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The Life Imaging Systems L3Di 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 such as distance, area, volume and angle measurements. 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 radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, cardiology, obstetrics and gynecology.

The Life Imaging Systems L3Di is a high performance computer system based on Apple Computer and Windows NT 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 during use, either with transducer positioner assemblies or with a 6-degree of freedom coordinate tracking system.

The provided document for K990560, the Life Imaging Systems L3Di, is a 510(k) summary and FDA clearance letter. It does not contain a detailed study report with specific acceptance criteria or performance metrics in a structured table, nor does it provide the detailed information requested regarding sample sizes, ground truth establishment, or expert qualifications for a clinical performance study.

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

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

No explicit acceptance criteria or performance metrics are detailed in a table format. The document states:

• Acceptance Criteria (Implied): The device's performance should satisfy the "design intent" and conform to "system performance specifications."
• Reported Device Performance: "Test results support the conclusion that actual device performance satisfies the design intent. Actual device performance as tested internally and by a third party conforms to the system performance specifications."

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The testing was done "internally" and by a "third party standards test house."

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 specified. The document only mentions that "Test results were reviewed by designated technical professionals." Their number and qualifications are not detailed, and it's unclear if these professionals established a "ground truth" in the clinical sense, or merely reviewed engineering test results.

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

• Not specified.

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 comparative effectiveness study is mentioned. This device is described as an "add-on accessory" for acquiring, analyzing, and processing 3D ultrasound images, and its functionality appears to be focused on image reconstruction and measurement tools rather than AI-assisted diagnosis for human readers.

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

• The document implies that the "software testing and validation" and "additional system testing" would be considered similar to a standalone evaluation of the device's technical performance against its specifications. However, no specific details are provided on how this "standalone performance" was quantified or measured for clinical efficacy.

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

• Not specified. Given the device's function (image acquisition, 3D reconstruction, analysis, and measurement), the "ground truth" for technical validation would likely involve comparing the device's output (e.g., reconstructed 3D images, measured distances, volumes) against known physical properties of test phantoms or highly accurate reference measurements, rather than clinical ground truth like pathology or outcomes.

8. The sample size for the training set

• Not applicable/Not specified. The document describes software "validation" and "testing," which refers to evaluating the software's functionality and adherence to specifications, not machine learning model training. There is no indication that this device uses AI/ML that requires a training set.

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

• Not applicable/Not specified, as there is no mention of a training set for an AI/ML model.

Summary based on the document:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (LIS 6000A) based on technological characteristics and intended use. The "Test Discussion" and "Test Conclusions" describe internal software validation and system testing by a third party to ensure the device meets its design intent and performance specifications. This appears to be a technical validation rather than a clinical performance study with human readers, specific ground truth (like pathology), or detailed statistical metrics often associated with AI diagnostic devices. No specific acceptance criteria or performance numbers are quantified in the document, which is typical for a 510(k) summary demonstrating substantial equivalence primarily through technical compliance rather than novel clinical claims requiring extensive clinical trial data.

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The LIS 6000A is intended to acquire a full resolution set of B-Mode images. The source of these images is the analog video or digital video output of a diagnostic ultrasound system. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice).

The LIS 6000A is intended to acquire a full resolution set of Color Flow images. The source of these images is the analog video or digital video outputs of a diagnostic ultrasound system. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice).

The LIS 6000A is intended to acquire a high resolution set of B-Mode loops. The source of these loops is the analog video or digital video output of a diagnostic ultrasound system. Gating is accomplished by analyzing externally generated cardiac and/or respiratory signals. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice).

The LIS 6000A is intended to acquire a high resolution set of Color Flow loops. The source of these loops is the analog video or digital video output of a diagnostic ultrasound system. Gating is accomplished by analyzing externally generated cardiac and/or respiratory signals. Image acquisition excernally generator linear (parallel slice), axial (propeller slice) or sector (fan slice).

The LIS 6000 is intended to reformat the acquired B-Mode and Color Flow data sets into a single volumetric data space and subsequently display multiple planar cross sections of that space, either individually, or together in a 3D polyhedral display

The LIS 6000A is intended to display three different volumetric rendering display modes: Maximum intensity, surface rendering and volume rendering.

The LIS 6000A will make basic distance, area, and volume measurements based on boundaries defined in user selected cross sectional planes.

The LIS 6000 is a device which can acquire, display, and post process diagnostic ultrasound images.

Data acquisition involves video grabbing a set (or sets) of ultrasound frames, each frame representing a planar image, while positioning the ultrasound probe such that the set of 2D planes acquired spans a predefined volume with a known relationship between the planes. The probe positioning devices are described below. Three types of acquisitions are defined for the LIS 6000A: ungated, single phase gated and multiphase gated.

The provided document does not contain information about acceptance criteria or a study proving the device meets them. The text describes a medical device, the Life Imaging Systems LIS 6000A - Image Processing System, and its accessories, detailing its function, acquisition methods, post-processing capabilities, and intended uses. It also includes a comparison table with a predicate device, the TomTec EchoScan.

Therefore, it is not possible to provide the requested information, including:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or the effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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