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510(k) Data Aggregation
(181 days)
The surgical mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
The proposed device, Surgical Mask, is a single use, three-layer, flat-pleated mask. The inner and outer layers of the mask are made of PP Spunbonded Non-woven Fabric, and the middle layer is made of Melt-blown Nonwoven Fabric. The proposed devices are available in three types, ear-loop, Tie-on and Headband. The ear straps of headband type and ear loop type are made of Spandex and Polyester, and the ear strap of tie-on type is made of PP Spunbonded Non-woven Fabric. The ear strap is held in place over the users' mouth and nose. The nose clip is made of Galvanized Iron Wire. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loops, tie-on and headband masks are available in different sizes to provide more options for user, as shown in the following table. The proposed devices were available with and without edging and they can be provided in sterile and non-sterile two versions. The proposed devices are blue.
The provided text is a 510(k) Summary for a Surgical Mask (K210908). This document describes the non-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than the performance of an AI/ML-based medical device.
Therefore, the information requested in your prompt regarding acceptance criteria and study proving an AI/ML device meets them (e.g., sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable to this document.
The document focuses on the physical and biological performance characteristics of the surgical masks. Here's a breakdown of the relevant information provided in relation to performance, but specifically for a surgical mask, not an AI device:
1. Table of acceptance criteria and reported device performance (for the Surgical Mask):
| Test | Acceptance Criteria | Reported Device Performance (Surgical Mask) |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | Viability $\geq$ 70% of blank | Viability of tested samples (PRS-WK002, PRS-WK017) $\geq$ 70% of the blank. 50% extract had higher viability than 100% extract. (Non-cytotoxic) |
| Sensitization | Non-sensitizing | No evidence of causing delayed dermal contact sensitization in guinea pigs for tested samples (PRS-WK002, PRS-WK017). (Non-sensitizing) |
| Irritation | Non-irritating | Irritation response category for tested samples (PRS-WK002, PRS-WK017) was Negligible for polar and non-polar extracts. (Non-irritating) |
| Performance Testing | ||
| Resistance to Penetration by Synthetic Blood (at 120 mmHg) | No penetration at 120 mmHg | Sterile Ear loop Non-edging (PRS-WK002): Pass at 120mmHg for 3 lots. Non-sterile Ear loop Non-edging (PRS-WK017): Pass at 120mmHg for 3 lots. |
| Particulate Filtration Efficiency (PFE) | $\geq$98% | Sterile Ear loop Non-edging (PRS-WK002): 98.19%, 98.20%, 98.24% for 3 lots (Average 98.21%). Non-sterile Ear loop Non-edging (PRS-WK017): 98.22%, 98.16%, 98.22% for 3 lots (Average 98.20%). |
| Bacterial Filtration Efficiency (BFE) | $\geq$98% | Sterile: Average 99.64%. Non-sterile: Average 99.60%. Individual lot results provided were all >99.5%. |
| Differential Pressure | <6.0 $mmH_2O/cm^2$ | Sterile Ear loop Non-edging (PRS-WK002): 3.03, 3.01, 3.01 $mmH_2O/cm^2$ for 3 lots (Average 3.02 $mmH_2O/cm^2$). Non-sterile Ear loop Non-edging (PRS-WK017): 2.88, 2.88, 2.85 $mmH_2O/cm^2$ for 3 lots (Average 2.87 $mmH_2O/cm^2$). |
| Flammability | Class 1 | All tested models/lots (Sterile Ear loop Edging, Non-edging; Headband Edging, Non-edging; Tie-on; Non-sterile Ear loop Edging, Non-edging; Headband Edging, Non-edging; Tie-on) showed Class 1 results. |
Regarding the specific questions about an AI/ML device:
- 2. Sample sized used for the test set and the data provenance: Not applicable to a surgical mask. Tests were performed on samples of the mask.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Performance tests were laboratory-based, not expert-opinion based.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for the surgical mask's performance is objective measurement against established standards (e.g., ASTM, EN, ISO).
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable.
In conclusion, the provided document is a 510(k) submission for a physical medical device (surgical mask) and does not contain the type of information requested for a software AI/ML device. The "study that proves the device meets the acceptance criteria" refers to the non-clinical laboratory tests detailed in the document, which demonstrate the mask's physical and biological barrier properties meet the relevant standards for its intended use.
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