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For the temporary management of stress urinary incontinence in women

The device is a single use vaginal pessary, inserted into the vagina, by the user, using a tampon-like applicator. The device is composed of a high density polyethylene core, a nonwoven overwrap, and a withdrawal cord. The overwrap helps to facilitate ease of insertion and removal. The device is removed by a withdrawal cord made from tampon withdrawal cord material. Upon removal, the device is disposed of in a trash receptacle. The pessary is a single-use device. It is designed for daily use up to 12 hours in 24 hours. The device is available in one size and is sold over-the-counter.

This document details the premarket notification for the "Always/Tampax bladder supports" device. However, it does not contain information about the acceptance criteria or a study proving the device meets specific performance acceptance criteria related to its primary function of managing stress urinary incontinence (SUI).

Instead, the document focuses on:

• Substantial Equivalence: Demonstrating that the device is substantially equivalent to a legally marketed predicate device (Improve Bladder Supports/TIPI OTC K131198). This is the primary goal of a 510(k) submission.
• Safety and Efficacy Studies: Two clinical studies (a safety study and an efficacy and safety study) were conducted to support the device's safety and effectiveness. However, these studies evaluated the device's performance in general terms (e.g., well-tolerated, minimal effect on vaginal wall, statistically significant and clinically meaningful improvement in symptoms, able to self-administer appropriately) rather than against specific, quantifiable performance acceptance criteria for SUI management.
• Non-Clinical Tests: These tests focused on design verification (e.g., applicator force, withdrawal cord strength, core stiffness, dimensions) and biocompatibility (cytotoxicity, sensitization, irritation, genotoxicity, systemic toxicity, local effects after implantation, TSS risk). These are about the device's physical and biological properties.
• Label Comprehension and Self-Selection: A study to ensure users understand the labeling and can self-select the product appropriately for an OTC device.

Therefore, many of the requested items cannot be answered directly from the provided text as the information is not present in the content.

Based on the provided text, here is what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, the document does not explicitly define specific, quantitative acceptance criteria for the device's performance related to SUI management (e.g., "reduce SUI episodes by X%" or "reduce pad weight by Yg"). The clinical studies conclude that the device was effective and safe, and provided a "statistically significant and clinically meaningful improvement" in SUI symptoms and pad weight gain, but without defining a specific benchmark for "improvement" as an acceptance criterion.

The non-clinical tests (e.g., cytotoxicity, withdrawal cord strength) do have implied acceptance criteria (e.g., "non-cytotoxic," "not broken or detached") but these are for device safety and integrity, not the clinical performance in managing SUI.

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

• Efficacy and Safety Study (Clinical Tests):
  • Sample Size: Not explicitly stated. The text mentions it was a "single-arm, open label, multi-center, 4-week efficacy study."
  • Data Provenance: Not explicitly stated (e.g., country of origin). The studies were "multi-center." They are prospective as they are described as "studies performed" to evaluate the device.
• Safety Study (Clinical Tests):
  • Sample Size: Not explicitly stated. Described as "A randomized, 2-arm (pad control), single-blind (vaginal examiner), multi-center, 3-month safety study."
  • Data Provenance: Not explicitly stated (e.g., country of origin). The studies were "multi-center." They are prospective.
• Label Comprehension and Self-Selection Study:
  • Sample Size: Not explicitly stated. It describes "Three cohorts were tested: 1) A population of women... ages 18 and older; 2) A population of women... ages 18 and older with low literacy; 3) A population of women... ages 65 and older."
  • Data Provenance: Not explicitly stated (e.g., country of origin). Likely prospective.

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

• This information is not provided in the document for any of the clinical studies. The clinical studies evaluated patient-reported outcomes (SUI episode frequency, pad weight gain) and physician observations (vaginal examinations), but there is no mention of "ground truth" being established by a panel of experts. The safety study explicitly mentions a "single-blind (vaginal examiner)," implying a single expert for certain assessments in that study, but their qualifications are not provided.

4. Adjudication Method for the Test Set

• This information is not provided in the document. The studies are described as clinical trials with various designs (randomized, single-blind, open label), but no details on adjudication processes for outcomes are mentioned.

