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510(k) Data Aggregation
(119 days)
The Procter & Gamble Company
Relieves the symptoms and discomfort of dry mouth, refreshes, moisturizes/hydrates, soothes oral irritation and lubricates oral dryness.
Provides long lasting relief for up to 6 hours.
The Oral-B® Dry Mouth Oral Rinse is a non-sterile clear liquid formulated as an artificial saliva (LFD) intended to be marketed over the counter for at-home use. The artificial saliva for dry mouth is formulated with gel film forming polysaccharides, sodium hyaluronate, which possess lubricating and moisturizing properties. Oral-B® Dry Mouth Oral Rinse also contains water, moisturizers/humectants, thickener, surfactant, pH adjusters, preservative, sweetener and flavor that collectively form the device formulated at a pH of 6 and designed to help relieve and manage the symptoms of dry mouth. A list of device components can be found in Table 5-1. None of the constituents used in the device are novel materials not previously used in a legally marketed US-medical device).
The device is intended to be used for 30 seconds each use, up to five times daily for consumers 12 years or older. Oral-B® Dry Mouth Oral Rinse is supplied in a 16-fluid ounce white Polyethylene Terephthalate (PET) bottle, with a white polypropylene closure and a clear polypropylene dosing cup.
Here's an analysis of the acceptance criteria and study as described in the provided document:
This document is a 510(k) summary for the Oral-B® Dry Mouth Oral Rinse (K203567), which seeks to update its "Indications for Use" from providing relief for "up to 4 hours" to "up to 6 hours." The device itself is identical to a previously cleared predicate device (K201277).
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document presents the acceptance criteria implicitly through the study's objective: to demonstrate longer-lasting relief. The performance is reported as the outcome of that demonstration, not against explicit, pre-defined quantitative thresholds in the same way one might see for, say, diagnostic accuracy.
| Acceptance Criteria (Implied) | Reported Device Performance (K203567) |
|---|---|
| Demonstrate efficacy in relieving dry mouth symptoms immediately post-use. | Oral-B® Dry Mouth Oral Rinse was more effective than water at providing immediate dry mouth moisturization. |
| Demonstrate efficacy in relieving dry mouth symptoms up to 6 hours post-use. | Oral-B® Dry Mouth Oral Rinse was more effective than water at providing overnight and up to 6 hours of relief of dry mouth symptoms. |
| Support the modified "Indications for Use" statement: "Provides long lasting relief for up to 6 hours". | Analysis of the clinical study results support the Indication for Use statement of "Provides long lasting relief for up to 6 hours". The majority of study subjects using the subject device achieved dry mouth symptom relief at all time points including 4- and 6- hours post-treatment. |
| No new safety concerns compared to predicate. | No formulation/technological changes from the predicate; device is considered as safe as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number. The document mentions "subjects with self-reported dry mouth symptoms."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study was a "controlled, randomized, 3-treatment, parallel clinical study," indicating it was prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The study used "an Oral Examination" to identify subjects who experienced dry mouth symptoms. It's not specified how many experts conducted these examinations or their particular qualifications (e.g., dentist, physician, etc.).
- Ground truth was also partly established by "subject responses to the Dry Mouth Inventory (DMI) questionnaire," which is a self-reported measure.
4. Adjudication Method for the Test Set
- The document does not mention an adjudication method for the test set or for establishing ground truth. The primary endpoints appear to be direct comparison of product efficacy against a control based on symptom relief.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This study evaluated the direct clinical effect of an oral rinse on dry mouth symptoms, not the performance of an AI algorithm assisted by human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This document describes a medical device that is an oral rinse, not an AI algorithm. Therefore, there is no "algorithm only" performance to report.
7. Type of Ground Truth Used
- The ground truth for effectiveness was based on a combination of:
- Clinical assessment: "Oral Examination" to determine dry mouth symptoms.
- Patient-reported outcomes: "subject responses to the Dry Mouth Inventory (DMI) questionnaire" measuring dry mouth symptom relief.
8. Sample Size for the Training Set
- N/A. As this is not an AI/machine learning device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- N/A. As this is not an AI/machine learning device, there is no "training set" or ground truth establishment for one.
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(112 days)
The Procter & Gamble Company
Relieves the symptoms and discomfort of dry mouth, refreshes, moisturizes/hydrates, soothes oral irritation and lubricates oral dryness.
