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The Power Vision 8000 is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transesophageal, peripheral vascular, and musculo-skeletal (both conventional and superficial).

The PowerVision 8000 Ultrasound System is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 10 MHz.

The provided document is a 510(k) Summary for the Toshiba SSA-390A/PowerVision 8000 Ultrasound Imaging System. This document focuses on demonstrating substantial equivalence to predicate devices, primarily by comparing intended use, technological characteristics, and safety considerations. It does not contain information about a study proving the device meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy) using a test set with ground truth established by experts.

The core of this submission is to confirm that the new device does not raise new questions of safety or effectiveness compared to previously cleared devices. It relies on the predicate devices' prior approvals and compliance with general safety standards.

Therefore, many of the requested details about acceptance criteria and a performance study demonstrating those criteria cannot be extracted from this document, as such a study is not presented.

Here's a breakdown of what can be inferred or directly stated from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This table cannot be fully completed from the provided document as specific diagnostic performance acceptance criteria (e.g., sensitivity, specificity, or accuracy thresholds) and corresponding reported performance are not included. The "acceptance criteria" here relate to demonstrating substantial equivalence based on technical specifications and indications of use, rather than a clinical performance study.

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

Not applicable. No diagnostic performance study with a test set is described. The submission relies on establishing substantial equivalence to a predicate device, which usually involves demonstrating similar technical specifications and safety profiles rather than a clinical study comparing diagnostic outputs.

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. No diagnostic performance study with a test set and ground truth is described.

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

Not applicable. No diagnostic performance study with a test set 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 applicable. This is a 1999 submission for a diagnostic ultrasound system, not an AI-assisted device. No MRMC study is mentioned.

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 algorithm.

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

Not applicable. No diagnostic performance study with ground truth is described. The "ground truth" in this context is the FDA's existing clearance for the predicate device and its established safety and effectiveness.

8. The sample size for the training set

Not applicable. This is a diagnostic ultrasound system, not an AI/ML device that undergoes training.

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

Not applicable. This is a diagnostic ultrasound system, not an AI/ML device that undergoes training.

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The Power Vision 6000 is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transesophageal, peripheral vascular, and musculo-skeletal (both conventional and superficial).

The PowerVision 6000 Ultrasound System is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 10 MHz.

The provided document is a 510(k) Summary for the Toshiba SSA-370A/PowerVision 6000 Ultrasound Imaging System. It outlines the device description, intended use, and substantial equivalence to predicate devices, but does not contain any information regarding acceptance criteria or specific studies proving the device meets acceptance criteria.

The tables within the document (pages 3-20) are "Diagnostic Ultrasound Indications For Use Form" for various transducers. These tables indicate whether certain clinical applications (e.g., Fetal, Abdominal, Cardiac) and modes of operation (e.g., B, M, PWD, Color Doppler) are "New indication (N)", "Previously Cleared by FDA (P)", or "Added under Appendix E (LTF)". This information describes the intended uses of the device and its transducers based on prior clearances or new submissions, but does not present performance data or acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on regulatory classification and claiming substantial equivalence to predicate devices rather than providing performance study details.

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Color Angio is a post-processing modification to the Power Mode display that was cleared with the SSA-380A system in K933743. It is an amplitude based color display subset of color doppler imaging that performs frame addition to accentuate minute vascular structures and signal the presence of blood, rather than the motion of flow. This feature is independent of velocity, angle of incidence and direction of interrogation and reduces the effects of aliasing.

Here's an analysis of the provided 510(k) summary, specifically focusing on acceptance criteria and study details.

Based on the provided document (K963705), there is insufficient information to fully answer all aspects of your request. This 510(k) appears to be for a "Color Enhancement Function for the SSA-380A" (Amplitude Doppler), which is a post-processing modification. The submission primarily focuses on establishing substantial equivalence to a previously cleared device (SSA-380A in K933743) rather than presenting a detailed performance study with specific acceptance criteria as one might see for a diagnostic AI algorithm.

However, I can extract and infer information from the text to the best of my ability based on the nature of 510(k) submissions for such modifications:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document does not provide a formal table of acceptance criteria with specific numerical thresholds (e.g., sensitivity, specificity, AUC > X%) or a detailed study demonstrating these criteria being met. The acceptance criteria for such a modification typically revolve around maintaining the safety and effectiveness of the predicate device and demonstrating that the changes do not introduce new risks or alter the fundamental intended use.

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

• Sample Size: This information is not provided in the document.
• Data Provenance: This information is not provided in the document. Given the nature of a 510(k) for a post-processing modification to an existing system, it's possible that internal testing or comparison to existing images was performed, but no details are given. It's likely such a modification would not involve a large, formal clinical trial with a "test set" in the way an AI diagnostic algorithm would.

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

• This information is not provided in the document. For a color display enhancement, "ground truth" might involve expert subjective assessment of image quality, clarity, and visualization of structures, but no details on such a process are given.

4. Adjudication Method for the Test Set

• This information is not provided in the document, and it's unlikely a formal adjudication method was used given the nature of the submission.

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

• No, a MRMC comparative effectiveness study is not mentioned or implied. The document focuses solely on the device itself and its substantial equivalence. The concept of "human readers improve with AI vs without AI assistance" is not applicable here as this is a display enhancement for human interpretation, not an AI assisting in a diagnostic task.

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

• This information is not explicitly stated, but the "Color Enhancement Function" (Color Angio) is an algorithm (post-processing modification) that operates independently to generate the enhanced display. Its performance is its standalone generation of this enhanced image. However, its effectiveness is ultimately dependent on human interpretation of that image.

7. The Type of Ground Truth Used

• This information is not explicitly provided. For a display enhancement feature, "ground truth" might implicitly refer to:
  • Physics-based validation: Ensuring the algorithm correctly processes amplitude data.
  • Subjective expert assessment: Experts reviewing enhanced images and confirming improved visualization of vascular structures compared to non-enhanced images.
  • Clinical observation: Demonstrating that the enhanced images aid in clinical assessment (e.g., finding minute vessels).
  • Given the brevity, it's most likely that internal technical validation and perhaps a limited expert review were performed, focusing on whether the feature did what it claimed (accentuated structures, reduced aliasing).

8. The Sample Size for the Training Set

• This information is not provided. As this is described as a "post-processing modification" rather than a machine learning model requiring extensive training data, the concept of a "training set" in the context of AI (neural networks, etc.) is likely not applicable in the way you're thinking. It's more likely a traditional image processing algorithm.

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

• This information is not provided, and as noted above, a "training set" with established ground truth in the AI sense is likely not applicable to this type of device modification.

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