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

In addition to routine examination glove's intended use, the gloves are Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.

KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are dark magenta in color, and are single use only, non-sterile, disposable gloves. The powder-free gloves are made of synthetic copolymers of acrylonitrile and butadiene. The product will be sold as a disposable and non-sterile product in extrasmall, small, medium, large, and extra-large sizes.

The provided text describes the acceptance criteria and study results for "KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid." This is a medical device, specifically examination gloves, and the acceptance criteria and studies are related to its physical properties, biocompatibility, and resistance to permeation by certain chemicals.

Here's an analysis based on your request:

1. Table of acceptance criteria and the reported device performance:

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

The document does not explicitly state the exact sample sizes used for each specific test (e.g., how many gloves were tested for pinholes, or how many individual permeation tests were conducted for each chemical). However, it references recognized standards like ASTM D6319 (for dimensions and physical properties, which dictates sampling plans), ASTM D5151 (for holes, which specifies AQLs), and ISO 2859-1:1999 (Sampling Procedures and Tables for Inspection by Attributes). Meeting these AQLs (Acceptable Quality Levels) implies specific sample sizes would have been drawn and tested in accordance with the standards.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, given it's an FDA 510(k) submission, the studies would have been conducted by the manufacturer (Kimberly-Clark Corporation) or their designated testing facilities, likely in a controlled, prospective manner to generate data for the submission. The testing standards are international (ASTM, ISO), suggesting globally recognized methods.

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

This information is not applicable to this type of device and study. The testing described involves objective, quantitative measurements of physical and chemical resistance properties according to established engineering and material science standards (ASTM, ISO). "Ground truth" in this context is defined by the objective measurement procedures and acceptance criteria outlined in these standards, not by expert consensus or interpretation of images/clinical data.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 refer to processes for resolving disagreements among multiple human readers in diagnostic imaging or clinical studies. The studies presented here are laboratory-based, objective material property tests.

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 (examination gloves), not an AI-powered diagnostic tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant.

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

This is not applicable. As stated above, this is not an AI algorithm. The performance described is inherent to the physical glove material and construction.

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

The "ground truth" for this device's performance is established by objective, quantitative measurements conducted in a laboratory setting according to internationally recognized standards and test methods. For example:

• Dimensions: Measured directly using calibrated instruments.
• Tensile Strength & Elongation: Measured using universal testing machines as per ASTM standards.
• Freedom from Pinholes: Determined by water leak tests following ASTM D5151.
• Powder Content: Measured gravimetrically as per ASTM D6124.
• Biocompatibility: Determined by laboratory animal studies (e.g., skin irritation, sensitization, systemic toxicity) following ISO 10993 guidelines, which define the biological response.
• Permeation Resistance: Measured by quantifying breakthrough time of specific chemicals using analytical techniques (e.g., chromatography) as per ASTM D6978-05.

8. The sample size for the training set:

This is not applicable. These studies are for a physical product validation, not for training an AI or machine learning model. There is no "training set" in this context.

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

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

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The nitrile powder free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition to routine examination glove's intended use, the gloves are Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.

KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are 245mm in length and dark magenta in color, and are single use only, non-sterile, disposable gloves. The powder-free gloves are made of synthetic copolymers of acrylonitrile and butadiene. The product will be sold as a disposable and non-sterile product in extrasmall, small, medium, large, and extra-large sizes.

The provided document describes the safety and performance testing of KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves. However, this is a 510(k) premarket notification for a medical glove, not an AI/ML medical device. Therefore, the information required to answer the specific questions about acceptance criteria for an AI/ML device, such as sample sizes for test/training sets, data provenance, expert ground truth establishment, or clinical study design (MRMC), is not present in this document.

The document focuses on non-clinical performance tests of the physical and chemical properties of the gloves.

Here's an attempt to extract relevant "acceptance criteria" and "reported performance" based on the provided document, framed as close as possible to the request, while highlighting the limitations for an AI/ML context.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is for a physical medical device (gloves), the "acceptance criteria" are defined by recognized standards (e.g., ASTM, ISO) for physical properties, chemical resistance, and biocompatibility.

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U by Kotex® Click® Unscented Menstrual Tampon is an unscented tampon inserted into the vagina to absorb menstrual fluid.

