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The EchoTech Easy3D is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images. It is intended to acquire, analyze, store, and retrieve digital ultrasound images for computerized 3D image processing. Easy3D is an add-on accessory to existing diagnostic ultrasound systems. Easy3D employs freehand scanning without the use of a coordinate and position sensor, therefore, the extension of the data set in the scanning direction is unknown. The images are not intended for use in diagnosis or quantitative measurements. The Easy3D is intended as a general purpose digital 3D ultrasound image processing tool for use in obstetrics for qualitative evaluation of deformities and determination of the need for further fetal ultrasound studies.

The EchoTech 3D FreeScan system is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images. It is intended to acquire, and retrieve digital ultrasound images for computerized 3D image processing. Easy3D is an add-on accessory to existing diagnostic ultrasound systems. Easy3D employs freehand scanning with the use of a coordinate and position sensor and, optionally, with heart cycle (R-Peak) triggering, which enables cardiovascular imaging.

The EchoTech EasyArchive system is indicated to acquire, digitize, archive, and retrieve single or sequences of 2D ultrasound images. EasyArchive is an add-on accessory to existing diagnostic ultrasound systems. EasyArchive is intended as a general purpose digital ultrasound image processing and archiving tool for use in radiology, neurology, gastroenterology, surgery, orthopedics, cardiology, oncology, obstetrics and gynecology.

The EchoTech Quanticon system is indicated in the acquisition of either heart cycle (R-Peak) triggered or nontriggered sequences of 2D ultrasound images for use in the evaluation of contrast agent-based ultrasound exams. In the sequence of images multiple Regions Of Interest (ROI) can be selected. Inside these chosen regions the average gray value or the number of color pixels is calculated over time. Quanticon is intended an add-on accessory to existing diagnostic ultrasound systems. Quanticon is intended as a general digital ultrasound processing and archiving tool for use in cardiology, radiology, and neurology,

The EchoTech EasyStress system is indicated for the acquisition of heart cycle (R-Peak) triggered sequences of 2D ultrasound images for use in performing, scoring, measuring, and archiving stress echo studies. The EasyStress system utilizes the ASE Standard for Wall Motion Scoring to quantify wall motion abnormalities of the heart. EasyStress is an add-on accessory to existing diagnostic ultrasound systems. EasyStress is a digital ultrasound image processing and archiving tool for use in cardiology.

The following products produced by Echotech 3D Imaging Systems are included in this 510(k) premarket notification:

• Easy3D Family .
• 3D FreeScan .
• EasyArchive .
• Quanticon .
• EasyStress .

All of the subject products are accessories to diagnostic ultrasound imaging systems. The products are high performance computer systems based on Intel motherboard and WindowsNT standards. The systems incorporate commercially available image digitizer circuit boards for acquisition, storage, annotation, reporting, and retrieval of ultrasound image data. They also incorporate proprietary image processing software developed by EchoTech 3D Imaging Systems.

The EchoTech Easy3D Family system is a high performance computer system based on Intel motherboard and WindowsNT standards. It incorporates a commercially availabel image digitizer circuit board for acquisition, storage and retrieval of ultrasound image data. The device is an add-on accessory for any existing diagnostic imaging ultrasound system.

The system acquires either heart cycle (R-Peak) triggered or nontriggered sequences of 2D ulrasound images (B/W and Color) The 2D ulrasound images are acquired through video output port of the host ultrasound system as the ultrasound transducer is moved across the patient scan site. The resulting set of digitized 2D images is then converted into a 3D data volume under the assumption that a predefined scan movement was followed. In this step redundant gray values are eleminated, gaps are filled by a trilinear interpolation and the images are sorted depending on the time delay to the R-Peak. The acquisition process might be R-Peak triggered by the heart cycle. This is done by importing an Audio or TTL signal from the Physio module of the ultrasound system.

The EchoTech 3D FreeScan system is a high performance computer system based on Intel motherboard and WindowsNT standards. It incorporates a commercially availabel image digitizer circuit board for the acquisition, storage and retrieval of digital dynamic 3D ultrasound image data sets. The device is an add-on accessory for any existing diagnostic imaging ultrasound system.

The device records ultrasound transducer spatial position in six degrees of freedom during use. Coordinate tracking is achieved with a miniature magnetic field sensor within a transmitted pulsed magnetic field. This is done by attaching a plastic holding plate to the probe of the host ultrasound system, to which the receiver of an electromagnetic sensor device is attached.

2D ulrasound images are acquired triggerd sequentially in a series of steps as the ultrasound transducer is moved across the patient scan site. The resulting set of digitized 2D images is then converted into a 3D data volume. The acquisition process is R-Peak triggered by the heart cycle. This is done by importing an Audio or TTL signal from the Phvsio module of the ultrasound system.

The commercially available coordinate sensor device consists of an IBM compatible PC board, a tranmitter and a receiver. The transmitter generates a spherical magnetic field and the receiver can be moved anywhere within 1m of the transmitter to generate a set of 3 translational and 3 angulation values.

