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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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K-Y® Brand WARMING UltraGEL is intended as personal lubricant to be used with or without a condom.

The lubricous nature of this product helps to supplement the body's own natural lubricating fluids, thereby relieving friction to help enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal, anal or penile tissues for purpose of lubrication, and moisturization and is compatible with latex condoms. K-Y® Brand WARMING UltraGEL has the additional benefit of imparting a warming sensation when applied to the genital area.

Personal Lubricant For vaginal/penile and condom application during sexual intimacy

K-Y® Brand WARMING UltraGEL is a non-sterile, clear, non-staining, non-greasy, water soluble gel for use as a personal lubricant. This product imparts a gentle warming sensation when applied to the genitalia. This product was designed to meet a customer need for an intimate lubricant that does not feel cold when applied. K-Y® Brand Warming UltraGEL can reduce friction during sexual intercourse thereby enhancing sexual intimacy. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards as defined by ASTM D 3492. K-Y® Brand WARMING UltraGel is not a contraceptive nor spermicide.

This document describes the 510(k) clearance for K-Y® Brand WARMING UltraGEL Personal Lubricant, focusing on demonstrating its substantial equivalence to the predicate device, K-Y® Brand Warming LIQUID Personal Lubricant. Since this is a personal lubricant, the "device performance" in the context of this submission refers to its safety and effectiveness in providing lubrication and a warming sensation, especially its compatibility with condoms.

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Biocompatibility Testing: Not specified, but conducted by an "outside laboratory." Usually involves in-vitro and in-vivo animal models per ISO 10993, but specific numbers are not provided for the test set.
• Human Repeated Insult Patch Test: Not specified.
• Consumer Perception Study: Not specified for the number of subjects, only percentages reported.
• In-Home Consumer Use Study: 245 reported responses. Data provenance is implied to be from the US, as the study was conducted under FDA regulations (21CFR Part 812 for Investigational Device Exemption and 21CFR Parts 50 and 56). This was a prospective study.

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

• Biocompatibility Testing: Conducted by an "outside laboratory in compliance with Good Laboratory Practices (GLPs)." No specific number or qualifications of experts are provided in the summary.
• Human Repeated Insult Patch Test: Not specified. Conducted by an "outside laboratory."
• Consumer Perception Study: The "ground truth" here is the subjects' subjective experience and self-reported perceptions of warmth. No external experts defining ground truth.
• In-Home Consumer Use Study:
  • Tolerability/Irritation: "Consented female subjects received gynecological examinations at baseline and following the last coital episode." This implies gynecologists were the experts establishing the ground truth for physical irritation. The number of gynecologists is not specified, nor are their specific qualifications (e.g., years of experience), but it is generally assumed that certified medical professionals perform such examinations.
  • Warming Sensation/Enhanced Intimacy: The "ground truth" is the subjects' subjective self-reported experiences and perceptions. No external experts defining ground truth.

4. Adjudication Method for the Test Set

• Biocompatibility Testing: No information on adjudication method. Results were likely evaluated against ISO 10993 and G95-1 criteria.
• Human Repeated Insult Patch Test: No information on adjudication method. Clinical assessment by trained personnel would be standard.
• Consumer Perception Study: No adjudication as it relies on subjective self-reporting.
• In-Home Consumer Use Study:
  • Tolerability/Irritation (Gynecological Exam): Not explicitly stated, but typically a single gynecologist would perform the examinations for consistency. If multiple gynecologists were involved, a consensus or independent review process might be employed, but it is not detailed.
  • Warming Sensation/Enhanced Intimacy: No adjudication as it relies on subjective self-reporting.

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. The device is a personal lubricant, not an imaging or diagnostic AI system. Therefore, an MRMC comparative effectiveness study involving human "readers" (e.g., radiologists) with or without AI assistance was not performed and is irrelevant to this submission.

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

• This is not applicable. As mentioned above, the device is a personal lubricant, not an algorithm or AI system. Its performance is directly tied to human interaction and perception, and there is no "standalone" algorithmic performance to evaluate.

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

• Biocompatibility: Scientific standards (ISO 10993, G95-1) and laboratory test results.
• Human Contact Sensitization: Clinical observation and assessment by medical professionals (implied).
• Warming Sensation/Enhanced Intimacy: Subjective self-reported perceptions and experiences of male and female subjects.
• Tolerability/Irritation: Objective clinical assessment by gynecologists (mottled irregular erythema observation) and subjective self-reported experiences.

8. The Sample Size for the Training Set

• Not applicable / No specific training set mentioned. For a personal lubricant, there is typically no "training set" in the sense of machine learning. The studies described are validation studies to demonstrate safety and effectiveness for substantial equivalence. The product formulation itself resulted from R&D, not an algorithm trained on a dataset.

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

• Not applicable. As there is no "training set" for an AI or algorithmic device, the concept of establishing ground truth for it does not apply here. The product's development would have involved formulation chemists and product developers, guided by established chemical and physiological principles, and consumer research to meet desired characteristics.