The U by Kotex® Click® Unscented Menstrual Tampon is a conventional unscented menstrual tampon consisting of an absorbent pledget and a telescoping three-piece plastic applicator. The device will be manufactured in Regular, Super, and Super Plus absorbencies. The absorbent pledget consists of an absorbent core of radially wound rayon ribbon compressed into a grooved cylinder with a rounded, bullet-like tip, a non-woven overwrap cover, and a rayon-polyester blend withdrawal string. The three-piece applicator consists of an outer insertion tube (barrel) with a textured grip and formed with a closed, rounded tip in a petal-like design, a clear middle telescopic tube (telescope), and an elongated insertion tube (plunger). Each tampon is individually sealed in a plastic film primary wrapper and then packaged in sealed multi-unit containers for retail sale.

The document describes a 510(k) submission for a medical device, which generally means comparing a new device to a legally marketed predicate device to demonstrate substantial equivalence. For this type of submission, extensive acceptance criteria and detailed clinical studies as might be found for novel technologies are often not present in the same format. Instead, the focus is on showing that the modified device performs as safely and effectively as the predicate.

Based on the provided text, here's a breakdown of the requested information:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance for a test set. Instead, it states that the device was assessed against various standards and guidance documents. The "Performance" column in Table 05-02 indicates the outcome of the tests, rather than specific numerical acceptance criteria. Similarly, for other performance characteristics, the document states they "were assessed in accordance with the 2005 FDA guidance document," implying compliance with the requirements within that guidance, but without listing specific numerical targets.

However, we can infer some "performance" outcomes from the biocompatibility tests:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "No clinical tests were performed as part of this device modification." Therefore, there is no clinical test set, sample size, or specific data provenance (country, retrospective/prospective) for clinical performance in the traditional sense. The performance data discussed relates to non-clinical laboratory testing. The document does not specify sample sizes for these non-clinical tests (e.g., how many tampons were tested for absorbency, string strength, etc.).

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

Not applicable. Since no clinical tests were performed and no human interpretation of data for diagnostic purposes is relevant to this device, no "experts" in the context of establishing ground truth for a test set are mentioned. The testing was conducted against regulatory standards and guidelines by presumably qualified laboratory personnel.

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

Not applicable. This device is a menstrual tampon, and the performance assessment is based on physical and chemical properties and biocompatibility, not on a diagnostic interpretation requiring adjudication of results from multiple readers.

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 menstrual tampon and does not involve AI or human readers for diagnostic purposes.

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

Not applicable. This device is a physical medical device (menstrual tampon), not an algorithm or software.

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

For the non-clinical tests, the "ground truth" is defined by the established regulatory standards and guidance documents (e.g., ISO 10993 series for biocompatibility, 2005 FDA guidance for tampons for performance characteristics). Compliance with these standards indicates acceptable performance. There isn't a "ground truth" derived from expert consensus, pathology, or outcomes data in the typical sense applied to diagnostic devices.

8. The sample size for the training set

Not applicable. This is a 510(k) submission for a physical medical device, not an AI or machine learning device requiring a training set.

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

Not applicable for the reason mentioned above.

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The 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.

The device is a disposable examination glove. The subject gloves are made of Synthetic: Nitrile & Polychloroprene. They are non-sterile and intended for Over-The-Counter use.

The provided document is a 510(k) Premarket Notification for medical examination gloves. It details the safety and performance characteristics of "KIMTECH™ PRIZM™ Multi-Layered Exam Glove" and "KIMTECH™ PRIZM™ Xtra Multi-Layered Exam Glove," particularly regarding their resistance to chemotherapy drugs, opioid Fentanyl Citrate, and simulated gastric acid.

Here's an analysis of the acceptance criteria and the study proving the device meets these criteria, based on the provided text:

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

The acceptance criteria are generally established standards from ASTM and ISO. The reported device performance is indicated as "Pass" for all tested attributes. Chemical permeation times are specific performance metrics for the glove's resistance to various substances.

Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size (number of gloves or test replicates) used for each specific test. It indicates that "Non-Clinical Testing was conducted to demonstrate that the two proposed devices met all required design specifications." The testing appears to follow relevant ASTM and ISO standards, which would typically specify sample sizes.

