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The intended use of this device is as a personal lubricant compatible with latex condom.
K-Y® Brand Warming Liquid is intended as a personal lubricant compatible with latex condom.

This device is a condom compatible personal lubricant that has been specifically developed to produce a warming sensation when in contact with moist skin and mucosal membrane.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:

Device: K-Y® Brand Warming Liquid (Personal Lubricant)

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes for the "test set" in terms of specific numbers of condoms, consumers for the use test, or participants for the RIPT.

• Condom Compatibility: Tested with "leading commercial brands of latex condoms." (No specific number mentioned). Data provenance is from "laboratory testing."
• Lubricity: Compared to the "predicate device." Data provenance is from "laboratory testing."
• Warming Claim: Assessed via a "consumer use test." Data provenance is from human participants. No country of origin is specified, nor whether it was retrospective or prospective, but "consumer use test" typically implies prospective.
• Non-sensitizing: Assessed via "human RIPT" (Repeat Insult Patch Test). Data provenance is from human participants. No country of origin is specified, nor whether it was retrospective or prospective, but an RIPT is a prospective clinical study.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of medical device evaluation (e.g., radiologists interpreting images). The evaluations are based on:

• Laboratory testing for physical properties (condom compatibility, lubricity).
• Pre-clinical evaluations for ingredient safety.
• Consumer self-reporting for the warming claim (implied from "consumer use test").
• Medical/Toxicological experts for interpreting RIPT results (implied by "human RIPT shows that the proposed device is non-sensitizing," but no specific number or qualifications are provided).

4. Adjudication Method for the Test Set:

No specific adjudication method (like 2+1 or 3+1) is described for any of the tests. The results seem to be direct outcomes of laboratory measurements, pre-clinical assessments, and consumer feedback/RIPT results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices where multiple human readers evaluate cases with and without AI assistance to measure improvement in diagnostic performance. The K-Y® Brand Warming Liquid is a personal lubricant, not a diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is not an algorithm or AI-driven system. The "performance data" refers to the physical and biological characteristics of the lubricant itself.

7. The Type of Ground Truth Used:

The "ground truth" for this device's evaluation is based on a combination of:

• Objective Laboratory Data: For condom compatibility and lubricity.
• Pre-clinical Safety Data: For ingredient safety.
• Subjective Human Perception/Response: For the warming claim (consumer use test) and non-sensitization (RIPT, which has objective endpoints but measures a biological response in humans).
• Comparison to Predicate Device: Many of the claims are based on "comparable" or "equivalent" performance to legally marketed predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve a "training set" in the context of an AI/ML algorithm. The product formulation and testing are based on traditional chemical and biological safety/efficacy assessments.

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

Not applicable, as there is no training set for an algorithm.

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K-Y® Brand Intrigue™ is intended as a personal lubricant for penile and vaginal application compatible with latex condom.

This device is a personal lubricant compatible with latex condom.

The provided text is a 510(k) summary for a medical device called "K-Y Brand Intrigue™," which is a personal lubricant. This document states that the device is "substantially equivalent to currently marketed predicate device, K-Y® Brand ULTRA GEL™."

However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria. It is a regulatory filing focused on establishing substantial equivalence to a predicate device, not on presenting performance data against predefined criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The requested sections (1-9) detailing performance metrics, sample sizes, expert qualifications, etc., are not present in this regulatory submission.

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Patient lubricants are devices intended to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. When used as an accessory to a medical device such as a condom, they are considered Class II Medical Devices.

K-Y® Brand WARMING LIQUID is principally intended as personal lubricant to supplement the body's own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal, anal or penile tissue for purpose of lubrication, and moisturization. It is also compatible with latex condoms.
Personal Lubricant (compatible with latex condoms)

K-Y® Brand WARMING LIQUID is a non-sterile clear non-staining, non-greasy, high viscosity liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a latex condom during intimate sexual activity. K-Y® Brand WARMING LIQUID is not a contraceptive or spermicide. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.

The provided document describes the safety and performance testing of K-Y® Brand WARMING LIQUID™ Personal Lubricant, not an AI device. As such, many of the requested categories related to AI device evaluation (e.g., sample size for the test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable.

