Search Results

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 U Deliver Bolink ENFit Enteral Feeding Sets are intended for over-the-counter use to deliver liquid nutritional formulas or water to a patient's enteral access device (feeding tube).

The U Deliver Bolink ENFit Enteral Feeding Sets consist of two configurations:

• U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector (ref. BK-2085) .
• U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector (ref: BK-2405)
  The U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a safety screw connection meeting the requirements of clauses 4 "General requirement" and 5 "Dimensional requirements for enteral feed reservoir connectors" of ISO18250-3, "Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral applications', to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3, 'Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications'.
  The U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a screw cap with a 40 mm thread, to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3
  Both sets are constructed from medical grade, biocompatible materials, and are supplied non-sterile for single patient use only.

The provided document is an FDA 510(k) clearance letter for a medical device: "U Deliver Bolink ENFit Enteral Feeding Sets." It describes the device, its intended use, and the basis for its substantial equivalence to a predicate device.

However, the document does not contain any information about an AI/ML-driven medical device. Specifically, it does not describe:

• An AI algorithm or its performance.
• Acceptance criteria for an AI model.
• A study that proves an AI device meets acceptance criteria, including details on sample size, data provenance, expert ground truth establishment, adjudication, MRMC studies, standalone performance, or training set details.

The "Performance Data" section explicitly states: "No new device testing was necessary as no changes have been been made to the device design, materials or packaging. The testing necessary for this submission was usability testing to demonstrate that both laypersons with no prior tube feeding experience and caregivers/tubefeeders were able to perform the essential tasks using only the proposed instructions for use. The results of usability testing demonstrate that the subject device(s) are appropriate for over-the-counter use." This confirms that the critical study mentioned was a usability test for a physical device, not an AI performance study.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI device based on this document.

The document pertains to the clearance of a physical medical device (enteral feeding sets) and its change in indications for use from prescription-only to over-the-counter, based on usability testing and substantial equivalence to a cleared predicate device.

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

The U Deliver Bolink ENFit Enteral Feeding Sets are intended to deliver liquid nutritional formulas or water to a patient's enteral access device (feeding tube).

The U Deliver Bolink ENFit Enteral Feeding Sets consist of two configurations:

• U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector (ref. . BK-1085)
• U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector (ref: BK-1405) .
  The U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a safety screw connection meeting the requirements of clauses 4 "General requirement" and 5 "Dimensional requirements for enteral feed reservoir connectors" of ISO/DIS 18250-3. 'Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral applications', to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3, 'Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications'.
  The U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a screw cap with a 40 mm thread, to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3
  Both sets are constructed from medical grade, biocompatible materials, and are supplied non-sterile for single patient use only.

This document is a 510(k) premarket notification for the U Deliver Bolink ENFit Enteral Feeding Sets, establishing substantial equivalence to a predicate device. As such, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial or a performance study with human subjects or medical imaging analysis.

Instead, the document focuses on bench testing to demonstrate physical and functional equivalence of the U Deliver Bolink ENFit Enteral Feeding Sets to the predicate device and compliance with recognized standards.

Here's an analysis of the information provided, addressing the requested points where applicable, and noting where the information is not present in this type of submission:

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

The document does not provide a formal table of acceptance criteria with reported performance in a quantitative manner for specific benchmarks. Instead, it lists the types of bench tests conducted, implying that the acceptance criteria for these tests are met by conforming to recognized standards (ISO 80369-3, ISO 80369-20, ISO/DIS 18250-3, ISO 10993) or by demonstrating equivalence to the predicate device.

Bench Tests Performed (Implied performance met as per standards/equivalence):

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each bench test. It generally states that "Bench tests have been carried out on samples of the U Deliver Bolink ENFit Enteral Feeding Sets."
• Data Provenance: The document implies that the testing was performed by or for the manufacturer (Cedic S.r.l., Italy, a contract manufacturer). The submission itself is from U Deliver Medical, LLC (USA). The testing is prospective (conducted specifically for this submission).

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 question is not applicable to this type of device and submission. This is a medical device for delivering nutritional formulas, not an imaging or diagnostic device that requires expert interpretation to establish a 'ground truth'. The "ground truth" here is compliance with technical standards and functional performance metrics, verified through engineering bench tests.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation (e.g., radiology reads) to resolve discrepancies in expert opinions. This submission relies on objective engineering measurements and compliance with recognized standards.

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 a software device, an AI-powered diagnostic tool, or a device that involves "human readers." It's a physical enteral feeding set.

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

Not applicable. This device does not involve algorithms or AI. It is a physical medical device.

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

The "ground truth" for this device is established by:

• Technical Standards: Compliance with FDA-recognized international standards such as ISO 80369-3, ISO 80369-20, ISO/DIS 18250-3, and ISO 10993. These standards define the required physical dimensions, mechanical properties, and biocompatibility.
• Predicate Device Equivalence: Demonstrating that the subject device performs similarly to or better than the legally marketed predicate device (Metrixcare Enteral Feeding Sets, K132424) in relevant functional aspects (e.g., flow rate).

