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The Procedure mask/Surgical mask/Face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.

The subject device is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of polypropylene nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The subject device is available in one type, ear loop. The ear loops are made of polyester and spandex. The ear loops model is held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The nose clip is made of Iron and polypropylene. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loop masks are available in two size, 17.5 × 9.5 cm and 14.5 × 9.5 cm. And the colors for the ear loop mask are yellow, blue and white. The ear loop masks are available in level 1, level 2 and level 3 masks based on ASTM F2100-23. This is a single-use, disposable device, provided non-sterile.

The provided document is a 510(k) Clearance Letter for a medical device: Procedure mask/Surgical mask/Face mask. This type of document, specifically the "Summary of Non-Clinical Test" section, details the performance characteristics required for the device to meet regulatory standards.

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

Important Note: The provided document is for a medical mask, not an AI-powered diagnostic device. Therefore, many of the typical questions regarding AI/software performance studies (e.g., sample size for test set, number of experts, adjudication, MRMC studies, training set details, ground truth for AI) are not applicable to this submission. The "study" here refers to physical and biological performance testing of the mask material itself.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are based on established standards like ASTM F2100-23, ASTM F1862/F1862M-24, ASTM F2101-23, EN 14683:2019+AC:2019, 16 CFR Part 1610, and ISO 10993 series. The table below summarizes these criteria and the reported performance:

Table 1: Acceptance Criteria and Reported Device Performance

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The Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. Fluidshield* 3 Surgical Masks(s) and Fluidshield* 3 Procedure Face Mask(s) are single use, disposable device(s), provided non-sterile.

The subject device(s) are ASTM F2100 Level 3 (orange in color) Surgical and Procedure Mask(s). The Fluidshield* 3 Surgical Mask(s)s and Fluidshield* 3 Procedure Masks family of products are a four-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Masks are provided with earloops. A malleable nosepiece is placed within the bindings to conform around the wearer's nose. The Fluidshield* 3 Surgical Mask(s)s and Fluidshield* 3 Procedure Mask(s) family will be provided in designs with and without a protective visor. The Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) family are single use, disposable devices, provided non-sterile.

This document describes the FDA 510(k) clearance for several Fluidshield® 3 Surgical and Procedure Masks. However, it does not contain the level of detail regarding study design, sample sizes, ground truth establishment, or expert qualifications that would be present in a comprehensive study report for an AI/software device. The information provided is typical for a medical device clearance describing performance characteristics and compliance with standards, not for an AI comparative effectiveness or standalone study.

Based on the provided text, here's what can be extracted and what cannot:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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The ViVi® Toga Premium is a component of the ViVi® System and is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

The ViVi® Toga Premium is a one-piece head and body cover that is worn by healthcare professionals. The ViVi® Toga Premium is a component of the ViVi® Surgical Helmet System and worn over the air-exchanging surgical helmet. The ViVi® Toga Premium is used with the ViVi® Helmet or the ViVi® Helmet HPL (High Power LED) with Light Emitting Diode (LED) light to provide a barrier between the operating environment and the surgical personnel to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

ViVi® Toga Premium is designed and has been tested to meet the applicable AAMI PB70 standards for level 4 compliance. The AAMI standard does not cover apparel for the head, face, and eyes. Therefore, the hood area and the lens are exempt from classification under this standard.

The provided FDA 510(k) clearance letter for the ViVI® Toga Premium is for a Class II surgical apparel device. This document primarily details the substantial equivalence of the ViVi® Toga Premium to a predicate device based on non-clinical performance data. It explicitly states that "No clinical evaluation is necessary for this device."

Therefore, this document does not describe a study involving an AI/Machine Learning (ML) algorithm with a test set, ground truth, expert adjudication, or MRMC studies. The device is a physical product (surgical toga/gown), and its "performance" is related to its physical properties and barrier capabilities, not diagnostic or predictive accuracy.

Given the information provided, it's not possible to fulfill the request for acceptance criteria and study details related to an AI/ML device. The "study" mentioned in the document refers to non-clinical laboratory testing of material properties.

However, I can extract the acceptance criteria and the "reported device performance" based on the provided document as it relates to this specific physical device.

Acceptance Criteria and Reported Device Performance for ViVi® Toga Premium (Surgical Apparel)

Based on the provided FDA 510(k) clearance letter for the ViVi® Toga Premium, the acceptance criteria and reported device performance relate to its physical properties and barrier capabilities, as it is a surgical apparel device and not an AI/ML device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the standards and tests performed, with "PASS" indicating successful compliance.

