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This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.

Surgical Face Mask ear loop yellow, Surgical Face Mask ear loop blue, Surgical Face Mask tie-on yellow, and Surgical Face Mask tie-on blue

Here's a breakdown of the acceptance criteria and study information for the Epard Protective Products Surgical Face Mask, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on the Table:

• "N/A (implied)": The document states "Equivalence is demonstrated through intended use, materials, design and testing methods" and "no significant differences between the application device and the predicate." For performance characteristics where the predicate result is given as the "Acceptance Criteria or Results" for the new device, this implies the new device met or exceeded these values. The document doesn't explicitly list the new device's numerical performance for each criterion but rather indicates it passed against the established criteria, which are the predicate's results for some metrics.
• "Passed": For Fluid Resistance, the predicate's result was "No visual detection of penetration," and this was also the acceptance criteria for the new device, which it passed.

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

The provided 510(k) summary does not specify the sample size used for the test set for any of the performance characteristics.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are standard ASTM and military specifications, implying laboratory testing. The submission is from Epard Protective Products, Ltd. in Hubei, China, so the testing was likely conducted by or contracted by this manufacturer, possibly in China or a certified testing facility elsewhere. The nature of the performance tests suggests individual product testing, rather than human data that would be classified as retrospective or prospective clinical data.

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

Given the nature of the device (surgical face mask) and the performance criteria (fluid resistance, filtration efficiency, differential pressure, flammability), the "ground truth" is established through objective laboratory testing according to standardized protocols (ASTM, Mil-Spec, CFR).

Therefore, no human experts were used to establish ground truth in the way one might for diagnostic imaging interpretation. The "ground truth" is the result derived from the physical testing methods themselves.

4. Adjudication Method for the Test Set

As the "ground truth" is established through objective, standardized physical testing rather than human interpretation, no adjudication method (like 2+1 or 3+1 consensus) was applicable or used. The test results are quantitative or qualitative (e.g., "no visual detection") outcomes of the laboratory procedures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study was mentioned or conducted. This type of study is typically relevant for diagnostic or interpretive devices (e.g., AI in radiology) where human readers are involved in assessing cases. Surgical face masks are passive protective equipment, and their performance is evaluated through material science and physical property testing, not through human reader interpretation of cases.

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

This question is not applicable to a surgical face mask. Standalone performance studies refer to the performance of an algorithm or AI without human involvement, common in AI-powered diagnostic tools. A surgical face mask is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device is based on objective measurements and observations derived from standardized laboratory performance tests. These are:

• Quantitative measurements: Percentage for filtration efficiency, mm H2O/cm2 for differential pressure.
• Qualitative observation: "No visual penetration" for fluid resistance.
• Classification: "Flammability Class."

This is akin to laboratory/physical property ground truth.

8. The Sample Size for the Training Set

This question is not applicable. This device is a physical product, not an AI or machine learning model that requires a "training set." The testing described evaluates the manufactured product's inherent physical properties against established standards.

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

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

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The following Prestige Ameritech Surgical Masks are single use disposable devices intended to be worn in the operating room as well as dental, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.

Prestige Ameritech Earloop Surgical Mask-Blue, Pink, Green, White, Yellow, Peach Prestige Ameritech Earloop Surgical Mask with splash shield-Blue Green, White, Peach Prestige Ameritech Earloop Surgical Mask Tissue-Blue, Pink, White, Yellow Prestige Ameritech Tie on Surgical Mask-Blue, Pink, Green, White, Peach Prestige Ameritech Tie on Surgical Mask with splash shield-Blue, Green, White, Peach

The Prestige Ameritech Surgical Mask device is composed of three layers of material flat folded and pleated to form the Mask. The inner layer is composed of cellulose or spunbonded polypropylene, the middle layer is a meltblown polypropylene filter material and the outer layer is a medical grade tissue or spunbonded polypropylene. Masks with splash shields have anti-fog plastic shields attached to masks. Masks are held in place on wearer with tie strips or latex free elastic loops and contain a malleable aluminum nosepiece strip. All of the materials used in this device are typical materials commonly used in the construction of Surgical Face Masks and are being used in current legally marketed devices.

The provided 510(k) summary describes the Prestige Ameritech Face Mask, a surgical face mask. The acceptance criteria and device performance are based on bench testing of physical properties rather than clinical studies with human participants. Therefore, several of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set information) are not applicable or cannot be extracted from this document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the results of the predicate devices, as the Prestige Ameritech device aims to demonstrate substantial equivalence by performing similarly or better.

