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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (liver, pancreas, and gall bladder), Intraoperative Neurological, Pediatric, Small Organ (breast, testes and thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

The Aloka SSD-4000 Ver.3.1 functions in the same manner as its predicates and other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka SSD-4000 transducers can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow. The SONOReal accessory (K023473) is an add on device.

The provided document is a 510(k) Summary for the Aloka Model SSD-4000 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a previously cleared device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information typically found in a study proving a device meets specific acceptance criteria, and many of your requested items cannot be extracted.

Here's an analysis of what can and cannot be answered based on the provided text:

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

• Not present. The document does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for image quality or diagnostic accuracy. It asserts that the device functions in the same manner and has the same capabilities (gray-scale and Doppler) as its predicates. The safety acceptance criteria are related to acoustic power output levels and compliance with various electrical and physical safety standards.

  Here's a table of the safety compliance criteria mentioned:

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

• Not present. As this is a 510(k) submission based on substantial equivalence, there is no mention of a test set with patient data, sample sizes, or data provenance. The assessment relies on technical comparisons to predicate devices and adherence to regulatory standards.

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 present. No test set requiring ground truth established by experts is described in this document.

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

• Not present. No test set or adjudication method 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

• Not present. This device is a diagnostic ultrasound system, not an AI-powered image analysis tool. Therefore, no MRMC study or AI-related comparative effectiveness is mentioned.

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

• Not present. This device is not an algorithm, but a hardware diagnostic ultrasound system with an optional 3D accessory. No standalone algorithm performance is discussed.

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

• Not present. As there is no test set for diagnostic accuracy, no ground truth type is specified.

8. The sample size for the training set

• Not present. The document does not describe a training set as it pertains to AI or machine learning. The "development and production" mentioned relate to traditional medical device manufacturing processes and quality assurance.

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

• Not present. This is not applicable as no training set for an algorithm is described.

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Intended to be used by or under the direction of a physician and in conjunction with a standard ultrasound system to provide 3D and Multi-planar clinical imaging in radiology, fetal, gynecology, small organs (breast, thyroid, testes, etc.), urology, neonatal, surgery, orthopedics, abdominal, oncology (tumor volume assessment) and adult cephalic. SONOReal™ is intended to visualize features that the user may wish to examine more closely in routine 2D ultrasound diagnostic imaging examinations. The user is offered the capability to perform linear, area and volumetric measurements of the subject being scanned. SONOReal™ does not provide any diagnostic interpretations.

The BioMediCom SONOReal 3D System, cleared via K994385, K012084 and 020068, is an accessory device which adds 3D visualization capability to conventional, commercially available two dimensional imaging systems. The device does not provide diagnostic interpretation and is intended for use by or under the order of a physician. It is used to visualize features that may require closer examination in routine 2D ultrasound diagnostic imaging exams.

The provided 510(k) summary for the BioMediCom SONOReal 3D System does not contain specific information about acceptance criteria or a detailed study proving the device meets acceptance criteria in the format requested.

Here's an analysis of what is available and what is missing:

Key Missing Information:
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance studies with acceptance criteria. As such, it does not include:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance.
• Ground truth details for test or training sets.
• Training set sample size or how its ground truth was established.

Analysis of Provided Information Relevant to the Request:

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

   • N/A. The document outlines the "Intended Use" (similar functions as the predicate device), the "Device Description," and a "Comparison Chart for Substantial Equivalence" to other BioMediCom and EchoTech devices. The comparison chart focuses on functional capabilities, hardware specifications, and software features, aiming to show that the new device is substantially equivalent to previously cleared devices. It does not present specific performance metrics or acceptance criteria for those metrics.

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

   • N/A. No information on a test set (or any study data) is provided. The submission relies on substantial equivalence.

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):

   • N/A. No information on ground truth establishment or experts is provided.

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

   • N/A. No information on adjudication is 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:

   • N/A. This device appears to be an accessory for 3D visualization and measurement, not an AI-based diagnostic tool. No MRMC study is mentioned. The device explicitly states it "does not provide any diagnostic interpretations."

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

   • N/A. No standalone performance study information is provided.

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

   • N/A. No information on ground truth is provided.

