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The DISPOSABLE FACE MASK is 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, provided non-sterile.

The DISPOSABLE FACE MASK is flat pleated style mask, utilizing ear loops way for wearing, and they all has nose clip design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer facing layers are made of spunbonded non-woven, and the middle layer is made of melt-blown non-woven the model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex. The nose clip contained in the proposed device(s) is in the layers of face mask to allow the user to fit the mask around their nose, which is made of PE coated Tin-plate wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

The provided document describes the safety and effectiveness of a DISPOSABLE FACE MASK (Models: TX-005, TX-006) by Jiujiang Taixin Technology Co., Ltd. It is a 510(k) premarket notification, indicating a comparison to a legally marketed predicate device (K202424) rather than a de novo approval requiring extensive clinical trials. Therefore, the "study" referred to is a series of non-clinical performance and biocompatibility tests conducted according to established international standards.

Here's a breakdown of the requested information:

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

2. Sample sized 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 sample sizes used for each performance test. The tests were performed according to specified ASTM and ISO standards, which would dictate the appropriate sample sizes for each test in a prospective manner. The provenance of the data is from Jiujiang Taixin Technology Co., Ltd. in China. The tests are non-clinical, meaning they are laboratory tests, not human subject studies.

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 is a non-clinical device (face mask). "Ground truth" in the context of expert review for medical imaging or clinical diagnosis is not applicable here. The performance criteria are objective measurements defined by international standards (ASTM, EN, ISO). The "ground truth" is the specified performance criteria for each test.

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

Adjudication methods like 2+1 or 3+1 are used for human expert review, typically in clinical studies or for establishing ground truth in image analysis. This is a non-clinical device, so such adjudication is not applicable. The device performance is determined by objective laboratory 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

No MRMC comparative effectiveness study was done. This is a basic medical device (face mask) and does not involve AI or human reader interpretation.

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

Not applicable. This device does not incorporate an algorithm.

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

The "ground truth" for the performance tests are the established international standards (ASTM F2101, EN 14683, ASTM F2299, ASTM F1862, 16 CFR Part 1610, ISO 10993). These standards define the acceptable range or threshold for each performance characteristic (e.g., BFE ≥ 98%, Flammability Class 1, non-cytotoxic).

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

Not applicable, as this device does not use an AI/ML algorithm or a training set.

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Disposable Face Mask is indicated as a protective nose and mouth covering for healthcare workers involved in medical and surgical procedures. The masks are indicated for use in procedure or situation where there is a risk of exposure to microorganisms and body fluids.

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It appears you've provided an FDA 510(k) clearance letter for a "Disposable Face Mask" (K203152). This document does not contain any information about acceptance criteria or a study proving that an AI/medical device meets acceptance criteria.

The 510(k) process for a disposable face mask primarily focuses on demonstrating substantial equivalence to a predicate device, which often involves showing adherence to specific performance standards (e.g., fluid resistance, filtration efficiency) rather than AI model performance metrics.

Therefore, I cannot fulfill your request using the provided text. The document is about a low-risk medical device (a face mask) and does not involve AI or complex performance studies described by your detailed questions.

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The Disposable Face 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, provided non-sterile.

The Disposable Face Mask is single use, three-layer, flat-pleated mask with ear loops and nose clip. The inner and outer layers of the mask are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene. The ear loops are held in place over the users' mouth and nose by two elastic ear straps. The ear loops are made of spandex and nylon. The nose clip is a malleable iron wire covered by polyethylene. Users 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. The Disposable Face Mask is blue and provided non-sterile.

The document describes the non-clinical tests performed on the Disposable Face Mask (K210815) to demonstrate its safety and effectiveness, and its substantial equivalence to the predicate device (K202211).

Here's a 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

• Sample Size for performance tests: 32 samples per lot for 3 non-consecutive lots (total 96 samples for each performance test).
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It refers to "Non-Clinical Test Conclusion," implying laboratory testing rather than human subject studies. Given the manufacturer's location in China (Biobase Scientific (Shandong) Co., Ltd.), it's highly probable the testing was conducted in China.

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

• Not Applicable (N/A): This study involves non-clinical laboratory testing of a physical device (face mask) against established performance standards, not diagnostic or interpretive tasks requiring human expert ground truth.

4. Adjudication Method for the Test Set

• Not Applicable (N/A): This study does not involve human adjudication for ground truth. It relies on objective laboratory measurements against defined performance criteria.

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 (N/A): This document describes the testing of a medical device (face mask), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study is irrelevant.

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

• Not Applicable (N/A): This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Objective Laboratory Measurements: The "ground truth" for the device's performance is established through quantitative measurements obtained from standardized laboratory tests (e.g., Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration, Flammability, Resistance to Penetration, and Biocompatibility tests) according to recognized international and national standards (ASTM, EN, ISO, CFR).

8. The Sample Size for the Training Set

• Not Applicable (N/A): This is a physical medical device, not a machine learning model, so there is no "training set."

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

• Not Applicable (N/A): There is no training set for a physical medical device.

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The Disposable Face Mask is 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, provided non-sterile.

The proposed device, Disposable Face Mask is a three-layer, single-use, flat-pleated mask. The ear loops to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. The disposable surgical mask is available in four different specifications: 14.5cmx9.5cm and 17.5cmx9.5cm. The device is single use and provided non-sterile.

The provided text describes the 510(k) submission for a Disposable Face Mask (K202905) and its equivalence to a predicate device (K160269). However, it does not contain information related to an AI/ML-enabled medical device or a clinical study involving human readers and AI assistance.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI device. The document is strictly about the non-clinical testing and comparison of a traditional medical device (face mask) to a predicate device to demonstrate substantial equivalence.

The document covers:

• Device: Disposable Face Mask
• Purpose: To protect against transfer of microorganisms, body fluids, and particulate material.
• Regulatory Class: Class II, Product Code FXX.
• Acceptance Criteria/Performance (based on standards for face masks):
  • Fluid Resistance (ASTM F1862)
  • Particulate Filtration Efficiency (ASTM F2299)
  • Bacterial Filtration Efficiency (ASTM F2101)
  • Differential Pressure (EN 14683)
  • Flammability (16 CFR 1610)
  • Biocompatibility (ISO 10993-5 and ISO 10993-10)

Here's a breakdown of what can be extracted from the document, tailored as much as possible to your request, but highlighting the absence of AI/ML specifics:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 'acceptance criteria' are implicitly derived from the performance of the predicate device and the relevant ASTM/EN standards for medical face masks. The proposed device had to meet or exceed these to demonstrate substantial equivalence.

Regarding AI/ML specific information (which is not in the document):

2. Sample size used for the test set and data provenance: Not applicable to this device type or study.
3. Number of experts used to establish the ground truth and qualifications: Not applicable. Ground truth for a face mask's performance is established through standardized laboratory testing (e.g., measuring filtration efficiency, fluid resistance) against predefined physical criteria, not expert interpretation of AI outputs.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No, this was not done as it's not an AI-enabled device requiring human-in-the-loop assessment.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth: (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on physical and biological laboratory measurements according to established international standards (ASTM, EN, ISO).
8. Sample size for the training set: Not applicable, as 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.

In summary, the provided document details the regulatory clearance of a disposable face mask, focusing on non-clinical performance testing against established standards and comparison to a predicate device, not on the performance of an AI/ML system.

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