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DuraBlue ™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:

• . Pre-vacuum steam at 270°F/132°C for 4 minutes
• . 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes
• Advanced Sterilization Products (ASP) STERRAD® 100S system. .
• . Advanced Sterilization Products (ASP) STERRAD® NX system, Standard and Advanced Cycles
• . Advanced Sterilization Products (ASP) STERRAD® 100NX system, Standard, Flex, Express, and DUO Cycles
• . Lumen, Non Lumen, and Flexible Cycles in the Amsco® V-PRO® 1, Amsco® V-PRO® 1 Plus and Amsco® V-PRO® max Low Temperature Sterilization Systems

The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of ' the enclosed device(s) until used.

For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200, and for 30 minutes for Models CH300, CH400, CH500 and CH600. Models CH400, CH500 and CH600 have been validated for pre-vacuum steam sterilization of two lumens 3 mm in diameter or larger and 400 mm in length or less.

For EO sterilization, the wrap has been validated for an aeration time of 8 hours at 55 ℃. Models CH400, CH500 and CH600 have been validated for EO sterilization of two lumens of 3 mm diameter or larger and 400 mm in length or less.

All models of DuraBlue™ Sterilization Wrap have been validated for Advanced Sterlization Products (ASP) STERRAD® 100S sterilization of lumens 2.5 mm in diameter or larger and 250 mm in length or less.

All models of DuraBlue™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX cycles in Table 1.

All models of DuraBlue™ Sterilization Wrap have been validated for use with the STERIS Amsco® V-PRO® cycles in Table 2. The DuraBlue™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed STERIS Amsco® V-PRO® sterilization cycles.

DuraBlue™ Sterlization Wraps are made from 100% polypropylene spunbond-meltblown-spunbond (SMS) trilaminate nonwoven fabric. Each double-layer wrap is comprised of a single sheet of SMS fabric that has been folded in half and sealed to itself on the three non-folded edges. This wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically. This product is for over-the-counter use only.

They are intended to be used to enclose another medical device that is to be sterilized by a health care provider using:

• Pre-vacuum steam at 270°F/132°C for 4 minutes .
• . 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes
• . Advanced Sterilization Products (ASP) STERRAD® 100S System
• Advanced Sterilization Products (ASP) STERRAD® NX System, Standard and Advanced . Cycles
• Advanced Sterilization Products (ASP) STERRAD® 100NX, Standard, Flex, Express, and . DUO cycles
• Lumen, Non Lumen, and Flexible Cycles by the STERIS Amsco® V-PRO® 1, Amsco® V-. PRO® 1 Plus and Amsco® V-PRO® MAX Low Temperature Sterilization Systems

The modification to the predicate devices is the clarification to the sterility maintenance information provided in the Indications for Use portion of the Instructions for Use labeling and involves extending the real-time aging data from 180 days to 365 days. This change is being made in order to comply with 21CFR880.6850 which states "A sterilization wrap (pack, sterilization wrapper, bag, or accessories) is a device intended to be used to enclose another medical device that is to be sterlized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used." Additionally, maintenance of package sterility was validated with realtime testing for a duration of 365 days for each indicated sterilization process.

Extensive performance testing has also been completed on DuraBlue™ Sterlization Wrap. Successful completion of the sterilization performance tests demonstrated that the wrap allows for sterlization of the enclosed contents and also maintains sterility of the enclosed devices. Physical properties testing included in this submission also supports the fact that the integrity of the wrap properties is not compromised after sterilization by the indicated sterilization processes and storage because the polypropylene material is inert and very stable.

This submission covers six different models of DuraBlue™ Sterilization Wrap. Each model is made from material of a different basis weight, though all models utilize the same material technology.

The provided text describes the DuraBlue™ Sterilization Wrap and elaborates on its acceptance criteria and the studies conducted to demonstrate its performance and substantial equivalence to predicate devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The device's performance was proven through "extensive performance testing" and "sterility validation studies" in accordance with applicable requirements recommended in the FDA's Guidance Document: "Premarket Notifications for Medical Sterilization Packaging System in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002)."

The primary modification for this 510(k) submission was the extension of real-time aging data from 180 days to 365 days to comply with regulations regarding maintaining sterility.

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

The document provides details of specific loads used for each type of sterilization validation study and for each wrap model (CH100 - CH600). These loads vary in composition (huck towels, drapes, metal mass, lumens) and weight.

