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KIMGUARD* Smart Fold* Sterilization Wrap (KC450 and KC650) is intended to enclose another medical device that is to be sterilized by a healthcare provider using:

• Advanced Sterilization Products' STERRAD® Sterilization Systems that include:
  • STERRAD® 100S o
  • STERRAD® NX® [Standard Cycle, Advanced Cycle] O
  • STERRAD® 100NX®). [Standard Cycle, Flex Cycle, EXPRESS cycle, DUO Cycle] C

KIMGUARD* Smart Fold* Sterilization Wraps (KC450 are intended to allow sterlization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

KIMGUARD* Smart Fold* Sterilization Wrap is comprised of two pre-shaped sheets of KIMGUARD Sterilization Wrap (blue base sheet and white intermediate sheet), which include reinforcement strips, and adhesively seamed on three edges to allow convenient wrapping with two sheets (i.e., white and blue) simultaneously. The fabric is a nonwoven spunbondmeltblown-spunbond (SMS) composite sheet manufactured with polypropylene with less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of a potassium phosphate anti-static treatment. Two strips of blue SMS are adhesively bonded to the white SMS intermediate layer for added strength. These reinforcement strips also function as a "reference line" to indicate proper sterilization tray placement by the user. The Smart-Fold wrap also incorporates pull tabs comprised of blue SMS material for convenient aseptic opening of wrapped packages.

The provided document is a 510(k) premarket notification for the KIMGUARD* Smart-Fold* Sterilization Wrap (Models KC450 and KC650). It describes the device's indications for use, comparison to predicate devices, and a summary of nonclinical tests performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it lists "Performance Requirements" and indicates "Passed" for each. The acceptance criterion implicitly seems to be "meeting the performance requirements" or demonstrating that the wrap "maintains sterility until used, after completion of the sterilization processes provided by the STERRAD® Sterilization Systems." The specific quantitative thresholds for these "passed" results are not detailed in this summary.

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

The document does not specify the exact sample size for the test set used in the nonclinical tests. For example, it doesn't state how many wraps were tested for "STERRAD Sterilant Penetration" or "Maintenance of Package Integrity."

The data provenance is not explicitly stated. The tests were performed as part of a 510(k) submission to the FDA, suggesting they were conducted by the manufacturer (Kimberly-Clark Health Care, later Halyard Health) to demonstrate device performance. It is implied to be prospective testing specifically for this submission, rather than retrospective data analysis from external sources. No information about country of origin of the data beyond the manufacturer's location (Roswell, GA) is provided.

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

This type of information is generally not applicable to a device like a sterilization wrap. The "ground truth" for a sterilization wrap is typically established through objective laboratory testing according to established standards (e.g., ISO, ASTM, or specific sterilization system validation protocols) rather than expert interpretation of images or clinical assessment. Therefore, there's no mention of experts establishing ground truth in this context.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective human assessment, such as in clinical trials or image interpretation studies where multiple readers agree on a diagnosis. This is not relevant for the performance testing of a sterilization wrap, which relies on objective measurements and tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are used to evaluate the performance of diagnostic devices often involving human readers interpreting images or data, with or without AI assistance. This device is a physical medical device (sterilization wrap) rather than a diagnostic tool, so such a study is not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This question is not applicable to the device under review. The KIMGUARD* Smart-Fold* Sterilization Wrap is a physical product, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. Type of Ground Truth Used

The "ground truth" for the performance tests appears to be established through:

• Objective laboratory testing and controlled experiments: For STERRAD Sterilant Penetration, this would involve measuring the presence or absence of sterilant penetration.
• Adherence to relevant ISO standards for biocompatibility: For Material Compatibility/Biocompatibility, this refers to ISO 10993-5:2009 (Cytotoxicity) and ISO 10993-10:2010 (Dermal Irritation).
• Functional testing: For Material Usability post-sterilization, this would likely involve evaluating the physical properties and integrity of the wrap after sterilization.
• Time-based integrity testing: For Maintenance of Package Integrity (180 Days), this involves evaluating the barrier properties and physical integrity of the package over an extended period.

The ground truth is based on the outcomes of these standardized and objective tests, rather than expert consensus, pathology, or clinical outcomes data in the way these terms are typically used for diagnostic or therapeutic devices.

8. Sample Size for the Training Set

This information is not applicable. As stated previously, this device is a physical medical product, not an AI/ML algorithm that requires a 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 a physical medical device like a sterilization wrap.

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Kimberly-Clark* U by Kotex® Security® is an unscented menstrual tampon inserted into the vagina to absorb menstrual fluid.