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

• Sample Size: The document does not specify the exact sample sizes (number of garments or material samples) used for each individual non-clinical test. The testing is reported as "tests were conducted and completed," indicating standard laboratory evaluations.
• Data Provenance: Not applicable in the context of clinical data. The tests are material and performance tests conducted in a laboratory setting. No geographical origin of "data" in the sense of patient data is mentioned, as this is a physical product. The manufacturer is THI Total Healthcare Innovation GmbH, based in Austria. The predicate device manufacturer is Zimmer Surgical, Inc.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This device is surgical apparel, and its "performance" is assessed through standardized physical and biological material testing, not through expert human interpretation of data like images or clinical outcomes. There is no "ground truth" in the diagnostic AI sense.

4. Adjudication Method for the Test Set

• Not applicable. As described above, there is no expert adjudication process for this type of device. Performance is determined by meeting pre-defined regulatory standards and test method specifications.

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

• No. An MRMC study is a type of clinical study used to evaluate the performance of diagnostic devices (often imaging-based AI) by comparing the accuracy of multiple human readers with and without AI assistance across multiple cases. This does not apply to a surgical apparel device.

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

• Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

• Not applicable in the context of AI/ML. The "ground truth" for this device's performance is derived from established international and national standards (e.g., ISO, ASTM, ANSI/AAMI, CFR), which define objective physical and chemical properties and test methodologies. Meeting these standards serves as the "truth" for device functionality.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. This is not an AI/ML device and does not have a training set or associated ground truth.

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The Dream Medi Sterile Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter.

In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile.

Dream Medi Surgical Gowns are made from SMS material. They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. They provide AAMI Level-3 protection.

The Level 3 Gowns have five different sizes: Small (S), Medium (M), Large (L), Extra Large (XL), Extra Extra Large (XXL).

SMS is a multi-ply material consisting of layers of spunbond and meltblown polypropylene.

The body is made from 44g Blue SMS and the sleeve is made from 54g Blue SMS. Sleeve opening is made from pure polyester. The collar closure is made from dacron. All gowns are sterilized with ethylene oxide.

This document, a 510(k) Clearance Letter, describes the regulatory approval of a surgical gown (Dream Medi Sterile Surgical Gown), not a medical device that relies on complex algorithms, image analysis, or AI. Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-driven device (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable to this document.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance of the surgical gown against established standards for protective apparel, as detailed in Section 8.0 "Summary of Non-Clinical Testing."

Here's a breakdown of the relevant information from the provided document, addressing the prompt as best as possible given the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

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The Medline Level 4 Surgical Gown with Breathable Sleeves is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Medline Level 4 Surgical Gown with Breathable Sleeves meets the Level 4 requirements of ANSI/AAMIPB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

The Medline Level 4 Surgical Gown with Breathable Sleeves is also sold in a non-sterile version to repackagers/kitting entities, to be sterilized using the validated ethylene oxide sterilization method according to ISO 11135-1 in its final finished form, as a kit component.

The Medline Level 4 Surgical Gown with Breathable Sleeves is a single-use, sterile, disposable medical device that is provided in a variety of sizes (Large, X-Large, 3X-Large, 3X-Large and X-Long (only Sirus)) and styles (Sirus, Aurora and Eclipse). The Medline Level 4 Surgical Gown with Breathable Sleeves is constructed from nonwoven SMS (spunbond, meltblown, spunbond), a poly-fabric reinforcement on the chest front panel, and a breathable film (Polyester ether and polyester) for the sleeves. Each gown is designed with a hook and loop closure at the neck, ties at the waist, knitted cuffs at the end of the sleeves as well as a transfer tab for ease in donning. The Medline Level 4 Surgical Gown with Breathable Sleeves has been tested according to ANSI/AAMI PB70:2022 and meets AAMI Level 4 barrier level protection for a surgical gown.

This document describes the performance testing for the Medline Level 4 Surgical Gown with Breathable Sleeves (K242844), a surgical apparel device. The information provided is based on non-clinical testing only, as no clinical testing was performed for this 510(k) submission.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes non-clinical tests conducted to verify design specifications. For each test listed in the table, the "Results" column indicates a "Pass," meaning the acceptance criteria were met.

• Sample Size: The specific sample sizes for each non-clinical test (e.g., number of fabric specimens tested for ASTM F1671) are not detailed in this summary. The 510(k) summary typically provides a high-level overview, and the detailed test reports (which FDA reviews) would contain this information.
• Data Provenance: The tests are generally performed by accredited testing laboratories or the manufacturer's own qualified labs. The document does not specify the country of origin of the data. Given it's an FDA submission, the tests would typically adhere to recognized international standards like ISO and ASTM. These are prospective tests performed specifically to support the regulatory submission of this new device.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. For this type of medical device (surgical gowns), "ground truth" is established through adherence to standardized, objective performance tests (e.g., measuring water resistance, breaking strength, biocompatibility). These are not studies that rely on expert interpretation of images or clinical outcomes to establish ground truth in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set:

• None. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation or clinical endpoints, often in the context of diagnostic accuracy or clinical trials. As this is a non-clinical performance evaluation against objective standards, no adjudication method is used. The results are quantitative measurements interpreted against pre-defined thresholds.