• Pre-vacuum Steam Sterility Validation Studies:
  • CH100: 16 huck towels
  • CH200: 2 huck towels, 3 fluid-resistant drapes
  • CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs of metal mass
  • CH400: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 8 lbs of metal mass
  • CH500: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 12 lbs of metal mass
  • CH600: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 20 lbs of metal mass
• EO Sterility Validation Studies:
  • CH100: 16 huck towels
  • CH200: 2 huck towels, 2 fluid-resistant drapes, 2.5 lbs of metal mass
  • CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs of metal mass
  • CH400: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 7.5 lbs of metal mass
  • CH500: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 11.5 lbs of metal mass
  • CH600: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 19.5 lbs of metal mass
• Advanced Sterilization Products (ASP) STERRAD® 100S Sterility Validation Studies:
  • CH100: Metal Instruments
  • CH200 - CH600: 15 in. x 10 in. x 1.2 in. tray containing metal instruments
• Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX Sterility Validation Studies:
  • CH100 - CH600: 23 in. x 11 in. x 4 in. tray containing metal instruments
• STERIS Amsco® V-PRO® Sterility Validation Study:
  • CH100: Metal Instruments
  • CH200 - CH600: 17 in. x 10 in. x 3.5 in. tray containing metal instruments

The "Note" section on page 6 states: "The loads used in the Sterility Validation Study corresponded to the maximum wrapped package content weights in Table 3."

Data Provenance: The document does not specify the country of origin of the data. The studies are prospective in nature, as they involve testing the device's performance under various sterilization conditions and aging.

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

This information is not explicitly provided in the document. The studies performed are laboratory-based performance tests and sterility validation studies rather than analyses requiring expert interpretation of medical images or clinical outcomes. Therefore, the "ground truth" would be established by the results of standardized biological and physical tests and measurements, often conducted by trained technicians in controlled environments.

4. Adjudication Method for the Test Set:

This information is not applicable to this type of device submission. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies among multiple human readers in diagnostic studies. Here, the "test set" refers to physical samples undergoing rigorous laboratory tests.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output, and the AI's assistance to human readers is being evaluated. The DuraBlue™ Sterilization Wrap is a sterilization packaging device, not a diagnostic tool requiring human interpretation aided by AI.

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

Not applicable in the context of an AI algorithm. The device itself is a physical product (sterilization wrap), and its performance is evaluated in a standalone manner (i.e., the wrap's ability to maintain sterility, its material properties, and compatibility with sterilization methods). There is no "algorithm" in the typical sense for this device.

7. The Type of Ground Truth Used:

The ground truth used for these studies is based on:

• Sterilization Efficacy: Demonstrated by the ability to achieve and maintain sterility, likely through biological indicator (BI) testing or other validated methods to confirm the absence of viable microorganisms.
• Microbial Barrier Properties: Assessed through aerosol challenge tests, measuring the ability of the wrap to prevent microbial ingress.
• Event-Related Shelf Life: Determined by real-time aging studies over 365 days, followed by integrity and sterility testing at various time points.
• Material Compatibility: Physical property testing (e.g., tensile strength, tear resistance) after sterilization, and chemical compatibility assessments to ensure the polypropylene material is not compromised.
• Biocompatibility: Standardized tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993 or similar standards.

Essentially, the "ground truth" is established by objective, measurable results from validated laboratory tests and standards.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical product, not an AI/ML model that requires a "training set" of data.

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

Not applicable. As there is no training set for an AI/ML model, this question does not apply.

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Cardinal Health DuraBlue™ Sterilization Wrap is intended to enclose another medical device that is to be sterilized by a health care provider using the following modalities:

• Pre-vacuum steam at 270°F/132°C for 4 minutes
• 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes

The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s). Maintenance of package sterility was validated with real-time aging testing for a duration of 180 days for each indicated modality.

For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200 and 30 minutes for Models CH300, CH400, CH500, and CH600. Models CH400, CH500, and CH600 have been validated for pre-vacuum steam sterilization of two lumens 3 mm in diameter or larger and 400 mm in length or less.

For EO sterilization, the wrap has been validated for an aeration time of 8 hours at 55℃. Models CH400, CH500, and CH600 have been validated for sterilization of two lumens of 3 mm diameter or larger and 400 mm in length or less for EO sterilization.

Cardinal Health DuraBlue™ Sterilization Wraps are double layer sterilization wraps made from 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric. They are intended to be used to enclose another medical device that is to be sterilized by a health care provider pre-vacuum steam at 270°F/132°C for 4 minutes, or 100% ethylene oxide (EO) with a concentration of 725-735 mgL at 131°F/55°C and 40%-80% relative humidity for 60 minutes. This wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically.