The data provenance is from non-clinical testing conducted by Kimberly Clark Corporation, based in the United States. The testing is performed for premarket notification, indicating it's prospective data for the purpose of demonstrating substantial equivalence to a legally marketed predicate device.

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

This information is not applicable. The device is a medical examination glove, and the performance evaluation is based on objective, quantifiable physical and chemical tests (e.g., tensile strength, resistance to chemical permeation, and biocompatibility) against established standards. There is no qualitative assessment or "ground truth" to be established by human experts in the context of diagnostic interpretation.

4. Adjudication method for the test set

This information is not applicable. As stated above, the evaluation relies on objective measurements against engineering and chemical standards, not on human interpretation that would require 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 information is not applicable. This is a 510(k) submission for exam gloves, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance is relevant.

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

This information is not applicable, as this is not an AI-powered device.

7. The type of ground truth used

The "ground truth" for evaluating these examination gloves is provided by established international and national standards for medical device performance. Specifically:

• ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application
• ASTM D412-2006a: Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension
• ASTM D573-2004: Standard Test Method for Rubber-Deterioration in an Air Oven
• ASTM D3767-03: Standard Practice for Rubber Measurement of Dimensions
• ASTM D5151-2006: Standard Test Method for Detection of holes in Medical Gloves
• ASTM D6124-2006: Standard Tested Method for Residual Powder on Medical Gloves
• ASTM D6978-05 (Reapproved 2013): Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
• ISO 2859: Sampling Procedures and Tables for Inspection by Attributes
• ISO 10993-10: Biological Evaluation of medical Devices-Part 10: Tests for Irritation and Sensitization
• ISO 10993-11: Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity

These standards define the methodologies and acceptable limits for various physical, chemical, and biological properties of the gloves.

8. The sample size for the training set

This information is not applicable. The device is a physical product (exam glove), not a machine learning model, so there is no "training set."

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

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

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The Nitrile Powder Free patient examination glove is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.

KIMTECH™ Purple Nitrile™ Examination Gloves, Powder Free, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric acid and Fentanyl in Simulated Gastric acid are single use only, non-sterile, disposable gloves. The powder-free gloves are made of a synthetic copolymer of acrylonitrile and butadiene with a purple color additive. The gloves are available in extra small, medium, large, and extra-large sizes.

This document is a 510(k) Premarket Notification for KIMTECH™ Purple Nitrile™ Powder Free Examination Gloves. It focuses on demonstrating that the proposed device is substantially equivalent to legally marketed predicate devices, particularly concerning its resistance to permeation by chemotherapy drugs, fentanyl citrate, simulated gastric acid, and fentanyl in simulated gastric acid.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the permeation resistance of the gloves are defined by the "Minimum Breakthrough Detection Time" for each substance. For other characteristics, the acceptance criteria are generally "Complies with" or "Pass" based on recognized ASTM and ISO standards.

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The U by Kotex® Click® Unscented Menstrual Tampons are inserted into the vagina to absorb menstrual fluid.

The subject devices are conventional unscented menstrual tampons consisting of an absorbent pledget, an overwrap, a withdrawal string, and a plastic applicator. The absorbent pledget consists of a ribbon of rayon fibers. A rayon-polyester blend withdrawal string is placed on the ribbon and the ribbon is radially wound, then compressed into a traditional eight-groove bulletshaped pledget, overwrapped with a non-woven cover material. The tampon component is inserted into a three-piece plastic applicator consisting of an inner tube (plunger), a clear middle telescopic tube (telescope), and an outer insertion tube (barrel) formed with a closed, rounded tip. Each tampon component with applicator is wrapped in an individual plastic film wrapper, and packaged in a sealed multi-unit container for retail sale. Tampons are available in Regular, Super and Super Plus absorbencies in various counts.

The document you provided is a 510(k) Premarket Notification from the FDA for a menstrual tampon. This type of document is a submission to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. It doesn't typically contain detailed clinical study reports for AI algorithms.

However, I can extract the acceptance criteria and the self-reported study details regarding the performance testing of the U by Kotex® Click® Unscented Menstrual Tampons as described in the document.

