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Pie Medical's Picus 3D ultrasound system is intended to be used by a physician to perform general diagnostic ultrasound studies including cardiac, peripheral vascular, fetal, abdominal, small organ, neonatal cephalic, transrectal and transvaginal.

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This 510(k) summary describes a new ultrasound imaging system, the Picus 3D, and compares it to existing predicate devices (Pie Medical 300LC (Picus) K002880 and Esaote AU5 3D K000931) to establish substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and studies:

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

The document does not explicitly state "acceptance criteria" or provide a table of performance metrics with specific targets and reported results. Instead, it utilizes a "Comparison Chart for Substantial Equivalence" to demonstrate that the Picus 3D device is comparable in features and functionality to the predicate devices. The underlying acceptance criterion for this submission is that the new device is substantially equivalent to legally marketed predicate devices, meaning it does not raise new questions of safety or effectiveness.

The "reported device performance" is implicitly shown by the detailed feature comparison in the table, demonstrating that the Picus 3D either matches or is equivalent in capability to the predicate devices across various technical specifications and clinical applications. For example, regarding imaging modes, the Picus 3D includes 3D imaging, which was present in one predicate (Esaote AU5 3D K000931) but not the other (Picus K002880), indicating an expansion of capabilities while maintaining equivalence to an existing 3D device.

Here's a summary derived from the comparison chart, focusing on the features presented as comparable for establishing substantial equivalence:

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

This 510(k) summary does not mention any specific test set sample sizes, data provenance, or details of a clinical study for demonstrating performance. This type of submission relies on the concept of substantial equivalence to predicate devices that have already demonstrated safety and effectiveness through their prior market clearance. The data provenance would implicitly refer to the existing clinical use and safety record of the predicate devices.

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 noted above, this 510(k) submission establishes substantial equivalence through feature comparison, not new clinical performance data with ground truth established by experts.

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

Not applicable. No new test set requiring adjudication 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 not an AI/CAD-focused device and 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 an ultrasound imaging system, which is a human-in-the-loop device by nature (operated by a sonographer/physician).

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

Not applicable. No new ground truth establishment is described for this submission. The "ground truth" for demonstrating safety and effectiveness relies on the established performance and safety profiles of the predicate ultrasound devices already on the market.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device that would typically require a training set.

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

Not applicable. No training set is described.

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The AU6 (Technos/TechnosMP) ultrasound imaging system is intended to be used by a physician for diagnostic imaging in pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic and musculoskeletal applications.

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This is a 510(k) premarket notification for an ultrasound imaging system. Such notifications typically focus on establishing substantial equivalence to a legally marketed predicate device rather than presenting detailed standalone performance studies with specific acceptance criteria and outcome metrics like accuracy, sensitivity, or specificity.

Based on the provided document, here's what can be extracted and what cannot be determined:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for image quality or diagnostic accuracy/performance. The "reported device performance" is essentially that it is substantially equivalent to the predicate devices and supports the specified imaging modes and clinical applications.

The tables within the document (e.g., "Comparison Chart for Substantial Equivalence", and tables for individual transducers) indicate capabilities and modes of operation for various clinical applications, rather than quantifiable performance metrics against acceptance criteria.

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

The document does not provide any information about a specific "test set" in the context of an accuracy study. This submission is a 510(k) for an ultrasound imaging system, which primarily demonstrates substantial equivalence through technical comparison and compliance with performance standards (e.g., electrical safety, acoustic output), rather than clinical performance studies against a gold standard for specific diagnostic tasks. The "data provenance" for a clinical test set is therefore unstated.

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

This information is not provided as there is no mention of a clinical performance study with a test set requiring expert-established ground truth.

4. Adjudication Method for the Test Set:

This information is not provided as there is no mention of a clinical performance study with a test set requiring adjudication.

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

The document does not report on an MRMC comparative effectiveness study, nor does it mention any effect size of human readers improving with AI vs. without AI assistance. This device is an ultrasound imaging system, not an AI-powered diagnostic aide in the context of this submission.

6. Standalone (Algorithm Only) Performance Study:

The document does not report on a standalone performance study. The device is an ultrasound imaging system, where its "performance" for 510(k) purposes is largely demonstrated through technical specifications and adherence to safety and performance standards.

7. Type of Ground Truth Used:

As no clinical performance study with a "test set" is described, there is no mention of the type of ground truth used (e.g., expert consensus, pathology, outcomes data).

8. Sample Size for the Training Set:

The document does not provide any information about a training set. This is not an AI/machine learning device in the context of this 510(k) submission.

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

This information is not provided as no training set is mentioned.

Summary of the Study (Based on the 510(k) provided):

The "study" presented in this 510(k) is a substantial equivalence comparison. The manufacturer, Biosound Esaote, sought clearance for the AU6 (Technos/Technos MP) Ultrasound Imaging System with the addition of 3D Imaging Mode and Musculoskeletal Indication.

The study primarily involves a technical comparison of the proposed device (AU6 Technos/Technos MP with 3D/Musculoskeletal additions) against predicate devices: the Esaote AU5 3D (K000931) for 3D capabilities and the Esaote AU6 Digital (Technos K990360) for general ultrasound capabilities.

The "acceptance criteria" are implicitly met if the new device demonstrates similar technological characteristics and performance specifications for the modes and applications it claims, and meets relevant electrical and ultrasound safety standards (IEC 60601-1 and Track 3 for Ultrasound safety). The performance is "reported" by affirming the device's capabilities match or are comparable to the predicates for the cleared indications and modes, while explicitly highlighting the new applications (Musculoskeletal Conventional, Musculoskeletal Superficial, and 3D imaging in certain contexts) as additions with these capabilities. The FDA's letter of clearance confirms that the device is "substantially equivalent" for the stated indications for use.

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