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The GRI-Alleset Veress Needle is a disposable, single-use, sterile device intended to be used in minimally-invasive abdominal procedures for the establishment of pneumoperitoneum.

The GRI-Alleset Veress Needle is a disposable, single-use, sterile surgical instrument used during minimally invasive surgery for the establishment of peritoneum of the abdominal cavity prior to abdominal surgery. The device is comprised of a 14 gauge stainless steel needle (120mm and 150mm in length) which is attached to a plastic handle that contains a stopcock with a luer lock connector. The spring-loaded, blunt stylet extends beyond the needle tip and retracts as the needle is pushed through the abdominal tissue; it automatically advances forward once the peritoneum is penetrated. A red safety indicator, attached to the proximal end of the stylet, is exposed above the handle as an indication of an exposed needle tip. The device is provided sterile via ethylene oxide.

This document describes the premarket notification (510(k)) for the GRI-Alleset Veress Needle, a disposable, single-use, sterile device intended for establishing pneumoperitoneum in minimally invasive abdominal procedures. The submission aims to demonstrate substantial equivalence to a predicate device, the Ethicon Endopath Ultra Veress Needle (K983925).

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a separate table as "acceptance criteria." Instead, the document outlines performance tests that were conducted and states that the "results show acceptable results and demonstrate that the GRI-Alleset Veress Needle meets its specifications." The direct comparisons are made against the predicate device.

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

The document does not explicitly state the sample sizes for the test sets used in the biocompatibility, sterilization, mechanical bench testing, or shelf-life studies. It only mentions that these tests were "conducted in comparison with the predicate." The data provenance is not specified, but typically such testing would be performed in a controlled laboratory environment. The studies are prospective in the sense that the new device was evaluated against established standards and a predicate.

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

This information is not provided in the document. For medical devices like a Veress needle, "ground truth" is typically established through adherence to engineering standards, validated test methods, and comparison data from a legally marketed predicate, rather than expert consensus on a test set in the way AI algorithms are evaluated (e.g., image interpretation). The "experts" would be the engineers, quality specialists, and toxicologists conducting and interpreting the tests according to relevant ISO standards.

4. Adjudication Method for the Test Set

Not applicable in the context of this device and the tests performed. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic accuracy assessments where there might be disagreement among human readers or interpreters. For device performance testing against engineering standards, results are typically objective and measurable.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic tools or AI algorithms where human interpretation is involved. The GRI-Alleset Veress Needle is a surgical instrument, and its effectiveness is assessed through physical and mechanical performance tests, not through reader interpretation.

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

This question is not applicable. The GRI-Alleset Veress Needle is a physical surgical instrument, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on:

• Established ISO Standards: For biocompatibility (ISO 10993 series) and sterilization (ISO 11135-1).
• Performance Specifications: The device must meet its own design specifications and perform comparably to the legally marketed predicate device (Ethicon Endopath Ultra Veress Needle).
• Predicate Device Performance: The predicate device itself serves as a benchmark for acceptable performance.

8. The Sample Size for the Training Set

This question is not applicable. Training sets are used for machine learning models. The GRI-Alleset Veress Needle is a hardware medical device, and its development does not involve machine learning training sets.

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

This question is not applicable, as there is no training set for a hardware medical device.

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The RoyalGuard Surgical Gown, i600, Breathable is a single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The RoyalGuard Surgical Gown, i600, Breathable has been tested as Level 4 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

The RoyalGuard Surgical Gown, i600, Breathable (i90-61xx-S1) consists of a tri-laminate fabric Breathable Viral Barrier (BVB) including an outer and inner layer of spunbond polyolefin fabric with a middle layer of breathable monolithic film in the gown front body and gown sleeves. The gown sleeves critical zones also consist of an additional layer of Film Reinforcement Bi-laminate material, including a layer of spunbond and a layer of film. The gown back panels are comprised of a single layer of SMS (polyolefin nonwoven). The RoyalGuard Surgical Gown, i600, Breathable (i90-61xx-S1) is provided with neck binder, hook and loop tabs, belt ties, removable transfer accessory, and cuffs. There are eight regular sizes and two special sizes (A-frame) available for each design in both sterile and non-sterile packaging configurations, including: S, M, L, XL, XXL, L-XLONG, XXL-XLONG, A-frame L-XLONG, Aframe XL-XLONG. The two special sizes (A-frame L-XLONG, A-frame XL-XLONG) have much wider bottom that are designed for sitting procedures. The RoyalGuard Surgical Gown, i600, Breathable (i90-61xx-51) has been tested according to AAMI PB70:2012 and met the AAMI Level 4 liquid barrier performance requirements. It is constructed with or without thumb-hooks in cuffs. The addition of thumb-hooks does not impact the performance of the gown in accordance with AAMI PB70 requirement.

