(37 days)
Alpha Pro Tech's 695 N95 Respirator Mask meets the CDC guidelines for TB Exposure Control within healthcare facilities. These devices are also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. It is intended to be a single use, disposable device. This would also include use as a procedure mask, isolation mask and/or dental face mask.
Alpha Pro Tech's 695 N95 Respirator Masks consists of a polypropylene meltblown filter media sandwiched between non-woven wetlaid outer and inner covers. The mask is secured using two polyester covered non-latex rubber headbands. Fitting around the face is facilitated using a nose wire and an adjustable chin wire made from aluminum. No fiberglass media is used in this product.
The provided text is a 510(k) summary for a medical device (an N95 respirator mask). This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study against acceptance criteria in the manner one might find for a novel diagnostic algorithm or drug.
Therefore, many of the requested categories for a study proving device performance are not directly applicable to this document. However, I can extract the relevant information where available and note where specific information is not provided because it's outside the scope of a 510(k) summary for this type of device.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For an N95 respirator, the "acceptance criteria" are typically the performance standards set by NIOSH (National Institute for Occupational Safety and Health) for filtration efficiency and breathability, and also potentially for fluid resistance if intended for surgical use. The provided document doesn't detail specific numerical acceptance criteria within this device's 510(k) submission but states its overall conformity.
| Acceptance Criteria Category (Implied by N95 designation and intended use) | Reported Device Performance (as stated or implied) |
|---|---|
| Particulate Filtration Efficiency (N95 standard) | "NIOSH approved" implies meeting N95 filtration standards (at least 95% efficiency against non-oil-based particulates). Conforms due to substantial equivalence. |
| Fluid Resistance (for surgical use) | Intended to "protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material" implies fluid resistance. Specific performance values are not given. |
| Breathability (Airflow Resistance) | "NIOSH approved" implies meeting N95 breathability standards. Conforms due to substantial equivalence. |
| Biocompatibility | Not explicitly stated in terms of a test, but implicitly covered by the materials used (polypropylene, polyester, aluminum) and predicate equivalence. |
| Flammability | Not explicitly stated. |
2. Sample size used for the test set and the data provenance
Not applicable. This is not a study involving a test set of data samples for an algorithm or diagnostic. The device itself (the mask) is the "test article." The statement "NIOSH approved" indicates that NIOSH conducted tests on samples of the mask design to ensure it meets their performance criteria. The provenance of NIOSH testing data would be their own laboratories.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no "ground truth" established by experts in the context of an algorithm's performance for this type of device submission. The "ground truth" for an N95 respirator's performance is objective measurement of filtration efficiency, breathability, and other physical properties against established standards by testing bodies like NIOSH.
4. Adjudication method for the test set
Not applicable. There is no expert adjudication for a test set in this context.
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
Not applicable. This is a physical device (respirator mask), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm.
7. The type of ground truth used
For the N95 respirator, the "ground truth" is defined by the NIOSH performance standards for N95 respirators. Compliance with these physical standards (e.g., filtration efficiency, airflow resistance) is the ground truth.
8. The sample size for the training set
Not applicable. There is no training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
Summary of what the document does provide in lieu of a typical performance study:
- Predicate Device Comparison: The 510(k) focuses on demonstrating "substantial equivalence" to a legally marketed predicate device (Aearo Company's Pleats Plus 1050 Respirator Masks). This is the primary method of clearance for this type of device.
- Technological Characteristics Comparison: The submission states that the Alpha Pro Tech 695 N95 Respirator Mask "has the same technological characteristics" as the predicate, including:
- Both are NIOSH approved.
- Both are made of nonwoven meltblown polypropylene.
- Both incorporate a forming nosepiece.
- Both employ a flat pleated style.
- Both are secured using dual elastic head straps.
- Intended Use Alignment: The intended use of the Alpha Pro Tech mask aligns with the predicate and meets CDC guidelines for TB Exposure Control and protection against microorganisms, body fluids, and particulate material during surgical procedures.
- Materials: Describes the construction materials (polypropylene meltblown filter media, non-woven wetlaid covers, polyester-covered non-latex rubber headbands, aluminum nose and chin wires).
- NIOSH Approval: The most critical piece of performance information is the statement "NIOSH approved," which means the mask has undergone and passed the rigorous testing prescribed by NIOSH for N95 respirators, covering filtration efficiency, breathing resistance, and strap integrity. This approval is the evidence of performance against established standards.
§ 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.