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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/Level 4 barrier protection for a surgical gown per ANSU 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.

Disposable Surgical Gown

This document is a 510(k) clearance letter for a Disposable Surgical Gown. It is a regulatory document addressing the substantial equivalence of the device to a predicate device, not a study report for a medical AI/ML device.

Therefore, the requested information about acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details for an AI/ML device is not applicable to this document.

The document discusses:

• The device name: Disposable Surgical Gown
• Regulation Number: 21 CFR 878.4040
• Regulatory Class: Class II
• Product Code: FYA
• Indications for Use: "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/Level 4 barrier protection for a surgical gown per ANSU 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."

The acceptance criteria mentioned for the surgical gown are related to its physical performance as a barrier: "meets the requirements of AAMI Level 3/Level 4 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70)." However, this document does not provide a study detailing how these criteria were met or the specific results.

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Disposable Surgical Gown (Level 3, MF2103 Series)/ Disposable Surgical Gown (Level 3, MF2104 Series)/ Disposable Surgical Gown (Level 4, MF2105 Series) 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. It is single use, disposable and supplied sterile.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, MF2103 Series and MF2104 Series met the requirements for Level 3 classification, MF2105 Series met the requirements of Level 4 classification.

Not Found

This document is a 510(k) premarket notification from the FDA, specifically concerning the substantial equivalence determination for Disposable Surgical Gowns. It clarifies that the device is found substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about an AI/ML-based medical device, its acceptance criteria, or the study that proves it meets those criteria. The device in question is a physical product (surgical gowns), and the assessment is based on physical barrier performance standards (ANSI/AAMI PB70:2012), not on AI/ML algorithm performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including details like:

1. A table of acceptance criteria and the reported device performance: Not applicable as the "performance" here refers to physical barrier properties, not algorithmic output.
2. Sample sizes used for the test set and the data provenance: Not applicable. Testing for surgical gowns involves physical property tests (e.g., liquid barrier, particulate material transfer), not data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical product like a surgical gown is established by standardized physical testing methods, not expert consensus on data.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is relevant for AI-assisted image interpretation, not physical products.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable in the context of AI/ML. The "ground truth" for the gowns is their adherence to ANSI/AAMI PB70:2012 standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on the regulatory clearance for a medical device (surgical gowns) based on their physical barrier performance against industry standards, not on an AI/ML algorithm's diagnostic or analytical performance.

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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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The StringKing Disposable Surgical Gown is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter. The StringKing Surgical Gowns meet Level 3 and Level 4 requirements of ANSI/AAMI PB 70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.

The Disposable Surgical Gown consists of a multi-layer nonwoven spunbond-meltblownspunbond (SMS) polyolefin & Film Lamination in the critical zones and a single layer of lighter, more breathable nonwoven SMS polvolefin in the non-critical zones. The StringKing Disposable Surgical Gown is designed for easy donning and doffing with hook and loop neck tabs, belt ties, removable transfer accessory, and polyester wrist cuffs. The StringKing Disposable Surgical Gown is one gown design that meets both Level 4 requirements of AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The gown will be marketed as a L3 gown as well as a L4 gown. The StringKing Disposable Surgical Gowns are single use, disposable medical devices that will be provided sterile.

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

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 explicitly state the specific sample sizes for each individual test. It generally uses phrases like "All samples passed," indicating that a sufficient number of samples were tested to meet the requirements of the respective standards.

The data provenance is from non-clinical testing conducted according to recognized international and national standards (e.g., ANSI/AAMI PB70:2012, AATCC, ASTM, ISO, CFR). The testing was for the StringKing Disposable Surgical Gown. The document does not specify the country of origin of the testing facilities, but the standards are international. This is retrospective in the sense that the studies were performed and results collected before this submission.

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

This section is not applicable as the device is a physical product (surgical gown) and the "ground truth" for its performance is established through objective, standardized laboratory testing (e.g., measuring forces, penetration, chemical residues) against predefined thresholds, not through expert human interpretation or consensus of observational data.

