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The Procedure Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. All models are single use, disposable devices, provided non-sterile.

Model GFM31A Procedure Mask will be provided with a nose wire for general medical use, and without a nose wire for use in an MRI environment. This model of Procedure Mask is manufactured with three layers. The user facing layer is made of white polypropylene spunbond; the filtration/middle layer is made of white polypropylene meltblown; and the outer layer is made of blue polypropylene spunbond. The ear loops are welded to the mask and are used to keep the mask close to the mouth and the nose. This device is not made with natural rubber latex. The PVC coated nose wire, when present, is used to fit the facemask around the user's nose. The product intended to be used in an MRI environment is constructed with the same materials except for the nose wire. The Procedure Mask is to be provided as a non-sterile, single use, disposable device.

Model GFM42A Procedure Mask is manufactured with four layers. The user facing layer is made of white polypropylene spunbond; the filtration layer is made of white polypropylene meltblown; the next layer is made of blue polypropylene spunbond; and the outer layer is made of blue polypropylene spunbond. The ear loops are welded to the mask and are used to keep the mask close to the mouth and the nose. This device is not made with natural rubber latex. The PVC coated nose wire is used to fit the facemask around the user's nose. The Procedure Mask is to be provided as a non-sterile, single use, disposable device.

Model GFM43A Procedure Mask is manufactured with four layers. The user facing layer is made of white polypropylene spunbond; the filtration layer is made of white polypropylene meltblown; the next layer is made of blue polypropylene spunbond; and the outer layer is made of blue polypropylene spunbond. The ear loops are welded to the mask and are used to keep the mask close to the mouth and the nose. This device is not made with natural rubber latex. The PVC coated nose wire is used to fit the facemask around the user's nose. The Procedure Mask is to be provided as a non-sterile, single use, disposable device.

The provided document contains information on the acceptance criteria and performance testing for a medical device (Procedure Mask). However, it does not include information typically associated with studies proving device performance against acceptance criteria in the context of AI/ML or diagnostic devices, such as:

• Sample size for a test set (it mentions testing on "three non-consecutive production lots" for the ASTM performance tests, which refers to the mask itself, not a dataset for an AI model).
• Data provenance for the test set.
• Number of experts or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Effect size of human readers improving with AI assistance.
• Standalone performance (for an AI algorithm).
• Type of ground truth (beyond the mask's physical performance).
• Sample size for the training set.
• How ground truth for the training set was established.

This document is for a Procedure Mask, a physical medical device, not an AI/ML-driven diagnostic or image analysis device. Therefore, the questions related to AI/ML study design are not applicable to the information contained in this document.

The acceptance criteria here pertain to the physical and functional performance of the mask as per relevant ASTM and ISO standards for medical face mask materials and biocompatibility.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from ASTM F2100 levels (Level 1, Level 2, Level 3) which define performance requirements for medical face masks. The tables within the document compare the proposed device's performance to the predicate device's performance against these standards.

Model GFM31A (ASTM Level 1)

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The SafeSource Direct Procedure Mask with Ear Loops is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodily fluids, and particulate material. These procedure masks are intended for use in infection control practices to reduce to blood and bodily fluid. The procedure masks are single use, disposable devices, provided non-sterile.

The SafeSource Direct Surgical Mask with Ties is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodly fluids, and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid. The surgical masks are single use, disposable devices, provided non-sterile.

The Procedure Mask with Ear Loops (PM3001, PM3003) is a non-sterile, single use, three-layer, flat-folded mask with ear loops, and a nose wire. The Procedure Mask with Ear Loops is constructed of inner and outer layers consisting of spunbond polypropylene and a middle layer of meltblown polypropylene. The welded ear loops made of spandex/elastane fiber and polyester filament keep the user's mouth and nose. The ethylene propylene copolymer coated aluminum nose wire allows the user to fit the mask around their nose.

