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The Unscented Menstrual Tampons are inserted into the vagina to absorb menstrual discharge.

The unscented menstrual tampons consist of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by an overwrap ("security veil") and a removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The tampon design is cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion.

According to different composition materials and design styles, the unscented menstrual tampons of this submission are divided into 3 categories (Unscented menstrual long applicator tampon, Unscented menstrual Cardboard Applicator Tampon, Unscented menstrual Digital Tampons) and 6 sub-categories (Organic cotton + Two Plastic tube, Cotton + cardboard tube, Organic cotton + cardboard tube, Cotton (digital style), Organic cotton(digital style), viscose(digital style).

The tampons are provided in 4 absorbencies: Light(L) (≤6g), Regular(R) (6-9g), Super (S)(9-12g) and Super Plus (SP)(12-15g). Only some sub-categories of tampons contain all absorbencies. Each device is individually wrapped and then packaged in sealed multi-unit containers for retail sale. All tampons and applicators are provided non-sterile and for single use only.

The provided FDA 510(k) clearance letter and summary for K251033 pertains to unscented menstrual tampons, which are medical devices designed for absorbing menstrual discharge. This documentation focuses on demonstrating the substantial equivalence of the new tampons to a predicate device (K232598) primarily through material composition, design, and physical performance characteristics, rather than performance metrics related to diagnostic accuracy or clinical outcomes that would typically involve AI/ML models or human reader studies.

Therefore, many of the requested points regarding acceptance criteria and study details for AI/ML device performance (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) are not applicable to this type of device submission. The "acceptance criteria" here relate to meeting established safety and performance standards for tampons.

Here's an analysis based on the provided document:

Device Type: Unscented Menstrual Tampons (medical device, not AI/ML driven)

Purpose of the Study (as described): To demonstrate substantial equivalence of the subject device (new tampons) to a legally marketed predicate device (existing tampons) by showing that differences in material composition and design do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a tampon submission, the "performance" relates to physical and biocompatibility characteristics, not diagnostic accuracy. The acceptance criteria are implicit in the standards followed and the successful completion of the tests.

• Pledget length (Dry): 37±3.0--50±3.0 mm
• Pledget diameter (Dry): 11.5±1.0--15.2±1.0 mm
• Total length of product: 118.0±2.0 mm
• Length of push rod: 70±1 mm
• Outside diameter (outer tube): 14.5±0.2--16.2±0.2 mm
• Weights: L: 3.90-4.40g; R: 4.45-5.15g; S: 5.65-6.45g; SP: 6.45-7.35g
  These differ from the predicate's specific values but are deemed "not raise different questions of safety and effectiveness." |
  | Functionality (Absorbency) | Meet industry standards for relevant absorbency ratings (e.g., Light (≤6g), Regular (6-9g), Super (9-12g), Super Plus (12-15g)). | Absorbency categories are listed, aligning with standard ranges. Performance data showing the specific absorbency achieved for each tampon type would be in the full submission, but the table indicates these categories are used. |
  | General Safety/Effectiveness | Overall safety and effectiveness comparable to predicate. | "The nonclinical tests demonstrate that the subject device, Unscented Menstrual Tampon, is as safe and effective as the legally marketed predicate device (K232598). Therefore, the subject device is substantially equivalent to the predicate device." |

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

• Sample Size for Test Set: Not explicitly stated in the provided summary for any of the biocompatibility, microbiology, or chemical residue tests. These tests are typically performed on a representative sample of units to demonstrate compliance with standards.
• Data Provenance: The manufacturing company is Unibeauty (Hubei) Technology Co.,Ltd. in Xiantao City, Hubei Province, China. The document does not specify the country of origin for the data itself (e.g., where the lab testing was performed) beyond the company's location. The studies described are "nonclinical performance testing." implicitly prospective, as they were conducted to support the 510(k) submission.

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

Not applicable. This submission is for a physical medical device (tampons), not an AI/ML diagnostic device that requires expert human interpretation to establish ground truth for testing. The "ground truth" here is established by standardized laboratory testing methods (e.g., chemical analysis, microbiological assays, physical measurements) interpreted by qualified laboratory personnel, not by medical experts forming a consensus on image interpretation.

4. Adjudication Method for the Test Set

Not applicable. As this is not a study involving human readers or interpretation, there is no adjudication method in the sense of resolving discrepancies between expert opinions. Laboratory results are typically verified through standard lab practices and quality control processes.

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

No. An MRMC study is relevant for AI/ML diagnostic tools to assess the impact of AI assistance on human reader performance. This submission is for a physical device, so no such study was conducted or is relevant.

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

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this type of device is established through:

• Standardized Laboratory Testing Results: Biocompatibility (cytotoxicity, sensitization, irritation), microbiology (growth of bacteria, toxin production), chemical residue analysis, and physical property measurements (dimensions, weight, absorbency).
• Compliance with Recognized Standards: The tests were conducted according to international standards like ISO 10993 series and FDA guidance documents specific to menstrual tampons.

