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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 requrements 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 Surgical Gowns are single use, disposable medical devices, provided sterile.

The proposed device Surgical Gown is model 40083, its body, sleeve and belt are made of SSMMS non-woven material, and cuff is made of cotton. The proposed device is available in XS, S, M, L, XL, 2XL, 3XL sizes. 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 blue color.

This document is a 510(k) Premarket Notification from the FDA regarding a Surgical Gown. It evaluates the device's substantial equivalence to a legally marketed predicate device. The information provided is primarily focused on the physical and barrier performance characteristics of the surgical gown, not an AI/Software as a Medical Device (SaMD) product.

Therefore, most of the requested information regarding AI/SaMD performance criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone algorithm performance," and "training set details," is not applicable to this submission.

However, I can extract the relevant information regarding the surgical gown's acceptance criteria and the studies proving it meets those criteria:

Device: Surgical Gown (Model 40083)
Intended Use: To be worn by operating room personnel during surgical procedures to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. It meets AAMI Level 3 barrier protection.

Acceptance Criteria and Reported Device Performance:

Details Regarding the Study:

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

   • Seam Strength, Breaking Strength, Tear Strength: "Average result from 30 samples" for each test.
   • Lint and other generation: "Average result from 6 samples."
   • Water Penetration Resistance, Static Hydrostatic Resistance, EO/ECH Residual, Cytotoxicity, Irritation, Sensitization, Flammability: The specific number of samples for these tests is not explicitly stated as "X samples" in the provided text, but the results are reported as "PASS," indicating that the required sample sizes for the respective standards were met.
   • Data Provenance: The document does not specify the country of origin for the testing data (e.g., in-house testing by the manufacturer's lab in China, or third-party labs). The submission is from Ammex-Weida (Hubei) Health and Safety Products Co., Ltd in China. All studies described are non-clinical, laboratory-based tests. They are not categorized as retrospective or prospective clinical studies.

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

   • Not applicable. This is not an AI/SaMD product requiring expert-derived ground truth for diagnostic accuracy. The "ground truth" here is defined by the objective physical and chemical standards and their corresponding test methods (e.g., AATCC, ASTM, ISO).

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

   • Not applicable. This is not an AI/SaMD product. The results are from standardized laboratory tests.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is not an AI/SaMD product.

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

   • Not applicable. This is not an AI/SaMD product.

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

   • The "ground truth" for this device's performance is established by internationally recognized industry standards and test methods (e.g., ANSI/AAMI PB70:2012 for barrier performance, ASTM for material strength, ISO for biocompatibility, etc.). These standards define the quantitative and qualitative acceptance criteria for the device's physical safety and performance.

7. The sample size for the training set:

   • Not applicable, as this is not an AI/SaMD product that requires a training set.

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

   • Not applicable, as this is not an AI/SaMD product that requires a training set.

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The 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.

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

The proposed device Surgical Gown its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The proposed device is available in S(110×130cm), M(120×140cm), L(130×150cm), XL(140×160cm), XXL(150×170cm), XXXL(155×180cm) sizes . This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.

The proposed device Reinforced Surgical Gown is its body, sleeve and belt are made of SMMS nonwoven material, and cuff is made of cotton. The reinforced and critical zone is front chest and sleeves. This zone is reinforced with PP/PE composite breathable film. The proposed device is available in S(110×130cm), M(120×140cm), L(130×150cm), XL(140×160cm), XXL(150×170cm), XXXL(155×180cm) sizes. 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.

The provided FDA 510(k) summary for the Surgical Gown and Reinforced Surgical Gown details the device's technical specifications and non-clinical testing for substantial equivalence to a predicate device, rather than an AI/ML-driven medical device. Therefore, the information requested regarding acceptance criteria, study methodologies, and performance related to AI/ML device evaluation (such as sample sizes for test/training sets, expert consensus, MRMC studies, or ground truth establishment) is not applicable to this document.

