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The Kangbeier Child Surgical Mask is intended to be worn by the patient (ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms and particulate materials. The Kangbeier Child Surgical Mask is a single use, disposable device, provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.

The Kangbeier Child Surgical Mask is composed of three layers of materials and pleated to form the mask. The inner layer is composed of spun-bond nonwoven polypropylene, the middle layer is meltblown polypropylene filter material, and the outer layer is spunbond nonwoven polypropylenen. The color on the outer layer is consists of Phthalocyanine Blue and PE wax and PP. Masks are held in place on wearer with elastic spun-bond polypropylene earloop and contain a malleable aluminum nosepiece strip.

The Kangbeier Child Surgical Mask is appropriately sized to the smaller faces of children across a diverse population.

The Kangbeier Child Surgical Mask is a single use, disposable device, provided nonsterile with no shelf-life. Storage conditions will not affect device safety of effectiveness. All of the materials used in this device are typical materials commonly used in the construction of Surgical Masks and are being used in current legally marketed devices.

The provided text is a 510(k) Summary for the Kangbeier Child Surgical Mask. It demonstrates the device's substantial equivalence to a predicate device, K160100, "Prestige Ameritech Pediatric/Child's Face Mask."

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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The PRIMED level 1 Pediatric Facemask is a single use, disposable device that is intended to be used by patient/child 4 to 12 years old in healthcare setting under an adult supervision to provide a barrier for the respiratory tract from microorganisms, body fluids and particulate material.

The PRIMED level 1 Pediatric Facemask is a single use, disposable device intended to be used by patient/child 4 to 12 years old in healthcare setting under an adult supervision to prevent the transmission of microorganism.

PRIMED Pediatric Mask (PG4-1680) is composed of 4 layers of non-woven material bounded together and pleated to form a mask. This mask is appropriately sized to the smaller faces of children between ages of 4 to 12 years old. PRIMED pediatric mask meets the requirements of ASTM F2100 for level 1 procedure mask while providing a lower differential pressure this mask is single use, disposable and is provided non-sterile. All of materials used in this device are typical materials commonly used in the construction of legally marketed surgical/ procedure masks with a safe history of use. The mask is not made with natural rubber latex.

The provided text describes the regulatory clearance (510(k)) for the PRIMED Pediatric Facemask, classifying it as a Class II medical device (Surgical Apparel, product code OXZ). The document details the device's indications for use and presents a comparison to predicate devices, along with performance data demonstrating compliance with relevant standards.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for the PRIMED Pediatric Facemask are based on meeting or exceeding the performance requirements for a Level 1 procedure mask as per ASTM F2100. The table below summarizes these criteria and the reported performance of the device.

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

The document does not explicitly state the sample sizes used for each individual test (e.g., number of masks tested for BFE, PFE, etc.). It only provides the performance results.

The data provenance is implied to be from laboratory testing performed by the manufacturer or accredited testing facilities, as evidenced by the reference to specific ASTM, EN, ISO, and CPSC standards. The document does not specify the country of origin of the testing data, nor does it indicate if the data is retrospective or prospective in the context of clinical trials. These are performance tests on the device itself, not clinical data from human subjects.

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 document. The "ground truth" for the performance tests of a medical facemask (like BFE, PFE, fluid resistance) is established by the validated and standardized test methods themselves (e.g., ASTM F2101 for BFE). These are objective measurements in a laboratory setting, not subjective assessments by human experts.

4. Adjudication Method for the Test Set:

This information is not applicable as the tests are objective laboratory measurements, not subjective assessments 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:

This information is not applicable. The device is a pediatric facemask, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study related to AI assistance for human readers is irrelevant to this device.

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

This information is not applicable. The device is a physical medical product (facemask), not an algorithm or AI system.

7. The type of ground truth used:

The "ground truth" for the device's performance is based on objective measurements obtained through standardized laboratory tests according to recognized international and national standards (ASTM, EN, ISO, CPSC). This is an objective, quantitative ground truth for the physical and functional properties of the mask materials and construction.

8. The sample size for the training set:

This information is not applicable. As a physical medical device (facemask), there is no 'training set' in the context of machine learning. The design and manufacturing processes are refined through engineering principles and testing to meet specifications, not through machine learning training.

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

This information is not applicable for the same reasons as point 8.

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The Dukal Level 1 Pediatric Face Masks are intended to be worn by the patient/child to cover the nose and mouth to provide a barrier for the respiratory tract from microorganisms, body fluids, and particulate material. Recommended ages are 4-12. The face mask is specifically for use with patients whose age or illness may prevent them from taking necessary precautions in situations where transfer of microorganisms, body fluids, and particulates can occur. The face masks are recommended for use in a healthcare setting with appropriate adult supervision. The Dukal Level 1 Pediatric Face Masks are single use, disposable devices that are provided non-sterile.