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 typically performed for diagnostic devices (especially those involving image interpretation by human readers) to assess how an AI algorithm impacts reader performance. The Medline Level 4 Surgical Gown is a protective apparel, not a diagnostic device, and its performance is evaluated through physical and material property tests, not human reader studies.

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

• Not Applicable. This question typically pertains to AI/ML software as a medical device (SaMD). The Medline Level 4 Surgical Gown is a physical medical device. Its performance is inherent in its material properties and manufacturing, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is established by objective, quantitative measurements against published national and international standards. This includes:

• Biocompatibility Standards: ISO 10993 series (Cytotoxicity, Irritation, Sensitization).
• Barrier Performance Standards: ASTM F1671 (blood-borne pathogens), AATCC 42 (impact penetration), AATCC 127 (hydrostatic pressure), and ANSI/AAMI PB70:2022 (overall liquid barrier performance classification).
• Material Strength Standards: ASTM D5034 (breaking strength), ASTM D5587 (tearing strength), ASTM D1683 (sewn seam failure).
• Other Performance Standards: 16 CFR 1610 (flammability), ASTM E96 (water vapor transmission/breathability).

The "ground truth" is therefore the measured physical and chemical properties of the gown, compared against the predefined acceptance criteria of these standard test methods.

8. The Sample Size for the Training Set:

• Not Applicable. The concept of a "training set" is relevant for machine learning algorithms. This device is a manufactured product, not an AI algorithm. Its design and manufacturing process would involve material selection and engineering, not machine learning training.

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

• Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.

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The AAMI Level 4 Protective Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The AAMI Level 4 Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012 - Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities; but has an open back which is non-protective.

The AAMI Level 4 Protective Gown is a single use, disposable medical device and is provided non-sterile.

The AAMI Level 4 Protective Gown is a single use, disposable medical device and is provided non-sterile. It has an open back which is non-protective.

This document is a 510(k) clearance letter for an AAMI Level 4 Protective Gown. It is not a study report for a diagnostic device or an AI/software-as-a-medical-device (SaMD) product. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not applicable to this document.

The document states that the device "meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012 - Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities". This indicates the performance standard the device is intended to meet, but it doesn't provide the detailed acceptance criteria or a study write-up in the format requested for a software device.

In summary, the provided text does not contain the information necessary to answer the specific questions about acceptance criteria, study design, and performance metrics as it pertains to a diagnostic or AI device. It is a regulatory clearance for a physical medical device (a protective gown).

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Aurelia Surgical Masks ASTM Level-3 (2130) is intended for use to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device and provided non-sterile

The Aurelia Surgical Masks ASTM Level 3 are constructed with three layers of nonwoven polypropylene. The direct body contact materials include polypropylene, polyurethane, and nylon. The indirect body contacting materials include polypropylene and aluminum wire coated with melt-blown polypropylene embedded within the three layers.

The provided text is a 510(k) summary for the Aurelia Surgical Mask ASTM Level-3 (2130). It details the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device, rather than a study proving a device meets AI/ML acceptance criteria.

Therefore, many of the requested data points (like sample size for test/training sets in an AI/ML context, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training) are not applicable to this document. This document describes the testing of a physical medical device (a surgical mask) against established performance standards for such devices.

Here's a breakdown based on the provided text, focusing on the relevant information:

Acceptance Criteria and Device Performance for Aurelia Surgical Mask ASTM Level-3 (2130)

This section describes the performance testing of a physical product (surgical mask) against established standards.

1. Table of Acceptance Criteria and Reported Device Performance

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Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non sterile.

The Surgical face mask is single use, three-layer, flat-pleated style with ear loops/ties and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the straps are made of nonwoven fabrics, the middle layer is made of melt blown fabrics.

The model of proposed device, tie-on, is held in place over the user's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.

The model of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.

The ties/ear loops are not made with natural rubber latex. The nose piece on the layers of face mask is to allow the user to fit the face mask around their nose, which is made of Polypropylene with iron core. The Surgical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.

This document is a 510(k) summary for a Surgical Face Mask. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

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

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The Stryker Steri-Shield 8 disposables, including all hood and toga models, are components of the Stryker Steri-Shield 8 Personal Protection System and are intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganism and particulate material. The Stryker Steri-Shield 8 disposables are sterile, disposable, single-use only devices.

The Stryker Steri-Shield 8 Surgical Protective Equipment consist of Stryker Steri-Shield 8 Surgical Hoods and Steri-Shield 8 Surgical Togas.