This submission covers six different models of Cardinal Heatth DuraBlue™ Sterilization Wrap. Each model is made from material of a different basis weight, though all models utilize the same material technology.

The provided text describes the DuraBlue™ Sterilization Wrap and its performance. Here's a breakdown of the requested information based on the document:

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

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

• Sample Size: The document does not explicitly state the numerical sample size for the "test set." Instead, it describes loads used for Sterility Validation Studies for each of the six DuraBlue™ Sterilization Wrap models (CH100-CH600) for both pre-vacuum steam and EO sterilization. These loads consist of specific quantities of huck towels, fluid-resistant drapes, fluid-resistant table covers, stacked tray liners, lumens, and metal mass. The "Note" clarifies that these loads corresponded to the maximum recommended wrapped package content weights.
• Data Provenance: The document does not specify the country of origin of the data. It states that the device is manufactured by Cardinal Health 200, LLC in McGaw Park, IL, USA. The studies are described as "Event-Related Shelf Life testing" and "Sterility Validation Studies." The study refers to "FDA's Guidance Document Premarket Notification 510(k) Submissions for Medical Sterilization Packaging System in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002)," suggesting these are prospective validation studies conducted to meet regulatory requirements. Thus, the data appears to be prospective.

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

This information is not provided in the document. The studies are described as "Sterilization Efficacy" and "Microbial Barrier Properties" testing, implying laboratory-based validation rather than expert-driven ground truth establishment.

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

This information is not provided in the document. The nature of the testing (sterilization efficacy, microbial barrier) does not typically involve adjudication by human experts in the same way imaging or clinical diagnostic studies might.

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 sterilization wrap, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

This is also not applicable. The device is a physical product (sterilization wrap) and does not involve an algorithm or AI. Its performance is evaluated through physical and microbiological testing.

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

The ground truth for the performance claims (e.g., sterilization efficacy, microbial barrier, sterility maintenance) is established through laboratory-based scientific testing and validation methodologies, often involving microbiology (e.g., spore kill, microbial challenge) and physical testing (e.g., material compatibility, aging). This is akin to a "gold standard" of direct physical and biological measurement, rather than expert consensus or pathology in a medical imaging context.

8. The sample size for the training set:

This is not applicable. As a physical product, the DuraBlue™ Sterilization Wrap does not have a "training set" in the context of machine learning or AI. Its design and material properties are based on engineering principles and prior knowledge, not iterative training on a data set.

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

This is not applicable for the same reasons mentioned in point 8.

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Cardinal Health DuraBlue™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131 F/55°Cand 40%-80% relative humidity for 60 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed devices for 30 days. The wrap has been validated for an aeration time of 8 hours at 55°C. Models CH400, CH500 and CH600 have been validated for sterilization of two lumens of 3mm diameter or larger and 400mm in length or less.

Cardinal Health DuraBlue™ Sterilization Wrap is not indicated for use with gravity steam sterilization.

Cardinal Health DuraBlue™ Sterilization Wraps are double layer sterlization wraps made from 100% polypropylene spunbond-mettblown-spunbond (SMS) fabric. Cardinal Health DuraBlue™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a heath care provider by 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterlity of the enclosed device(s) for 30 days. The wrap was validated for an aeration time for EO sterilization of 8 hours at 55°C. Models CH400, CH500 and CH600 have been validated for EO sterlization of two lumens 3 mm in diameter or larger and 400 mm in length or less. The wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterlized pack to be opened aseptically.

This submission covers six different models of Cardinal Health DuraBlue™ Sterilization Wrap. Each model is made from material of a different basis weight, though all models utilize the same material technology.

Here's a breakdown of the acceptance criteria and study information for the DuraBlue™ Sterilization Wrap, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail format for each test. Instead, it states that "Successful completion of the sterilization performance tests listed below demonstrated that the wrap both allows for sterilization of the enclosed contents and maintains sterility of the enclosed contents until opened." The reported performance is that the wrap did successfully pass these tests, demonstrating substantial equivalence to the predicate device.

