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510(k) Data Aggregation
(96 days)
Disposable Surgical Face Mask
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
| Test Methodology | Accepted Criteria (Level 3) | Reported Device Performance (EFX3PLYSMSK) | Result |
|---|---|---|---|
| Fluid Resistance ASTM F1862 | 160mm Hg. | 95 of 96 samples passed | Pass |
| Particulate Filtration Efficiency ASTM F2299 | ≥98% | 99.79% Filtration average efficiency across 96 samples | Pass |
| Bacterial Filtration Efficiency ASTM F2101-19 | ≥98% | 99.8% Filtration average efficiency across 96 samples | Pass |
| Differential Pressure (Delta P) AMST F2100-19 |
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(780 days)
Disposable Surgical Face Mask
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(287 days)
Disposable surgical face mask
The Disposable surgical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials 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 blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.
The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond Nonwoven fabric polypropylene, and the middle layer is made of melt blown polypropylene filter. The filter fiber is used for particle adsorption, mechanical sieve retention, inertial deposition, and electrostatic adsorption deposition, so that the air containing harmful substances is filtered through the filter material of the mask and then inhaled or exhaled.
The style of the device, ear loops, is held in place over the users' mouth and nose by two ear loops welded to the facemask. The ear loops are not made with natural rubber latex but made of polyester and spandex.
The nose piece contained in the proposed device is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of polypropylene and iron.
The proposed device should be stored in a dry, ventilated and pollution-free area; the temperature should be 0-40 ℃, and the humidity should not be higher than 80%; Keep away from fire sources, avoid dust exposure and direct sunlight.
The proposed device is sold non-sterile and is intended to be a single use, disposable device.
The provided text is a 510(k) summary for a disposable surgical face mask. It does not detail a study involving AI assistance for human readers or the establishment of ground truth by multiple experts for an AI device. Instead, it focuses on demonstrating substantial equivalence of the new medical device (a surgical mask) to a legally marketed predicate device through non-clinical performance testing and biocompatibility studies.
Therefore, most of the requested information regarding AI device acceptance criteria, MRMC studies, ground truth establishment for AI, and training/test set details for an AI model cannot be extracted from this document as it pertains to a different type of medical device evaluation.
However, I can provide information based on the performance testing of the surgical mask, interpreted as its "acceptance criteria" and "device performance".
Here's the information that can be extracted:
Device Acceptance Criteria and Performance (for a Disposable Surgical Face Mask)
The acceptance criteria and performance data are based on non-clinical testing against established standards for medical face masks and biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
The device (Disposable surgical face mask, Model: AD-PR02, AD-PR02-2, AD-PR02-S01, AD-PR02-S02 manufactured by Shandong Aida Medical Products Co., Ltd) was tested against the requirements for an ASTM F2100-2020 Level 2 classification mask.
| Characteristic | Acceptance Criteria (ASTM F2100-2020 Level 2) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Resistance to Penetration by Synthetic Blood | ≥ 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | Yes |
| Particulate Filtration Efficiency (PFE) | ≥ 98% | Pass (specific value: 98.46%) | Yes |
| Bacterial Filtration Efficiency (BFE) | ≥ 98% | 99.9% | Yes |
| Differential Pressure (Delta P) |
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(428 days)
Disposable Surgical Face Mask
The disposable 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, Disposable Surgical Face Mask is a three-layer, flat-folded mask. The mask body is made of 25g/m2 polypropylene (PP) non-woven cloth. The mask contains tie strings or ear loop to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Polyurethane and spandex, and tie strings are made of polypropylene nonwoven cloth. The nose clip which is made of Iron-Zinc strip covered by polyethylene terephthalate (PET) covering. The disposable surgical face mask is available in two different specifications: 17.5×9.5cm and 16.5×8.5cm. The device is single use and provided sterile.
The document describes the testing and acceptance criteria for a "Disposable Surgical Face Mask" (K212649). This is a medical device, not an AI/ML device, therefore, many of the requested categories such as "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "sample size for the training set" are not applicable.