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

• No, an MRMC comparative effectiveness study was not done. This device is a physical, over-the-counter vaginal pessary for SUI management, not an AI-based diagnostic or assistive software. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

• No, this is not applicable. As mentioned above, the device is a physical medical device, not an algorithm or AI software. There is no algorithm to perform in a standalone capacity.

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

• For the clinical efficacy study, the "ground truth" or primary outcome measures appear to be patient-reported outcomes data (SUI episode frequency, reduction in pad weight gain) and possibly clinical observation data from vaginal examinations.
• For the safety study, the "ground truth" or outcome measures were adverse events, physical examinations, visual vaginal examinations, clean catch urine collection, and vaginal swabbing.
• For the non-clinical tests (e.g., biocompatibility), the ground truth is derived from standardized test methods and their defined pass/fail criteria (e.g., ISO standards, specific observable reactions). For example, "non-cytotoxic" and "non-irritating" serve as the ground truth.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set. The clinical studies mentioned are for evaluation of the device itself, not for training an algorithm.

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

• Not applicable. As above, there is no AI/ML algorithm or training set for this device.

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The Oral-B® Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene, including the reduction of dental plaque and the treatment and prevention of gingivitis.

The Oral-B® Test Drive Power Brush Trial Program Kit is indicated for use under the supervision of a dental professional as part of the Oral-B® Test Drive Power Brush Trial Program.

The Oral-B® Test Drive Power Brush Trial Program is designed to introduce potential users to a power toothbrush as a means to promote good oral hygiene, including the reduction of dental plaque and the treatment and prevention of gingivitis. The program kit that is used in the trial program contains a power toothbrush consisting of a rechargeable handle, charger, replacement brush heads, and instructions for the proper use and care of the device. Additionally, the program kit contains plastic dental sheaths to prevent soiling of the multi-user handle and instructions for cleaning and disinfection of the reusable handle. The program kit is indicated for use as an introductory trial to a power toothbrush under the supervision of a dental professional as part of the Oral-B® Test Drive Power Brush Trial Program.

This document is a 510(k) premarket notification for a Class I powered toothbrush. It asserts substantial equivalence to a predicate device and does not involve AI or complex diagnostic criteria. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and AI performance metrics are not applicable to this type of device and submission.

Here's an breakdown of the relevant information provided and why other categories are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the sense of specific numerical performance metrics for a diagnostic or AI device. For a Class I powered toothbrush, substantial equivalence is primarily based on comparing the new device's intended use, design, dimensions, materials, biocompatibility, and general performance to a legally marketed predicate device.

The document states:

• Acceptance Criteria (Implied): The Oral-B® Test Drive Power Brush Trial Program Kit must perform comparably to the predicate device (Oral-B® Rechargeable Toothbrush, K061199) and demonstrate the ability to withstand multiple uses and disinfection without compromising integrity or performance.
• Reported Device Performance:
  • "Benchtop testing for the program kit was performed under conditions that simulated normal use and worst case scenario for wear. The performance testing demonstrated that the program kit handle can sustain multiple fittings of the brush head onto the reusable handle, and that the integrity of the seal remains intact with normal use."
  • "Benchtop testing also demonstrates that the cleaning and disinfection procedure results in satisfactory disinfection of the handle, and that the repeated exposure of the handle to the disinfectant had no effect on the physical characteristics or performance of the device."

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

• Sample Size for Test Set: Not explicitly stated numerically. The benchtop testing was conducted on an unspecified number of "program kit handles" and "brush heads" to simulate normal use and worst-case scenarios.
• Data Provenance: The testing was "benchtop testing," implying internal lab testing conducted by the manufacturer, Procter & Gamble. No country of origin for test data is specified beyond the manufacturer's location. The testing is prospective in the sense that it was conducted on the device prior to submission, rather than analyzing pre-existing patient data.

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

Not applicable. This is not an AI/diagnostic device that requires expert-established ground truth for performance evaluation. The "ground truth" here is adherence to manufacturing specifications and functional performance.

