Search Results

The Surgical Face Masks, Model: EFDS-LS-Pn BLU is intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids and particulate material. This face 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 mask provided non-sterile.

Surgical Face Masks, Model: EFMDS-L50Pn BLU

This document is a 510(k) clearance letter from the FDA for a surgical face mask. It does not contain information about a medical device that uses AI or a study proving its performance against acceptance criteria. Therefore, I cannot provide the requested information.

The document discusses:

• The device name: Surgical Face Masks, Model: EFMDS-L50Pn BLU
• Its regulatory classification (Class II, Product Code FXX, Regulation Number 21 CFR 878.4040)
• Its intended use: "to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material... for use in infection control practices to reduce the potential exposure to blood and body fluids."
• It clarifies that it's a "single-use, disposable mask provided non-sterile."

It is a clearance based on substantial equivalence to legally marketed predicate devices, not on a performance study demonstrating AI software's accuracy.

Therefore, I cannot answer the questions about acceptance criteria, study details, expert ground truth, MRMC studies, or standalone algorithm performance, as these are not relevant to the provided text.

Ask a specific question about this device

The surgical 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 potential exposure to blood and body fluids. this is a single-use, disposable device, provided non-sterile. This mask is safe for use in the MR environment.

The Surgical Face Masks (Ear Loops and Tie-On) are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane) or ties (polyester/polypropylene). A malleable nosepiece is placed within the binding for comfort and individualized fit. The surgical face masks will be provided in white and blue, and options for added cup keeper (polypropylene), visor (polyester), or both. The surgical face masks are single-use, disposable devices, provided non-sterile. This mask is safe for use in the MR environment.

This document is a 510(k) Premarket Notification from the FDA regarding "Surgical Face Masks (Ear Loops And Tie-On)" manufactured by SAN-M PACKAGE CO., LTD. It focuses on demonstrating substantial equivalence to a predicate device (K160269) by the same manufacturer.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the subject device are based on demonstrating substantial equivalence to the predicate device (K160269), which itself would have met specific performance standards. The performance tests are based on ASTM F2100-11 standards for medical face masks.

Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a non-clinical performance and biocompatibility testing program, as detailed in Table 3 of the submission. The key objective was to demonstrate that the subject device performs "as well as or better than the identified predicate device" (K160269) across all specified test parameters, and specifically that the change in nose clamp material (from polyethylene coated steel wire to just polyethylene) does not negatively impact performance, and allows for MR safety.

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

The document does not explicitly state the specific sample sizes (number of masks tested) for each of the performance tests (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability, Biocompatibility). However, it implies that the tests were conducted according to the relevant ASTM and ISO standards, which typically specify sample sizes for such evaluations.

• Data Provenance: The document does not specify the country of origin of the data beyond the manufacturer (SAN-M PACKAGE CO., LTD.) being located in Japan. The type of study is prospective non-clinical performance and biocompatibility testing conducted on the newly manufactured subject device and, for comparison, on the predicate device.

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

This information is not applicable in this context. The "ground truth" for a medical mask's performance is established by adherence to recognized performance standards (e.g., ASTM F2100-11, ISO 10993) and measured through objective laboratory tests. There is no concept of expert consensus or interpretation for these physical and biological performance characteristics.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes, where human reviewers make subjective assessments that might require a consensus. Performance tests for surgical masks are objective, standardized laboratory measurements that yield quantitative results (e.g., filtration efficiency percentages, pressure differentials, pass/fail for chemical tests).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. An MRMC study is relevant for evaluating diagnostic imaging devices where multiple readers interpret cases to assess the effectiveness of an AI system, with and without AI assistance. The device in question is a surgical face mask, which does not involve human interpretation or AI assistance in its function or evaluation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. This concept applies to AI/ML software as a medical device (SaMD). The device under review is a physical medical device (surgical face mask), not an algorithm or software. Its performance is evaluated through direct physical and biological testing.

7. Type of Ground Truth Used

The "ground truth" for the performance of the surgical face masks is established through objective, standardized laboratory measurements against predefined thresholds and criteria outlined in recognized national and international standards (e.g., ASTM F2100-11 for mask performance, ISO 10993 for biocompatibility, 16 CFR 1610 for flammability, MIL-M-36945C for differential pressure). It is not based on expert consensus, pathology, or outcomes data in the traditional clinical sense, but rather on physical and chemical properties and biological response.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical product (surgical face mask), not an AI/ML algorithm 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.

