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510(k) Data Aggregation
(171 days)
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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(112 days)
The surgical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. this is a single-use, disposable device, provided non-sterile. This mask is safe for use in the MR environment.
The Surgical Face Masks (Ear Loops and Tie-On) are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane) or ties (polyester/polypropylene). A malleable nosepiece is placed within the binding for comfort and individualized fit. The surgical face masks will be provided in white and blue, and options for added cup keeper (polypropylene), visor (polyester), or both. The surgical face masks are single-use, disposable devices, provided non-sterile. This mask is safe for use in the MR environment.
This document is a 510(k) Premarket Notification from the FDA regarding "Surgical Face Masks (Ear Loops And Tie-On)" manufactured by SAN-M PACKAGE CO., LTD. It focuses on demonstrating substantial equivalence to a predicate device (K160269) by the same manufacturer.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the subject device are based on demonstrating substantial equivalence to the predicate device (K160269), which itself would have met specific performance standards. The performance tests are based on ASTM F2100-11 standards for medical face masks.
| Test Parameter / Acceptance Criteria (per ASTM F2100-11) | Subject Device Performance (San-M Surgical Masks) | Predicate Device Performance (K160269) | Comparison |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | |||
| Level 1: Pass at 80 mmHg | Pass at 80 mmHg | Pass at 80 mmHg | Equivalent |
| Level 2: Pass at 120 mmHg | Pass at 120 mmHg | Pass at 120 mmHg | Equivalent |
| Level 3: Pass at 160 mmHg | Pass at 160 mmHg | Pass at 160 mmHg | Equivalent |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | |||
| $\ge 98%$ | Pass at 99.6% (all levels) | Pass at 99.6% (all levels) | Equivalent |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | |||
| $\ge 98%$ (Level 1, 2) | Pass at >98% (Level 1, 2) | Pass at >98% (Level 1, 2) | Equivalent |
| $\ge 99%$ (Level 3) | Pass at >99.9% (Level 3) | Pass at >99% (Level 3) | Equivalent |
| Differential Pressure ($\Delta$P) (MIL-M-36945C) | |||
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(195 days)
Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The surgical face masks are single use multi-laver masks with outer laver and inner laver of polypropylene spunbond that sandwich a meltblown polypropylene filter material. The surgical face mask includes malleable aluminum nosepiece that can be bent to contour the nose. The surgical face masks are held in place with ear loops made of polyester/Lycra.
The information provided describes the acceptance criteria and performance of a Surgical Face Mask (K202708), comparing it to a predicate device (K201729).
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (Predicate/Standard) | Reported Device Performance (K202708) | Outcome |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Fluid Resistant at 80 mmHg | Lot 20201013: Passed 80 mmHg | |
| Lot 20201022: Passed 80 mmHg | |||
| Lot 20201105: Passed 80 mmHg | Meets | ||
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | ≥ 95% | Lot 20201013: PASSED 99.866% | |
| Lot 20201022: PASSED 99.9784% | |||
| Lot 20201105: PASSED 99.9879% | Meets (Exceeds) | ||
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | ≥ 95% | Lot 20201013: PASSED 99.9% | |
| Lot 20201022: PASSED 99.9% | |||
| Lot 20201105: PASSED 99.9% | Meets (Exceeds) | ||
| Differential Pressure (EN 14683 Annex C) |
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(109 days)
The Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
The proposed device, is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of spun-bonded nonwoven polypropylene, and the middle layer is made of melt-blown nonwoven polypropylene. The proposed devices are available in two types, ear-loop and Tie-on. The ear loops are made of nylon and spandex, and the ties are made of spun-bonded nonwoven polypropylene. The ear loops/tie-on is held in place over the users' mouth and nose by ear loops/ties welded to the mask. The nose clip is made of Medical polypropylene+Q235. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. Both the ear loop and tie-on masks are available in different sizes to provide more options for user. The proposed device can be provided in sterile and non-sterile two types.
The document you provided is a 510(k) Premarket Notification for Surgical Face Masks. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical or standalone study.
Therefore, the information requested in your prompt (acceptance criteria, details of a study proving device performance, sample sizes, expert involvement, ground truth establishment, etc.) is not present in this document. This 510(k) primarily relies on non-clinical performance testing and a comparison of technological characteristics to a predicate device.