4. Adjudication method for the test set

Not applicable. No expert adjudication process is detailed as this is not a diagnostic device requiring interpretation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

Not applicable. This is not an AI-assisted diagnostic device, so MRMC studies are irrelevant.

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

Not applicable. There is no algorithm or AI component in this device.

7. The type of ground truth used

For this device, the "ground truth" effectively refers to:

• Functional Performance: The ability of the handle to sustain multiple brush head fittings and maintain seal integrity.
• Disinfection Efficacy: The cleaning and disinfection procedure achieving "satisfactory disinfection."
• Material Compatibility: The handle's physical characteristics and performance remaining unaffected by repeated exposure to disinfectant.
  These are established through engineering and microbiology testing in a lab setting.

8. The sample size for the training set

Not applicable. There is no AI or machine learning component requiring a training set.

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

Not applicable.

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The TAMPAX® L Plastic Applicator Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid.

Unscented menstrual tampons for absorption of menstrual fluid. The tampon is a conventional design consisting of an absorbent pledget, an overwrap, a withdrawal cord and an applicator. The materials of construction are cotton, rayon, polypropylene and polyester. The device functions by absorbing menstrual fluid after being inserted into the vagina.

The provided text is a 510(k) summary for a medical device called TAMPAX® L Plastic Applicator Tampons, unscented. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics typically found in AI/ML performance studies.

Therefore, many of the requested elements for describing an AI/ML acceptance criteria study (sample size for test/training sets, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable or not present in this document.

The document highlights the device's technological characteristics and nonclinical tests to establish safety and equivalence to a predicate device.

Here's an analysis based on the available information:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable / Not Provided. This document describes nonclinical tests for a physical medical device (tampon), not a software or AI/ML device that would have a "test set" and "data provenance" in the traditional sense of AI/ML. The "tests" here refer to laboratory evaluations of material properties and physical performance.

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

• Not Applicable / Not Provided. Ground truth establishment by experts is not relevant in the context of material and physical property testing of a tampon.

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

• Not Applicable / Not Provided. Adjudication methods are not relevant for the type of nonclinical tests described.

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, not an AI/ML system.

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

• Not Applicable. This is a physical medical device, not an AI/ML system.

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

• Not Applicable / Not Provided. For the nonclinical tests mentioned (biocompatibility, extractions, Syngyna, expulsion force, withdrawal cord strength), the "ground truth" would be established by validated physicochemical or biomechanical laboratory testing methods, not expert consensus or pathology in the context of an AI/ML model.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/ML system, so there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML model, there is no ground truth needed for it.

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TAMPAX® Pearl Plastic Applicator Unscented Tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

The device is a conventional unscented menstrual tampon consisting of an absorbent pledget, an overwrap, a withdrawal cord, an absorbent braid, and an applicator.

This document provides a 510(k) summary for the TAMPAX® Pearl Plastic Applicator Unscented Tampons. The purpose of this summary is to demonstrate the device's substantial equivalence to predicate devices, focusing on safety and effectiveness.

Here’s an analysis of the provided information, framed by your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) summary for a menstrual tampon, the "AI" related questions are not applicable to this type of medical device submission. The device described does not involve AI, image analysis, or expert-driven diagnostic interpretations. Therefore, sections 2-6 and 8-9 are specifically tailored to human-read diagnostic studies or AI-driven medical devices and cannot be fully answered or are entirely irrelevant for this tampon submission.

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

• Test Set (Clinical Trials): The exact sample size for the clinical trials is not specified in the provided text. The document states "In the clinical trials that were performed..." but does not give numerical details about participants.
• Data Provenance: The document does not specify the country of origin of the data. It implies prospective clinical evaluations ("clinical trials that were performed").
• Preclinical Testing: No sample sizes are provided for the preclinical toxicology or microbiology testing.

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

• Not Applicable. This is a physical medical device (tampon), not a diagnostic device requiring expert interpretation or ground truth establishment in the traditional sense of image analysis or diagnostic studies. The safety and effectiveness are assessed through laboratory tests and clinical observations rather than expert consensus on a diagnostic output.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this is not a diagnostic study requiring adjudication of expert opinions. Clinical observations were made during trials, and laboratory tests were conducted, but an adjudication method for a "test set" in the context of interpretation is not relevant here.