This device is a conventional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord and an applicator. The absorbent pledget consists of a ribbon of rayon fibers and cotton, overwrapped with a non-woven fabric. A withdrawal cord is placed through the pledget and knotted. The tampon pledget is compressed. The formed pledget is inserted into a two-piece plastic applicator consisting of an inner tube (plunger), and an outer insertion tube (barrel) with flexible petals that form a closed, rounded tip. Each tampon is individually wrapped in a plastic film wrapper and multiple tampons are packaged in sealed cartons for commercial sale. Tampons are available in Regular, Super and Super Plus absorbencies in various counts.

This document describes a 510(k) premarket notification for Kimberly-Clark U by Kotex® Security® Unscented Menstrual Tampons*. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices.

The information provided focuses on the biocompatibility and absorbency of the device. It does not describe an AI medical device or a clinical study with human readers. Therefore, several sections of your request are not applicable to this document.

Here's the breakdown of the available information:

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 for the specific biocompatibility tests. It mentions that "Testing from the reference device, U by Kotex® Sleek® K112635, was used to support the safety of new applicator colors." This indicates that some of the test data was retrospective, drawn from a previously approved device. The country of origin for the data is not specified, but the submission is to the U.S. FDA.

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

Not applicable. This document is for a medical device (menstrual tampon), not an AI device relying on expert-established ground truth from images or clinical assessments. The "ground truth" here is the physical and chemical properties of the materials and the absorbency performance as measured by standardized tests.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or adjudication of results. The results are objective measurements against established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI medical device and therefore no MRMC study comparing human readers with and without AI assistance was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not an AI medical device.

7. Type of Ground Truth Used

The ground truth used for this device's performance evaluation includes:

• Standardized Biocompatibility Test Results: Based on ISO 10993 series and USP 661, these are objective laboratory measurements of material properties and their biological interactions.
• Syngyna Absorbency Requirements: A regulatory standard (21 CFR §801.430) for measuring absorbency, representing a controlled, objective test.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for this device would be its manufacturing process and quality control.

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

Not applicable for the same reason as above.

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The Kimberly-Clark KC300 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(s), provided non-sterile.

The Kimberly-Clark* KC 300 Face Mask is a four layer mask, constructed of polyester and polypropylene materials. The outer facing layer is currently made of polypropylene spunbond fabric. With the proposed change, the outer facing layer will be made of polyethylene/polyester material used in a predicate device. The inner facing layer is currently made of polyester cellulose. With the proposed change, the inner facing layer will also be made of polyethylene/polyester material used in a predicate device. Kimberly-Clark KC300 Face Mask(s) is a single use, disposable device, provided nonsterile.

The Kimberly-Clark KC300 Face Mask is a surgical mask that was tested against several ASTM standards and military specifications to ensure its safety and effectiveness.

1. Acceptance Criteria and Reported Device Performance:

The device's performance was evaluated against the following criteria, and all reported results met these criteria:

2. Sample Size and Data Provenance:

The document does not specify the exact sample sizes used for each test. The tests were performed according to established ASTM standards (ASTM F2100-11, ASTM F1862-07, ASTM F2101-07, ASTM F2299-03), military specifications (MIL-M369454C), and ISO 10993 standards. These are standard laboratory tests for medical devices, implying the data is likely from prospective testing conducted on device samples. The country of origin of the data is not explicitly stated but is implicitly within the regulatory framework for FDA submission in the USA.

3. Number of Experts and Qualifications for Ground Truth:

This section is not applicable. The device is a surgical mask, and its performance is evaluated through objective, standardized laboratory tests rather than through expert review of clinical cases or images.

4. Adjudication Method for the Test Set:

This section is not applicable. Adjudication methods like 2+1 or 3+1 consensus are used in studies involving subjective interpretation (e.g., image reading by multiple experts). The performance of a surgical mask is determined by quantifiable physical and biological tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This section is not applicable. MRMC studies evaluate human reader performance, often with and without AI assistance, especially in diagnostic imaging. The KC300 Face Mask is a physical device, and its effectiveness is measured through laboratory tests, not human interpretation.

6. Standalone Performance (Algorithm Only):

This section is not applicable. A surgical mask is a physical device, not an algorithm. Therefore, "standalone" performance in the context of algorithms does not apply.

7. Type of Ground Truth Used:

The ground truth for this device is based on objective, standardized laboratory test results that conform to recognized industry standards (ASTM, MIL-SPEC, ISO). These standards define specific measurable criteria for attributes like filtration efficiency, fluid resistance, flammability, and biocompatibility.

