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This device is intended for use by qualified personnel in the Doctor's Office, Operating Room and Nursing Station. The Advanced Image and Data Archiving Compact II System (AIDA Compact II) is a Windows based archiving and documentation station. It allows capture and annotation of video sequences and patient data recording during a diagnostic or therapeutic procedure. It allows capture and annotation of the surgical procedure for documentation purposes. Images captured and distributed by AIDA are for viewing and reference purposes and are not intended for primary diagnosis.

It offers an optional Windows® based solution to communicate with other picture archival communication systems (PACS) using DICOM and with Hospital Information Systems (HIS) using the HL7 standard. Also as a part of the AIDA Compact II System, the Storz Application Manager software (SAM) enables the selection and integration of AIDA with the Storz Communication Bus (SCB) or other third party image capturing devices.

The Advanced Image and Data Archiving Compact II System (AIDA Compact II) is a Windows based archiving and documentation station. It allows capture and annotation of video sequences and patient data recording during a diagnostic or therapeutic procedure. It allows capture and annotation of the surgical procedure for documentation purposes. Images captured and distributed by AIDA are for viewing and reference purposes and are not intended for primary diagnosis. It offers an optional Windows® based solution to communicate with other picture archival communication systems (PACS) using DICOM and with Hospital Information Systems (HIS) using the HL7 standard. Also as a part of the AIDA Compact II System, the Storz Application Manager software (SAM) enables the selection and integration of AIDA with the Storz Communication Bus (SCB) or other third party image capturing devices.

This document is a 510(k) clearance letter from the FDA for the AIDA Compact II device. It does not contain information about the device's acceptance criteria or any study details. The letter states that the device is a "Picture archiving and communications system" and is intended for use in recording and archiving image sequences and patient data during diagnostic or therapeutic procedures for viewing and reference purposes, not for primary diagnosis.

Therefore, I cannot provide details on the acceptance criteria or study that proves the device meets them based on the provided text. The document's purpose is to grant market clearance, not to detail the technical validation of the device.

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The Bioptron Pro and Bioptron Compact III Light Therapy Systems is indicated for adjunctive use in providing temporary relief of is includied for dejaried shoulder pain of musculoskeletal origin.

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I am sorry, but based on the provided document, the information required to answer your request is not present. This document is a 510(k) clearance letter from the FDA for a light therapy system, and it primarily focuses on establishing substantial equivalence to a predicate device. It does not contain details about:

• Specific acceptance criteria with numerical targets.
• A study proving the device meets acceptance criteria, including sample sizes, data provenance, expert qualifications, or adjudication methods.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
• Standalone algorithm performance.
• The type of ground truth used.
• Training set details (sample size, ground truth establishment).

Therefore, I cannot fulfill your request for this specific input.

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