(79 days)
The Humask Pro Vision 3000 mask is single use disposable intended to be worn in the operating room as well as dental, isolation, and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.
The Humask Pro Vision 3000 is a clear window surgical mask. A Medical grade face mask with a transparent window.
The provided text is a 510(k) Summary for the Humask Pro Vision 3000, a surgical mask. It primarily focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria for an AI/ML-based medical device. Therefore, much of the requested information regarding AI/ML device testing (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, effect sizes, ground truth establishment) is not present in this document.
However, I can extract information related to the performance data provided for the physical mask itself and present what is available, while clearly indicating what information is not available based on the provided text.
Here's an attempt to answer your request based on the provided document, with many sections marked as "Not Applicable" or "Not Provided" due to the nature of the document.
Understanding the Device: The Humask Pro Vision 3000 is a physical surgical mask, not an AI/ML-based diagnostic or prognostic device. The performance data mentioned pertains to the physical characteristics and safety of the mask itself, such as its filtration efficiency and biocompatibility.
Acceptance Criteria and Reported Device Performance
The document describes performance tests conducted on the Humask Pro Vision 3000 to demonstrate its safety and effectiveness, similar to the predicate device. These tests align with FDA guidance for surgical mask submissions.
Table of Acceptance Criteria and Reported Device Performance (as detailed for a physical mask):
| Performance Metric | Acceptance Criteria (Implied by standard compliance) | Reported Device Performance Against Criteria |
|---|---|---|
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | Must meet specified filtration efficiency for bacteria (e.g., typically ≥ 95% or ≥ 98% for Level 1, 2, or 3 surgical masks, though the specific class/level is not explicitly stated in the document, compliance implies meeting the relevant standard). | Met specified criteria. (Document states: "The subject devices met all specified criteria and did not raise new safety or performance questions.") |
| Particle Filtration Efficiency (PFE) (ASTM F2299) | Must meet specified filtration efficiency for particulate matter (e.g., typically ≥ 95% or ≥ 98% for Level 1, 2, or 3 surgical masks). | Met specified criteria. |
| Differential Pressure (EN 14683) | Must meet specified breathability requirements (e.g., a certain delta P in mm H2O/cm²). Allows for easy breathing while maintaining filtration. | Met specified criteria. |
| Flammability (16 CFR PART 1610) | Must demonstrate slow burning or non-burning characteristics when exposed to a flame. (Typically, Class 1 - Normal Flammability). | Met specified criteria. |
| Resistance to Synthetic Blood (ASTM F1862) | Must resist penetration of synthetic blood at specific pressures (e.g., 80, 120, or 160 mmHg, depending on the mask level). This tests fluid barrier protection. | Met specified criteria. |
| Cytotoxicity (ISO 10993-5) | Must not demonstrate cytotoxic effects. | Met specified criteria. |
| Allergenicity and Sensitization (ISO 10993-10) | Must not demonstrate significant allergenic or sensitization potential. | Met specified criteria. |
Study Proving Device Meets Acceptance Criteria:
The document states: "The following performance data support the substantial equivalence of the Humask Pro Vision 3000." and "The subject devices met all specified criteria and did not raise new safety or performance questions. Based on the performance testing, the Humask Pro Vision 3000 was found to have a safety and effectiveness profile that is similar to the predicate device."
This indicates that various standardized tests (ASTM, EN, ISO, CFR) were performed on the Humask Pro Vision 3000, and the results demonstrated compliance with the requirements outlined in those standards, thus proving it meets the implied acceptance criteria for a surgical mask of its type.
Regarding AI/ML-specific Study Information (Not applicable to this device, but addressing your prompt structure):
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Sample size used for the test set and the data provenance: Not applicable. This is a physical mask.
- Provenance: Not specified for the physical test samples (e.g., number of masks tested for BFE, PFE).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical mask is established by validated laboratory test methods and equipment, not human expert consensus.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI/ML device that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the physical mask's performance is established by standardized laboratory testing procedures (e.g., the specific methodologies outlined in ASTM F2101 for BFE, ASTM F2299 for PFE, etc.). These methods are designed to objectively measure the physical properties and performance of the mask.
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The sample size for the training set: Not applicable. This is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
§ 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.