Please note: The requested information regarding sample sizes for training/test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and how ground truth for training data was established are not applicable in this context, as the device is a physical menstrual tampon, not an AI/software device. The "studies" referenced are laboratory performance tests for physical and chemical properties and biocompatibility.

Here's the information extracted from your document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Non-sensitizing (per ISO 10993-10:2010)
• Non-irritating (per ISO 10993-10:2010)
• Non-toxic (Acute Systemic Toxicity per ISO 10993-11:2006) | - The pledget was demonstrated to be non-cytotoxic.
• The pledget was demonstrated to be non-sensitizing.
• The pledget was demonstrated to be non-irritating.
• The pledget was demonstrated to be non-toxic. |
  | Performance Testing (Syngyna Absorbency) | Absorbency range meets requirements of 21 CFR §801.430(f)(2) for each absorbency level (Regular, Super, Super Plus) - Specific numerical ranges are not provided in this document, but implied by regulatory compliance. | The subject tampons met the requirements of 21 CFR §801.430(f)(2) for each absorbency level. |
  | Chemical Residues | - No detectable 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD)
• No detectable 2,3,7,8-tetrachlorofuran dioxin (TCDF)
• No detectable pesticide residues
• No detectable herbicide residues | There were no detectable 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD); 2,3,7,8-tetrachlorofuran dioxin (TCDF); or any pesticide and herbicide residues. |
  | Mechanical Performance | - String strength: ≥ 10 lb force
• Fiber shedding: ≤ 2 mg/tampon
• Tampon integrity (dry): ≥ 20 daN
• Tampon integrity (wet): ≥ 15 daN | - The subject tampons met the string strength specification of ≥ 10 lb force.
• The subject tampons met the fiber shedding specification of ≤ 2 mg/tampon.
• The subject tampons met the tampon integrity (dry) specification of ≥ 20 daN.
• The subject tampons met the tampon integrity (wet) specification of ≥ 15 daN. |
  | Microbiology Testing | - Bioburden: Total Aerobic Microbial Count (TAMC) ≤ 200 cfu/g (per USP )
• Bioburden: Total Yeast/Mold Count (TYMC) ≤ 20 cfu/g (per USP )
• Absence of pathogenic organisms (S. aureus, E. coli, P. aeruginosa, Salmonella species, C. albicans, C. sakazakii) (per USP )
• No alteration of normal vaginal microflora growth
• No increase in production of Toxic Shock Syndrome Toxin-1 (TSST-1)
• No enhancement of S. aureus growth | - The subject tampons passed the Bioburden test with TAMC ≤ 200 cfu/g and TYMC ≤ 20 cfu/g.
• The subject tampons passed the test for absence of pathogenic organisms (S. aureus; E. coli; P. aeruginosa; Salmonella species; C. albicans; and C. sakazakii).
• The subject tampons did not alter growth of normal vaginal microflora.
• The subject tampons did not increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1).
• The subject tampons did not enhance the growth of S. aureus. |

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

• Sample Size for Test Set: Not explicitly stated in the document for each test. The document mentions "The following studies have been performed..." and refers to compliance with ISO standards and FDA guidance, which would typically involve specific sample sizes per test methodology, but these are not detailed in this summary.
• Data Provenance: The studies were performed by Kimberly-Clark Corporation to support the substantial equivalence of their device. The exact country of origin for the data generation process is not specified beyond Kimberly-Clark having their main address in Neenah, WI, USA. The studies are prospective in the sense that they are laboratory tests performed on the new device to demonstrate its properties.

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

• Not Applicable. This is a physical medical device, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests comes from established analytical and biological methodologies (e.g., ISO standards, USP chapters).

4. Adjudication method for the test set:

• Not Applicable. As this is not an AI algorithm or clinical trial with subjective assessments, there is no adjudication method by experts. The results are based on objective laboratory measurements against predefined thresholds.

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 a physical medical device (menstrual tampon), not an AI-assisted diagnostic or imaging device.

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

• Not Applicable. This refers to a physical product, not an AI algorithm.

