Search Results
Found 8 results
510(k) Data Aggregation
(208 days)
Disposable Medical Surgical Mask
The Disposable Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Disposable Medical 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 sterile.
The Disposable Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Disposable Medical 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 sterile.
The proposed device(s) are Blue color, and Flat Pleated type mask(s), utilizing Ear Loops to secure to the users head and a pliable Nose Piece for fitting the facemask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene melt-blown fabric.
The Medical Surgical Masks-Sterile is held in place over the users' mouth and nose by two elastic ear loops affixed to the facemask. The elastic ear loops are made with nylon or spandex.
The nose piece contained in the proposed device(s) is contained within the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene and metal wire.
The proposed device(s) are sold sterile and are intended to be single-use, disposable devices.
The provided document is a 510(k) Summary for a medical device, a "Disposable Medical Surgical Mask". It details the device's technical characteristics, performance, and biocompatibility compared to a predicate device, as well as the non-clinical tests performed to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM F1862 | Resistance to penetration by synthetic blood | 120 mm Hg | 120 mm Hg (Table 2 and Test Method/Results table, page 7) |
| ASTM F2299 | Sub-micron particulate filtration efficiency at 0.1 micron | ≥ 98% | ≥ 98% (Table 2 and Test Method/Results table, page 7) |
| ASTM F2101 | Bacterial Filtration Efficiency | ≥ 98% | ≥ 99% (Table 2 and Test Method/Results table, page 7) |
| EN 14683 Annex C | Differential Pressure |
Ask a specific question about this device
(158 days)
Disposable Medical Surgical Mask
The Disposable Medical Surgical 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 in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided sterile.
The Disposable Medical Surgical Mask is composed of mask body, nose clip and ear loop. The body of the 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 nose clip is made of plastic materials and iron wire, ear loop is made of spandex.
The size of the Disposable Medical Surgical Mask is 17.5*9.5cm with tolerance +/- 0.2cm, the length of the ear loop is 17cm with tolerance +/-5 cm, and the length of the nose clip should no less than 8.0cm.
The outer layer of Disposable Medical Surgical Mask will be provided in blue, the inner layer of the Disposable Medical Surgical Mask will be provided in white, and it will be provided with sterile and is intended to be single use, disposable devices.
This document describes the premarket notification for a Disposable Medical Surgical Mask. It does not contain information about an AI/ML powered device, so I cannot answer your questions as they pertain to the criteria for AI/ML powered medical devices.
The document discusses the substantial equivalence of the proposed device to a legally marketed predicate device, focusing on material composition, intended use, and performance characteristics consistent with surgical masks.
However, I can extract the acceptance criteria and performance results for this non-AI medical device.
1. A table of acceptance criteria and the reported device performance
| Item | Proposed device | Acceptance Criteria (level 2) | Result |
|---|---|---|---|
| Fluid Resistance Performance | |||
| ASTM F1862 | 32 out of 32 pass at | ||
| 120 mmHg | 29 out of 32 pass at 120 mmHg | PASS | |
| Particulate Filtration Efficiency | |||
| ASTM F2299 | 99.9% | ≥ 98% | PASS |
| Bacterial Filtration Efficiency | |||
| ASTM F2101 | 99.9% | ≥ 98% | PASS |
| Differential Pressure (Delta P) | |||
| EN 14683 Annex C | 3.26 mmH2O/cm² |
Ask a specific question about this device
(258 days)
Disposable Medical Surgical Mask
The "Disposable Medical Surgical Mask" is intended to be worn to protect both the patient on the from the transfer of microorganisms, body fluids and particulate material. The 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 nonsterile.
The "Disposable Medical Surgical Mask" is single use, without face shield, Flat Pleated type, utilizing ear loops for wearing, and it has a Nose clip design for fitting the facemask around the nose. The "Disposable Medical Surgical Mask" is manufactured with three layers. The inner and outer layers are made of Spunbond fabric (Polypropylene), and the middle filter layer is made of a meltblown 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 ear loop is made of Knited nylon and spandex. The nose clip 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 Synthetic iron wire, PP and PE. The "Disposable Medical 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 a submission for a Disposable Medical Surgical Mask seeking FDA clearance (K210348) by demonstrating substantial equivalence to a predicate device (K202463).
Here's the analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided document includes two tables that effectively serve this purpose, one for general performance and another for biocompatibility.