Pediatric face masks are intended to be worn by the patient/child to cover the nose and mouth to provide a barrier for the respiratory tract from microorganisms, body fluids, and particulate material. The mask is available in the following product sizes: Regular Size (14.5x9cm) and Extra Small Size (12.5x8cm). The Dukal Level 1 Pediatric Face Mask (both sizes) are composed of three layers of materials and pleated to form the mask. The inner layer is composed of Polypropylene (Spunbond), the middle layer is Polypropylene (Meltblown) filter material, and the outer layer is polypropylene (Spunbond). The masks (both sizes) are held in place on wearer with knitted polyester/spandex elastic ear loop and contain a malleable aluminum nosepiece strip. The masks (both sizes) have decorative patterns, printed with colored inks.

This document describes the performance testing for the Dukal Level 1 Pediatric Face Mask. The device is a medical face mask and the acceptance criteria and performance are based on established standards for such devices.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is compared to the requirements specified by various test standards, primarily ASTM F2100-19 Level 1 requirements for medical face masks.

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Children Face Mask is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials. The mask is specifically for child or pediatric patients to provide protection for the respiratory tract. This face mask is recommended for use in a healthcare setting with appropriate adult supervision.

Children Face Mask is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials.

This document is a 510(k) premarket notification decision letter from the FDA regarding a Child Face Mask. It does not contain information about an AI/ML medical device, clinical study, acceptance criteria, or ground truth establishment.

Therefore, I cannot answer your request based on the provided text. The document is about a physical medical device (face mask) and its regulatory clearance, not about the performance or validation of an AI system.

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The iMask Child's Face Mask is intended to be worn by the patient/child (recommended ages 4-12) to provide protection for the respiratory tract. This is a single use, disposable device, provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.

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The provided text describes an FDA 510(k) clearance for a child's face mask. It does not contain information about acceptance criteria for a device that relies on performance metrics such as accuracy, sensitivity, or specificity. Therefore, I cannot generate the requested table and answer the study-related questions ([2] through [9]).

The document is a regulatory letter confirming that the "iMask Child's Face Mask" is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. It does not include performance study data, details about a test set, expert involvement, or algorithm-specific information.

To elaborate, the product in question is a "Face Mask," which is a physical device (surgical apparel). The concept of acceptance criteria, test sets, ground truth, experts, and AI assistance, as outlined in your prompt, typically applies to diagnostic or AI-driven medical devices that output a result based on data processing (e.g., image analysis, signal processing). For a physical product like a mask, acceptance criteria would typically involve material safety, biocompatibility, filtration efficiency (for certain mask types), breathability, and fit, rather than algorithmic performance metrics.

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Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Mask (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Mask, Medicom SafeMask Premier Procedure Earloop Face Mask (ASTM Level 1) and Medicom SafeMask Premier Pediatic Procedure Earloop Face Mask are intended to be worn by the patient/ child (recommended 4-12 years of age). The face mask is to be placed on nose and mouth as a protective barrier to provide respiratory protection in procedures or situations where there is a risk of microorganism, body fluid and particulate aerosol transfer. It is a single use, non-sterile disposable device that is recommended for use in healthcare settings with appropriate adult supervision.

Medicom Pediatric/Child's Face Mask is a manufactured pleated three-layer mask construction utilizing ultrasonic bonding. The patterned (ink printed) outer layer is composed of spunbound polypropylene (SBPP) material. The filter media is composed of meltblown polypropylene (MBPP). The inner is either tissue/ cellulose or a spunbound polypropylene (SBPP) layer. Bindings are composed of nonwoven polyester and earloops are made of flat elastic knitted polyester band. A malleable polypropylene nosepiece (made of plastic covered iron wire or 100% aluminum piece) is placed within the bindings for comfort and individualized fit around the wearer's nose. Medicom Pediatric/Child's Face Mask is a non-sterile single use disposable device. The device safety of effectiveness is not affected by storage conditions with no shelf life.

The provided text describes the acceptance criteria and performance data for AMD Medicom's pediatric procedure earloop face masks.

Here's the information extracted and organized as requested:

1. Table of Acceptance Criteria and 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 individual performance test (PFE, BFE, differential pressure, blood penetration). It only provides the performance range for a "range of performance based on design variations" for the subject device.