7. The type of ground truth used:

• For biocompatibility: Ground truth is established by the specified ISO 10993 standards.
• For performance testing (Syngyna absorbency): Ground truth is established by the FDA Guidance "Menstrual Tampons and Pads: Information for Premarket Notification Submissions" issued July 27, 2005, and specifically 21 CFR §801.430(f)(2).
• For chemical residues: Ground truth is established by analytical chemistry methods for detecting specific compounds.
• For mechanical performance: Ground truth is established by design specifications (e.g., ≥ 10 lb force, ≤ 2 mg/tampon) based on industry standards and safety considerations.
• For microbiology testing: Ground truth is established by reference to USP and , as well as established microbiological methods for assessing impact on microflora and toxin production.

8. The sample size for the training set:

• Not Applicable. This is a physical product, not an AI product that requires a training set.

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

• Not Applicable. As above, no training set for this type of device.

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The ON-Q* QuikBloc* Over-the-Needle Catheter Set is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative, percutaneous, or perineural. The ON-Q* QuikBloc* Over-the-Needle Catheter Set is contraindicated for the epidural space.

ON-Q* QuikBloc* Over-the-Needle (OTN) Catheter Sets are available in four product codes (20 GA x 4" Needle, 16 GA x 3" Catheter (with and without Stimulating needle); 20 GA x 6" Needle, 16 GA x 5" Catheter (with and without stimulating needle)). The kits include: 1) ON-Q* QuikBloc* Over-the-Needle Catheter Set (some models include an integrated stimulating cable) 2) Removable Needle Wing 3) Non-DEHP 24 inch Needle Extension Set, 4) Non-DEHP 6 inch Catheter Extension Set 5) Connector Securement Device 6) Occlusive Dressing 7) Adhesive Strips 8) Catheter ID label These devices are sold as disposable, sterile, single use, devices.

Here's an analysis of the provided text regarding acceptance criteria and device performance:

Based on the provided text, the document describes a 510(k) premarket notification for a medical device, the ON-Q* QuikBloc* Over-the-Needle (OTN) Catheter Set. It asserts substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving quantitative performance against those criteria as would be expected for a novel device or a device demonstrating new clinical claims.

Therefore, much of the requested information for acceptance criteria and a detailed study is not present in this document.

However, I can extract the information that is implicitly or explicitly stated:

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

No explicit quantitative acceptance criteria or detailed performance metrics are provided in this document. The submission is based on substantial equivalence.

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

• Sample Size for Test Set: Not specified. The document mentions "evaluated for biocompatibility by their corresponding vendors" and "Gamma or EO sterilized samples of the components...were tested". This suggests component-level testing rather than a specific clinical test set for the integrated device.
• Data Provenance: The document states "tested in vitro or in laboratory animals". It doesn't specify country of origin or whether it was retrospective or prospective, but animal and in vitro testing are typically prospective lab studies.

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

Not applicable/specified. This document describes a 510(k) submission based on substantial equivalence and non-clinical testing (biocompatibility, functionality). There is no mention of a human-reader study or ground truth established by experts for performance evaluation.

4. Adjudication method for the test set

Not applicable/specified. There is no mention of human-reader studies or a need for 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 catheter set, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

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

7. The type of ground truth used

For biocompatibility, the "ground truth" would be established by the standardized methods and endpoints defined in ISO 10993 guidelines (e.g., absence of cytotoxicity, irritation, sensitization). For functionality, the "ground truth" would be the successful operation of the device according to its design specifications and user instructions. There is no mention of pathology, expert consensus, or outcomes data in a clinical sense for performance claims in this document.

8. The sample size for the training set

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

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

Not applicable.

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The Aero Blue* Performance Surgical Gowns are 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 Aero Blue* Performance Surgical Gowns meet the Level 3 requirements of the AAMI PB70: 2012 Liquid Barrier classifications. The Aero Blue* Performance Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.

A Spunbond/Film/Spunbond/Meltblown/Spunbond design (SFSMS) that provides AAMI Level 3 liquid barrier protection in the critical zone of the gown. The back of the gown is a SMS (spunbond/meltblown/spunbond fabric that is air-breathable and provides AAMI Level 1 liquid barrier protection.

Acceptance Criteria and Device Performance Study for Aero Blue* Performance Surgical Gowns

This document outlines the acceptance criteria and the study that demonstrates the Aero Blue* Performance Surgical Gowns meet these criteria, based on the provided 510(k) summary (K140539).

