perform remote viewing of images, without compression, via a DICOM 3.0 compatible output. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

The provided text is a 510(k) summary for the Medison SA9900 Ultrasound System and its associated transducers. It describes the device, its intended uses, and claims substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, especially in terms of diagnostic performance or clinical effectiveness.

The document focuses on regulatory compliance, electromechanical safety standards, and acoustic output limits. It lists various clinical applications and modes of operation, indicating whether these were "new indications" (N) or "previously cleared" (P) under a prior 510(k) (K002185). The FDA's letter confirms substantial equivalence based on the provided information, but this refers to regulatory equivalence, not a direct demonstration of performance against specific clinical acceptance criteria in a study.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from this document.

Here's an attempt to fill in what can be gleaned, and explicitly state what is missing:

Acceptance Criteria and Device Performance Study (Medison SA9900 Ultrasound System)

The provided 510(k) summary does not include specific quantitative acceptance criteria related to diagnostic performance or clinical effectiveness, nor does it detail a study that evaluates such performance against those criteria.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (SA8800/HDI1500 System, K974269) by showing compliance with:

• Intended Use: The SA9900 has similar intended uses and clinical applications as the predicate.
• Technological Characteristics: The device operates in an identical manner (piezoelectric material, sound wave reflection, electrical signal processing) and has similar features (B-mode, M-mode, Doppler, 3D imaging, measurements, analysis packages).
• Safety Standards: The device meets electromechanical safety standards (e.g., EN 60601-1, UL 2601-1, IEC 61157).
• Acoustic Output Limits: The device's acoustic output limits (ISPTA: 720 mW/cm2, MI: 1.9) are the same as predicate Track 3 devices and are within regulatory limits.

Table of Acceptance Criteria and Reported Device Performance (as inferable from the document):

Missing Information:

1. Sample size used for the test set and the data provenance: Not mentioned. No specific "test set" in the context of diagnostic performance is described.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. No ground truth for diagnostic performance is described.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document pertains to a diagnostic ultrasound system, not an AI/CAD device, and no MRMC study is mentioned.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
7. The sample size for the training set: Not applicable. This is a hardware/software system, not a machine learning model requiring a specific training set as typically understood in AI/ML contexts. The "training" here would refer to engineering and development.
8. How the ground truth for the training set was established: Not applicable.

Summary:

The provided K012867 document is a 510(k) summary demonstrating regulatory substantial equivalence to a predicate device (SA8800/HDI1500 System, K974269) based on identical technological characteristics, intended uses, compliance with safety standards, and acoustic output limits. It focuses on the technical and regulatory aspects required for market clearance rather than providing data from a clinical performance study with specific diagnostic acceptance criteria. A post-clearance special report for acoustic output measurements on production line devices was requested by the FDA, indicating that further safety compliance confirmation was needed after the initial clearance.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal OB/GYN
Abdominal
Pediatric
Small Organ (breast, thyroid, testicle)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-Rectal
Trans-Vaginal
Peripheral-Vascular
Muscular-Skeletal (Conventional, Superficial)

Typical examinations performed using the system are:
General abdominal and pelvic studies including organ surveys, assessment, and retro-peritoneal cavity studies.
Study of small parts including breasts, shoulders, thyroid, and the abdominal wall.
Pediatric scans of organs and bony structures.
Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
Monitoring procedures for infertility studies (other than in vitro fertilization).
First, second and third trimester pregnancy studies.
Prostate, prostate biopsy guidance, and rectal wall studies.
Neonatal head studies.
Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries.
Cardiac studies in adults and children.
Biopsy guidance for tissue or fluid sampling.
Conventional podiatry scans.

The SA600011 scanner is a 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, or as a combination of these modes. SA600011 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.

Five different models of transducers are available and any two may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. More detailed explanations of these functions and controls are included in the Operator's manual, and in the software/firmware documentation included in this 510(k) Notification. Patient contact materials are the same as those previously cleared in the predicate device, SA5500 Ultrasound System and Transducers (K992761) and SA9900 Ultrasound System and Transducers (K002185).

