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510(k) Data Aggregation
(133 days)
The Nordiwell Medical Face Mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate matters. 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(s) and provided non-sterile.
The Nordiwell Medical Face Mask has a flat-folded design consisting of three layers that are comprised of an (polypropylene spunbond) inner and outer cover web and (polypropylene melt blown) filter web. The mask has earloops or tie strings to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. This is a single use, disposable device, provided non-sterile.
This document is a 510(k) Premarket Notification for a medical face mask. It does not describe an AI/ML powered medical device, but rather a physical product. Therefore, many of the requested criteria regarding AI/ML model evaluation (e.g., training set, ground truth acquisition, MRMC studies, standalone performance with human-in-the-loop, number of experts for ground truth) are not applicable.
However, I can extract the acceptance criteria and performance data for this physical medical device from the provided text.
Here's the information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test Item | Acceptance Criteria | Reported Device Performance | Study Conclusion |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862-17) | ≥ 29 of 32 pass at 120 mmHg | 31 of 32 pass at 120 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299-17) | ≥ 98% | 99.9%, 32 of 32 pass | Pass |
| Bacterial Filtration Efficiency (ASTM F2101-19) | ≥ 98% | 99.9%, 32 of 32 pass | Pass |
| Differential Pressure (Delta P) (EN 14683:2019, Annex C and ASTM F2100-19) |
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(46 days)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only.
The Nordiwell Surgical Face Masks are composed of 3-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), inner layer (polypropylene spunbond white), filter (polypropylene melt-blown, white) and ties (polypropylene spunbond white). The mask contains a malleable nosepiece which is centrally positioned between the opposed side edges along the top edge of the mask. The nosepiece is a stable anchor in the vicinity of the nose and readily bent to conform to contours of a person's face. Thus the nosepiece can provide a firm fit over the nose and then to secure the mask over the users' mouth and face. The mask is a single use, provided non-sterile. This device is not made with natural rubber latex and Shelf-life of the device is 2 years. The subject of this submission is a design change to the ear-loop in the Nordiwell Medical Face Mask(K202615). The ear-loop of the Nordiwell Medical Face Mask(K202615) is changed to tie in the subject device.
This document describes the acceptance criteria and supporting study for the Nordiwell Surgical Face Mask (K210181), which is a surgical face mask.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the ASTM F2100 Level 3 standard for surgical face masks.
| Performance Characteristic | Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance |
|---|---|---|
| Fluid Resistance | 160 mmHg | 32 of 32 pass at 160 mmHg |
| Particulate Filtration Efficiency (PFE) | ≥ 98% at 0.1 micron | > 99.9% |
| Bacterial Filtration Efficiency (BFE) | ≥ 98% | ≥ 98% |
| Differential Pressure (Delta P) | ** |
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(113 days)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only.
The Nordiwell Medical Face Masks are composed of 3-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), inner layer (polypropylene spunbond white), filter (polypropylene melt-blown, white) and ear-loops. The mask contains a malleable nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face. The mask is a single use, provided non-sterile. This device is not made from Natural Rubber Latex. Shelf-life of the device is 2 years.
The provided text describes the acceptance criteria and the study conducted for the Nordiwell Medical Face Mask (K202615) to demonstrate substantial equivalence to a predicate device. This is a medical device, specifically a surgical face mask, not an AI/ML powered device. Therefore, many of the requested categories in the prompt, such as those related to AI model performance, expert ground truth, adjudication methods, and training/test sets for AI, are not applicable.
Here's the information that can be extracted from the provided text, focused on the device's physical and performance characteristics:
1. Table of Acceptance Criteria and Reported Device Performance
Device: Nordiwell Medical Face Mask (K202615)
| Item | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862-17) | ≥29 of 32 pass at 160 mmHg | 32 of 32 pass at 160 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299-17) | ≥ 98% | > 99.9% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101-19) | ≥ 98% | > 99.9% | Pass |
| Differential Pressure (Delta P) (EN 14683:2019, Annex C and ASTM F2100-19) |
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