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The N95 Surgical Respirator AP0018 and AP0028 are intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.

SHUENN BAO SHING Corp. N95 Surgical Respirator AP0018 and AP0028 are flat pleated 3-ply masks with a center layer of polypropylene meltblown material by inner and outer layers of nonwoven material. The mask has 2 braided synthetic elastic headbands and a flexible wire tie nosepiece that allows the respirator to form to the bridge of the wearer's nose. No fiberglass media is used in this product.

Here's an analysis of the acceptance criteria and the study conducted for the SHUENN BAO SHING Corp. N95 Surgical Respirator (types AP0018 and AP0028), based on the provided 510(k) summary document:

This document is a 510(k) summary for a medical device (N95 Surgical Respirator), which is typically used to demonstrate substantial equivalence to a legally marketed predicate device rather than to rigorously "prove" device performance against a novel set of acceptance criteria through a full-scale clinical trial. Therefore, the "study" referred to here encompasses the non-clinical tests performed to demonstrate equivalency.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for N95 Surgical Respirators are based on established regulatory standards and guidance for such devices, primarily from NIOSH and ASTM. The device's performance is demonstrated by its compliance with these standards, effectively making the performance metrics of the new device equivalent to or better than those of the predicate device for substantial equivalence.

Table 1: Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are the requirements outlined in the specified standards, and "reported device performance" is the statement of compliance to these standards.

Study Details

1. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "sample size" in the context of a clinical test set, as no clinical tests were performed. The testing conducted was non-clinical (bench testing). For these bench tests (e.g., NIOSH, flammability, biocompatibility), the sample sizes would typically be determined by the specific test standards themselves, but these details are not provided in this summary.

Data Provenance: The document originates from SHUENN BAO SHING Co., Ltd. in Taiwan, R.O.C. The tests were performed in compliance with US regulatory standards (NIOSH, CFR, ISO). The data is retrospective in the sense that it represents lab test results conducted on the manufactured device models.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This was a non-clinical bench testing study, not requiring expert consensus for a "ground truth" in the way a clinical diagnostic study would. Compliance to engineering and material science standards was assessed.

3. Adjudication Method for the Test Set

Not applicable. As this was non-clinical bench testing against established standards, the results are typically objectively measured and compared to the standard's limits. No adjudication method in the context of expert review for clinical outcomes is mentioned.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A MRMC study is relevant for evaluating the performance of diagnostic tools that involve human interpretation (e.g., radiologists reading images). This 510(k) pertains to a physical device (surgical respirator), for which such a study is not applicable.

5. Standalone Performance (Algorithm Only)

Not applicable. This is a physical N95 surgical respirator, not an AI algorithm. Its performance is inherent in the device itself, without a "human-in-the-loop" or standalone algorithm component.

6. Type of Ground Truth Used

For non-clinical tests, the "ground truth" is defined by the objective standards and test methods (e.g., NIOSH 84.188 for exhalation resistance, 16 CFR 1610 for flammability). The device's physical properties and performance characteristics are measured against the specified limits within these standards.

7. Sample Size for the Training Set

Not applicable. There is no training set in the context of machine learning or AI models, as this is a physical device submission.

8. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set. The "ground truth" for the device's acceptable performance is established by the regulatory standards mentioned above.

Summary Takeaway:

The provided document is a 510(k) summary demonstrating substantial equivalence of a new surgical respirator to existing predicate devices. The "study" in this context refers to a series of non-clinical bench tests performed according to recognized national and international standards (NIOSH, CFR, ISO) to prove the new device meets the same performance characteristics as its predicates. It explicitly states that "no clinical tests were performed." Therefore, many of the typical questions for AI/diagnostic device studies (like sample size for test/training sets, expert ground truth, MRMC studies) are not applicable here.

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The Delta N95 Respirator and Surgical Mask will be used for the health care practitioner from blood and body fluids and particulates and to meet the NIOSH / CIX' TB Prevention Guidelines.

DELTA N95 RESPIRATOR AND SURGICAL MASK is indicated for respiratory protective device. This disposable Surgicul mask is a one-piece, light weight half mask with filter material forming the mask. The component includes an inner serim hayer, netting material forming the mask. The component includes an inner scrim layer, netting layer, meltblown protection layer, outer scrim layer and clastic band. DELTA N95 RESPIRATOR AND SURGICAL MASK is NIOSH approved (Approval #TC-84A-0003) and has a filtration efficiency level of 95% and is effective against particulate acrosols free of oil. DELTA N95 RESPIRATOR AND SURGICAL MASK is available in four sizes, extra small, small, medium and large. The nose clip and elustic headband ensures effective face to mask seal.

The provided text describes a medical device (DELTA N95 RESPIRATOR AND SURGICAL MASK) and compares it to predicate devices. However, it does not contain information about acceptance criteria, a specific study proving the device meets these criteria, or any details related to AI/algorithm performance (standalone or with human readers).

The document is a 510(k) summary for a premarket submission of a physical medical device (an N95 respirator and surgical mask), focusing on demonstrating substantial equivalence to existing devices. Therefore, a significant portion of the requested information cannot be extracted from the provided text.

Based on the information available, here's what can be provided:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for this device are those defined by the Code of Federal Regulations, Title 42, Part 84 for N95-class of Respiratory Protective Devices, and meeting CDC guidelines for preventing transmission of Mycobacterium tuberculosis.

2. Sample size 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 submission focuses on product specifications and comparison to predicates, not specific test data results for a particular sample size.

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 information is not provided in the document. This type of detail is not typically included in a 510(k) summary for a physical respiratory protection device unless specific clinical studies requiring expert evaluation were conducted and reported.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done as this is a physical medical device (respirator/mask), not an AI/software device designed to assist human readers. Thus, there is no discussion of human readers or AI assistance.

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

No, a standalone algorithm performance study was not done as this is a physical medical device (respirator/mask), not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this type of device, the "ground truth" would be established by standardized laboratory testing methods to measure filtration efficiency, fit, and other performance characteristics as defined by NIOSH (42 CFR Part 84) and potentially fluid resistance (as it is also a surgical mask). It's not based on expert consensus, pathology, or outcomes data in the typical sense for diagnostic/screening devices.

8. The sample size for the training set

This information is not applicable and not provided. This device is a physical product, not a machine learning model that requires a "training set."

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

This information is not applicable and not provided. As explained above, it's not a machine learning model.

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