The 3D FreeScan system digitizes R-Peak triggerd the ulrasound images from the video output port of the host ultrasound system through a video cable. The images are stored in the computer memory. In a postprocessing step the oblique images are transformed into a Cartesian coordinate system. In this step redundant gray values are eleminated, gaps are filled by a trilinear interpolation and the images are sorted depending on the time delay to the R-Peak.

The EchoTech EasyArchive system is a high performance computer system based on Intel motherboard and WindowsNT standards. It incorporates a commercially availabel image digitizer circuit board for acquisition, storage and retrieval of ultrasound image data. The device is an add-on accessory for any existing diagnostic imaging ultrasound system.

The system acquires single 2D ultrasound images or sequences of 2D ulrasound images. The EasyArchive system digitizes the ulrasound images from the video output port of the host ultrasound system through a video cable. The images or sequneces are stored in the computer memory. The data can be stored along with patient adminstrative data in a data base on the EasyArchive harddisk or on removeable media for later display and retrieval.

The EchoTech QuantiCon system is a high performance computer system based on Intel motherboard and WindowsNT standards. It incorporates a commercially availabel image digitizer circuit board for acquisition, storage and retrieval of ultrasound image data. The device is an add-on accessory for any existing diagnostic imaging ultrasound svstem.

The system acquires either heart cycle (R-Peak) triggered or nontriggered sequences of 2D ulrasound images. In the sequence of images multiple Regions Of Interest (ROI) can be selected. Inside these regions the average gray value or the number of color pixel is calculated over time.

The QuantiCon system digitizes the ulrasound images from the video output port of the host ultrasound system through a video cable. The trigger signal for the acquisition process is taken from the ultrasound system either as an Audio beep or as a TTL signal. The images are stored in the computer memory. In a postprocessing step the images are lossless compressed (runlength compression). The postprocessed data can be stored along with patient adminstrative data in a data base on the QuantiCon harddisk or on removeable media for later display and retrieval.

The EchoTech EasyStress system is a high performance computer system based on Intel motherboard and WindowsNT standards. It incorporates a commercially availabel image digitizer circuit board for acquisition, storage and retrieval of ultrasound image data. The device is an add-on accessory for any existing diagnostic imaging ultrasound system.

The system acquires heart cycle (R-Peak) triggered sequences of 2D ulrasound images. Corressponding to the guidelines of the American Society of Echocardiographie ASE 16 sequences can be acquired. (4 stress phases and for each stress phase four standard views of the heart). The sequences can be synchronized replayed either sorted after stress phase or standard views. In the replay mode wall mation scoring WMS can be carried out following the guidelines of the ASE. The EasyStress system digitizes the ulrasound images from the video output port of the host ultrasound system through a video cable. The trigger signal for the acquisition process is taken from the ultrasound system either as an Audio beep or as a TTL signal. The images are stored in the computer memory. In a postprocessing step the images are lossless compressed (runlength compression). The postprocessed data can be stored along with patient adminstrative data in a data base on the EasyStress harddisk or on removeable media for later display and retrieval.

Here's an analysis of the provided text regarding acceptance criteria and the study conducted for the EchoTech 3D Imaging Systems K013088 submission:

Summary of Acceptance Criteria and Device Performance for K013088

It's important to note right away that the provided text is a 510(k) summary from 2002. At that time, the level of detail regarding acceptance criteria and performance studies in 510(k) summaries was often much less granular than what is typically expected for AI/ML-driven devices today. The document focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance metrics against specific acceptance criteria.

The acceptance criteria are implicitly met by demonstrating that the device functions as intended and is safe and effective when compared to predicate devices. The "Table of Acceptance Criteria and Reported Device Performance" below will reflect this interpretive approach given the limited explicit detail.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document explicitly states: "Testing was performed according to internal company procedures. Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted." It also mentions "Additional system testing was done by a third party standards test house." However, no specific sample sizes (e.g., number of cases, images, or patients) for the test set are provided.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. Given the nature of a 510(k) submission from 2002, such details were often not a required component in the summary. The focus was on demonstrating the functionality and safety of the software system itself.

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

• The document does not specify the number of experts used to establish ground truth for the test set.
• It also does not detail the qualifications of any experts (e.g., "radiologist with 10 years of experience"). This type of detail is typical for clinically validated AI algorithms, but not for software systems focused on image acquisition, processing, and archiving, especially from this era. The primary "ground truth" seems to be the expected functional output of the software (e.g., does it correctly acquire, store, and process images as designed).

4. Adjudication Method for the Test Set

• The document does not describe any adjudication method (e.g., 2+1, 3+1). As mentioned above, the testing appears to be functional and system-level validation against specifications rather than a clinical performance study requiring expert consensus beyond verifying software output.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was mentioned or indicated. The device described is an "add-on accessory" for image acquisition, processing, storage, and retrieval. It's not an AI diagnostic aid intended to improve human reader performance or a standalone diagnostic algorithm. Therefore, an MRMC study and a human-in-the-loop effect size improvement would not be applicable or expected for this type of device based on the provided information.