Here's the information extracted and organized as requested, with "N/A" for sections not relevant to a non-AI medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| No | Item | Test Method/Standard | Type | Acceptance Criteria | Reported Performance for Ear Loop Type | Reported Performance for Tie-on Type |
|---|---|---|---|---|---|---|
| 1 | Particulates Filtration Efficiency | ASTM F2299/F2299M-03(2017) | Ear loop | ≥98% | Lot 1: 98.81% | |
| Lot 2: 98.78% | ||||||
| Lot 3: 98.8% | N/A (listed separately below) | |||||
| Tie-on | ≥98% | N/A (listed above) | Lot 1: 98.82% | |||
| Lot 2: 98.78% | ||||||
| Lot 3: 98.79% | ||||||
| 2 | Bacterial Filtration Efficiency | ASTM F2101-19 | Ear loop | ≥98% | Lot 1: 99.9% | |
| Lot 2: 99.91% | ||||||
| Lot 3: 99.91% | N/A (listed separately below) | |||||
| Tie-on | ≥98% | N/A (listed above) | Lot 1: 99.91% | |||
| Lot 2: 99.9% | ||||||
| Lot 3: 99.91% | ||||||
| 3 | Fluid Resistance | ASTM F1862/F1826M-17 | Ear loop | 120 mmHg | Lot 1: No penetration at 120 mmHg | |
| Lot 2: No penetration at 120 mmHg | ||||||
| Lot 3: No penetration at 120 mmHg | N/A (listed separately below) | |||||
| Tie-on | 120 mmHg | N/A (listed above) | Lot 1: No penetration at 120 mmHg | |||
| Lot 2: No penetration at 120 mmHg | ||||||
| Lot 3: No penetration at 120 mmHg | ||||||
| 4 | Differential Pressure | EN 14683:2019 | Ear loop | △P |
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(109 days)
Disposable Surgical Face Mask (M663BE, M663BT)
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring 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 Disposable Surgical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops or ties. The blue colorant is polypropylene (PP) master batch.
The body of the mask is composed of four layers: the inner(4th layer) and outer(1st layers are made of spun-bond polypropylene, the 2nd layer is made of polyethylene film and the 3rd layer is made of melt blown polypropylene. The nose piece is made of Iron core coated with polypropylene, ear loop is made of Nylon and Spandex, and the ties are made of spun-bond polypropylene. Each mask contains ear loops or ties to secure the mask over the user's face and mouth with a bendable nose piece to firmly fit over the nose. This device is not made with natural rubber latex. The disposable surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
The provided FDA 510(k) summary describes the acceptance criteria and the study results for the Disposable Surgical Face Mask (M663BE, M663BT).
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | To demonstrate resistance to penetration by synthetic blood. | ASTM F2100 Level 3 | |
| 29 out of 32 pass at 160 mmHg for Level 3 | Pass | ||
| 32 out of 32 pass at 160 mmHg, 3 lots | |||
| Particulate Filtration Efficiency (ASTM F2299) | To demonstrate the functionality of the subject device. | ≥ 98% | Pass |
| Average 99.929%, 99.947%, 99.978% | |||
| Bacterial Filtration Efficiency (ASTM F2101) | To demonstrate the functionality of the subject device. | ≥ 98% | Pass |
| Average 99.8%, 99.9%, 99.8% | |||
| Differential Pressure (EN 14683 Annex C) | To demonstrate the functionality of the subject device. |
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(86 days)
Disposable Surgical Face Mask (FM-34EE,FM-44EE)
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring of microorganisms, body fluids and particulate material. These surgical 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 subject Disposable Surgical Face Masks have two model: FM-34EE, Level 2 and Model: FM-44EE, Level 3.
The Disposable Surgical Face Masks (Model: FM-34EE, Level 2) are three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is polypropylene (PP) master batch.
The inner layer and outer layer of FM-34EE mask are made of spun-bond polypropylene, the middle layer is made of melt-blown polypropylene.
The Disposable Surgical Face Masks (Model: FM-44EE, Level 3) are four-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer, filtration layer and outer layer. The colorant is polypropylene (PP) master batch.