This document describes the premarket notification (510(k)) for the RoyalGuard Surgical Gown, i600, Breathable. The core of this submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

The acceptance criteria and device performance are based on physical and barrier performance testing, not an AI/human reader study for diagnostic accuracy. Therefore, several of the requested sections related to AI performance, expert consensus, and MRMC studies are not applicable.

Here's the information as it applies to this medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, "acceptance criteria" primarily refer to adherence to established national and international standards for surgical gowns, and "device performance" refers to the results of testing against those standards.

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

• Sample Size: The document does not specify exact sample sizes (number of gowns or material samples) for each test. Medical device testing is typically performed on a statistically relevant number of samples to ensure representativeness and consistency.
• Data Provenance: The testing was conducted by GRI Medical & Electrical Technology Co., Ltd. (the applicant/manufacturer). The nature of the testing (physical and barrier performance) strongly suggests these were prospective lab tests performed on manufactured samples of the RoyalGuard Surgical Gown. The country of origin for the data generation would be China, where the manufacturer is located, given the contact information provided (JiaXing, ZheJiang, China).

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 physical and biological performance study for a surgical gown, not an AI/diagnostic imaging study. Ground truth is established by standardized test methods (e.g., AAMI PB70, ASTM, ISO standards) and objective measurements performed in a lab setting, not by expert interpretation of images or clinical outcomes.

4. Adjudication method for the test set:

• Not Applicable. As this is not a study involving human interpretation or subjective assessment, adjudication methods are not relevant. Test results are quantitative measurements against established pass/fail criteria from recognized 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:

• 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 not an AI/algorithm device.

7. The type of ground truth used:

• The "ground truth" for this device is based on objective measurements from performance standards and laboratory testing. For example:
  • AAMI PB70:2012 (Liquid Barrier Performance): This standard defines specific tests (e.g., ASTM F1671 for viral penetration, AATCC 42 for impact penetration) with quantitative pass/fail criteria to classify gown barrier levels. The ground truth is the measured resistance to fluid and viral penetration.
  • ISO 10993 (Biocompatibility): This set of standards uses in vitro and in vivo tests to assess materials for cytotoxicity, sensitization, and irritation. The ground truth is the observed biological response (or lack thereof) to the material.
  • 16 CFR Part 1610 (Flammability): This standard defines methods to test flammability and classifies materials based on burn rate. The ground truth is the measured flammability.
  • ASTM Physical Properties: These standards define methods for measuring material properties like basis weight, tensile strength, tear strength, and seam strength. The ground truth is the measured physical property.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device that requires a training set. The device is a manufactured product tested against performance standards.

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

• Not Applicable. See point 8.

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The gentleheel® devices are heel incision devices for blood sampling in newborns, premature and low birth weight infants, and toddlers. The gentleheel has a sharps prevention feature to protect the user from a sharps injury.

The gentleheel is designed to be an easy to use, safe, one handed heel incision device for acquiring blood samples from the heels of newborns. The welded plastic housing is designed to prevent accidental exposure to the blade, to be ergonomic for improved handling, and compatible with an infant's foot. The user is instructed to remove the trigger lock. When the gentleheel is placed against the infant's heel and the user presses the trigger mechanism it automatically makes the incision by starting the blade in a continuous motion from inside the housing, into the infant's heel, and then back within the housing. The trigger mechanism is no longer functional and the blade remains inside the housing through disposal. The entire device is discarded in a sharps container after use.

The gentleheel comes in models for Newborn, Preemie, Micro-Preemie and Toddler. The models are differentiated by the styles and colors of the housing (see definitions below).

The provided text describes the 510(k) premarket notification for the "gentleheel" device, a heel incision device for blood sampling. It does not contain an acceptance criteria table or a detailed study report that proves the device meets specific performance criteria.

