Search Results

The Procedure mask/Surgical mask/Face mask is 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, provided non-sterile.

The subject device is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of polypropylene nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The subject device is available in one type, ear loop. The ear loops are made of polyester and spandex. The ear loops model is held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The nose clip is made of Iron and polypropylene. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loop masks are available in two size, 17.5 × 9.5 cm and 14.5 × 9.5 cm. And the colors for the ear loop mask are yellow, blue and white. The ear loop masks are available in level 1, level 2 and level 3 masks based on ASTM F2100-23. This is a single-use, disposable device, provided non-sterile.

The provided document is a 510(k) Clearance Letter for a medical device: Procedure mask/Surgical mask/Face mask. This type of document, specifically the "Summary of Non-Clinical Test" section, details the performance characteristics required for the device to meet regulatory standards.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: The provided document is for a medical mask, not an AI-powered diagnostic device. Therefore, many of the typical questions regarding AI/software performance studies (e.g., sample size for test set, number of experts, adjudication, MRMC studies, training set details, ground truth for AI) are not applicable to this submission. The "study" here refers to physical and biological performance testing of the mask material itself.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are based on established standards like ASTM F2100-23, ASTM F1862/F1862M-24, ASTM F2101-23, EN 14683:2019+AC:2019, 16 CFR Part 1610, and ISO 10993 series. The table below summarizes these criteria and the reported performance:

Table 1: Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) 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 of the wearer to blood and body fluids. Fluidshield* 3 Surgical Masks(s) and Fluidshield* 3 Procedure Face Mask(s) are single use, disposable device(s), provided non-sterile.

The subject device(s) are ASTM F2100 Level 3 (orange in color) Surgical and Procedure Mask(s). The Fluidshield* 3 Surgical Mask(s)s and Fluidshield* 3 Procedure Masks family of products are a four-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Masks are provided with earloops. A malleable nosepiece is placed within the bindings to conform around the wearer's nose. The Fluidshield* 3 Surgical Mask(s)s and Fluidshield* 3 Procedure Mask(s) family will be provided in designs with and without a protective visor. The Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) family are single use, disposable devices, provided non-sterile.

This document describes the FDA 510(k) clearance for several Fluidshield® 3 Surgical and Procedure Masks. However, it does not contain the level of detail regarding study design, sample sizes, ground truth establishment, or expert qualifications that would be present in a comprehensive study report for an AI/software device. The information provided is typical for a medical device clearance describing performance characteristics and compliance with standards, not for an AI comparative effectiveness or standalone study.

Based on the provided text, here's what can be extracted and what cannot:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

Aurelia Surgical Masks ASTM Level-3 (2130) is intended for use to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device and provided non-sterile

The Aurelia Surgical Masks ASTM Level 3 are constructed with three layers of nonwoven polypropylene. The direct body contact materials include polypropylene, polyurethane, and nylon. The indirect body contacting materials include polypropylene and aluminum wire coated with melt-blown polypropylene embedded within the three layers.

The provided text is a 510(k) summary for the Aurelia Surgical Mask ASTM Level-3 (2130). It details the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device, rather than a study proving a device meets AI/ML acceptance criteria.

Therefore, many of the requested data points (like sample size for test/training sets in an AI/ML context, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training) are not applicable to this document. This document describes the testing of a physical medical device (a surgical mask) against established performance standards for such devices.

Here's a breakdown based on the provided text, focusing on the relevant information:

Acceptance Criteria and Device Performance for Aurelia Surgical Mask ASTM Level-3 (2130)

This section describes the performance testing of a physical product (surgical mask) against established standards.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The ProGear® Surgical Mask with Oxafence® is a single-use, disposable device used to cover the nose and mouth of the wearer to protect from transfer of microorganisms, body fluids and particulates. The outer layer of the face mask is coated with methylene blue (0.47 micrograms per square cm area).

The ProGear® Surgical Mask with Oxafence® inactivates of the following test viruses after five minutes of contact with the treated surface of the face mask in laboratory (in vitro) tests under a lighting intensity of 500 ± 25 lux.

Influenza A/PR/8/34/H1N1 (TC adapted, ATCC VR-1469), 3-log or 99.9% inactivation Betacoronavirus 1 OC43 (ATCC VR-1558), 4-log or 99.99% inactivation Feline Calicivirus F-9 (ATCC VR- 782), 4-log or 99.99% inactivation

Antiviral efficacy on other viruses has not been evaluated. Correlations between in vitro testing results and any clinical event have not been evaluated.

The ProGear® Surgical Mask with Oxafence® is a single-use, disposable device used to cover the nose and mouth of the wearer to protect from transfer of microorganisms, body fluids and particulates. The outer layer of the face mask is coated with methylene blue (0.47 micrograms per square cm area).

This document is a letter from the FDA regarding the clearance of a surgical mask, not a study report for an AI/ML device. Therefore, it does not contain information about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement in the context of an AI/ML device.

The provided text describes the "Indications for Use" for the ProGear® Surgical Mask with Oxafence®, Model AV82030, and lists the antiviral efficacy against specific viruses in laboratory (in vitro) tests. This information pertains to the performance of the physical device as a surgical mask, not a software or AI/ML product.

Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI/ML device from this document.

Ask a specific question about this device

PRIMED Surgical Masks and PRIMED Procedure Masks are single use, non-sterile products intended to be worn by operating room and health care personnel in health care setting and during surgical procedures to protect both the patient and the operating room personnel from transfer of microorganisms, body fluids and particulate materials.

PRIMED Surgical masks and PRIMED Procedure masks are single use, non-sterile masks composed of a melt-blown filter layer placed between layers of non-woven inner and SS outer layer(s) material. PRIMED Medical Products Inc. offers various models in two main categories: Procedure masks with ear loops and Surgical masks with head ties. The level of protection varies based on the basis weight of the inner layer and the number of outer layers used in the mask's construction, in accordance with ASTM F2100:2023 specifications.