The inner layer and outer layer of FM-44EE are made of spun-bonded polypropylene, the second layer is made of PE film, the filtration layer is made of melt-blown polypropylene.
The ear loops of both models are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are 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 aluminum.
The Disposable Surgical Face Masks of both models are sold non-sterile and are intended to be single use, disposable devices.
The masks are designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.
The acceptance criteria and study proving the device meets them are detailed below, based on the provided text.
The device in question is the "Disposable Surgical Face Masks (FM-34EE, FM-44EE)".
1. Table of Acceptance Criteria and Reported Device Performance
The device includes two models: FM-34EE (Level 2) and FM-44EE (Level 3). The acceptance criteria and performance are outlined for both levels where applicable.
| Performance Testing | Test Methodology | Acceptance Criteria for Level 2 Barrier | Acceptance Criteria for Level 3 Barrier | Reported Performance (Result for both Levels) |
|---|---|---|---|---|
| Bacterial Filtration Efficiency | ASTM F2101 | $\geq$ 98% | $\geq$ 98% | Passed (Level 2: average 99.9%, Level 3: average 99.9%) |
| Differential Pressure (mmH2O/cm²) | EN 14683:2019 Annex C | $ |
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(62 days)
Disposable Surgical Face Mask (M01, M02)
The Disposable 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 Disposable Surgical Face Mask is blue color, single use, that-folded masks with nose piece and ear loops or ties. The blue colorant is polypropylene (PP) master batch.
The body of the mask is composed of three layers: the inner and outer layers are made of polypropylene spun-bond nonwoven fabric, and the middle layer is made of polypropylene melt blown non-woven fabric. The nose clip is made of galvanized iron wire coated by polypropylene (PP), ear loop is made of Nylon and Spandex, and the ties are made of polypropylene spun-bond nonwoven fabric.
The size of surgical face masks is 17.5*9.5cm with tolerance±5%, the length of the ear loop is about 15.5cm to 16.5cm, and the length of the ties is 40 cm.
The disposable surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
The provided document is a 510(k) summary for a Disposable Surgical Face Mask. This type of medical device is generally subject to performance testing against established standards, rather than clinical studies requiring expert interpretation or AI/algorithm performance. Therefore, many of the requested elements (like MRMC studies, details on experts, ground truth for training sets, etc.) are not applicable to this specific device submission.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a non-powered, non-software-driven medical device (disposable surgical face mask). Its performance is evaluated against recognized industry standards for surgical masks.
| Test Methodology | Purpose | Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | To assess resistance to penetration by synthetic blood. | 29 out of 32 pass at 160 mmHg for level 3 | Pass: 32 out of 32 pass at 160 mmHg, 3 lots |
| Particulate Filtration Efficiency (ASTM F2299) | To demonstrate functionality and efficiency of materials in filtering particulates. | ≥ 98% | Pass: Average 99.1% |
| Bacterial Filtration Efficiency (ASTM F2101) | To demonstrate functionality and efficiency in filtering bacteria. | ≥ 98% | Pass: Average 99.5% |
| Differential Pressure (EN 14683 Annex C) | To measure breathability. |
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(196 days)
Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)
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 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/sterile.
The proposed devices are three-layer, flat pleated masks. A mask is composed of a mask body, a nose piece, two ear loops and two side tapes. The mask body is manufactured with three layers, the inner layer and the outer layer are made of spunbond polypropylene nonwoven fabric, and the middle layer is made of meltblown polypropylene nonwoven fabric. The proposed device 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 knitted elastic loops (made of polyester and spandex). The nose piece is in the layers of face mask to allow the user to fit the face mask around their nose, which is a iron wire with polypropylene covering. In order to improve the wearing comfort, two side tapes are welded to the mask body along the width direction to cover the mask edges. The side tapes are made of spunbond polypropylene nonwoven fabric (the same material as the inner layer). The proposed device contains two models, and the structure, materials and dimensions of the two models are exactly the same except the status. Disposable Surgical Face Mask is provided non-sterile and Disposable Surgical Face Mask (Sterile) is provided sterile. They are both intended to be single use, disposable devices. The proposed devices can meet the requirements for the performance class of Level 3 specified in ASTM F2100.