8. The Sample Size for the Training Set

Not applicable. This device does not involve an AI/ML model that requires a training set.

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

Not applicable. As there is no AI/ML model, there is no training set and therefore no ground truth establishment for a training set.

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The tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

The SABA® Tampons are traditional unscented menstrual tampons. The SABA® Tampons are available either with a single use applicator or as a digital tampon (without an applicator). Except for the inclusion of the applicator, both types of tampons are made of the same materials. Each device consists of a tampon, including a 100% viscose pledget ("absorbent core") surrounded by a non-woven fabric cover blend of polyethylene and polyester, a removal cord of 67% polyester/33% viscose, and an applicator (only for the applicator tampon). The applicator is made of an inner tube of high-density polypropylene and an external tube of low-density polyethylene, both with 5% pink pigment. The applicator has a smooth, rounded tip to ease insertion.

Both the applicator and applicator free SABA® Tampons are provided in three absorbencies of regular (6-9g), super (9-12g), and super plus (12-15g). Each device is individually wrapped in a metallized printed bi-oriented polypropylene lamination and packaged in sealed multi-unit containers for retail sale. It is provided non-sterile and for single use only.

This document is a 510(k) clearance letter for SABA® Tampons, a type of menstrual tampon. The provided text does not contain any information about acceptance criteria or study data related to an AI/ML medical device.

The document details the substantial equivalence of the SABA® Tampons to a predicate device (K231341) based on non-clinical performance data, biocompatibility, microbiology testing, and shelf-life testing specific to tampons. It explicitly states:

• "No clinical studies are included in this submission."
• "This device does not include any use of software."
• "The device does not have any electrical source so no electrical safety or EMC testing are included in this submission."
• "No animal studies are included in this submission."

Therefore, it is impossible to describe acceptance criteria or a study proving device performance for an AI/ML medical device based on the provided text. The request's premise about AI/ML device evaluation is not applicable to the SABA® Tampons 510(k) submission.

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The Unscented Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

The Unscented Tampons are traditional unscented menstrual tampons. Except for the raw materials, they share the same design. The Unscented Tampons are provided with a cardboard applicator tampon. Each device consists of a tampon, including an absorbent 100% organic cotton or 100% viscose pledget , a 100% organic cotton or polyester and cotton removal string ("withdrawal cord"), and a cardboard applicator . The tampon is of the traditional cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion. The Unscented Tampons are provided in 4 absorbencies: light (less than or equal to 6g), regular (69g), super (912g) and super plus (12~15g). Each device is individually wrapped. It is provided non-sterile and for single use only.

The provided text describes the 510(k) premarket notification for an "Unscented Tampon." As such, the acceptance criteria and performance study details relate to the safety and performance of a medical device (a tampon), not an AI/algorithm-based device or a diagnostic tool.

Therefore, I cannot extract information related to:

• A table of AI acceptance criteria and reported device performance.
• Sample sizes for a test set or data provenance for AI.
• Number of experts, their qualifications, or adjudication methods for ground truth in AI.
• Multi-reader multi-case (MRMC) comparative effectiveness studies for AI.
• Stand-alone (algorithm-only) performance.
• Training set sample sizes or ground truth establishment for AI.

The document discusses "acceptance criteria" and "study" in the context of non-clinical testing for a physical medical device (tampon) to demonstrate its substantial equivalence to a predicate device.

Here's a summary of the non-clinical testing performed for the Unscented Tampon, which serves as the "study that proves the device meets the acceptance criteria" for this type of medical device:

1. Acceptance Criteria and Reported Device Performance (Non-AI Device)

The "acceptance criteria" for this device are established by meeting relevant FDA guidance documents and standards, demonstrating safety and performance comparable to a predicate device. The document states that "Non-clinical testing was conducted to verify that the subject devices meet all design and performance specifications similarly to the predicate device."

Here's a table summarizing the tests (which are the "acceptance criteria" for a tampon) and the reported performance:

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

• Sample Size: The document does not specify the exact number of tampons tested for each non-clinical test (e.g., how many tampons were subjected to biocompatibility testing, how many for dimension checks, etc.). It only mentions "the organic cotton tampon and the viscose tampon" being tested.
• Data Provenance: The tests are described as non-clinical laboratory tests performed to demonstrate substantial equivalence. The country of origin of the data is not explicitly stated in the summary, but the applicant company is SHANDONG INTCO HYGIENE PRODUCTS CO., LTD. in China. The data would be prospective, as it's generated specifically for this submission.

3. Number of Experts Used and Their Qualifications

• This is not applicable as the study described is non-clinical laboratory testing of a physical product (tampon), not an AI/diagnostic software. No experts are mentioned as establishing "ground truth" in the diagnostic sense. The "ground truth" for these tests is defined by established laboratory testing standards and methods (e.g., ISO standards, 21 CFR 801.430).