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 diagnostic device, and therefore neither an MRMC study nor AI assistance is relevant.

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

• Not Applicable. This device does not involve an algorithm or AI.

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

For this device, "ground truth" is established through:

• Standardized Laboratory Testing: For absorbency, the syngyna absorbency test (21 CFR 801.430) serves as the defined standard. For toxicology and microbiology, standard methods are used to determine parameters like irritation, sensitization, and microbial growth/toxin production. These are objective measures against predefined criteria.
• Clinical Observation: Absence of adverse events in clinical trials serves as "ground truth" for clinical safety, relying on participant reporting and investigator observation.
• Comparison to Predicate: The ultimate "ground truth" for substantial equivalence is that the new device performs equivalently to the legally marketed predicate devices, as demonstrated by the above tests.

8. The sample size for the training set

• Not Applicable. This device does not involve an algorithm or AI, so there is no "training set."

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

• Not Applicable. This device does not involve an algorithm or AI, so there is no "training set" and therefore no ground truth established for it.

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To remove plaque and food particles from between the teeth as part of a comprehensive dental treatment program to reduce tooth decay and to treat and prevent gingivitis.

Crest Glide dental floss is a manual dental floss comprised of polytetrafluoroethylene monofilament fiber and a coating comprised of beeswax, gum arabic, water, flavor and other ingredients for color and cosmetic benefits. The floss was developed to improve ease of sliding between tight spaces to achieve effective plaque removal. Each of the materials that could come in contact with the user of this device is comprised of well-defined materials that are safe for use in the oral cavity.

The provided text is for a 510(k) premarket notification for a dental floss product (Crest Glide Dental Floss). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical performance against specific acceptance criteria for AI/ML-based medical devices.

Therefore, many of the requested fields regarding AI/ML device evaluation criteria (such as number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this document.

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The primary "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to existing legally marketed predicate devices and that the device is safe and effective for its intended use. Specifically, for the expanded indication of "treatment and prevention of gingivitis," the acceptance criterion appears to be showing that the addition of dental floss to toothbrushing is effective.

Reported Device Performance:

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

The document references four clinical trials to support the expanded indication. The individual sample sizes for each study are not explicitly stated in this summary.

• Study 1: "Assessment of treatment responses to dental flossing in twins." J of Periodont; August 2006, 77(8):1386-91. (Specific sample size not provided)
• Study 2: "A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing." The University of Texas Health Science Center at San Antonio Dental School, USA. Study conducted in Guatemala. Final Study Report. (Specific sample size not provided. Provenance: Guatemala)
• Study 3: "Comparative effectiveness of flossing and brushing in reducing interproximal bleeding." J of Periodontol; May 1989; 60(5): 243-247. (Specific sample size not provided)
• Study 4: "Comparison of the use of different modes of mechanical oral hygiene in prevention of plaque and gingivitis." J of Periodontol; August 2008; 79(8): 1386-1394. (Specific sample size not provided)

The studies appear to be prospective clinical trials, given their titles and publication dates.

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 dental mechanical device, and the endpoint for clinical studies would typically involve objective measurements (e.g., plaque indices, bleeding scores) rather than subjective expert interpretation for "ground truth" in the AI/ML sense.

4. Adjudication method for the test set

Not applicable. This is a dental mechanical device; adjudication in the context of expert review for AI/ML ground truth is not relevant here. Clinical trial methodologies would have their own blinding and assessment protocols.

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 manual dental floss, not an AI/ML diagnostic or assistive device for human readers.

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

Not applicable. This is a manual dental floss.

7. The type of ground truth used

The "ground truth" or primary outcome measures in these studies would likely be objective clinical parameters related to oral health, such as:

• Plaque scores/indices
• Gingival bleeding scores/indices
• (Potentially) Measures of inflammation or other periodontal health indicators.

These are direct clinical measurements, not expert consensus or pathology in the context of diagnostic imaging.

8. The sample size for the training set

Not applicable. This is a traditional medical device (dental floss), not an AI/ML algorithm that requires a "training set."