Ask a specific question about this device

Surgical 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 of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

Surgical 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 of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The surgical face masks are single use multi-laver masks with outer laver and inner laver of polypropylene spunbond that sandwich a meltblown polypropylene filter material. The surgical face mask includes malleable aluminum nosepiece that can be bent to contour the nose. The surgical face masks are held in place with ear loops made of polyester/Lycra.

The information provided describes the acceptance criteria and performance of a Surgical Face Mask (K202708), comparing it to a predicate device (K201729).

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

The document references "32/32" or similar notations for the lots tested for PFE, BFE, and Fluid Resistance. This likely indicates that all 32 samples from each lot tested met the criteria for these specific tests. However, the precise definition of "sample" in this context (e.g., individual masks, or a batch from which tests are performed) and the overall sample size for each test (e.g. how many masks in total were subjected to fluid resistance) and lot are not explicitly stated in granular detail beyond the "32/32" type notation.

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data provided, although the manufacturer is INTCO Medical (HK) Co., Ltd.

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

This information is not applicable as the device is a surgical face mask and the testing performed is for physical and biological properties in accordance with established ASTM, EN, and ISO standards, not for diagnostic accuracy requiring expert consensus.

4. Adjudication method for the test set

This information is not applicable as the evaluation is based on objective, standardized laboratory 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

This information is not applicable. The device is a surgical face mask, not an AI-powered diagnostic tool, and therefore no MRMC study was conducted.

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 surgical face mask, not an AI-powered algorithm.

7. The type of ground truth used

The ground truth for the performance criteria is based on established industry standards and regulatory requirements (e.g., ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, EN 14683 Annex C, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards define the acceptable range or threshold for each performance characteristic.

8. The sample size for the training set

This information is not applicable. The device is a passive medical device (surgical face mask), not a machine learning model, so there is no training set in the AI sense.

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

This information is not applicable for the reasons stated above.

Ask a specific question about this device

The Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

The proposed device, is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of spun-bonded nonwoven polypropylene, and the middle layer is made of melt-blown nonwoven polypropylene. The proposed devices are available in two types, ear-loop and Tie-on. The ear loops are made of nylon and spandex, and the ties are made of spun-bonded nonwoven polypropylene. The ear loops/tie-on is held in place over the users' mouth and nose by ear loops/ties welded to the mask. The nose clip is made of Medical polypropylene+Q235. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. Both the ear loop and tie-on masks are available in different sizes to provide more options for user. The proposed device can be provided in sterile and non-sterile two types.

The document you provided is a 510(k) Premarket Notification for Surgical Face Masks. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical or standalone study.

Therefore, the information requested in your prompt (acceptance criteria, details of a study proving device performance, sample sizes, expert involvement, ground truth establishment, etc.) is not present in this document. This 510(k) primarily relies on non-clinical performance testing and a comparison of technological characteristics to a predicate device.

Specifically:

• No clinical study was conducted or included in this submission. The document explicitly states this in Section 7: "No clinical study is included in this submission."
• The "acceptance criteria" for a 510(k) are typically met by demonstrating that the new device performs "as well as" or "better than" the predicate device in relevant non-clinical tests or by meeting recognized consensus standards. The document shows tables of test results (e.g., Bacterial Filtration Efficiency, Particulate Filtration Efficiency, Fluid Resistance) against, or in comparison to, the predicate device and relevant standards (e.g., ASTM F2100 Level 2).
• There is no mention of human experts establishing ground truth for a test set, adjudication methods, or MRMC studies because there was no clinical study.

However, I can extract information related to the device performance and testing that was done to support the 510(k) clearance, framed as "reported device performance" against relevant "acceptance criteria" derived from the standards and predicate comparison:

The provided 510(k) Premarket Notification for Surgical Face Masks (K202843) demonstrates substantial equivalence to a predicate device (K173062) by relying on non-clinical performance testing rather than a clinical study. Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of human data, expert adjudication, or MRMC studies is not applicable to this submission.

Instead, the device meets "acceptance criteria" by demonstrating performance in laboratory tests in accordance with recognized consensus standards (e.g., ASTM F2100 Level 2) and by showing that its technological characteristics are substantially equivalent to the predicate device.

Here's an interpretation of the requested information based on the provided document, focusing on the non-clinical testing performed:

1. Table of Acceptance Criteria (as per standards/predicate comparison) and Reported Device Performance:

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

• Sample Size: Not explicitly stated for each test, but general non-clinical testing typically involves a sufficient number of samples to ensure statistically valid results based on the specific test standard.
• Data Provenance: The tests were conducted by a Chinese company (B.J.ZH.F.Panther Medical Equipment Co., Ltd) and are presumably laboratory tests on manufactured device samples. The document doesn't specify if the testing was done in China or elsewhere, but it is implied to be non-clinical, in-vitro/bench testing.
• Retrospective/Prospective: Not applicable to non-clinical bench testing.

