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510(k) Data Aggregation
(88 days)
Disposable surgical mask
The Disposable surgical masks are intended to be worn to protect 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 masks are single use, three-layer, flat - folded masks with ear loops and nose piece. The Disposable surgical masks are manufactured with three layers, the inner and outer layers are made of non-woven fabric (polypropylene), and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' 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 in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of spandex wrapped with metal wire. The surgical face masks will be provided in blue. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
The provided document describes the FDA 510(k) clearance for a "Disposable surgical mask" (K220532), demonstrating its substantial equivalence to a predicate device. The clearance is based on non-clinical performance testing.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Item | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 120 mmHg | 3 non-consecutive lots tested: All passed (implied) | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Lot1: 98.43%, Lot2: 98.18%, Lot3: 98.54% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Lot1: 99.9%, Lot2: 99.9%, Lot3: 99.9% | Pass |
| Differential Pressure (MIL-M-36954C) |
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(470 days)
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate material. The face masks are single use, disposable device, provided non-sterile.
The ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond non-woven polypropylene and the middle layer is constructed of melt blown non-woven polypropylene. The mask is held in place over the 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 is made of malleable polyethylene with Galvanized iron wire and allows the user to fit the facemask around their nose. The ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G is sold non-sterile and is intended to be a single use, disposable device.
The provided text is related to the FDA 510(k) clearance for a surgical mask. It details the device description, intended use, and a comparison of technological characteristics and performance between the subject device and a predicate device.
However, the questions you've asked about "acceptance criteria and the study that proves the device meets the acceptance criteria" are typically associated with artificial intelligence (AI) or machine learning (ML) medical devices, which involve performance evaluation against ground truth established by experts.
The document provided is for a physical medical device (a surgical mask) and its performance is evaluated against established physical and biological standards (e.g., fluid resistance, bacterial filtration efficiency, flammability, biocompatibility). It does not involve AI/ML performance metrics, expert adjudication, or MRMC studies.
Therefore, I cannot answer your specific questions based on the provided text, as they are not relevant to the type of device and study described in the FDA 510(k) submission for a surgical mask.
To give a complete answer, I would need a document related to an AI/ML medical device submission.
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(93 days)
Disposable Surgical Mask
The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Surgical 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.
Disposable Surgical Mask, Ear Loop Type, Size M and S is a single use, three-layer, flat-pleated mask with ear loops and a nose piece. The Disposable Surgical Mask is manufactured with three layers, of which the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The latex free elastic ear loops are made of polyamide fibers and spandex. The nose piece in the layers of face mask allows the user to fit the face mask around their nose, which is made of core iron wire with halogen-free polyethylene covering. The Disposable Surgical Mask will be provided in blue of outside and white of inside. The Disposable Surgical Mask is provided non-sterile and for single use.
The provided document is a 510(k) Premarket Notification for a Disposable Surgical Mask (K212944). It describes the device, its intended use, and a comparison with a predicate device, along with non-clinical test results.
However, the questions you've asked are typically relevant to the validation of Artificial Intelligence (AI)/Machine Learning (ML) medical devices, particularly those that involve image analysis, diagnosis, or risk prediction. This document is for a physical medical device (surgical mask) and the submitted information pertains to its physical performance characteristics, not its performance in an AI/ML context.
Therefore, many of your specific questions, such as those related to:
- Ground truth establishment by experts
- Adjudication methods
- Multi-reader multi-case (MRMC) studies
- Standalone algorithm performance
- Training set size and ground truth establishment
are not applicable to the context of this 510(k) submission for a surgical mask. The document does not involve AI/ML.
I can, however, extract the relevant information regarding the acceptance criteria and the study that proves the device meets those criteria for the surgical mask, based on the provided text.
Acceptance Criteria and Device Performance for Disposable Surgical Mask (K212944)
The device in question is a Disposable Surgical Mask, and its performance is evaluated against established physical and biological standards for medical masks.
Here's a summary tailored to the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Test Method | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| Fluid Resistance Performance | ASTM F1862 | 29 out of 32 pass at 120 mmHg | 31 out of 32 pass at 120 mmHg | Pass |
| Particulate Filtration Efficiency | ASTM F2299 | ≥ 98% | 99.7% | Pass |
| Bacterial Filtration Efficiency | ASTM F2101 | ≥ 98% | 99.5% | Pass |
| Differential Pressure (Delta-P) | MIL-M-36954C |
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(314 days)
Disposable Surgical Mask
The Disposable Surgical 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. The Disposable Surgical Masks are single use, disposable device, provided non-sterile.
Disposable Surgical Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (High-density Polyethylene) to provide a firm fit over the nose. There are four models for Disposable Surgical Mask with different colors and sizes. All six models are Ear Loop type in blue or white colors and two sizes including 145mm×90mm and 175×95mm.
The provided document is a 510(k) summary for a Disposable Surgical Mask (K210042). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria in the context of an AI/ML medical device. The document details performance testing for physical and material properties of the surgical masks.
