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510(k) Data Aggregation
(207 days)
PRIMED Surgical Masks and PRIMED Procedure Masks are single use, non-sterile products intended to be worn by operating room and health care personnel in health care setting and during surgical procedures to protect both the patient and the operating room personnel from transfer of microorganisms, body fluids and particulate materials.
PRIMED Surgical masks and PRIMED Procedure masks are single use, non-sterile masks composed of a melt-blown filter layer placed between layers of non-woven inner and SS outer layer(s) material. PRIMED Medical Products Inc. offers various models in two main categories: Procedure masks with ear loops and Surgical masks with head ties. The level of protection varies based on the basis weight of the inner layer and the number of outer layers used in the mask's construction, in accordance with ASTM F2100:2023 specifications.
The provided text is an FDA 510(k) summary for PRIMED Surgical Masks and PRIMED Procedure Masks. It describes the acceptance criteria and the study that proves the device meets those criteria. However, it does not include information about a complex AI-driven medical device, a multi-reader multi-case (MRMC) study, or detailed information about ground truth establishment by experts as would be relevant for an AI/CADe system.
Therefore, the following response will be tailored to the information available in the provided document, which pertains to a physical medical device (surgical masks) and its performance against established standards, rather than an AI/software device.
Here's the information as extracted and interpreted from the document:
Acceptance Criteria and Device Performance for PRIMED Surgical Masks and PRIMED Procedure Masks
The device under review is PRIMED Surgical Masks and PRIMED Procedure Masks. The performance of these masks is evaluated against established physical and biocompatibility standards rather than a typical AI/CADe performance criteria.
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are derived from ASTM F2100-23 standards for medical face masks and other relevant ISO and CFR standards for biocompatibility and flammability.
| Test Performed | Test Method | Acceptance Criteria (Level 1 Masks) | Acceptance Criteria (Level 3 Masks) | Results (All Variants) |
|---|---|---|---|---|
| Bacterial Filtration Efficiency | ASTM F2101 | ≥ 95% | ≥ 98% | Pass |
| Sub-micron Particulate Filtration | ASTM F3502 | ≥ 80% | ≥ 85% | Pass |
| Differential Pressure (Breathability) | EN 14683 | < 5 mmH2O/cm² | < 6 mmH2O/cm² | Pass |
| Resistance to Penetration by Synthetic Blood | ASTM F1862 | 80 mmHg | 160 mmHg | Pass |
| Flammability | 16 CFR 1610 | Class I | Class I | Pass |
| Cytotoxicity | ISO 10993-5 | Non-Cytotoxic | Non-Cytotoxic | Pass |
| Sensitization | ISO 10993-10 | Non-sensitizing | Non-sensitizing | Pass |
| Irritation | ISO 10993-23 | Not an irritant | Not an irritant | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of masks tested for BFE). These are typically defined by the test methodologies themselves (e.g., ASTM F2101 specifies sample sizes).
The data provenance is from non-clinical testing performed by the manufacturer, PRIMED Medical Products Inc., which is based in Edmonton, AB, Canada. The studies are prospective in the sense that they are conducted specifically for the purpose of demonstrating device performance for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the device is a physical product (surgical masks) and not an AI or diagnostic software. Therefore, human experts are not establishing "ground truth" in terms of clinical diagnoses or interpretations of images. The "truth" is established by direct physical, chemical, and biological testing against engineering and material standards.
4. Adjudication Method for the Test Set
This is not applicable as there is no human interpretation or decision-making process being adjudicated. The tests involve objective measurements against predefined thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/software in diagnostic imaging where human readers' performance with and without AI assistance is evaluated. This submission is for a physical medical device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical product (surgical mask), not an algorithm or software. The "performance" is the inherent physical and chemical properties of the mask.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the surgical masks is established directly through physical, chemical, and biological laboratory testing against well-defined, objective national and international consensus standards (e.g., ASTM F2100-23, EN 14683, ISO 10993 series, 16 CFR 1610). There is no "expert consensus," "pathology," or "outcomes data" utilized to establish ground truth in the context of diagnostic accuracy for this device.
8. The Sample Size for the Training Set
This is not applicable. Surgical masks are physical devices, not AI or machine learning models that require training sets. The document describes performance testing of the final manufactured product.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above. There is no training set for a physical device like a surgical mask.
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