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Antibacterial bandages are to be applied to the skin for the management of minor cuts.minor scrapes. This device is only applicable to adults.

The device, Antibacterial bandage, is to be applied topically to the skin for management of minor cuts, minor scrapes. Antibacterial bandage is made of polyethylene tape, absorbent pad and release paper. The absorbent pad contains 95±10 ug/cm2 (0.8% by weight) benzalkonium chloride. Antibacterial bandage is available in different sizes. The antibacterial bandage is EO sterilized and is for single use only.

The provided text describes an antibacterial bandage, not an AI device. Therefore, it does not contain information about acceptance criteria or studies related to AI device performance. The document focuses on regulatory approval (510(k)) for the antibacterial bandage based on substantial equivalence to a predicate device.

The document discusses the following for the Antibacterial bandage:

• Acceptance Criteria (as demonstrated by testing):

  • Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic Toxicity, Material-mediated Pyrogenicity, Endotoxin testing)
  • Sterilization (EO sterilization, complying with ISO 11135:2014)
  • Shelf Life (Accelerated Aging per ASTM F1980-16, Real-time ageing study)
  • Storage and Transport (ASTM 4169-16)
  • Antibacterial Finishes (AATCC 100: 2019)
  • Wound Healing Performance (comparable to predicate device in porcine study)

• Study Proving Acceptance Criteria:

  • Non-clinical tests: Conducted to verify the proposed device met design specifications and was safe and effective.
    • Biocompatibility tests
    • Sterilization testing
    • Shelf life testing (accelerated aging and real-time ageing)
    • Storage and transport testing
    • AATCC 100: 2019 for antibacterial finishes.
  • Animal studies: A porcine wound healing study was carried out to evaluate the cytotoxicity and wound healing performance, demonstrating no significant difference from the predicate device.

The document explicitly states: "No clinical study is included in this submission."

Therefore, I cannot provide the requested information regarding AI device acceptance criteria, performance tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI device, as this information is not present in the provided text.

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Allmed Surgical Face Masks(Ear Loops) are intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The surgical face mask is a single use, disposable device provided non-sterile.

Allmed surgical face masks (ear loops) are composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), filter layer (polypropylene meltblown, white), and inner layer (polypropylene spunbond, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical face mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical face mask is a single use, disposable device, provided non-sterile.

The document describes the acceptance criteria and performance of the Allmed Surgical Face Masks (Ear Loops) as per their 510(k) summary. This is not a study of an AI-powered device, but rather a regulatory submission for a medical device (surgical face mask). Therefore, information related to AI-specific studies, such as multi-reader multi-case studies, standalone algorithm performance, number of experts for ground truth, or training set details, is not applicable or present in this document.

Here's the information available:

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

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

The document does not specify the exact sample sizes used for each performance test (e.g., number of masks tested for BFE, PFE, etc.). It mentions AQL (Acceptable Quality Level) values for some tests, which implies a sampling plan was used, but the specific sample size "n" is not provided. The data provenance is presumed to be from testing conducted by or for Allmed Medical Products Co., LTD, based in China (No.180, GongYuan Road, Majiadian Town, Zhijiang City, Hubei Province), as they are the submitter of the 510(k). The tests appear to be a prospective evaluation of the manufactured device.

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 medical device (surgical face mask) performance evaluation against established ISO/ASTM standards, not an AI or diagnostic imaging device requiring expert ground truth for interpretation.

4. Adjudication method for the test set:

Not applicable. Device performance is determined by passing predefined thresholds in standardized laboratory tests, not by expert 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 not an AI-assisted device.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

The "ground truth" for the performance criteria is based on established international standards (ASTM, EN, ISO, CFR) for surgical face masks. These standards define the acceptable physical and biological properties for the device to perform its intended function.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

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The Surgical Masks are 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. This is a single use, disposable device(s), provided non-sterile.

The Surgical Masks are blue color, single use, three-layer, flat -folded masks with nose clip and ear loops. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of polypropylene spunbonded nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of iron strip wrapped by plastic. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.

The provided document describes the acceptance criteria and study results for the Allmed Medical Products Co., Ltd. Surgical Mask.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Fluid Resistance (ASTM F1862): 3 lots were tested, and a total of 32 samples per lot were assessed (implied by "32 out of 32 pass"). The provenance of this data is not specified (e.g., country of origin, retrospective/prospective).
• Other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility): The document does not explicitly state the sample sizes used for these tests. The provenance of this data is not specified (e.g., country of origin, retrospective/prospective).

