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The Gerson 1730 N95 Particulate Respirator is intended to be worn by operating room personnel during healthcare procedures to protect both the patient and healthcare professionals from the transfer of microorganisms, bodily fluids and particulate material.

This device also meets CDC guidelines for TB exposure.

Subject device is also a surgical mask and is single use / disposable.

The 1730 N95 Particulate Respirator and Surgical Mask is constructed from a white nonwoven material used for the inner and outer shell. The polypropylene meltblown filter media is layered between the inner and outer shell. The headband is made of elastic and welded to the mask. The inside nosepiece is made of an open celled foam and the outside nosepiece, which conforms to the nose, is made of aluminum.

The 1730 N95 Particulate Respirator is approved by NIOSH as per 42 CFR 84. The certification number assigned is TC-84A-160 for a type N95 Particulate Respirator. The N95 must meet the prescribed test criteria of a 0.3 micron diameter challenge and requiring a 95% efficiency. This mask is also fluid resistant as per the ASTM D583-65 Method 1 and is resistant to synthetic blood as per protocol number 9602202-01 conducted by Nelson Laboratories. Breathing resistance was tested as per 42 CFR 84.

The provided text describes a 510(k) premarket notification for the "Gerson 1730 N95 Particulate Respirator," which is seeking substantial equivalence to a predicate device. This document does NOT describe the acceptance criteria and study proving a device meets acceptance criteria in the way typically found for software or AI/ML devices with specific performance metrics (e.g., sensitivity, specificity).

Instead, this document focuses on confirming that the N95 respirator meets regulatory standards and performance equivalence for a physical product. The "acceptance criteria" here are defined by the required performance for an N95 respirator and surgical mask designation, and the "study" refers to the testing performed to demonstrate these physical properties.

Here's a breakdown based on the provided text, adapted to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "sample size for the test set" in the context of clinical data or image sets. It refers to a physical product undergoing standardized testing.

• For Particulate Filtration Efficiency and Breathing Resistance: These tests are conducted according to NIOSH standards (42 CFR 84). The sample size for such physical product testing is typically defined by the standard and involves a set number of units. The document does not explicitly state the number of units tested but implies compliance with the standard which would dictate this.
• For Fluid Resistance: "Protocol number 9602202-01 conducted by Nelson Laboratories." While the specific number of masks tested isn't given, Nelson Laboratories is a reputable testing facility, implying adherence to their established protocols for sample size.
• Data Provenance: The testing was performed by NIOSH (for N95 certification) and Nelson Laboratories (for fluid resistance). This implies controlled laboratory settings and not human subject data from a specific country or retrospective/prospective study.

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

Not applicable in the context of this device. The "ground truth" for a physical respirator's performance is established through objective, standardized engineering and material science tests, not through expert clinical consensus for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or adjudication involved in the objective measurements of filtration efficiency, fluid resistance, or breathing resistance. These are direct measurements comparing physical properties to established benchmarks.

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. This is a physical N95 respirator, not an AI/ML-based diagnostic or assistive device. Therefore, no MRMC studies or AI assistance are relevant.

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

Not applicable. This is a physical N95 respirator, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Standardized Test Methods and Criteria: Primarily NIOSH (National Institute for Occupational Safety and Health) standards for N95 respirators (42 CFR 84) and ASTM (American Society for Testing and Materials) standards (ASTM D583-65 Method 1) for fluid resistance.
• Predicate Device Performance: Demonstrating that the new device performs equivalently to a legally marketed predicate device (Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735).

8. The Sample Size for the Training Set

Not applicable. This is a physical product and does not involve a "training set" in the context of machine learning.

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

Not applicable. As there is no training set, there is no corresponding establishment of ground truth for a training set.

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The Gerson Model 2130 /2131 Disposable Surgical N95 Particulate Respirators are intended to be worn by operating room personnel during surgical procedures to protect the wearer from transfer of both the surgical patient and particulate material. The respirator is a single-use disposable.

The 2130 and 2131 Model respirators are available in either blue or white colors.

