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510(k) Data Aggregation
(231 days)
The surgical face mask(Model: Flat Ear Loop/CN102) are intended to be worn to protect both the patient and healtheare 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(s), provided non-sterile.
The surgical face mask is pleated three-layer mask. The inner and outer layers are made of spun-bond polypropylene. The middle layer is made of melt blown polypropylene filter.only the outer layers' color is blue (colorant: Pigment Blue15:3 /CAS number:147-14-8), which is held to cover the users' mouth and nose by two polyester and spandex elastic bands ultrasonic welded to the surgical face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the surgical face mask is in the middle layer of surgical face mask to allow the user to fit the surgical face mask around their noses, which is made of malleable aluminum wire coated with polypropylene resin.All of the material used in the construction of the new masks are being used in currently marketed devices.
The dimensions of each surgical face mask are length 175±10 mm and width 90±10 mm,The dimensions of nose piece is length 110±10 mm, and the ear loop is length 180±20 mm. The surgical face mask are sold non-sterile and are intended to be single use,disposable devices.
The document describes the non-clinical tests performed to demonstrate that the Crown Name Disposable Hygiene Products Fty., Ltd. Surgical face mask (Model: Flat Ear Loop/CN102) meets the acceptance criteria for a Level 2 surgical mask according to ASTM F2100.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item (Performance Level 2) | Acceptance Criteria (Level 2) | Reported Device Performance (Subject Device) | Result |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) ASTM F2101-19 | BFE ≥ 98% | Lot A: 99.89%, Lot B: 99.89%, Lot C: 98.87% | Pass |
| Differential Pressure (Delta-P) EN 14683:2019, Annex C | Delta-P < 6.0 mm H₂O/cm² | Lot A: 3.3 mm H₂O/cm², Lot B: 3.3 mm H₂O/cm², Lot C: 3.3 mm H₂O/cm² | Pass |
| Sub-micron Particulate Filtration Efficiency (PFE) at 0.1 micron ASTM F2299 | PFE ≥ 98% | Lot A: 98.36%, Lot B: 98.49%, Lot C: 98.43% | Pass |
| Resistance to Penetration by Synthetic Blood ASTM F1862 | 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | Pass |
| Flame Spread 16 CFR Part 1610 | Class 1: Burn time ≥ 3.5 seconds | Class 1 | Pass |
| Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxic | Device is non-cytotoxic | Pass |
| Irritation (ISO 10993-10:2010) | Non-irritating | Device is non-irritating | Pass |
| Sensitization (ISO 10993-10:2010) | Non-sensitizing | Device is non-sensitizing | Pass |
2. Sample Size Used for the Test Set and Data Provenance
For the performance tests (BFE, Delta-P, PFE, Synthetic Blood Resistance, Flame Spread):
- Sample Size: 3 non-consecutive lots were tested. For each lot, a sample size of 32 devices (or samples from devices) was used.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, beyond stating that "non-clinical tests were conducted." Given the context of a 510(k) submission, these are typically laboratory-based, prospective performance tests conducted by the manufacturer or a contracted lab.
For Biocompatibility tests (Cytotoxicity, Irritation, Sensitization):
- Sample Size: Not explicitly stated, but typically these tests involve standardized in-vitro or in-vivo (animal) models, not human subjects, and follow specific protocols for sample numbers.
- Data Provenance: Similar to performance tests, these are laboratory-based, prospective tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a surgical mask, and its performance is evaluated through standardized non-clinical laboratory tests against established numerical criteria (e.g., BFE %, PFE %, pressure resistance). There is no "ground truth" derived from expert interpretation in the way there would be for an AI diagnostic device evaluating medical images. The acceptance criteria are objective performance measures.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing. The results are quantitative measurements against predefined criteria, 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 is not an AI diagnostic device, and no human-in-the-loop studies were performed or are relevant for a surgical mask.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm-based device. The tests performed assess the physical and filtration properties of the mask itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by objective, standardized laboratory test methods (e.g., ASTM F2101 for BFE, ASTM F2299 for PFE, ASTM F1862 for synthetic blood resistance, EN 14683 for differential pressure, 16 CFR Part 1610 for flammability, and ISO 10993 for biocompatibility). The results are quantitative measurements compared against predefined regulatory and standard criteria for a Level 2 surgical mask.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth establishment for it.
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