4. Adjudication method for the test set

This is not applicable for the same reasons as above. Performance is determined by meeting objective criteria in standardized tests, not by human adjudication of qualitative or ambiguous data.

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 is not applicable. The device is a surgical gown, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI are not relevant.

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

This is not applicable. The device is a physical product and does not involve any algorithms or AI for its function or evaluation.

7. The type of ground truth used

The ground truth for the performance of the surgical gown is established by objective measurements and adherence to predefined thresholds specified in international and national standards (e.g., ANSI/AAMI PB70:2012, ASTM D5034, AATCC 127, ISO 10993, etc.). These standards define what constitutes a "pass" or "fail" for various performance characteristics like liquid barrier, flammability, tensile strength, tear strength, seam strength, viral penetration, and biocompatibility.

8. The sample size for the training set

This is not applicable. The device is a physical medical device and does not involve any machine learning algorithms that require a "training set."

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

This is not applicable as there is no training set for this type of device.

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The Disposable Surgical Gown Rk-3011C is 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.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Disposable Surgical Gown Rk-3011C surgical gowns met the requirements for Level 3 classification.

This is a single use, disposable device(s), provided non-sterile. The Surgical Gowns is to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user.

The proposed surgical gown is a single use, disposable medical device provided as bulk, non-sterile items to repackagers/ relablers for further packaging and Ethylene Oxide (EO) sterilization.

The gown is manufactured with four layers: the inner and outer layers are made of spun-bond polypropylene and the middle layers are made of melt blown polypropylene. All gowns are reinforced with polypropylene and microporous reinforcement material. The proposed surgical gown is only available in the available sizes of the proposed surgical gown are M, L, XL, and XXL.

The cuffs are composed of cotton and terylene. The back is open with ties to secure the gown.

The provided text describes the acceptance criteria and the study results for a medical device, specifically a "Disposable Surgical Gown Rk-3011C".

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
The document does not explicitly state the sample size for each test. The tests are non-clinical (laboratory-based) and are likely performed on a representative sample of the surgical gowns. The data provenance is not explicitly mentioned but implies standard laboratory testing for medical devices, which is generally global in applicability.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the study involved non-clinical performance testing against established physical and chemical standards, not expert assessments of clinical outcomes or images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the study involved non-clinical performance testing against objective, measurable standards, not subjective assessments requiring adjudication.

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 is not applicable. The device is a surgical gown, and the study focuses on its physical and chemical properties, not artificial intelligence or human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a surgical gown, and the study focuses on its physical and chemical properties, not algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this study is defined by established international and national standards for surgical gowns, such as ASTM, AATCC, ANSI/AAMI, and ISO. These standards provide objective, measurable criteria for physical properties (e.g., tensile strength, tear strength, water resistance) and biological safety (e.g., biocompatibility, residuals).

8. The sample size for the training set
This is not applicable. The device is a physical product (surgical gown) and does not involve a training set as would be used for AI or machine learning models.

9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device and study.

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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.

In addition, 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). This is a single use, disposable device, provided sterile. The surgical gown has six sizes - S, M, L, XL, XXL and XXXL.

The Disposable surgical gown is composed of collar, body, sleeve and tie. The back is full opening, the neck and waist are laced, the sleeve are made of cotton closure by sewing, and the rest are made of heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.

The document details the non-clinical testing performed for the Disposable Surgical Gown (G4003) to support its substantial equivalence claim.

1. Table of acceptance criteria and the reported device performance

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

The document does not explicitly state the sample sizes for each specific non-clinical test. However, the tests are performed according to recognized international and national standards (e.g., ASTM, AATCC, ISO, CPSC). Data provenance is from Xiantao Topmed Nonwoven Protective Products Co., Ltd. located in Hubei Province, China, likely from prospective testing specifically conducted for this submission.

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

This section is not applicable as the document describes non-clinical performance and biocompatibility testing of a physical product (surgical gown), not a diagnostic or AI device that requires expert ground truth establishment. The "ground truth" for these tests is defined by the objective measurement criteria within the specified standards.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving multiple readers, not for objective non-clinical performance testing.

