Search Results

The Surgical Face Mask (Non-sterile) is intended to be worn to protect both the patient and healthcare personnel 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. This a single use, disposable device(s), provided non-sterile.

The Surgical Face Masks (Non-sterile) are blue color, three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is blue polypropylene (PP) master batch.

The inner layer and outer layer of the mask are made of spun-bonded non-woven fabric (polypropylene), the middle layer is made of polypropylene melt-blown non-woven fabric. The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of galvanized iron wire coated by PE.

The Surgical Face Mask (Non-sterile) is sold non-sterile and are intended to be single use, disposable devices.

The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.

The document provided is a 510(k) Pre-market Notification for a Surgical Face Mask (Non-sterile). It outlines the non-clinical testing performed to establish substantial equivalence to a predicate device. This type of submission relies on performance testing against established standards rather than clinical studies for device functionality.

Here's a breakdown of the requested information based on the provided text:

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)

• Sample Size for Performance Tests: For Bacterial Filtration Efficiency, Differential Pressure, Sub-micron Particulate Filtration Efficiency, Resistance to Penetration by Synthetic Blood, and Flammability, 3 non-consecutive lots were tested, with a sample size of 32 per lot.
• Sample Size for Biocompatibility Tests: The exact sample size for cytotoxicity, irritation, and sensitization tests is not specified, but the tests were performed on the mask material.
• Data Provenance: The document does not explicitly state the country of origin of the test data or whether the studies were retrospective or prospective. Given the applicant is from China (Xiantao Junhui Plastic Products Co., Ltd.), it is highly probable that the testing was conducted in China or a region following these international standards. The testing is non-clinical performance testing rather than human subject data.

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 section is not applicable. The device is a surgical face mask, and its performance is evaluated through standardized non-clinical laboratory tests (e.g., filtration efficiency, breathability, fluid resistance, flammability, biocompatibility) based on criteria defined in established standards (ASTM, EN, ISO, CFR). There is no "ground truth" in the clinical sense established by human experts for these types of tests. The "ground truth" is the objective measurement against the specified standard's criteria.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 refer to methods used to resolve discrepancies among multiple expert readers or scorers, typically in medical imaging or clinical trials. As stated above, the device performance is determined by objective laboratory measurements against predefined standards.

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 section is not applicable. MRMC studies and AI assistance are relevant to diagnostic or interpretation devices, particularly in medical imaging. The device in question is a surgical face mask, which does not involve human readers interpreting data or AI assistance.

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

This section is not applicable. "Standalone performance" or "algorithm only" refers to the performance of an AI or software algorithm without human intervention, again typically for diagnostic or interpretative devices. The surgical face mask does not use an algorithm.

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

The "ground truth" for this device's performance is based on objective measurements against established international and national standards. For example:

• For Bacterial Filtration Efficiency, the ground truth is the measured percentage of bacteria filtered, compared against the ≥98% standard.
• For Resistance to Penetration by Synthetic Blood, the ground truth is the number of samples passing the test at 160 mmHg, compared against the 29 out of 32 pass standard.
• For Biocompatibility, the ground truth is determined by the results of standardized tests for cytotoxicity, irritation, and sensitization, compared against criteria like "non-cytotoxic," "negligibly irritating," and "non-sensitizing."

8. The sample size for the training set

This section is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical product (a surgical face mask) and does not involve machine learning or AI, and therefore no training set.

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

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

Ask a specific question about this device

The masks are 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 adult 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 proposed device is a three-layer, flat pleated mask. Each mask is composed of a mask body, a nose piece and two ear loops. The mask body is manufactured with three layers, the inner layer and the outer layer are made of polypropylene spunbond nonwoven fabric, and the middle layer is made of polypropylene meltblown nonwoven fabric. It is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are made of polyester and polyurethane, not made from natural rubber latex. The nose piece is in the layers of face mask to allow the user to fit the face mask around his nose, which is made of polyethylene.

The proposed device is provided non-sterile and is intended to be a single use, disposable device.

The provided text is a 510(k) Summary for a Surgical Face Mask. It outlines the device, its intended use, and comparative data against predicate and reference devices to demonstrate substantial equivalence. However, this document does not describe the specific study design elements typically associated with proving a device meets acceptance criteria for an AI/ML-based medical device, as requested in the prompt.

The document details performance testing for physical characteristics of a surgical face mask (e.g., fluid resistance, filtration efficiency, flammability, biocompatibility), which are relevant for demonstrating the safety and effectiveness of the mask itself. It does not contain information about an AI/ML algorithm or its performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the AI/ML device meets the acceptance criteria based on the provided text. The text is for a physical medical device (surgical face mask), not an AI/ML device.

If the request was simply to describe the acceptance criteria and study proving the surgical face mask meets its criteria, the following information can be extracted:

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

Since the document is for a physical device, the following points regarding AI/ML device studies are not applicable and thus cannot be extracted from the text:

• Sample size used for the test set and data provenance (e.g., country of origin, retrospective/prospective)
• Number of experts used to establish ground truth and their qualifications
• Adjudication method for the test set
• Multi-reader multi-case (MRMC) comparative effectiveness study and effect size
• Standalone (algorithm-only) performance
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How ground truth for the training set was established

Ask a specific question about this device

The Surgical Face Mask (non-sterile) 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 a single use, disposable device(s), provided non-sterile.

The proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. 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 made of nylon and spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

Here's a breakdown of the acceptance criteria and study information for the "Surgical Face Mask (non-sterile)" as presented in the FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes for each specific test (e.g., number of masks tested for BFE). However, for Fluid Resistance (ASTM F1862), the criteria and result are given as "32 out of 32 passes," suggesting a sample size of 32 tests for this particular performance characteristic.

• Data Provenance: The tests appear to be conducted by or on behalf of Nantong Taiweishi Medical Technology Co., Ltd. in China, as indicated by the company's address on the document. The document presents these tests as non-clinical laboratory evaluations. There is no information provided about whether these studies were retrospective or prospective, but given they are laboratory performance tests for device clearance, they would typically be considered prospective studies on manufactured samples.

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

This type of information is generally not applicable to the performance testing of a physical product like a surgical face mask. The "ground truth" here is established by the standardized test methods themselves (e.g., ASTM F2100, F1862, F2299, F2101, EN 14683, ISO 10993, 16 CFR 1610). The results are quantitative measurements against predefined criteria, not subjective expert interpretations. Therefore, no experts were used to establish ground truth in the traditional sense of clinical or image-based studies.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, these are objective physical and biological performance tests against established standards, not studies requiring expert adjudication of subjective findings.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance (with or without AI assistance) is being evaluated against some ground truth. This document pertains to the performance characteristics of a physical medical device (surgical face mask).

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

No, this question is not applicable. This device is a physical product, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth is established by standardized test methods and predefined acceptance criteria from recognized international and national standards such as ASTM, ISO, EN, and CFR. These standards define the methodology for measuring specific performance characteristics and the thresholds for acceptable performance (e.g., ≥ 98% BFE, Class 1 Flammability).

8. The Sample Size for the Training Set:

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

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

Not applicable. As above, this information is not relevant for a physical medical device.

Ask a specific question about this device