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510(k) Data Aggregation
(343 days)
The 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 surgical mask is single use, three-layer, flat-pleated style with ear loops 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 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 galvanized iron wire. The disposable medical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
The provided text describes the acceptance criteria and the results of non-clinical tests for a surgical mask (K202746). It explicitly states that no clinical study was implemented.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Items | Acceptance Criteria (Level 2, ASTM F2100-19) | Reported Device Performance (Result) |
|---|---|---|
| Bacterial filtration efficiency (BFE) (%) | ≥98 | 99.8~99.9% |
| Differential pressure (mmH2O/cm²) | <6.0 mmH2O/cm² | 4.0~4.4 mmH2O/cm² |
| Sub-micron particulate filtration efficiency at 0.1 micron, % (PFE) | ≥98 | 99.68~99.83% |
| Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass result | 29 of 32 test articles passed at 120mmHg | 32 of 32 test articles passed at 120mmHg |
| Flame spread | Class 1 | Class 1, Non Flammable |
| Cytotoxicity | Comply with ISO 10993-5 (non-cytotoxic) | Noncytotoxic |
| Irritation | Comply with ISO 10993-10 (non-irritating) | Nonirritating |
| Sensitization | Comply with ISO 10993-10 (non-sensitizing) | Nonsensitizing |
2. Sample size used for the test set and the data provenance
- Sample Size for Synthetic Blood Resistance: 32 test articles (masks).
- Data Provenance: The document doesn't explicitly state the country of origin or whether the tests were retrospective or prospective, but it refers to recognized standards (ASTM F2100-19, ISO 10993-5, ISO 10993-10). These are likely laboratory tests conducted to specific protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The tests are non-clinical, laboratory-based performance and biocompatibility tests against established standards, not expert-adjudicated clinical outcomes.
4. Adjudication method for the test set
- Not applicable. This is not a study requiring human adjudication of results. The acceptance criteria are objective measurements against defined metrics.
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
- No. This is a medical device (surgical mask), not an AI-assisted diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a surgical mask, not an algorithm.
7. The type of ground truth used
- Objective Performance Standards: The ground truth is established by recognized international and national standards for medical face masks and biocompatibility, specifically:
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological Evaluation of Medical Device - Part 10: Stimulation and allergic reaction
8. The sample size for the training set
- Not applicable. This device does not involve a training set as it is not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this device.
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(339 days)
The Disposable medical face mask is intended to be worn to protect both the patient and healthcare personnel from 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(s), provided non sterile.
The disposable medical face mask is single use, three-layer, flat-pleated style with ear loops 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 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 galvanized iron wire. The disposable medical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
The provided document describes the acceptance criteria and the study conducted for a Disposable Medical Face Mask (K202745), not an AI-powered medical device. Therefore, many of the requested fields related to AI/MRMC studies, number of experts, and ground truth establishment are not applicable.
However, I can extract the information relevant to the performance testing of the medical face mask as described in the document.
Here's a breakdown of the acceptance criteria and study results for the Disposable Medical Face Mask:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Purpose | Acceptance Criteria (Level 2, ASTM F2100-19) | Reported Device Performance |
|---|---|---|---|
| Bacterial filtration efficiency (BFE) (%) | To evaluate Bacterial filtration efficiency (BFE) (%) | ≥98 | Pass |
| Differential pressure (mmH2O/cm²) | To evaluate Differential pressure (mmH2O/cm²) | <6.0 mmH2O/cm² | Pass |
| Sub-micron particulate filtration efficiency at 0.1 micron, % (PFE) | To evaluate Sub-micron particulate filtration efficiency at 0.1 micron, % (PFE) | ≥98 | Pass |
| Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass result | To evaluate Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass result | 29 of 32 test articles passed at 120mmHg | Pass |
| Flame spread | Not explicitly stated purpose in the document, but standard testing for medical masks. | Class 1 | Pass |
Biocompatibility Testing:
| Item | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Cytotoxicity | To evaluate cytotoxicity | Noncytotoxic | Pass (device is noncytotoxic) |
| Irritation | To evaluate irritation | Nonirritating | Pass (device is nonirritating) |
| Sensitization | To evaluate sensitization | Nonsensitizing | Pass (device is nonsensitizing) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Performance Testing: Three nonconsecutive lots were tested, with each lot having 32 samples, for a total of 96 samples.
- Data Provenance: The document does not explicitly state the country of origin of the data beyond the manufacturer being in China. The testing was described as conforming to recognized standards like ASTM F2100-19 and FDA guidance. The studies are retrospective in the sense that they are conducted on manufactured samples to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a physical product (face mask) with performance measured against established physical and chemical standards (e.g., filtration efficiency, pressure differential, blood penetration). It does not involve human expert interpretation for "ground truth" in the way an AI diagnostic device would.
4. Adjudication Method for the Test Set
- Not Applicable. As mentioned above, the tests are objective measurements against defined standards, not subjective interpretations requiring adjudication.
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 device is a disposable medical face mask, not an AI-powered diagnostic tool. No MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is based on pre-defined, objective, and standardized laboratory test methods (e.g., those referenced in ASTM F2100-19) and their corresponding quantitative or qualitative pass/fail criteria. These standards are established through expert consensus in the field of material science and medical device testing, but not for case-by-case "ground truth" establishment as in diagnostic imaging.
8. The sample size for the training set
- Not Applicable. This refers to a manufactured physical product; there is no "training set" in the context of an algorithmic device.
9. How the ground truth for the training set was established
- Not Applicable. As above, there is no training set for this type of device.
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