The SA6000II uses digital beamforming technology. The SA6000II supports a variety of Linear and Curved Linear Array probes for wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 2.0 MHz to 10 MHz. These probes can be applied to a variety of fields such as fetal, abdominal, intra-operative, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-rectal, trans-vaginal, peripheral-vascular, muscular-skeletal. The same clinical uses were cleared for the predicate device, SA5500 Ultrasound System (K992761) and SA9900 Ultrasound System (K002185).

SA6000II provides high quality images and various measuring functions. It can measure distances and calculate areas, circumferences and volumes, as well as calculate the date of delivery by using BPD (biparietal diameter), OFD (occipito-frontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APD (anteroposterior abdominal diameter), TTD (transverse trunk diameter), GS (gestational sac), etc.

Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. The operating Modes of SA6000II are B, M, or as a combination of these modes. M-mode uses the sweep display method that has its images flow from the left to the right on the monitor. The SA6000II supports the Cine function (capable of storing up to 64 frames) and real-time zoom function to the region-of-interest. Management of patient history is possible by an image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

The provided 510(k) summary for the Medison America, Inc. SA6000II Diagnostic Ultrasound System focuses on demonstrating substantial equivalence to predicate devices (SA5500 and SA9900). It does not present a study with specific acceptance criteria and reported device performance in the manner typically seen for AI/ML-based medical devices or novel diagnostic tools.

Instead, the submission primarily details the device's technical characteristics, intended use, and acoustic output limits, comparing them to established predicate devices. The "acceptance criteria" here are implicitly the FDA's requirements for substantial equivalence, meaning the device's technological characteristics and intended uses are as safe and effective as a legally marketed device.

Therefore, the following information is extracted and presented based on the context of a 510(k) submission for a diagnostic ultrasound system:

1. Table of Acceptance Criteria and Reported Device Performance

Summary of the "Study" (Demonstration of Substantial Equivalence)

The "study" in this context is a comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical trial measuring diagnostic accuracy or reader performance. The manufacturer, Medison America, Inc., asserts that the SA6000II Ultrasound System is substantially equivalent to the currently marketed SA5500 System (K992761) and SA9900 System (K002185).

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a traditional "test set" in the context of an algorithm or diagnostic performance study. The evaluation for substantial equivalence primarily relies on engineering specifications, technical comparisons, and compliance with recognized standards. There is no mention of a clinical "test set" of patient data used for performance verification in the document.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The submission is a 510(k) for an ultrasound system, not an AI/ML diagnostic algorithm. Ground truth for image interpretation would traditionally be established by the interpreting physician during clinical use, not as part of this specific regulatory submission for the device itself.

4. Adjudication Method for the Test Set

Not applicable. There is no described test set requiring adjudication in this document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this 510(k) summary. This type of study is typically performed for AI-assisted diagnostic devices to measure the impact of AI on human reader performance, which is not the focus of this traditional ultrasound device submission.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone algorithm performance study was not done or described. The SA6000II is a diagnostic ultrasound system that functions by acquiring and displaying data for interpretation by a competent healthcare professional. It is not an AI algorithm intended for standalone diagnosis.

7. The Type of Ground Truth Used

The "ground truth" for the claims in this submission is primarily based on technical specifications, compliance with international safety and performance standards (e.g., IEC, UL, CSA), and the established safety and effectiveness of its predicate devices. For example, acoustic output limits are verified against recognized standards, and biocompatibility is confirmed by using materials identical to those cleared in predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is a diagnostic ultrasound system, not an AI/ML algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set was Established

Not applicable. As this is not an AI/ML algorithm, there is no training set mentioned or described within the document.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal OB/GYN, Abdominal, Small Organs (breast, thyroid, testicle), Pediatric, Neonatal Cephalic, Trans-Vaginal, Trans-Rectal, Peripheral Vascular, Cardiac.
Typical examinations performed using the system are: General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies. Study of small parts and superficial structures including breasts, shoulders, thyroid, and the abdominal wall. Pediatric scans of organs, superficial, and bony structures. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Neonatal head studies. Podiatry scans of superficial structures including muscles, tendons and bones. General cardiac studies in adults. Prostate, bladder and rectum visualization.