However, I can extract the acceptance criteria and reported device performance from the provided text, focusing on the aspects that were evaluated.

Acceptance Criteria and Reported Device Performance

Study Details (Non-AI Specific)

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

   • Dermal Sensitization Study: Albino guinea pigs (specific number not provided).
   • Rabbit Penile Irritation Study: Rabbits (specific number not provided).
   • 10-Day Rabbit Vaginal Irritation Study: Rabbits (specific number not provided).
   • Mouse Systemic Injection Study: Mice (specific number not provided).
   • Human 21-Day Cumulative Irritation Assay: Healthy humans (specific number not provided).
   • Human Repeat Insult Patch Test: Healthy human skin (specific number not provided).
   • Two-Phase Consumer Use Study: Males and Females (initial perception and home use). Number of participants not explicitly stated, but implies a cohort.
   • Data Provenance: Studies conducted by "outside laboratories" (preclinical) and within the US (implied by FDA submission context and "healthy humans" / "consumers" for clinical tests). These are prospective studies designed to evaluate the product.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for these types of preclinical and clinical safety/performance studies. Ground truth is established by direct observation, laboratory measurements, and clinical assessments (e.g., macroscopic and microscopic findings for irritation, gynecological examinations).

3. Adjudication method for the test set: Not applicable for these types of studies. Results are based on direct measurements and observations, not a consensus among reviewers of a complex output.

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 is not an AI device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.

6. The type of ground truth used:

   • Preclinical: Histopathological examination (macroscopic and microscopic findings), physiological responses (mortality), and direct observation of skin reactions.
   • Clinical: Direct observation of skin reactions, gynecological examinations, and subject self-reporting (perception of warmth).
   • Compatability/Lubricity: ASTM standard testing and laboratory coefficient of friction measurements.

7. The sample size for the training set: Not applicable. This is not an AI device.

8. How the ground truth for the training set was established: Not applicable. This is not an AI device.

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Patient lubricants are devices intended to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. When used as an accessory to a condom, patient lubricants are deemed Class II Medical Devices.

K-Y® Brand Ultra Gel™ is principally intended as personal lubricant to supplement the body's own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal, anal or penile tissue for lubrication, and moisturization purposes. It is also compatible with latex condoms.

Personal Lubricant compatible with latex condoms, helps enhance intimacy.

K-Y® Brand Ultra Gel™ is a non-sterile water- based personal lubricant designed to supplement the body's own natural lubrication fluids. This formula is a clear, non-irritating, non-greasy, non-staining, high viscosity liquid gel. This highly lubricous product may be used with or without a latex condom during intimate sexual activity. K-Y® Brand Ultra Gel™ is not a contraceptive or spermicide. It is however, compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.

This K-Y® Brand Ultra Gel™ Personal Lubricant 510(k) summary does not contain the level of detail typically found in a clinical study report for a diagnostic device. It focuses on demonstrating substantial equivalence to a predicate device through pre-clinical and limited clinical testing, rather than establishing specific performance metrics against a defined acceptance criterion with a dedicated study.

However, based on the provided text, I can infer the "acceptance criteria" relate to performance as safe and effective, and "substantially equivalent" to the predicate device. The "study" refers to the body of testing conducted to support this claim.

Here's an attempt to structure the information based on your request, with significant caveats due to the nature of the provided document:

Acceptance Criteria and Device Performance for K-Y® Brand Ultra Gel™ Personal Lubricant

This submission focuses on demonstrating substantial equivalence of K-Y® Brand Ultra Gel™ Personal Lubricant to its predicate device, K-Y® Brand LIQUID Personal Lubricant. The acceptance criteria are implicitly met by demonstrating safety, non-irritation, and comparable performance to the predicate device, particularly in terms of lubricity and consumer satisfaction.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for Test Set and Data Provenance

Due to the nature of this 510(k) summary, specific sample sizes for each test are not explicitly provided.

