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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.

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Disposable Surgical 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 Surgical Isolation Gowns meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/A AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Surgical Isolation Gowns are single use, disposable medical devices: provided non-sterile.

Surgical Isolation Gown is designed for the medical personnel using in medical environment, not intended for use in the operating room. The employed material is SMS compound non-woven fabric. It is a kind of Non- Reinforced surgical isolation gown. Disposable Surgical Isolation Gowns are constructed from a blue PE SMS (spun-bond, melt-blown, spun-bond) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical isolation gown. The Disposable Surgical Isolation Gown is a single use, disposable medical device that will be provided in a variety of non-sterile packaging configurations with 6 sizes, S, M, L, XL, XXL, and XXXL.

This document is a 510(k) premarket notification for a medical device called "Disposable Surgical Isolation Gowns." It aims to demonstrate that the device is substantially equivalent to a previously cleared predicate device.

Here's an analysis of the provided information, focusing on acceptance criteria and study details:

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)

The document does not explicitly state the specific sample sizes used for each individual test conducted on the "Disposable Surgical Isolation Gowns." However, it references various ASTM, ISO, AATCC, and CPSC standards, which would typically define the required sample sizes for each test method. The provenance of the data (country of origin, retrospective/prospective) is not provided. These are non-clinical bench tests performed on the physical product.

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 section is not applicable. The "Disposable Surgical Isolation Gowns" device is a physical product, and its performance is evaluated through standardized laboratory tests (non-clinical tests) against predefined acceptance criteria, not through expert interpretation of data or images. Ground truth here is based on the objective results of these physical and chemical tests.

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

This section is not applicable. As mentioned above, the evaluation involves objective laboratory measurements against set standards, not subjective assessments requiring adjudication by multiple experts.

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

This section is not applicable. The device is a physical medical garment (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

This section is not applicable. The device is a physical medical garment, not an algorithm.

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

The "ground truth" for the performance of the Disposable Surgical Isolation Gowns is based on objective measurements obtained from standardized physical, chemical, and biological tests as defined by national and international standards (e.g., AAMI, ASTM, ISO, CPSC). These standards specify the test methods and the criteria for acceptable performance. For example:

• Mechanical properties: Breaking strength, tear strength, seam strength.
• Barrier properties: Water-proof property (liquid penetration), static hydrostatic resistance.
• Safety/Biocompatibility: Cytotoxicity, irritation, sensitization.
• Flammability: Flammability class.
• Particulate generation: Lint and other particles generation.

8. The sample size for the training set

This section is not applicable. The 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 section is not applicable. As there is no training set for a machine learning model, this information is not relevant.

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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 material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical 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 Surgical Gowns are single use, disposable medical devices; provided sterile or non-sterile. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.

Surgical Gown is designed for the medical personnel using in operation. The employed material is SMS compound non-woven fabric. The material has many good properties, such as soft, clean, good filtration and uniformity and waterproof, they are not sensitive to human beings, difficult to fluff, they don't have any peculiar smell, other matters and primary color. The gowns are for safe use in the operating room environment, i.e., lint free, free of toxic ingredients and non-fast dyes. It is a kind of Non- Reinforced surgical gown. The chest front and sleeve critical zones of the Disposable Surgical Gowns are constructed from a blue polyolefin SMS (spunbond, meltblown, spunbond) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown. The Disposable Surgical Gown is a single use, disposable medical device that will be provided in a variety of nonsterile packaging configurations.

The provided text describes the 510(k) summary for Disposable Surgical Gowns (K202532). It details non-clinical testing conducted to demonstrate substantial equivalence to a predicate device (K170762).

Here's the breakdown of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Disposable Surgical Gowns are primarily based on meeting the performance requirements for AAMI Level 3 barrier protection as per ANSI/AAMI PB70:2012, along with other physical properties and biocompatibility.

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

The document specifies the following sample sizes for the non-clinical tests:

• Hydrostatic Pressure (AATCC127:2014): 3 non-consecutive lots tested, using a sample size of 32/lot.
• Water-proof Property (AATCC42:2013): 3 non-consecutive lots tested, using a sample size of 32/lot.
• Tear strength (Trapezoid Method, ASTM D 5587-2015): Sample size of 5 pcs.
• Breaking Strength (ASTM D 5034-2009(2017)): Sample size of 8 pcs.
• Sewn seam strength (sleeve seam) (ASTM D1683/D1683M-2017(2018)): Sample size of 5 pcs.
• Water-vapor resistance (ASTM F 1868-2017): Sample size of 3 pcs.
• Lint and other particles generation in the dry state (ISO 9073-10: 2003): Sample size of 5 pcs.
• Mass per unit area (ASTM D3776/D3776M-2009(2017)): Sample size of 5 pcs.
• Burning Behavior (16 CFR Part 1610): Sample size of 5 pcs.
• Biocompatibility (Cytotoxicity, Irritation, Sensitization): Specific sample sizes are not explicitly stated, but the tests were performed according to ISO 10993-5 and ISO 10993-10.

