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Sovereign America Surgical Mask is intended for use by adult patients and healthcare personnel to protect against the transfer of microorganisms, bodily 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 Sovereign America Surgical Mask, Models 2000SM2 and 2000SM3, is a single use, three-layer, flat-pleated surgical mask with ear loops and a nose piece. Each device is composed of three layers of nonwoven polypropylene, with the outer layer (Layer 1) and inner layer (Layer 3) being spun-bond nonwoven polypropylene, and the middle layer (Layer 2) being melt-blown nonwoven polypropylene. Layer 1 contains a blue pigment. Each device utilizes two elastic ear loops, ultrasonically welded to the mask, to hold the device in place over the users' mouth and nose. The ear loops are polyester spandex elastic, and not made with natural rubber latex. Each device also utilizes a malleable nose piece, made of polypropylene coated aluminum wire, to allow the user to fit the device around the bridge of the nose. Each is provided non-sterile and intended to be a single use, disposable device.

This document is a 510(k) Pre-Market Notification for a surgical mask, not an AI/ML device, so many of the requested categories (e.g., training set, expert adjudication, MRMC study, standalone performance) are not applicable.

Here's the information based on the provided text, focusing on the acceptance criteria and performance of the Sovereign America Surgical Mask (Models 2000SM2 and 2000SM3):

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

The device performance is compared against ASTM F2100-19 standards for Level 2 and Level 3 surgical masks, and against the predicate device (K160269).

Model 2000SM2 (Level 2 Performance)

Model 2000SM3 (Level 3 Performance)

Biocompatibility Testing (Both Models)

2. Sample size used for the test set and the data provenance:

• Fluid Resistance (ASTM F1862):
  • Model 2000SM2: "32/32 passed" (implies a sample size of 32 surgical masks for this test).
  • Model 2000SM3: "31/32 passed" (implies a sample size of 32 surgical masks for this test).
• For other performance tests (Bacterial Filtration Efficiency, Particulate Filtration Efficiency, Differential Pressure, Flammability, and Biocompatibility), specific sample sizes are not explicitly stated in the document, beyond the implication that testing was conducted on samples of the device.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It refers to "Non-Clinical Testing" which implies laboratory testing of the physical products.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is a physical medical device (surgical mask) that undergoes laboratory performance testing against recognized consensus standards (e.g., ASTM F2100, ISO 10993), not a diagnostic algorithm requiring expert "ground truth" establishment in the traditional sense.

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

Not applicable. This is not an AI/ML device or a diagnostic requiring adjudication of human reader interpretations. Performance is measured directly from laboratory tests.

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 a surgical mask, not an AI diagnostic tool.

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

Not applicable. This is a surgical mask, not an algorithm.

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

The "ground truth" for the device's performance is defined by the recognized consensus standards themselves (e.g., ASTM F2100, ASTM F1862, ASTM F2101, ASTM F2299, EN 14683/MIL-M-36954C, 16 CFR 1610, ISO 10993 series). The device's physical properties and performance characteristics are directly measured and compared against these predefined numerical and qualitative criteria.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is a physical medical device, not an AI/ML model.

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

Not applicable.

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Sovereign America Surgical Mask is intended for use by healthcare personnel to protect both patients and healthcare personnel against the transfer of microorganisms, bodily fluids and particulate material. This is a single use, disposable device, provided non-sterile.

The Sovereign America Surgical Mask is a single use, three-layer, flatpleated surgical mask with ear loops and a nose piece. The device is composed of three layers of nonwoven polypropylene, with the outer layer (Layer 1) and inner layer (Layer 3) being spun-bond nonwoven polypropylene, and the middle layer (Layer 2) being melt-blown nonwoven polypropylene. Layer 1 contains a blue pigment. The device utilizes two elastic ear loops, ultrasonically welded to the mask, to hold the device in place over the users' mouth and nose. The ear loops are polyester spandex elastic, and not made with natural rubber latex. The device also utilizes a malleable nose piece, made of polypropylene coated aluminum wire, to allow the user to fit the device around the bridge of the nose. The mask is provided non-sterile and intended to be a single use, disposable device.

Here's a breakdown of the acceptance criteria and the study information for the Sovereign America Surgical Mask (K201095), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document describes non-clinical testing in conformity with recognized consensus standards. It does not specify sample sizes for each individual test conducted on the Sovereign America Surgical Mask. The results presented (e.g., "29 out of 32 passed") indicate the sample size for the fluid resistance test was 32. For the other tests, while a range is given for some (e.g., "99.1 - 99.8%"), the exact number of samples tested to achieve these ranges is not explicitly stated.

The data provenance is based on laboratory testing of the device itself; thus, it is prospective in the sense that the testing was performed on the manufactured device. There is no information regarding the country of origin of the data beyond the standards themselves being international (e.g., ASTM, ISO, EN, CFR) and the submission being to the U.S. FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This information is not applicable to this type of device and study. The "ground truth" for surgical mask performance is established by the specified measurable parameters and pass/fail criteria outlined in the referenced consensus standards (e.g., ASTM F2100, ASTM F1862, ISO 10993). These are objective, quantifiable measurements performed according to standardized protocols, not subjective expert assessment.

4. Adjudication Method for the Test Set:

This is not applicable. As the testing involves objective measurements against established standards, there is no need for expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI or diagnostic imaging devices where human readers assess cases. For a surgical mask, the effectiveness is determined by its physical performance characteristics.

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

This question is not applicable to a surgical mask. It's a physical device, not an algorithm or AI system. The performance evaluated is the inherent physical properties of the mask.

7. The Type of Ground Truth Used:

The ground truth used for this study is based on objective, measurable criteria defined by recognized consensus standards. These standards set specific thresholds for fluid resistance, filtration efficiency, differential pressure, flammability, and biocompatibility. The mask's performance is then directly compared against these predefined numerical and qualitative thresholds.

8. The Sample Size for the Training Set:

This question is not applicable. This is a physical device, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

This question is not applicable as there is no training set for a physical surgical mask.

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