• Preclinical Biocompatibility Studies: Conducted by outside laboratories. Data provenance not specified (e.g., country of origin). These would typically be prospective animal or in vitro studies.
• Human Irritation Studies: Involved human subjects. Details on number of subjects, country of origin, or retrospective/prospective nature are not provided. These are typically prospective clinical trials.
• Consumer-Use Testing: Involved consumers. Specific sample size, country of origin, or retrospective/prospective nature are not provided. These are typically prospective user studies.
• Condom Compatibility Testing: Conducted according to ASTM D 3492 standards. This is lab-based testing; human subjects are not involved for this specific test.

3. Number of Experts and Qualifications for Ground Truth

Not applicable in the context of this 510(k) summary. "Ground truth" as understood in AI/imaging devices (e.g., expert consensus on medical images) is not relevant here. The "truth" is established by laboratory measurements, biological responses, and consumer feedback against defined criteria.

4. Adjudication Method for the Test Set

Not applicable. The tests described are laboratory analyses (e.g., coefficient of friction, biocompatibility, ASTM standards) and direct human or consumer responses (irritation, consumer preference). There is no "test set" requiring adjudication by multiple experts in the sense of a diagnostic interpretation.

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

No. This type of study (MRMC) is relevant for diagnostic devices where human readers interpret medical images or data, and its goal is to assess the impact of AI assistance on human performance. K-Y® Brand Ultra Gel™ is a personal lubricant, not a diagnostic device.

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

No. This concept applies to AI algorithms. K-Y® Brand Ultra Gel™ is a physical product, not an algorithm. Its performance is evaluated through physical and biological interactions, as well as user experience.

7. Type of Ground Truth Used

The "ground truth" for the various tests can be categorized as follows:

• Preclinical Biocompatibility (Non-irritation, non-sensitizing, no toxicity): Laboratory measurements and biological assays (e.g., cytotoxicity tests, sensitization tests, systemic toxicity tests) following established GLP guidelines.
• Human Irritation Studies: Direct human response/observation by trained medical professionals (e.g., dermatologists or clinical researchers) assessing skin reactions.
• Condom Compatibility: Adherence to the specified ASTM D 3492 standard, which involves physical testing methods to evaluate material integrity and performance.
• Lubricity: Objective laboratory measurement of the coefficient of friction.
• Consumer-Use Testing (Texture/Consistency, Moisturizing Properties): Subjective consumer feedback and preference ratings, likely via questionnaires or surveys, quantified statistically.

8. Sample Size for the Training Set

Not applicable. The concept of a "training set" is relevant for machine learning algorithms. K-Y® Brand Ultra Gel™ is a chemical formulation, not an AI model.

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

Not applicable. There is no training set for this type of product.

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o.b. Tampons are used to absorb menstrual fluid or other vaginal discharge.

o.b. ® Non-applicator Tampons are used to absorb menstrual fluid. The modified tampon will be available in the 15-18 gram syngyna absorbency range. o.b.® Non-applicator Tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.

The provided text describes a 510(k) summary for a modified o.b.® Tampon. The objective of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new performance criteria for a novel device. Therefore, the information provided does not align with the typical structure of reporting acceptance criteria and a study proving a device meets those criteria for a new or significantly modified medical device that requires clinical performance evaluation.

Specifically, the document focuses on substantial equivalence for the modified o.b.® Tampons. The "acceptance criteria" here are implicitly tied to demonstrating that the modified tampon is as safe and effective as the predicate device.

However, based on the provided text, I can extract the following information relevant to the intent of the questions, reinterpreting "acceptance criteria" as the characteristics that needed to be equivalent or demonstrated as safe.

Here's a breakdown of the available information in response to your questions:

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

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

• Sample Size: Not explicitly stated for either biocompatibility or clinical testing.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The document only mentions "preclinical and clinical testing."

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

• This information is not provided as the regulatory submission focuses on demonstrating substantial equivalence through specific tests (e.g., syngyna absorbency, biocompatibility, clinical safety comparable to existing products) rather than a diagnostic performance study requiring expert ground truth in the traditional sense.