Therefore, most of the requested information regarding AI/ML device testing (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not applicable to this type of device and submission.
However, I can extract the relevant acceptance criteria and performance data for the Disposable Surgical Mask as presented in the document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Material Performance):
This table is directly from the "IX. PERFORMANCE DATA" section of the document. The acceptance criteria and results refer to the physical and barrier performance of the surgical mask material.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Bacterial Filtration Efficiency | To determine the bacterial filtration efficiency (BFE) | Level 2 ≥ 98% | 32/32 Passed at ≥99.9% |
| Particulate Filtration Efficiency | To determine the particle filtration efficiency (PFE) | Level 2 ≥ 98% | 32/32 Pass at ≥99.5% |
| Differential Pressure (delta-P) | To measure breathability/resistance to airflow | Level 2 |
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(204 days)
Disposable Surgical Mask (Model: YYKZ-01)
The DISPOSABLE SURGICAL 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. It is for single- use and provided non-sterile.
The "DISPOSABLE SURGICAL MASK" is single use, blue color, without face shield, Flat Pleated type, utilizing elastic ear loops for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The "DISPOSABLE SURGICAL MASK" is manufactured with three layers. The inner and outer layers are made of Non-woven fabric (Polypropylene), and the middle filter layer is made of a melt blown fabric (Polypropylene). The subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The elastic ear loop is made of Polyester and Spandex. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of iron strip and polypropylene. The"DISPOSABLE SURGICAL MASK" is sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.
The provided text describes the performance data and acceptance criteria for a Disposable Surgical Mask (Model: YYKZ-01) in a 510(k) summary. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (ASTM F2100-19 Level 1) | Reported Device Performance |
|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥95% | Accepted (Average 99.9%) |
| Particulate Filtration Efficiency (PFE) | ≥95% | Accepted (Average 99.8%) |
| Differential Pressure |
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(110 days)
Disposable surgical mask
The Disposable Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are 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 ear loops way for wearing, and they all have 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 Polypropylene non-woven fabric, and the middle layer is made of polypropylene melt-blown cloth. 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 Elastic materials consisting of Nylon low elastic yarn 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 and galvanized iron wire plastic materials. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The document describes the non-clinical performance testing of a disposable surgical mask to demonstrate its substantial equivalence to a predicate device, rather than a study involving an AI-powered device or human readers. Therefore, much of the requested information regarding AI assistance, human readers, effect size, and ground truth establishment for AI models is not applicable to this document.
However, I can provide information based on the performance testing of the surgical mask.
1. A table of acceptance criteria and the reported device performance
| Item | Reported Device Performance | Acceptance Criteria (Level 2) | Result |
|---|---|---|---|
| Fluid Resistance Performance ASTM F1862 | 31 out of 32 Pass at 120 mmHg | 29 out of 32 Pass at 120mmHg | PASS |
| Particulate Filtration Efficiency ASTM F2299 | 99.4% | ≥ 98% | PASS |
| Bacterial Filtration Efficiency ASTM F2101 | 99.36% | ≥ 98% | PASS |
| Differential Pressure (Delta P) EN 14683 Annex C | 4.43mmH2O/cm² |
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(107 days)
Disposable Surgical Mask (non sterile)
Disposable surgical 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. 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 Disposable surgical mask (non sterile) is single use, three-layer, flat-pleated style with ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The Disposable surgical mask (non sterile) will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
The provided text describes a 510(k) premarket notification for a Disposable Surgical Mask (non-sterile), K211451, submitted by Qinhuangdao Taizhi Medical Technology Co., Ltd. The document primarily focuses on demonstrating substantial equivalence to a predicate device (K182515, Surgical Face Mask by Wuhan Dymex Healthcare Co., Ltd.) through non-clinical testing.
Based on the provided text, the device in question is a Disposable Surgical Mask, not an AI or imaging device. Therefore, many of the requested criteria (e.g., sample size for test set/training set, expert qualification, adjudication method, MRMC study, standalone performance, type of ground truth) typically associated with the development and validation of AI/ML-based medical devices or diagnostic tools are not applicable.
The acceptance criteria and study proving the device meets them are related to the physical and performance characteristics of a surgical mask, as per established standards and guidance for such products.
Here's the information extracted from the document, tailored to the nature of this device:
Acceptance Criteria and Device Performance for Disposable Surgical Mask (K211451)
The device demonstrates conformance to recognized standards and requirements for surgical face masks through non-clinical performance and biocompatibility testing. The testing was conducted to establish substantial equivalence to a predicate device (K182515).
1. Table of Acceptance Criteria and Reported Device Performance
The following table summarizes the performance testing results against established acceptance criteria for surgical masks (specifically, Level 2, ASTM F2100-19):
| Items | Performance Report | Acceptance Criteria (Level 2, ASTM F2100-19) | Result |
|---|---|---|---|
| Bacterial filtration efficiency (BFE) (%) | 99.9% | ≥98% | Pass |
| Differential pressure (mmH2O/cm²) | 2.8-3.6 mmH2O/cm² |
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(164 days)
ECOMA Level 2 Disposable Surgical Mask with Ear Loops
The surgical 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 ECOMA surgical mask is composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), filter layer (polypropylene melt blown, white), and inner layer (polypropylene spunbond, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical face mask is a single use, disposable device, provided non-sterile.