However, it does mention that performance and safety testing were completed, including:

• Cutting profile
• Trigger force and reverse safety
• Drop testing
• Simulated use testing

It also states that "The sharps prevention feature was fully tested to the FDA’s guidance document as demonstrated in the performance testing." This implies that there were acceptance criteria for the sharps prevention feature, likely based on FDA guidance, and the device met them.

Based on the provided text, I cannot fill out the requested table or provide detailed information for points 2 through 9. The document is a 510(k) summary, which provides an overview but typically doesn't include the granular details of the studies themselves.

Here's what can be inferred or stated based on the text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not specified in the provided text.

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

• Not applicable/specified. This device is a manual surgical instrument, not an AI/diagnostic device where expert ground truth is typically established for image interpretation. The "ground truth" for its performance would be its physical characteristics and functionality.

4. Adjudication method for the test set:

• Not applicable/specified.

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

• No, this is not an MRMC study. Such studies are typically for diagnostic AI systems or interpretation tasks.

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

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

7. The type of ground truth used:

• For biocompatibility: Laboratory assays compliant with ISO 10993-1.
• For sharps prevention: Adherence to FDA guidance document criteria.
• For other performance tests: Engineering specifications, functional requirements, and safety standards.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the machine learning sense.

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

• Not applicable.

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The ComfortGuard Surgical Gown, i600, Film Reinforced is a single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) consists of a multi-layer in the critical zones (SMS & Film Lamination), single layer of SMS (polyolefin nonwoven) in the noncritical zones in the body and sleeve, single layer of SMS (polyolefin nonwoven) in the back panel with a lower basis weight SMS.

The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) is provided with neck binder, hook and loop tabs, belt ties, removable transfer accessory, and cuffs. There are eight regular sizes and two special sizes (A-frame) available for each design in both sterile and nonsterile packaging configurations, including: S, M, L, XL, XXL, L-XLONG, XXL-XLONG, XXL-XLONG, Aframe L-XLONG, A-frame XL-XLONG. The two special sizes (A-frame L-XLONG, A-frame XL-XLONG) have much wider bottom that are designed for sitting procedures. And the reinforcement still covers the critical zone as in the other product codes.

The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) has been tested according to AAMI PB70:2012 and met the AAMI Level 4 liquid barrier performance requirements. It is constructed with or without thumb-hooks in cuffs, with pleats in the back panels, with a lower basis weight SMS in the back panel. The addition of thumb-hooks, back pleats, and the use of a lighter basis weight material in the back panels does not impact the performance of the gown in accordance with AAMI PB70 requirement.

Here's a breakdown of the acceptance criteria and study information for the ComfortGuard Surgical Gown, i600, Film Reinforced, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the AAMI PB70 standard for liquid barrier performance, along with other ASTM and ISO standards for physical properties and biocompatibility.

2. Sample Size for the Test Set and Data Provenance

• Sample Size:
  • For the AAMI PB70 / ASTM F1671-13 (Viral Penetration) and AATCC 42-2013 (Impact Penetration) tests, the specified sample size is n=32 for each critical zone/material type, with an acceptance quality limit (AQL) of 4% and a rejection quality limit (RQL) of 20%.
  • For the physical property tests (Basis Weight, Grab Tensile, Trapezoid Tear, Seam Strength), results are reported as "Results obtained from Three Lots" for Mean (Min, Max). The specific sample size per lot for these tests is not explicitly stated, but implies multiple samples were taken across these three lots.
• Data Provenance:
  • The document does not explicitly state the country of origin of the data for these performance tests. Given that the manufacturer is "GRI Medical & Electronic Technology Co., Ltd." located in JiaXing, China, it is plausible the testing was performed in China or by labs contracted by the manufacturer.
  • The studies described are prospective in nature, as they involve testing the manufactured device according to specific standards to determine its performance characteristics.

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

• This document describes performance testing of a physical medical device (surgical gown) against recognized industry standards (AAMI PB70, ASTM, ISO).
• No human experts are used to establish "ground truth" in the context of diagnostic performance (e.g., radiologists interpreting images). Instead, the "ground truth" is established by the standardized testing methodologies themselves, which provide objective, measurable results (e.g., pass/fail for viral penetration, grams for impact penetration, Newtons for tensile strength).
• The "experts" involved would be the certified laboratory technicians performing these tests, who are qualified to conduct tests according to the specified ASTM/ISO/AAMI standards. Their specific qualifications (e.g., years of experience) are not detailed in this summary.