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For vaginal/penile and condom application during sexual intimacy

Description of Delly is a non-sterile, clear, non-staining, non-greasy, water soluble ielly for use as a personal lubricant. This product imparts a gentle warming sensation when Jen' for use as a personal nas designed to meet a customer need for a lubricant that does not feel cold when applied. K-Y® Brand Warming Jelly reduce can reduce friction that does not feel cold which upplives and intimacy. It is compatible with latex during sexual mercounse theres your Compatibility Testing conducted according the condonis as defined by ASTM D 3492. K-Y® Brand WARMING Jelly is not a contraceptive nor spermicide.

The provided text describes the 510(k) summary for the K-Y® Brand WARMING Jelly Personal Lubricant. It outlines preclinical and clinical testing to demonstrate safety and substantial equivalence to a predicate device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" with numerical thresholds for each test. Instead, it describes the tests and then reports the positive (or negative, where appropriate) outcomes as evidence of safety and performance. I've inferred the acceptance criteria based on the reported results.

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

• Human Repeated Insult Patch Test: The sample size is not explicitly stated, but the test compared the product to the currently marketed K-Y® Brand Warming LIQUID.
• Consumer Perception Study (Warming): The total number of participants is not explicitly stated. It mentions "75.50% of the participants felt the product warmed well."
• In Home Consumer Use Study:
  • Female subjects: Consented female subjects received speculum examinations at baseline and following the last coital episode. The exact number of subjects is not explicitly stated but is implied to be at least 245 based on the reported responses.
  • Reported Responses: 245 reported responses for various criteria.
  • Data Provenance: The studies are described as "Human Clinical Testing" and "Preclinical Testing of Formulation," implying prospective human studies conducted by an "outside laboratory." The country of origin is not explicitly stated, but the submission is to the FDA in the US.

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

• In Home Consumer Use Study (Gynecological Examinations): The study involved "gynecological examinations at baseline and following the last coital episode." It then states, "It was concluded that the product did not cause irritation as determined by final gynecological examination." This implies a medical professional (likely a gynecologist) performed these examinations. The number of such experts and their specific qualifications (e.g., years of experience) are not specified in this document.
• Other studies (Human Repeated Insult Patch Test, Biocompatibility): The "ground truth" here would be laboratory analysis and expert interpretation of those results. The number and qualifications of experts involved in these analyses are not specified.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for any of its human studies. The results appear to be reported based on the observations and findings of the individuals conducting the tests and assessments. For the In Home Consumer Use Study, the "conclusion" about irritation was "determined by final gynecological examination," suggesting a single expert's assessment or the consensus of a study team.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or interpretative tasks where multiple human readers assess cases with and without AI assistance. The K-Y® Brand Warming Jelly is a personal lubricant, and the studies focused on safety, biocompatibility, and consumer perception, not diagnostic effectiveness.

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

N/A (Not Applicable). This device is a personal lubricant, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not relevant to this product. The testing performed evaluates the product's direct interaction with the human body and user perception.

7. The Type of Ground Truth Used

• Biocompatibility: Laboratory test results (e.g., contact sensitization, systemic toxicity measurements) interpreted against established scientific standards (ISO 10993 and G93-1).
• Human Repeated Insult Patch Test: Clinical observation by trained professionals for skin reactions, comparing the test product to a predicate.
• Consumer Perception Studies: Self-reported subjective experience of participants (e.g., rating warming, feedback on intimacy enhancement, discomfort).
• In Home Consumer Use Study (Irritation): Objective medical assessment via "gynecological examinations" by a qualified professional.
• Condom Compatibility: Laboratory testing results based on ASTM D 3492.

8. The Sample Size for the Training Set

N/A (Not Applicable). This device is a personal lubricant, not an AI or machine learning model. Therefore, there is no "training set" in the context of data science. The "formulation" of the product is proprietary and developed through chemical and material science processes, not through a data-driven training set.

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

N/A (Not Applicable). As explained above, there is no "training set" for this product. The ground truth for its development and testing is established through standard preclinical and clinical methodologies for medical devices, focusing on safety, biocompatibility, and intended use performance.

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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:

The tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string, which are the same materials as the predicate.

(The specific absorbency range of the predicate is not explicitly stated, but the modified tampon falls within established regulatory ranges, and the submission argues this change does not alter substantial equivalence.) |
| Intended Use: Same as the predicate device. | The modified o.b.® Tampons are inserted into the vagina to collect menstrual fluid. This is the same intended use as current commercial tampons. |
| Biocompatibility: No adverse biological reactions. | Biocompatibility testing has been conducted on tampons made with these commercial materials. The results of these tests demonstrate that the modified o.b.® Tampon is equivalent to legally marketed tampons. This testing included Microbiological testing. |
| Safety (Clinical): No new or increased safety risks. | Clinical Testing has been conducted. Results of preclinical and clinical testing indicate that the safety of the modified tampon is comparable to current legally marketed, commercial tampons. |

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

• Vaginal Irritation: Conducted in Rabbits on rayon and extracts thereof.
• Acute Systemic Toxicity: Conducted on rayon and extracts thereof.
• Intracutaneous Toxicity: Conducted on rayon and extracts thereof. |
  | Dermal Irritation/Sensitization | - Repeat Insult Patch Test: Confirmed lack of potential for human dermal irritation and sensitization. |
  | Microbiological Safety | - Microbiological Testing: Conducted on rayon and extracts thereof. |
  | Overall Safety Comparison | - Conclusion: Non-clinical and clinical testing results indicate that the safety of the modified tampon is comparable to current legally marketed, commercial tampons. |

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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