Specifically:
- No clinical study was conducted or included in this submission. The document explicitly states this in Section 7: "No clinical study is included in this submission."
- The "acceptance criteria" for a 510(k) are typically met by demonstrating that the new device performs "as well as" or "better than" the predicate device in relevant non-clinical tests or by meeting recognized consensus standards. The document shows tables of test results (e.g., Bacterial Filtration Efficiency, Particulate Filtration Efficiency, Fluid Resistance) against, or in comparison to, the predicate device and relevant standards (e.g., ASTM F2100 Level 2).
- There is no mention of human experts establishing ground truth for a test set, adjudication methods, or MRMC studies because there was no clinical study.
However, I can extract information related to the device performance and testing that was done to support the 510(k) clearance, framed as "reported device performance" against relevant "acceptance criteria" derived from the standards and predicate comparison:
The provided 510(k) Premarket Notification for Surgical Face Masks (K202843) demonstrates substantial equivalence to a predicate device (K173062) by relying on non-clinical performance testing rather than a clinical study. Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of human data, expert adjudication, or MRMC studies is not applicable to this submission.
Instead, the device meets "acceptance criteria" by demonstrating performance in laboratory tests in accordance with recognized consensus standards (e.g., ASTM F2100 Level 2) and by showing that its technological characteristics are substantially equivalent to the predicate device.
Here's an interpretation of the requested information based on the provided document, focusing on the non-clinical testing performed:
1. Table of Acceptance Criteria (as per standards/predicate comparison) and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (based on ASTM F2100 Level 2 or predicate) | Reported Device Performance (K202843) |
|---|---|---|
| Fluid Resistance | Pass at 120 mmHg (Same as Predicate) | Pass at 120 mmHg |
| Particulate Filtration Efficiency (PFE) | Meet requirements for Level 2 (~98.98% for predicate) - Note: ASTM F2100 Level 2 minimum PFE is ≥ 98% at 0.1 µm. | Average 98.98% |
| Bacterial Filtration Efficiency (BFE) | Meet requirements for Level 2 (~99.4% for predicate) - Note: ASTM F2100 Level 2 minimum BFE is ≥ 98%. | Average 98.92% |
| Differential Pressure (Delta P) | Meet requirements for Level 2 (Average 2.7 $mmH_2O/cm^2$ for predicate) - Note: ASTM F2100 Level 2 maximum Delta P is |
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(217 days)
The surgical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided nonsterile.
The Surgical Face Masks (Ear loops and Tie-on) are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane) or ties (polypropylene/polyester). A malleable nosepiece is placed within the binding for comfort and individualized fit. The surgical face masks will be provided in white or blue and with the option for a visor. The surgical face masks are single-use, disposable devices, provided non-sterile.
The provided document describes the acceptance criteria and performance of Surgical Face Masks (Ear loops and Tie-on) as part of a 510(k) premarket notification. The study aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove device meets an absolute acceptance criteria.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" but rather "performance requirements" as outlined by recognized standards (ASTM F2100-11 for various levels) and then reports the device's performance against these requirements. It also compares the proposed device's performance to predicate devices.
Acceptance Criteria (Performance Requirements from ASTM F2100-11) and Reported Device Performance
| Test | Level 1 Acceptance Criteria (Per ASTM F2100-11) | Level 1 Reported Device Performance | Level 2 Acceptance Criteria (Per ASTM F2100-11) | Level 2 Reported Device Performance | Level 3 Acceptance Criteria (Per ASTM F2100-11) | Level 3 Reported Device Performance |
|---|---|---|---|---|---|---|
| ASTM F1862 (Fluid Resistance) | Pass at 80 mmHg | Pass at 80 mmHg | Pass at 120 mmHg | Pass at 120 mmHg | Pass at 160 mmHg | Pass at 160 mmHg |
| ASTM F2299 (Particulate Filtration Efficiency) | ≥ 95% | Pass at 99.6% | ≥ 95% | Pass at 99.6% | ≥ 98% | Pass at 99.7% |
| ASTM F2101 (Bacterial Filtration Efficiency) | ≥ 95% | Pass at >98% | ≥ 95% | Pass at >98% | ≥ 98% | Pass at >99% |
| MIL-M36945C (Differential Pressure) |
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