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

• This information is not applicable/not provided for this type of submission. Adjudication methods are typically used in studies where a new diagnostic or prognostic tool's output is compared against a consensus expert reading for 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:

• This information is not applicable/not provided. The device is a tampon, not an AI-assisted diagnostic or imaging tool.

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

• This information is not applicable/not provided. The device is a tampon.

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

• For absorbency, the ground truth is established by the syngyna test method (21 CFR 801.430), which is a standardized laboratory procedure.
• For biocompatibility, the ground truth would be established by standardized microbiological testing and potentially other biological assays, demonstrating no significant adverse reactions compared to established safety profiles.
• For clinical safety, the ground truth would be based on clinical observation and outcomes data from the "Clinical Testing" to show comparability to legally marketed tampons, likely looking for adverse event rates, irritation, or other safety endpoints. Specific methods are not detailed.

8. The sample size for the training set:

• This information is not applicable/not provided. There is no "training set" in the context of this device and its testing methodology.

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

• This information is not applicable/not provided.

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o.b. ® Tampons are used to absorb menstrual fluid or other vaginal discharge.

o.b. ® non-applicator and applicator Tampons are used to absorb menstrual fluid. The modified tampon will be available in Regular, Super, and Super Plus syngyna absorbency ranges. o.b.® non-applicator and applicator Tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the modified o.b.® Tampons are primarily based on biocompatibility and user safety, demonstrating equivalence to legally marketed tampons. The performance is reported through the results of specific preclinical and clinical evaluations.

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

• Test Set Sample Size: The document does not explicitly state the sample sizes for the preclinical or clinical evaluations.
• Data Provenance: The document does not explicitly state the country of origin of the data. The studies are referred to as "Preclinical Evaluations" and "Clinical Evaluations," implying that they were conducted specifically for this submission. The nature of these tests (e.g., vaginal irritation, microflora studies) suggests they would be prospective studies.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The nature of the studies (biocompatibility, clinical safety) suggests that the interpretation of results would have been performed by qualified professionals (e.g., toxicologists, microbiologists, clinicians), but specifics are not given.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or similar devices where different human readers interpret cases. Tampons are a medical device for menstrual fluid absorption, and their evaluation focuses on safety, performance, and biocompatibility, not interpretive tasks for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to the device described. The device is a physical product (tampon), not an algorithm or AI system. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for this device's safety and performance is established through experimental data from preclinical and clinical studies, demonstrating the physical, chemical, and biological properties of the modified tampons. The ultimate ground truth essentially compared the modified tampon's characteristics to the known safe and effective profile of the predicate device and general medical standards for such products.

• For biocompatibility: Lab test results (e.g., cytotoxicity assays, genotoxicity assays, irritation studies).
• For clinical studies: Human physiological responses (e.g., absence of sensitization, maintained vaginal microflora, absence of irritation).

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical product, not an AI or machine learning model that requires a "training set."

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

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

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o.b. Tampons are used to absorb menstrual fluid or other vaginal discharge.

o.b. ® tampons are used to absorb menstrual fluid or other vaginal discharge. These tampons will be available in regular, super and super plus absorbencies, and in applicator and non-applicator versions. o.b. ® non-applicator tampons are made of cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string. o.b. ® applicator tampons are made of cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string. The applicator consists of a cardboard laminate with a coating.

The provided text describes the 510(k) submission for o.b.® applicator and non-applicator tampons. This submission concerns a medical device rather than a software or AI-powered solution, so the typical structure for AI/software acceptance criteria and study details (like sample size for test/training sets, expert adjudication, MRMC studies, standalone performance) does not directly apply.

However, I can extract the relevant "acceptance criteria" (performance aspects tested) and the "study" conducted to demonstrate equivalence for this specific medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Applicability:

For this device (tampons), the "acceptance criteria" are related to its biological and physical safety, as assessed through specific non-clinical (and implicitly "clinical" in the sense of human patch testing) tests. The "reported device performance" is the outcome of these tests, demonstrating that the device meets these safety standards and is comparable to previously marketed devices.

