(143 days)
The Surgical Mask intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These devices 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 sterile.
The model EH-1 is made of mask body, nose clip, ear loops and nose pad, whit color. The model EH-2 is made of mask body, nose clip, straps and nose pad, green color.
The mask body is manufactured with three layers, the inner and outer layers are made of nonwoven Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The straps and ear loops are held in place over the users' mouth and nose by two elastic straps welded to the mask body. It is made of nylon & spandex.
The nose clip in the layers of mask body is to allow the user to fit the mask body around their nose. It is made of polypropylene plastic wrapped metallic wire.
The nose pad which is made by 100% polyurethane is placed between the nose bridge and the mask body to let the user feel comfortable.
The buckle is use to clamp the ear loops and adjust the length and tightness of the mask. It is made of Polypropylene.
The colorant of white (EH-1)is Titanium dioxide, CAS Number is 13463-67-7; and the colorant of green(EH-2) is Pigment Green 7, CAS Number is 1328-53-6.
The EH-1 will be provided in white and the EH-2 will be provided in green. The Surgical Masks are sold sterilized with ethylene oxide gas and are intended to be single use, disposable devices.
The provided document describes the acceptance criteria and results for a Surgical Mask (device name). It details non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance (EH-1 & EH-2) |
|---|---|---|
| Synthetic Blood Penetration Resistance (ASTM F1862) | ≥ 29 samples out of 32 pass (AQL 4%) | Level 3 pass at 160mmHg (both models pass at 160mmHg) |
| Differential Pressure (Delta P) (EN 14683) | 29 out of 32 pass | Level 3 pass at ≤ 6.0 mmH20/cm2 (both models are ≤ 6.0 mmH20/cm2) |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | 29 out of 32 pass | Level 3 pass at ≥98% (both models are ≥98%) |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | 29 out of 32 pass | Level 3 pass at ≥98% (both models are ≥98%) |
| Flammability (16 CFR 1610) | Class I | Class I |
| Cytotoxicity (ISO 10993-5) | Under the conditions of the study, the device is non-cytotoxic. | Non-cytotoxic |
| Skin Irritation (ISO 10993-10) | Under the conditions of the study, the device is non-irritating. | Non-irritating |
| Skin Sensitization (ISO 10993-10) | Under the conditions of the study, the device is non-sensitizing. | Non-sensitizing |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Physical Performance Tests (e.g., Blood Penetration, BFE, PFE, Delta P): The acceptance criteria explicitly state "≥ 29 samples out of 32 pass". This indicates that 32 samples were likely used for these specific tests for each model (EH-1 and EH-2).
- Sample Size for Biocompatibility Tests (Cytotoxicity, Skin Irritation, Skin Sensitization): The specific sample sizes for these tests are not provided in the document, only the qualitative results.
- Data Provenance: The document states "non-clinical tests were conducted to verify that the subject device met all design specifications." The manufacturer is Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd. in PEOPLE'S REPUBLIC OF CHINA. The tests appear to be prospective as they were conducted to demonstrate compliance for this specific device submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. This study involved non-clinical performance testing of a physical device (surgical mask) against established industry standards (e.g., ASTM, EN, ISO, CFR). Ground truth is established by the test methods themselves and their quantifiable outcomes, not by expert consensus or interpretation of medical images/data.
4. Adjudication Method for the Test Set:
- Not applicable. As stated above, this is non-clinical performance testing against objective standards, not a study requiring adjudication of expert opinions.
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 submission for a surgical mask, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or assessment of AI assistance was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device (surgical mask). There is no algorithm involved.
7. The Type of Ground Truth Used:
- The ground truth for the device's performance is established by objective, quantitative measurements against recognized international standards (ASTM F2100, ASTM F1862, ASTM F2101, ASTM F2299, EN 14683, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards define specific test procedures and criteria for evaluating properties like bacterial filtration efficiency, blood penetration resistance, differential pressure, flammability, and biocompatibility.
8. The Sample Size for the Training Set:
- Not applicable. This refers to non-clinical testing of a physical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See explanation for point 8.
§ 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.