(162 days)
The PointCore Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided nonsterile.
The PointCore Surgical Mask is a surgical mask with ear loops and nose piece for fitting and securing the mask to the to the user's face. The ASTM Level of the subject device is ASTM Level 2. The finished size of the mask is 175mm x 95 mm. The masks are comprised of three layers: an outer polyethylene/polyester layer, a meltblown nonwoven filter layer, and an inner polypropylene layer. The mask also includes an adjustable nose strip and flat or round elastic ear loop. The nosepiece is manufactured from a reinforced plastic piece with a metal insert.
The provided text is a 510(k) Summary for the PointCore Surgical Mask and contains information regarding performance testing against established standards, which serve as acceptance criteria. However, it does not describe a study involving an AI/Machine Learning device or human readers. The document is for a medical device (surgical mask), not an AI diagnostic/screening tool. Therefore, many of the requested categories are not applicable to this submission.
Here's an analysis of the provided text against your requested criteria:
The document describes the performance testing of a PointCore Surgical Mask, a physical medical device, not an AI or machine learning algorithm. Therefore, many of your requested items regarding AI/ML studies, human readers, and ground truth establishment for AI models are not applicable.
However, I can extract the information relevant to the acceptance criteria and performance testing of the surgical mask:
1. A table of acceptance criteria and the reported device performance
The document references ASTM and other standards for performance testing. Here's a summary:
| Performance Characteristic | Acceptance Criteria (Standard Reference) | Reported Device Performance (PointCore Surgical Mask) |
|---|---|---|
| Fluid Resistance | ASTM F1862 | Passed acceptance criteria of ASTM F1862 |
| Particle Filtration Efficiency | ASTM F2299 | No specific numerical value reported, but implies meeting standard for ASTM Level 2 mask. |
| Bacterial Filtration Efficiency | ASTM F2101 | No specific numerical value reported, but implies meeting standard for ASTM Level 2 mask. |
| Differential Pressure | MIL-M36945C | No specific numerical value reported, but implies meeting standard for ASTM Level 2 mask. |
| Flammability | 16 CFR 1610 | No specific numerical value reported, but implies meeting standard. |
| Biocompatibility | ISO 10993 | No specific numerical value reported, but implies meeting standard. |
Note: For filtration efficiency, differential pressure, and flammability, the document states that the mask is "ASTM Level 2." While the exact numerical criteria for Level 2 are not explicitly listed in this document, meeting ASTM Level 2 for these characteristics implies meeting specific numerical thresholds defined by the ASTM standards.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document only lists the standards used for testing (e.g., ASTM F1862) but does not detail the specific sample sizes used for each test or the provenance of the test materials.
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 is not applicable. The device is a surgical mask, and its performance is evaluated against standardized physical and biological tests, not against expert medical interpretations or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. As explained above, the device is a surgical mask and its performance is determined by objective laboratory tests based on established standards, not by human adjudication of diagnostic outputs.
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 is not applicable. No AI component is described for this device, and no MRMC study or human reader assistance is relevant to the performance of a surgical mask.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This 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 a surgical mask's performance is established by objective measurements against internationally recognized standards (e.g., ASTM, MIL-M, CFR, ISO). For example:
- Fluid Resistance: Measured by resistance to penetration by synthetic blood.
- Filtration Efficiency: Measured by the ability to filter out specific sizes of particles or bacteria.
- Differential Pressure: Measured by breathability.
- Flammability: Measured by flame spread rate.
- Biocompatibility: Measured by absence of cytotoxic, irritating, or sensitizing effects as per ISO 10993.
8. The sample size for the training set
This is not applicable. There is no AI/ML model for this device that would require a training set.
9. How the ground truth for the training set was established
This is not applicable. There is no AI/ML model for this 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.