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

• Sample Size (Non-clinical): Not explicitly stated with numerical values. For animal studies (Vaginal Irritation in Rabbits), a typical sample size for such tests involves a small group of animals (e.g., 3-6 rabbits per test group), but the exact number is not provided in the document.
• Sample Size (Clinical/Human Patch Test): "A Repeat Insult Patch Test" typically involves a moderate number of human subjects (e.g., 50-200) for dermal sensitization testing. The exact number is not specified.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the submission is to the U.S. FDA, implying that the studies would adhere to U.S. regulatory standards. These are considered prospective tests conducted specifically to support the 510(k) submission.

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

This section is not applicable in the context of this device and study. The "ground truth" for tampon safety is established through standardized laboratory and animal testing protocols, and sometimes human patch tests, which rely on objective measurements and established scientific methods rather than expert consensus on interpretive data (like in imaging or diagnostics).

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert interpretations, typically in diagnostic or imaging studies. The safety tests performed for tampons are objective and do not involve such interpretive adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. MRMC studies are specific to evaluating the impact of an assistance (like AI) on human performance in diagnostic tasks. This submission is for a physical medical device (tampon) and does not involve AI or human "readers" interpreting cases.

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

This is not applicable. This question is relevant to AI/software performance. The device is a tampon, which operates "standalone" in the sense that it performs its physical function without a human-in-the-loop interaction in the way AI algorithms do.

7. The Type of Ground Truth Used

The "ground truth" used for non-clinical testing (biocompatibility, toxicity) is based on:

• Standardized laboratory assays: Measuring specific biological responses (e.g., cell viability for cytotoxicity).
• Animal models: Observing physiological reactions in rabbits for irritation.
• Human volunteers: Observing dermal reactions in the Repeat Insult Patch Test.

Essentially, the ground truth is derived from objective biological and toxicological endpoints as defined by established scientific and regulatory testing guidelines.

8. The Sample Size for the Training Set

This is not applicable. "Training set" refers to data used to train machine learning models. This submission is for a physical device, not an AI or software product.

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

This is not applicable for the same reasons as #8.

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REACH® Antibacterial Toothbrush is used to remove adherent plaque and food debris from teeth to reduce tooth decay. This device is made of a shaft (handle) with synthetic bristles attached at one end. An antibacterial agent has been added to the handle portion. The antibacterial activity is limited to the handle of the toothbrush.

Both the modified device and the predicate device are manual toothbrushes consisting of a shaft with synthetic bristles at one end. Antibacterial agents have been incorporated into the devices.

The acceptance criteria and study proving the device meets them are summarized below:

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Test Set Sample Sizes:
  • Microbiology Study: "several different strains of bacteria" were exposed. The exact number of strains or individual samples is not specified.
  • Analytical Study: Not explicitly stated, but implies a sufficient number of samples were run for the HPLC analysis of the two solutions (toothpaste/water slurry and alcohol/water solution).
  • Mucous Membrane Irritation: Implies a comparison between "toothbrushes with antibacterial agent" and "toothbrushes without antibacterial agent" in hamster cheek pouches. The specific number of hamsters or toothbrushes is not provided.
  • In vitro Cytotoxicity Study: Implies a comparison between "toothbrushes with an added antibacterial agent" and "toothbrushes without an added antibacterial agent" as tested on mammalian cell cultures. The specific number of cell cultures or toothbrush samples is not provided.
• Data Provenance: Not explicitly stated, but given Johnson & Johnson Consumer Franchises Worldwide is the submitter and the reports are part of a 510(k) submission, the studies were likely conducted internally or by contract research organizations within the United States. The studies are prospective in nature, designed to evaluate the safety and performance of the modified device.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable as the reported studies are laboratory and preclinical tests, not analyses requiring expert human interpretation of medical images or data. The "ground truth" for these tests comes from the scientific methods themselves (e.g., inhibition zones, HPLC readings, irritation scores, cytotoxicity assays).

4. Adjudication Method:

• Not applicable for these types of laboratory and preclinical studies.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a toothbrush, not a diagnostic device involving human readers of medical cases.

