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Surgical Face Mask is 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 Surgical face mask is single use, three-layer, flat-pleated style with ear loops/ties and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the straps are made of nonwoven fabrics, the middle layer is made of melt blown fabrics.

The model of proposed device, tie-on, is held in place over the user's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.

The model of proposed device, ear loops, is held in place over the user's 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 ties/ear loops are not made with natural rubber latex. The nose piece on the layers of face mask is to allow the user to fit the face mask around their nose, which is made of Polypropylene with iron core. The Surgical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.

This document is a 510(k) summary for a Surgical Face Mask. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The Surgical Face Mask is blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.

The body of the face mask is composed of 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 two elastic ear loops are welded to the face mask, can held the face mask in place over the users' mouth and nose. The elastic ear loops are made of Spandex and polyester, is not made with natural rubber latex.

The nose piece is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of PP-Ferrum wire.

The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

The document is a 510(k) premarket notification for a Surgical Face Mask. It primarily focuses on the device's substantial equivalence to a predicate device, supported by non-clinical performance testing and biocompatibility assessments. It explicitly states that no clinical studies were performed. As such, the information provided does not pertain to the "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/human-in-the-loop diagnostic device as implied by the detailed questions.

Therefore, many of the requested details, such as those related to AI performance, human reader improvement, ground truth establishment for training and test sets, expert consensus, and multi-reader multi-case studies, are not applicable to this document.

However, I can extract the acceptance criteria and the device performance for the non-clinical tests conducted for this surgical face mask.

Here's the information based on the provided document, addressing the extractable points and noting the non-applicability of others:

Device: Surgical Face Mask (Kingstar Medical (Xianning) Co., Ltd.)
Predicate Device: K210433 Surgical Face Mask (Wuhan Dymex Healthcare Co., Ltd.)

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

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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.

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Surgical Mask is 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 Durio Surgical Face Mask is a non-sterile, single use, flat-pleated style surgical mask with ear loops and nose piece. The Durio Surgical Face Mask is available in three or four ply models. In all cases, the inner and outer layers of the Durio Surgical Face Mask are made of non-woven spunbond polypropylene (PP). The outer layer repels fluid and droplets. The middle layer is made of non-woven melt blown PP fabric for filtration by mechanical blocking and electrostatic attraction. For the four-ply model, there is an additional middle layer made of non-woven spunbound PP. The ear loops are made of polyester covered spandex yarn. The elastic ear loops pull inward from welding on the outer layer to reduce gaps as the side between the face and mask. The nose strip is made of zinc electro galvanized steel wire allowing adjustability and to let it stand fixed for better fit. The Durio Surgical Face Mask is provided in blue. The device is not made from any natural rubber latex.

The provided document is a 510(k) Premarket Notification for a medical device (Durio Surgical Face Mask). It is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device.

Crucially, this document is NOT about an AI/ML medical device where the "device performance" refers to the output of an algorithm against a ground truth. Instead, the "device performance" here refers to the performance of the physical surgical face mask according to established ASTM (American Society for Testing and Materials) standards.

Therefore, many of the requested elements of your prompt (e.g., sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth for AI, training set ground truth establishment) do not apply to this document as it does not describe an AI medical device.

However, I can extract the relevant information regarding the acceptance criteria and the study that proves the device meets those criteria for this physical medical device.

Here's the breakdown:

Acceptance Criteria and Reported Device Performance (Physical Surgical Face Mask)

The acceptance criteria for the Durio Surgical Face Mask are defined by specific ASTM standards and a CFR regulation, demonstrating its barrier performance and safety. The "study" proving these criteria involved various bench performance tests as opposed to a study on an AI/ML algorithm.

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

Note on ASTM F2100 Levels: The document states that the 3-ply model meets Level 2, and the 4-ply model meets Level 3 of ASTM F2100. This standard defines performance requirements for medical face masks by classifying masks at Level 1, 2, or 3 based on their barrier properties (BFE, PFE, fluid resistance, differential pressure). By stating "Level 2 (3-Ply) and Level 3 (4-Ply)", it implicitly means the masks met the criteria for these specific levels for BFE, PFE, and synthetic blood penetration.

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

• Sample Size: The document does not specify the exact sample size for each bench performance test. It broadly states that "Durio Surgical Face Masks passed the testing in accordance with internal requirements and standards." Regulatory submissions for physical devices typically rely on accredited lab testing according to the relevant standard. These standards often dictate minimum sample sizes for testing (e.g., a certain number of masks for BFE or PFE testing).
• Data Provenance: The tests were conducted by an "applicant's internal" process ("Durio completed various bench performance tests... passed the testing in accordance with internal requirements and standards") likely in Malaysia (given the sponsor's location in Johor Bahru, Malaysia). The nature of these tests for a physical device is inherently "prospective" as new masks are manufactured and tested.

