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A surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device is a sterile latex powder-free surgical glove that is formulated using natural rubber latex and is brown in color. The glove is coated with hydrogel polymer coating. The glove is manufactured using molds that feature an independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only. This glove is suitable for use as a specialty surgical glove intended for orthopedic procedures or other procedures where a thicker barrier may be desired such as trauma and reconstructive surgery.

The provided document describes the predicate device and the performance data that supports substantial equivalence for the "Cardinal Health™ Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating." This is a medical device approval summary, and as such, it focuses on non-clinical tests to demonstrate performance in line with existing standards for gloves, rather than a study for an AI-powered diagnostic device.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set size, ground truth for training set) are not applicable to this type of device and submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. For medical gloves, testing is typically done on a representative sample from production lots according to the specified ASTM standards. The standards themselves define the sampling plans.
• Data Provenance: The tests are non-clinical (laboratory/material tests). As such, there is no "country of origin of the data" in the sense of patient data. The tests were performed by the manufacturer (Cardinal Health 200, LLC) in a laboratory setting to demonstrate compliance with international and national standards. These are retrospective analyses of material properties.

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

• Not applicable. These are objective physical and chemical property tests, not expert-adjudicated diagnostic interpretations. The "ground truth" is defined by the technical specifications and methodologies of the referenced ASTM, ISO, and FDA standards.

4. Adjudication method for the test set

• Not applicable. The tests involve objective measurements against defined criteria, not subjective interpretations 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

• Not applicable. This is not an AI-powered 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-powered diagnostic device.

7. The type of ground truth used

• Ground Truth: The "ground truth" is defined by the Pass/Fail criteria and quantitative limits specified in the referenced international standards (ASTM D3577, ISO 10993-10, AS/NZ 4179) and FDA guidance for medical gloves (e.g., 21 CFR 800.20, FDA Medical Glove Guidance Manual, ASTM D5712). These standards establish the acceptable physical, chemical, and biological properties for safe and effective surgical gloves.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it is not a machine learning or AI algorithm.

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

• Not applicable. This device does not involve a training set.

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Cardinal Health SmartGown™ 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 Cardinal Health SmartGown™ surgical gown is a single use, disposable medical device provided sterile and non-sterile.

The Cardinal Health SmartGown™ surgical gowns are constructed of a multi-layer construction of a nonwoven outer layer, breathable film core and a nonwoven inner layer and have been tested according to AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health care Facilities. The Cardinal Health SmartGown™ surgical gown is a single use, disposable medical device that will be provided in a variety of sterile and non-sterile packaging configurations. This submission covers 12 models of Cardinal Health SmartGown surgical gowns, see Table 1 below.

This document describes the testing and acceptance criteria for the Cardinal Health SmartGown™ surgical gown. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Cardinal Health SmartGown™ surgical gown are established by various ASTM and AATCC standards, as well as the AAMI PB70:2012 Level 4 requirements. The reported device performance confirms that the gowns meet or exceed these criteria.

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

• Sample Size: For almost all tests (Basis Weight, Grab Tensile, Mullen Burst, WVTR, Flammability, Trap Tear, Water Impact, Hydrostatic Pressure, ASTM F1670, ASTM F1671), the sample size used was n=32.
• Data Provenance: The document does not specify the country of origin of the data. However, it indicates that the tests were performed on "Final finished goods, that were twice EO sterilized (Cardinal Health SmartGown™ surgical gown)". This suggests the data is prospective as it's from testing the manufactured device against established performance standards.

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

This is a medical device (surgical gown) performance testing, not a diagnostic AI study. Therefore, there are no human experts establishing "ground truth" in the traditional sense of medical image interpretation or clinical diagnosis. The "ground truth" here is the adherence to established internationally recognized material testing standards and regulatory guidance (ASTM, AATCC, AAMI PB70:2012, FDA Guidance). The experts involved would be the testing laboratories and their personnel following these standard protocols. The document does not specify their individual qualifications beyond executing the tests according to the standards.

4. Adjudication Method for the Test Set

Not applicable. As this is not a study involving human interpretation or clinical outcomes, there is no adjudication method in the context of resolving differing expert opinions. The outcome of each test is a direct measurement or observation against a predefined standard.

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

Not applicable. This is not an AI-powered diagnostic or assistive device. It is a surgical gown, and its performance is evaluated through standardized physical and barrier protection tests, not through human reader interpretation.

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

Not applicable. This device is not an algorithm or AI. It is a physical medical device.