The provided text is an FDA 510(k) summary for PRIMED Surgical Masks and PRIMED Procedure Masks. It describes the acceptance criteria and the study that proves the device meets those criteria. However, it does not include information about a complex AI-driven medical device, a multi-reader multi-case (MRMC) study, or detailed information about ground truth establishment by experts as would be relevant for an AI/CADe system.

Therefore, the following response will be tailored to the information available in the provided document, which pertains to a physical medical device (surgical masks) and its performance against established standards, rather than an AI/software device.

Here's the information as extracted and interpreted from the document:

Acceptance Criteria and Device Performance for PRIMED Surgical Masks and PRIMED Procedure Masks

The device under review is PRIMED Surgical Masks and PRIMED Procedure Masks. The performance of these masks is evaluated against established physical and biocompatibility standards rather than a typical AI/CADe performance criteria.

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are derived from ASTM F2100-23 standards for medical face masks and other relevant ISO and CFR standards for biocompatibility and flammability.

Ask a specific question about this device

Ask a specific question about this device

The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) 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 of the wearer to blood and body fluids. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) are single use, disposable device(s), provided non-sterile.

The subject device(s) are ASTM F2100 Level 1 (white in color) Procedure and Surgical Mask(s). The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Mask(s) are provided with earloops. A malleable nosepiece is placed within the bindings. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family will be provided in designs with and without a protective visor. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family are single use, disposable devices, provided non-sterile.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Ask a specific question about this device

Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) 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 of the wearer to blood and body fluids. The Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) are single use, disposable device(s), provided non-sterile.

The subject device(s) are ASTM Level 1 (blue in color) Surgical and Procedure Mask(s). The Fluidshield* 1 Procedure Mask and the Fluidshield* 1 Surgical Mask are a three-layer mask, constructed of non-woven materials. The Surgical Masks (28802) are provided with ties while the Procedure Masks (25869) are provided with earloops. A malleable nosepiece is placed within the bindings to conform with the wearer's nose. The Fluidshield* 1 Procedure Mask and the Fluidshield* 1 Surgical Mask are single use, disposable devices, provided non-sterile.

The provided document is a 510(k) Premarket Notification for a medical device (surgical masks), not for an AI/software device. Therefore, the information requested regarding acceptance criteria, study design, ground truth establishment, and expert involvement for a software/AI device is not applicable and cannot be extracted from this document.

The document describes the non-clinical performance testing for surgical masks, which focuses on physical and biological properties rather than AI algorithm performance.

Here's an analysis of the provided information, specifically addressing the non-AI device context:

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 specify the exact sample sizes used for each of these non-clinical performance tests. These are standard laboratory tests typically performed on a statistically relevant number of samples to ensure representativeness. The provenance (country of origin, retrospective/prospective) is not detailed for these laboratory tests.

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 is not applicable to the performance testing of surgical masks. Ground truth, in the context of material and product performance, is established by adherence to standardized testing protocols (e.g., ASTM, ISO, EN) and validated laboratory methods, not by expert consensus or interpretations of complex data like medical images.

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

Not applicable. These are objective, quantitative laboratory tests with defined pass/fail criteria, not subjective assessments requiring expert adjudication.

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:

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an AI-assisted device.

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

The "ground truth" for these tests is the objective measurement against established performance standards (e.g., specific filtration percentages, pressure differentials, flame spread classes), as defined by the international standards mentioned (ASTM, EN, ISO, CFR).

8. The sample size for the training set:

Not applicable. There is no training set for a non-AI medical device like a surgical mask.

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

Not applicable. There is no training set for a non-AI medical device.

Ask a specific question about this device

The Fluidshield* 2 Surgical Mask is 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 of the wearer to blood and body fluids. The Fluidshield* 2 Surgical Mask is a single use, disposable device, provided non-sterile.

The Fluidshield* 2 Procedure Mask is 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 of the wearer to blood and body fluids. The Fluidshield* 2 Procedure Mask is a single use, disposable device, provided non-sterile.

The subject device(s) are ASTM Level 2 Surgical and Procedure Mask(s). Fluidshield* 2 Surgical Mask(s), Fluidshield* 2 Procedure Mask(s) family of products are a four-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Masks are provided with earloops and a malleable nosepiece.

The Fluidshield* 2 Surgical Mask(s), Fluidshield* 2 Procedure Mask(s) family will be provided in designs with and without a protective visor. The Fluidshield* 2 Surgical Mask(s), Fluidshield* 2 Procedure Mask(s) family are single use, disposable devices, provided non-sterile.

The provided document is a 510(k) Premarket Notification for medical devices, specifically surgical and procedure masks. It describes non-clinical performance testing to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria derived from clinical performance. Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable or cannot be extracted from this document as it pertains to a different type of evaluation.

However, I can extract information related to the acceptance criteria and reported device performance from the non-clinical testing section.

1. Table of acceptance criteria and the reported device performance:

Ask a specific question about this device

HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) is 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 of the wearer to blood and body fluids. The HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) is a single use, disposable device, provided non-sterile.

The subject device is an ASTM F2100 Level 1 (green in color) Surgical Mask. The ASTM F2100 Level 1 Surgical Mask family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties and a malleable nosepiece. The HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) is provided with fog-free foam. These masks are single use, disposable devices, provided non-sterile.

This information describes the performance testing for a medical device (a surgical mask), not an AI/ML device. Therefore, many of the requested criteria regarding AI/ML studies are not applicable.

Here's the breakdown of the provided information:

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

Ask a specific question about this device