(147 days)
The medical surgical mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
The proposed device, Medical Surgical Mask is a three-layer, single-use, flat-pleated mask. The mask body is made of 25g/m2 PP non-woven cloth. The mask contains tie strings or ear loops to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Nylon and PU, and tie strings are made of Nylon. The nose clip which is made of Iron strip covered by polypropylene covering. The device is provided in sterile.
The provided document (K202029) describes the substantial equivalence determination for a Medical Surgical Mask. It is a 510(k) premarket notification, which means the device is being compared to a legally marketed predicate device to establish substantial equivalence, rather than proving novel safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implied by the similarity comparison to the predicate device and the adherence to relevant ASTM and ISO standards for medical face masks. The "Performance" section within Table 1 provides the reported device performance, and the "Remark" column indicates how it compares to the predicate.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate and Standards) | Reported Device Performance (Medical Surgical Mask) | Remark (vs. Predicate) |
|---|---|---|---|
| Fluid resistance | Pass at 120 mmHg | Pass at 120 mmHg | Same |
| Particulate efficiency level | Average 99.74% at 0.1µm (Predicate's value) | Average 98.87% | Similar |
| Bacterial filtration level | Average 99.4% (Predicate's value) | Average 99.46% | Similar |
| Differential pressure | Average 2.7 mmH2O/cm² (Predicate's value) | Average 3.72 mmH2O/cm² | Similar |
| Flammability | Class 1 | Class 1 | Same |
| Cytotoxicity (Biocompatibility) | No Cytotoxicity | No Cytotoxicity | Same |
| Sensitization (Biocompatibility) | No Sensitization | No Sensitization | Same |
| Irritation (Biocompatibility) | No Irritation | No Irritation | Same |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each non-clinical test (e.g., how many masks were tested for particulate efficiency). It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
- Sample size: Not explicitly stated for each test.
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The sponsor is based in Beijing, China, so it's likely the testing was conducted there or by a certified lab, but this is not confirmed in the text. The tests are "non-clinical," implying they were laboratory-based rather than involving human subjects or real-world data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this submission. This is a 510(k) for a medical surgical mask, which relies on non-clinical performance testing against established standards and comparison to a predicate device, not on expert interpretation of medical images or clinical outcomes. Therefore, there are no "experts" establishing ground truth in the context of a typical AI/diagnostic device study.
4. Adjudication method for the test set
This information is not applicable. Since there are no human readers or expert interpretations involved in establishing ground truth for a medical mask's performance tests, there's no need for an adjudication method.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance to assess the AI's impact on their performance. This 510(k) is for a physical medical device (surgical mask) and does not involve AI or human interpretation in its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This is also relevant for AI/diagnostic devices. The medical surgical mask is a physical barrier device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is established by objective, standardized laboratory testing against specified ASTM and ISO standards for medical face masks. These standards define the methodologies and criteria for evaluating attributes like fluid resistance, particulate efficiency, bacterial filtration, differential pressure, flammability, and biocompatibility. The results are quantitative measurements or pass/fail determinations based on these established test procedures.
8. The sample size for the training set
Not Applicable. This device is a physical product (medical mask) and does not involve machine learning or AI models, so there is no "training set."
9. How the ground truth for the training set was established
Not Applicable. As there is no training set for an AI/ML model, there is no ground truth to be established for it.
§ 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.