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

• Sample Size: Not specified in the document. These are bench tests, so sample sizes would refer to the number of mask samples tested for each characteristic.
• Data Provenance: The data is generated from laboratory bench testing (non-clinical tests) of the device and predicate devices. No information about the country of origin or whether it's retrospective or prospective is provided, but it's understood to be prospective testing for the submission.

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

Not applicable. The ground truth for these performance characteristics is established through standardized laboratory test methods (e.g., ASTM F1862, ASTM F2299, ASTM F2101, MIL M36954C, 16CFR 1610). Experts are involved in designing and executing these tests, but "ground truth" isn't established through expert consensus in the typical sense for medical imaging or diagnostic devices.

4. Adjudication method for the test set

Not applicable. This is not a study involving human interpretation or subjective assessments that would require 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 a surgical mask, not an AI-powered diagnostic device, so MRMC studies and AI assistance are not relevant.

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

The "ground truth" for the device's performance is objective measurement against established industry standards and test methodologies. For example:

• Fluid Resistance: Visual observation of penetration after exposure to synthetic blood.
• Particulate Filtration Efficiency: Quantitative measurement of particle removal at a specific micron size.
• Bacterial Filtration Efficiency: Quantitative measurement of bacterial removal.
• Differential Pressure: Measurement of airflow resistance.
• Flammability: Classification based on burn rate.

8. The sample size for the training set

Not applicable. This is a physical device, and the submission does not describe a training set in the context of machine learning or AI.

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

Not applicable. No training set is described.

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Surgical Face Mask is Device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.

Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) are flat pleated 3-ply (at least) masks with an inner and outer layer (spunbonded I mk) are nat produce o psy (a a meltblown polypropylene filter material, also with elastic loops and/or strip. The nosepiece for all Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) is malleable aluminum wire. All the materials used in the construction of the Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) are being used in currently marked devices.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document sometimes lists the predicate's performance in the "Acceptance Criteria" column implicitly by comparing the new device's performance to it. For particulate filtration, it seems the predicate's "2.0 microns" is the filtration size it achieves, and the new device achieves a much higher percentage at a smaller particle size (0.1 micron), indicating superior performance.

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

The document does not specify the sample size used for the test set for any of the performance criteria (Fluid Resistance, Particulate Filtration, BFE, Delta-P, Flammability).

The data provenance is not explicitly stated. However, given that Hong Ya Non-Woven Products Co., Ltd. is located in P.R. China and the submission is to the FDA, it's highly probable the testing was conducted retrospectively on samples of the manufactured device. The location where the tests were performed is not mentioned.

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

This information is Not Applicable in this context. The study is a series of non-clinical, laboratory-based performance tests for a surgical mask. Ground truth is established by the standardized methods of the tests themselves, not by expert consensus on clinical data. For example, BFE is measured by a specific laboratory procedure, not by a panel of experts reviewing cases.

4. Adjudication Method for the Test Set

This information is Not Applicable. As with the ground truth, the tests are objective laboratory measurements, not subjective evaluations requiring adjudication among multiple observers.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human interpretation is involved. The listed tests are non-clinical performance evaluations of a physical product.

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

Yes, a standalone performance evaluation was done. All the tests (Fluid Resistance, Particulate Filtration Efficiency, BFE, Delta-P, Flammability) are standalone assessments of the device's physical properties and performance characteristics, without human intervention in the loop for interpreting results.

7. The Type of Ground Truth Used

The ground truth for the device's performance is established by standardized laboratory test methods. The specific standards mentioned include:

• Fluid Resistance: ASTM F1862-05 (Synthetic Blood Penetration Resistance Test)
• Bacterial Filtration Efficiency (BFE): ASTM F2101-01
• Particulate Filtration Efficiency: ASTM F1215 (Latex Particle Challenge)
• Differential Pressure (Delta-P): MIL M 36954 C
• Flammability: 16CFR 1610
• Biocompatibility: ISO 10993

8. The Sample Size for the Training Set

This information is Not Applicable. Surgical masks are not typically "trained" in the sense of machine learning algorithms. The device's performance is inherent to its design and materials.

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

This information is Not Applicable for the reasons stated in point 8.

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