The provided document is a 510(k) Premarket Notification for the ECOMA Level 2 Disposable Surgical Mask with Ear Loops. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical effectiveness study of the device itself. Therefore, many of the requested categories regarding human expert studies, multi-reader multi-case studies, and human-in-the-loop performance are not applicable to this type of regulatory submission for this medical device.
Here's the information extracted from the document regarding acceptance criteria and performance, as applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM F2101-Bacterial Filtration Efficiency (BFE) | ≥ 98% Average BFE for all samples tested | 96/96 samples passed ≥ 98% Average BFE (3 lots, 32 samples per lot with a lot size of 200,000 each) |
| ASTM F2299-Particulate Filtration Efficiency (PFE) | ≥ 98% Average PFE for all samples tested | 96/96 samples passed ≥ 98% Average PFE (3 lots, 32 samples per lot with a lot size of 200,000 each) |
| Differential Pressure | Samples must be |
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(127 days)
Purism Disposable Surgical Mask
The Purism Disposable Surgical 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 Purism Disposable Surgical Masks are manufactured with 3 layers, the inner facing layer and outer facing layer are composed of non-woven fabric, the middle layer is made up of melt-blown fabric. The surgical masks are single use, flat-folded with ear loops. 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 Surgical Masks are sold non-sterile and are intended to be disposable mask.
The provided document is an FDA 510(k) clearance letter for a medical device: "Purism Disposable Surgical Mask". This document does not describe an AI/ML-driven medical device, nor does it detail a study involving AI assistance for human readers or a standalone AI algorithm. It's a standard regulatory submission for a physical medical product (a surgical mask) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.
Therefore, many of the requested items related to AI/ML device studies (such as MRMC studies, human reader improvement with AI, ground truth establishment for training sets, etc.) are not applicable to this document.
However, I can extract information related to the acceptance criteria and the study (non-clinical testing) that proves the device meets these criteria, as detailed in the document.
Here's the breakdown based on the provided text, addressing the applicable points:
Device Name: Purism Disposable Surgical Mask
Regulatory Class: Class II
Product Code: FXX
Regulation Name: Surgical apparel (21 CFR 878.4040)
Predicate Device: K182514 Disposable Surgical Face Mask (Xiantao Zhibo Non-woven Products Co., Ltd)
1. Table of Acceptance Criteria and Reported Device Performance
The document presents non-clinical performance testing and biocompatibility testing.
Non-Clinical Performance Testing:
| Performance Testing Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance | To evaluate the resistance of medical face masks to penetration by the impact of a small volume (~2 mL) of a high-velocity stream of synthetic blood. | At least 29 out of 32 specimens per lot show passing results at 160 mmHg | 94 out of 96 pass at 160mmHg |
| Particulate Filtration Efficiency (PFE) ASTM F2299 | To determine the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres. | ≥ 98% Average PFE for all samples tested | 96/96 Samples Pass at Average of 99.90% |
| Bacterial Filtration Efficiency (BFE) ASTM F2101 | To measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials. | ≥ 98% Average BFE for all samples tested | 96/96 Samples Pass at Average of 99.88% |
| Differential Pressure (Delta P) EN 14683 | To determine the pressure required to breathe through the final manufactured face mask. | Samples must be |
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(157 days)
Disposable Surgical Mask
The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluid and particulate materials. 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 provided non-sterile.
Disposable Surgical Mask is a single-use, disposable surgical mask to cover the nose and mouth to protect the wearer from microorganisms, body fluids and particulates. Disposable Surgical Mask consists of the following materials: Non-woven cloth in the front and back layers, melt-blown cloth in the middle layer, a nose clip and two ear loops in Spandex. The Disposable Surgical Masks are provided non-sterile.
The provided document is a 510(k) premarket notification for a Disposable Surgical Mask (K210267). It details the device's characteristics, its comparison to a predicate device, and the results of non-clinical performance testing.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device (Disposable Surgical Mask, K210267) is a surgical mask intended to meet Level 2 performance according to ASTM F2100:2019. The acceptance criteria and the device's reported performance are summarized in the table below:
| Test Item | Test Method | Acceptance Criteria (Level 2) | Reported Device Performance |
|---|---|---|---|
| Synthetic Blood Penetration Resistance | ASTM F1862/F1862M-17 (according to ASTM F2100:2019) | Pass at 120 mmHg | 32/32 passed at 120 mm/Hg (Pass) |
| Flammability of Clothing Textiles | 16 CFR Part 1610 (according to ASTM F2100:2019) | Class 1 (≥3 Seconds burn time) | 32/32 Passed ≥3 Seconds burn Time-Class 1 (Pass) |
| Differential Pressure (Delta P) | EN 14683: 2019, Annex C (according to ASTM F2100:2019) |
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