(165 days)
The N95 Surgical Respirator AP0018 and AP0028 are intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.
SHUENN BAO SHING Corp. N95 Surgical Respirator AP0018 and AP0028 are flat pleated 3-ply masks with a center layer of polypropylene meltblown material by inner and outer layers of nonwoven material. The mask has 2 braided synthetic elastic headbands and a flexible wire tie nosepiece that allows the respirator to form to the bridge of the wearer's nose. No fiberglass media is used in this product.
Here's an analysis of the acceptance criteria and the study conducted for the SHUENN BAO SHING Corp. N95 Surgical Respirator (types AP0018 and AP0028), based on the provided 510(k) summary document:
This document is a 510(k) summary for a medical device (N95 Surgical Respirator), which is typically used to demonstrate substantial equivalence to a legally marketed predicate device rather than to rigorously "prove" device performance against a novel set of acceptance criteria through a full-scale clinical trial. Therefore, the "study" referred to here encompasses the non-clinical tests performed to demonstrate equivalency.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for N95 Surgical Respirators are based on established regulatory standards and guidance for such devices, primarily from NIOSH and ASTM. The device's performance is demonstrated by its compliance with these standards, effectively making the performance metrics of the new device equivalent to or better than those of the predicate device for substantial equivalence.
Table 1: Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Standard Reference) | Reported Device Performance (Compliance) |
|---|---|---|
| NIOSH Exhalation Resistance | 84.188 | Complied with relevant requirements |
| NIOSH Inhalation Resistance | 84.180 | Complied with relevant requirements |
| NIOSH Sodium Chloride (NaCl) - N95 | 84.181 | Complied with relevant requirements |
| Flammability | 16 CFR 1610, Class I | Complied with relevant requirements |
| Biocompatibility | ISO 10993 | Complied with relevant requirements |
| Regulatory Class | Class II (ASTM2100-04 Low Barrier) | Class II (ASTM2100-04 Low Barrier) |
| NIOSH Approval Number (AP0018) | (Predicate: TC-84A-006) | TC-84A-4049 (New Approval) |
| NIOSH Approval Number (AP0028) | (Predicate: TC-84A-2630) | TC-84A-4175 (New Approval) |
Note: The "acceptance criteria" here are the requirements outlined in the specified standards, and "reported device performance" is the statement of compliance to these standards.
Study Details
1. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size" in the context of a clinical test set, as no clinical tests were performed. The testing conducted was non-clinical (bench testing). For these bench tests (e.g., NIOSH, flammability, biocompatibility), the sample sizes would typically be determined by the specific test standards themselves, but these details are not provided in this summary.
Data Provenance: The document originates from SHUENN BAO SHING Co., Ltd. in Taiwan, R.O.C. The tests were performed in compliance with US regulatory standards (NIOSH, CFR, ISO). The data is retrospective in the sense that it represents lab test results conducted on the manufactured device models.
2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This was a non-clinical bench testing study, not requiring expert consensus for a "ground truth" in the way a clinical diagnostic study would. Compliance to engineering and material science standards was assessed.
3. Adjudication Method for the Test Set
Not applicable. As this was non-clinical bench testing against established standards, the results are typically objectively measured and compared to the standard's limits. No adjudication method in the context of expert review for clinical outcomes is mentioned.
4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC study is relevant for evaluating the performance of diagnostic tools that involve human interpretation (e.g., radiologists reading images). This 510(k) pertains to a physical device (surgical respirator), for which such a study is not applicable.
5. Standalone Performance (Algorithm Only)
Not applicable. This is a physical N95 surgical respirator, not an AI algorithm. Its performance is inherent in the device itself, without a "human-in-the-loop" or standalone algorithm component.
6. Type of Ground Truth Used
For non-clinical tests, the "ground truth" is defined by the objective standards and test methods (e.g., NIOSH 84.188 for exhalation resistance, 16 CFR 1610 for flammability). The device's physical properties and performance characteristics are measured against the specified limits within these standards.
7. Sample Size for the Training Set
Not applicable. There is no training set in the context of machine learning or AI models, as this is a physical device submission.
8. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set. The "ground truth" for the device's acceptable performance is established by the regulatory standards mentioned above.
Summary Takeaway:
The provided document is a 510(k) summary demonstrating substantial equivalence of a new surgical respirator to existing predicate devices. The "study" in this context refers to a series of non-clinical bench tests performed according to recognized national and international standards (NIOSH, CFR, ISO) to prove the new device meets the same performance characteristics as its predicates. It explicitly states that "no clinical tests were performed." Therefore, many of the typical questions for AI/diagnostic device studies (like sample size for test/training sets, expert ground truth, MRMC studies) are not applicable here.
§ 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.