The document focuses on the physical and barrier properties of surgical gowns. Here is a summary of the acceptance criteria and performance as presented in the non-clinical testing section:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample sizes for test set and data provenance:

• Seam strength: Reported result is an average from 30 samples.
• Breaking strength: Reported result is an average from 30 samples.
• Tear strength: Reported result is an average from 30 samples.
• Lint and other generation in the dry state: Reported result is an average from 6 samples.
• The document does not specify the country of origin of the data or whether the tests were retrospective or prospective, beyond stating "Non-clinical tests were conducted to verify that the proposed device met all design specifications."

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

• This is not applicable as the device is a physical product (surgical gown) and not an AI/ML-driven device requiring expert interpretation for ground truth. Performance is measured against established physical and chemical standards.

4. Adjudication method for the test set:

• Not applicable for physical product testing. Performance is determined by quantitative measurements against predefined criteria in laboratory settings.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• Not applicable. This type of study is relevant for AI-assisted diagnostic or interpretative devices, not for surgical gowns.

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

• Not applicable as this is not an AI/ML driven device.

7. The type of ground truth used:

• The "ground truth" for this device's performance is established by physical and chemical measurement standards (e.g., ASTM, ISO, AATCC, CPSC standards) and the specified acceptance criteria for each test. For example, a seam strength greater than or equal to 30N is the "ground truth" for acceptable seam strength.

8. The sample size for the training set:

• Not applicable. There is no AI/ML component requiring a training set.

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

• Not applicable. There is no AI/ML component or training set.

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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 requrements 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 non-sterile. Before the use, the Surgical Gowns must be sterilized by EO sterilization based on ISO 11135:2014.

The Surgical Gown is composed of collar, body, sleeve and tie, in a blue color, offered in sizes S, M, L, XL and XXL. The neck and waist are laced, the sleeves are made of polyester elastic 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.

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

Device: Surgical Gown (K222999)

1. Table of Acceptance Criteria and Reported Device Performance:

The reported device performance for all criteria met or exceeded the acceptance criteria.

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

The document does not explicitly state the specific sample sizes used for each individual test (e.g., how many gowns were tested for impact penetration). It only states that the device "was tested and conformed to the related recognized standards." The provenance of the data is implied to be from testing conducted by or for Hubei Woozon Healthcare Co.,Ltd. The document does not specify the country of origin of the data or whether the tests were retrospective or prospective, beyond stating that they were non-clinical tests.

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

Not applicable. This device is a surgical gown, and its performance is evaluated through standardized physical, chemical, and biological barrier tests, not through expert human interpretation of medical images or data requiring ground truth establishment by medical experts.

4. Adjudication Method for the Test Set:

Not applicable. As described above, the evaluation relies on adherence to standardized test methods and their defined pass/fail criteria, rather than expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No. This type of study is not relevant for the evaluation of a surgical gown. MRMC studies are typically conducted for AI/CAD systems that assist human readers in interpreting medical images.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. The "device" in this context is a physical product (surgical gown), not an algorithm or AI system. Its performance is inherent to the product itself, not an algorithmic output.

7. The Type of Ground Truth Used:

The "ground truth" for the surgical gown is established by the specified performance requirements and limitations outlined in the recognized standards (e.g., AAMI PB70, AATCC, ASTM, ISO, 16 CFR). These standards define the acceptable levels of barrier protection, strength, flammability, and biocompatibility. The results of the tests conducted directly against these standards serve as the evidence that the device meets the "ground truth" requirements.

8. The Sample Size for the Training Set:

Not applicable. This device is a manufactured product, not an AI/machine learning model that requires a training set.

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

Not applicable, for the same reason as point 8.

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Surgical gowns are intended to be worn by operating room personnel procedure to protect both the surgical patient and the operating room persomel from transfer of microorganisms, body fluids, and particulate material. This device is provided sterile.

Per ASNI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the standard (non-reinforced) surgical gowns meet Level 2 classification and the reinforced surgical gowns meet Level 3 classification.

Surgical gowns are intended to be worn by healthcare professionals to protect both the patient and the healthcare professional from the transfer or microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and ethylene oxide (EO) sterilized. They are available in six sizes: S, M, L, XL, XXL and XXXL.

The proposed surgical gowns are constructed of a Spunbond (SMS) nonwoven material, with cuffs made of polyester and elastic, offered in standard (non-reinforced) and reinforced surgical gowns, in blue color.

