(32 days)
The Shanghai Ganghai Model GIKO 1400 Healthcare Particulate Respirator And Surgical Mask is A NIOSH Approved N95 Single use, disposable, LATEX FREE NON-sterile product. It is A NON-Fiberglass, fluid Resistant MASK 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. This device Also meets CDC Guidelines for TB Exposure Control.
The Shanghai Ganghai Type N95 Healthcare Particulate Respirator and Surgical Mask Model GIKO 1400 is of a duckbill style. It constructed from a white nonwoven material used in the inner and outer shell. The polypropylene melt blown filter media is layered between the inner and outer shell. The headband is made of elastic rubber. The inside nosepiece utilizes a closed cell foam and the outside nosepiece which conforms to the nose is made of plastic coated aluminum.
Here's a breakdown of the acceptance criteria and the study details for the Shanghai Ganghai Type N95 Healthcare Particulate Respirator and Surgical Mask Model GIKO 1400, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Identified Risk | Performance Standard / Mitigation Measure | Reported Device Performance |
|---|---|---|
| Particulate Filtration Efficiency | NIOSH 42 CFR 84 - 0.3 micron diameter challenge, 95% efficiency | NIOSH Approved (TC-84A-4282) - Meets 95% efficiency against 0.3 micron particulate. |
| Fluid Resistance | ASTM F1862-00 Standard Test Method for Resistance of Medical Face Mask to Penetration by Synthetic Blood | Resistant to synthetic blood (Nelson Laboratories conducted). |
| Breathing Resistance | NIOSH 30 CFR 11 section 11.140-9 | Tested as per NIOSH 30 CFR 11 section 11.140-9. (Implicitly passed, as it stated "passed" generally). |
| Flammability | 16 CFR Part 1610 | Flammability testing conducted by Nelson Laboratories (Implicitly passed, as it stated "passed" generally). |
| Material Biocompatibility | Cytotoxicity Agar Overlay, Sensitization Buehler Method | Tested (Implicitly passed, as it stated "passed" generally). |
| Bacterial Barrier (Inadequate barrier for bacteria) | NIOSH TC-84A-4282 (N95 approval implies bacterial filtration) | NIOSH approved (TC-84A-4282). |
| Air Exchange (Inadequate air exchange) | NIOSH TC-84A-4282 (N95 approval implies adequate breathability) | NIOSH approved (TC-84A-4282). |
| TB Exposure Control | CDC Guidelines for TB Exposure Control | Meets CDC Guidelines for TB Exposure Control. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size for each individual test (e.g., how many masks were tested for particulate filtration, fluid resistance, etc.). The testing was performed by NIOSH (for N95 certification) and Nelson Laboratories (for other tests). The data provenance is derived from these testing bodies. It's a retrospective evaluation of the device against established standards rather than a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable in the context of this device. The "ground truth" here refers to established regulatory standards and performance criteria (e.g., 95% filtration efficiency, resistance to synthetic blood). These are objective measurements against published standards, not subjective assessments by human experts.
4. Adjudication Method for the Test Set
This information is not applicable. As mentioned above, the "ground truth" is based on objective testing against predefined standards, not on expert consensus requiring adjudication.
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
This is not applicable. This document describes a medical device (respirator mask), not an AI-powered diagnostic tool, and therefore no MRMC study with human readers and AI assistance would have been performed or reported here.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
This is not applicable. This document describes a medical device (respirator mask), not an algorithm.
7. The Type of Ground Truth Used
The ground truth used is primarily objective performance standards and regulatory guidelines established by entities like NIOSH, ASTM, and CDC. This includes:
- NIOSH 42 CFR 84: For particulate filtration and breathing resistance.
- ASTM F1862-00: For resistance to synthetic blood.
- 16 CFR Part 1610: For flammability.
- Biocompatibility Standards: For cytotoxicity and sensitization.
- CDC Guidelines for TB Exposure Control.
8. The Sample Size for the Training Set
This is not applicable. This document describes a medical device for which "training sets" in the AI sense are not relevant. The device is manufactured according to specifications and tested against established performance criteria.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. As explained above, there is no "training set" in the context of this medical device. The "ground truth" for evaluating the mask's performance is based on the aforementioned objective performance standards and regulatory guidelines.
§ 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.