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

Not applicable. As above, this is not an AI/ML device.

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The TAMPAX® Pearl Plastic™ unscented and scented Tampons are intended to be inserted into the vagina to absorb menstrual fluid.

Scented or scented deodorized, unscented menstrual tampons for absorption of menstrual fluid.

This document is a 510(k) summary for a medical device (TAMPAX® Pearl Tampons) seeking clearance from the FDA. The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, many of the requested sections regarding acceptance criteria, study details, and AI-specific metrics cannot be extracted from the provided text. The document primarily describes the device, its intended use, and a safety assessment, then states conclusions about its safety and substantial equivalence to existing products.

Here's a breakdown of what can and cannot be answered:

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

• Cannot be provided in the requested format. The document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding quantitative device performance metrics in the way a diagnostic AI study would.
• What is stated: "The results of these safety tests support the conclusion that the 510(k) device is equally as safe as the predicate devices." and "The device is designed to acquire and hold menstrual fluids similar to the fluid handling capabilities of the predicate devices." This indicates a qualitative comparison for safety and functionality rather than quantitative performance against a set of predefined thresholds.

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

• Not explicitly stated for a "test set" in the context of device performance. The document mentions "in vitro microbiological testing, biocompatibility evaluation and extraction testing" as part of the safety assessment. However, it does not specify sample sizes or data provenance (country, retrospective/prospective) for these tests in a way that aligns with evaluating a device's diagnostic performance against a ground truth.

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)

• Not applicable/Not stated. This type of information is relevant for studies validating diagnostic algorithms where expert consensus or pathological analysis establishes ground truth. For a menstrual tampon, the "ground truth" would likely relate to material properties, absorbency, and safety markers, which are evaluated through lab tests, not expert interpretation of outputs.

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

• Not applicable/Not stated. Adjudication methods are used in studies involving human interpretation or subjective assessments, typically for diagnostic image analysis or similar tasks. This is not described for a tampon.

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, not an AI-powered diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

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

• Not applicable. This is not an algorithm or AI device.

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

• Implied ground truth for safety and function: The "ground truth" for this device would be established through laboratory testing standards for absorbency, material composition, biocompatibility, and microbiological safety. The document refers to "in vitro microbiological testing, biocompatibility evaluation and extraction testing." These tests have their own established methods and criteria for determining safety and performance, which serve as the "ground truth" for evaluating the tampon's characteristics.

8. The sample size for the training set

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

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

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

Summary of what the document does provide regarding the device and its assessment:

The document describes the submission of a 510(k) premarket notification for TAMPAX® Pearl Tampons (unscented and scented). The primary goal of this submission is to demonstrate substantial equivalence to predicate devices (TAMPAX Pearl Tampons® unscented and scented: K011996; K040312; K051290).

Key "Acceptance Criteria" (implicit, based on 510(k) process for this device type):

• Safety: The device is as safe as predicate devices.
• Effectiveness/Functionality: The device is designed to acquire and hold menstrual fluids similar to the fluid handling capabilities of the predicate devices.
• Technological Characteristics: The device is similar to the predicate devices in terms of basic component materials, overall design, and labeling.
• Intended Use: Consistent with predicate devices.

Study that proves the device meets the (implicit) acceptance criteria:

• Study Type: A battery of safety evaluations was conducted.
• Specific Tests Mentioned:
  • In vitro microbiological testing
  • Biocompatibility evaluation
  • Extraction testing
• Results/Conclusions:
  • "The results of these safety tests support the conclusion that the 510(k) device is equally as safe as the predicate devices."
  • "The results of evaluations for this device support the conclusions that it is safe for its intended use and substantially equivalent to the cited predicate devices."

In conclusion, this document describes a traditional medical device submission (a tampon) seeking clearance based on substantial equivalence, not a performance study for an AI-driven diagnostic device. Therefore, the detailed metrics and study design elements typically associated with AI performance evaluation are not present.

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To promote good oral hygiene including plaque removal and treating and preventing gingivitis.