1. Acceptance Criteria and Reported Device Performance

The Aero Blue* Performance Surgical Gowns are designed to meet the Level 3 requirements of the AAMI PB70: 2012 Liquid Barrier classifications in the critical zone, and Level 1 in the non-critical back zone. The non-clinical testing performed demonstrated compliance with these and other relevant standards.

Note: The document explicitly states "All results of testing met acceptance criteria." This implies that the device performed within the established limits for each test.

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

The 510(k) summary does not specify the exact sample sizes used for each individual non-clinical test. It lists the standards and test methods applied. For instance, for liquid barrier and blood penetration, it refers to standards like AAMI PB70:2012 and ASTM F-1670-08. These standards typically define minimum sample sizes for testing to ensure statistical validity.

The data provenance is retrospective, as the tests were conducted on the manufactured Aero Blue* Performance Surgical Gowns to demonstrate compliance with established standards. The country of origin of the data is not explicitly stated but is implicitly from the manufacturer's testing facilities or accredited third-party labs where these standards are tested, likely within the US given the submission to the FDA.

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

This section is not applicable for this medical device. The "ground truth" for the performance of a surgical gown is established by objective, standardized test methods and criteria defined by recognized national and international standards organizations (e.g., AAMI, ASTM, ISO, CPSC). These standards specify the methodology, equipment, and acceptable limits for performance. There is no human expert "ground truth" to be established in the context of device performance testing for surgical gowns.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic device evaluations where expert consensus is needed to establish ground truth. As noted above, the performance of a surgical gown is evaluated against predefined objective criteria and standardized test results. Therefore, no human adjudication method was employed or is relevant for this type of device testing.

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

An MRMC study is not applicable and was not done. This type of study assesses the impact of a device (often an AI algorithm) on human reader performance, typically in diagnostic imaging. The Aero Blue* Performance Surgical Gowns are barrier garments, not diagnostic tools, and do not involve human "readers" or AI assistance in their function.

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

A standalone study of an algorithm is not applicable and was not done. The Aero Blue* Performance Surgical Gown is a physical medical device, not an algorithm or software. Its performance is evaluated directly through physical and material property tests.

7. The Type of Ground Truth Used

The ground truth used for the device's performance claims is based on objective, quantitative measurements and qualitative assessments derived from recognized industry standards and test methods. Specifically:

• Standardized Test Data: The "Pass" results in the "Summary of Non-Clinical Testing" indicate that the device met the precise, objective criteria set forth by each referenced standard (e.g., AAMI PB70:2012 for liquid barrier, ASTM-1670-08 for synthetic blood penetration, ISO 10993 for biocompatibility).
• Performance Metrics: The "ground truth" is defined by specific physical and material properties (e.g., water resistance, tensile strength, flammability, cytotoxicity) measured against predefined thresholds in the standards.

8. Sample Size for the Training Set

A "training set" is not applicable to this device. Training sets are used in the development of machine learning algorithms. The Aero Blue* Performance Surgical Gowns are physical products whose performance is determined by their material composition, design, and manufacturing processes, and subsequently validated through non-clinical laboratory testing.

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

This question is not applicable as there is no training set for this device. The physical and chemical properties of the materials, and thus the performance characteristics of the gown, are established through material science, engineering, and validated test methods, not through an iterative process of training an algorithm on a dataset with established ground truth.

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The Kimberly-Clark* MIC-KEY* SF Low Profile Gastrostomy Tube and Accessories are indicated for use in patients who require long term feeding, are unable to tolerate oral feeding, who are at low risk for aspiration, require gastric decompression and/or medication delivered directly into the stomach through a secured (initial placement) or formed (replacement) stoma.

Kimberly-Clark* MIC-KEY* SF Continuous Feed Extension Set is indicated for use with the MIC-KEY* SF Low Profile Gastrostomy Tube to facilitate nutrition, medication delivery, and gastric decompression.

Kimberly-Clark* MIC-KEY* SF Bolus Feed Extension Set is indicated for use with the MIC-KEY* SF Low Profile Gastrostomy Tube to facilitate nutrition, medication delivery, and gastric decompression.

