(83 days)
Meets the CDC guidelines for TB exposure control. Has a filter efficiency level of 95% against solid particulate aerosols free of oil (Type N95 respirator). Designed to be fluid resistant to splash and spatter of blood and body fluids.
Respirator consisting of nonwoven inter facing, filter media(s), a fluid barrier film, and an outer facing. It covers the nose and mouth of the wearer, and is held in place with two synthetic clastic headbands, conforming to the curvature of the wearer's nose with a malleable nosepiece.
This document is a 510(k) Premarket Notification for a respirator and surgical mask. It primarily focuses on demonstrating equivalence to a predicate device through performance testing. Therefore, it does not involve the type of study design or criteria typically used for AI-driven medical devices, which the provided questions are geared towards.
Here's an analysis based on the information provided, highlighting why many questions are not directly applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Filtration Efficiency ≥ 95% for 0.3 micron particles (NIOSH standard) | Met NIOSH required sodium chloride test; no filtration efficiency drop below 95%. |
| No fluid penetration with 2cc synthetic blood at arterial speed | No fluid penetration observed. |
| Qualitative Face Fit test passed | Samples tested successfully. |
| Initial inhalation resistance < 35mm H2O (NIOSH standard) | Met requirements of NIOSH airflow resistance test. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Subject device samples" for each test but does not specify the exact sample size for any of the performance tests. The provenance of the data (country of origin, retrospective/prospective) is not stated, but given it's a 510(k) submission, it's presumed to be data generated by the manufacturer for the specific device, likely through prospective testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to the provided document. The device is a physical product (respirator/surgical mask), and its performance is evaluated against established physical and material standards (e.g., NIOSH, fluid resistance). There is no "ground truth" derived from expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 are used in clinical studies where multiple experts interpret medical images or clinical data. Here, objective physical tests are performed.
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 question is not applicable. MRMC studies are used for evaluating diagnostic devices, often involving AI, where human readers interpret cases. This document concerns a physical barrier device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. There is no algorithm or AI component in this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by objective engineering and material science standards and regulatory requirements (e.g., NIOSH standards for filtration efficiency and airflow resistance, simulated fluid challenge for fluid resistance). There is no "expert consensus," "pathology," or "outcomes data" in the typical medical imaging sense.
8. The sample size for the training set
This question is not applicable. There is no AI model or algorithm that requires a training set for this device.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above; there is no training set.
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Tecnol Medical Products, Inc. 510(k) Premarket Notification J (6) I Land Ret News Respirator and Surgical Mask with FluidShield® Protection
APR 3 0 1997
Tab H
1 of 2
510(k) SUMMARY
12:18
| (1) Submitter: | Tecnol Medical Products, Inc. 7201 Industrial Park Blvd. Fort Worth, TX 76180 |
|---|---|
| Prepared By: | Ruth L. Jones |
| Date Submitted: | March 24, 1997 |
| (2) Device Name/ Trade Name: | Tecnol PFR95 TM Particulate Filter Respirator and Surgical Mask FluidShield ® Protection |
| Common Name: | Surgical Mask Also sometimes referred to as a particulate respirator. |
Classification Name: Surgical Apparel, as described in 21 CFR 878.4040
- Gerson Isolair APR Type N95 Model 2735 Respirator (3) Predicate Device: and Surgical Mask .
- Respirator consisting of nonwoven inter facing, filter Device Description: (4) media(s), a fluid barrier film, and an outer facing. It covers the nose and mouth of the wearer, and is held in place with two synthetic clastic headbands, conforming to the curvature of the wearer's nose with a malleable nosepiece.
- Intended Use: Meets the CDC guidelines for TB exposure control. (2) Has a filter efficiency level of 95% against solid particulate aerosols free of oil (Type N95 respirator). Designed to be fluid resistant to splash and spatter of blood and body fluids.
- No new technological characteristics are used in the (6) Technological PFR95TM mask. Characteristics Comparison:
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Techol Medical Products, Inc. 510(k) Premarket Notification
From Particulate Filter Respirator and Surgical Mask with FluidShield® Protection
Tab H 2 of 2
Performance Data: (7)
Filtration Efficiency: Subject device samples met the NIOSH required sodium chloride test with 0.3 micron particles. At no time can the filtration efficiency drop below 95%.
Fluid Resistance: Subject device samples were challenged with 2cc of synthetic blood at a speed simulating release of blood from an artery. No fluid penetration was observed.
Face Fit: Subject device samples were tested using a qualitative fit test.
Ease of Breathing: Subject device samples met the requirements of the NIOSH airflow resistance test which requires initial resistance (inhalation) to be less than 35mm H2O.
CONCLUSION: The results of these nonclinical tests, when compared with data available and/or claims made on the predicate device, demonstrate that the subject device is as safe and effective as the predicate device, and performs as well as the predicate device.
f\p&510(k)/pfi-tabh3.doc
§ 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.