The SonoAce SA-9900 scanner is a multiple-mode, multiple-application ultrasound imaging system. The cart-mounted console contains an ultrasound generator/receiver offering a full complement of conventional operating modes, software-based parameter controls, and recording. The selection of eight transducers to be offered with the system permits a wide range of clinical applications. The various transducers adapt the system for the specific imaging tasks. Eight different models of transducers are available. In addition to the initial operational settings for each transducer preprogrammed in the system, usercustomized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. Patient contact materials have been tested for biocompatibility in accordance to their intended use and are used for each individual transducer. The SonoAce SA-9900 uses digital beamforming technology. The SonoAce SA-9900 supports a variety of Linear and Convex probes for wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. The SonoAce SA-9900 provides high quality images and various measuring functions. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. Operating Modes of the SonoAce SA-9900 are B-Mode, M-Mode, Tissue Harmonic Imaging (THI), Color-flow Doppler, Continuous (CW) Doppler, Pulsed (PW) Doppler and Power Doppler. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

This looks like a 510(k) premarket notification for an ultrasound system, not an AI device. The document describes the technical characteristics and intended uses of the SonoAce SA-9900 Diagnostic Ultrasound System and its various transducers. It establishes substantial equivalence to other legally marketed ultrasound devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not applicable to this type of medical device submission. These details are typically required for AI/ML-driven devices where the algorithm's performance needs to be rigorously validated against a defined ground truth.

The acceptance criteria for this ultrasound system would typically involve meeting established performance standards for diagnostic ultrasound equipment (e.g., acoustic output limits, image quality, measurement accuracy), and demonstrating substantial equivalence to predicate devices, which is what this document primarily focuses on.

Here's a breakdown of why each requested point is not present or relevant in this context:

1. A table of acceptance criteria and the reported device performance: While the document mentions acoustic output limits (ISPTAd, TIS/TIB/TIC, MI) as being "the same as predicate Track 3 devices," it does not provide a comprehensive table of acceptance criteria for image quality, diagnostic accuracy, or specific performance metrics that would be expected for an AI device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document does not describe a test set or data used for algorithm validation.
3. 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. Ground truth for an AI algorithm is not established for an ultrasound system itself in this manner.
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, as this is not an AI device being submitted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on:

• Substantial Equivalence: Comparing the SonoAce SA-9900 to predicate devices like Medison/Kretztechnik Combison 530D, SonoAce SA-8800, and SonoAce 6000C/Ultramark 400C.
• Device Description: What the system is and how it works (multiple-mode, multiple-application ultrasound imaging system with various transducers and operating modes).
• Intended Use: Listing the clinical applications (Fetal OB/GYN, Abdominal, Small Organs, Pediatric, Neonatal Cephalic, Trans-Vaginal, Trans-Rectal, Peripheral Vascular, Cardiac, Muscular-Skeletal).
• Technological Characteristics: Describing the digital beamforming technology, frequency range of probes, and acoustic output limits.
• Indications for Use Tables: Detailed tables for each transducer showing which clinical applications and modes are supported, including new indications (marked 'N') compared to previously cleared ones ('P').

In summary, this submission is for a conventional diagnostic ultrasound system, not an AI-powered one, and therefore the requested AI-specific validation details are not part of this documentation.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal - OB/GYN, Abdominal, Small Organs (breast, thyroid, testicle), Pediatric, Neonatal Cephalic, Trans-Vaginal, Trans-Rectal, Peripheral Vascular. Typical examinations performed using the system are: General abdominal and pelvic studies including organ surveys. assessment, and retroperitoneal cavity studies. Study of small parts and superficial structures including breasts, shoulders, thyroid, and the abdominal wall. Pediatric scans of organs, superficial, and bony structures. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Neonatal head studies. Podiatry scans of superficial structures including muscles, tendons and bones. Prostate, bladder and rectum visualization. Tissue Harmonic Imaging (THI) is a B-Mode imaging technique that enables a dramatic reduction in naturally occurring artifacts caused by interaction of certain tissue types and low frequency soundwaves. Seven of the twelve probes offered with the system will be indicated for Tissue Harmonic Imaging (THI-Mode). The THI-Mode will be used for fetal, abdominal, pediatric, and small organ clinical applications.