Kimberly-Clark* MIC-KEY* SF Patient Starter Kit is indicated to provide necessary components to begin enteral feeding after placement of the Kimberly-Clark* MIC-KEY* SF Gastrostomy Tube.

Kimberly-Clark* MIC-KEY* SF Over-the-Wire Stoma Measuring Device is indicated for measuring the length of a stoma prior to placement of a low profile feeding tube.

Low profile Gastrostomy feeding tube and accessories to facilitate nutrition, medication delivery, and gastric decompression for single patient use.

The Kimberly-Clark* MIC-KEY* SF Low Profile Gastrostomy Tube external feeding head, feeding catheter, and disc-shaped retention balloon are manufactured with polyurethane. The feeding catheter is inserted into the stomach through a secured or formed stoma and is held in place with a retention balloon that is filled with sterile or distilled water. The device is provided with feeding catheter outer diameters that range from 10Fr to 24Fr, and with feeding tube lengths that range from 0.8cm to 6.0cm to fit different stoma diameters and lengths, respectively. The device incorporates a balloon fill indicator to alert the user when the balloon is not optimally inflated and incorporates an extension set connector that snaps with an audible double click that helps confirm that the connection of the extension set is secure. In addition, the feeding port includes a one-way dome valve that does not require a closure cap/strap.

The Kimberly-Clark* MIC-KEY* SF Bolus Feed Extension Set and Kimberly-Clark* MIC-KEY* SF Continuous Feed Extension Set engage to the feeding port using a snap-in connector and are made from DEHP-free materials. The feed valve and extension set ports have been designed to help prevent misconnections with Luer style connectors in alignment with ISO 80369-1 requirements.

The Kimberly-Clark* MIC-KEY* SF Over-the-Wire Stoma Measuring Device consists of a head, catheter, retention balloon, that are composed of polvurethane.

The provided text describes a 510(k) summary for the Kimberly-Clark* MIC-KEY* SF Low Profile Gastrostomy Tube and Accessories. It outlines the device, its intended use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "All results of testing met acceptance criteria." However, it does not explicitly list the specific acceptance criteria for each test performed. It only lists the standards to which the device was tested.

The following standards were used for testing:

• ISO 10993-1: 2009 Biological Evaluation of Medical Devices-Part 1: Evaluation and testing within a risk management process
• ISO 10993-3: 2009 Biological Evaluation of Medical Devices-Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
• ISO 10993-5: 2009 Biological Evaluation of Medical Devices-Part 5: Tests for in vitro cytotoxicity
• ISO 10993-6: 2007 Biological Evaluation of Medical Devices-Part 6: Test for Local Effects After Implantation
• ISO 10993-7: 2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
• ISO 10993-10: 2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and delayed-type Hypersensitivity
• ISO 10993-11: 2006 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity
• ISO 10993-12: 2007 Biological Evaluation of Medical Devices-Part 12: Sample Preparation and Reference Materials
• ANSI/AAMI/ISO 11607-1 (2006) Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
• ISO 11135-7: 2007 Sterilization of health care products -Ethylene oxide - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
• ANSI/AAMI ID54:1996/(R)2012 Enteral feeding set adapters and connectors
• ASTM F640-07 - Standard Test Methods for Determining Radiopacity for Medical Use

Missing Information:

The provided text does not contain any of the following information:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document only states "Summary of Testing" and lists standards without detailing specific test methodologies, sample sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a medical device for feeding tubes, not an AI or diagnostic imaging device requiring expert ground truth for interpretation. The testing focuses on biological safety and performance against established engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the type of testing described (biocompatibility, sterilization, physical performance).
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, as this is a medical device (gastrostomy tube), not an AI or diagnostic imaging system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The ground truth for this device's performance is based on conformance to the established national and international standards listed, which often involve specific physical, chemical, and biological tests with predefined pass/fail criteria.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

In summary: The document confirms that the Kimberly-Clark* MIC-KEY* SF Low Profile Gastrostomy Tube and Accessories underwent a series of tests to ensure compliance with relevant medical device standards (primarily ISO and AAMI/ANSI). All tests met acceptance criteria, concluding that the device is substantially equivalent to its predicate devices in terms of design, biocompatibility, performance, and principles of operation. However, the specific details of the acceptance criteria for each test and the methodologies (like sample size) are not elaborated in this 510(k) summary. The nature of the device (a physical medical implant/accessory) means that many of the AI/diagnostic-specific questions are not relevant.