8. Sample Size for the Training Set:

This section is not applicable. Surgical masks are physical devices, and their performance is evaluated directly through testing, not through a "training set" in the context of machine learning. The term "training set" is relevant for AI algorithms.

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

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

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KIMBERLY-CLARK LAVENDER NITRILE Powder-Free Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile, powder-free, textured-fingertip, ambidextrous patient examination glove with a polymer coating on the donning surface without chlorination.

The document describes the Kimberly-Clark LAVENDER NITRILE Powder-Free Exam Gloves, which is a Class I medical device. The submission is a 510(k) premarket notification, indicating that the device is seeking to demonstrate substantial equivalence to existing legally marketed predicate devices rather than proving novel safety and efficacy.

Here's an analysis of the provided information regarding acceptance criteria and the study:

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 (bench testing and animal-based biocompatibility studies) for the Kimberly-Clark LAVENDER* NITRILE Powder-Free Exam Gloves. It does not provide specific sample sizes for these tests, nor does it detail the provenance of the data in terms of geographical origin or retrospective/prospective nature. However, for bench testing of medical gloves, these tests typically involve a defined number of gloves per batch or lot to ensure statistical significance, and ISO 10993 standards for biocompatibility also outline testing parameters.

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

Since this involves laboratory and animal-based testing for a Class I general purpose exam glove, the concept of "experts" establishing ground truth in the way it's used for AI/diagnostic devices (e.g., radiologists, pathologists) is not directly applicable. The "ground truth" for these tests is established by adhering to the methodologies and pass/fail criteria defined in the referenced ASTM and ISO standards, which are developed by expert committees in their respective fields (e.g., materials science, toxicology). The individuals conducting these tests would be trained laboratory personnel.

4. Adjudication Method for the Test Set:

Not applicable in the context of bench and animal-based biocompatibility testing for an exam glove. The results are typically quantitative measurements or observations against predefined pass/fail criteria within the standards.

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

No. This type of study is specifically relevant for diagnostic devices that involve human interpretation of medical images or data, often comparing AI-assisted performance to unassisted human performance. This is not applicable to an exam glove.

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

No. This concept is for AI/software devices. The Kimberly-Clark LAVENDER* NITRILE Powder-Free Exam Gloves are a physical medical device. The "performance" described here relates to the physical and chemical properties of the glove itself.

7. The Type of Ground Truth Used:

The ground truth for the device's performance is based on the objective measurements and observations derived from standardized test methods (ASTM D6319, ASTM D5151, ASTM D6124) for physical properties and freedom from pinholes, and results from animal-based biocompatibility studies (ISO 10993 Parts 1, 10) for skin irritation, sensitization, and systemic toxicity. These standards define the expected performance and safety profile for medical examination gloves.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable, as there is no training set for this device.

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KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes are indicated for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.

KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes are available in adult sizes 7.0, 7.5, 8.0, 8.5 and 9.0mm with a Murphy Eve. They include a separate lumen with a dorsal opening above the cuff to provide access to the subglottic space. The subglottic space is reached via a normally open suction valve which includes a one-way port for rinsing the subglottic space with sterile saline (0.9% Sodium Chloride solution) or administering an air bolus to assist in maintaining a patent suction lumen patency. These devices are sold as disposable, sterile, single use, devices.

The provided text describes a 510(k) premarket notification for a modification to an existing medical device, the Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes. This is not a study proving device meets acceptance criteria in the sense of a new AI/software medical device.

The original device (K120985) was already cleared, and this submission (K131254) is for a "Special 510(k): Device Modification" where the only change is the raw material used to bond the cuff to the endotracheal tube. Therefore, the "acceptance criteria" and "study" are focused on demonstrating that this change does not negatively impact the safety and effectiveness, and that the modified device remains substantially equivalent to the predicate.