4. Adjudication Method for the Test Set

• None. As explained above, the tests are objective, quantifiable physical and barrier performance assessments governed by specific standards. The results are not subject to human interpretation or adjudication in the way that, for example, diagnostic image reviews would be. The acceptance/rejection criteria are pre-defined by the AQL/RQL and specific performance thresholds.

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

• No. An MRMC study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance, to assess the impact of AI on clinical decision-making. This document describes the performance of a surgical gown, which is a physical barrier device, not a diagnostic tool requiring human interpretation.

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

• Not applicable. This question pertains to AI-powered diagnostic algorithms. The ComfortGuard Surgical Gown is a physical medical device; there is no "algorithm" or "human-in-the-loop" aspect to its performance evaluation beyond standard quality control and testing procedures for manufactured goods.

7. The Type of Ground Truth Used

• The "ground truth" for the performance of the surgical gown is established by objective, quantitative measurements performed according to internationally recognized standards and specifications. These include:
  • Standardized Test Results for Barrier Performance: Meeting "Pass" criteria for viral penetration (ASTM F1671-13) and having impact penetration values below specified thresholds (AATCC 42-2013), as outlined in AAMI PB70.
  • Standardized Test Results for Physical Properties: Meeting or exceeding specified minimums or ranges for Basis Weight (ASTM D3776), Grab Tensile (ASTM D5034-09), Trapezoid Tear (ASTM D5587), and Seam Strength (ASTM D1683).
  • Biocompatibility Testing: Demonstrating non-cytotoxicity, non-sensitization, and non-irritation as per ISO 10993-5 and ISO 10993-10.
  • Flammability Testing: Meeting Class 1 requirements as per 16 CFR Part 1610 (2014).

8. The Sample Size for the Training Set

• Not applicable. This device is a physical product, not an AI model. Therefore, there is no "training set" in the machine learning sense. The manufacturing process is implicitly "trained" through process controls and quality management, but not data-driven machine learning.

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

• Not applicable. See point 8.

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ComfortGuard Plus Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. ComfortGuard Plus Surgical Gown, i500 have been tested and are classified as Level 3 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

ComfortGuard Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. ComfortGuard Surgical Gown, i500 have been tested and are classified as Level 3 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

The ComfortGuard Plus Surgical Gown, i500 (i90-70xx-S1) is comprised of a single layer of polyolefin nonwoven SMS fabric throughout the entire gown, with no additional reinforcement.

The ComfortGuard Surgical Gown, i500 (i90-80xx-S1) is comprised of a single layer of polyolefin nonwoven SMS fabric throughout the entire gown, with no additional reinforcement.

Both groups of surgical gowns are provided with neck binder, hook and loop tabs, belt ties, removable transfer accessory, and cuffs. There are eight sizes available for each design in both sterile and non-sterile packaging configurations, including: S, M, L, XL, XXL, L-XLONG, XL-XLONG, and XXL-XLONG, see Intended use/Indication for use.

Both groups of surgical gowns have been tested according to AAMI PB70:2012 and met the AAMI Level 3 liquid barrier performance requirements. They are constructed with or without thumbhooks in cuffs, with pleats in the back panels, with a lower basis weight SMS in the back panel. The addition of thumb-hooks, back pleats, and the use of a lighter basis weight material in the back panels does not impact the performance of the gown in accordance with AAMI PB70 requirement.

This document describes the acceptance criteria and the study that proves the device (ComfortGuard Plus Surgical Gown, i500 and ComfortGuard Surgical Gown, i500) meets these criteria.

Acceptance Criteria and Device Performance

The acceptance criteria for the surgical gowns are based on their performance as protective apparel, specifically their liquid barrier performance (AAMI PB70 standard) and other physical and safety properties.

Table 1: Acceptance Criteria and Reported Device Performance

Note on Reported Performance: The reported device performance values are the "Mean" results obtained from three lots, as provided in the tables within the document. The values in parenthesis (Min, Max) represent the range of results obtained. The document states that both devices "meet the predetermined specifications" for these physical properties.