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 surgical gown, not an AI or diagnostic tool, so no MRMC study was conducted or is relevant.

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 surgical gown, not an algorithm or AI system.

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

For these non-clinical tests, the "ground truth" is established by objective measurements and results obtained from standardized testing methodologies, as defined by the various ASTM, AATCC, ISO, and CPSC standards cited (e.g., tearing strength in Newtons, impact penetration in grams, hydrostatic pressure in cm).

8. The sample size for the training set

This section is not applicable. The device is a physical surgical gown. There is no concept of a "training set" as there would be for an AI or machine learning model.

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

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

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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 Gown is model UM-148, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of polyester. The proposed device is available in sizes: S(120×135cm), M(125×140cm), L(130×145cm) and XL(135×150cm). This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012. The proposed devices are disposable medical devices and provided in sterile and a blue color.

The provided text describes a 510(k) premarket notification for a medical device, specifically a "Disposable Surgical Gown (UM-148)". This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" and "study" described are about showing that the new surgical gown performs comparably to established standards and a predicate device, rather than proving a new clinical claim.

Here's an analysis of the provided information, formatted as requested:

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

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

• Tearing Strength (ASTM D5587-15): 10 samples.
• Breaking Strength and Elongation (ASTM D5034-09): 10 samples.
• Failure in Sewn Seams (ASTM D1683M-17): 10 samples.
• Water Penetration Resistance (AATCC 42-2013): 3 nonconsecutive batches.
• Evaporative Resistance (ASTM F1868-17): 13 samples.
• Water Resistance: Hydrostatic Pressure Test (AATCC 127-2014): 3 nonconsecutive batches.
• Flammability (CPSC 16 CFR Part 1610-2008): 5 samples.
• Linting (ISO 9073-10:2003(E)): 13 samples.
• Biocompatibility (ISO 10993-10 and ISO 10993-5): Sample sizes for the specific in vitro and in vivo tests are not explicitly stated, but the tests were performed "under the conditions of the study".

The data provenance is from non-clinical tests conducted by or on behalf of Unimax Medical Products Co., Ltd. in China. These are prospective tests performed on the proposed device to demonstrate its performance against recognized industry standards.

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

Not applicable. This is a submission for a physical medical device (surgical gown) where performance is measured against established scientific and engineering standards for materials and protective properties, not based on expert interpretation of observational data. The "ground truth" is defined by the objective metrics specified in the test methodologies (e.g., N for strength, g for water penetration, cm for hydrostatic pressure).

4. Adjudication method for the test set

Not applicable. Performance is measured against quantitative and qualitative criteria defined by the respective standards, and the results are reported directly (e.g., "PASS", "45.5N"). There is no subjective interpretation or adjudication process involved as would be the case for image-based diagnostic AI, for example.

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 not an AI-enabled diagnostic device. It is a physical product (surgical gown).

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

Not applicable. This is not an AI-enabled diagnostic device.

7. The type of ground truth used

The ground truth is based on established industry standards and objective physical measurements. For example:

• AAMI/ANSI PB70:2012 defines liquid barrier performance levels.
• ASTM standards define methods and acceptance criteria for material strengths (tearing, breaking, seam).
• AATCC standards define methods for water resistance.
• CPSC 16 CFR Part 1610 defines flammability classes.
• ISO 9073-10 defines linting criteria.
• ISO 10993 standards define biocompatibility criteria based on in vitro (cytotoxicity) and in vivo (irritation, sensitization) tests.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. The tests are directly measuring the physical properties of the manufactured product.

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

Not applicable. There is no training set for this type of device.

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Disposable Surgical Gown is 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. In addition, this surgical gown meets the requirements of AAMI Level 4 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. It is single use, disposable medical devices, provided sterile.

The subject devices 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 materials.

In addition, this surgical gown meets the requirements of AAMI Level 4 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.

The proposed device is single use, disposable medical devices and provided sterile.

The main materials of device are SMS nonwoven +TPU membrane, PP and Polyester fiber, and the main manufacturing technique are Ultrasonic welding and Sewing.