For the anthropometry study, the subject device's evaluation involved participants aged 4-12 years old, ranging from 84.8 cm (33.4 inches) to 170.2 cm (67 inches) in height and 16.3 kg (35.94 pounds) to 76.7 kg (169.1 pounds) in weight. The sample size for this study is not explicitly stated, but it refers to a study on children based on the given age, height, and weight ranges.
The data provenance is not explicitly mentioned as retrospective or prospective, nor is the country of origin of the data provided. However, the manufacturer is in Canada, and the predicate device's anthropometric study refers to the "current US population."

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

This information is not provided in the document. The tests performed are laboratory-based and do not involve expert interpretation or ground truth establishment in the context of medical image analysis or similar fields.

4. Adjudication method for the test set

This information is not applicable as the tests are laboratory measurements of physical and biological properties.

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

This information is not applicable. The device is a medical face mask, not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance are not relevant.

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

This information is not applicable as the device is a medical face mask, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance tests (PFE, BFE, differential pressure, etc.) is established by the specifications defined in the referenced ASTM, Mil, and EN standards. These standards dictate the methodology and expected outcomes for measuring the specific properties of the face masks. For biocompatibility and product safety tests, the "ground truth" is defined by meeting the specified criteria (e.g., "Criteria met," "≤20 ppm," "Class 1") according to the referenced ISO and CPSC standards.

8. The sample size for the training set

This information is not applicable. The device is a physical product (face mask), not a machine learning model that requires a training set.

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

This information is not applicable for the same reason as point 8.

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The Prestige Ameritech Pediatric/Child Face Mask is intended to be worn by the patient/Child Facemask is a single use, disposable device, provided non-sterile. The Pediatric/Child Facemask is intended to be worn by the patient (ages 4-12) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms and particulate materials. The mask is specifically for use with patients whose age or illness may prevent them from taking necessary precautions where transfer of microorganisms, body fluids, and particulates can occur.

The Prestige Ameritech Pediatric/Childs Face Mask is manufactured using ultrasonic bonding, composed of three layers of materials and pleated to form the mask. The inner layer is composed of nonwoven, the middle layer is meltblown polypropylene filter material, and the outer layer is cellulose. Decorative patterns are printed with colored inks. Masks are held in place on wearer with knitted polyester/spandex elastic earloop and contain a malleable aluminum nosepiece strip. The Pediatric/Child's Face Mask is appropriately sized to the smaller faces of children across a diverse population. The Pediatric/Child's Face Mask is a single use, disposable device, provided non-sterile with no shelf-life. Storage conditions will not affect device safety of effectiveness. All of the materials used in this device are typical materials commonly used in the construction of Surgical Masks and are being used in current legally marketed devices. This product is not made with natural rubber latex.

The provided text describes the acceptance criteria and performance of the Prestige Ameritech Pediatric/Child's Face Mask, comparing it to a predicate device. Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes for each test performed on the Prestige Ameritech Pediatric/Child's Face Mask. It mentions that the anthropometric study sample for determining fit was "representative of the current US population in both gender and racial distribution," implying a prospective study, but exact numbers are not given. The origin of the data is not specified beyond being generated for a U.S. FDA 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This document pertains to the performance testing of a physical medical device (a face mask) against established industry standards. There is no mention of "experts" in the context of establishing ground truth for a test set, as the evaluation relies on standardized laboratory testing methods rather than expert interpretation of data like in an AI/imaging study.

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

Not applicable. The evaluation is based on objective laboratory test results against predefined standards, not on human interpretation 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 review of a physical medical device (face mask) and does not involve AI or human "readers."

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

Not applicable. This is a review of a physical medical device (face mask) and does not involve an algorithm.

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

The "ground truth" for the device's performance is based on the results of standardized laboratory tests conducted according to recognized national and international standards (e.g., ASTM F2101, Mil M36954C, ISO 10993, CPSC, EN 71-3). These standards define the methodology and expected outcomes for measuring properties like filtration efficiency, breathability, flammability, and biocompatibility. For anthropometry, it's based on measurements against a "representative" population sample.

8. The sample size for the training set

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

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

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

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The Kimberly-Clark Pediatric/ Child Facemask, is intended to be worn by the patient/child (recommended ages 4-12) to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.

The Kimberly-Clark Pediatric/ Child Facemask is a three layer mask, constructed of nonwoven polyester blends and polypropylene materials. Bindings are nonwoven polyester and earloops are knitted polyester/lycra. A malleable nosepiece is placed within the bindings for comfort and individualized fit around the wearer's nose. The Pediatric/ Child Facemask is appropriately sized to the smaller faces of children across a diverse population. The Pediatric/ Child Facemask is a single use, disposable device, provided non-sterile.