The Combison® 530/Voluson® 530D scanner is a multiple-mode, multipleapplication ultrasound imaging system. The cart-mounted console contains an ultrasound generator/receiver offering a full complement of conventional operating modes, software-based parameter controls, and recording. The selection of twelve transducers offered with the system permits a wide range of clinical applications. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. The Combison® 530/Voluson® 530D uses digital beamforming technology. The Combison® 530/Voluson® 530D supports a variety of linear and convex probes for wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 3.5 MHz to 7.5 MHz. The Combison® 530/Voluson® 530D provides high quality images and various measuring functions. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. Operating Modes of the Combison® 530/Voluson® 530D are B, B/B, B/M, M and, Doppler, Volume and Power Doppler Mode. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing. The Tissue Harmonic Imaging (THI-Mode) Option consists of a software add-on.

This 510(k) Premarket Notification is for the addition of a Tissue Harmonic Imaging (THI-Mode) option to the Combison® 530/Voluson® 530D Diagnostic Ultrasound System. The submission claims substantial equivalence to the Medison SA8800/HDI 1500 System (K974269), which also features THI-Mode.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria or reported device performance in the typical sense of quantitative metrics. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device (Medison SA8800/HDI 1500 System with THI-Mode, K974269) by showing that:

• Intended Use is the same: The THI-Mode is intended for fetal, abdominal, pediatric, and small organ clinical applications, which aligns with the predicate device.
• Technological Characteristics are similar: The device operates identically to predicate devices in principle (piezoelectric material, sound wave reflection, electrical signal conversion) and the THI-Mode is a software add-on.
• Acoustic Output Limits are within acceptable ranges:
  • TIS/TIB/TIC: 0.0 - 4.0 (Range)
  • ISPTA.3: 720 mW/cm² (Maximum)
  • MI: 1.9 (Maximum)
    These limits are stated to be the same as "predicate Track 3 devices." This implicitly means the reported performance in terms of acoustic output meets the established safety limits for such devices, which is a form of acceptance criteria for safety.
• New Indications for Use (with THI) are cleared: The FDA clearance explicitly lists several transducers (S-AB, S-ACP 3-5, S-ACP 4-7, S-NLP, S-VAW 3-5, S-VAW 4-7, S-VNW) for which Tissue Harmonic Imaging (N) is a new indication, indicating that the device has been found safe and effective for these applications when using THI.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not provide information on a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). The submission relies on demonstrating substantial equivalence to an already cleared device, implying that the safety and effectiveness of THI technology were established with the predicate device (K974269).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. As there is no explicitly defined "test set" and a study demonstrating performance is not detailed, there is no mention of experts for ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not provided. Given the absence of a detailed study with a test set, adjudication methods are not discussed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI (THI-Mode in this case) assistance was not conducted or reported in this document. The submission focuses on substantial equivalence based on the technological characteristics and safety data of the device and its predicate.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The document describes the THI-Mode as a "software add-on" that is a "B-Mode imaging technique that enables a dramatic reduction in naturally occurring artifacts." While this describes the algorithmic function, the submission does not present a standalone performance evaluation of the algorithm separate from the overall ultrasound system and its clinical use by a human operator. The focus is on the integrated system's safety and intended use.

7. The Type of Ground Truth Used:

Ground truth for the performance of the THI-Mode itself is not explicitly defined or used within the context of a dedicated performance study in this document. The approval seems to be based on the established safety and effectiveness of the existing THI technology (as demonstrated by the predicate device K974269) and the physical and technical specifications being within acceptable ranges. The "ground truth" for the overall device's safety and effectiveness implicitly comes from established medical practice for diagnostic ultrasound and previous FDA clearances for the base system and the predicate THI-enabled system.

8. The Sample Size for the Training Set:

The document does not mention a training set or its sample size. The THI-Mode is described as a "software add-on," implying an algorithmic approach. However, there's no detail provided on how this algorithm was developed or "trained."

9. How the Ground Truth for the Training Set Was Established:

This information is not provided, as there is no mention of a training set in the document.

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