Search Results

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.

Ask a specific question about this device

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.

The following information typically required for an AI/ML device is NOT found in this document because it describes a physical medical glove:

2. Sample size used for the test set and the data provenance: Not applicable. For gloves, testing involves physical samples tested according to standards. The document lists the ASTM and ISO standards used for testing the gloves. There's no "test set" of data in the AI/ML sense. Data provenance would refer to the origin of the physical glove samples tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties and chemical resistance is established by laboratory measurements against defined standards, not human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept pertains to human interpretation/labeling of data in AI/ML studies.
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 strictly for AI/ML performance studies involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" equates to the results of standardized, objective laboratory tests for physical and chemical properties (e.g., tensile strength, resistance to permeation, absence of pinholes, etc.) and biocompatibility studies.
8. The sample size for the training set: Not applicable. This device does not use an AI/ML model that requires training data.
9. How the ground truth for the training set was established: Not applicable. No training set is used.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for permeation for each drug). However, it references standards like ISO 2859 Sampling Procedures and Tables for Inspection by Attributes, indicating that sampling was conducted according to recognized statistical methods for quality control.

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. However, considering it's a 510(k) submission, the data would typically be derived from laboratory tests conducted for the purpose of the submission. The "Test Results Follow" tables imply that the data presented is the result of direct testing.

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 submission. The "ground truth" for glove performance (like permeation, tensile strength, or freedom from holes) is established through physical and chemical testing against defined standards (ASTM, ISO), not through expert consensus or interpretation of complex medical images/data. There are no "experts" establishing a clinical ground truth for these performance tests.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or experts when establishing a clinical ground truth, often in image-based diagnostic studies. For physical device testing, the results are typically quantitative measurements or pass/fail determinations against scientific standards, not subject to human adjudication in that manner.

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

This information is not applicable. MRMC studies are relevant for AI-powered diagnostic tools where human readers are interpreting medical images or data. This document describes a physical medical device (examination gloves) and its performance against chemical permeation and physical characteristics; it 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

This information is not applicable. This device is not an algorithm or AI. It is a physical product, and its performance is measured independently in a laboratory setting.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the performance claims of these gloves is based on objective measurements and adherence to established industry standards (ASTM D6978-05 for permeation, ASTM D6319 for physical properties, ISO 10993 for biocompatibility). The results are direct measurements of physical and chemical resistance, not subjective interpretations or clinical outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device. Training sets are used for machine learning algorithms. The performance of these gloves is determined through physical testing, not by training a model.

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

This information is not applicable for the reason stated in point 8.

Ask a specific question about this device

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:

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 <61> and <62>, 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.

Ask a specific question about this device

KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:

· Pre-vacuum steam at 270°F / 132°C for 4 minutes. The wrap was validated for dry times of 20 minutes for models KC100 and KC200.

· 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 was validated for aeration times for EO sterilization of 8 hours at 43.3 °C for models KC100 and KC200.

KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

Test results validated that KIMGUARD* ONE-STEP* Sterilization Wraps (KC100, KC200) allowed sterilization of the enclosed devices by the ethylene oxide sterilization and by pre-vacuum cycles.

These models of the KIMGUARD* ONE-STED* Sterilization Wrap have been validated for use with the ethylene oxide and pre-vacuum cycles in Table 1 (see page 2 of 2)

KIMGUARD* ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap ultrasonically seamed on two edges. This allows for convenient wrapping with two sheets simultaneously.

The sheets of sterilization wrap are square or rectanqular fabric produced using a three-layer SMS (spunbond-meltblown-spunbond) process. The wrap fabric (white or blue color) is composed of polypropylene with the addition of less than 2% by weight of phthalocvanine blue pigment (blue fabric only), less than 1% by weight titanium dioxide pigment, and less than 0.009% by weight of a potassium phosphate anti-static treatment. The wrap allows a sterilized package to be opened aseptically.

This FDA 510(k) summary describes KIMGUARD® ONE-STEP® Sterilization Wrap intended to enclose medical devices for sterilization and maintain sterility.