8. The sample size for the training set

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

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

Not applicable. There is no training set for this device.

Ask a specific question about this device

The U&U Intravascular Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

The U&U Intravascular Administration Set is a gravity single use device sterilized with Ethylene Oxide gas. It is utilized to administer fluids from a container to a patient's vascular system through a catheter or needle inserted into a vein. The device includes the following components: Protective cap, Spike, Drip chamber, Back check valve, Pinch clamp, Slide clamp, Stopcock, Micron filter, Needleless Y-site, Male luer lock, Luer lock cap.

This document is a 510(k) premarket notification for a medical device called the "U&U Intravascular Administration Set." It aims to demonstrate that this new device is substantially equivalent to a legally marketed predicate device, the "Zyno Medical Administration Set" (K120685). The information provided focuses on the non-clinical testing performed.

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

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

The document provides a table comparing the technological characteristics of the submission device (U&U Intravascular Administration Set) and the predicate device (Zyno Medical Administration Set). It also includes a summary of non-clinical test results for the submission device, which effectively acts as a table of acceptance criteria and reported performance.

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

The document states, "When appropriate, predicate devices were tested using the exact same method and sample size, for direct comparison of results." However, the specific sample sizes used for each test (e.g., for particulate contamination, leakage, flow rate, tensile strength) are not detailed in this document.

The data provenance is from non-clinical bench testing performed by U&U Medical Technology Co., Ltd. and its contract manufacturer. The document doesn't specify the country of origin of the raw data, but the submitting company is based in China, and the contract manufacturer is also in China. The data is prospective as it involves tests conducted on the newly manufactured U&U Intravascular Administration Set.

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

This is not applicable as this study is not evaluating a diagnostic algorithm or a clinical scenario requiring expert interpretation to establish "ground truth." The "ground truth" here is objective physical and chemical properties measured against established engineering standards and specifications.

4. Adjudication method for the test set:

This is not applicable for the same reason as point 3. The testing involves objective measurements rather than subjective assessments requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. This document is for a physical medical device (intravascular administration set), not an AI-powered diagnostic tool, and therefore no MRMC study was performed.

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

This is not applicable as there is no algorithm or AI component in this medical device.

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 engineering standards and specifications, specifically those outlined in ISO 8536-4 (Infusion Equipment for Medical Use, Part 4: Infusion sets for single use, gravity feed), as well as general expectations for such devices (e.g., "No Leakage," "Normal" principle of operation). The predicate device's characteristics also serve as a benchmark for substantial equivalence.

8. The sample size for the training set:

This is not applicable as this is a physical medical device and does not involve machine learning algorithms requiring a training set.

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

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

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

The U fit Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The U fit Dental Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

The U fit Implant System is a dental implant system made of Titanium-6A1-4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for lading affer a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of these systems have been treated with RBM (Resorbable Blasted Media). The Fixture diameters are 3.8, 3.9, 4.0, 4.1, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm and lengths are 7. 8.5, 10. 11.5, 13, 14.5 mm in this system. The contained various abutments and accessories in the system are cover screw, abutment screw, healing abutment, solid abutment, transfer abutment, milling abutment, Temporary Abutment, protect cap, solid impression coping, solid lab analog, impression coping/pick-up, impression coping/transfer, and fixture lab analog. The material of abutments and accessories are Ti-6A1-4V ELI(ASTM F-136), POM-C and stainless steel. The abutment diameters are 4.0, 4.1, 4.4, 4.5, 4.8, 5.0, 5.5, 5.8, 6.0, 6.3, 6.5, 6.8, 7.0, 7.3, 7.8 and Heights are 4.0, 5.5, 7.0, 9.0. The implants are supplied sterile and the abutments and accessories are provided non-sterile. The abutments and accessories should be sterilized before use.

The provided text is a 510(k) summary for the U fit Dental Implant System. It describes the device, its intended use, and compares it to predicate devices. However, it does not include information about specific acceptance criteria or a "study that proves the device meets the acceptance criteria" in the format typically associated with clinical performance evaluations for AI/ML devices.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of materials, intended use, and non-clinical performance testing. The "acceptance criteria" here implicitly refer to meeting the standards outlined in the FDA's guidance for root-form endosseous dental implants and abutments, and satisfying general safety and effectiveness requirements by demonstrating similarity to legally marketed devices.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format for performance metrics relevant to an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence.

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

This information is not applicable as the submission describes a medical device (dental implant system) made of physical materials, not an AI/ML software device that would use a "test set" of data in the common sense. The "testing" referred to is biocompatibility, sterilization validation, and material property testing, which are typically performed on samples of the manufactured device components rather than a "data set."

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

This information is not applicable. The assessment for this type of device does not involve expert readers establishing ground truth from images or data. Ground truth is established through laboratory testing following recognized standards.

4. Adjudication Method:

This information is not applicable. There is no adjudication method described as there are no expert interpretations to reconcile.