Provides long lasting relief for up to 4 hours.
The Oral-B® Dry Mouth Oral Rinse is a non-sterile clear liquid formulated as an artificial saliva (LFD) intended to be marketed over the counter for at-home use. The artificial saliva for dry mouth is formulated with gel film forming polysaccharides, sodium hyaluronate, which possess lubricating and moisturizing properties. Oral-B® Dry Mouth Oral Rinse also contains water, moisturizers/humectants, thickener, surfactant, pH adjusters, preservative, sweetener and flavor that collectively form the device formulated at a pH of 6 and designed to help relieve and manage the symptoms of dry mouth. A list of device components can be found in Table 5-1. None of the constituents used in the device are novel materials not previously used in a legally marketed US-medical device).
The device is intended to be used for 30 seconds each use, up to five times daily for consumers 12 years or older. Oral-B® Dry Mouth Oral Rinse is supplied in a 16-fluid ounce white Polyethylene Terephthalate (PET) bottle, with a white polypropylene closure and a clear polypropylene dosing cup.
The provided text describes the regulatory clearance for the Oral-B® Dry Mouth Oral Rinse and details its characteristics and performance. Here's a breakdown based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance for this device is based on a "substantial equivalence" determination rather than specific pre-defined acceptance criteria for performance metrics in the way a diagnostic device might have. Substantial equivalence means the device is as safe and effective as a legally marketed predicate device. The performance data presented focuses on demonstrating this equivalence.
| Feature / Criteria | Acceptance (Implied by Substantial Equivalence Determination) | Reported Device Performance |
|---|---|---|
| Intended Use | Relief of dry mouth symptoms, similar to predicate. | Relief of dry mouth symptoms (Matches predicate). |
| Indication for Use | Relieves symptoms & discomfort of dry mouth, refreshes, moisturizes/hydrates, soothes oral irritation, lubricates oral dryness, and provides long-lasting relief (up to 4 hours), similar to predicate and supported by clinical data. | Relieves the symptoms and discomfort of dry mouth, refreshes, moisturizes/hydrates, soothes oral irritation and lubricates oral dryness. Provides long lasting relief for up to 4 hours. (Supported by clinical study showing effectiveness vs. water and potential superiority to comparator). |
| Biocompatibility | Consistent with ISO 10993-1 and predicate device. | Demonstrated consistent with FDA guidance "Use of International Standard ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." |
| Chemical & Physical Properties (pH, Viscosity, etc.) | Comparable to predicate device such that differences do not raise safety/effectiveness concerns. | pH: 5.5 - 6.4 (Predicate: 5.5-7.0) |
| Viscosity: > 29 cP (Predicate: 20.39 Sct (22.0 cP*)) | ||
| Specific Gravity: 1.04 (Predicate: 1.06) | ||
| Surface Tension: Not explicitly quantified for subject, but "comparative chemical and physical property data... support a finding of substantial equivalence." | ||
| Shelf Life Stability | Demonstrated 24-month shelf life. | Shelf life stability testing provides for a 24-month shelf life of the subject device. |
| Effectiveness in Relieving Dry Mouth Symptoms | More effective than water for immediate moisturization and long-term relief, and demonstrates up to 4 hours duration of effect. | Clinical study demonstrated Oral-B® Dry Mouth Oral Rinse was more effective than water at providing immediate dry mouth moisturization and overnight and long-term relief of dry mouth symptoms. Pilot study results supported duration of effectiveness for up to 4 hours. |
| Safety | No novel materials not previously used in legally marketed US-medical devices, and no concerns raised by compositional differences compared to predicate. | "None of the constituents used in the device are novel materials not previously used in a legally marketed US-medical device)." Compositional differences "do not raise any concerns of safety and effectiveness." |
Note: The "acceptance criteria" here are implied by the FDA's regulatory standard of substantial equivalence to a predicate device, rather than specific numerical targets for performance metrics often seen in diagnostic AI/ML device clearances.
2. Sample size used for the test set and the data provenance
- Sample Size for the test set: Not explicitly stated as a separate "test set" in the context of an algorithm evaluation. The clinical study was a controlled, randomized, 3-treatment, 3-period crossover clinical study. The number of participants in this study is not specified in the provided text.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): The clinical study was described as "conducted" which implies prospective data collection. The country of origin of the data is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an oral rinse, not a diagnostic imaging or AI device requiring expert ground truth for a test set. The clinical study evaluated subjective symptom relief and objective measures related to dry mouth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a diagnostic device requiring adjudication of expert readings.