The Oral-B® toothbrush is a manual toothbrush comprised of a shaft with synthetic bristles at one end. The bristles are arranged in a pattern to achieve effective mechanical plaque removal. Some of the bristle tufts have a wear indicator function. These Indicator bristles are colored with FDA approved colorant, FD&C Blue No. 2.

The provided text describes a 510(k) submission for an Oral-B® manual toothbrush, where the manufacturer is seeking to expand the indication for use to include "treating and preventing gingivitis." The core of the submission emphasizes that the device is substantially equivalent to legally marketed predicate devices, with no changes in material, design, or manufacturing process, but only an expanded indication.

However, the document does not contain specific acceptance criteria in a quantitative format (e.g., a specific percentage reduction in gingivitis or plaque). Instead, it states that numerous controlled clinical studies have been performed and "collectively, these studies demonstrate that Oral-B® manual toothbrushes are effective at treating and preventing gingivitis via the physical/mechanical removal of plaque."

Therefore, it is not possible to construct a table of acceptance criteria and reported device performance as requested, because specific quantitative metrics and thresholds for acceptance are not detailed in the provided text.

Furthermore, the document primarily functions as a 510(k) summary and the FDA's response, rather than a detailed study report. As such, many of the specific details about the studies (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not present in the given text.

Based on the provided information, here's what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

As stated above, the document does not explicitly list quantitative acceptance criteria. Instead, it refers to a body of clinical evidence supporting the expanded indication. The reported "performance" is qualitative, indicating effectiveness in treating and preventing gingivitis and removing plaque.

Study Details

Due to the nature of the provided document (a 510(k) summary and FDA letter), many of the specific study details are not available in the text.

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

   • Not available in the provided text. The document states "numerous controlled clinical studies" but does not provide specific sample sizes for these studies, their design (retrospective/prospective), or their geographic origin. The bibliography lists several clinical investigations but does not offer these details in the provided snippets.

2. 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):

   • Not available in the provided text. This type of detail is typical for device performance studies involving interpretation, but for a manual toothbrush assessing plaque and gingivitis, the "ground truth" would likely be based on clinical measurements (e.g., Gingival Index, Plaque Index) performed by trained dental professionals rather than "experts establishing ground truth" in the diagnostic imaging sense. However, no specific details on the assessors or their qualifications are provided.

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

   • Not available in the provided text. Adjudication methods are typically relevant for studies where subjective assessments by multiple readers need to be reconciled, such as in diagnostic imaging. For clinical measurements of plaque and gingivitis, standard clinical protocols for measurement and inter-examiner reliability would be more typical, but no such details are provided.

4. 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 question pertains to AI-assisted diagnostic tools. The device in question is a manual toothbrush, which is a physical device, not an AI or diagnostic software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

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

   • Not applicable. As above, this question is for AI/software devices. The manual toothbrush is a standalone physical device. Its performance is its intrinsic mechanical action.

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

   • Implied Clinical Measurements/Outcomes: While not explicitly stated, for plaque removal and gingivitis improvement, the ground truth would be based on clinical indices and outcomes data (e.g., Gingival Index scores, Plaque Index scores, bleeding on probing, etc.) measured by trained dental examiners.

7. The sample size for the training set:

   • Not applicable. This question is typically for machine learning models. For a physical device like a toothbrush, there isn't a "training set" in the machine learning sense. The clinical studies establish its effectiveness.

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

   • Not applicable. As above, this refers to machine learning models.

Summary of available information regarding the "study that proves the device meets the acceptance criteria":

• Device: Oral-B® "sub-brand" manual toothbrush.
• Expanded Indication: To promote good oral hygiene including plaque removal and treating and preventing gingivitis.
• Proof basis: "Numerous controlled clinical studies" have evaluated the effectiveness of the manual brush at removing plaque and improving and maintaining gingival health, and assessed soft and hard tissue safety.
• Conclusion: These studies "demonstrate that Oral-B® manual toothbrushes are effective at treating and preventing gingivitis via the physical/mechanical removal of plaque." The information "supports the safety and effectiveness" and "substantial equivalence to the predicate devices without raising any new safety and effectiveness issues."
• Underlying studies: A bibliography lists several clinical investigations conducted from 1996 to 2007, some of which compare power toothbrushes to manual toothbrushes, or compare different manual toothbrushes. These titles suggest that the studies indeed focused on efficacy in plaque removal and gingivitis reduction.