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

• Sample Size: The document does not explicitly state the specific numerical sample sizes used for each test (e.g., how many wraps were tested for sterility maintenance, how many cycles for sterilization efficacy). It mentions that "Extensive performance testing has been completed" and details the specific "loads used in the validation studies" for each of the six models (CH100 to CH600). These loads represent the tested configurations for evaluating sterilization efficacy and pack integrity.
  • CH100: 16 huck towels
  • CH200: 2 huck towels, 2 fluid resistant drapes, 2.5 lbs metal mass
  • CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs metal mass
  • CH400: 4 stacked tray liners, 7.5 lbs metal mass in a tray
  • CH500: 4 stacked tray liners, 11.5 lbs metal mass in a tray
  • CH600: 4 stacked tray liners, 19.5 lbs metal mass in a tray
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It describes laboratory-based performance testing conducted to support the 510(k) submission.

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. The testing described is primarily laboratory-based performance testing of the physical properties and sterilization efficacy of the wrap itself, rather than studies requiring human expert interpretation of results (like medical imaging).

4. Adjudication Method for the Test Set:

This information is not applicable for the type of device and testing described. Adjudication methods (like 2+1 or 3+1) are typically used for studies where human experts are making judgments (e.g., diagnosing conditions from images) and their agreement needs to be resolved. The tests here involve measurable physical properties, sterility, and chemical residuals.

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 to this device. An MRMC study is relevant for diagnostic devices that are interpreted by human readers, often with or without AI assistance. The DuraBlue™ Sterilization Wrap is a medical packaging device, not a diagnostic tool, and involves no human "readers" in its performance evaluation in this context.

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

This is not applicable as the device is a physical sterilization wrap, not an algorithm or software. The performance tests are inherently "standalone" in that they evaluate the material itself and its interaction with the sterilization process, without human intervention during the actual sterilization or sterility maintenance phase.

7. The Type of Ground Truth Used:

The ground truth for the performance tests would be based on:

• Sterility Assessment: Typically involves biological indicator (BI) testing (e.g., showing inactivation of spores) and microbial challenge testing to confirm the sterilization process efficacy and the wrap's ability to maintain a sterile barrier. This is a scientific, objective measure.
• Physical Property Standards: Measurements of tear resistance, burst strength, porosity, etc., against predefined engineering specifications and industry standards.
• Chemical Analysis: Measurement of EO residuals in accordance with regulatory limits.
• Visual Inspection: For pack integrity, tears, or compromise.

Essentially, the ground truth is established through objective, standardized laboratory testing methods to demonstrate the physical, chemical, and biological performance of the wrap.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" in the context of this device. The DuraBlue™ Sterilization Wrap is a manufactured medical product that undergoes performance validation, not an artificial intelligence algorithm that requires a dataset for training.

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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These powder-free sterile light brown colored surgeon's gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Please note that the following drug has extremely low permeation time of less than 30 minutes: Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 0.20 minute.

The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using neoprene synthetic polymer and are coated with nitrile coating. The gloves are manufactured using exact same material used in the currently cleared device, Duraprene SMT gloves, that have been legally marketed by Cardinal Health under K102500. The gloves are manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. They are light brown in color and are offered powder-free and sterile.

The acceptance criteria and device performance are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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 mentioned (e.g., number of gloves tested for permeation, number of animals for biocompatibility). The testing was conducted according to established international and national standards (ISO 10993-10, ASTM D3577, ASTM D6124, ASTM D6978, 21 CFR 800.20). These standards typically specify the required sample sizes for such tests to ensure statistical validity. The data provenance is not specified in terms of country of origin, but it is implied to be from testing labs adhering to these standards, likely in association with Cardinal Health for regulatory submission in the USA. The data would be prospective, as it was generated specifically for this 510(k) submission.

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

This device is a medical glove, a physical product, and the "ground truth" for its performance is established through objective laboratory testing against material and safety standards, not through expert consensus on interpretation of data like in an imaging study. Therefore, the concept of "experts used to establish ground truth" in the way it applies to diagnostic AI is not relevant here. The ground truth is defined by the technical specifications and performance limits set by the referenced ASTM and ISO standards and FDA regulations. The "experts" in this context would be the qualified laboratory personnel conducting the tests and the regulatory bodies defining these standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, performance is measured against objective standards, not through subjective human interpretation 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 typically used for diagnostic devices where human readers interpret images or other data, and the AI's impact on their performance is being evaluated. This document pertains to a medical glove, where performance is assessed through physical and chemical testing.

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

Yes, a standalone performance assessment was done. The device performance (e.g., physical properties, biocompatibility, chemotherapy drug permeation) was evaluated independently through laboratory testing, without a "human-in-the-loop" component in the sense of a diagnostic interpretation task. The "algorithm" here is the glove itself, and its performance is measured directly against predefined criteria.