Performance Test Results:
| Test Item | Test Standard | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| BFE (Bacterial Filtration Efficiency) | ASTM F2101-19 | ≥98% | Accepted (≥98%) |
| PFE (Particulate Filtration Efficiency) | ASTM F2299-03(2017) | ≥98% | Accepted (≥98%) |
| Differential Pressure | EN 14683:2019+AC (2019)(E), Annex C | 10% occurs in three or more animals, the test article did not meet the requirements. (2) If slight signs are observed, and no more than one animal showed gross symptoms or died, repeat with ten animals. If all ten animals show no meaningful biological reactivity, the test article met the requirements. | Under the condition of the test, the test article was found to be non-systemic toxicity. |
2. Sample size used for the test set and the data provenance
- Sample Size: For performance testing (BFE, PFE, Differential Pressure, Synthetic Blood Penetration Resistance, Flammability), the testing was performed using 3 nonconsecutive lots of 32 samples per lot.
- Data Provenance: Not explicitly stated regarding country of origin or specific lab accreditation, but the tests were "conducted below testing" for the proposed device, suggesting the tests were specifically performed for this submission. The lack of further detail on provenance beyond "Proposed Device" suggests these are new tests conducted for the submission. The classification and purpose indicate these are likely laboratory tests rather than human clinical data. The submission is from Weihai Dishang Medical Technology Co., Ltd in Weihai, Shandong, China.
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 to this type of device and study. The "ground truth" for surgical masks is established by objective measurements based on specified ASTM and ISO standards (e.g., filtration efficiency, differential pressure). There are no human experts "establishing ground truth" in the way radiologists establish ground truth for medical images. The acceptance criteria themselves serve as the ground truth.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations, primarily in imaging studies where multiple readers interpret cases and disagreements need to be resolved. For objective laboratory tests like those performed on a surgical mask, there is no subjective interpretation requiring an adjudication process.
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. This is a submission for a physical medical device (surgical mask), not an AI-powered diagnostic tool, therefore no MRMC study, human readers, or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth used for this device is based on established objective laboratory test results that meet internationally recognized standards (ASTM, EN, ISO) for performance and biocompatibility. These standards define the acceptable range for parameters like filtration efficiency, pressure differential, and biological reactions.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of testing a physical medical device like a surgical mask. These are direct performance and safety evaluations.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set involved.
Ask a specific question about this device
(43 days)
Disposable medical surgical mask
The Disposable medical surgical mask is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The 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.
The Disposable medical surgical mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The 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.
The proposed device(s) are 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(s) are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene meltblown fabric.
The Disposable medical surgical mask is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with nylon and spandex.
The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene coated steel wire.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
The acceptance criteria and device performance for the "Disposable medical surgical mask" (K212097) are detailed in the provided tables.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance (K212097) |
|---|---|---|---|
| ASTM F1862 | Resistance to penetration by synthetic blood | 160 mm Hg | 160 mm Hg (32 out of 32 pass) |
| ASTM F2299 | Sub-micron particulate filtration efficiency at 0.1 micron | ≥ 98% | ≥ 99% |
| ASTM F2101 | Bacterial Filtration Efficiency | ≥ 98% | ≥ 99% |
| EN 14683 Annex C | Differential Pressure |
Ask a specific question about this device
(212 days)
Disposable medical surgical mask
The disposable medical 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 as sterile and non-sterile.
The surgical mask consists of a mask body, a nose piece, and ear loops. The mask body is divided into three layers, the inner and outer layers are made of polypropylene fabrics; the middle layer is composed of Melt-blown cloth (polypropylene); the nose piece is made of polypropylene & iron (Fe), and the ear loops are made of nylon & spandex.
The provided document is a 510(k) Premarket Notification for a Disposable Medical Surgical Mask. This type of device is a physical product and not an AI/ML software device. Therefore, the questions regarding AI/ML specific criteria (such as training sets, ground truth establishment methods, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this submission.
The document details the acceptance criteria and a study proving the device meets these criteria for a medical mask. The study focuses on bench testing and biocompatibility testing, which are standard for physical medical devices of this type.
Here’s the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Test Methodology (standard) | Purpose | Acceptance Criteria | Results (for both sterile and non-sterile masks, as they show very similar results in the combined summary table) |
|---|---|---|---|
| ASTM F 1862-17 | Fluid Resistance Performance | 29 out of 32 pass at 160 mmHg | Lot 1# pass at 160mmHg; |
| Lot 2# pass at 160mmHg; | |||
| Lot 3# pass at 160mmHg | |||
| ASTM F2101-19 | Bacterial Filtration Efficiency | ≥ 98% | Lot 1# 99.6%-99.9%; |
| Lot 2# 99.7%-99.9%; | |||
| Lot 3# 99.6%-99.9% | |||
| EN 14683: 2019 | Differential Pressure (Delta-P) |
Ask a specific question about this device
(155 days)
Disposable Medical Surgical Mask
The Disposable Medical 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 proposed device(s) are 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(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt-blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the 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 polyethylene coated steel wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided text describes the 510(k) premarket notification for a Disposable Medical Surgical Mask (K202511). This is a regulatory submission for a medical device, and as such, the "study" referred to is primarily a set of performance tests conducted to demonstrate substantial equivalence to a predicate device, rather than a clinical trial or an AI algorithm validation study.