The Surgical Mask with Ties (SM3001, SM3003) is a non-sterile, single use, three-layer, flat-folded mask with ties, and a nose wire. The Surgical Mask with Ties is constructed of inner and outer layers consisting of spunbond polypropylene and a middle layer of meltblown polypropylene. The welded polypropylene tie straps keep the mask close to the user's mouth and nose. The ethylene propylene coated aluminum nose wire allows the user to fit the mask around their nose.

This document describes the performance of a medical device, specifically Procedure Masks with Ear Loops and Surgical Masks with Ties, submitted for FDA 510(k) clearance (K221134). The device is compared to a predicate device (K202899) to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are based on ASTM F2100-19 for medical face mask performance, and other relevant standards like ASTM F1862/F1862M-17 (Fluid Resistance), ASTM F2299/F2299M-03 (Particulate Filtration Efficiency), ASTM F2101-19 (Bacterial Filtration Efficiency), EN 14683:2019 + AC:2019 Annex C (Differential Pressure), 16 CFR 1610 (Flammability), ISO 10993-5: 2009 (Cytotoxicity), and ISO 10993-10: 2010 (Irritation and Sensitization).

There are two tables provided in the document:

• Table 1: Comparison of Performance Testing for Proposed ASTM Level 1 Procedure Mask with Ear Loops (PM3001) and Surgical Mask with Ties (SM3001) with Predicate Device
• Table 2: Comparison of Performance Testing for Proposed ASTM Level 3 Procedure Mask with Ear Loops (PM3003) and Surgical Mask with Ties (SM3003) with Predicate Device

Table 1: ASTM Level 1 Masks (PM3001 & SM3001)

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The Procedure Masks / Surgical Masks are intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Procedure Masks / Surgical Masks with Polyethylene nose wire can be used in MRI environment.

Procedure Mask / Surgical Mask, Ear loops and Tie-On. This is a single use, disposable device(s), provided non-sterile.

The provided text is a U.S. FDA 510(k) clearance letter for a Procedure Mask/Surgical Mask. It describes the device, its intended use, and states that it has been determined to be substantially equivalent to legally marketed predicate devices.

However, the document does NOT contain any information regarding the acceptance criteria, device performance testing (including details on sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details) for an AI/ML-driven device.

This document pertains to traditional medical device clearance (a surgical mask), which goes through a different evaluation process than AI/ML-driven software as a medical device (SaMD). The questions you've asked are highly relevant to the regulatory clearance of AI/ML-driven medical devices, but the provided text does not offer this information.

Therefore, I cannot fulfill your request using the given input, as the necessary information is absent.

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The Procedure Masks / Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Procedure Masks (68-8506-G (Green, ear loop, level 1) & 68-8508-G (Green, ear loop, level 3) are single use, three-layer, flat-folded masks with ear loops, and nose wire. The Procedure Masks are manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ear loops welded are used to keep the mask close to the nose. The elastic ear loops are not made with natural rubber latex. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The procedure masks will be provided in green. The Surgical Masks (68-8536-B (Blue, tie-on, level 1) & 68-8538-B (Blue, tie-on, level 3) are single use, threelayer, flat-folded masks with Ties, and nose wire. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ties welded are used to keep the mouth and the nose. The tie is made of spunbond polypropylene. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The surgical masks will be provided in Blue. The procedure masks are sold non-sterile and are intended to be single use, disposable device.

The provided document is a 510(k) Premarket Notification for a Procedure Mask/Surgical Mask. It describes the device's technical specifications and performance testing. However, it is important to note that this document is for a medical device (a mask) and not a software or AI-based device. Therefore, many of the requested elements for describing an AI study, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or training set details, are not applicable in this context.

The document focuses on demonstrating that the proposed device is substantially equivalent to a legally marketed predicate device by meeting certain performance criteria.

Here's the information derived from the document that is applicable to your request, formatted as closely as possible:

1. Table of Acceptance Criteria and Reported Device Performance

The device was tested against the ASTM F2100 requirements for Level 1 and Level 3 masks.

Acceptance Criteria and Device Performance for Level 1 Masks:

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