Study Proving Device Meets Acceptance Criteria

The provided document is a 510(k) Pre-market Notification for surgical gowns, demonstrating substantial equivalence to a predicate device. The "study" in this context refers to the comprehensive testing conducted to prove that the new devices meet established performance standards (acceptance criteria) and are as safe and effective as a legally marketed predicate device.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

(See Table 1 above)

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

• Sample Size: For the AATCC and ASTM tests (Hydrostatic Pressure, Impact Penetration, Grab Tensile, Trapezoid Tear, Seam Strength), the acceptance criteria specify a sample size of n=32 (Acc=3; Rej=4) for the AQL/RQL statistical sampling plan. The test results reported were "obtained from Three Lots".
• Data Provenance: The document does not explicitly state the country of origin where the testing was performed. The applicant, GRI Medical & Electrical Technology Co., Ltd., is located in China, suggesting the data may originate from testing facilities in China or a contracted lab. The data is retrospective, as it represents results from tests already performed to support the 510(k) submission.

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

This type of submission for surgical apparel does not involve clinical studies with human "experts" establishing ground truth in the way a diagnostic AI device would. The "ground truth" for the performance of these surgical gowns is established by adherence to recognized industry standards (AAMI PB70, ASTM, 16 CFR, ISO) and laboratory testing methodologies described within those standards. The expertise lies in the certified labs and technicians performing these specific material and barrier tests. There is no mention of "experts" in the context of clinical interpretation or adjudication.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing. Performance is measured against objective, quantitative physical and barrier properties according to established industry standards, not subjective expert opinion requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly AI-assisted ones, where human readers interpret medical images. Surgical gowns are physical barrier devices, and their effectiveness is determined by laboratory performance testing, not human reading of cases. Therefore, there is no effect size reported for human readers improving with AI vs without AI assistance.

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

Not applicable. This device is a physical product (surgical gown), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" is defined by the objective, quantitative performance requirements of the referenced industry standards:

• AAMI PB70: Liquid barrier performance and classification for protective apparel.
• 16 CFR Part 1610: Flammability standards.
• ISO 10993-5 (Cytotoxicity) & ISO 10993-10 (Irritation & Sensitization): Biocompatibility standards.
• ASTM D3776, D5034-09, D5587, D1683: Physical property testing standards (basis weight, tensile strength, tear resistance, seam strength).
• AATCC 127-2014 & AATCC 42-2013: Hydrostatic pressure and impact penetration for liquid barrier.

These standards provide the pre-defined, objectively measurable criteria for performance.

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 "training" for this device would refer to the manufacturing processes and quality control to consistently produce gowns meeting the specifications.

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

Not applicable, as there is no "training set" in the context of AI. For the manufacturing process, the "ground truth" (or target specifications) for quality control and process validation would be established by the engineering and quality teams based on material properties, design requirements, and the performance criteria outlined in the regulatory standards (e.g., AAMI PB70 Level 3).

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GRI single use drapes (both sterile and non-sterile) are made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

Non-sterile GRI surgical drapes are sold, in bulk as single use items, to repackager/relabeler establishments for further packaging and ethylene oxide (EtO) sterilization.

GRI single use surgical equipment covers (both sterile and non-sterile) are protective barrier covers intended to be used to cover surgical equipment and provide a protective barrier for that equipment.

Non-sterile GRI surgical equipment covers are sold, in bulk as single use items, to repackager/relabeler establishments for further packaging and ethylene oxide (EtO) sterilization.

GRI's single use drapes and surgical equipment covers with AAMI Liquid Barrier Level 3 claim are constructed with various base sheet fabric and reinforcement fabric types, provided in various sizes and shapes, and may contain fluid collection pouches or clear film panels as components. The base sheet fabric is a three layer laminate comprised of polypropylene spunbond/polypropylene mettblown/polypropylene spunbond. Layers are thermally embossed together producing a single layer with various basis weights. Fabric is topically treated to enhance water repellency and to assure static dissipation. The drape reinforcement fabrics are constructed of various configurations of spunbond, meltblown and film. The reinforcement materials are spunbond/film laminate. The primary component of these materials is polypropylene with surfactant and blue pigment.

Based on the provided text, here's a detailed breakdown of the acceptance criteria and the study for the GRI Sterile and Non-Sterile Surgical Drapes and Surgical Equipment Covers:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that "All tests results met acceptance criteria and were substantially equivalent to the predicate devices." While the specific numerical acceptance criteria for each test are not detailed in this summary, the general statement indicates successful compliance.

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

The document does not specify the exact sample sizes used for the performance testing.
The origin of the data is not explicitly mentioned as a country, but GRI Medical & Electronic Technology Co., Ltd. is located in ZheJiang, China. This suggests the testing may have been conducted there or by a contracted lab. The study is retrospective in the sense that it relies on laboratory testing of the device rather than a clinical trial.