This document primarily concerns the regulatory approval (510(k) clearance) of a medical device, specifically a Disposable Surgical Face Mask, by the FDA. The information provided heavily focuses on non-clinical performance testing against established standards, rather than the type of clinical study involving human-in-the-loop performance or expert consensus typically found in AI/CADe device submissions.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not available within this document because the device is a physical product (a face mask) and its evaluation relies on established material and performance standards, not on image interpretation or diagnostic algorithms.
Here's the breakdown based on the provided document:
Acceptance Criteria and Device Performance for Disposable Surgical Face Mask
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against the requirements for Level 3 as specified in ASTM F2100-19 and other relevant standards.
| Test (Standard) | Purpose | Acceptance Criteria per ASTM F2100-19 (AQL=4.0%) | Reported Performance (Disposable Surgical Face Mask) | Reported Performance (Disposable Surgical Mask (Sterile)) |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Verify the fluid resistance of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-19. | Pass at 160 mmHg | 96 out of 96 pass at 160 mmHg | 96 out of 96 pass at 160 mmHg |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | Verify the bacterial filtration efficiency of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-19. | ≥ 98% | 99.5%~99.7% (Average: 99.6%) | 99.7%~99.9% (Average: 99.8%) |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | Verify the particulate filtration efficiency of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-19. | ≥ 98% | 99.37%~99.99% (Average: 99.74%) | 99.32%~99.85% (Average: 99.63%) |
| Differential Pressure (Delta-P) (EN 14683) | Verify the differential pressure of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-19. |
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(181 days)
Disposable Surgical Face Mask
The Disposable 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 proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the face mask around the nose. The outer layer is blue, and the colorant material is identified as Phthalocyanine Blue , CAS number: 147-14-8. 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, tie-on, is held in place over the uers'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 uers's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document primarily details the substantial equivalence determination for a Disposable Surgical Face Mask (K211696) to a predicate device (K133070). The acceptance criteria and "study" mentioned in the document refer to a series of non-clinical performance and biocompatibility tests conducted on the proposed device to demonstrate that it meets established standards for surgical masks, specifically ASTM F2100 Level 3 requirements.
Here's the breakdown of the information as requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology (Non-Clinical) | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| ASTM F2299-03 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres (Particulate Filtration Efficiency) | ≥98% | ≥ 99% (Passed for 3 lots) |
| ASTM F1862-17 Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity) (Fluid Resistance Performance) | Level 3, No penetration at 160mmHg | Passed at 160 mmHg (for 3 lots) |
| ASTM F2101-19 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (Bfe) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus. (Bacterial Filtration Efficiency) | ≥98% | ≥ 99% (Passed for 3 lots) |
| Differential Pressure (Delta P) EN14683:2019, Annex C and ASTM F2100-19 (Breathability) |
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(154 days)
Disposable Surgical Face Mask
The Disposable 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. 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 device(s), provided non sterile.
The Disposable Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.
The Disposable Surgical Face Mask is single use, three-layer, flat-pleated style with ear-loop and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the ear-loop is made of spandex and polyester, and the middle layer is made of melt blown fabrics. During use, the ear-loop shall be tied over user ear. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The Disposable Surgical Face Mask is provided in blue color. The mask is sold non-sterile and are intended to be single use, disposable devices.
The document describes the acceptance criteria and performance of a "Disposable Surgical Face Mask" (K210643) compared to a predicate device (K203200).
Here's the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria | Reported Device Performance | ASTM F2100 Level (if applicable) |
|---|---|---|---|
| Fluid Resistance (ASTM F1862M-17) | 160 mmHg (Level 3) | 95 of 96 samples passed at 160mmHg | Level 3 |
| Particulate Filtration Efficiency (PFE) (ASTM F2299-03) | ≥98% | 96/96 samples passed at ≥98% | Level 3 |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-19) | ≥98% | 94/96 samples passed at ≥98% | Level 3 |
| Differential Pressure (EN 14683 Annex C) |
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