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The SpectraShield 9500 Surgical N95 Respirator is a single use, disposable, surgical N95 respirator, 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. In vitro (laboratory) tests have demonstrated 99.99% kill on the surface of the outer layer of the respirator when tested in vitro against single isolates of the following test bacteria: Streptococcus pyogenes, MRSA (Methicillin Resistant Staphylococcus aureus), and Haemophilus influenzae, under tested contact conditions.

No clinical studies have been conducted comparing the ability of an untreated surgical N95 respirator and the SpectraShield model 9500 surgical N95 respirator to protect the wearer from infection, and the antibacterial treatment cannot effect pathogens that are inhaled around the edges of the respirator.

The SpectraShield 9500 Surgical N95 respirator is a single use device, intended for occupational use to protect against microorganisms, body fluids, and particulate material,

The SpectraShield model 9500 Surgical Respirator is a molded shape surgical respirator composed of 4 layers of material, molded to form the respirator. 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 antimicrobial agent to provide antimicrobial performance. The respirator has 2 latex-free non-allergenic elastic straps and an aluminum nose strip.

Here's an analysis of the acceptance criteria and study information for the SpectraShield model 9500 Surgical Respirator based on the provided text:

Device: SpectraShield model 9500 Surgical Respirator

1. Table of Acceptance Criteria and Reported Device Performance:

Note: For several tests (Particulate Filtration Efficiency, Differential Pressure, Bacterial Filtration Efficiency), explicit numerical acceptance criteria from the predicate or regulatory guidance are not stated in the provided text, but the device's performance is listed as "Pass." The acceptance criteria for these would typically be derived from the relevant ASTM/Mil standards or comparison to the predicate device's performance if not explicitly noted. In this case, the predicate device's performance for these tests is generally lower, implying the SpectraShield's performance meets or exceeds the necessary thresholds.

2. Sample Size Used for the Test Set and Data Provenance:

The document describes various performance tests for the SpectraShield 9500. However, it does not specify the sample sizes used for each individual test (e.g., how many respirators were tested for fluid resistance, filtration efficiency, etc.).

Data Provenance: The tests are described as in vitro (laboratory) tests. There is no mention of country of origin for the data, nor whether the studies were retrospective or prospective, as they are laboratory performance evaluations of the device itself, not clinical studies involving human subjects.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable to the type of studies described. The "ground truth" here is established by standardized test methods (e.g., ASTM, ISO, Mil standards) and objective measurements, not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set:

This information is not applicable. The tests performed are objective, laboratory-based measurements against established standards, not studies requiring adjudication of subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document explicitly states: "No clinical studies have been conducted comparing the ability of an untreated surgical N95 respirator and the SpectraShield model 9500 surgical N95 respirator to protect the wearer from infection, and the antibacterial treatment cannot effect pathogens that are inhaled around the edges of the respirator." Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, in essence. The testing performed for the SpectraShield 9500 is entirely standalone in the sense that it evaluates the device's physical and biological performance characteristics (e.g., filtration, fluid resistance, antimicrobial kill rate) directly, without human interaction or interpretation involved in the measurement process itself. The "device performance" in the table reflects these standalone results.

7. The type of ground truth used:

The ground truth for the performance tests is based on standardized test methodologies and objective measurements according to established industry and regulatory standards (e.g., ASTM F1862, ASTM F2299, Mil M36954C, ASTM F2101, 16CFR 1610, ISO 10993-10, ISO 10993-11, USP). For the antimicrobial efficacy, the "ground truth" results are the measured kill rates against specified bacteria under controlled in vitro conditions.

8. The sample size for the training set:

Not applicable. This device is a physical product (surgical respirator), not an AI/machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As above, there is no training set for this type of device.

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