Here's an analysis based on the provided text, structured to answer your questions where applicable, and noting where the information is not relevant to this type of submission (e.g., AI/software specific criteria):

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance Description of How Met |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Functional Performance | Suctioning Efficiency | Confirmed efficient suctioning. | Bench-top performance testing was conducted to confirm suctioning efficiency. |
| | ISO 5361:1999 (Anesthetic and respiratory equipment Tracheal tubes and connectors) | Conformance to standard. | Additional bench-top testing was conducted to assure conformance to this standard. |
| Biocompatibility | ANSI/AAMI/ISO 10993-3: 2003 (Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity) | Conformance to standard. | Biocompatibility testing was conducted to assure conformance to this standard. |
| | ANSI/AAMI/ISO 10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity) | Conformance to standard. | Biocompatibility testing was conducted to assure conformance to this standard. |
| | ANSI/AAMI/ISO 10993-6, 2007 (Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects After Implantation) | Conformance to standard. | Biocompatibility testing was conducted to assure conformance to this standard. |
| | ANSI/AAMI/ISO 10993-10: 2010 (Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization) | Conformance to standard. | Biocompatibility testing was conducted to assure conformance to this standard. |
| Overall Conclusion | Demonstrating no concerns of safety or effectiveness for the modified device and substantial equivalence to the predicate. | "All results of testing met acceptance criteria and demonstrate no concerns of safety or effectiveness for the modified device." "Test results confirm that the device is as safe and effective and performs as well as or better than the predicate device." | Based on bench-top and biocompatibility testing against relevant standards. |

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

This is not a study involving a "test set" in the context of an AI/software medical device. The "testing" refers to standard medical device verification and validation activities (bench-top and biocompatibility testing) on the physical device. The exact sample sizes for these tests are not provided in the summary, but they would be determined by the requirements of the specific ISO/ANSI/AAMI standards referenced. Data provenance is not applicable as this is not a data-driven AI study.

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

Not applicable. There is no "ground truth" establishment by experts in the context of an AI/software algorithm for this physical device modification. The "ground truth" for device performance is based on meeting the specifications of the referenced standards and internal engineering requirements.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication for this type of physical device 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

Not applicable. This is not an AI-assisted device. No MRMC study was conducted.

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

Not applicable. This is not an AI/software algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established performance requirements and safety profiles defined by:

• International Standards: ISO 5361:1999 (functional), ANSI/AAMI/ISO 10993 series (biocompatibility).
• Predicate Device Performance: The modified device must perform "as well as or better than" the predicate device (K120985).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no training set.

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

Not applicable. There is no training set. The "ground truth" for the overall device acceptability is based on compliance with established medical device standards and demonstrating substantial equivalence to the predicate device through bench-top and biocompatibility testing.

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KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes are indicated for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.

KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes are available in adult sizes 7.0, 7.5, 8.0, 8.5, and 9.0mm with a Murphy Eye. They include a separate lumen with a dorsal opening above the cuff to provide access to the subglottic space. The subglottic space is accessed via a normally open suction valve that includes a one-way port for rinsing the subglottic space with sterile saline (0.9% Sodium Chloride solution) or administering an air bolus to assist in maintaining a patent suction lumen patency. These devices are sold as disposable, sterile, single-use, devices.

The Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes were studied to confirm suctioning efficiency and adherence to various standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• The document describes "bench-top performance testing," "biocompatibility testing," and "sterilization validation." It specifies that bench-top testing was conducted to confirm suctioning efficiency and conformance to ISO standards. Biocompatibility testing was conducted to assure conformance to ISO 10993 series standards. Sterilization validation was done according to ISO 10993-7, ISO 11135-1, and ISO 11607-1.
• The specific sample sizes for each type of test or the provenance of any data (e.g., country of origin, retrospective/prospective) are not detailed in the provided text. The testing appears to be primarily laboratory/pre-clinical in nature for device performance and safety, rather than clinical data from human subjects.

3. Number and Qualifications of Experts for Ground Truth

• This information is not provided in the document. The studies mentioned are primarily engineering/bench-top performance, biocompatibility, and sterilization validation, which typically rely on standardized tests and measurements rather than expert human interpretation for establishing ground truth in the way a diagnostic AI system would.

4. Adjudication Method for Test Set

• This information is not applicable or provided. The described studies are not based on human-interpreted "test sets" requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not conducted or described for this device. This device is an endotracheal tube, not an AI-assisted diagnostic tool for which human reader improvement would be measured.

6. Standalone Performance Study

• The studies described are for the "standalone" performance of the device itself as a medical product (endotracheal tube), evaluating its physical properties, biological safety, and sterilization effectiveness. It is not an algorithm, so "standalone" in the context of AI performance (algorithm without human-in-the-loop) is not applicable here. The device's performance was evaluated inherently without human intervention beyond conducting the tests.

7. Type of Ground Truth Used

• The ground truth used for these studies is based on:
  • Defined performance specifications: For suctioning efficiency.
  • International and national standards: ISO and ANSI/AAMI/ISO standards for physical properties, biocompatibility, and sterilization.
  • Laboratory measurements and assays: To demonstrate conformance to these standards (e.g., cytotoxicity tests, irritation tests, ethylene oxide residual measurements).

