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The intended use is specific for each transducer: P12A - Vascular PT10A - Transcranial P10A - Cardiac PA11A - Cardiac/ Transcranial

The subject devices are diagnostic ultrasound transducers described in the following tables.

The provided text is a summary for diagnostic ultrasound transducers and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It primarily focuses on:

• Submitter Information: Company details and contact person.
• Device Identification: Trade names, common names, and classification names.
• Predicate Devices: Listing of previously cleared devices considered substantially equivalent.
• Device Description: Technical specifications of the P10A, P12A, PT10A, and PA11-A transducers, including modes, frequencies, physical characteristics, and safety requirements.
• Intended Uses: Specific applications for each transducer (Vascular, Transcranial, Cardiac).

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document serves as a 510(k) summary, which is typically a high-level overview for regulatory submission, rather than a detailed report of performance studies or acceptance criteria.

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