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Medical Protective Masks is intended to be worn to protect both the patient and healthcare persomel from transfer of microorganisms, body fluids and particulate material. It is 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 mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The mask is a single use, disposable device, provided non-sterile in black color.

The provided document (K223686) is a 510(k) Premarket Notification for Medical Protective Masks. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing and material comparisons.

It is crucial to understand that this document describes the regulatory acceptance of a medical mask device, NOT an AI/ML-driven device. Therefore, many of the requested fields regarding AI/ML-specific details (like training/test sets, ground truth establishment for AI, expert adjudication, MRMC studies, and standalone AI performance) are not applicable to this submission. The "study" referenced in the prompt (as proving the device meets acceptance criteria) refers to the non-clinical performance testing of the physical mask, not a clinical or AI-based study.

Here's the information extracted from the document relevant to the performance of the Medical Protective Masks:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Biocompatibility Testing:

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

• Sample Size: Not explicitly stated as a single "test set" size. For performance tests:
  • For Resistance to penetration by synthetic blood: "32 of 32 test articles" were used for each test (Test 1-3).
  • For other non-clinical tests (BFE, Differential Pressure, PFE, Flame Spread), the specific number of masks/samples tested is not explicitly detailed in the provided summary, but the results are reported as ranges or singular outcomes.
• Data Provenance: The document does not specify a country of origin for the non-clinical test data beyond the manufacturer being in China. The data would be from laboratory testing.
• Retrospective or Prospective: Not applicable in the context of mask performance testing. These are laboratory characterizations.

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 physical mask performance is established by recognized international standards (e.g., ASTM F2100-19, ISO 10993 series). These are objective, quantitative measurements performed by accredited laboratories, not subject to expert consensus in the way an AI model's ground truth for medical images would be.

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

• Not applicable. As noted above, these are objective physical and chemical tests, not subjective interpretations 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:

• No. This is a medical mask, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

• Not applicable. This is a physical medical mask, not an algorithm.

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

• The "ground truth" is based on objective, quantitative measurements defined by recognized international standards (e.g., ASTM F2100-19 for performance, ISO 10993 for biocompatibility). For example, Bacterial Filtration Efficiency is measured precisely by an instrument, not by an expert's opinion.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI model requiring a training set.

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

• Not applicable, for the same reason as above.

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The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These 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, provide non-sterile.

The subject device is a four-layer, single-use, flat-folded shape mask. The inner and outer layers of the mask are made of polypropylene spunbonded nonwoven, and the filter (2 layers) is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and headband. The ear loops and headband are made of polyester. The nose clip is made of polypropylene and wire, user can adjust the nose clip according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off.

This document describes the acceptance criteria and the study results for the Guangdong Golden Leaves Technology Development Co., LTD's Medical Protective Mask (models 8862, 8862A, 8862B, 8862C, 8862D, 8862E), as presented in their 510(k) Summary (K223068).

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against the ASTM F2100 standard for Medical Face Mask Materials. All models (Level 1, Level 2, and Level 3) of the Medical Protective Mask are stated to meet the performance requirements of all three levels.

Biocompatibility Testing

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

The document does not explicitly state the sample sizes used for each performance and biocompatibility test. It indicates that the tests were conducted according to the specified ASTM and ISO standards, which would implicitly define minimum sample sizes for valid results. The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, but it's generated for the purpose of this 510(k) submission.

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

Not applicable. The "ground truth" for this device is based on standardized performance and biocompatibility testing according to recognized international standards (ASTM, ISO, EN, 16 CFR). These standards define specific methodologies and criteria, rather than relying on expert consensus for interpreting test results.

4. Adjudication Method for the Test Set

Not applicable. The assessment relies on objective measurements against predefined thresholds as per the referenced standards, not on an adjudication process involving human reviewers for interpretation.

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 devices that involve human interpretation of images or other data. The Medical Protective Mask is a physical barrier device, and its effectiveness is determined by its material properties and physical performance as measured by objective tests.

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

Yes, the studies conducted were standalone performance tests of the device itself, without human-in-the-loop performance evaluation. The performance criteria (e.g., filtration efficiency, fluid resistance) are objective measurements of the mask's physical characteristics.