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

• Not applicable. The tests performed are non-clinical, laboratory-based performance tests for a surgical mask, not a diagnostic device requiring expert interpretation of results to establish ground truth.

4. Adjudication method for the test set:

• Not applicable. The tests performed are objective, quantitative laboratory measurements, not subjective human-interpreted data 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 is a non-clinical device (surgical mask), and no AI assistance or human reader studies were conducted.

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

• Not applicable. This is a non-clinical device (surgical mask), and no algorithm performance was assessed.

7. The type of ground truth used:

• For the non-clinical performance tests (Fluid Resistance, Filtration Efficiencies, Differential Pressure, Flammability), the "ground truth" is established by industry standards and regulatory requirements (e.g., ASTM, EN, CFR standards). The device's performance is measured against the specifications outlined in these standards.
• For biocompatibility tests (Cytotoxicity, Irritation, Sensitization), the "ground truth" is established by a scientifically validated methodology (ISO 10993 standards) to determine the biological response of the device material.

8. The sample size for the training set:

• Not applicable. This is a non-clinical device (surgical mask) and does not involve machine learning algorithms requiring a training set.

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

• Not applicable for the same reason as point 8.

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The Surgical Masks are 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 to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Surgical Masks are blue color, single use, three-layer, flat -folded masks with nose clip and ear loops. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of polypropylene spunbonded nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of iron strip wrapped by plastic. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.

This document describes the non-clinical testing performed to demonstrate that the Allmed Medical Products Co., Ltd. Surgical Mask is substantially equivalent to a predicate device (K153496). The acceptance criteria and performance data are based on standard test methods for surgical masks.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The term "Similar" in the "Result" column implies that the proposed device met or exceeded the performance of the predicate device and the specified acceptance criteria.

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

• Fluid Resistance (ASTM F1862): 3 lots were tested, with each lot likely consisting of 32 samples (as the criteria specifies "29 out of 32 pass"). Data provenance is not explicitly stated but implied to be from laboratory testing performed by or for the manufacturer.
• Particulate Filtration Efficiency (ASTM F2299), Bacterial Filtration Efficiency (ASTM F2101), Differential Pressure (EN 14683 Annex C): The report indicates performance from multiple tests (e.g., three percentages for PFE/BFE, three pressure values for Delta P), suggesting at least 3 samples were tested for each.
• Flammability (16 CFR 1610): Sample size not specified, but typically involves a set number of specimens from the material.
• Biocompatibility (ISO 10993-5, -10): Sample sizes for "in vitro" and "in vivo" (for irritation/sensitization) tests are defined by the respective ISO standards, but not explicitly stated in this summary.

Data Provenance: The data appears to be from non-clinical laboratory testing (bench testing) of the device. The country of origin of the data is not explicitly stated, but the manufacturer is based in China. The testing is assumed to be prospective, performed specifically for this 510(k) submission.

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

Not applicable. This is a submission for a surgical mask focusing on physical and biological performance characteristics measured through standardized laboratory tests, not subjective expert evaluation of data like medical image analysis. The "ground truth" is established by the specifications of the test standards themselves (e.g., a specific percentage filtration efficiency, a defined pressure drop).

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert opinions. The performance is objectively measured by established laboratory test methods.

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

No. This type of study (MRMC) is typically used for diagnostic devices that involve human interpretation of medical images or data. Surgical masks are medical devices with mechanical and biological filtration properties, evaluated through non-clinical bench testing.

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

Yes, in essence. The core of this submission relies on "standalone" performance testing of the device itself (the surgical mask) against established standards. There is no "human-in-the-loop" component in evaluating the fundamental performance characteristics of the mask (e.g., BFE, PFE, fluid resistance).

7. The Type of Ground Truth Used

The ground truth for the device's performance is established by international and national consensus standards and regulatory guidelines (e.g., ASTM F2100, ASTM F1862, ASTM F2101, ASTM F2299, EN 14683, 16 CFR 1610, ISO 10993 series). These standards define the methodology and the acceptable performance thresholds for surgical masks.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The device is a physical product (surgical mask) whose performance is evaluated through specified tests.

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

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

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