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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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The INT13 is a diagnostic ultrasound intraoperative transducer for use in abdominal surgery. The transducer can be used to image abdominal anatomy during abdominal surgical procedures. In Doppler mode, the transducer can provide information about blood flow in abdominal vessels.

The Esaote INT13 intraoperative transducer is designed and intended to be used in open (open as opposed to laparoscopic used with a trocar) abdominal surgical procedures. More specifically, the transducer is intended to be used to image abdominal anatomy during open surgical procedures.

This document describes a 510(k) premarket notification for a new diagnostic ultrasound transducer, the INT13 Intraoperative Transducer by Biosound, Inc. This submission focuses on establishing substantial equivalence to a predicate device, the Hitachi Intraoperative Ultrasound Transducer EUP - 033J (K884644), rather than presenting a study with acceptance criteria for device performance.

Therefore, the requested information regarding acceptance criteria and a study to prove the device meets them cannot be extracted from the provided text because such a study is not described.

The document primarily focuses on:

• Device Description: Specifications, materials, sterilization process.
• Intended Use: Diagnostic ultrasound intraoperative transducer for abdominal surgery, including Doppler mode for blood flow.
• Substantial Equivalence Comparison: A table comparing the INT13 to the predicate device (Hitachi EUP 088 J) based on intended use, technology, frequencies, operating modes, cable length, and safety standard.

In summary, the provided text does not contain information about acceptance criteria or a study demonstrating the device meets performance metrics. The core of this 510(k) submission is to argue for substantial equivalence to an existing device, which is a different regulatory pathway than proving specific performance against predefined acceptance criteria from a new clinical study.

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