(284 days)
The SpectraShield 9500 Surgical Mask is a single use, disposable, surgical mask, tested for continuous use up to 8 hours, embedded with a zeolite carrier containing a silver-copper agent on the outer layer and is not an antimicrobial drug. SpectraShield 9500 kills 99.99% of test bacteria after one hour of contact with the surface of the respirator, and inactivates 99.99% of test influenza viruses after 5 minutes of contact with the surface of the mask. In vitro (laboratory) tests have demonstrated 99.99% kill on the surface of the respirator when tested in vitro against single isolates of the following test bacteria: Streptococus pyogenes, MRSA (Methicillin Resistant Staphylococcus aureus), and Haemophilus influenzae, under tested contact conditions.
In vitro tests have demonstrated 99.99% inactivation on the surface of the mask when tested against the following seasonal, pandemic, avian, swine influenza viruses: Influenza A subtypes: H1N1 (A/ California/04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A/Puerto Rico/8/1934), H3N2 (A/Wisconsin/67/2005, A/Brisbane/10/2007, A/Hong Kong/8/1968, A/Victoria/3/75), H2N2 ( A/2/Japan/305/1957); Avian Flu (bird flu) subtypes: Avian Influenza A (H5N1), Avian Influenza A (H9N2), Swine Flu subtype: H1N1 (A/Swine/1976/1931), Equine Flu subtypes: H3N8 (A/Equine/2/Miami/1963), Influenza B strains: B/Florida/4/2006, B/Brisbane/60/2008, B/ Lee/40.
No clinical studies have been conducted comparing the ability of an untreated surgical mask and the SpectraShield model 9500 surgical mask to protect the wearer from infection, and the antibacterial/anti-influenza virus treatment cannot affect pathogens that are inhaled around the edges of the respirator.
The SpectraShield 9500 Surgical Mask is a single use device, intended for occupational use to protect against microorganisms, body fluids, and particulate material.
The SpectraShield model 9500 Surgical Mask is a molded shape surgical mask composed of 4 layers of material, molded to form the mask. A 2-ply meltblown polypropylene middle layer is sandwiched by inner and outer layers of 100% polyester nonwoven fabric. The inner and outside layers of polyester nonwoven fabric include fibers that have been embedded with an antibacterial/antiviral agent to provide antibacterial and antiviral performance. The mask has 2 elastic straps (not made with natural latex) and an aluminum nose strip.
The provided document is a 510(k) Summary for the SpectraShield Model 9500 Surgical Mask, describing its characteristics and comparing it to predicate devices to demonstrate substantial equivalence. It does not describe an AI medical device. Therefore, it is not possible to answer the request by extracting information about acceptance criteria for an AI device.
However, I can extract the acceptance criteria and performance data for the surgical mask as presented in the document, which are based on standard tests for such devices.
Here's the information regarding the SpectraShield Model 9500 Surgical Mask, formatted as requested for an "AI device," but adapted to fit the context of a physical medical device (surgical mask):
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Predicate Equivalent or Standard) | Reported Device Performance (SpectraShield Model 9500 Surgical Mask) |
|---|---|---|
| Fluid Resistance ASTM F1862 | Fluid resistant @ 160mm Hg | Pass: Fluid Resistant @ 160mm Hg |
| Particulate Filtration ASTM F2299 | >99.9% (Predicate: 99.87% at 0.1 microns) | Pass: 99.87% at 0.1 microns |
| Differential Pressure Mil M36954C | 4.9mm H20/cm2 (Predicate: 4.3mm H20/cm2) | Pass: 4.3mm H20/cm2 |
| Bacterial Filtration ASTM F2101 | >99.9% (Predicate: 99.9%) | Pass: 99.9% |
| Flammability 16CFR 1610 | Class 1 | Class 1 |
| Cytotoxicity ISO 10993-10 | USP reactivity score = 10⁶, 1 hr contact) | ≥ 99.99% kill (implied >4 log₁₀ reduction) |
| Bacterial Reduction after 12 hrs perspiration (S. pyogenes, H. influenzae, MRSA) (T₀ Inoculums >10⁶, 1 hr contact) | ≥ 99.99% kill (implied >4 log₁₀ reduction) | S. pyogenes: >4.25 log₁₀ reduction; H. influenzae: >4.18 log₁₀ reduction; MRSA: >4.11 log₁₀ reduction |
| Viral Reduction (16 strains of Influenza A & B viruses, 5 min contact) | 99.99% (>4.0 log₁₀) reduction | 99.99% (>4.0 log₁₀) reduction |
| Repeat Virus Challenge (H1N1, H5N1 after 4 & 8 hrs wear, 5 min contact) | 99.99% (>4.0 log₁₀) reduction | 99.99% (>4.0 log₁₀) reduction |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test. However, it indicates that the tests performed are in vitro (laboratory) tests. Data provenance is not explicitly stated beyond "in vitro (laboratory) tests," implying laboratory settings and not human clinical data or geographical origin. The study is a pre-market notification (510k) using performance data to demonstrate substantial equivalence to predicate devices, not a clinical study on patient outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the tests described are in vitro laboratory tests measuring physical and microbiological properties of the mask, not evaluations requiring expert interpretation of medical images or patient data to establish ground truth.
4. Adjudication method for the test set
This is not applicable as the tests are objective laboratory measurements, not subjective evaluations requiring adjudication.
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. The device is a surgical mask, not an AI diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a surgical mask, not an AI algorithm. The performance data presented are for the mask itself in laboratory settings.
7. The type of ground truth used
For the physical and biological tests (fluid resistance, filtration, pressure, flammability, cytotoxicity, skin irritation, systemic toxicity, physico-chemical, gas/leach-off), the "ground truth" is defined by the objective measurement adhering to established ASTM, Mil, CFR, ISO, and USP standards.
For bacterial and viral reduction, the "ground truth" is the quantitative reduction in viable microorganisms as measured in the in vitro laboratory tests.
8. The sample size for the training set
This is not applicable. The device is a physical product (surgical mask), not an AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no AI training set involved. The product's characteristics are inherent to its design and manufacturing.
§ 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.