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The IMT.LAB software is a Windows 2000/XP software application package to be used on a personal computer for the automatic measurement of the intima media thickness of the carotid artery from video images obtained from Esaote ultrasound systems.

The IMT LAB software is a Windows 2000/XP software application package that runs on a stand-alone personal computer. Video images from the carotid artery made with a standard ultrasound system can be used as input for the IMT.LAB software package. These images can be transferred digitally by means of a DICOM, BMP, or JPEG files from the ultrasound system to the IMT.LAB software. IMT.LAB uses proprietary techniques and algorithms to measure the Intima Media Thickness (IMT) from the far wall of the carotid artery. This information is used in addition to other medical data by a physician to help assess the cardiovascular health of a patient.

IMT.LAB can store the images and the measurement results on the hard disk for future reference.

Here's a summary of the provided 510(k) document regarding the IMT.LAB software, focusing on acceptance criteria and study details.

Please note: The provided 510(k) summary (K062598) primarily focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about specific performance acceptance criteria or a dedicated study demonstrating the device meets those criteria. The document asserts equivalence based on intended use and technological characteristics. Therefore, many of the requested fields will be marked as "Not Provided in Document."

IMT.LAB Software: Acceptance Criteria and Study Details (K062598)

This 510(k) summary for the IMT.LAB software primarily establishes substantial equivalence to previously cleared devices. It describes the device's intended use as an automatic measurement tool for carotid artery Intima Media Thickness (IMT) from ultrasound images. The document does not detail specific performance acceptance criteria or present a formal study proving the device meets such criteria in the way a clinical trial or performance study report might. Instead, equivalence is drawn to predicate devices that presumably already met applicable performance standards.

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: Not Provided in Document
• Data Provenance: Not Provided in Document (No specific test set or study is detailed)

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

• Number of Experts: Not Provided in Document
• Qualifications of Experts: Not Provided in Document

4. Adjudication Method for the Test Set

• Adjudication Method: Not Provided in Document

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

• MRMC Study Done?: No
• Effect Size of Human Readers with AI vs. Without AI: Not Applicable (No MRMC study was described)

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done?: No (The document describes the software and its intended use, but not a standalone performance study with metrics.)

7. Type of Ground Truth Used (for Test Set)

• Type of Ground Truth: Not Provided in Document

8. Sample Size for the Training Set

• Sample Size for Training Set: Not Provided in Document

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

• Method for Establishing Ground Truth: Not Provided in Document

Summary of Device Claimed Equivalence:

The IMT.LAB software is deemed substantially equivalent based on similarity in:

• Intended Use: Automatic measurement of intima media thickness of the carotid artery from ultrasound images.
• Image Source: Ultrasound images.
• Operating Environment: Standalone application on a personal computer with Microsoft Windows.
• Image Format: DICOM, JPEG, and Windows BMP (IMT.LAB v2.0 as submitted, vs. only JPEG and BMP for predicate SonoCalc, and AVI/BMP for QLAB).
• Features: Image storage, report generation, automatic distance measurement.
• Classification: 90LLZ (Radiological Image Processing System).

The 510(k) process for this device relies on demonstrating that the new version (IMT.LAB C:2.0) has technological characteristics and intended use that are equivalent to already legally marketed predicate devices, rather than presenting a de novo performance study against pre-defined acceptance criteria.

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The IMT.LAB software is a Windows 2000/XP software application package to be used on a personal computer for the automatic measurement of the intima media thickness of the carotid artery from video images obtained from Esaote Pie ultrasound systems.

The IMT.LAB software is a Windows 2000/XP software package to be used on a personal computer for the automatic measurement of the intima media thickness of the carotid artery from video images obtained from Esaote Pie ultrasound systems.

This submission focuses on establishing substantial equivalence for the IMT.LAB software, a picture archiving and communication system (PACS) intended for automatic measurement of intima media thickness (IMT) of the carotid artery from ultrasound images. The provided document does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance metrics. Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices (SonoMetric Health's SonoCalc and Philips Medical Systems' QLAB) based on technological characteristics and intended use.

Therefore, I cannot populate a table of acceptance criteria and reported device performance from this document. The document also does not describe a standalone study with a test set, expert ground truth, adjudication methods, or MRMC comparative effectiveness study results.

Here's what can be extracted and what is missing based on your request:

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

• Not provided in the document. The submission focuses on substantial equivalence based on intended use and technological characteristics compared to predicate devices, not on quantitative performance metrics or specific acceptance criteria for IMT accuracy.

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

• Not provided. The document does not describe a performance study with a test set.

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 provided. As there's no described performance study, there's no mention of experts establishing ground truth for a test set.

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

• 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:

• Not provided. The document does not describe an MRMC study.

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

• Not explicitly described as a standalone performance study with metrics. The device's "automatic measurement" function implies a standalone algorithmic capability, but no dedicated study demonstrating its performance in isolation is detailed in this submission. The comparison to predicate devices for "automatic distance measurement of the intima media thickness of an artery" is the closest information provided, but it's not a performance study.

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

• Not provided.

8. The sample size for the training set:

• Not provided.

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

• Not provided.

Summary of available information related to performance/validation (indirectly):

The submission argues for substantial equivalence primarily by comparing the IMT.LAB software's intended use and technological characteristics to two predicate devices: SonoMetric Health's SonoCalc (K030223) and Philips Medical Systems' QLAB (K021966).

• Key shared characteristics (implying similar performance expectations):
  • Intended Use: Automatic measurement of intima media thickness of the carotid artery from ultrasound video images.
  • Image Source: Ultrasound images.
  • Operating environment: Standalone application on a personal computer with Microsoft Windows.
  • Functionality: Automatic distance measurement of the intima media thickness of an artery.

This type of 510(k) submission, particularly for software that performs automated measurements and is compared to existing devices offering similar functionality, often relies on the predicate devices having already established safety and effectiveness. The current submission's focus is on demonstrating that the new device does not introduce new questions of safety or effectiveness compared to the predicates. Specific performance metrics (accuracy, precision, etc.) and studies to prove them are not detailed in this summary.

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