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510(k) Data Aggregation
(88 days)
The surgical face mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face masks are in infection control practices to reduce the potential exposure to blood & body fluid. This device is disposable, non-sterile and for single use only, Available models: Surgical Face Mask EL (Ear loops) Surgical Face Mask TO (Tie-on)
The CPL Surgical Face Mask is a 3-ply flat-pleated mask. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The nose wire contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene coated single core galvanized wire. The model Surgical Face Mask EL is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The ear loops are made of braided elastic band. The model Surgical Face Mask TO is provided with non-woven tie-on string. The dimensions of the test item are: length- 175 ± 5 mm and width- 95 ± 5 mm. The ear loop length of the model Surgical Face Mask EL is 170± 5 mm. The tie-on of the model Surgical Face Mask TO has a top strap length of 410 ± 10 mm and bottom strap length of 385 ± 10 mm. The surgical masks are single-use, disposable devices, provided non-sterile.
The document describes the acceptance criteria and the study conducted to demonstrate that the CPL Surgical Face Mask meets these criteria.
Here's the information extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| No. | Test Performed | Acceptance Criteria for Level 3 Classification (as per ASTM F2100 Requirements) | Reported Performance (Surgical Face Mask EL) | Reported Performance (Surgical Face Mask TO) | Result |
|---|---|---|---|---|---|
| 1. | Fluid resistance (ASTM F1862/F1862M-17) | Pass at 160 mmHg | Pass at 160 mmHg | Pass at 160 mmHg | Pass |
| 2. | Particulate Filtration Efficiency (PFE) (ASTM F2299 / F2299M - 03(2017)) | ≥ 98% | > 98% | > 98% | Pass |
| 3. | Bacterial Filtration Efficiency (BFE) (ASTM F2101-19) | ≥ 98% | > 98% | > 98% | Pass |
| 4. | Differential pressure (ΔΡ) (EN 14683 (Annex C): 2019) | < 6.0 mm H2O/cm² | < 4.0 mm H2O/cm² | < 5.0 mm H2O/cm² | Pass |
| 5. | Flammability (16 CFR 1610) | Class 1 | Class 1 | Class 1 | Pass |
| 6. | In-vitro Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic | Pass |
| 7. | Skin Irritation (ISO 10993-10:2010) | Non-irritating | Non-irritating | Non-irritating | Pass |
| 8. | Skin Sensitization (ISO 10993-10:2010) | Non-sensitizing | Non-sensitizing | Non-sensitizing | Pass |
2. Sample size used for the test set and data provenance:
- Sample Size: The performance testing was conducted using 3 nonconsecutive lots of the CPL Surgical Face Mask.
- Data Provenance: Not explicitly stated, but the applicant's address is listed as Himachal Pradesh, India, which suggests the testing was likely conducted in or around that region. The study is retrospective as it involves testing of manufactured products against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not a study requiring expert readers or ground truth establishment in that manner. The testing involves standardized laboratory methods for evaluating physical and biological properties of the mask.
4. Adjudication method for the test set:
- Not applicable; this is not a study involving human adjudication of results but rather direct measurement against established performance standards.
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/software device and 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 not an AI/software device.
7. The type of ground truth used:
- The "ground truth" for the performance tests are the pre-defined acceptance criteria set by international and national standards (e.g., ASTM F2100-19, ASTM F2101-19, ASTM F2299 / F2299M - 03(2017), EN 14683 (Annex C): 2019, ASTM F1862/F1862M-17, 16 CFR 1610, ISO 10993-5:2009, ISO 10993-10:2010). The device's performance is measured directly against these established standards.
8. The sample size for the training set:
- Not applicable. This is a medical device (surgical face mask) with performance testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is a medical device (surgical face mask) with performance testing, not a machine learning model.
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