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 an oral rinse, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an oral rinse, not an algorithm. The "device performance" refers to the product's physical and clinical efficacy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical study, the "ground truth" or primary outcome measures were likely:
- Subjective symptom relief: Patient-reported experiences of dry mouth moisturization and relief.
- Duration of effect: Measured time until symptoms returned or relief diminished.
- The comparison to water served as a control.
8. The sample size for the training set
Not applicable. This is a physical product (oral rinse) and does not involve AI/ML or a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical product (oral rinse) and does not involve AI/ML or a training set.
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(147 days)
The Procter & Gamble Company
The Oral-B® iO Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene.
The Oral-B® iO Test Drive Power Brush Trial Program Kit is indicated for use under the direct supervision of a dental professional, exclusively at conventions (e.g. professional, scientific, trade shows), as part of the Oral-B® iO Test Drive Power Brush Trial Program.
The Oral-B® iO Test Drive Power Brush Trial Program for conventions (e.g. professional, scientific, trade shows), is designed to introduce convention delegates to the newest, most advanced Oral-B electric rechargeable toothbrush as a means to promote good oral hygiene. The program kit contains a power toothbrush consisting of a rechargeable handle, a charger, replacement brush heads, and instructions for the proper use and care of the device. The program kit also contains plastic dental sheaths to prevent soiling and therefore allowing for easier cleaning of the multi-user handle. The sheath is manufactured by TIDI Products, LLC, is provided to Procter & Gamble as a finished, packaged non-sterile device (K132953) for inclusion in the program kit as an accessory. Detailed instructions for cleaning and disinfection of the reusable handle are also included. The program kit is indicated for use as an introductory trial, exclusively within the confines of a convention (e.g. professional, scientific, trade shows), under the direct supervision of a dental professional as part of the Oral-B® iO Test Drive Power Brush Trial Program.
The provided text is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) regarding a powered toothbrush. It concerns the "Oral-B iO Test Drive Power Brush Trial Program Kit" (K200881). The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Oral-B Test Drive Power Brush Trial Program Kit, K141018) and a reference device (Oral-B iO Rechargeable Power Toothbrush, a Class I, 510(k) exempt device).
The information provided does not relate to an AI/ML medical device, a multi-reader multi-case (MRMC) comparative effectiveness study, or the use of AI assistance for human readers. It lists performance data for a physical device, including biocompatibility, electrical safety, software verification, and cleaning/disinfection validation. Therefore, many of the requested categories related to AI/ML device performance and study design (e.g., sample size for test/training sets for AI, expert adjudication, ground truth definition for AI, effect size of AI assistance) are not applicable to this document.
However, I can extract the relevant acceptance criteria and how the device meets them based on the provided "PERFORMANCE DATA" section.
Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a physical medical device (a powered toothbrush) and not an AI/ML algorithm, the "acceptance criteria" are typically defined by compliance with recognized standards and successful completion of specific non-clinical and performance tests to demonstrate safety and effectiveness for its intended use, and ultimately substantial equivalence to a predicate device. The performance data section describes how the device meets these requirements.
