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Pasture F550S, Pasture F550CS, Pasture A520S, Pasture A520CS, Pasture E520S, and Pasture E520CS is a NIOSH certified N95 respirator, and is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.

Pasture F550S and Pasture F550CS respirators are disposable duck bill shaped N95 respirators with NIOSH certification number TC-84A-7504. They contain 5 layers composed of polypropylene, with a nose cushion, a synthetic elastic loop or strap, and a nosepiece which is the combination of zinc wires and embedded polyester inside of layers. F550CS is the same respirator as the F550S, but F550CS contains an adjustable buckle on the headband.

Pasture A520S and Pasture A520CS respirators are cup shaped N95 respirators with NIOSH certification number TC-84A-7454. They contain 4 layers composed of polypropylene with a synthetic elastic loop or a strap. A520CS is the same respirator as the A520S, but A520CS contains an adjustable buckle on the headband.

Pasture E520S and Pasture E520CS respirators are cup shaped N95 respirators with NIOSH certification number TC-84A-7453. They contain 4 layers composed of polypropylene with a nose cushion, synthetic elastic loop or strap, and an aluminum nosepiece. E520CS is the same respirator as E520S, but E520CS contains an adjustable buckle on the headband.

This document describes the premarket notification for several models of Pasture Surgical N95 Respirators (F550S, F550CS, A520S, A520CS, E520S, E520CS). The provided information is insufficient to answer all parts of the request as it pertains to medical device AI/ML performance studies. However, I can extract the relevant information from the document regarding the acceptance criteria and performance of these N95 respirators. The questions asked are typically for AI/ML devices, not for surgical respirators.

Here's an analysis based on the provided text, adapted to the context of a physical medical device (N95 respirator) and its regulatory submission.

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

The acceptance criteria for these N95 respirators are based on various performance standards and regulatory requirements for surgical masks and N95 respirators. The document primarily demonstrates substantial equivalence to a predicate device (WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095) through performance testing.

The following questions are not applicable to the provided document, as it concerns a physical medical device (N95 respirator) and not an AI/ML algorithm or software as a medical device (SaMD). The document does not describe a study involving readers, ground truth establishment by experts, or training/test sets in the context of an AI/ML device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This document describes a 510(k) premarket notification for physical N95 respirators, not an AI/ML device or its test set. Performance testing is typically conducted on a sample of manufactured devices according to established test methods for physical properties and biocompatibility. The specific sample sizes for each test (e.g., fluid resistance, flammability) are not detailed in this summary but would be specified in the full test reports referenced by the NIOSH certification and ASTM standards. The provenance of the data would be from the laboratories that performed these physical tests.

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)

• Not Applicable. Ground truth in the context of expert consensus is relevant for diagnostic AI/ML algorithms. For N95 respirators, the "ground truth" is determined by physical and chemical test results against a defined standard (e.g., NIOSH standards, ASTM F1862). Expert qualifications would pertain to the technicians conducting these standardized tests, ensuring they follow protocols, not to clinical interpretation of data.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in AI/ML performance studies to resolve discrepancies in expert interpretations to establish a robust ground truth. For N95 respirators, performance is objectively measured by standardized tests, not by expert consensus on clinical findings.

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. MRMC studies are designed to assess the impact of AI assistance on human reader performance, typically in diagnostic imaging. This document does not pertain to an AI device.

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

• Not Applicable. This question relates to the performance of an AI algorithm in isolation. The product is a physical N95 respirator.

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

• For physical devices like N95 respirators, the "ground truth" for performance is defined by adherence to established industry standards and regulatory requirements (e.g., NIOSH N95 certification, ASTM F1862 for fluid resistance, 16 CFR 1610 for flammability, ISO 10993 for biocompatibility). The tests objectively measure specific characteristics.

8. The sample size for the training set

• Not Applicable. Training sets are used for machine learning algorithms. This document describes a hardware device.

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

• Not Applicable. As above, training sets are not relevant to this type of device.

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Pasture 60S Surgical Mask is a surgical mask that is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.

Pasture 60S Surgical Mask is a flat pleated surgical mask. It is in 4 layers and composed of PP and Meltblown, also with elastic loops and nosepiece which is the combination of zinc wires and embedded polyester inside of layers.

The provided documents detail the 510(k) summary for the Pasture 60S Surgical Mask (K141875), comparing it to the predicate device, TIDI® Facemasks (K092580). The focus of this submission is on non-clinical performance testing for substantial equivalence, rather than a clinical study involving human readers or AI.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability, Biocompatibility). These tests are typically performed on a statistically significant number of samples according to the relevant test standards.