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 these types of non-clinical tests is established by adhering to the specified methodology and validated equipment outlined in the respective ASTM or ISO standards. There is no human "expert" adjudication in terms of clinical interpretation for this type of submission.

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

• Not applicable. There was no clinical study with human readers 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 device is a surgical face mask, not an AI-powered diagnostic tool. No MRMC study was performed.

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

• Not applicable. This device is a physical medical device (surgical face mask), not an algorithm or software. Its performance is inherent to its physical properties and material science.

7. The type of ground truth used:

• For physical properties and material performance: Ground truth is defined by the validated methodologies and performance specifications within recognized consensus standards (e.g., ASTM, ISO standards) for testing medical face masks. Biocompatibility "ground truth" is based on the biological response observed following testing as per ISO 10993 standards.

8. The sample size for the training set:

• Not applicable. This refers to AI/machine learning models.

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

• Not applicable. This refers to AI/machine learning models.

Ask a specific question about this device

The surgical 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 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 nonsterile.

The Surgical Face Masks (Ear loops and Tie-on) are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane) or ties (polypropylene/polyester). A malleable nosepiece is placed within the binding for comfort and individualized fit. The surgical face masks will be provided in white or blue and with the option for a visor. The surgical face masks are single-use, disposable devices, provided non-sterile.

The provided document describes the acceptance criteria and performance of Surgical Face Masks (Ear loops and Tie-on) as part of a 510(k) premarket notification. The study aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove device meets an absolute acceptance criteria.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" but rather "performance requirements" as outlined by recognized standards (ASTM F2100-11 for various levels) and then reports the device's performance against these requirements. It also compares the proposed device's performance to predicate devices.

Acceptance Criteria (Performance Requirements from ASTM F2100-11) and Reported Device Performance

Note: For ASTM F2299 and ASTM F2101, the document reports "Pass at" a certain percentage. The acceptance criteria for these would typically be a minimum percentage, which the reported values exceed.
Note: For Differential Pressure, the acceptance criteria are maximum values (e.g., <5.0 mmH2O/cm²), and the device's reported values fall within these limits.

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

The document does not explicitly state the sample sizes for the individual performance tests (e.g., how many masks were tested for fluid resistance). The nature of these tests (e.g., ASTM F1862, F2299, F2101) typically involves standardized replicates as specified by the respective standards.

The data provenance is from non-clinical tests conducted on the proposed device. The country of origin of the data is not specified, but the applicant is from Japan (SAN-M PACKAGE CO., LTD.) and the US Correspondent is Globizz Corporation. The tests are "non-clinical tests" as opposed to human studies, so the retrospective or prospective nature in the clinical sense is not directly applicable. These are laboratory-based performance tests usually conducted in a controlled environment.

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

This question is not applicable to this type of device and study. The "ground truth" for these tests are the established performance requirements of the referenced ASTM and ISO standards, which are objective, quantifiable measurements (e.g., pass/fail for fluid penetration, percentage filtration, pressure drop). These are not subjective interpretations requiring expert consensus.

4. Adjudication method for the test set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies involving subjective assessments by human readers/experts to resolve discrepancies. The performance tests for surgical masks are 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 is not applicable. The device is a surgical face mask, not an AI-powered diagnostic device. No MRMC study was conducted.

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

This is not applicable as the device is a physical product (surgical face mask), not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for these tests are the established performance requirements defined by recognized international and national standards:

• ASTM F2100-11: Standard Specification for Performance of Materials Used in Medical Face Masks
• ASTM F1862: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
• ASTM F2299: Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulate Matter Using a Latex Sphere Aerosol
• ASTM F2101: Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
• MIL-M36945C: General Performance Requirements for Filtering Facepiece Respirators (likely referenced for differential pressure, though the specific ASTM equivalent is often used now)
• 16 CFR 1610: Standard for the Flammability of Clothing Textiles
• ISO 10993 (specifically ISO 10993-5 and ISO 10993-10): Biological evaluation of medical devices for cytotoxicity, irritation, and sensitization.

These standards provide objective, measurable criteria, not expert consensus or pathology on individual cases.

8. The sample size for the training set

This is not applicable. This is a physical product, not a machine learning model, so there is no "training set."

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

This is not applicable as there is no "training set."

Ask a specific question about this device