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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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The primaGARD Surgical Equipment Covers are Non-sterile surgical equipment covers, identified in 21 CFR, part 878.4370. The drapes are made of natural and/or synthetic material and used as a protective equipment covering. The primary purpose of this drape is to isolate equipment from contaminating the sterile field during surgery. This is to maintain the sterile technique in an operating room.

The primaGARD Surgical Equipment Covers are Non-sterile surgical equipment covers, identified in 21 CFR, part 878.4370. The drapes are made of natural and/or synthetic material and used as a protective equipment covering.

This document is a 510(k) clearance letter from the FDA for a medical device called "primaGARD Surgical Equipment Covers." It is not a study report or clinical trial document, and therefore, it does not contain the information requested in your prompt regarding acceptance criteria, device performance, study design, or ground truth establishment.

A 510(k) clearance signifies that the FDA has found the device to be "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety and effectiveness. This process typically involves demonstrating equivalence to existing devices through a comparison of technological characteristics and, sometimes, limited performance testing against established standards, but not a full-scale clinical study with the details you've requested.

Therefore, I cannot populate the table or answer the specific questions based on the provided text.

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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 NoNSterile Surgical Drape, identified in 21 CFR, part 878.4730, as a medical device intended to be used 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. The drapes are made of natural and/or synthetic material and used as a protective patient covering. One example of use of this drape is to isolate the site of surgical incision from particulate, microbial and other forms of contamination.

The primaGARD Surgical Drapes are NoNSterile Surgical Drape, identified in 21 CFR, part 878.4730, as a medical device intended to be used 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. The drapes are made of natural and/or synthetic material and used as a protective patient covering.

The provided text is a 510(k) premarket notification letter from the FDA to PrimeLine Medical Products, Inc. regarding their Primagard Nonsterile Femoral Angiography Drapes. This document does not contain any information about acceptance criteria or a study proving that the device meets those criteria, as it relates to a device's performance in a clinical or technical sense.

The letter is a regulatory document confirming that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA has determined the new device is as safe and effective as a previously approved device. The "indications for use" statement describes what the device is intended to be used for, but it does not specify performance metrics or study results.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, ground truth types, training set details) from this document because it is not a study report or a technical specification document for the device's performance.

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Surgical Masks are surgical apparel, identified in 21 CFR, part 878.4040, 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.

Not Found

This document is a 510(k) premarket notification approval letter for surgical masks. It does not contain information on acceptance criteria or a study proving that a device meets such criteria in the manner requested (i.e. for an AI-powered medical device).

Therefore, I cannot provide the detailed information requested in the prompt based on the provided text. The document pertains to a traditional medical device (surgical mask) and its substantial equivalence to a predicate device, not an AI/ML-based device requiring a study with acceptance criteria as described.

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Surgical Masks are surgical apparel, identified in 21 CFR, part 878.4040, as a medical device intended to be world by operating room personnel from the transfer of protect bour the barger fluids, and particulate matcrial.

Procedure Masks PM 4-301 + Pm4-31

This document is a 510(k) premarket notification decision letter from the FDA regarding "Procedure Masks: PM4-301 and PM4-304" manufactured by Primline Medical Products, Incorporated. It confirms that the device is substantially equivalent to a legally marketed predicate device.

The provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. It is a regulatory approval document, not a study report.

Therefore, I cannot provide the requested information from the given input.

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Surgical Apparels, shoe and head covers, are worn by operating room personnel during surgical procedures to help protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

PrimeLine Medical Products Inc., priMED brand Head and Shoe Covers

I am sorry, but the provided text is a 510(k) clearance letter for "Primed Shoe Covers, Primed Head Covers" and an associated "Statement of Indications for Use". This document does not describe a study that involves acceptance criteria for device performance, nor does it contain information about AI-powered devices or diagnostic algorithms.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

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Cotton Gauze Sponges are designed as single use, and general use medical devices in the management of wounds.

Cotton Gauze Sponges

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter for "priMED 'Prime-Plus' Cotton Gauze Sponges" and a "Statement of Indications for Use."

This type of document primarily confirms that a medical device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics as a device already on the market, or is as safe and effective.

The provided text does not contain any information about acceptance criteria for device performance, study details, sample sizes, expert qualifications, or ground truth establishment. These details are typically found in the full 510(k) submission, study reports, or design control documentation, which are not part of these specific pages.

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