Search Results

The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.

The proposed device Disposable Surgical Gowns have body, sleeve and belt are made of SMMS nonwoven material, and cuff is made of cotton. The Disposable Surgical Gowns are blue color, sterilized by ethylene oxide gas, single use and disposable medical device. The proposed device is available in S (115×140cm), M (120×150cm), L (130×160cm), XL (140×170cm), XXL (150×175cm), and XXXL (170×180cm).

This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.

This document is a 510(k) Premarket Notification from the FDA for Disposable Surgical Gowns. It details the device, its intended use, comparison to a predicate device, and results of non-clinical tests.

Here's the breakdown of the acceptance criteria and study information, based on your request, extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

For the performance tests (Seam strength, Breaking strength, Tear strength, Lint generation), the reported sample size is 10 samples for which an average result is provided for each.

For Water Penetration Resistance, Static hydrostatic resistance, EO/ECH residuals, and Flammability, a specific sample size isn't explicitly stated but the results are indicated as "PASS."

For Biocompatibility (Cytotoxicity, Irritation, Sensitization), the sample size is not explicitly mentioned, but the statements refer to "the conditions of the study" and "the device extract."

The data provenance is from Xiamen Probtain Medical Technology Co., Ltd. in Xiamen, Fujian, China. The studies are non-clinical tests conducted to verify that the proposed device met design specifications. The document does not specify whether the tests were retrospective or prospective, but as they are laboratory performance and material tests for a new device submission, they would typically be conducted prospectively on newly manufactured samples.

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

This type of information is not applicable to this document. The "device" in question is a surgical gown, and the testing involves physical material properties and biological compatibility, not an AI/diagnostic device that would require human experts to establish ground truth from medical images or clinical data. The acceptance criteria are based on established industry standards (e.g., ASTM, ISO, AAMI, CPSC) and regulatory requirements for medical devices.

4. Adjudication Method for the Test Set

This is not applicable. As this is not an AI/diagnostic device, there is no human interpretation or adjudication of outputs against a ground truth. The results are based on objective measurements from standardized tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

This is not applicable. This document evaluates a physical medical device (surgical gown), not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant.

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

This is not applicable. This document evaluates a physical medical device (surgical gown), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by validated test methods and industry standards. For example:

• Physical properties: ASTM standards (D1683M-17, D5034-09, D5587-15) define how to measure properties like seam strength, breaking strength, and tear strength, and define passing criteria.
• Barrier performance: ANSI/AAMI PB70:2012 specifies the liquid barrier performance and classification for protective apparel, which dictates the acceptable levels for water penetration and hydrostatic pressure.
• Flammability: CPSC 16 CFR Part 1610-2008 sets the standard for flammability of clothing textiles.
• Biocompatibility: ISO 10993 series (ISO 10993-5, ISO 10993-10) defines the methods and acceptance criteria for cytotoxicity, irritation, and sensitization.
• Sterilization residuals: ISO 10993-7:2008 sets the acceptable limits for ethylene oxide and ethylene chlorohydrin residuals.

8. The Sample Size for the Training Set

This is not applicable. This document describes performance testing for a physical medical device, not the development or validation of an AI model with a training set.

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

This is not applicable. As there is no AI model or training set involved, the concept of establishing ground truth for a training set does not apply here.

Ask a specific question about this device

Disposable Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Isolation Gown meets the requirements of AAMI Level 3 barrier protection for a surgical isolation gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Isolation Gowns are single use, disposable medical devices, provided sterile.

Disposable Isolation Gowns are designed for the medical personnel use in medical environment, not intended for use in the operating room. The employed material is Polypropylene(PP) non-woven with polyethylene(PE) lamination. It is a kind of Non- Reinforced isolation gown. The Disposable Isolation Gowns are constructed from a blue PP&PE (non-woven fabric, PE lamination) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical isolation gown. The Disposable Isolation Gowns are blue color, sterilized by ethylene oxide gas , single use, disposable medical device that will be provided in a variety of sterile packaging configurations with 6 sizes, S,M,L,XL,XXL,and XXXL

The provided document describes the acceptance criteria and the results of non-clinical tests for the "Disposable Isolation Gowns" (K223411) from Xiamen Probtain Medical Technology Co., Ltd.

Here's the requested information:

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

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

• Sample Size for Mechanical/Physical Tests: For most mechanical and physical tests (Seam strength, Breaking strength, Tear strength, Lint and other generation), the results are reported as an "Average result from 10 samples."
• Sample Size for Biocompatibility Tests: Not explicitly stated but generally follows ISO 10993 standards which define sample sizes.
• Data Provenance: The tests were conducted to verify that the proposed device met design specifications. The document does not specify the country of origin of the testing data beyond listing the applicant's address in Xiamen, Fujian, China. The studies are non-clinical (laboratory-based performance and safety tests), not related to patient data, so "retrospective or prospective" does not apply in the typical sense.

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 product is a medical device (isolation gown), not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for these tests is established by adherence to recognized international and national standards (e.g., AAMI, ASTM, ISO, CPSC). The experts involved would be laboratory technicians and engineers who are qualified to perform these specific standard tests, but their specific number or qualifications are not detailed in this submission as it's not relevant for this type of device.

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

Adjudication methods like 2+1 or 3+1 are typically for clinical studies or studies involving human readers/interpreters. This document describes non-clinical laboratory testing of a physical product against established performance standards. Therefore, an adjudication method is not applicable and not mentioned.

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, an MRMC comparative effectiveness study was not done. This device is a disposable isolation gown, not an AI-powered diagnostic or assistive technology that would involve 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-only performance study was not done. This is not an algorithmic device. The "standalone" performance here refers to the physical gown's performance against defined standards.