This is a 510(k) summary for a surgical gown, which is a low-risk medical device. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of AI algorithm performance. Therefore, many of the requested criteria, which are typically relevant for AI/ML device evaluations, are not applicable here.

Here's an analysis based on the provided document:

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

The document provides a summary of performance testing in Table 2, outlining the test method, purpose, acceptance criteria, and result (Pass/Fail or specific finding).

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

The document relates to non-clinical performance testing of a physical medical device (surgical gown) against established standards. It does not involve a "test set" in the context of data for an AI/ML algorithm. Therefore, information about data provenance, retrospective/prospective studies, and sample sizes for data are not applicable. The tests were likely conducted on a sample of the manufactured gowns.

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 testing involves standardized laboratory methods (e.g., AATCC, ASTM, ISO standards) to measure physical and chemical properties of the surgical gown, not expert review or interpretation of data.

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

This is not applicable. There is no "test set" of data requiring expert adjudication, as the conformity is based on objective laboratory measurements against defined 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

This is not applicable. The device is a surgical gown, not an AI/ML diagnostic or assistive tool for human readers.

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, not an AI algorithm.

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

The "ground truth" for this device's performance is defined by the acceptance criteria within the international and national consensus standards listed (e.g., AATCC 127, ASTM F 2407, ISO 10993-5). The device's physical and biological properties were measured and compared directly to these established benchmarks.

8. The sample size for the training set

This is not applicable. The document describes a physical medical device, not an AI/ML algorithm that requires training data.

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

This is not applicable, as there is no training set for an AI/ML algorithm.

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The 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 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.

The 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 polyester elastic closure by sewing, and the rest are made of SMS nonwoven material, in a blue color. It has been tested according to AAMI PB70:2012 and meet AAMI Level 4 barrier level protection for a surgical gown. The proposed devices are single use, disposable medical devices and EO that sterilized. They are available in six sizes: S, M, L, XL, XXL and XXXL

This document describes the safety and performance of a Surgical Gown, not an AI-powered medical device. Therefore, many of the requested details about acceptance criteria for AI model performance and ground truth establishment are not applicable.

However, I can extract the relevant acceptance criteria and the reported device performance for the physical surgical gown based on the provided text.

Device: Surgical Gown (K222403)
Intended Use: To protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material during surgical procedures, meeting AAMI Level 4 barrier protection.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is assessed through non-clinical laboratory tests.

Missing/Not Applicable Information (for AI/Software Device)

The following points are not applicable to this submission as it concerns a physical medical device (surgical gown) rather than a software or AI-powered device. The document explicitly states "No clinical study is included in this submission."

2. Sample size used for the test set and the data provenance: Not applicable. Tests are performed on physical samples of the surgical gown materials and finished products, not a "test set" of data in the AI sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is established by standardized material testing methods, not expert human interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
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 (expert concensus, pathology, outcomes data, etc): For this device, the "ground truth" is defined by the performance standards of the physical and chemical tests listed (e.g., specific thresholds for water penetration, tensile strength, sterility, biocompatibility).
8. The sample size for the training set: Not applicable (no AI training involved).
9. How the ground truth for the training set was established: Not applicable.

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Surgical gowns are sterile, disposable, and single use devices that 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. This device is sterilized using Ethylene Oxide (EO) following the Validation and routine control under ANSI/AAMI/ISO 11135 (2014).

The Sterile Level 4 Surgical Gown 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. The proposed devices are single use and EO sterilized. The Sterile Level 4 Surgical Gowns are available in five models including S、 M、L、XL and XXL. The proposed surgical are constructed of a SMS nonwoven material (SMS+Film covering material+Velcro tape+Cuff material) and it is a kind of reinforced surgical gown and blue color.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

The document is a 510(k) Summary for a "Surgical Gown" (K212812). It focuses on demonstrating substantial equivalence to a predicate device (K121152) through non-clinical performance tests.

1. Table of Acceptance Criteria and Reported Device Performance

The table below summarizes the acceptance criteria and the claimed performance of the subject device, as presented in the "Comparison of technological characteristics with the Predicate" section and the "Test Method" table.

