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The N95 Particulate Respirator (MF01) is single-use, disposable device, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

The N95 particulate respirator (Model MF-01) is NIOSH certified (TC-84A-7697), pouched-shaped respirators when worn. The flat-folded respirator is composed of four layers-inner layer, filter (2 layers) and outer layer. The four layers are combined via ultrasonically welded. The respirator also contains a nose-piece enclosed in a binding tape welding the top edge to conform to the contours of the face. The respirator contains straps to secure the respirator in place on the wearer. The respirator is offered in white. The respirator is provided non-sterile and for single use only.

This document is a 510(k) Premarket Notification for a Master-Frank N95 Particulate Respirator. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study of diagnostic AI. Thus, much of the requested information (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth types for AI models) is not applicable or present in this document.

However, I can extract the acceptance criteria and reported device performance from the "Non-Clinical Performance Data" and "Performance testing" sections, which are focused on the physical performance and biocompatibility of the respirator.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each of the biocompatibility and physical performance tests. It refers to established standards (e.g., ISO 10993, ASTM F1862, 16 CFR 1610, NIOSH certification), which would have their own specified sample sizes. The data provenance is from tests conducted on the Master-Frank N95 Particulate Respirator (Model MF-01) by accredited labs for NIOSH certification and other standards. The document doesn't specify the country of origin of the testing data itself, but the manufacturer is based in China. The data is prospective as it pertains to the device being submitted for clearance.

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

Not applicable in the context of this device clearance. The "ground truth" for these tests is defined by the objective measurement criteria within the specified international standards and NIOSH certification protocols. These tests are conducted by trained technicians in certified laboratories, following stringent procedures rather than subjective expert interpretation.

4. Adjudication method for the test set

Not applicable. The tests performed are objective, quantitative measurements following standardized protocols (e.g., measuring filter efficiency, fluid penetration, flame spread). There is no "adjudication" in the sense of reconciling differing expert opinions. The results are either "pass" or "fail" against defined thresholds.

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 document is for the clearance of an N95 particulate respirator, not an AI-powered diagnostic device. Therefore, no MRMC study involving human readers or AI assistance was performed or reported.

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

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

7. The type of ground truth used

The "ground truth" for the performance claims of the N95 respirator is based on objective, standardized physical and biocompatibility testing criteria. Examples include:

• Physical Measurements: Filtration efficiency (% of particles filtered), differential pressure (airflow resistance), fluid penetration (absence of synthetic blood penetration at a given pressure), and flame spread time.
• Biocompatibility Assessments: Observational and analytical results from in vitro cytotoxicity assays, irritation tests (e.g., skin irritation), and sensitization tests (e.g., skin sensitization) performed according to ISO 10993 standards.

These are verifiable, objective measures against international standards and regulatory requirements.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/machine learning device. The device is a physical product designed and manufactured to meet specific performance standards.

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

Not applicable. As there is no training set for an AI model, the concept of establishing ground truth for a training set does not apply here. The device's performance is established through direct physical and biological testing against predefined standards.

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Master & Frank Surgical Drapes (Sterile) is a single use article intended to be used as a protective patient covering, such as to isolate a site of surgical incision for microbial and other contamination..

Master & Frank Surgical Drapes (Sterile), is manufactured from nonwoven fabric , PE & Reinforce layer. The Surgical Drapes includes (3) basic configurations of SPLIT DRAPE , THYROID SHEET and PEDIATRIC LAPAROTOMY DRAPE. The Surgical Drapes is supplied sterile and for single use only.

The provided document is a 510(k) summary for the Master & Frank Surgical Drapes (Sterile). It describes the device, its intended use, and a performance summary. However, it does not contain a detailed study with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or specific types of studies (MRMC or standalone) as requested in your prompt.

The document focuses on demonstrating substantial equivalence to a predicate device (Medline Disposable Surgical Drapes & Gowns K964142) by stating that the device meets applicable standards.

Here's a breakdown of what the document does provide in relation to your request, and what it does not provide:

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

• Acceptance Criteria (Implicit via Standards Met): The document states: "In terms of Physical specification -- ASTM D1424 , ASTM D5034 & NFPA Flammability standards --- etc, Biological specification ISO 10993 series & Sterilization Specification ISO 11137 & ISO 11607-1 , the device are designed to meet applicable standards .."
  • This implies that the acceptance criteria are adherence to these specific standards for physical properties, biological safety, and sterilization.
• Reported Device Performance: The document only generically states that the device is "designed to meet applicable standards." It does not provide specific numerical or qualitative results for each standard (e.g., actual tensile strength measurements, specific flammability ratings, or detailed biocompatibility test reports).

The following information is NOT available in the provided text:

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

• The document mentions "bench testing contained in this submission" but provides no details on sample sizes or data provenance.

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 type of information is not relevant or included for a physical device like a surgical drape. Ground truth is established by adherence to documented standards and test methods.

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

• Not applicable as no human adjudication is described for the physical and biological testing of a surgical drape.

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 medical device (surgical drape), not an AI/software product requiring human reader studies.

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

• Not applicable, as this is not an AI/software algorithm.

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

• For this device, the "ground truth" would be established by the specifications defined in the referenced ASTM, NFPA, and ISO standards, and the results of laboratory tests performed according to those standards. The document only confirms the device "is designed to meet applicable standards."

8. The sample size for the training set:

• Not applicable as this is not a machine learning/AI model that requires a training set. The "design" for a physical device is not "trained" in this context.

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

• Not applicable for the same reason as point 8.

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Master & Frank Surgical Gowns (Sterile) are single use article of surgical apparel that is intended to be worn by operating room personnel during surgical procedures to help protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Master & Frank Surgical Gowns (Sterile), is manufactured from non-woven fabric. This surgical Gown is supplied sterile and for single use only.

The provided text is a 510(k) summary for a medical device, specifically Master & Frank Surgical Gowns (Sterile). It outlines the device description, intended use, and a performance summary. However, it does not describe an AI medical device, but rather a physical sterile surgical gown.

Therefore, the requested information regarding acceptance criteria and a study proving a digital device meets those criteria (which would typically involve performance metrics like accuracy, sensitivity, specificity, statistical analysis of a test set, expert adjudication, etc.) is not applicable to this submission.

The "Performance Summary" section of the 510(k) states:

"In terms of Physical specification -- ASTM D1424 , ASTM D5034 & NFPA Flammability standards----etc, Biological specification ISO 10993 series & Sterilization Specification ISO 11137 & ISO 11607-1 , the device are designed to meet applicable standards.."

This indicates that the acceptance criteria for this physical device are based on compliance with established industry standards for physical properties (like tear strength, tensile strength, flammability), biological safety (biocompatibility), and sterilization. The "study" proving it meets these criteria would typically involve bench testing against these specific material and sterilization standards, rather than the types of studies performed for AI software (e.g., test set evaluations with ground truth derived from expert consensus or pathology).

Since the submission is not for an AI device, I cannot provide the requested details regarding AI-specific criteria.

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