The provided text is a 510(k) Summary for a medical device (Disposable Surgical Gown) and does not describe an AI/ML-driven device or study. Therefore, most of the requested information regarding acceptance criteria, training/test sets, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device is not applicable.

Instead, the document details the device's physical properties, material composition, and performance against established industry standards for surgical gowns. The "study" mentioned is a series of non-clinical tests to verify the device meets design specifications and relevant standards.

Here's a breakdown of the relevant information from the document, tailored to the non-AI/ML context:

Device Description: Disposable Surgical Gown

Purpose of the "Study" (Non-Clinical Testing): To verify that the proposed device (Disposable Surgical Gown) meets all design specifications and complies with relevant standards for surgical gowns, demonstrating its safety and effectiveness compared to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a table of non-clinical tests conducted, their purpose, acceptance criteria, and results.

Additional Performance Claim: The device also meets the requirements of AAMI Level 4 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. This is a key difference and perceived improvement over the predicate device, which met Level 3.

2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each specific test, nor does it detail the provenance of the materials tested (e.g., country of origin). However, it implies standardized testing conducted to meet regulatory and industry standards. The tests are "non-clinical" and laboratory-based, focused on material properties of the manufactured gown samples.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable as this is not an AI/ML-driven study requiring expert interpretation of data/images. The "ground truth" is established by the specified industry standards and test methodologies (e.g., ASTM, AAMI, ISO, AATCC, 16 CFR).

4. Adjudication Method for the Test Set:
Not applicable. Performance is determined by standardized physical and chemical tests against defined numerical criteria, not by human adjudication of qualitative data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI/ML diagnostic or assistive device. The comparison is between the proposed device's physical properties and the requirements of recognized standards, as well as a direct comparison of specifications with a predicate device.

6. Standalone (Algorithm Only) Performance:
Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:
The "ground truth" for the performance evaluation is based on established industry standards and test methodologies (e.g., ANSI/AAMI PB70:2012 for liquid barrier performance, ASTM F2407-06 for specifications of surgical gowns, ISO 10993 for biocompatibility). The device must demonstrate that its physical and chemical properties meet or exceed the requirements set forth in these standards.

8. Sample Size for the Training Set:
Not applicable. There is no concept of a "training set" for this type of device and non-clinical testing. The manufacturing process and material selection are validated against the final product specifications.

9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set. The "ground truth" for establishing the device's design and performance goals is rooted in existing regulatory requirements and recognized consensus standards for surgical apparel.

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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. In addition, 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). This is a single use, disposable device, provided sterile.

The proposed device is a poly-reinforced surgical gown, the critical zone is front chest and sleeves. The critical zone is reinforced with PP/PE composite breathable film. The proposed device is available in four different sizes, include M, L, XL,TL. The proposed devices can meet the requirements for Level 3 per ANSVAAMI PB70:2012. The proposed devices are disposable medical devices and provided sterile.

The document is a 510(k) Premarket Notification from the FDA regarding a Disposable Surgical Gown. It outlines the device's technical specifications and compares it to a predicate device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance and safety testing required for regulatory clearance, not studies involving AI or human reader performance as one might expect for a diagnostic AI device.

Here's an analysis based on the provided document:

This document describes the testing for a Disposable Surgical Gown, which is a physical medical device, not a diagnostic AI/algorithm. Therefore, concepts like "MRMC comparative effectiveness study," "standalone algorithm performance," "human readers improve with AI," "number of experts for ground truth," "adjudication method," and "training set size/ground truth establishment" are not applicable to this type of medical device submission. The "acceptance criteria" relate to physical and biological performance characteristics of the gown.

Non-Clinical Performance and Safety Testing for Disposable Surgical Gown

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

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

The document states that results are "Average result from 3 nonconsecutive batches" for several tests (Tearing Strength, Breaking Strength, Seam Strength, Water Impact, Evaporative Resistance, Hydrostatic Pressure, Flammability, Linting). The specific number of gowns or material samples per batch is not explicitly stated but implies a representative sample was taken from different production runs.