6. Standalone Performance Study:

• Yes, all the described studies (Microbiology Study, Analytical Study, Mucous Membrane Irritation, and In vitro Cytotoxicity Study) are standalone evaluations of the device's characteristics and performance. They assess the device itself against scientific benchmarks and comparisons to a non-antibacterial version, without human-in-the-loop performance measurement.

7. Type of Ground Truth Used:

• The ground truth used for these studies is based on objective scientific measurements and established laboratory protocols:
  • Microbiology: Direct observation of bacterial growth inhibition (Zone of Inhibition).
  • Analytical: Quantitative chemical analysis using High-Performance Liquid Chromatography (HPLC) to detect specific compounds.
  • Mucous Membrane Irritation: Histopathological or macroscopic assessment of tissue irritation in a preclinical model.
  • In vitro Cytotoxicity: Observation of cell lysis and viability in mammalian cell cultures following USP guidelines.

8. Sample Size for the Training Set:

• Not applicable. These are verification and validation studies (test sets) for a physical device, not an AI/machine learning model that requires a "training set."

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

• Not applicable, as there is no training set for an AI/machine learning model in this context.

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o.b.® Applicator Tampons are inserted into the vagina to collect menstrual fluid. This is the same intended use as current commercial tampons.
o.b. applicator tampons are used to absorb mentrual fluid or other vaginal discharge.

o.b.® Applicator Tampons are used to absorb menstrual fluid or other vaginal discharge. These tampons will be available in regular, super and super plus absorbencies.
o.b.® Applicator Tampons are made of cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.
The applicator consists of a cardboard laminate with a coating.

This document describes the premarket notification (510(k)) for the o.b.® Applicator Tampon, focusing on its substantial equivalence to an already marketed device. The changes relate to the applicator coating, not the tampon itself.

Here's an analysis of the provided text in the context of your questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Non-clinical testing: Not explicitly stated how many samples were used for cytotoxicity, vaginal irritation, and microbiological testing. It only mentions extracts of the coated applicator were tested.
• Clinical testing (Repeat Insult Patch Test): The sample size for this human study is not specified in the provided document.
• Data Provenance: Not specified. Given the manufacturer (Personal Products Company, Skillman, NJ), the testing was likely conducted in the USA or a region adhering to similar regulatory standards, but this is an inference, not explicit in the text. The type of study is a premarket approval study for a medical device modification.

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

• This information is not applicable to this type of submission. This 510(k) is comparing a modified device to a predicate device based on specific non-clinical and clinical tests, not evaluating interpretations by human experts or establishing a "ground truth" for diagnostic purposes. The "ground truth" here is the safety of the materials as determined by established scientific laboratory and human safety testing protocols.

4. Adjudication Method for the Test Set

• Not applicable. As above, this submission does not involve adjudication of expert readings or diagnoses. The "adjudication" is essentially the FDA's review and concurrence with the testing results presented by the manufacturer.

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

• No. This is not a diagnostic device or an AI-based system, so an MRMC study is not relevant to this submission.

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

• No. This is a physical medical device (tampon applicator), not an algorithm or AI system.

7. The Type of Ground Truth Used

• The ground truth used here is based on scientific laboratory test results (biocompatibility, microbiological) and human safety study outcomes (dermal irritation/sensitization). The "ground truth" is that the modified material is safe and comparable to the predicate device, as evidenced by these tests.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device. There is no "training set" in the context of an AI/ML algorithm. The "training" for the device design would be based on general scientific and engineering principles and prior knowledge about materials used in similar devices.

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

• Not applicable. As mentioned, there is no "training set" in the AI/ML sense. The "ground truth" for the development of medical devices generally relies on established scientific literature, regulatory standards, and previous experience with similar materials and designs. Any modifications are then rigorously tested against these established safety and performance benchmarks.

In summary, the provided document details a 510(k) summary for a modified tampon applicator. The focus is on demonstrating substantial equivalence to a predicate device through non-clinical biocompatibility and microbiological testing, and a clinical (human) patch test for dermal safety. It does not involve AI, diagnostic accuracy, or expert consensus on interpretations, which explains why many of your questions are not applicable to this specific submission.

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