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 non-AI device. "Ground truth" for these performance tests is established by the specified ASTM and ISO standards' methodologies, not by human expert consensus or labeling.

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

• Not Applicable. This relates to human expert review and consensus for data labeling, which is not relevant for a physical device's bench 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 specific to AI/ML device evaluations.

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

• Not Applicable. This is specific to AI/ML device evaluations.

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

• Defined by Standardized Test Methods: The "ground truth" for the device's performance is determined by adherence to standardized, quantitative testing methods defined in documents like ASTM F2101, ASTM F2100, ASTM F1862/F1862M, 16 CFR 1610, and ISO 10993. For example:
  • BFE: Percentage of bacteria filtered.
  • PFE: Percentage of sub-micron particles filtered.
  • Synthetic Blood Penetration: Pass/fail based on blood penetration.
  • Biocompatibility: Absence of toxic, irritating, or sensitizing responses in preclinical models.

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an AI/ML model that requires a training set.

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

• Not Applicable. This is a physical device, not an AI/ML model.

In summary, the document demonstrates the substantial equivalence of the Durio Surgical Face Mask to a predicate device based on standardized, non-clinical bench testing for its physical and barrier properties, addressing safety and effectiveness without involving AI/ML components or associated data science methodologies.

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The Surgical 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 ininfection 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(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 nonwoven fabric (polypropylene), and the middle layer is made of melt blown fabric (polypropylene). 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 Polyester 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 .iron and zinc. The proposed device(s) are sold nonsterile and are intended to be single use, disposable device.

This document describes the acceptance criteria and the study proving that the "Surgical Face Mask (L 175*95mm)" device meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

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This single-use surgical mask EFXPLY3SMSK is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure of blood and body fluids. This is a single use, disposable device, non-sterile.

The device is a flat pleated type mask the outer layer being blue and the inner layer being white, utilizing ear loops to secure the mask in place, and a nose bridge is also incorporated for a proper fit around the nose. The device number is EFX3PLYSMSK.

The device is 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 material. The model EFX3PLYSMSK device is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of polypropylene and spandex. The nose bridge contained within the device is placed between the layers of the surgical mask to allow the user to fit the surgical mask properly around their nose. The nose bridge is made up of galvanized with polyethylene.

Here's a breakdown of the acceptance criteria and study information for the Disposable Surgical Face Mask, based on the provided document:

Acceptance Criteria and Device Performance

Level 3 Performance

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The Medline Surgical Face Mask and Medline Procedural Face Mask are intended to be worn to protect both the patient and the healthcare worker from the 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. These masks are single use, disposable, non-sterile devices.

The Medline Surgical Face Mask and Medline Procedural Face Mask are single-use, disposable device, provided non-sterile. Depending on the configurations, the Medline Surgical Face Mask and Medline Procedural Face Mask are composed of three or four layers of nonwoven materials: an outer layer, middle filtration layer(s) and an inner facing layer. The outer/inner facing layers are constructed of non-woven fabric and the middle filtration layer(s) are constructed of melt blown non-woven fabric. Each mask contains tie strings or ear loops to secure the user's face and mouth, and come in a flat pleated style that includes a malleable nosepiece to provide a firm fit over the nose. The Medline Surgical Face Mask and Medline Procedural Face Mask may also come equipped with an antifog foam stripe, anti-glare stripe and/or a face shield to cover the upper part of the face. The Medline Surgical Face Mask and Medline Procedural Face Mask may also be provided in an ASTM Fluid level of Level 1, Level 2 or Level 3. The color of the facemasks will be available in white, yellow, blue, or pink stripes.

The provided document is a 510(k) Premarket Notification for a Medline Surgical Face Mask and Medline Procedural Face Mask. It primarily focuses on demonstrating substantial equivalence to a predicate device, which is different from an AI/ML medical device where the emphasis would be on the performance of an algorithm.

Therefore, the document does not contain the information requested regarding the acceptance criteria and study proving an AI/ML device meets those criteria. Specifically, it lacks data on:

• A table of acceptance criteria and reported device performance: This document specifies performance criteria and test results for physical properties of surgical masks (e.g., bacterial filtration efficiency, fluid resistance, flammability), not for the performance of an AI/ML algorithm.
• Sample size used for the test set and data provenance: No test set for an AI/ML algorithm is mentioned.
• Number of experts used to establish ground truth and their qualifications: Not applicable to a physical mask.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: No training set for an AI/ML algorithm is mentioned.
• How ground truth for the training set was established: Not applicable.