This device also meets CDC Guidelines for TB Exposure Control.

Not Found

This document is a 510(k) clearance letter from the FDA for the Gerson Model 2130/2131 Surgical N95 Particulate Respirators. It does not contain information about acceptance criteria or a study proving device performance in the context of the requested information. The document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than detailed performance study results against specific criteria.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample size, ground truth details, MRMC study, standalone performance, training set details) from the provided text.

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The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is 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.

This device also meets CDC Guidelines for "B Exposure Control.

The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is constructed from a white nonwoven material used in the inner and outer shell. The polypropylene melt blown filter media is layered between the inner and outer shell. The headband is made of rubber stapled to the mask. The inside nosepiece utilizes a closed cell foam and the outside nosepiece which conforms to the nose is made of aluminum.

The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is approved by NIOSH as per 42 CFR 84. The certification number assigned is TC-84A-160 for a type N95 Particulate Respirator. The Type N95 must meet the prescribed test criteria which specifies the use of 0.3 micron diameter challenge and requiring a 95% efficiency. This mask is also fluid resistant as per (ASTM D583 65 Method) and is resistant to synthetic blood as per Protocol number 9602202-01 conducted by Nelson Laboratories. Breathing resistance was tested as per NIOSH 30 CFR11 section 11.140-9.

Here's an analysis of the provided text regarding the Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735, structured to address your specific questions.

Important Note: The provided document is a 510(k) summary from 1996 for a respirator/surgical mask. It predates the widespread use of "AI" and "machine learning" in medical devices, and therefore, many of your questions related to AI-specific studies (e.g., sample size for AI test sets, AI ground truth, MRMC studies for AI improvement) are not applicable to this device. This document describes a physical medical device, not an AI algorithm.

Acceptance Criteria and Device Performance

Study Information (as applicable to a physical device)

1. Sample size used for the test set and the data provenance:

   • The document does not specify exact sample sizes for each test listed (e.g., number of respirators tested for filtration efficiency, number of samples for synthetic blood penetration).
   • Data Provenance: The tests were conducted by recognized laboratories like NIOSH (a US federal agency) and Nelson Laboratories (a US-based contract testing lab), and Gerson (the manufacturer). This indicates the data is from specific laboratory testing environments rather than clinical patient data. The summary doesn't imply any particular country of origin for the data itself beyond the testing locations. The studies are prospective in the sense that they are specifically designed to test the device's performance against established standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable as the device is a physical respirator, not an AI-driven diagnostic tool where expert consensus on "ground truth" (e.g., disease presence in an image) would be required. The "ground truth" here is the pass/fail criteria defined by regulatory standards (e.g., 95% efficiency, resistance to penetration). The "experts" are the scientists and engineers at NIOSH and Nelson Laboratories who conduct and interpret the standardized tests according to defined protocols.

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

   • This concept is not applicable to the testing of this physical device. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in human expert interpretations (e.g., reading medical images) are resolved to establish a definitive ground truth. Here, the "truth" is determined by objective physical measurements against a standard.

4. 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. This document describes a physical medical device (respirator/mask), not an AI algorithm intended to assist human readers (e.g., radiologists). Therefore, no MRMC study for AI assistance was performed.

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

   • This is not applicable. This device is not an algorithm.

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

   • The "ground truth" for this device's performance is based on pre-defined, objective physical and chemical testing standards and regulatory requirements. Examples include:
     • NIOSH standards: 95% filtration efficiency for 0.3 micron particles.
     • ASTM standards: Fluid resistance.
     • Specific laboratory protocols: Synthetic blood penetration.
     • NIOSH breathing resistance criteria.

7. The sample size for the training set:

   • This is not applicable. This device is not an AI algorithm; therefore, there is no "training set" in the context of machine learning. The term "training set" might loosely apply to the initial prototypes and iterative designs developed by Gerson Co., Inc. and tested internally, but it's not discussed in this 510(k) summary as a formal "training set" for an algorithm.

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

   • This is not applicable as there is no "training set" for an AI algorithm.

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