7. The Type of Ground Truth Used

The ground truth used for this device's acceptance is based on established material testing standards and regulatory performance classifications:

• ASTM International Standards: Various ASTM standards (e.g., D3776, D5034, D5733, D774, E96, F1670, F1671) define the methods for testing physical properties and barrier resistance.
• AATCC Standards: AATCC standards (e.g., 42, 127) define methods for water resistance.
• AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes: This standard sets the performance levels for surgical apparel, with the device aiming for Level 4.
• 16 CFR Part 1610 (Flammability): A regulatory standard for flammability.

The device's performance is compared directly against the specified requirements within these standards.

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 device is a physical product whose performance is evaluated through empirical testing against established standards.

9. 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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Convertors® Surgical gowns are made from natural and synthetic materials 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 the transfer of transfer of microorganisms body fluids and particulate The gown is a single use material. disposable device intended for repackaging and sterilization before use.
The single use product is a disposable non-sterile gown designed to be repackaged and sterilized prior to use. This product may be sterilized using Sterilization of Health Care Products-Requirements for Validation and Routine Control-Industrial moist Heat Sterilization Ethylene Oxide following and the Validation and Routine Control under ANSI/AMMI/ISO 11134 7 11135. For more information about sterilization of this product, contact Cardinal health, Inc.

SMS polyolefin, the standard, fabric and poly-reinforced gowns are comprised of a single layer of SMS polyolefin fabric. The fabricreinforced gowns have an additional layer of SMS polyolefin fabric in the sleeve and body areas; the polyreinforced gowns have an additional layer of polyolefin film in the sleeve and body areas.

The Breathable Surgical Gown with Breathable sleeves consists of an outer and inner layer of spunmelt polyolefin non-woven fabric with a middle layer of breathable monolithic film throughout the entire gown. The Breathable Sleeve Surgical Gown consists of sleeves containing an outer and inner layer of spunmelt polyolefin non-woven fabric with a middle layer of breathable monolithic film with a gown body comprised of spunmelt non-woven (SMS) with polyolefin-based film reinforcement.

The Breathable gown is comprised of a single layer of spunlace non-woven fabric (a blend of wood pulp and polyester) through the gown. An additional layer of breathable film adhesive laminated to the non-woven fabric in two configurations 1) through the entire gown and 2) in the front and sleeves.

The O. R. Surgical gowns are comprised of a wood pulp/polyester spunlaced fabric.

The provided text describes the Convertors® SMS Polyolefin Gowns, Breathable Surgical Gowns, and O.R. Surgical Gowns. This document is a 510(k) summary for these surgical gowns, and it primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria for the device itself.

Therefore, much of the requested information regarding detailed performance studies, sample sizes for test sets, expert ground truth establishment, MRMC studies, and standalone algorithm performance, as typically found for AI/ML medical devices, is not present in this document because it pertains to traditional medical device clearance based on substantial equivalence.

However, I can extract the available information, particularly regarding the acceptance criteria as defined by the "performance attributes" being the same as the predicate devices, and the general testing conducted.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of explicit numerical acceptance criteria and corresponding device performance values. Instead, the primary "acceptance criterion" for this 510(k) clearance is substantial equivalence to existing predicate devices. This means that the new devices are considered safe and effective if their performance attributes are "the same" as the legally marketed predicate devices.

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

• Sample Size: Not specified for the performance testing. The document states "All materials used in the fabrication of this Convertors® SMS Polyolefin Gowns... were evaluated through biological qualification safety tests" and "These materials also were tested in accordance with industry recognized test methods." The exact number of gowns or material samples tested is not provided.
• Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The testing appears to be primarily lab-based (biological and material performance tests). The country of origin of the data is not specified beyond being generated by Cardinal Health Inc.

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/not provided. The "ground truth" for this type of device clearance is generally established through adherence to recognized consensus standards for material properties and biological safety (e.g., ISO 10993) and comparison to predicate devices, rather than through expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method for the test set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typical in diagnostic studies where multiple readers interpret images. This document describes material and biocompatibility 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 information is not applicable/not provided. MRMC studies are relevant for diagnostic devices that involve human interpretation assisted by AI. This document is for surgical gowns.

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

This information is not applicable/not provided. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this submission is based on:

• Consensus Standards: Adherence to established standards such as ISO 10993 Part-1 for biological evaluation of medical devices.
• Industry Recognized Test Methods: Performance against established material and barrier property tests.
• Predicate Device Equivalence: The performance of the new gowns is considered "acceptable" because their intended use and performance attributes are "the same" as legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable/not provided. There is no "training set" as this is not an AI/ML device.

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