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

This information is not applicable. MRMC studies are used for evaluating diagnostic software where human readers' performance is assessed with and without AI assistance. This device is a physical implant, not a diagnostic software.

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

This information is not applicable. This is not an algorithm or software device.

7. Type of Ground Truth Used:

The "ground truth" for verifying the safety and effectiveness of a dental implant system of this type is established through:

• Material Specifications: Adherence to ASTM standards (e.g., ASTM F136 for Ti-6Al-4V ELI).
• Biocompatibility Testing: Results from in vitro and in vivo tests (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, hemocompatibility) according to ISO 10993.
• Sterilization Validation: Demonstrated sterility assurance level (SAL) according to ISO 11737 and ISO 17665.
• Surface Characterization: Chemical analysis and SEM imaging to confirm the RBM treatment and lack of residuals.
• Mechanical Testing (Implied): Although not explicitly detailed in the summary, dental implants typically undergo mechanical strength and fatigue testing to ensure they can withstand physiological loads. This is usually part of meeting the FDA's "Class II Special Controls Guidance Document."

8. Sample Size for the Training Set:

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

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

This information is not applicable.

Ask a specific question about this device

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

This device is a conventional unscented menstrual tampon consisting of an absorbent pledget, overwrap, a withdrawal string and an applicator. The terminology used in describing the device in rest of this 510(k) submission is as follows; Complete device: U by KOTEX Click* Unscented Menstrual Tampons with applicator Tampon component: Absorbent pledget, overwrap and a withdrawal string. Applicator: Inner plunger tube, a clear middle telescopic tube and an outer insertion tube (barrel) formed with a closed, rounded tip. 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 bullet-shaped pledget, overwrapped with a non-woven fabric. The withdrawal string will be available in pink and white colors. The tampon component is inserted into a three-piece plastic applicator consisting of an inner plunger tube, a clear middle telescopic tube and an outer insertion tube (barrel) formed with a closed, rounded tip. Each tampon with applicator is wrapped in an individual plastic film wrapper and packaged in sealed multi-unit containers for retail sale.

The provided text describes a Special 510(k) for Kimberly-Clark U by KOTEX Click Unscented Menstrual Tampons. This submission is for modifications to an already legally marketed device, primarily concerning the addition of new colorants for the applicator and a minor applicator design improvement. The core tampon component remains largely unchanged.

The study presented focuses on demonstrating that the modified device is substantially equivalent to the predicate device in terms of safety and effectiveness. This is not a study to prove a device meets specific acceptance criteria related to an AI algorithm's performance. Instead, it's a regulatory submission demonstrating equivalence for a medical device (menstrual tampon).

Therefore, I cannot populate most of the requested fields because the input document does not pertain to the performance of an AI algorithm or a study designed to establish its acceptance criteria and performance against those criteria. It is a regulatory filing for a physical medical device.

However, I can extract the information related to the preclinical testing performed to demonstrate safety and effectiveness for this specific device.

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

Important Note: The "acceptance criteria" here are the standards and regulations the device must meet to demonstrate safety and effectiveness for a menstrual tampon. This is different from the acceptance criteria for an AI algorithm's performance (e.g., sensitivity, specificity, AUC).

The following information cannot be provided from the given document as it pertains to AI algorithm studies, which is not the subject of this 510(k) summary:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Ask a specific question about this device

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

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

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

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

4. Adjudication Method:

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

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

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

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

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

7. Type of Ground Truth Used:

The ground truth used for this evaluation is based on:

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

8. Sample Size for the Training Set:

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

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

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

Ask a specific question about this device

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

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

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons, formatted according to your request:

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 size used for the test set of the preclinical or effectiveness studies. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not provided in the document. The studies listed (e.g., biocompatibility tests, syngyna absorbency) are laboratory-based tests with objective criteria, rather than expert-driven assessments requiring a "ground truth" established by human experts.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are laboratory-based and do not involve human interpretation requiring adjudication.

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

No MRMC comparative effectiveness study was mentioned or implied. The submission is for a modification (new applicator colors) to an already legally marketed device, and the focus is on demonstrating equivalence through preclinical and performance tests, not on improving human reader performance with AI.

6. Standalone (Algorithm Only) Performance Study

This is not applicable as the device is a physical menstrual tampon and not an algorithm or AI-driven system.

7. Type of Ground Truth Used

The "ground truth" for the acceptance criteria mentioned generally refers to:

• Established biological responses/endpoints: For biocompatibility tests (e.g., cell viability for cytotoxicity, inflammatory response for irritation/sensitization, systemic effects for toxicity).
• Standardized physical measurement: For syngyna absorbency, the ground truth is a specific absorbency value determined by the standardized test method outlined in 21 CFR § 801.430.

8. Sample Size for the Training Set

This is not applicable as the device is not an AI/ML algorithm that requires a training set. The existing device (predicate) serves as a basis for substantial equivalence for the modified device.

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

This is not applicable for the reasons stated in point 8.

Ask a specific question about this device