8. The sample size for the training set:

   • N/A. No information on a training set is provided.

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

   • N/A. No information on a training set or its ground truth establishment is provided.

Summary:

This 510(k) summary for the BioMediCom SONOReal 3D System focuses entirely on demonstrating substantial equivalence to predicate devices (K980308, K994385, K012084, K020068) by comparing its intended use, hardware, and software features. It is for an "accessory device which adds 3D visualization capability to conventional, commercially available two dimensional imaging systems" and explicitly states it "does not provide diagnostic interpretation." Therefore, it does not include the detailed performance study information with acceptance criteria and ground truth establishment that would be expected for a device claiming diagnostic capabilities or significant algorithmic performance. The FDA's clearance is based on this substantial equivalence argument.

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Intended to be used by or under the direction of a physician and in conjunction with a standard ultrasound system to provide 3D and Multi-planar clinical imaging in fetal and gynecological applications. SONOReal™ is intended to visualize features that the user may wish to examine more closely in routine 2D ultrasound diagnostic imaging examinations. The user is offered the capability to perform linear, area and volumetric measurements of the subject being scanned. SONOReal™ does not provide any diagnostic interpretations.

Adds 3D imaging capability to commercial 2D ultrasound imaging systems. Hardware includes Pentium III 833 MHz, Frame Grabber (VHS/S-VHS Input), Video out, and Handheld controller. Software features include Volume data acquisition w/frame grabbing of video data b/w while using a Gyroscopic sensor system, Conditioning & transformation of the acquired data into a Cartesian volume, Surface rendering, Segmentation of structures from 3D data, and Measurement and calculations Via this submission.

The provided 510(k) summary for the BioMediCom SONOReal 3D System focuses on the addition of a measurement function to an already existing 3D ultrasound system. The document does not contain a detailed study with acceptance criteria and reported device performance metrics in the way a typical clinical trial or performance study would.

Instead, the submission appears to be a substantial equivalency claim, comparing the new device (with the added measurement function) to predicate devices already on the market. The comparison chart primarily details hardware and software features, not specific performance metrics against pre-defined acceptance criteria for the measurement function itself.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not present in the provided text.

Based on the information available, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or report performance data for the measurement function. The "Comparison Chart for Substantial Equivalence" implies that the new device's measurement capabilities are considered equivalent to those of the predicate devices. However, no quantitative performance metrics (e.g., accuracy, precision) for these measurements are provided, nor are specific acceptance criteria for these metrics.

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The document does not describe a test set or study conducted for the measurement function.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set:

• Adjudication Method: Not specified, as no test set or expert review process for performance is detailed.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

• MRMC Study: No, there is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed.

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

• Standalone Performance: Not explicitly mentioned or detailed. The measurement function is integrated into a system intended for use by a physician, implying human interaction.

7. The type of ground truth used:

• Type of Ground Truth: Not specified, as no specific performance study with a defined ground truth is described.

8. The sample size for the training set:

• Sample Size for Training Set: Not specified. This submission is for an addition of a measurement function to an existing device, and the details of how that measurement function was developed or trained (if it involved machine learning which is unlikely given the date) are not provided.

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

• Ground Truth Establishment for Training Set: Not specified.

Summary of Study (Based on the Document's Content):

The document K020068 is a 510(k) Summary for the SONOReal 3D System - Addition of Measurement Function by BioMediCom, Ltd. It is a submission to demonstrate substantial equivalence to legally marketed predicate devices, not primarily a detailed performance study with quantitative acceptance criteria for the added measurement function.

The "study" presented is a comparison of features and intended use between the modified SONOReal 3D System (with measurement function) and existing predicate devices (EchoTech 3D FreeScan K980308 and BioMediCom Baby Face K994385, and the original SonoReal 3D K012084).

The core argument for equivalence is that:

• The basic function (adding 3D imaging capability to 2D ultrasound) is the same.
• The hardware specifications are similar or improved (Pentium III 833 MHz vs. Pentium II 400 MHz).
• The software features are largely comparable, with the key update being the addition of measurement and calculations to the SONOReal 3D system, making it functionally similar to the EchoTech 3D FreeScan which already had "Measurements & calculations".
• The intended uses for fetal and gynecological applications are maintained and aligned with the capabilities being added.