Data Provenance: The document states that the non-clinical tests were conducted to verify that the proposed device met design specifications. Given the applicant's address (Anhui Medpurest Medical Technology Co.,Ltd, China) and the submission correspondent's address (Shanghai SUNGO Management Consulting Co., Ltd, China), it can be inferred that the testing was performed in China or by labs contracted by the applicant. The data is retrospective in nature, as it's a summary of tests already performed for regulatory submission.

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

This document describes non-clinical performance and biocompatibility testing for a physical medical device (surgical gowns). It does not involve diagnostic image analysis or clinical interpretation. Therefore, the concept of "experts establishing ground truth for a test set" in the context of medical image analysis or similar tasks is not applicable here. The ground truth for these tests is established by standardized testing methodologies and instruments as defined by the listed ASTM, AATCC, ISO, and CPSC standards.

4. Adjudication method for the test set

As this is non-clinical performance and material property testing, an adjudication method (like 2+1 or 3+1) is not applicable. The results are quantitative measurements obtained through defined protocols. Pass/Fail criteria are based on exceeding or falling below specified thresholds in the relevant standards.

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. This type of study is relevant for AI-powered diagnostic devices where human interpretation is assisted by AI. This submission is for a physical medical device (surgical gowns), and no AI component is described.

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

No, a standalone performance study was not done in the context of an algorithm. This submission is for a physical medical device (surgical gowns) and does not involve an algorithm. The "standalone" performance here refers to the physical and barrier properties of the gown itself, which are measured directly through the non-clinical tests.

7. The type of ground truth used

The ground truth for this device's performance is established by standardized laboratory testing and measurements based on the referenced national and international standards (e.g., AAMI, ANSI, ASTM, AATCC, ISO, CPSC). For example:

• For barrier protection, the ground truth is the measured hydrostatic pressure and water impact performance against the specified level (AAMI Level 3).
• For physical properties like tear strength and breaking strength, the ground truth is the force required to tear or break the material as measured by testing machines.
• For biocompatibility, the ground truth is the measured biological response (e.g., cell viability for cytotoxicity, skin reaction for irritation/sensitization) compared to established toxicity thresholds.

8. The sample size for the training set

Not applicable. This submission is for a physical medical device (surgical gowns) and does not involve AI/machine learning, and therefore does not have a "training set."

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

Not applicable. As there is no training set mentioned or implied for this device, the method for establishing ground truth for a training set is irrelevant.

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Disposable Surgical Gowns, which are blue colored and EO sterilized, are indicated 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. It could achieve Level 3 Barrier Performance as per AAMI PB70:2003. It is for single use only.

Disposable Surgical Gowns are 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. Disposable Surgical Gowns are manufactured from three layers nonwoven fabric that is comprised of Spunbond (SMS) materials. Disposable Surgical Gowns are reinforced with an additional layer of SPP (Syndiotactic Polyprogylene) laminating film in the sleeve and body areas for higher barrier protection. The proposed Disposable Surgical Gowns include four sizes, which are presented in Table V-1 General Description.

The provided text describes a 510(k) summary for disposable surgical gowns, focusing on their physical and biological properties. It does not contain any information about an AI-powered device, a test set, expert readers, or ground truth establishment in the context of medical imaging or diagnostic algorithms.

Therefore, I cannot fulfill your request to describe acceptance criteria and study proving device meets acceptance criteria for an AI device based on the provided text.

The document discusses:

• Device: Disposable Surgical Gowns
• Intended Use: Protection during surgical procedures.
• Acceptance Criteria (for this product): Primarily physical barrier performance (e.g., Level 3 per AAMI PB70), tear strength, fire protection, and biocompatibility, along with manufacturing standards. These are verified through bench tests against established standards (e.g., ASTM, AAMI, ISO).
• Study Proving Acceptance: "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards..."

The text provided does not contain the information requested for an AI-powered device, such as:

1. A table of acceptance criteria and reported device performance (for an AI).
2. Sample size for a test set or data provenance for an AI.
3. Number of experts or their qualifications for ground truth establishment for an AI.
4. Adjudication method for a test set for an AI.
5. MRMC comparative effectiveness study or effect size for AI assistance.
6. Standalone performance of an algorithm.
7. Type of ground truth (expert consensus, pathology, outcomes data) for an AI.
8. Sample size for a training set for an AI.
9. How ground truth for the training set was established for an AI.

The information is related to the regulatory approval process for a physical medical device (surgical gowns), not an AI/software as a medical device.

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