(70 days)
Paneffort 3-ply Surgical and Procedural 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 non-sterile.
The Paneffort 3-Ply Surgical and Procedural masks are flat pleated 3-ply device, which consist of three layers, i.e., Outer layer is made of Spunbond Polypropylene, Middle/Filter layer is made of Melt-blown Polypropylene and Inner layer is made of Spunbond Polypropylene. There are two options for the mask to be secured on the user, viz. earloops or tie-on. Earloops are made of spandex and polyamide and the tie-on model are made of spunbond polypropylene. The nosepiece is made up of Iron wire, polypropylene and Zinc, and is encased between Outer and Middle later. Paneffort 3-ply Surgical and Procedural masks are available in blue colour.
The provided text is a 510(k) Premarket Notification for Paneffort 3-Ply Surgical and Procedural Masks. It details the device's technical specifications, intended use, and comparative testing against predicate devices to demonstrate substantial equivalence.
Based on the provided information, here's a description of the acceptance criteria and the study that proves the device meets them:
Device: Paneffort 3-Ply Surgical and Procedural Masks
Regulatory Class: Class II
Product Code: FXX
Regulation Name: Surgical Apparel (21 CFR 878.4040)
The study focuses on non-clinical performance and biocompatibility testing, primarily against ASTM F2100 standards for surgical masks. It does not describe a study involving human readers or AI-assisted performance analysis, as the device is a physical medical mask, not a diagnostic AI system or image analysis tool. Therefore, questions 2, 3, 4, 5, 8, and 9 are largely not applicable as they pertain to clinical studies, AI performance evaluation, and ground truth establishment for such studies, which are not relevant to this type of device submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from ASTM F2100-19e1, an FDA-recognized consensus standard for medical face mask materials. The performance results show that the Paneffort masks meet or exceed these criteria for both Level 2 and Level 3 masks.
| Parameters | Acceptance Criteria (ASTM F2100-19e1) | Reported Device Performance (Paneffort 3-Ply Surgical/Procedural Masks) | Comments |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | ≥98% | Pass at >98% (for Level 2 and Level 3) | Meets criteria. Table 5 (page 5) lists ">99.9 %" for subject device and predicate, while Table 3 (page 9) states ">98%". The most stringent stated passing result for the subject device is ">99.9 %". The crucial point is that it Passes at > 98%. |
| Differential Pressure (Delta-P) (EN 14683 Annex C) | 99% (for Level 2 and Level 3) | Meets criteria. Table 5 (page 5) lists "≥ 99.20%" for subject device and predicate, while Table 3 (page 9) states ">99%". The crucial point is that it Passes at > 98%. | |
| Resistance to Penetration by Synthetic Blood (ASTM F1862) | ≥120 mm Hg (for Level 2) | Pass at ≥120 mm Hg (specifically ≥120 mm Hg, and tested at 160 mm Hg) | Meets criteria for both Level 2 and Level 3. The test result for the subject device is "Pass at 160 mm Hg", exceeding the 120 mm Hg requirement for Level 2 and meeting the 160 mm Hg requirement for Level 3. |
| Flammability (16 CFR Part 1610) | Class 1 | Class 1 | Meets criteria. |
| Biocompatibility - Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Pass - Non-cytotoxic | Meets criteria. |
| Biocompatibility - Irritation (ISO 10993-10) | Non-irritating | Pass - Non-irritating | Meets criteria. |
| Biocompatibility - Sensitization (ISO 10993-10) | Non-sensitizing | Pass - Non-sensitizing | Meets criteria. |
2. Sample Size and Data Provenance
- Sample Size: The document does not specify the exact sample size for each performance test (e.g., how many masks were tested for BFE, PFE, etc.). It only provides the acceptance criteria and whether the tested product met them.
- Data Provenance: The data is gathered from non-clinical laboratory testing of the subject device (Paneffort 3-Ply Surgical and Procedural Masks). The manufacturer is Paneffort (Cambodia) Garment Co. Ltd. (Cambodia), and the legal manufacturer is PANEFFORT, LLC (USA). The testing was conducted in accordance with FDA-recognized consensus standards (ASTM and ISO). The document does not specify if the tests were performed retrospectively or prospectively, but typically, these are prospective tests conducted on representative samples of the manufactured product.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. This is a non-clinical performance and biocompatibility study of a physical device (surgical mask), not an AI or image analysis system requiring expert review for ground truth establishment. The "ground truth" is the objective measurement defined by the standards (e.g., a BFE of >98%).
4. Adjudication Method for Test Set
- Not applicable. This is a non-clinical performance and biocompatibility study. Adjudication methods are relevant for clinical studies, especially those involving subjective assessments or disagreements among human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This study does not involve human readers or AI assistance. It is a technical performance assessment of a surgical mask.
6. Standalone (Algorithm Only) Performance
- Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
- The "ground truth" for this device and study type is established by objective, standardized test methods and criteria defined by international consensus standards (ASTM F2100-19e1, ASTM F2101, EN 14683, ASTM F2299, ASTM F1862, 16 CFR Part 1610, ISO 10993-5, ISO 10993-10). The performance of the mask is measured directly against these established physical and biological benchmarks.
8. Sample Size for Training Set
- Not applicable. This is a physical medical device, not an AI model, so there is no "training set."
9. How Ground Truth for Training Set was Established
- Not applicable. As there is no training set for an AI model, this question is not relevant.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.