7. The Type of Ground Truth Used

The ground truth used for evaluating the Medical Protective Mask's performance is based on established international standards and testing methodologies. For example:

• Performance data: Directly measured physical properties (e.g., filtration rates, pressure differential, fluid penetration, flammability) against the numerical thresholds defined by ASTM F2100:2019, EN 14683: 2019, and 16 CFR Part 1610.
• Biocompatibility data: Laboratory test results (cytotoxicity, sensitization, irritation) against the criteria defined by ISO 10993-5:2009 and ISO 10993-10:2010.

8. The Sample Size for the Training Set

Not applicable. This device is a medical mask evaluated by its physical properties and biocompatibility. There is no "training set" in the context of machine learning or AI models. The testing described is for the final product's performance validation.

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

Not applicable, as there is no training set for this device. The regulatory submission focuses on demonstrating that the physical device meets established performance and safety standards through non-clinical testing.

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Medical Protective Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is 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 mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively.

The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The mask is a single use, disposable device, provided non-sterile in white color.

The provided text is a 510(k) summary for Medical Protective Masks, a Class II medical device. It does not describe an AI medical device. Therefore, it is not possible to answer the questions about acceptance criteria and study proving device performance for an AI device.

The document focuses on non-clinical performance testing of the medical masks to demonstrate substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA. The tests are for physical properties and biocompatibility of the mask, not for an AI algorithm's performance.

Here's an analysis of what is provided regarding acceptance criteria and performance, as it relates to the physical mask device, to clarify why it doesn't fit the AI-focused query:

1. Table of Acceptance Criteria and Reported Device Performance (for the physical mask):

Biocompatibility Testing:

Remaining questions from the prompt cannot be answered from the provided text as they pertain to AI/software device evaluation, not physical medical devices:

• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
• 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)
• Adjudication method (e.g. 2+1, 3+1, none) for the test set
• 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
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

The document explicitly states: "No clinical study implemented for the Medical Protective Masks." (Section 8.0). This further emphasizes that the evaluation framework is for a physical product's performance against recognized standards, not an AI algorithm.

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The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Medical Protective Mask is 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 Medical Protective Mask is a single use, two-panel, flat-folded mask with ear loops and nose piece. The mask is designed into a C-shape when flat-folded. The C-shaped design allows for an expanded chamber for the mask in use. The mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively. The elastic ear loops are made of spandex and polyester, which are welded to the facemask to hold the mask in place over the users' mouth and nose. The elastic ear loops are not made with natural rubber latex. The nose piece is a Iron core covered with polypropylene. The dimensions of each mask are length 162±5 mm and width 102±5 mm. The dimensions of nosepiece is length 90±10 mm and width 5±0.5 mm, and the ear loop is length 185±5 mm and width 5±0.5 mm. The mask is a single use, disposable device, provided non-sterile in white color.

This document is an FDA 510(k) premarket notification for a medical protective mask. It does not describe an AI medical device or an MRMC study. Therefore, most of the requested information regarding acceptance criteria and studies proving device performance, especially those related to AI and human reader improvement, cannot be extracted from this document.

However, I can provide the acceptance criteria and reported performance for the physical and biological characteristics of the medical protective mask based on the provided text.

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

This table details the performance criteria for the Medical Protective Mask (Model: KF-A F02(N)) based on ASTM F2100 Level 2 standards.

Information Not Applicable or Not Found in the Document:

The provided document is a 510(k) premarket notification for a Medical Protective Mask, which is a physical device, not an AI/software-based medical device. Therefore, the following points related to AI, imaging, and clinical studies are not applicable or not found in this document:

2. Sample size used for the test set and the data provenance: Not applicable for this type of device and testing. The performance tests are laboratory-based, often using standard samples or methods (e.g., bacterial aerosols, synthetic blood).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for masks is established by standardized laboratory test methods, not expert clinical interpretation.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for AI-assisted image interpretation, not mask performance. The document explicitly states "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This refers to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device's performance is based on standardized laboratory test methods and established measurement criteria (e.g., ASTM F2101 for BFE, ASTM F2299 for PFE, ASTM F1862 for fluid resistance, ISO 10993 for biocompatibility).
8. The sample size for the training set: Not applicable, as this is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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