7. The Type of Ground Truth Used

The ground truth used is based on objective measurements and predefined standards (ASTM D3577, ASTM D6978, ISO 10993-10, 21 CFR 800.20). For example:

• Physical properties: Measured values (e.g., dimensions, tensile strength) compared against specified limits in ASTM D3577.
• Freedom from holes: Determined by a water leak test (ASTM D5151) and assessed against AQL (Acceptable Quality Level) requirements as per 21 CFR 800.20 and ASTM D3577.
• Powder residual: Quantitative measurement of powder per glove (ASTM D6124) compared against the < 2.0 mg/glove requirement for "powder-free."
• Chemotherapy drug permeation: Measured breakthrough detection time of specific chemotherapy drugs compared against a standard detection limit (0.01 µg/cm²/minute) over a specified testing period (up to 240 minutes) detailed in ASTM D6978 for each drug.
• Biocompatibility: Results from established biological evaluation tests (e.g., primary skin irritation, guinea pig maximization) against criteria in ISO 10993-10.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not a software algorithm that requires a "training set" in the context of machine learning.

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

Not applicable. As above, this is a physical medical device, not an AI/ML algorithm requiring a training set.

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This powder-free surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device is a disposable device intended for over the counter use and is provided sterile. It is not made with natural rubber latex. Instead, it is formulated from polyisoprene, which is synthetic rubber latex. This sterile polyisoprene powder-free surgical glove is manufactured using exact same material used in the currently cleared device, Esteem Blue glove (K042574) that has been legally marketed by Cardinal Health for many years. The glove is coated with emollient coating containing Glycerol, Gluconolactone, D-Sorbitol and Provitamin-B. The glove is manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. It is offered powder-free and sterile.

This document describes the regulatory submission for Sterile Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera® Coating (hereinafter referred to as "the device"). The submission is a 510(k) premarket notification, indicating that the device is a modification of a currently marketed device (Esteem® Blue Sterile Polyisoprene Powder-Free Surgical Gloves with Neu-Thera Coating, cleared under 510(k) K042574).

The document is a summary of safety and effectiveness, focusing heavily on comparative performance data with a predicate device rather than a comprehensive new device study. Therefore, many of the typical elements of an AI/ML device acceptance criteria and study are not applicable in this context.

Here's an analysis based on the provided text, addressing the points you requested:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device (surgical gloves), the "acceptance criteria" are based on meeting established industry standards (ASTM and ISO) and regulatory requirements (21 CFR). The "performance" is demonstrated by showing that the new device meets these standards and is comparable to the predicate device.

Comparative Performance Summary (New Device vs. Predicate Device)

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

The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for Freedom from Holes). However, it implies that standard methodologies prescribed by ASTM and ISO were followed for each test, which would inherently include appropriate sample size requirements for those standards.

• Data Provenance: The tests are non-clinical (laboratory/bench testing) performed on the manufactured gloves. There is no information regarding the country of origin of the data beyond the applicant's location (McGaw Park, IL, USA). The data is generated prospectively as part of the manufacturing and quality control process for the device submission.

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

This is not applicable to this type of device. The "ground truth" for surgical gloves is established by objective engineering and material science standards (e.g., tensile strength, tear resistance, barrier integrity, biocompatibility as per ISO/ASTM standards), not by human expert opinion or interpretation like in an AI/ML diagnostic device.

4. Adjudication Method for the Test Set

This is not applicable. As the tests are objective, physical, and chemical measurements against defined standards, there is no need for expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This submission is for a physical medical device (surgical gloves), not an AI/ML diagnostic or assistive device for human readers. There are no "human readers" in the context of this device's function.

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

This is not applicable. There is no algorithm or AI component in this device. Performance is assessed through physical, chemical, and biological testing of the material and finished product.

7. The Type of Ground Truth Used

The "ground truth" (or basis for compliance) for this device is based on:

• Industry Standards: Compliance with established ASTM (American Society for Testing and Materials) standards (e.g., D3577 for rubber surgical gloves, D6124 for residual powder) and ISO (International Organization for Standardization) standards (e.g., 10993-1, 10993-10 for biocompatibility).
• Regulatory Requirements: Meeting specifications outlined in 21 CFR (e.g., 800.20 for Freedom from Holes).

These standards define the acceptable physical properties, chemical composition, and biological safety for surgical gloves.

8. The Sample Size for the Training Set

This is not applicable. 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 is not applicable. There is no "training set" or need for establishing a ground truth for it.

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