This K113340 submission is for a Kimberly-Clark Pediatric/Child Facemask, which is a physical device, not an AI/ML powered device. Therefore, many of the requested elements for describing an AI/ML study (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size and ground truth establishment) are not applicable.

However, I can provide information based on the provided text regarding the acceptance criteria and study that proves the device meets the acceptance criteria for this specific medical device submission, focusing on the material characteristics and performance relevant to a face mask.

Here's the breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The device, a Kimberly-Clark Pediatric/Child Facemask, was tested against various standards. The summary states that "All results of testing met acceptance criteria." Specific numerical acceptance criteria are not detailed in the provided text, but the standards themselves imply the criteria.

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

• Sample Size for Test Set: The document does not specify the sample size (e.g., number of masks, number of material swatches) used for each of the tests.
• Data Provenance: Not explicitly stated, but the tests were performed by Kimberly-Clark as part of their 510(k) submission. This is prospective testing conducted specifically for this regulatory submission. There is no information about country of origin for the data.

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 device subject to performance testing against established engineering and medical standards, not diagnostic or interpretive tasks requiring expert ground truth for a test set in the same sense as an AI/ML medical device. The "ground truth" would be the objective results of the validated test methods.

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

Not applicable. This concept applies to human interpretation of data for ground truth establishment, not to objective physical product testing.

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/ML device, nor does it involve human readers/interpreters.

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

Not applicable. This is not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for this device's performance is established by the results of standardized physical, chemical, and biological tests (e.g., flammability, particulate filtration efficiency, bacterial filtration efficiency, biocompatibility) against the pre-defined criteria within the referenced standards (Mil-M369454C, PSC CS-191-53, ASTM F 2299, ASTM 2101-07, ISO 10993).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

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The Kimberly-Clark Pediatric/ Child Facemask, is intended to be worn by the patient/child (recommended ages 5-12) to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.

The Kimberly-Clark Pediatric/ Child Facemask is a three layer mask, constructed of nonwoven polyester blends and polypropylene materials. Bindings are nonwoven polyester and earloops are knitted polyester/lycra. A malleable nosepiece is placed within the bindings for comfort and individualized fit around the wearer's nose. The Pediatric/ Child Facemask is appropriately sized to the smaller faces of children across a diverse population. The Pediatric/ Child Facemask is a single use, disposable device, provided non-sterile.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study for the Kimberly-Clark Pediatric/Child Facemask:

This document describes a medical device, specifically a surgical mask, and its submission for FDA clearance. The "studies" referred to are bench tests and consumer evaluations, not clinical trials in the sense of comparing diagnostic accuracy or treatment outcomes. Therefore, many standard questions related to a typical AI/diagnostic device study (like MRMC, expert consensus for ground truth, training set size, etc.) are not applicable here.

Acceptance Criteria and Reported Device Performance

Study Information (as applicable to a medical device bench test submission):

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

   • Sample Size: Not explicitly stated in the provided text for each specific test. For bench testing of materials, this would typically involve a certain number of material samples or manufactured devices.
   • Data Provenance: The tests are described as conducted by Kimberly-Clark, implying internal testing or contracted lab testing. The country of origin of the data (i.e., where the labs were located) is not specified. The tests are general standards, not tied to a specific population's data. These are bench tests, not data derived from retrospective or prospective patient studies.

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

   • Not Applicable. For bench testing of a physical product like a mask, "ground truth" is established by the standardized test methods themselves and the precise measurement of physical properties. Experts are involved in conducting and interpreting these tests, but it's not a consensus interpretation of clinical data.

3. Adjudication method for the test set:

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of data where consensus is needed to establish ground truth (e.g., image reading). This is a physical product undergoing standardized performance tests.

4. 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-powered diagnostic or interpretive device. It is a physical product (face mask) undergoing performance testing.

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

   • Not Applicable. This is not an algorithm-based device.

6. The type of ground truth used:

   • Performance against established industry and regulatory standards. The "ground truth" here is determined by whether the device's measured performance (e.g., BFE, PFE, flammability, biocompatibility) meets the numerical thresholds or qualitative criteria set forth in the referenced standards (Mil-M369454C, ASTM F2101-07, PSC CS-191- 53, ASTM F2299, ISO 10993, EN 71-3) and by the "consumer evaluation of potential mechanical and physical hazards."

7. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of this type of medical device submission. The device design and materials are developed, and then the finished product is tested against standards.

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

   • Not Applicable. As there is no training set, this question is not relevant.

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