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DDS software is combined with appropriate hardware to form a diagnostic review station. DDS is used to display and manipulate patient images and demographic information, for diagnostic, review and referral purposes. It is a software package which may be marketed as a software only solution, or in conjunction with standard hardware. DDS can be used as a stand-alone system or in connection with a larger system.

DDS software is combined with appropriate hardware to form a diagnostic review station. DDS is used to display and manipulate patient images and demographic information, for diagnostic, review and referral purposes. It is a software package which may be marketed as a software only solution, or in conjunction with standard hardware. DDS can be used as a stand-alone system or in connection with a larger system.

The provided text is a 510(k) summary for the DDS diagnostic image review station. It does not contain any information regarding acceptance criteria or the results of a study proving the device meets said criteria.

The document primarily focuses on:

• Company Information and Contact: Impax Technology Inc., Paula Pfeifle.
• Submission Date: October 18, 1999.
• Device Name: DDS (with various trade names like DS3000, RS3000, etc.).
• Common Name: Diagnostic Review Station.
• Intended Use: To display and manipulate patient images and demographic information for diagnostic, review, and referral purposes, as a software package (with or without standard hardware), and as a standalone or connected system.
• Substantial Equivalence: Comparison to Radworks Medical Imagining Software with Quality Control Module.
• Technological Comparison: Both are software packages for standard PC hardware (Windows NT), DDS also supports Unix/Solaris. Both query, retrieve, transmit medical images, provide high-quality display, and allow digital processing, measurement, and annotation.
• Non-Clinical Performance and Test Data: Stated as following "standard procedures: test plans are developed, testing is carried out through a variety of automated and manual testing, and test results are recorded and reported." It also mentions "extensively tested by programmers, quality assurance specialists, and potential customers."
• Substantial Equivalence Conclusions: The intended use and technological characteristics are equivalent to the predicate device.
• FDA Clearance Letter: Confirms 510(k) clearance (K993532) on December 15, 1999, based on substantial equivalence for the stated indications for use.
• Indications for Use Statement: Reiterates the intended use of the DDS software.

Therefore, I cannot provide the requested table or detailed study information because it is not present in the given text. The document describes a regulatory submission for substantial equivalence based on technological comparison and non-clinical software testing, not a clinical performance study with specific acceptance criteria and results.

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