8. Sample Size for Training Set

• The concept of a "training set" is not applicable here. This is a physical medical device (endotracheal tube), not a software algorithm that undergoes machine learning training.

9. How Ground Truth for Training Set Was Established

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

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KIMGUARD ONE-STEP* Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 270°F/132°C for 4 minutes or 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. KIMGUARD ONE-STEP* Sterilization Wrap is also intended to be used in the Amsco® V-PRO™ 1 Low Temperature Sterilization System's cycle, the Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PROTM 1 Cvcle) and Non Lumen Cycles, and the V-PRO™ Low Temperature Sterilization System's Flexible Cycle. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened within the period of time for which performance data demonstrating maintenance of sterility has been provided. The wrap was validated for aeration times for EO sterilization of 8 hours at 55 °C or 12 hours at 43.3 °C. The KIMGUARD ONE-STEP* Sterilization Wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100 and 200, and for 30 minutes for Models 300, 400, 500, and 600. The KIMGUARD ONE-STEP* Sterilization Wrap was validated to be effectively aerated during the pre-programmed V-PRO™, the V-PRO™ 1 Plus, and the V-PRO™ Flexible Sterilization Cycles.

KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization.

KIMGUARD ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap ultrasonically seamed on two sides. This allows for convenient wrapping with two sheets simultaneously. The sheets of sterilization wrap are square or rectanqular fabric produced usinq a polypropylene three-layer SMS (spunbond-meltblown-spunbond) process.

The KIMGUARD ONE-STEP* Sterilization Wrap is intended to maintain the sterility of enclosed medical devices until opened, after being sterilized by prevacuum steam, 100% ethylene oxide (EO), or specific Amsco® V-PRO™ Low Temperature Sterilization System cycles.

Here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the KIMGUARD ONE-STEP* Sterilization Wrap are related to its ability to maintain sterility after various sterilization methods for specified durations. The reported device performance indicates that the wraps meet these criteria.

Note regarding other criteria: The document also mentions other validated parameters, which, while not presented in a table format with specific acceptance criteria and performance data like sterility maintenance, were assessed for the device. These include:

• Aeration times for EO sterilization: 8 hours at 55 °C or 12 hours at 43.3 °C.
• Dry times for pre-vacuum steam sterilization: 20 minutes for Models 100 and 200; 30 minutes for Models 300, 400, 500, and 600.
• Effective aeration during V-PRO™, V-PROTM 1 Plus, and V-PROTM Flexible Sterilization Cycles.
• Biocompatibility (irritation and sensitization) in compliance with ISO 10993.
• Sterilant penetration characteristics.
• Physical integrity.

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

The document provides specific details for the maximum wrapped package content weights and descriptions of loads used in the sterility maintenance validation studies for each wrap model and sterilization cycle. These descriptions indicate the specific items (e.g., huck towels, fluid-resistant drapes, metal mass) and their quantities/weights that constituted the 'samples' or 'test sets' used for validating sterility maintenance.

• Pre-Vacuum Steam and Ethylene Oxide Sterilization Cycles (Table 1):

  • KC100 (3 lbs): 16 huck towels (17"x 29")
  • KC200 (6 lbs): 2 huck towels (17"x 29"), 2 fluid resistant U-drape (68"x109"), 1 fluid resistant universal bar drape (70" x 108")
  • KC300 (9 lbs):
    • Pre-Vacuum Steam: 15 huck towels (17"x 29"), 1 small fluid resistant drape (60"x 76"), 5 lbs of metal mass
    • EO: 16 huck towels, 2 fluid resistant large drapes (76"x100"), 1 fluid resistant small drape (76"x60"), 1 fluid resistant table cover (60"x 90")
  • KC400 (13 lbs): 4 tray liners 20" x 25" stacked, 10" x 10" x 3 ½ " tray containing 11 lbs of metal mass
  • KC500 (17 lbs): 4 tray liners 20" x 25" stacked, 10" x 10" x 3 ½ " tray containing 15 lbs of metal mass
  • KC600 (25 lbs): 4 tray liners 20" x 25" stacked, 10" x 10" x 3 ½ " tray containing 23 lbs of metal mass

• Amsco V-PRO™ Low Temperature Sterilization System (Table 2):