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Poise Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex condoms but is compatible with polyisoprene and polyurethane condoms.

Poise Personal Lubricant is a water soluble, clear, colorless, viscous liquid composed of purified water, hydroxyethyl cellulose (Natrosol 250), propylene glycol, benzoic acid and sodium hydroxide. Poise Personal Lubricant is presented as a non-sterile product. It is neither a contraceptive nor a spermicide and is sold over-the-counter. The product is packaged in a seventy-four ml plastic, cylindrical pump bottle placed inside a display carton. The outside of the display carton contains a tamper evident seal. Poise Personal Lubricant is a non-greasy and fragrance-free formulation which contains only United States Pharmacopeia (USP) or National Formulary (NF) ingredients.

The Kimberly-Clark Poise® Personal Lubricant is not an AI/ML device, and therefore, the requested information regarding AI/ML acceptance criteria and studies is not applicable.

The provided documentation describes the traditional 510(k) submission process for a medical device (personal lubricant) and focuses on demonstrating substantial equivalence to a predicate device (Durex® Play™ Lubricant). The "acceptance criteria" discussed in this context are related to the safety and effectiveness of the lubricant itself, as proven by various non-clinical laboratory tests.

Here's an overview of the "acceptance criteria" and how the device met them, based on the provided text, adapted to the closest relevant information:

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

Note: The cytotoxicity result shows "Non-cytotoxic ≤ 3.13%". The document clarifies that while propylene glycol has moderate cytotoxic potential in vitro, cytotoxicity is not demonstrated in vivo for the lubricant.

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

The document does not specify human "test sets" or "data provenance" in the context of clinical trials as it pertains to AI/ML devices. The studies conducted are non-clinical (laboratory and animal studies).

• For Cytotoxicity (In Vitro): Not specified (cell culture).
• For Sensitization (In Vivo): Guinea Pig Maximization Assay. Sample size not specified.
• For Vaginal Irritation (Rabbit): Rabbit Vaginal Irritation study. Sample size not specified.
• For Subacute Toxicity (Rabbit): Two-week Rabbit Vaginal Exposure. Sample size not specified.
• For Genotoxicity (In Vitro): Bacterial Reverse Mutation, Chromosome Aberration. Sample sizes not specified (cell culture).
• For Genotoxicity (In Vivo): Mouse Micronucleus. Sample size not specified.
• For Ocular Irritation (In Vitro): 3D Cell Culture (EpiOcular). Sample size not specified (cell culture).
• For Microbial Limits Test: Three process validation lots were used.
• For Oral Toxicity Assessment: Based on individual component assessment, not a direct animal or human study for the final product in this context.

All these studies represent preclinical data. The "country of origin" is not specified, but these are standard international laboratory tests.

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

This information is not applicable as there is no "test set" requiring expert ground truth in the context of an AI/ML device. The "ground truth" for the non-clinical studies is established by the results of the specific biological or chemical assays performed in a laboratory setting, following recognized standards (e.g., ISO, OECD, USP).

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

Not applicable. There is no "test set" and no human expert adjudication as would be relevant for an AI/ML device.

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 device.

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

Not applicable. This is not an AI device.

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

The "ground truth" for the performance of the personal lubricant is based on:

• Biological/Chemical Assay Results: For biocompatibility endpoints (e.g., cytotoxicity, sensitization, irritation, genotoxicity, oral toxicity). These are determined by the specific methodologies of the laboratory tests referenced (e.g., ISO 10993 series, OECD guidelines, MatTek EpiOcular MTT Viability Assay).
• Microbial Testing Standards: For microbial limits, ground truth is established by meeting predefined USP and criteria (≤ 100 cfu/ml and no objectionable organisms).
• Physical/Chemical Property Measurements: For characteristics like pH, viscosity, specific gravity, osmolality, and long-lasting lubricity (coefficient of friction). These are measured and compared to the predicate device and established specifications.
• Condom Compatibility Testing Standards: ASTM-D7661-10 was used to determine compatibility with different condom materials.

8. The sample size for the training set

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

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

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

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