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The IS4/DF4 plug can be indicated for a patient with an implantable pacemaker/defibrillator that has an unused IS4/DF4 receptacle. The plug prevents the ingression of bodily fluids/blood inside the IS4/DF4 receptacle.

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The provided text describes a 510(k) premarket notification for a medical device called the "IS4/DF4 Port Plug." This document is a letter from the FDA to Oscor Inc. stating that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance results, sample sizes for testing or training, expert qualifications, ground truth establishment methods, or details about any studies (standalone or MRMC comparative effectiveness) that would typically be included in a technical report or clinical trial summary.

The content is purely administrative, focusing on the FDA's regulatory decision of substantial equivalence based on the provided indications for use and the device's classification. It states that the device "prevents the ingression of bodily fluids/blood inside the IS4/DF4 receptacle." This is a functional description, but not a quantifiable performance criterion with an associated study result.

Therefore, based on the provided text, it is not possible to answer the detailed questions about acceptance criteria, study design, sample sizes, expert involvement, or ground truth. The document is a regulatory approval letter, not a technical performance report.

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