  • KC100 (3 lbs): 3 lbs metal mass, 6 forceps
  • KC200 (6.5 lbs): 2.5 lbs metal mass, 6 forceps, V-PRO tray (17" x 10" x 3½") at 4 lbs
  • KC300 (9 lbs): 5 lbs metal mass, 6 forceps, V-PRO tray (17" x 10" x 3½") at 4 lbs
  • KC400 (10 lbs): 6 lbs metal mass, 6 forceps, V-PRO tray (17" x 10" x 3½") at 4 lbs
  • KC500 (10 lbs): 5 lbs metal mass, 6 forceps, V-PRO tray (21" x 10" x 3½") at 5 lbs
  • KC600 (10 lbs): 5 lbs metal mass, 6 forceps, V-PRO tray (21" x 10" x 3½") at 5 lbs

The document does not specify the exact number of replicates (i.e., how many times each load/wrap combination was tested) within these studies. The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a country of origin, but it is part of a 510(k) submission to the US FDA, implying the studies were conducted to meet US regulatory requirements.

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. For sterility maintenance studies of this nature, the "ground truth" is typically established through microbiological culture methods to detect microbial ingress, rather than expert interpretation of images or other subjective assessments.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method, as the sterility maintenance testing would involve objective laboratory assessments (e.g., growth or no-growth in culture media) rather than subjective expert review needing 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. The device is a sterilization wrap, not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI assistance are irrelevant to its evaluation.

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

This is not applicable for the same reasons as #5. The device is a physical product, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for sterility maintenance testing would be based on microbiological assay results (i.e., sterility testing). If a wrapped package is challenged and subsequently tested for the presence of viable microorganisms, the absence of growth would indicate sterility was maintained. This is a direct, objective measure of the device's primary function in this context. Other aspects like biocompatibility (ISO 10993) would use endpoints specified by that standard.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product and does not involve AI or machine learning models that require a "training set."

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

This is not applicable for the same reasons as #8.

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A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05:

Bleomycin sulfate (15 mg/ml), Busulfan (6 mg/ml), Carboplatin (10 mg/ml), Cisplatin (1.0 mg/ml), Cyclophosphamide (20.0 mg/ml), Cytarabine HCl (100 mg/ml), Dacarbazine (10 mg/ml), Daunorubicin HCl (5.0 mg/ml), Docetaxel (10.0 mg/ml), Doxorubicin HCl (2.0 mg/ml), Epirubicin (Ellence) (2 mg/ml), Etoposide (20.0 mg/ml), Fludarabine (25 mg/ml), Fluorouracil (50.0 mg/ml), Gemcitabine HCl (38.0mg/ml), Idarubicin HCl (1.0mg/ml), Ifosfamide (50.0 mg/ml), Irinotecan HCl (20.0 mg/ml), Mechlorethamine HCl (1.0 mg/ml), Melphalan (5 mg/ml), Methotrexate (25 mg/ml), Mitomycin-C (0.5 mg/ml), Mitoxantrone (2.0 mg/ml), Paclitaxel (6.0 mg/ml), Rituximab (10 mg/ml), ThioTEPA (10.0 mg/ml), Trisenox (0.1 mg/ml), Vincristine Sulfate (1.0 mg/ml)

The following drugs had NO breakthrough detected up to 240 minutes:

Please note that the following drug has low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 30.7 minutes

Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves are 9.5-inch long, non-sterile, purplecolored nitrile, powder-free, ambidextrous patient examination glove that meets the specifications of ASTM D 6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.

Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves are 12-inch long, non-sterile, purplecolored nitrile, powder-free, ambidextrous patient examination glove that meets the specifications of ASTM D 6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.

Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves are 12-inch long, non-sterile, purplecolored nitrile, powder-free, ambidextrous patient examination glove that meets the specifications of ASTM D 6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. In addition these gloves were tested for use with the drugs listed in the Intended Use(s) section below, per ASTM D6978-05 "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."

These gloves meet the 2008 Glove Guidance Manual recommended minimum thickness and length specifications for gloves tested for use with chemotherapy drugs.

The provided 510(k) summary (K113423) describes the non-clinical testing performed for Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (9.5" Length), Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (12" Length), and Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (12") Tested for Use with Chemotherapy Drugs. As these are patient examination gloves, the evaluation focuses on their physical properties, safety, and, for one specific type, resistance to chemotherapy drugs, rather than AI/ML performance. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, human-in-the-loop performance, expert qualifications for ground truth, and training set information) are not applicable.

Here's an analysis of the acceptance criteria and study findings based on the provided document:

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 (e.g., number of gloves tested for dimensions, pinholes, etc.). It generally states that testing was conducted according to the referenced ASTM and ISO standards. These standards typically define sampling plans.

