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This product is intended for use in infection control practices to minimize contamination caused by exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.

The Fluid Resistant Masks are constructed of a light weight spunbonded polyolefin or cellulosic outer facing, a meltblown polyolefin filter media, and a light weight spunbonded polyolefin or cellulosic inner facing. The three layers of the mask body are collated and sonically welded around the edges to enclose the filter media. The bodies have either light weight polyolefin or cellulosic nonwoven material sonically welded or otherwise attached to both sides of the body (ties on the surgeons tie masks) or polyolefin/elastic earloops sonically welded or otherwise attached to both sides of the body. The masks have a malleable aluminum wire encapsulated in the facing to form the mask to fit the nose.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them, structured to address your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are in comparison to predicate devices, rather than explicit numerical thresholds. The study demonstrates performance comparable to or better than these predicates.

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

• Sample Size: The document does not explicitly state the numerical sample size (e.g., number of masks tested) for each experiment (Water Resistance, Differential Pressure, Latex Particle Challenge). It only reports averages.
• Data Provenance: The studies were performed by Nelson Laboratories, a third-party testing facility. The data provenance (country of origin, retrospective/prospective) is not specified beyond this. Given the context of a 510(k) submission, these would be prospective tests conducted specifically for the submission.

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

Not applicable. This device is a physical product (fluid-resistant mask) and its performance is evaluated through objective laboratory tests against established standards or predicate devices, not by expert interpretation or consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests are objective laboratory measurements, not subjective evaluations requiring 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 document describes a physical medical device (fluid-resistant mask), not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies and AI-related effectiveness are irrelevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or software device. The "standalone" performance refers to the mask's inherent physical properties.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through standardized laboratory testing procedures and comparison to the performance of legally marketed predicate devices.

• Water Resistance: Measured by the percent increase in blotter weight after water impact.
• Differential Pressure: Measured as the air exchange differential (Delta P).
• Latex Particle Challenge: Measured by the filtration efficiency for specific particle sizes.

The predicate devices (Tecnol Fluid Resistant Surgical Mask K874608 and 3M Fluid Resistant Mask K910110) serve as the benchmark for "truth" in terms of acceptable market performance. The text also mentions that the masks filter "at an average efficiency of greater than 95% when tested at both 1.0 micron and 0.1 micron particle sizes," implying this is a general performance claim for such masks, which the new device meets or exceeds.

8. The Sample Size for the Training Set

Not applicable. There is no machine learning or AI algorithm involved, so there is no training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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This product is intended for use in infection control practices to minimize contamination caused by exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.

The Fluid Resistant Eyeshield Masks are constructed of a light weight spunbonded polyolefin or cellulosic outer facing, a meltblown polyolefin filter media, and a light weight spunbonded polyolefin or cellulosic inner facing. The three layers of the mask body are collated and sonically welded around the edges to enclose the filter media. The bodies have either light weight polyolefin or cellulosic nonwoven material sonically welded or otherwise attached to both sides of the body (ties on the surgeons tie masks) or polyolefin/elastic earloops sonically welded or otherwise attached to both sides of the body. The masks have a malleable aluminum wire encapsulated in the facing to form the mask to fit the nose. An optical quality eyeshield is attached to the mask by ultrasonic welding.

This 510(k) summary describes a Fluid Resistant Eyeshield Mask and its equivalence to existing predicate devices. The "acceptance criteria" here refers to the performance standards that demonstrate the new device is as safe and effective as the predicate devices. The "study" refers to the testing conducted to show this equivalence.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to predicate devices and the performance of those devices. The document does not explicitly state numerical "acceptance criteria" but rather presents test results for both the new device and a predicate device (Tecnol Fluid Resistant Mask) to show similar or better performance. The 3M predicate device is only listed, not elaborated on in the test results.

• 1.0 micron: 99.3%
• 0.1 micron: 98.4%
  Cellulosic Inner Facing:
• 1.0 micron: 99.2%
• 0.1 micron: 99.2% |

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

The document does not explicitly state the sample size used for each specific test (e.g., how many masks were tested for water resistance, differential pressure, or particle challenge).

The data provenance is from Nelson Laboratories SOPs, which suggests these were laboratory-based tests. There is no information provided about the country of origin of the data or whether it was retrospective or prospective in the context of clinical use. These are material science tests, not clinical studies.

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

N/A. This is a medical device focused on material properties and physical performance, not diagnostic accuracy where expert ground truth establishment is typically required. The "ground truth" for these tests comes from standardized laboratory procedures and instrument readings.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments. These tests are objective, quantitative laboratory measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an imaging or diagnostic device that would typically involve a multi-reader multi-case study. The evaluation focuses on the physical performance of the mask.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This is not an algorithm or AI-driven device.

7. The Type of Ground Truth Used

The "ground truth" for these tests is the quantitative measurement obtained through standardized laboratory procedures:

• Water Resistance: Measured by the percentage increase in blotter weight after water exposure.
• Differential Pressure: Measured pressure drop across the material.
• Latex Particle Challenge: Measured filtration efficiency of particles at specified micron sizes.

8. The Sample Size for the Training Set

N/A. There is no "training set" in the context of material performance testing for this type of device.

9. How the Ground Truth for the Training Set Was Established

N/A. No training set is applicable.

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