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

This information is not applicable to this type of device and study. The "ground truth" for surgical drapes and equipment covers relates to objective performance criteria (e.g., barrier properties, strength, biocompatibility), which are measured in laboratory settings against established standards, not through expert consensus in a clinical diagnostic context.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like "2+1" are typically used in studies involving human interpretation (e.g., image analysis by radiologists) to resolve discrepancies.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, especially with and without AI assistance. This document describes the performance testing of physical barriers (surgical drapes and equipment covers).

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

This information is not applicable. The device is a physical product (surgical drapes and equipment covers), not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI does not apply. The device itself is "standalone" in that its physical properties are tested.

7. The Type of Ground Truth Used:

The ground truth used for this device is based on objective performance standards and test methods. Specifically, the document mentions compliance with:

• AAMI Standard PB70 for liquid barrier performance.
• Other unnamed standards for biocompatibility (cytotoxicity, primary skin irritation, sensitization), hydrostatic pressure, impact penetration, tear strength, tensile strength, linting, and flammability.

8. The Sample Size for the Training Set:

This information is not applicable. This is not a machine learning or AI-driven device, so there is no "training set."

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

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

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GRI's Non Reinforced, Film Reinforced, and Fabric Reinforced Surgical Gowns are sterile or non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

GRI's Non Reinforced, Film Reinforced and Fabric Reinforced Surgical Gowns are made from SMS fabrics and polypropylene/polyethylene protective reinforcement to provide user protection in surgical settings. The gowns are available in various designs and combinations of materials, sizes, and reinforcement configurations.

The Non Reinforced Surgical Gowns meet the requirements of AAMI Level 2 liquid barrier requirements.

The Fabric-Reinforced Surgical Gowns meet the requirements of AAMI Level 3 liquid barrier requirements.

The Film-Reinforced Surgical Gowns meet the requirements of AAMI Level 3 liquid barrier requirements.

This document describes the validation of GRI Surgical Gowns for their liquid barrier properties and other physical characteristics, demonstrating substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document details that the GRI Surgical Gowns met acceptance criteria for various bench tests. While explicit numerical acceptance criteria are not provided, the performance is described in relation to AAMI liquid barrier levels and general physical properties.

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

The document does not explicitly state the sample sizes used for each specific test. However, it indicates that "performance testing" was conducted. The data provenance is not specified, but the device manufacturer, GRI Medical & Electronic Technology Co., Ltd., is located in ZheJiang, China, suggesting the testing might have been conducted in China or by a certified testing facility accredited to international standards. The study is a retrospective submission for regulatory clearance (510(k)), meaning the testing was completed prior to the submission date.

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 to this testing. The "ground truth" for surgical gowns, in this context, is established by adherence to recognized national/international standards (like AAMI for liquid barrier properties) and standard test methods for physical properties. There is no involvement of human experts for "ground truth" establishment in the way it would be for a diagnostic AI device assessing medical images. The performance is objectively measured against physical/chemical standards.

4. Adjudication Method for the Test Set:

This information is not applicable. The testing involves objective physical measurements and comparisons against established technical standards (e.g., AAMI levels). There is no "adjudication" in the sense of resolving disagreements among human observers for image interpretation.

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 information is not applicable. The device under review is a surgical gown, a physical medical device, not an AI-powered diagnostic tool. Therefore, an MRMC study involving human readers and AI assistance is irrelevant.

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

This information is not applicable. As a surgical gown, the device does not involve an algorithm or AI. Its performance is entirely standalone in terms of its physical properties and barrier function without human-in-the-loop interaction in a diagnostic or interpretive sense.

7. The Type of Ground Truth Used:

The "ground truth" for the device's acceptable performance is based on:

• Established Standards: Adherence to AAMI (Association for the Advancement of Medical Instrumentation) liquid barrier classifications (Level 2 and Level 3).
• Bench Testing Protocols: Standardized laboratory tests for physical properties such as biocompatibility, hydrostatic pressure, impact penetration, resistance to blood penetration, "fly around" (linting), tensile strength, tear strength, and seam strength. These tests have defined methodologies and criteria for pass/fail.

8. The Sample Size for the Training Set:

This information is not applicable. Since the device is a physical product and not an AI/machine learning model, there is no "training set."

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

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

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