The provenance of the data is indicated by the laboratories that conducted the tests:

• Biocompatibility test: SUPER LABORATORY SGS (TAIWAN) LTD
• Flammability test: Taiwan Textile Research Institute
• Synthetic Blood Penetration test: Taiwan Textile Research Institute
• Particulate Filtration Efficiency: Nelson Laboratories (a well-known US-based lab for such testing)
• Bacterial filtration efficiency: Taiwan Textile Research Institute
• Differential pressure testing: Taiwan Textile Research Institute

The data is retrospective, as it refers to tests conducted on the device for this 510(k) submission. The countries of origin for the testing are Taiwan (for most tests) and the USA (for Particulate Filtration Efficiency).

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable. The device under review is a surgical mask, and the evaluation is based on objective, standardized physical and biological performance tests, not on interpretations or diagnoses by human experts.

4. Adjudication Method

This is not applicable. The performance tests yield objective numerical or categorical results (e.g., "Pass," "99.4%", "Class 1"), which do not require expert adjudication in the context of this 510(k) submission.

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

No. This type of study is relevant for diagnostic or interpretive devices where human readers evaluate cases with and without AI assistance. The Pasture 60S Surgical Mask is a physical barrier device, and its safety and effectiveness are assessed through laboratory performance tests, not human interpretation of medical images or data.

6. Standalone Performance Study (Algorithm Only)

No. This concept is applicable to software algorithms or AI systems operating independently. The Pasture 60S Surgical Mask is a physical device, and its "standalone performance" is demonstrated through the various laboratory tests listed.

7. Type of Ground Truth Used

The "ground truth" for the performance criteria is established by internationally recognized test standards and regulatory requirements for surgical masks, such as those related to fluid resistance (ASTM F1862), particulate filtration efficiency (ASTM F2299), bacterial filtration efficiency (ASTM F2101), differential pressure (MIL-M-36954C or EN 14683), flammability (16 CFR Part 1610), and biocompatibility (ISO 10993 series). The results of the laboratory tests are compared against these predetermined standards.

8. Sample Size for the Training Set

This is not applicable. The device is a physical product, not a machine learning model, hence there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

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This device is a disposable filtering facepiece respirators intended for use by the general public in public health medical emergencies - Pasture™ A520G Respirator and Pasture™ F550G Respirator

Pasture F550G respirator is a duck bill mask as described in NIOSH N95 standard It 1s in 5 layers and composed of spunbond, meltblown and polyester, also with nose cushion, elastic loops and/or strip and nosepiece which is the combination of zinc wires and embedded polyester inside of layers

Pasture A520G respirator is a cone shaped mask as described in NIOSH N95 standard It is in 4 layers and composed of spunbond, meltblown and polyester, also with synthetic rubber band which is coated with polyester and free of latex

The provided text describes a 510(k) summary for Filtering Facepiece Respirators (Pasture™ F550G & A520G). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria, sample sizes, and expert evaluations as would be expected for a diagnostic or AI-driven device.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth type for test/training sets, training set size) are not applicable or not available in this type of submission. This 510(k) is for a physical device (respirator), and the "performance" discussed is related to its physical properties and NIOSH certification, not an AI algorithm.

Here's the information that can be extracted or derived from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are typically the requirements for NIOSH certification and meeting the performance of the predicate device. The document primarily relies on comparative testing to the predicate device and NIOSH certification.

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

• Sample Size: Not specified in the 510(k) summary. For physical products like respirators, testing typically involves a sufficient number of units to demonstrate consistent performance against standards (e.g., NIOSH testing protocols would define sample sizes for particle filtration, breathability, fit, etc.). However, these specific numbers are not provided here.
• Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. The testing would have been conducted to support the NIOSH certification and biocompatibility claims. This is prospective testing specifically for the device submission.

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

• Not Applicable. This is a physical device (respirator), not an AI diagnostic. "Ground truth" in the context of diagnostic performance by experts is not relevant here. Performance is assessed against physical and biochemical standards.

4. Adjudication Method for the Test Set

• Not Applicable. As above, no expert adjudication is involved for physical performance testing of a respirator.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is not an AI diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. There is no algorithm. The device itself is the "standalone" product.

7. The Type of Ground Truth Used

• Physical/Chemical Standards: The "ground truth" for a respirator's performance is established by standardized testing methods defined by bodies like NIOSH (e.g., particle filtration efficiency, breathing resistance, fit testing protocols) and biocompatibility standards (e.g., ISO 10993 for cytotoxicity, sensitization, irritation). The predicate device's performance also acts as a reference for substantial equivalence.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. No training set is involved.

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