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The intended use is the same.

The revised Arbor Medical Syringefilter is as safe and effective as the original. The proposed plastic housings and membrane have passed Class VI testing as did the original housings and membrane. The proposed product is manufactured the same as the original. The method of sterilization is the same as the original version.

Given the input, there is no information about acceptance criteria, device performance, specific studies, sample sizes, expert involvement, or any of the detailed aspects requested in the prompt.

The provided text is a very brief "Summary of Safety and Effectiveness" for a device called "Arbor Medical Syringefilter" (K960928) from 1997. It makes general statements about the revised product being "as safe and effective as the original" and mentions some basic tests like "Class VI testing" and "HIMA Challenge" for a 0.2um filter. However, it does not provide any quantitative data, specific study designs, or detailed methodologies.

Therefore, I cannot fulfill your request based on the provided text. I can only report that:

• No acceptance criteria or reported device performance are present in the text.
• No studies proving the device meets acceptance criteria are described.
• No information regarding sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details is available in the provided document.

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Per FDA Safety Alert: Hazards of Precipitation Associated with Parental Nutrition, issued April 18, 1994, an IV filter is indicated for use when infusing either central or peripheral parenteral nutrition admixtures. Both pore sizes of filters are being offered. a 0.22um air eliminating filter for nonligid containing admixtures, and a 1.2um air eliminating filter for lipid containing admixtures.

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This document is a 510(k) summary for a medical device called AutoPrime™ I.V. Filter and set. It does not contain the information requested in your prompt regarding acceptance criteria and study details for a device's performance, especially for AI/algorithm-based devices.

The document focuses on:

• Device Identification: Trade name, common name, classification, contact person.
• Predicate Device Comparison: Stating that the AutoPrime™ is as safe and effective as two other named I.V. administration sets.
• Intended Use: Filtering intravenous solutions, specifically mentioning parenteral nutrition admixtures based on an FDA Safety Alert.
• Technological Characteristics: Comparing the 0.22um and 1.2um filters to their predicate counterparts, noting similarities in bacterial/Candida retention claims and materials of construction.
• Lack of Bench Test Data Requirement: Stating that bench test data is "not required due to there being no technological differences that raise issues of safety or efficacy."

Therefore, I cannot provide the requested information (acceptance criteria, device performance table, sample sizes, ground truth details, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) from this document. This document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices, not on detailed performance validation studies as typically conducted for novel AI/machine learning devices.

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