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This diagnostic ultrasound system (UltraVision) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients, (thyroid, breast, and testicles) and for peripheral vessel, abdominal, and superficial muscular skeletal diagnosis.

The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.

The UltraVision 2 is a portable Diagnostic Ultrasound System which applies the latest technologies to produce optimal images. Various image parameter adjustments, a 15 inch high resolution display, and custom probes are configured to provide clear and stable images. It operates in B-mode, M-Mode, Color Flow Doppler Mode, Pulsed Wave Doppler Mode, and E-Mode.

This document is a 510(k) Premarket Notification from the FDA for a diagnostic ultrasound system. It outlines the safety and effectiveness of the UltraVision 2 Diagnostic Ultrasound System by comparing it to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on establishing "substantial equivalence" to a predicate device rather than presenting a performance study with specific acceptance criteria and outcome metrics for diagnostic accuracy. Substantial equivalence is determined by demonstrating that the new device has the same intended use and operational characteristics, or if different, that these differences do not raise new questions of safety or effectiveness.

Therefore, the "acceptance criteria" here are largely compliance with regulatory standards and similarity to the predicate device in terms of technical specifications and safety.

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

The document explicitly states: "Clinical Test: Clinical testing not required." This indicates that no clinical "test set" in the traditional sense of patient data was used to demonstrate the device's diagnostic performance for its 510(k) clearance. The assessment was based on non-clinical engineering and safety testing, and a comparison of technical specifications to a predicate device. Therefore, information on sample size, data provenance, or study design for diagnostic performance is not applicable here.

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, as no clinical test set requiring ground truth established by experts was used.

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

Not applicable, as no clinical test set requiring adjudication was used.

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. The UltraVision 2 Diagnostic Ultrasound System is a standalone ultrasound imaging device, not an AI-assisted diagnostic tool. No MRMC study or AI-related performance evaluation was performed or required.

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

Not applicable. The UltraVision 2 is an ultrasound imaging system, not an algorithm. Its performance is evaluated as an imaging device, not as an AI or algorithmic diagnosis tool. The "E-mode" (Elastography) provides a "qualitative representation of relative tissue stiffness," but it is an imaging mode, not an automated diagnostic algorithm.

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

Not applicable, as no clinical performance study requiring ground truth was conducted. The "ground truth" for this submission focuses on compliance with technical and safety standards, as well as the functional equivalence of the device to its predicate.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable, as no training set was used.

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This diagnostic ultrasound system (UltraVision) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients. (thyroid, breast, and testicles) and for superficial muscular skeletal diagnosis.

The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.

The UltraVision 2 is a portable Diagnostic Ultrasound System which applies the latest technologies to produce optimal images. Various image parameter adjustments, a 15 inch high resolution display, and custom probes are configured to provide clear and stable images. It operates in B-mode and.

Here's an analysis of the provided text regarding acceptance criteria and the study proving device performance:

Unfortunately, the provided FDA 510(k) summary for the UltraVision 2 Diagnostic Ultrasound System does not contain the specific acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for an AI/ML medical device submission.

This document is a 510(k) premarket notification for a traditional diagnostic ultrasound system, not an AI/ML-powered device. Therefore, the type of performance metrics, clinical study design, and ground truth establishment you're asking about are not present in this specific regulatory submission.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Siemens Acuson S2000 Ultrasound System). This is a common pathway for traditional medical devices, where the new device is shown to be as safe and effective as a legally marketed device without necessarily presenting novel clinical performance studies against specific acceptance criteria.

Let's break down why your requested information isn't fully available and what is described:

Based on the provided document, here's what can be inferred and what is missing or not applicable:

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

• Not Applicable in the traditional sense for AI/ML performance. This document does not present specific quantitative performance metrics (e.g., sensitivity, specificity, AUC) with corresponding acceptance criteria because it's not a clinical performance study of an AI/ML algorithm.
• The "performance" being demonstrated is the substantial equivalence to a predicate diagnostic ultrasound system based on shared technological characteristics and safety standards.

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 clinical test set is described. The assessment is based on demonstrating that the UltraVision 2 "uses the same fundamental scientific technologies as the predicate device" and passes non-clinical safety 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 Applicable. There is no clinical test set requiring expert-established ground truth.

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

• Not Applicable. No clinical test set.

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 not an AI-assisted device. No MRMC study was conducted or described. The document explicitly states: "Clinical Test: Clinical testing not required."

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

• Not Applicable. Not an AI algorithm.

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

• Not Applicable. No specific ground truth is established for clinical performance as clinical testing was not required for this 510(k). The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

• Not Applicable. No training set for AI/ML.

What the document does say about "acceptance criteria" and "proof":

The "proof" for the device meeting regulatory requirements in this 510(k) comes from demonstrating:

• Substantial Equivalence: The primary "acceptance criterion" is that the UltraVision 2 Diagnostic Ultrasound System is substantially equivalent to the legally marketed predicate device (Siemens Acuson S2000 Ultrasound System, K081148) in terms of intended use, technological characteristics, and safety profiles.
  • Evidence for Substantial Equivalence:
    • Similar Intended Use: Both are diagnostic ultrasound systems. The UltraVision 2's applications (small parts: thyroid, breast, testicles, and superficial musculoskeletal diagnosis) are a subset of the predicate's broader applications but still within its scope.
    • Similar Operating Principles: Both transmit ultrasonic energy, process echoes, and display images. Both use LCDs, hand-held transducers, and have similar operating modes (B-mode explicitly mentioned for UltraVision 2, with predicate having B, C, D, M).
    • Similar Transducer Technology: Both use linear transducers (HL5-10EPN for UltraVision 2, 14L5 for predicate) with comparable frequency bandwidths (5-12 MHz vs. 5-14 MHz) and number of elements (128).
    • Compliance with Recognized Standards:
      • IEC 60601-1 (Safety Requirements for Medical Equipment)
      • IEC 60601-1-2 (EMC Requirements for Medical Equipment)
      • IEC 60601-2-37 (Diagnostic Ultrasound Safety Standards)
      • Acoustic output testing (per FDA guidance dated Sept 9, 2008)
      • ISO 10993 (Biocompatibility - Parts 1, 5, 10). The document states: "The patient contact materials of human body surface are evaluated under ISO 10993 and determined acceptable for the specified usage of the system. Both systems have the same acceptance level for biocompatibility."

The key "differences" acknowledged (size and weight) are deemed not to raise new questions of safety or effectiveness.

In summary, for K150580, the "acceptance criteria" revolve around established safety standards and demonstration of technological similarity and equivalent performance to a predicate device, rather than specific clinical outcome metrics from a de novo study.

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