Here's a table summarizing the "acceptance criteria" (or performance areas tested for compliance) and the reported device performance:
| Acceptance Criteria/Performance Area | Reported Device Performance |
|---|---|
| Biocompatibility | Tests: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-12). Consistent with ISO 10993 guidance and FDA recommendations. |
| Results: Passed all tests. Confirmed non-cytotoxic, non-sensitizing, and non-irritating, even after cleaning and disinfection. Materials are the same as those used in the predicate and reference device. | |
| Electrical Safety | Standards: UL 1431, IEC 60335-1, IEC 60335-2-52 (as outlined in ISO 20127). |
| Results: Compliant results. Confirms construction addresses risk of fire, shock, and physical injury per specified consensus standards. | |
| Electromagnetic Compatibility (EMC) | Standards: Title 47 CFR Parts 15B, 15C, and 18 of the Federal Communications Commission. |
| Results: Compliant results. Assures unintentional and intentional radiation are within federally prescribed limits across the full RF bandwidth. | |
| Software Verification & Validation | Guidance: FDA guidance documents "General Principles of Software Validation" (Jan 2002) and "Content of Premarket Submissions for Software Contained in Medical Devices" (May 2005). Consistent with "Moderate" Level of Concern. |
| Results: Verification activities demonstrate that the device performs as intended. | |
| Cleaning and Disinfection Validation | Conditions: Simulated normal use and worst-case scenario for wear. |
| Results: Demonstrated satisfactory cleaning and high-level disinfection. Repeated exposure to cleaning and disinfection procedures had no effect on physical characteristics or performance. Established a reuse life of 240 uses and subsequent cleaning and disinfection cycles. (Note: The table on page 7 shows "Reuse Life" for the subject device as "100 cycles" compared to "240 cycles" for the predicate. This seems like a discrepancy or change from the text on page 12, which states 240 uses were established. The 100 cycles value might be a specific finding or target, while 240 cycles was the tested limit without performance degradation.) | |
| Human Factors Usability Testing | Studies: Several formative studies (to develop/test instructions, software, training) and one summative study (to validate user ability to follow instructions). |
| Results: Summative study validated that users, after training, could read and understand labeling and follow instructions (with software aid) to properly clean and disinfect the reusable toothbrush handle. | |
| Substantial Equivalence | Conclusion: Based on intended use, technological characteristics, and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device (K141018). |
Since this is not an AI/ML device, the following points are largely not applicable or cannot be definitively answered from the provided text:
-
Sample sizes used for the test set and the data provenance:
- For biocompatibility, electrical safety, EMC, and software, "samples" are devices or components. Specific numbers of units tested are not provided in this summary, but these are typically engineering and lab tests, not clinical studies with human subjects for efficacy.
- For Cleaning and Disinfection Validation, the document mentions testing under "simulated normal use and worst-case scenario for wear" and establishing a "reuse life of 240 uses." This number (240 cycles) could be considered a "sample size" for this specific durability test.
- For Human Factors Usability testing, "several formative and a summative" studies were performed. The number of participants in these studies (i.e., "sample size") is not specified.
- Data Provenance: The manufacturer is Procter & Gamble Manufacturing GmbH (Marktheidenfeld, Germany) and distributed in the U.S.A. by Procter & Gamble, Co. (Cincinnati, Ohio). The studies are non-clinical, not patient data (retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML (e.g., highly accurate disease labels) is not relevant for this type of device submission. The "ground truth" here is compliance with engineering standards and predefined performance specifications. Expert validation is implicitly part of these standardized testing processes (e.g., certified labs, qualified engineers).
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is typically related to expert review of medical images or patient data for ground truth establishment in AI/ML studies.
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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 powered toothbrush, not an AI-assisted diagnostic or therapeutic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is a software component (Level of Concern - Moderate), but it's part of the device's function (e.g., user interface, power management, potentially guidance for cleaning), not a standalone diagnostic algorithm. The software verification confirms it "performs as intended."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is derived from:
- Compliance with recognized standards: ISO 10993 (biocompatibility), UL 1431, IEC 60335 series, ISO 20127 (electrical safety), 47 CFR Parts 15B, 15C, 18 (EMC).
- Successful completion of pre-defined non-clinical tests: Cleaning/disinfection validation (e.g., microbial reduction, material integrity), Human Factors Usability (user ability to follow instructions).
- Performance against specifications: e.g., reuse life, satisfactory cleaning/disinfection.
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning.
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How the ground truth for the training set was established: Not applicable for the same reason as above.
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(205 days)
PROCTER & GAMBLE
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.
| Acceptance Criteria (Explicitly stated for performance) | Reported Device Performance (Related to SUI management) |
|---|---|
| Not explicitly defined in terms of SUI management metrics within the provided text for acceptance against a specific threshold. | "statistically significant and clinically meaningful improvement in the symptoms that were most important to each woman, whether it was a reduction in SUI episode frequency, a reduction in pad load, or both." |
| "Well-tolerated" / "Safe" | "device was well-tolerated, with no serious AEs." |
| "majority of the AEs that were observed were 'mild' and spontaneously resolved." | |
| "minimal effect on the vaginal wall and surrounding structures." | |
| "Appropriate self-administration" | "women were able to appropriately... self-administer the device." |
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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(147 days)
PROCTER & GAMBLE CO.
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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(79 days)
THE PROCTER & GAMBLE COMPANY
The TAMPAX® M 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.
This document is a 510(k) summary for a menstrual tampon, focusing on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study to prove a device meets specific performance criteria.
