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The surgical face 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 potential exposure to blood and body fluids. this is a single-use, disposable device, provided non-sterile. This mask is safe for use in the MR environment.

The Surgical Face Masks (Ear Loops and Tie-On) are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane) or ties (polyester/polypropylene). A malleable nosepiece is placed within the binding for comfort and individualized fit. The surgical face masks will be provided in white and blue, and options for added cup keeper (polypropylene), visor (polyester), or both. The surgical face masks are single-use, disposable devices, provided non-sterile. This mask is safe for use in the MR environment.

This document is a 510(k) Premarket Notification from the FDA regarding "Surgical Face Masks (Ear Loops And Tie-On)" manufactured by SAN-M PACKAGE CO., LTD. It focuses on demonstrating substantial equivalence to a predicate device (K160269) by the same manufacturer.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the subject device are based on demonstrating substantial equivalence to the predicate device (K160269), which itself would have met specific performance standards. The performance tests are based on ASTM F2100-11 standards for medical face masks.

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The surgical face 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 intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided nonsterile.

The Surgical Face Masks (Ear loops and Tie-on) are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane) or ties (polypropylene/polyester). A malleable nosepiece is placed within the binding for comfort and individualized fit. The surgical face masks will be provided in white or blue and with the option for a visor. The surgical face masks are single-use, disposable devices, provided non-sterile.

The provided document describes the acceptance criteria and performance of Surgical Face Masks (Ear loops and Tie-on) as part of a 510(k) premarket notification. The study aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove device meets an absolute acceptance criteria.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" but rather "performance requirements" as outlined by recognized standards (ASTM F2100-11 for various levels) and then reports the device's performance against these requirements. It also compares the proposed device's performance to predicate devices.

Acceptance Criteria (Performance Requirements from ASTM F2100-11) and Reported Device Performance

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The N95 Particulate Respirator and Surgical Mask, Models TN01-12 are single-use, disposable devices, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

The N95 Particulate Respirator and Surgical Mask, Models #TN01-11 and #TN01-12 are NIOSH certified (TC 84A-3348), pouchedshaped respirators when worn. The flat-folded masks are composed of four layers of materials consisting of polypropylene and polyethylene (inner layer), polypropylene meltblown (two filter layers), and polypropylene spunbond (outer layer). The masks contain a conformable nose clamp enclosed in a binding tape welding the top edge to conform to the contours of the face. In addition, the masks contain an ultrasonically welded, polyurethane elastic headband not made with natural rubber latex, to secure the masks in place on the wearer. The masks are offered in orange or white.

The provided document describes the acceptance criteria and performance of the N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12, in comparison to a predicate device.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes used for each performance test (e.g., number of masks tested for fluid resistance or flammability). It simply states that the models meet the requirements of the standards. The provenance of the data is not specified beyond indicating it was a submission to the FDA. The tests are described as performance testing and non-clinical tests, which are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable to the type of device and testing described. The "ground truth" for N95 masks is established through standardized laboratory performance tests according to recognized standards (e.g., ASTM, NIOSH, ISO) and not through expert consensus or interpretation of medical images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like 2+1 are typically used in studies where human readers interpret medical data (e.g., radiology studies) and their findings need to be reconciled. For performance testing of a physical device like an N95 mask, objective laboratory measurements are taken against predefined criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a physical N95 mask, not an AI-powered diagnostic tool. Therefore, MRMC studies and "human readers improving with AI" are irrelevant to this document.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. The device is a physical N95 mask; there is no algorithm or AI component involved. The testing described is for the physical performance of the mask.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance of the N95 mask is based on objective measurements against established performance standards set by regulatory bodies and testing organizations. These include:

• ASTM F1862 for Fluid Resistance
• NIOSH Certification (TC 84A-3348) for Particulate Filtration Efficiency, Bacterial Filtration Efficiency, and Differential Pressure
• 16 CFR 1610 for Flammability
• ISO 10993 series for Biocompatibility (cytotoxicity, irritation, sensitization)

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of performance testing for a physical medical device like an N95 mask. Training sets are relevant for machine learning or AI models.

9. How the ground truth for the training set was established

This information is not applicable, as there is no training set for this type of device and study.

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