The data provenance is from non-clinical laboratory testing conducted by Kimberly-Clark Corporation, likely within the United States (as the applicant is based in Roswell, GA, and submitted to the U.S. FDA). The studies are prospective in the sense that the testing was performed specifically to evaluate the performance of these new glove models against established standards.

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

Not applicable for this type of device. The "ground truth" for glove performance is established by the specified ASTM and ISO standards, which dictate methodologies and acceptable limits for physical and chemical properties. Human experts are involved in conducting these standardized tests and interpreting results against predefined criteria, but not in a "ground truth" sense as understood in AI/ML validation.

4. Adjudication Method for the Test Set

Not applicable. The performance is measured against objective, standardized laboratory test methods, not subjective human assessments 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 device is a medical glove, not an AI/ML-powered diagnostic or assistive tool.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for the performance of these gloves is defined by established consensus standards (ASTM D 6319-10, ASTM D 5151-06, ASTM D 6124-06, ISO 10993 Parts 10 & 11, ASTM D 6978-05, ASTM F 739-07, and the 2008 FDA Glove Guidance Manual). These standards specify the methods and acceptable performance limits for various physical, chemical, and biological properties of examination gloves. For the chemotherapy-tested gloves, the specific breakthrough times for various drugs further contribute to the performance "ground truth."

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML model involved; therefore, no training set.

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

Not applicable, as there is no AI/ML model or training set.

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KimGuard Smart-Fold* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by prevacuum steam at 270°F/132°C for 4 minutes or 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 also to maintain sterility of the enclosed device(s) until opened. The wrap was validated for aeration times for EO sterilization of 8 hours at 131°F/ 55°C or 12 hours at 110°F/ 43.3°C. The KimGuard Smart-Fold* Sterilization Wrap was validated for dry times for prevacuum steam sterilization of 20 minutes for Model KC250 and for dry times of 30 minutes for Models KC450, KC550 and KC650.

KimGuard Smart-Fold* Sterilization Wrap is comprised primarily of two pieces of KimGuard Sterilization Wrap fabric (the blue base layer and the white intermediate layer). The fabric is a nonwoven spunbondmeltblown-spunbond (SMS) fabric composed of a top (inner) layer of spunbond, a center laver of meltblown, and a bottom (outer) layer of spunbond. SMS nonwoven fabrics are composed of polypropylene and white titanium dioxide and phthalocyanine blue pigments. Two strips of blue SMS are adhesively bonded to the white SMS intermediate layer for added strength. The reinforcement strips also contain a "reference line" feature designed to indicate proper sterilization tray placement to the user. Adhesive tape strips with release liners are included to secure the inner layers of the package. Users remove the release liners and use these adhesive strips to secure the wrap prior to sterilization. The Smart-Fold product also incorporates handles and pulls tabs comprised of blue SMS material and adhesive branding labels for aseptic opening.

Here's an analysis of the provided text regarding the KimGuard Smart-Fold Sterilization Wrap, broken down by your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria alongside reported numerical device performance results for direct comparison. Instead, it states that "All test results met acceptance criteria." The acceptance criteria mentioned are qualitative and relate to the successful fulfillment of certain functional and safety requirements.

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

• Test Set Sample Size: The document does not specify an exact numerical sample size for each test conducted. It describes the "Maximum Wrapped Package Content Weights Used in Sterility Maintenance Validation Study" and "Descriptions of Loads Used in Sterility Maintenance Validation Study" for each wrap model, which indicate the types and maximum weights of items tested within the wraps.
  • KC250: 6 lbs. (e.g., 2 huck towels, 2 fluid-resistant U-drapes, 1 fluid-resistant universal bar drape)
  • KC450: 13 lbs. (e.g., 4 tray liners, 10x10x3.5 inch tray with 11 lbs. metal mass)
  • KC550: 17 lbs. (e.g., 4 tray liners, 10x10x3.5 inch tray with 15 lbs. metal mass)
  • KC650: 25 lbs. (e.g., 4 tray liners, 10x10x3.5 inch tray with 23 lbs. metal mass)
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to testing conducted "in compliance with the applicable requirements recommended in Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002)," suggesting it was conducted specifically for this submission, implying a prospective study design for regulatory approval.

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 focuses on the physical and functional performance of the sterilization wrap itself, rather than diagnostic interpretation requiring expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided, as the tests described are objective measures of device performance (e.g., sterility maintenance, dry time, physical integrity) rather than subjective assessments that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a sterile barrier system, not a diagnostic imaging or screening tool that would involve human readers interpreting cases with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

Not applicable. This device is a physical product (sterilization wrap) and does not involve an algorithm. The performance described is its standalone function in maintaining sterility and allowing sterilization.