The Stryker Steri-Shield 8 Surgical Hood is a single piece device that covers the user's head, neck, and shoulder region and is intended to be worn with commercially available sterile surgical gowns. The Steri-Shield 8 Hoods are available with Standard (NPA), Peel Away (PA) and Anti-Reflective (AR) face shield options.

The Stryker Steri-Shield 8 Surgical Togas are a single piece device that covers the user's head, neck, arms, torso, and upper legs region. The Stryker Steri-Shield 8 Surgical Togas is offered in three configurations: Steri-Shield 8 Pullover Togas, Steri-Shield 8 Zippered Togas, and Steri-Shield 8 Tie Back Togas.

The Stryker Steri-Shield 8 Surgical Hoods and Togas is a medical device intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure to infectious bodily fluids, and the transfer of microorganisms and particulate material. The device is sterile, disposable, and for single-use only.

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

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

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ProPel SG3TM Surgical Gown is intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70.

The reusable Propel Surgical Gown is provided non-sterile and must be sterilized before use. Stertlization parameters are as follows:

Prevacuum Steam Sterilization: 132°C/270°F (temperature)/ 4 minutes (exposure time)/15 minute (dry time)

The ProPel SG3TM Surgical Gown is a reusable, woven surgical gown that provides an ANSI /AAMI PB70:2022 Level 3 Liquid Barrier Performance Barrier using 100% polyester with silicone coating in the critical zone. The critical zone inner ply and back of the surgical gown is made of polyester with electrostatic dissipative yarn (graphene) and silicone coating. The gown has polyester mesh and vented cape on the back panels of the gown for ventilation. The ProPel SG3TM Surgical Gown may undergo up to 60 reprocessing cycles.

The ProPel SG3™ Surgical Gown is available in small, medium, large, extra large (XL), 2XL and 3XL. The device will be sold as a non-sterile surgical gown that is to be laundered, sterilized and processed by the healthcare facility prior to first use and after each subsequent use.

The provided text describes the non-clinical testing performed on the ProPel SG3™ Surgical Gown to demonstrate its equivalence to a predicate device. It is important to note that this is a 510(k) submission, which aims to show substantial equivalence, not necessarily a study proving clinical effectiveness in the same way a new drug or high-risk device might.

Here's the information requested, based on the provided text:

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

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 refers to non-clinical testing of the physical and biological properties of the surgical gown material and design. For each test, "specimens" or "gowns" would be used as samples. However, the exact sample size (N) for each specific test (e.g., number of gowns for tensile strength, number of fabric pieces for hydrostatic resistance, number of biological samples for cytotoxicity) is not explicitly stated in this summary. For Evaporative Resistance, it mentions "average of 3 specimens".

The data provenance (country of origin, retrospective/prospective) is not provided in this document. Given that it's non-clinical testing of a manufactured product, it is likely that the testing was performed in a controlled laboratory environment, but the location is not specified.

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 is a non-clinical, laboratory-based study for a surgical gown. It does not involve medical imaging, diagnosis, or clinical decision-making by human experts where "ground truth" would be established by referring radiologists or other clinicians. The "ground truth" or "acceptance criteria" for these tests are based on established national and international standards (like ANSI/AAMI, ASTM, ISO, AATCC, 16 CFR, USP), which reflect a consensus of scientific and technical experts in materials science, biology, and medical device regulations. Therefore, this question is not applicable in the context of this device and study type.

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

Since this is non-clinical laboratory testing against predefined, objective standards, an adjudication method like 2+1 or 3+1 (typically used for resolving discrepancies in expert interpretations) is not applicable. The 'adjudication' is inherent in the test method itself, where results are measured objectively and compared against numerical acceptance criteria in a pass/fail manner.

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

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study is performed for diagnostic devices, particularly those involving human interpretation (e.g., radiologists reading images). This device is a surgical gown, which is a physical barrier protection device. Therefore, an MRMC study and effects related to human reader improvement with AI assistance are not applicable. The document explicitly states "SUMMARY OF CLINICAL TESTING Not Applicable", further confirming no clinical effectiveness study (which would include MRMC) was performed.

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

This refers to the performance of an AI algorithm without human involvement. Since the device is a surgical gown and not an AI-powered diagnostic or assistive tool, this question is not applicable.

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

The "ground truth" for the performance claims of the surgical gown is based on established national and international standards and test methods. These standards define measurable physical and biological properties (e.g., tensile strength, tear strength, barrier performance, biocompatibility) and their respective acceptance criteria.

8. The sample size for the training set

This question typically applies to machine learning or AI models. Since this is non-clinical testing of a physical medical device (surgical gown), there is no "training set" in the context of an AI algorithm. The gown samples tested were used to demonstrate compliance with the specified performance standards.

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

As there is no "training set" for an AI algorithm in this context, this question is not applicable. The "ground truth" for evaluating the gown's performance was established by recognized industry standards and test methodologies.

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