Therefore, many of the requested categories regarding clinical study design, ground truth establishment, expert involvement, and statistical analyses (like MRMC studies) are not applicable or cannot be extracted from this type of regulatory submission.
Here's a breakdown of the information that can be extracted, and where the requested information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Internal Standards/Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Material Safety & Biocompatibility | Established in predicate device (K081555), and biocompatibility tests for individual materials in previously cleared similar devices. | Passed (Biocompatibility testing completed; material safety established). |
| Applicator Expulsion Force | Acceptable limits (implied by comparison to predicate and safety assessment). | "Acceptable results" and "similar performance to the predicate device." |
| Applicator Click and Separation Force | Acceptable limits (implied by comparison to predicate and safety assessment). | "Acceptable results" and "similar performance to the predicate device." |
| Applicator Collapse Force | Acceptable limits (implied by comparison to predicate and safety assessment). | "Acceptable results" and "similar performance to the predicate device." |
| Tampon Pledget Exposure to Applicator Components | Negligible or no exposure. | "Negligible or no tampon pledget exposure to the applicator components." |
| Technological Characteristics (Overall Design) | Similar to predicate device (K081555) in basic component materials, overall design, and labeling. | Confirmed similar; new colors and modified applicator design, but same performance. |
| Fluid Handling Capabilities | Acquire and hold menstrual fluids similar to the predicate device. | Designed to acquire and hold menstrual fluids similar to the predicate device. (Implied equivalence through design and materials). |
| Safety and Efficacy Profiles | Equivalent to the predicate device. | Confirmed equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. This document refers to nonclinical tests and extractions, which typically involve a smaller number of physical units for engineering-style testing rather than a large clinical test set.
- Data Provenance: Not specified, but given the nature of the tests (engineering/material characterization), it would be internal lab data, likely from the US, created for this submission. It is retrospective in the sense that the testing was performed to support this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. This submission focuses on nonclinical performance testing and substantial equivalence, not the establishment of ground truth by human experts for a diagnostic or prognostic device.
4. Adjudication Method for the Test Set
- Not applicable. See point 3. Testing involves objective measurements of physical properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Affect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. This device is a menstrual tampon, not an AI-assisted diagnostic or imaging device. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical product, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For the nonclinical tests, the "ground truth" is based on pre-defined engineering specifications, material standards, and performance characteristics of the legally marketed predicate device (K081555). For material safety, previous biocompatibility testing results for similar devices serve as a basis.
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. See point 8.
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(22 days)
PROCTER & GAMBLE CO.
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
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate device performance) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Safety | Biocompatibility | Biocompatibility testing of each material completed in previously cleared devices. |
| Negligible or no tampon pledget exposure to applicator components | Extractions of plastic applicators confirmed negligible or no exposure. | |
| Functionality | Fluid handling capabilities (acquisition and retention) | Similar to fluid handling capabilities of the predicate device. |
| Expulsion force | No change in parameters from the predicate device; results within acceptable limits and similar to predicate. | |
| Tampon withdrawal cord anchor strength | No change in parameters from the predicate device; results within acceptable limits and similar to predicate. | |
| Syngyna testing | No change in parameters from the predicate device; results within acceptable limits and similar to predicate. | |
| Substantial Equivalence | Equivalent safety and efficacy profiles | The subject device and the predicate device have the same performance characteristics and equivalent safety and efficacy profiles. |
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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(27 days)
THE PROCTER & GAMBLE COMPANY
The TAMPAX® V 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 describes a 510(k) premarket notification for a medical device (TAMPAX® V Plastic Applicator Tampons, unscented) and not a study assessing an AI/ML powered device. As such, most of the requested information (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set size, etc.) is not applicable to this document.