6. Standalone Performance Study

• A standalone performance evaluation was implicitly done in the sense that the software and system functionalities were tested to ensure they met their design specifications. "Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Additional system testing was done by a third party standards test house." This indicates that the algorithm/system was tested independently for its intended functions (acquisition, storage, processing, 3D reconstruction, calculation of ROIs, WMS, etc.), even if specific standalone metrics (like sensitivity/specificity for a diagnostic task) are not provided. Given the device's function as an image processing tool rather than a diagnostic one, its standalone performance would relate to its ability to correctly process and present images.

7. Type of Ground Truth Used

• The ground truth used appears to be primarily related to engineering and functional specifications, and potentially logical correctness of image processing (e.g., a 3D reconstruction visually matches the input, ROI calculations are mathematically correct).
• There is no mention of ground truth established by expert consensus on clinical findings, pathology results, or patient outcomes data, as the device's indications for use are focused on image processing and archiving rather than providing a new diagnosis or clinical interpretation. For example, for the Easy3D system, it states "The images are not intended for use in diagnosis or quantitative measurements." and "intended as a general purpose digital 3D ultrasound image processing tool for use in obstetrics for qualitative evaluation of deformities and determination of the need for further fetal ultrasound studies." This implies the "ground truth" is whether the system correctly processes images for qualitative review, not whether it correctly identifies deformities itself.

8. Sample Size for the Training Set

• The document does not mention a training set sample size. This is expected as the device predates widespread use of AI/ML or deep learning, which would typically involve distinct training sets. The software's functionality would have been developed using conventional programming and algorithms, not by training on a large dataset.

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

• As there's no mention of a training set, there's also no information on how ground truth for a training set was established. The software development would have relied on established principles of image processing and system design, rather than data-driven machine learning models.

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The ECHOTECH 3D FreeScan system is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to record position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, obstetrics and gynecology.

The EchoTech 3D FreeScan is a high performance computer system based on Intel motherboard and Microsoft DOS/Windows standards. It incorporates a commercially available image digitizer circuit board and proprietary software for the acquisition, analysis, storage and retrieval of digital 3D ultrasound image data sets. The device is an add-on accessory for any existing diagnostic imaging ultrasound system.

The device records ultrasound transducer spatial position in six degrees of freedom during use. Coordinate tracking is achieved with a miniature magnetic field sensor within a transmitted pulsed magnetic field. This is done by attaching a plastic holding plate to the probe of the host ultrasound system, to which the receiver of an electromagnetic sensor device is attached.

2D ultrasound images are acquired sequentially in a series of steps as the ultrasound transducer is swept across the patient scan site. The resulting set of digitized 2D images is then converted into a 3D data volume.

The provided text does not contain detailed information about specific acceptance criteria, comprehensive study results, or the methodologies for establishing ground truth as requested in the prompt. The document is a 510(k) summary for the EchoTech 3D FreeScan, which primarily focuses on regulatory approval based on substantial equivalence to a predicate device.

However, I can extract the available information and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative acceptance criteria (e.g., accuracy, precision, speed, specific image quality metrics) are not provided. The performance is broadly stated as meeting "design intent" and "system performance specifications" without detailing what those specifications are.

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

Missing Information: The document does not specify the sample size used for the test set. It mentions "software testing and validation" and "additional system testing by a third party standards test house" but does not quantify the data used for these tests. Data provenance (country of origin, retrospective/prospective) is also not mentioned.

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

Missing Information: The document does not describe the establishment of a "ground truth" for a test set, nor does it mention the involvement or qualifications of experts in this capacity. The testing appears to be internal validation against design specifications rather than clinical performance evaluation against expert-derived ground truth.

4. Adjudication Method for the Test Set

Missing Information: No adjudication method is mentioned or implied, as there is no description of a clinical test set requiring expert consensus.

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

Missing Information: The document does not describe an MRMC comparative effectiveness study. The device is presented as an "add-on accessory" for acquiring and reconstructing 3D ultrasound data, not as an AI-driven diagnostic aid for human readers. Therefore, there is no mention of an effect size related to human reader improvement with or without AI assistance.

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

Information Provided (Indirectly): The "Test Discussion" states that "Software testing and validation were done at the module and system level" and "Additional system testing was done by a third party standards test house." This suggests standalone testing of the algorithm (or software components) against its design specifications was performed.
Missing Information: The specific metrics and results of this standalone performance are not detailed beyond a general statement of compliance.

7. The Type of Ground Truth Used

Missing Information: The document does not specify a type of "ground truth" (e.g., pathology, outcomes data, expert consensus) as would be relevant for clinical performance evaluation. The testing described appears to be focused on validating the device's technical functionality and conformity to internal design specifications.

8. The Sample Size for the Training Set

Missing Information: The document does not mention a training set. This device is described as an image acquisition, analysis, storage, and retrieval system for 3D ultrasound, not an AI/ML-based diagnostic algorithm that would typically require a training set.

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

Missing Information: As no training set is mentioned, the method for establishing its ground truth is also not applicable or discussed.

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