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

The document does not explicitly state the specific sample sizes used for each individual non-clinical test. It mentions that "Non clinical tests were conducted to verify that the proposed device met all design specifications." Without further detail, it is assumed that appropriate sample sizes, as typically required by the referenced ASTM and ISO standards for material testing, were used.

The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. However, given that the submitter is "Xianning Marveldas Protective Articles CO.,Ltd." from China and the tests are for a new device submission, these would be prospective tests performed by the manufacturer, likely at their own facilities or contracted testing labs, to demonstrate compliance.

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

This section is not applicable to this submission. The "ground truth" for the performance tests of a surgical gown is established by the specified acceptance criteria of recognized international standards (ASTM, AATCC, ISO, 16 CFR). These standards define objective, measurable physical and chemical properties, rather than subjective interpretations by human experts.

4. Adjudication Method for the Test Set

This section is not applicable. The tests are objective measurements against defined standards. There is no mention of "adjudication" in the context of expert review for establishing ground truth, as the ground truth is the numerical outcome of the physical/chemical tests and comparison against the specified acceptance criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This section is not applicable. This submission is for a medical device (surgical gown) that is evaluated based on its physical properties and biocompatibility, not on a diagnostic or therapeutic function requiring human-in-the-loop performance or clinical effectiveness studies with human readers. The document explicitly states: "No clinical study is included in this submission."

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 surgical gown, not an AI algorithm or a device with an algorithmic component. The performance evaluated is the physical and biological characteristics of the material.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical performance tests is based on established international and national standards and their defined acceptance criteria. These standards specify the methodology and the expected performance thresholds for various properties of surgical apparel, such as:

• Physical Property Standards: AATCC 127 (Hydrostatic pressure), AATCC 42 (Impact penetration), ASTM D 5034 (Tensile Strength), ASTM D 5733 (Tearing strength), ASTM D 1683 (Seam strength), 16 CFR Part 1610 (Flammability of Textiles), ASTM F1671 (Bacteriophage Phi-X174 penetration).
• Biocompatibility Standards: ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).

For each test, the "ground truth" is whether the device's measured performance meets or exceeds the specified numerical or categorical acceptance criteria set forth in these standards.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of a surgical gown submission; this term is typically relevant for machine learning or AI algorithm development. The device's characteristics are evaluated directly through testing, not through a model trained on data.

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

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

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The proposed surgical gowns 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, the surgical gowns met the requirements for Level 3 classification.

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 the end users after EtO sterilization validation to ISO 11135-1.

The proposed 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. The proposed devices are single use, disposable medical devices and can be provided in sterile two types. Both the sterile and non-sterile surgical gowns are blue colored and available in six sizes, including S, M. L, XL, XXL and XXXL. For non-sterile surgical gowns, they shall be sterilized by EO prior to use.

The proposed surgical gowns are constructed of a SMS nonwoven material (spunbond +meltblown + spunbond nonwovens) and has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3. It is a kind of non-reinforced surgical gown.

Here's a breakdown of the acceptance criteria and the study details for the Surgical Gown device (K221637), based on the provided document:

Acceptance Criteria and Device Performance

Study Information

The provided document describes non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than a study involving human subjects or artificial intelligence.

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

   • Hydrostatic Pressure: 3 non-consecutive lots, with a sample size of 32 per lot.
   • Water Resistance: 3 non-consecutive lots, with a sample size of 32 per lot.
   • Tearing Strength: 10 pieces.
   • Breaking Strength: 10 pieces.
   • Seam Strength: 10 pieces.
   • Evaporative Resistance: 3 pieces.
   • Lint and other particles generation: 10 pieces.
   • Flammability: 5 pieces.
   • Biocompatibility (Cytotoxicity, Irritation, Sensitization): Not explicitly stated, but the tests were performed "Under the condition of this study" or "Under the conditions of the study."
   • Ethylene Oxide Residuals: Not explicitly stated, but "shown in test report."
   • Data Provenance: The document does not specify the country of origin of the data beyond the manufacturer being in Hubei, China. The studies are non-clinical, likely laboratory tests, not retrospective or prospective patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This involves non-clinical laboratory testing against established physical and chemical standards, not expert evaluation of medical images or conditions where a "ground truth" established by experts would be relevant.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is not a study involving human reviewers or interpretation that would require an adjudication method. The results are based on objective measurements against specified standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a submission for a surgical gown, not an AI-assisted diagnostic or imaging device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical device (surgical gown), not an algorithm.

