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510(k) Data Aggregation
(82 days)
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
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM F2101-19 | Bacterial Filtration Efficiency | ≥ 98% | 99% (Pass) |
| ASTM F2299/F2299M-03(2017) | Sub-micron Particulate Filtration Efficiency | ≥ 98% | 99% (Pass) |
| EN 14683:2019, Annex C | Differential Pressure (Breathability) |
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(242 days)
The Aurelia Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Aurelia Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, provided nonsterile.
The proposed device, Aurelia Surgical Masks are three-layer masks constructed of nonwoven polypropylene. The inner and outer layers are made of spun-bonded polypropylene. The middle layer consists of 25gsm melt-blown polypyrene. The mask contains an ear loop to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of polyurethane and nylon. The nose clip which is made of 3mm aluminum flat wire. The disposable surgical face mask is available in two different specifications: ASTM Level 1 and ASTM Level 2. The masks meet the following ASTM 1 and ASTM 2 Technical standards.
The provided document is an FDA 510(k) premarket notification for surgical masks (Aurelia Surgical Mask ASTM Level 1 and Level 2). It focuses on demonstrating substantial equivalence to predicate devices based on performance testing against established ASTM standards for surgical masks.
Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/Software as a Medical Device (SaMD) is not directly applicable to this document. The document describes a physical medical device (surgical masks) and its performance validation, not an AI or software product.
However, I can extract and present the performance criteria and the reported performance for the surgical masks as per the ASTM standards mentioned, which function as acceptance criteria for these physical devices.
1. A table of acceptance criteria and the reported device performance
The document provides the following "Acceptance Criteria per ASTM F2100-19" and "Results" for the Aurelia Surgical Masks:
Table: Acceptance Criteria and Reported Device Performance
| Test | Purpose | Acceptance Criteria per ASTM F2100-19 | Reported Device Performance (Results) |
|---|---|---|---|
| For Level 1 Mask | |||
| Fluid Resistance (ASTM F1862) | This test is performed to evaluate Personal Protective Equipment against fluid penetration. An arterial spray is simulated to test the PPE. | Level 1: 80mmHg | Aurelia Mask Level 1: 80mmHg |
| Differential Pressure (Delta-P) (ASTM F2100-19 EN 14683:2019) | The purpose of this test is to ensure the drop in pressure is not too great so the user may breathe through the subject device. | Level 1: |
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(73 days)
The Kimberly-Clark KC100 Face Mask(s) 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 Kimberly-Clark KC100 face mask(s) is a single use, disposable device(s), provided non-sterile.
The Kimberly-Clark KC100 Procedure Mask(s) is a three layer mask, constructed of nonwoven polyester blends and polypropylene materials. Bindings are nonwoven polyester. The mask is provided with earloops or ties in either knifted polyester/lycra or nonwoven polyester. A malleable nosepiece is placed within the bindings for comfort and individualized fit around the wearer's nose and may or may not contain a fog free strip. Kimberly-Clark KC100 Procedure Mask(s) will be provided in a variety of colors, with and without a protective visor. Kimberly-Clark KC100 Procedure Mask(s) is a single use, disposable device, provided non-sterile.
The acceptance criteria and study proving K110455 device meets those criteria are detailed below, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Standard | Title | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mil-M369454C | Military Specifications: Surgical Mask, disposable 1992 | Not explicitly stated as an acceptance criterion in the provided text, but implies compliance with military specifications for surgical masks. | "All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria." This statement broadly covers compliance with this standard. |
| ASTM F2101-07 | Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol, Staphylococcus Aureus | Not explicitly stated in the provided text, but generally, acceptance criteria for BFE are a minimum percentage (e.g., ≥ 95% or ≥ 98%) depending on the mask type. | "All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria." |
| PSC CS-191-53 | Flammability Test Method (16 CFR 1610) for Flammability of Clothing Textiles | Not explicitly stated in the provided text, but relates to flammability resistance (e.g., Class 1 for fabrics). | "All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria." |
| ASTM F2299 | Standard Test Method for Evaluating the Initial Efficiency of Materials Used in Medical Masks to Penetration of Particulates Using Latex Spheres | Not explicitly stated in the provided text, but generally involves a minimum particle filtration efficiency (e.g., ≥ 95% for 0.1 µm particles). | "All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria." |
| ISO 10993 | Standards for evaluating the biocompatibility of a medical device | Not explicitly stated in the provided text, but implies the device passed various biocompatibility tests (e.g., cytotoxicity, irritation, sensitization). | "All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria." |
| F 1862 | Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood | Not explicitly stated in the provided text, but would typically involve a specific level of resistance to synthetic blood penetration (e.g., passing at a certain pressure). | "All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria." |
Note: While the document states "All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria," the specific quantitative acceptance criteria for each standard are not explicitly detailed in the provided text. These would typically be defined within the test protocols for each standard.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample sizes used for the test set for each of the listed standards. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective). Safety and performance testing of medical devices like masks is typically performed prospectively, but this is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device and testing. The "ground truth" for mask performance testing is established by objective measurements against standardized test methods (e.g., measuring BFE with a particle counter, resistance to blood penetration under specific pressure). It does not involve expert consensus on visual interpretations or diagnoses.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation of mask performance is based on objective, standardized tests, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed as this type of study is relevant for diagnostic imaging AI devices where human readers interpret medical images. This document describes a physical medical device (surgical mask) and its performance based on laboratory testing, not human-AI interaction for interpretation.
6. Standalone Performance Study
This document describes standalone performance testing for the physical device itself (Kimberly-Clark KC100 Face Masks). The tests performed (BFE, particle filtration, flammability, synthetic blood penetration, biocompatibility) are all designed to evaluate the mask's inherent protective properties and material characteristics in a laboratory setting, without human interaction. Therefore, a standalone performance study was done for the device.
7. Type of Ground Truth Used
The ground truth used for these studies is based on objective, quantitative measurements obtained through standardized laboratory test methods (e.g., BFE measured by specific equipment, particle penetration quantified by particle counters, flammability determined by burn rates, synthetic blood penetration by visual inspection at defined pressures, biocompatibility by cellular responses). It is not based on expert consensus, pathology, or outcomes data in the typical sense.
8. Sample Size for the Training Set
This information is not applicable as the device is not an AI algorithm requiring a training set. The performance is assessed through laboratory testing of physical samples.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above; there is no training set for a physical device.
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