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The primaGARD Surgical Drapes are Non-sterile Surgical Gowns, identified in 21 CFR, part 878.4970, as a medical device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

primaGARD Surgical Gowns

The provided documents are an FDA 510(k) clearance letter for "PrimaGard Surgical Gowns." This document type does not contain information about acceptance criteria or a study that proves a device meets those criteria, as it pertains to a physical medical device (surgical gowns) and not an AI/software-as-a-medical-device (SaMD).

Therefore, I cannot provide the requested information based on the given input. The 510(k) clearance process for surgical gowns primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, typically through performance testing against recognized standards for characteristics like barrier performance, fluid resistance, and sterility, rather than through clinical studies with "test sets," "ground truth," or "expert consensus" as would be seen for AI/SaMD.

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The primaGARD Surgical Drapes are Non-sterile Surgical Gowns, identified in 21 CFR, part 878.400, as a medical device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

primaGARD Surgical Gowns

This document describes a 510(k) premarket notification for a medical device, specifically "primaGARD Surgical Gowns." This type of submission is for substantiating that a new device is "substantially equivalent" to an already legally marketed device (predicate device). It does not contain the detailed acceptance criteria and study data proving a device meets those criteria in the way a performance study for an AI/ML diagnostic or prognostic device would.

Therefore, I cannot provide the requested information as it is not present in the provided document. The document primarily focuses on regulatory approval based on equivalence to a predicate device, not on specific performance metrics established through a standalone clinical study for this particular device.

To clarify, a 510(k) submission generally provides information like:

• Indications for Use: What the device is intended to be used for (provided in the document).
• Device Description: How the device works and its materials.
• Technological Characteristics: How it compares to the predicate device.
• Performance Data (often limited): This data, if present for a conventional device like a gown, typically relates to material properties, barrier effectiveness (e.g., fluid resistance, microbial penetration), and safety, rather than statistical performance metrics like sensitivity, specificity, or AUC as seen in studies for AI-powered diagnostic tools. The document does not describe the specific tests or the results demonstrating these properties.
• Comparison to Predicate Device: How the new device is "substantially equivalent."

In summary, the provided text is a regulatory clearance letter and an Indications for Use statement for a surgical gown, not a detailed study report for an AI/ML device.

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