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

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

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 does not explicitly state the specific sample sizes used for the "Maintenance of 365-Day Package Integrity," "Sterilant Penetration," and "Biocompatibility" tests. For the KIMGUARD® ONE-STEP® Sterilization Wrap Recommendations for Use (Table 1), the "test set" can be considered the specific configurations of loads used to validate the maximum wrapped package content weights:

• KC100: 16 huck towels (17"x 29") weighing 3 lbs.
• KC200: 2 huck towels (17"x 29"), 2 fluid resistant U-drapes (68"x 109"), 1 fluid resistant universal bar drape (70" x 108") weighing 6 lbs.

The data provenance is not explicitly mentioned as country of origin, but the applicant is Halyard Health, located in Alpharetta, GA, USA. The studies appear to be prospective as they were conducted to validate the device's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This product is a sterilization wrap, not an AI/imaging device. Therefore, the concept of "experts" to establish ground truth in the context of diagnostic interpretation is not applicable here. The validation involves standardized performance tests for sterilization and material properties. Compliance with relevant standards (e.g., ISO 10993 for biocompatibility) would be performed by qualified personnel in testing laboratories.

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

Not applicable for this type of device and study. Adjudication methods are typically used in clinical studies involving interpretation by 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 is not an AI/imaging device.

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

Not applicable. This is not an AI software. The device itself (the sterilization wrap) has a standalone performance (its ability to maintain sterility and allow sterilant penetration). The nonclinical tests essentially evaluate this "standalone" performance.

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

The "ground truth" for this device's performance is established by:

• Quantitative measurements and observations based on standardized test methods for:
  • Sterilant penetration (ensuring the sterilant reaches the enclosed medical device).
  • Microbiological challenge (implied by "maintenance of sterility" tests, indicating no microbial ingress).
  • Physical integrity tests to confirm the wrap remains intact over time, preventing contamination.
  • Biocompatibility tests according to ISO standards, which involve specific physiological responses.

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 as there is no training set for this device.

Ask a specific question about this device

KIMGUARD ONE-STEP® Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using:

• V-PRO® 60 Low Temperature Sterilization System that include:
  • o Lumen Cycle
  • Non Lumen Cycle o
  • Flexible Cycle O

KIMGUARD* ONE-STEP® Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

KIMGUARD* ONE-STEP® Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap that is ultrasonically seamed on two edges. This seamed configuration allows for convenient wrapping of an article using two sheets simultaneously.

The blue or white sheets of sterilization wrap are square or rectangular fabric produced using a three-layer SMS (spunbound-meltblown-spunbound) process. The blue wrap fabric is composed of polypropylene with the addition of 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 anti-static treatment. The white sheet has the same material composition but contains no blue pigment. The wrap allows a sterilized package to be opened aseptically.

I am sorry, but based on the provided document, the information required to compose the detailed response for "acceptance criteria and the study that proves the device meets the acceptance criteria" as requested is not available. The document is a 510(k) summary for a sterilization wrap, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics in the format requested for a device that typically involves AI or human interpretation.

Specifically, the document states:

• "All results of testing met acceptance criteria demonstrating that the KIMGUARD* ONE-STEP® Sterilization Wrap allows sterilization of contents by the V-PRO® 60 Low Temperature Sterilization System (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) and maintains sterility of contents until used."
• It lists a "Summary of Testing Performed" table with "Results" as "Passed" for "Sterilant Penetration", "Maintenance of Package Integrity (30 Days)", "Performance Testing", and "Material Biocompatibility."

However, it does not provide:

1. A table of specific acceptance criteria and reported device performance (e.g., quantifiable metrics like sensitivity, specificity, accuracy, or other performance thresholds with numerical results). The results are simply stated as "Passed."
2. Sample sizes used for the test set and data provenance.
3. Number of experts and their qualifications used to establish ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study details.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document describes a medical device (sterilization wrap) which functions as a physical barrier and facilitator of sterilization, not an AI-powered diagnostic or interpretive device. Therefore, the types of studies and performance metrics typically associated with AI/software-as-a-medical-device (SaMD) are not applicable here.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device