Therefore, many of the requested elements regarding AI performance, human reader studies, and sophisticated ground truth establishment are not applicable to this type of medical device submission. The device in question is a physical product (a surgical mask), not an AI algorithm or diagnostic tool.
Here's the breakdown based on the provided document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from recognized standards for surgical masks, primarily ASTM F2100 levels. The study demonstrates performance against these criteria.
| Item | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance Performance | 29 out of 32 pass at 160 mmHg | 32 out of 32 pass at 160 mmHg | Pass |
| Particulate Filtration Efficiency | $\ge$ 98% | 98.6% | Pass |
| Bacterial Filtration Efficiency | $\ge$ 98% | 99.9% | Pass |
| Differential Pressure (Delta-P) Test |
Ask a specific question about this device
(169 days)
Disposable Medical Surgical Masks
The Disposable Medical Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask with Ear Loop 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 Medical Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Disposable Medical Surgical Masks 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 Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond non-woven, and the middle layer is made of Melt-blown non-woven fabric.
The Disposable Medical Surgical Masks is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with Polyurethane fiber and Nylon.
The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of PE and iron wire.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
The proposed device(s) are meet the Level 3 Barrier requirements per ASTM F2100-19.
This document is a 510(k) Premarket Notification for a medical device (Disposable Medical Surgical Masks). It is a regulatory submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to the predicate device based on non-clinical performance and specifications.
Therefore, many of the typical acceptance criteria and study details relevant to AI/ML-based medical devices (like MRMC studies, expert adjudication, separate training/test sets for AI, human-in-the-loop performance, etc.) are not applicable to this document, as it describes a physical medical device (surgical masks) and its performance based on standardized material testing.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on meeting established industry standards for surgical masks, primarily ASTM F2100-19 for medical face mask materials, and other related standards (ISO 10993 for biocompatibility, ASTM F1862 for fluid resistance, etc.). The reported device performance is presented in comparison to these standards and a predicate device.
Table of Acceptance Criteria and Reported Device Performance (Summary from Section 6 and 7):
| Test Item / Performance Characteristic | Acceptance Criteria (from ASTM F2100 Level 3 Requirements or relevant standard) | Proposed Device Reported Performance | Status (Meets/Exceeds/N/A) |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | 160 mmHg | 160 mmHg | Meets |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 98.02 - 98.80% | Meets/Exceeds |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | ≥ 98% | 99.6 - 99.7% | Meets/Exceeds |
| Differential Pressure (MIL-M-36945C) |
Ask a specific question about this device
(211 days)
Disposable Medical Surgical Mask
The Disposable Medical Surgical Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, blood, body fluids and particulate material. This surgical mask is 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.
The Disposable Medical Surgical Mask (rectangular) is single use, three-layer, flat-folded masks with ear loops and nose piece. The Surgical Mask is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The mask is held in place by the elastic ear loops. The nose piece in the layers of surgical mask is to allow the user to fit the mask around their nose, which is made of malleable polyethylene wire. The mask is a single use, disposable device, provided non-sterile. This device is not made from Natural Rubber Latex.
The provided document is a 510(k) Premarket Notification for a Disposable Medical Surgical Mask, which is a Class II medical device. The document details the device's characteristics, intended use, and comparative analysis against a predicate device, focusing on non-clinical performance and biocompatibility testing. It is important to note that this document does not describe an AI/ML-driven medical device, and therefore, many of the requested criteria regarding AI model evaluation (e.g., training set, ground truth experts, MRMC studies) are not applicable.
However, I can extract the relevant information regarding the acceptance criteria and the study that proves the device meets those criteria, as detailed in the non-clinical performance testing section.
Here's the breakdown based on the provided text:
Device Type: Disposable Medical Surgical Mask (Not an AI/ML device)
1. A table of acceptance criteria and the reported device performance:
The device performance is evaluated against the ASTM F2100-19 standard for medical face masks, along with other relevant standards for specific tests.
| Performance testing Item | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance ASTM F1862 | ≥160 mmHg Pass: 29 out of 32 masks at 160 mmHg | 29 out of 32 pass at 160 mmHg | Pass |
| Particulate Filtration Efficiency ASTM F2299 | ≥ 98% | ≥ 98% | Pass |
| Bacterial Filtration Efficiency ASTM F2101 | ≥ 98% | ≥ 98% | Pass |
| Differential Pressure (Delta P) MIL-M-36954C |
Ask a specific question about this device
Page 1 of 1