The FDA's letter (K020068) confirms that, based on this information, the device is considered substantially equivalent to already marketed predicate devices for the stated indications for use. This means the FDA did not require a separate, detailed clinical performance study with explicit acceptance criteria and corresponding data to be submitted for this particular modification, as the functional addition (measurements) was deemed comparable to existing, legally marketed devices.

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Intended to be used by or under the direction of a physician and in conjunction with standard ultrasound system to provide 3D clinical imaging in fetal and gynecological applications. The SONOReal™ system does not currently provide any quantitative measurement capabilities or diagnostic interpretations. It is intended to visualize features that you may wish to examine more closely in routine 2D ultrasound diagnostic imaging examinations.

Adds 3D imaging capability to commercial 2D ultrasound imaging systems. Hardware includes Pentium III 833 MHz, Frame Grabber (VHS/S-VHS Input), Video out, and Handheld controller. Software features include Volume data acquisition w/frame grabbing of video data b/w while using a Gyroscopic sensor system, Conditioning & transformation of the acquired data into a Cartesian volume, Surface rendering, and Segmentation of structures from 3D data.

The provided text is a 510(k) Summary for the SONOReal 3D System, which is a digital ultrasound image analysis system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria.

Based on the provided document, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria or provide quantitative performance metrics for the SONOReal 3D System in a study. The summary primarily focuses on comparing the new device (BioMediCom SONOReal 3D System) with a predicate device (EchoTech 3D FreeScan) to establish "substantial equivalence" based on function, hardware, software features, and indications for use.

The relevant comparison table provided is:

Assessment: The "reported device performance" is essentially the feature set and intended use, which is deemed substantially equivalent to the predicate except for the lack of quantitative measurements and a narrower range of indications for use. There are no numerical performance metrics (e.g., accuracy, precision) provided in this document.

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

The document does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for a performance study. The focus is on comparison to a predicate device's specifications and functionality.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention any experts being used to establish ground truth for a test set. This type of information would typically be found in a clinical performance study, which is not detailed here.

4. Adjudication Method

The document does not describe any adjudication method. This is consistent with the absence of a detailed performance study involving expert assessment.

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

The document does not describe an MRMC comparative effectiveness study. It's a 510(k) submission focused on substantial equivalence rather than comparative effectiveness. Therefore, there's no mention of effect size for human readers with or without AI assistance.

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

The document does not describe a standalone performance study for the algorithm. The device, as described, is a system intended to be used "by or under the direction of a physician and in conjunction with a standard ultrasound system to provide 3D clinical imaging." It does not provide "quantitative measurement capabilities or diagnostic interpretations" for standalone assessment.

7. The Type of Ground Truth Used

The document does not specify any type of ground truth used for performance evaluation. Given the nature of a 510(k) submission demonstrating substantial equivalence, the "ground truth" for approval is primarily the existence and specifications of a legally marketed predicate device.

8. The Sample Size for the Training Set

The document does not mention any training set size. As a system that does not provide diagnostic interpretations or quantitative measurements, it's unlikely to have been developed using machine learning in the way typically requiring a "training set" for an AI algorithm. Its functions (volume data acquisition, conditioning, surface rendering, segmentation) are described as direct processing tasks.

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

Since no training set is mentioned (see point 8), there is no information on how ground truth for a training set was established.

Summary of Device Purpose and Approval Context:

The SONOReal 3D System is cleared as substantially equivalent to the EchoTech 3D FreeScan. Its purpose is to add 3D imaging capabilities to existing 2D ultrasound systems for fetal and gynecological applications. Crucially, the document states: "The SONOReal™ system does not currently provide any quantitative measurement capabilities or diagnostic interpretations. It is intended to visualize features that you may wish to examine more closely in routine 2D ultrasound diagnostic imaging examinations." This clarification indicates that the device's role is visualization, not automated diagnosis or measurement, which explains the absence of detailed performance studies against specific clinical acceptance criteria in this submission. The FDA's clearance is based on its similarity in function and safety to a predicate device.

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