(73 days)
The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is 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 "B Exposure Control.
The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is 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 rubber stapled to the mask. The inside nosepiece utilizes a closed cell foam and the outside nosepiece which conforms to the nose is made of aluminum.
The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is approved by NIOSH as per 42 CFR 84. The certification number assigned is TC-84A-160 for a type N95 Particulate Respirator. The Type N95 must meet the prescribed test criteria which specifies the use of 0.3 micron diameter challenge and requiring a 95% efficiency. This mask is also fluid resistant as per (ASTM D583 65 Method) and is resistant to synthetic blood as per Protocol number 9602202-01 conducted by Nelson Laboratories. Breathing resistance was tested as per NIOSH 30 CFR11 section 11.140-9.
Here's an analysis of the provided text regarding the Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735, structured to address your specific questions.
Important Note: The provided document is a 510(k) summary from 1996 for a respirator/surgical mask. It predates the widespread use of "AI" and "machine learning" in medical devices, and therefore, many of your questions related to AI-specific studies (e.g., sample size for AI test sets, AI ground truth, MRMC studies for AI improvement) are not applicable to this device. This document describes a physical medical device, not an AI algorithm.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Respirator Performance (NIOSH 42 CFR 84 Type N95 Requirements) | Approved by NIOSH as per 42 CFR 84. Certification number TC-84A-160 for a Type N95 Particulate Respirator. Must meet prescribed test criteria: use of 0.3 micron diameter challenge and requiring 95% efficiency. |
| Filtration Efficiency (NIOSH 42 CFR 1) | 95% efficient against a 0.3 micron particulate (scientifically established as the most penetrating particle size). |
| Resistance to Liquid (Synthetic Blood Penetration Resistance) (Protocol No. 9602202-01) | Resistant to synthetic blood as per Protocol number 9602202-01 conducted by Nelson Laboratories. |
| Fluid Resistance (ASTM D583-65 Method 1) | Fluid resistant as per (ASTM D583-65 Method). |
| Breathing Resistance (NIOSH 30 CFR 11 section 11.140-9) | Tested as per NIOSH 30 CFR 11 section 11.140-9. (Performance meets the standard, although specific values are not presented in the summary, implied by NIOSH approval). |
| Primary Skin Irritation | Tested by Gerson. (Performance implied to be acceptable, as there's no mention of failure or adverse events). |
| FHSA Primary Dermal Irritation | Tested by Nelson Laboratories. (Performance implied to be acceptable, as there's no mention of failure or adverse events). |
| Adherence to CDC Guidelines for TB Exposure Control | Meets CDC Guidelines for TB Exposure Control. |
Study Information (as applicable to a physical device)
-
Sample size used for the test set and the data provenance:
- The document does not specify exact sample sizes for each test listed (e.g., number of respirators tested for filtration efficiency, number of samples for synthetic blood penetration).
- Data Provenance: The tests were conducted by recognized laboratories like NIOSH (a US federal agency) and Nelson Laboratories (a US-based contract testing lab), and Gerson (the manufacturer). This indicates the data is from specific laboratory testing environments rather than clinical patient data. The summary doesn't imply any particular country of origin for the data itself beyond the testing locations. The studies are prospective in the sense that they are specifically designed to test the device's performance against established standards.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the device is a physical respirator, not an AI-driven diagnostic tool where expert consensus on "ground truth" (e.g., disease presence in an image) would be required. The "ground truth" here is the pass/fail criteria defined by regulatory standards (e.g., 95% efficiency, resistance to penetration). The "experts" are the scientists and engineers at NIOSH and Nelson Laboratories who conduct and interpret the standardized tests according to defined protocols.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This concept is not applicable to the testing of this physical device. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in human expert interpretations (e.g., reading medical images) are resolved to establish a definitive ground truth. Here, the "truth" is determined by objective physical measurements against a standard.
-
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 physical medical device (respirator/mask), not an AI algorithm intended to assist human readers (e.g., radiologists). Therefore, no MRMC study for AI assistance was performed.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This device is not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on pre-defined, objective physical and chemical testing standards and regulatory requirements. Examples include:
- NIOSH standards: 95% filtration efficiency for 0.3 micron particles.
- ASTM standards: Fluid resistance.
- Specific laboratory protocols: Synthetic blood penetration.
- NIOSH breathing resistance criteria.
- The "ground truth" for this device's performance is based on pre-defined, objective physical and chemical testing standards and regulatory requirements. Examples include:
-
The sample size for the training set:
- This is not applicable. This device is not an AI algorithm; therefore, there is no "training set" in the context of machine learning. The term "training set" might loosely apply to the initial prototypes and iterative designs developed by Gerson Co., Inc. and tested internally, but it's not discussed in this 510(k) summary as a formal "training set" for an algorithm.
-
How the ground truth for the training set was established:
- This is not applicable as there is no "training set" for an AI algorithm.
§ 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.