7. The Type of Ground Truth Used

The ground truth used for this device's testing is based on:

• Objective measurements of sterility: Demonstrated by the ability to prevent microbial ingress and maintain a sterile environment for a specified duration (up to 30 days).
• Physical and material property evaluations: Ensuring the wrap retains its integrity, permits sterilant penetration, and has appropriate dry/aeration times.
• Biocompatibility testing: Ensuring the materials are safe for patient contact.

These are established through standardized laboratory and performance testing methods relevant to sterilization wraps.

8. Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve machine learning or AI, and therefore no "training set" is used.

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

Not applicable, as no training set or machine learning algorithm is involved for this device.

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Kimberly-Clark* U by KOTEX Sleek* is an unscented menstrual tampon inserted into the vagina to absorb menstrual fluid.

This device is a conventional unscented menstrual tampon consisting of an absorbent pledget, overwrap, a withdrawal cord and an applicator. The terminology used in describing the device in rest of the 510(k) submission is as follows; Complete device: U by KOTEX Sleek* Unscented Menstrual Tampons with applicator Tampon component: Absorbent pledget, overwrap and a withdrawal cord. Applicator: Inner plunger tube and an outer insertion tube (barrel) formed with a closed, rounded tip with a unique textured grip. The absorbent pledget consists of a ribbon of rayon fibers. A rayon-polyester blend withdrawal cord is placed on the ribbon and the ribbon is radially wound, then compressed into a traditional eight-groove bullet-shaped pledget, overwrapped with a non-woven fabric. The withdrawal string will be available in pink and white colors. The tampon component is inserted into a two-piece plastic applicator consisting of an inner plunger tube and an outer insertion tube (barrel) formed with a closed, rounded tip. Each tampon with applicator is wrapped in an individual plastic film wrapper and packaged in sealed multi-unit containers for retail sale.

The provided document describes a Special 510(k) submission for Kimberly-Clark* U by KOTEX Sleek* Unscented Menstrual Tampons, focusing on demonstrating substantial equivalence to a predicate device (Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons; K091749). The "study" described is a preclinical evaluation to support this substantial equivalence claim, rather than a clinical trial with human subjects.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes preclinical testing rather than clinical testing with human subjects. Therefore, the concept of a "test set" in the context of human data or AI model evaluation is not directly applicable. The "samples" would refer to the materials/components of the tampon and applicator that underwent the various biocompatibility and extraction tests. The document does not specify the number of individual test articles or replicates used for each preclinical test.

• Data Provenance: Not applicable in the sense of country of origin for human data. The tests are laboratory-based.
• Retrospective or Prospective: These preclinical tests are conducted prospectively as part of the device development and submission process.

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

Not applicable. The "ground truth" for preclinical tests like biocompatibility and absorbency is established by adherence to recognized international and national standards (ISO, USP, CFR) and successful completion of the specified assays. These tests are evaluated by laboratory personnel and regulatory bodies against predefined pass/fail criteria, not by experts establishing a subjective ground truth.

4. Adjudication Method:

Not applicable. The results of the preclinical tests are objective and measured against established performance standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The device in question is a menstrual tampon, and the evaluation is preclinical for safety and effectiveness, and for demonstrating substantial equivalence.

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

No. This concept applies primarily to AI/ML software as a medical device. The evaluations performed here are for a physical medical device.

7. Type of Ground Truth Used:

The ground truth used for this evaluation is based on:

• Established Performance Standards: International standards (ISO 10993 for biocompatibility) and US Pharmacopeia (USP 661 for colorant extraction).
• Regulatory Requirements: 21 CFR § 801.430 for Syngyna absorbency, which defines the absorbency categories for menstrual tampons.
• Substantial Equivalence to a Predicate Device: The overarching goal is to demonstrate that the new device is as safe and effective as the legally marketed predicate device (K091749) by meeting the same standards and having similar technological characteristics.

8. Sample Size for the Training Set:

Not applicable. There is no concept of a "training set" as this is not an AI/ML model. The "training" for such a device would refer to the historical data, scientific literature, and previous product development that informs the design and manufacturing of the tampon, but it's not a formal "training set" in the context of machine learning.

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

Not applicable, as there is no training set as defined in AI/ML contexts. The "ground truth" for the device's design and manufacturing processes would be based on scientific principles, material science, engineering best practices, and historical performance data for similar predicate devices.

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