6. The type of ground truth used: The "ground truth" in this context is the predefined acceptance criteria set forth by established international and national standards (e.g., ANSI/AAMI PB70:2012, ASTM, ISO, AATCC, CFR standards). The device's performance is measured against these objective criteria.

7. The sample size for the training set: Not applicable. This is not a machine learning device that requires a training set.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

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Surgical Gown, Blue, Sterile and Surgical Gown, Blue, Non-Sterile intended to be worn by healthcare professionals to help protect both the patients and the healthcare workers from the transfer of microorganisms, body fluids, and particulate matters. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EiO) 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.

The Surgical Gowns meet the Level 3 ANSI/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities.

Not Found

This document is a marketing clearance letter for surgical gowns and does not contain information about software or AI/ML device studies. Therefore, I cannot provide the requested details regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

The document states that the surgical gowns meet "Level 3 ANSI/AAMI PB70:2012 Liquid Barrier and Performance Classification," which refers to a standard for protective apparel in healthcare. This is a performance standard for the physical product, not a study of an AI/ML algorithm.

Ask a specific question about this device

Ask a specific question about this device

The 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. In addition, this surgical gown meets the requirements of AAMI Level 3 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 Surgical gowns 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 provided text is a 510(k) summary for a medical device, specifically Surgical Gowns. It details the device's characteristics, intended use, and comparative testing against a predicate device to demonstrate substantial equivalence.

However, the request asks for information relevant to the acceptance criteria and the study that proves a device (likely an AI/ML powered device for diagnosis or similar application) meets those criteria. The provided document does not describe an AI/ML powered device, nor does it detail a study involving expert readers or AI assistance. Instead, it focuses on non-clinical performance testing of a physical product (surgical gowns) based on recognized standards.

Therefore, most of the specific points requested (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set) are not applicable to the content of this document.

I will attempt to answer the parts that are applicable based on the provided document, interpreting "acceptance criteria" as the performance requirements for the surgical gowns and "study" as the non-clinical performance testing conducted.

Here's an adaptation based on the provided document, acknowledging the limitations:

Acceptance Criteria and Device Performance for Surgical Gowns (K212718)

This document describes the non-clinical performance testing of surgical gowns (K212718) to demonstrate substantial equivalence to a predicate device, rather than a clinical study of an AI/ML device. Therefore, many of the requested criteria related to AI/ML device testing (e.g., expert readers, MRMC studies, ground truth for training) are not applicable.

Below is a table summarizing the acceptance criteria (performance requirements based on standards) and the reported device performance for the surgical gowns.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes (e.g., number of gowns) used for each non-clinical performance test. The data provenance is implied to be from the manufacturer's testing of their product. The testing is non-clinical performance testing, not a human study, and therefore terms like "retrospective or prospective" are not directly applicable in the typical sense for clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This device is a physical product (surgical gowns) and its performance is evaluated through standardized laboratory tests, not by human expert assessment of diagnostic outputs.

4. Adjudication Method for the Test Set:
Not applicable. Performance is determined by objective measurements according to recognized standards (e.g., AATCC 42, AATCC 127, ASTM D5034, ASTM D5733, 16 CFR Part 1610, AAMI PB70, ISO 10993).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
Not applicable. This is not an AI-assisted diagnostic device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical product, not an algorithm. The reported performance relates to the gown's material properties and barrier protection.

7. The Type of Ground Truth Used:
The "ground truth" for the surgical gowns' performance is established by the results of standardized laboratory testing (e.g., measurements of impact penetration, hydrostatic resistance, tensile strength, tear resistance, flame spread, and biocompatibility assays). These tests provide objective values that are compared against predefined criteria from recognized industry standards (e.g., AAMI PB70, ASTM, AATCC, ISO standards).

8. The Sample Size for the Training Set:
Not applicable. This is a manufactured product, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set is involved for this type of device.

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