Instead, the document details:

• Device Name: Medline Surgical Face Mask and Medline Procedural Face Mask
• Intended Use: To protect both the patient and healthcare worker from the transfer of microorganisms, body fluids, and particulate material; for use in infection control practices to reduce potential exposure to blood and body fluids. Single use, disposable, non-sterile.
• Predicate Device: Surgical Masks with Ear Loops or Ties, Level 1, Level 2, Level 3 (K202598)
• Non-Clinical Testing: Performance testing was completed based on standards like ISO 10993 (biocompatibility), ASTM F2101-19 (Bacterial filtration efficiency), ASTM F1862 (Resistance to penetration by synthetic blood), 16 CFR Part 1610 (Flammability), ASTM F2100 (Performance of Materials), EN 14683:2019 (Differential Pressure), and ASTM F2299 (Sub-micron particulate filtration efficiency).
• Clinical Testing: Not applicable (as stated in the document).

In summary, this document is for a medical device (surgical face mask) with physical performance requirements, not an AI/ML medical device, and therefore does not contain the specific information requested in the prompt about AI/ML device validation.

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The Surgical Face Mask is intended to be worn to protect both the patient and healthcare persomel 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 Surgical Face Mask is 3-layer, and it is two model is HSD-TYP2R (Ear loops) and HSD-TYP2RT (Tie-On). Flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (spandex and polyester) or tie tapes (spun-bond polypropylene). A malleable nose clip is placed in the layers of facemask for comfort and individualized fit. The surgical face mask color is blue. Product is Level 3 based on ASTM F2100-19. The surgical face mask is single-use, disposable devices, provided non-sterile.

This document is a 510(k) Premarket Notification from Wuhan Huashida Protective Products Co., Ltd. for their Surgical Face Mask. It is a submission to the FDA demonstrating that their device is substantially equivalent to a legally marketed predicate device.

The premise of a 510(k) submission is to demonstrate "substantial equivalence' to a legally marketed device, not necessarily to prove the device's independent safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) application. For a device like a surgical face mask, the FDA generally relies on performance testing against recognized standards rather than clinical studies, especially if the device is similar in design and materials to existing cleared devices.

Therefore, the information provided below is based on the provided document and tailored to how a 510(k) submission addresses "acceptance criteria" through non-clinical testing.

Here's an analysis of the provided text in relation to your request about acceptance criteria and the study proving the device meets them:

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

The document provides a table of acceptance criteria and results from non-clinical performance and biocompatibility testing.

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

This is not applicable for non-clinical performance and biocompatibility testing. Adjudication methods like 2+1 or 3+1 are used in studies where human readers (e.g., radiologists) are involved in interpreting medical images or data, and their disagreements need to be resolved to establish a "ground truth" or reference standard. This document pertains to physical device 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

This is not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools where human interpretation plays a role. This submission pertains to a surgical face mask, which is a physical barrier device, not an AI diagnostic tool. 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

This is not applicable. This question refers to the performance of an AI algorithm in isolation. The product is a surgical face mask, not an algorithm. The testing performed is standalone in the sense that it's the mask's performance being measured directly against established standards.

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

The "ground truth" in this context is based on pre-defined, quantitative performance specifications established by relevant industry standards and regulatory guidance. For example:

• Fluid Resistance: Resistance to penetration by synthetic blood at a specified pressure (ASTM F1862).
• Filtration Efficiency (Particulate & Bacterial): Percentage of particles/bacteria filtered out (ASTM F2299, ASTM F2101).
• Differential Pressure: How easily air can pass through (EN 14683).
• Flammability: A classification based on burn rate (16 CFR 1610).
• Biocompatibility: Absence of cytotoxic, irritating, or sensitizing effects as per ISO 10993 standards.

These standards define the 'truth' or expected performance for a surgical mask of a certain level.

8. The sample size for the training set

This is not applicable. This device is a manufactured medical product, not an AI algorithm that requires a "training set."

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

This is not applicable, as there is no "training set" for this type of device submission.

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The Disposable 4 layers surgical face mask is intended to be worn by adults, and protects both patients and healthcare personnel from microorganisms, body fluids and particulate material transfer within a professional healthcare environment. The mask is designed for use in infection control practices to reduce the potential exposure to blood and body fluids. It is a single-use, disposable device(s) , provided non-sterile.

The WellBefore 4 Layers disposable surgical mask is an adult-sized surgical mask equipped with earloops, designed to cower the user's nose and mouth. The surgical face masks are consists of Outer Layer(Non-woven fabric made from spunbond polypropylene), Second Layer(meltblown filtration fabric made from polypropylene), Third Layer(Electrostastic cotton made from ethylene-propylene side by side), Inner Layer(Non-woven fabric made from spunbond polypropylene), Nose Bridge(Double-wirenosepinmade by polypropylene, and Earloops(Polyster Fiber and Spandex). The mask acts as a physical barrier from fuids and particulate materials, and providing a level 3 barrier. It is a single-use, disposable device(s) , provided non-sterile.

Here's a breakdown of the acceptance criteria and study information for the Disposable 4 layers surgical face mask based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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Ask a specific question about this device