In essence, the 510(k) relies on a body of existing clinical evidence to support the expanded indication, rather than presenting a single, new, dedicated study with detailed acceptance criteria and performance metrics for this specific submission. The FDA's approval indicates they found this collective evidence sufficient to establish substantial equivalence for the expanded indication.

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Always® are unscented menstrual pads for absorption of menstrual and other vaginal discharge, and for absorption of urine loss associated with light incontinence due to stress-related activities such as laughs, coughs, sneezes and exercise.

The menstrual pad device has 4 primary components, 1) The permeable topsheet allows fluid to pass through into the core; 2) the absorbent core acquires and stores fluid; 3) the impermeable backsheet prevents fluid transfer beyond the core; 4) the attachment adhesive holds the pad in place, The absorbent core is held in place between the topsheet and the backsheet.

The provided text is a 510(k) summary for the Always® unscented menstrual pad, which is a Class I medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria and detailed performance studies like those required for higher-risk devices or novel technologies.

Therefore, the information requested in your prompt (acceptance criteria, specific study design details like sample size for test sets, expert involvement, MRMC studies, standalone performance, ground truth establishment, and training set details) is not applicable and not present in this 510(k) summary for a menstrual pad.

Here's why and what information is provided instead:

• Device Type: This is a menstrual pad, classified as a Class I device (unscented menstrual pad, 21 CFR 884.5435). Class I devices are subject to general controls, and typically do not require extensive clinical data to demonstrate effectiveness.
• Regulatory Pathway: A 510(k) submission primarily aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This means it performs as well as or better than the predicate, with the same intended use and similar technological characteristics.
• Focus of the Summary: The summary focuses on:
  • Device Description: What the pad is made of (topsheet, absorbent core, backsheet, adhesive).
  • Intended Uses: Absorption of menstrual fluid, other vaginal discharge, and light urine loss.
  • Technological Characteristics: Designed to acquire and hold fluids similar to the predicate devices.
  • Safety Assessment: A battery of in vitro microbiological testing, biocompatibility testing, and extraction testing. The conclusion is that it is "equally as safe an the predicate devices."
  • Conclusion: Safe for intended use and substantially equivalent to predicate devices regarding safety and effectiveness.

Specific answers to your requested points based on the provided text:

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

   • Acceptance Criteria: Not explicitly stated as quantifiable metrics. The overarching acceptance criterion is "substantial equivalence" to the predicate devices in terms of "safety and effectiveness."
   • Reported Device Performance: The text states, "The device is designed to acquire and hold menstrual fluids or light urine loss similar to the fluid handing capabilities of the predicate devices." No specific quantitative performance metrics (e.g., absorption capacity in grams, leakage rates, etc.) are provided in this summary. The "Safety Assessment" mentions "in vitro microbiological testing, biocompatibility testing and extraction testing," the results of which "support the conclusion that the 510(k) device is equally as safe an the predicate devices."

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

   • Not applicable/not provided. The "safety tests" are mentioned as a "battery of safety tests," but no details on sample sizes or data provenance are given. These are likely laboratory tests rather than human clinical trials.

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

   • Not applicable/not provided. This type of device evaluation doesn't typically involve expert consensus on a "ground truth" for performance. Safety tests are usually evaluated against established laboratory standards or predicate device results.

4. Adjudication method for the test set:

   • Not applicable/not provided.

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 product (menstrual pad), not an AI/imaging device requiring MRMC studies.

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

   • Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

   • For safety, the "ground truth" would be established by laboratory testing standards and comparison to the predicate devices' known safety profiles. For "effectiveness," the "ground truth" is that it performs similarly to the predicate devices based on its design and material characteristics. Specific outcome data or pathology are not mentioned.

8. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

   • Not applicable.

In summary, this 510(k) pertains to a low-risk device where the primary evidence for regulatory clearance is demonstrating substantial equivalence through a comparison of technological characteristics and safety data, rather than extensive clinical efficacy studies with detailed performance metrics and expert-adjudicated ground truth.