However, I can extract the acceptance criteria and reported device performance based on the information provided regarding the nonclinical tests and consumer preference testing.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Nonclinical Safety | Syngyna | No change from predicate device; within acceptable limits. | Results show no change from the predicate device. Results are within acceptable limits and similar to the predicate device. |
| Expulsion Force | No change from predicate device; within acceptable limits. | Results show no change from the predicate device. Results are within acceptable limits and similar to the predicate device. | |
| Tampon Withdrawal Cord Anchor Strength | No change from predicate device; within acceptable limits. | Results show no change from the predicate device. Results are within acceptable limits and similar to the predicate device. | |
| S. aureus Growth and TSST-1 Production | No adverse impact of modifications; within acceptable limits. | No adverse impact of the modifications on S. aureus growth and TSST-1 toxin production. Results are within acceptable limits and similar to the predicate device. | |
| User Preference/Safety | Consumer Preference In-use (Comfort) | Tampon and applicator are comfortable to use (no specific quantitative criteria given, implied positive user experience). | Confirmed that the tampon and applicator are comfortable to use. |
| Consumer Preference In-use (Adverse Events) | No reports of adverse events. | There were no reports of adverse events. | |
| General Equivalence | Material Safety and Design | Established in predicate 510(k) K061486. | Established in 510(k) submission K061486. |
| Biocompatibility | Completed in previously cleared similar 510(k) devices. Relevant for each material. | Biocompatibility testing of each material in the tampon has been completed in previously cleared similar 510(k) devices. | |
| Fluid Handling Capabilities | Similar to predicate device. | The device is designed to acquire and hold menstrual fluids similar to the fluid handling capabilities of the predicate device. (This is a design statement, performance is implied to result in similarity as per other tests). |
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: Not explicitly stated for any of the nonclinical tests. For "Consumer Preference In-use Testing," the sample size is not provided, only the outcome.
- Data Provenance: Not explicitly stated. The studies were conducted by The Procter & Gamble Company. Given the typical regulatory context for US FDA submissions, these tests would likely have been conducted in a controlled laboratory setting (for nonclinical) and with a consumer panel (for in-use testing), presumably within the US or compliant with international standards, but no country of origin is specified. The studies appear to be prospective for the current device's evaluation.
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 the device is a physical medical device, not an AI model requiring expert-established ground truth. The "ground truth" for the nonclinical tests is based on established scientific measurement standards for features like strength, fluid absorption, and microbial growth, and for in-use testing, it's based on user feedback.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept pertains to resolving discrepancies in expert labeling or diagnoses for AI model ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance evaluation includes:
- Established scientific/engineering measurements: For nonclinical tests like Syngyna, expulsion force, and withdrawal cord strength, the "ground truth" is derived from standardized physical and chemical testing methods.
- Microbiological assays: For S. aureus growth and TSST-1 production, the "ground truth" comes from controlled laboratory experiments measuring bacterial growth and toxin levels.
- Consumer self-reporting/feedback: For consumer preference in-use testing, the "ground truth" is based on the subjective experiences and reports of the participants regarding comfort and adverse events.
8. The sample size for the training set
Not applicable. There is no AI model or training set involved.
9. How the ground truth for the training set was established
Not applicable. There is no AI model or training set involved.
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(85 days)
THE PROCTER & GAMBLE CO.
The TAMPAX® C Plastic™ Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid.
Unscented menstrual tampons for absorption of menstrual fluid
The provided document is a 510(k) summary for a medical device (TAMPAX® C Plastic™ Tampons, unscented). This type of document is submitted to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, the study design and acceptance criteria differ significantly from what would be expected for a novel AI/software device. The document primarily focuses on non-clinical testing to establish equivalence based on material safety and specific design characteristics, rather than diagnostic performance metrics typical for AI studies.
Here's an analysis of the "acceptance criteria" and "study" described, interpreted within the context of a 510(k) submission for a tampon:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|---|
| Material Safety | Negligible or no tampon pledget exposure to applicator components via extraction. | Extractions of the 510(k) device plastic applicators performed under exaggerated conditions confirmed negligible or no tampon pledget exposure to the applicator components. (Similar to predicate device applicator extracts). |
| Applicator Expulsion Force | Within acceptable limits for safe and effective use. | Tests showed that the force is within acceptable limits. (Similar to the current applicator of the predicate device). |
| Wrapper Seal Strength | Within specified limits to maintain integrity. | Thwing-Albert measurement showed that the seal strength is within specified limits. (Similar integrity to the current wrapper of the predicate device). |
| Wrapper Peel Strength | Within specified limits to allow proper opening while maintaining integrity. | Instron measurement showed that the peel strength is within specified limits. (Similar integrity to the current wrapper of the predicate device). |
| Pledget Design | Identical to the predicate device pledget design. | The tampon pledget design was not changed from the predicate device. |
| Fluid Handling Capabilities | Similar to the fluid handling capabilities of the predicate devices. | The device is designed to acquire and hold menstrual fluids similar to the fluid handling capabilities of the predicate devices. (No specific numerical performance provided, but stated as similar to predicate). |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state numerical sample sizes for each test in the way an AI study would. Instead, it mentions "Extractions of the 510(k) device plastic applicators were performed," "Tests of the 510(k) tampon applicator expulsion force showed," "Tests of the seal strength... and peel strength... of the 510(k) modified wrapper showed."