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

The "ground truth" for the device's performance is defined by the acceptance criteria specified in recognized industry standards (e.g., AAMI PB70:2012, ASTM D1683M-17, ISO 10993). Therefore, it's a standards-based ground truth.

8. The sample size for the training set

This is a physical medical device (isolation gown) undergoing non-clinical performance and biological safety testing, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms.

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

As explained in point 8, there is no training set for this type of device.

Ask a specific question about this device

The Disposable Surgical Mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided sterile.

The Disposable Surgical Mask is composed of mask body, nose clip and ear loop. The mask is composed of three layers: the inner and outer layers are made of Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter, the nose clip is made of plastic materials and iron wire, ear loop is made of spandex.

The size of the disposable surgical mask is 17.5*9.5cm with tolerance +-5%, the length of the ear loop is 16cm with tolerance +-5%, and the length of the nose clip should no less than 8.0cm.

The outer layer of disposable surgical mask will be provided in blue, the inner layer of the disposable surgical mask will be provided in white, and it will be provided with sterile and is intended to be single use, disposable devices.

The document describes the non-clinical testing performed to demonstrate that the Disposable Surgical Mask (Model MP9017) manufactured by XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD meets its acceptance criteria and is substantially equivalent to a predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for each test in the acceptance criteria table (Table 2 and 3). However:

• Fluid Resistance (ASTM F1862): The acceptance criteria and performance indicate a sample size of 32 test articles.
• Other performance tests (PFE, BFE, Differential Pressure, Flammability): The specific sample sizes for these tests are not provided.
• Biocompatibility tests (Cytotoxicity, Irritation, Sensitization): The specific sample sizes are not provided, but these tests are typically conducted in vitro or on animal models following ISO 10993 guidelines.

Data Provenance: The non-clinical tests were conducted by the manufacturer, XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD, based in China (Xiamen, Fujian). The document does not specify if the data is retrospective or prospective, but as it's part of a 510(k) submission for a new device, these would typically be newly conducted prospective tests.

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

This information is not applicable as the acceptance criteria are based on established international standards (ASTM, EN, ISO, CFR) for medical device performance and biocompatibility, not on expert consensus for a ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are objective laboratory measurements against defined standards, not subjective assessments requiring expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." Surgical masks are typically evaluated through non-clinical performance and biocompatibility testing against established standards, not through studies involving human readers or comparative effectiveness with AI.

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. This device is a physical product (surgical mask), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the test results is based on objective measurements performed according to established international standards and test methods. For example:

• Fluid Resistance: Measured according to ASTM F1862.
• Filtration Efficiency: Measured according to ASTM F2299 (PFE) and ASTM F2101 (BFE).
• Differential Pressure: Measured according to EN 14683 Annex C.
• Flammability: Measured according to 16 CFR 1610.
• Biocompatibility: Evaluated according to ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical surgical mask and does not involve an AI algorithm that requires a training set. The term "training set" is relevant for AI/machine learning models.

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

This information is not applicable for the same reason as point 8.

Ask a specific question about this device

The Disposable Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Disposable Surgical Mask is composed of mask body, nose clip and ear loop. The body of the mask is composed of three layers: the inner and outer layers are made of Spun-bond polypropylene, and the middle layer is made of melt blown non-woven fabric, the nose clip is made of plastic materials and iron wire, ear loop is made of spandex.

The size of the disposable surgical mask is 17.5*9.5cm with tolerance±5% cm, the length of the ear loop is 16cm, and the length of the nose clip should no less than 8.0cm.

The outer layer of disposable surgical mask will be provided in blue, the inner layer of the disposable surgical mask will be provided in white, and it will be provided with non-sterile and is intended to be single use, disposable devices.

The provided document is a 510(k) summary for a Disposable Surgical Mask (K201893). This type of regulatory submission demonstrates substantial equivalence to a predicate device based on non-clinical performance data. It does not involve AI or complex medical imaging, and therefore, many of the requested criteria (like ground truth establishment by experts, MRMC studies, training set details, or sample size for test sets in an AI context) are not applicable to this document.

However, I can extract and present the relevant "acceptance criteria" and "device performance" in a structured way, based on the provided tables.

Acceptance Criteria and Reported Device Performance for Disposable Surgical Mask (K201893)

The study proves the device meets the acceptance criteria through a series of non-clinical performance tests designed to show equivalence to a predicate device (K182514).

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Applicability for Other Requested Information:

The following points are not applicable to this 510(k) submission for a non-AI medical device (surgical mask):

• 2. Sample size used for the test set and the data provenance: For physical performance tests like fluid resistance, specific sample sizes are often defined by the testing standards (e.g., 32 samples for ASTM F1862). The tests are typically conducted in a laboratory setting, and the data provenance would be internal testing reports, not patient data from specific countries or retrospective/prospective studies.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is for AI/imaging devices where human interpretation is the ground truth. Not applicable here.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as there's no human interpretation or ground truth adjudication in the context of physical performance testing of a surgical mask.
• 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 for AI-assisted diagnostic devices.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI algorithm performance.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is the defined performance standard (e.g., "≥ 98% BFE"). It's based on established scientific and engineering principles for material performance, not clinical outcomes or expert consensus on medical images.
• 8. The sample size for the training set: There is no "training set" for physical performance testing of a disposable surgical mask. This concept applies to machine learning models.
• 9. How the ground truth for the training set was established: Not applicable, as there is no training set.

In summary, this document describes a traditional medical device submission where the acceptance criteria are based on established performance standards for the product type, and the study proves compliance through direct physical and material testing, not through AI model validation methodologies.

Ask a specific question about this device