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TAMPAX® Compak Pearl Plastic Applicator Scented Tampons and TAMPAX® Compak Pearl Plastic Applicator Unscented Tampons are menstrual trim 180 that are inserted into the vagina and used to absorb menstrual fluid.

The device is a conventional menstrual tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. It is available in both scented and unscented versions.

• The absorbent pledget consists of a scented or unscented pad of rayon ● fibers overwrapped with a non-woven fabric. A cotton withdrawal cord is sewn to the pad, and the pad is compressed into a traditional bullet-shaped 彩 pledget.
• The formed pledget is inserted into a plastic applicator consisting of an inner . pusher tube and an outer insertion tube with a closed, rounded tip.
• Each tampon is wrapped in an individual plastic film wrapper and packaged . in sealed multi-unit containers for retail sale.

This document describes the Procter & Gamble Company's 510(k) submission for TAMPAX® Compak Pearl Plastic Applicator Scented and Unscented Tampons (K062638). This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a traditional artificial intelligence or medical imaging context. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This is a medical device submission, not an AI or diagnostic imaging study. The "tests" mentioned are referring to laboratory and performance evaluations for the tampon's physical and biological properties.

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

Not applicable. Ground truth as understood in AI/imaging studies (e.g., expert consensus on image interpretation) is not relevant here. The "truth" for safety and effectiveness is established by standardized laboratory testing and regulatory compliance.

4. Adjudication Method for the Test Set

Not applicable. This concept is not relevant to the described testing.

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

No. This type of study is for evaluating the performance of diagnostic systems, often in comparison to human readers. This submission is for a physical medical device (tampon).

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

Not applicable. There is no algorithm or AI component involved in this device.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily established through:

• Regulatory Standards: Compliance with specific CFR (Code of Federal Regulations) requirements, such as 21 CFR 801.430 for syngyna absorbency.
• Laboratory Testing: Results from in vitro microbiological testing, biocompatibility testing, and extraction testing using established scientific methodologies.
• Predicate Device Comparison: Establishing equivalence to previously approved devices.

8. The Sample Size for the Training Set

Not applicable. There is no AI model or "training set" in the context of this device submission.

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

Not applicable.

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TAMPAX® Tampons are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

The device is a conventional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The absorbent pledget consists of a pad of cotton and/or rayon fibers overwrapped with a non-woven fabric. A cotton withdrawal cord is sewn to the pad, and the pad is compressed into a traditional bullet-shaped pledget. The formed pledget is inserted into a flushable paper applicator consisting of an inner pusher tube and an outer insertion tube with an open distal end. Each tampon is wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.

Here's an analysis of the provided text regarding the acceptance criteria and study for the TAMPAX® Tampons (K061486), structured 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 a specific sample size for a test set as it relies heavily on the equivalence to a predicate device. The primary "test" mentioned is compliance with a regulatory standard (syngyna absorbency), which is a laboratory test, not a clinical study with a human subject test set.

• Sample Size: Not applicable/not explicitly stated for a "test set" in the traditional sense of a clinical trial.
• Data Provenance: Not applicable as it's primarily a regulatory compliance statement and reliance on prior predicate device testing.

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

Not applicable. This submission relies on regulatory standards and previous testing of a predicate device. There is no mention of a ground truth established by human experts for a specific test set within this document.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring expert adjudication is mentioned.

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 medical device submission for tampons, not an AI-powered diagnostic tool. Therefore, an MRMC study is irrelevant.

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

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

7. The Type of Ground Truth Used

The "ground truth" for demonstrating effectiveness and safety is primarily based on:

• Regulatory Standard Compliance: Specifically, 21 CFR §801.430 for syngyna absorbency. This is a defined, objective test.
• Equivalence to Predicate Device: The safety and effectiveness are established by demonstrating that the new device is "substantially equivalent" to an already approved predicate device (TAMPAX® Tampons, K040999) due to similar materials and intended use, with the only difference being applicator grip design. The ground truth for the predicate device would have been established through its own initial approval process.

8. The Sample Size for the Training Set

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

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

Not applicable. As there is no training set mentioned.

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