• Provenance: "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The manufacturer is Suzhou JaneE Medical Technology Co., Ltd. in China, implying testing was conducted or overseen by them or a contracted lab. The document does not specify if the data is retrospective or prospective, but for manufacturing quality control and regulatory submission, it would typically be prospective testing on newly produced batches.

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

Not applicable. This pertains to an AI/diagnostic device. For a physical device like a surgical gown, "ground truth" is established by adherence to recognized international standards and laboratory testing protocols.

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

Not applicable. This pertains to an AI/diagnostic device and human reader disagreement. Physical testing relies on standardized methodologies and calibrated equipment.

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 relates to AI-assisted diagnostic performance.

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

Not applicable. This relates to AI algorithm performance.

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

The "ground truth" for this device is based on established international and national standards and test methodologies for material properties and barrier performance (e.g., AAMI PB70, ASTM, AATCC, ISO, CPSC). Compliance with these quantitative and qualitative standards serves as the benchmark for acceptance. For biocompatibility, the ground truth is the absence of adverse biological reactions as defined by ISO 10993 standards.

8. The sample size for the training set:

Not applicable. This product is a physical device, not an AI algorithm that requires a training set.

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

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

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Disposable Surgical Gown and Disposable Reinforced Surgical Gown are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.

The proposed devices are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and are provided in sterile. There are two types of surgical gown: Disposable Surgical Gown and Disposable Reinforced Surgical Gown. And each type of surgical gown is available in six product sizes, including S, M, L, XL, XXL and XXXL. Disposable Surgical Gown have two models: ML515M45U and GD524ME65. Disposable Reinforced Surgical Gown have one model: PA528ME45R. Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.

The provided FDA 510(k) summary document (K212869) pertains to Disposable Surgical Gowns. This document describes the acceptance criteria and the study that proves the device meets those criteria, specifically through non-clinical performance testing and biocompatibility assessment rather than studies involving AI algorithms or human readers.

Therefore, many of the requested points regarding AI/human reader studies, ground truth establishment for such studies, and multi-reader multi-case analyses are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides extensive tables (Table 3 and Table 4) detailing the acceptance criteria and results for various non-clinical performance and biocompatibility tests.

Table 1: Summary of Performance Testing - Categorized for clarity

Table 2: Summary of Biocompatibility Testing

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

• Sample Size: The document does not explicitly state the specific number of units or samples tested for each non-clinical test. However, it indicates that the tests were performed in accordance with various ASTM, ISO, and AATCC standards, which typically specify appropriate sample sizes for such tests.
• Data Provenance: The tests are non-clinical, meaning they are laboratory-based and do not involve patient data. The manufacturer, Fugou County Shenxiang Manufacturing Co., LTD., is located in Henan Province, China. The testing would have been conducted by or overseen by the manufacturer or a third-party testing facility. The data is prospective in the sense that the tests were performed specifically to support this 510(k) submission.

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

• Not Applicable. This submission is for surgical gowns, a physical medical device. The "ground truth" for its performance is established through standardized laboratory testing (e.g., barrier properties, strength, flammability) rather than expert consensus on medical images or patient outcomes. The experts involved would be those qualified in materials science, textile engineering, microbiology, and standard compliance, who conduct and interpret the results of these physical and chemical tests.

4. Adjudication Method for the Test Set

• Not Applicable. As mentioned above, the "ground truth" is determined by objective, standardized test protocols, not by expert review or adjudication of subjective interpretations.

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 device is a surgical gown, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.

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

• Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" is defined by objective measurements and performance standards (e.g., ANSI/AAMI PB70:2012, 16 CFR Part 1610, ASTM, and ISO standards) for material properties (hydrostatic pressure, water impact, breaking strength, tearing strength, linting, air permeability) and biological safety (biocompatibility tests like cytotoxicity, irritation, sensitization, and sterilant residues).

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of a physical device like a surgical gown. The product’s design and manufacturing processes are developed to meet the performance criteria, and then tested to confirm compliance.

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

• Not Applicable. See point 8.

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