- Test Set Sample Size: Not specified quantitatively. The implication is that sufficient units were tested to demonstrate compliance with the criteria and similarity to the predicate.
- Data Provenance: This is not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective). The data is generated from laboratory testing of the physical device and its components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. For this type of device, "ground truth" is established by direct physical measurements and engineering standards, not by expert interpretation of clinical data.
- Qualifications of Experts: Not specified, but implied to be technicians or engineers qualified to perform the described physical and chemical tests (e.g., performing extractions, operating Thwing-Albert and Instron machines).
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no expert adjudication for physical/chemical test results as there would be for medical image interpretation or clinical outcomes. The results are objective measurements against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) and AI assists that interpretation. This is a physical, non-AI medical device.
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: No, a standalone performance study as typically understood for an AI algorithm was not done. This device is not an algorithm. Its "performance" is its physical characteristics and safety, measured directly.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this submission is based on engineering specifications, material science principles, and direct physical/chemical measurements. The primary method for establishing "equivalence" (which is the goal of a 510(k)) is by comparing these measured characteristics to those of the predicate device and established safety standards.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this device.
Summary in the Context of a 510(k) Submission:
This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (TAMPAX® Pearl Tampons, unscented, K081555). The "study" conducted for this device is a series of non-clinical, laboratory-based tests. The acceptance criteria essentially boil down to:
- The new device (TAMPAX® C Plastic™ Tampons) must exhibit material safety equivalent to or better than the predicate.
- Its functional physical characteristics (applicator expulsion force, wrapper integrity, pledget design, fluid handling) must be similar to or within acceptable limits compared to the predicate device.
The study "proves" the device meets these criteria by showing that the results of the specific physical and chemical tests either match the results of the predicate device (where available) or fall within established acceptable ranges for safe and effective use. The changes made (pigment addition, applicator shape, wrapper modification) were assessed to ensure they did not negatively impact the safety or fundamental performance, and the evidence provided supports this conclusion for FDA's substantial equivalence determination.
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(396 days)
PROCTER & GAMBLE CO.
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
| Acceptance Criteria Category | Description of Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety - Toxicology | Compliance with FDA guidance and applicable standards for irritation testing, sensitization testing, acute toxicity, and cytotoxicity. | Favorable safety outcomes reported from preclinical toxicology testing. Specific results (e.g., irritation score thresholds) are not provided, but the conclusion is that the device met the safety requirements in these areas. |
| Safety - Microbiology | No impact on the growth of Staphylococcus aureus; no impact on normal vaginal microflora; no increase in the production of TSST-1 (Toxic Shock Syndrome Toxin-1). | Preclinical microbiology testing confirmed that the device "does not impact the growth of Staphylococcus aureus or the normal vaginal microflora, nor does it increase the production of TSST-1." |
| Safety - Clinical Adverse Events | Absence of adverse events related to the test products during clinical trials. | "In the clinical trials that were performed, no adverse events related to the test products were reported." |
| Effectiveness - Absorbency | Compliance with the syngyna absorbency requirements of 21 CFR 801.430. This regulation defines the standard laboratory test for determining the absorbency of menstrual tampons. | "TAMPAX® Pearl Plastic Applicator Unscented Tampons comply with the syngyna absorbency requirements of 21 CFR 801.430." The report explicitly states, "Therefore, additional testing of these tampons is not necessary to establish their equivalence to the predicate tampons in terms of effectiveness." This indicates that the device met the regulatory absorbency standard. |
| Substantial Equivalence (Overall) | The device is equally as safe and effective as the predicate devices in terms of component materials, overall design, intended use, labeling, and performance. The primary change in the 510(k) device is the incorporation of a process aid to decrease microwave setting time for the pledget, which should not affect safety or effectiveness. | The submission concludes that "The results of evaluations of this device support the conclusions that it is safe for its intended use and that it is substantially equivalent to the cited predicate devices with regard to safety and effectiveness." The FDA's 510(k) clearance letter confirms this substantial equivalence determination. |
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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