4. Adjudication Method for the Test Set

• Not applicable as this is a non-clinical laboratory test of a physical product, not an AI/diagnostic software requiring expert adjudication of results.

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

• Not applicable. This is not an AI/diagnostic device. The comparison is between the proposed physical tampon and a predicate physical tampon based on measured attributes and safety profiles.

6. Standalone (Algorithm Only) Performance

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by validated laboratory testing methods and industry standards (e.g., ISO 10993 series, 21 CFR 801.430, and FDA guidance documents for menstrual tampons). These methods define what constitutes acceptable dimensions, absorbency, biocompatibility, etc.

8. The Sample Size for the Training Set

• Not applicable. As this is a non-clinical submission for a physical device, there is no "training set" in the context of an AI/machine learning model.

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

• Not applicable. There is no training set for a physical medical device.

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The Organic Cotton Tampon and Organic Cotton PESCV cord Tampon are intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

Organic Cotton Tampon and Organic Cotton PESCVcord Tampon are traditional unscented menstrual tampons. They share the same design and raw materials except the material of the removal strings. Each of them are available in two configurations (i.e., digital tampon and applicator tampon). Each device consists of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by an overwrap ("security veil") and a removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The tampon design is cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion. Both of Organic Cotton Tampon and Organic Cotton PESCVcord Tampon are provided in 4 absorbency: light (≤6g), regular (6-9g), super (9-12g) and super plus (12-15g). Each device is individually wrapped and then packaged in sealed multi-unit containers for retail sale. All tampons and applicators are provided non-sterile and for single use only.

The provided document is a 510(k) Premarket Notification for menstrual tampons. It does not contain information about a study proving that a device meets acceptance criteria in the context of an AI/ML medical device. The document describes non-clinical testing for physical and biological properties of tampons and states that "all samples met the predefined acceptance criteria," but it does not detail those acceptance criteria or performance metrics for a software or AI device.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as it pertains to AI/ML. The provided text is about a physical medical device (tampon) and its safety and effectiveness, not an AI/ML device.

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The TOSAMA Reusable Applicator is intended to be used to insert a digital (no applicator) menstrual tampon into the vagina.

The TOSAMA Reusable Applicator is a non-sterile, single user, reusable medical device. It is intended to be sold in three different packaging configurations: Applicator with prepackaged tampons (regular, super and super plus absorbency versions) and Applicator with loose tampons of super and regular absorbency. The device is comprised of a tampon holder and pusher made of thermoplastic elastomer and a lipstick-style cap to protect the applicator, which is made of polystyrene. The tampon holder and pusher are connected at the hinged base of the holder, which opens to load a tampon and closes to allow the pusher to eject a tampon. The holder and pusher are designed to stay connected and not separate during use, storage, or cleaning. The TOSAMA Reusable Applicator requires the user to load the applicator with a legally marketed menstrual tampon. The use-life of the subject TOSAMA Reusable Applicator is 2 years. The device requires the user to clean (holder and pusher) and disinfect (lipstick cap) before initial use, before long term storage and at the end of the menstrual cycle, as well as to clean the device after each use. The applicator is available in one size for all sizes of tampon absorbencies (Light, Regular, Super and Super Plus) and accommodates a maximal tampon diameter of 15 mm. The holder inner diameter is 8.2 + 0.25/- 0.10 mm, pusher length is 83.7 ±0.5 mm and total length and diameter of the applicator (without the lipstick cap) is 70.8 ± 1.0 mm and 19.6 ±0.05 mm respectively.

The provided text describes the regulatory clearance of the "TOSAMA Reusable Applicator" (K232060) and includes some information about its testing. However, it does not contain a detailed study report that proves the device meets specific acceptance criteria in the format requested.

The text generally states that "The results of the non-clinical performance data were acceptable and met the established acceptance criteria." but does not provide the specific "acceptance criteria" themselves or the detailed "reported device performance" against those criteria in a table. It also lacks significant details regarding the study design, sample sizes for test sets, data provenance, ground truth establishment, or multi-reader studies as typically found in comprehensive medical device performance reports.

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

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

Missing specific acceptance values and corresponding performance results.

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

• Sample Size for Test Set: Not specified for any of the tests (biocompatibility, bench testing, reprocessing).
• Data Provenance: Not specified. It's a regulatory submission from a Slovenian company (Tosama, d.o.o., Domžale, Slovenia). The testing would likely have been conducted by or for this company. Whether the data is retrospective or prospective is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This type of study (e.g., biocompatibility and functional bench testing for a reusable tampon applicator) would not typically involve human experts establishing "ground truth" in the way an AI diagnostic device would. Instead, the ground truth is based on standardized biochemical assays (for biocompatibility) or engineering measurements against design specifications (for bench testing). Therefore, this question is not directly applicable in the context of this device's testing according to the provided information.

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

• Not applicable for the types of tests described (biocompatibility, bench testing). Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints, not for objective laboratory or engineering tests.

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 type of study is specifically relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) use AI as an aid. The TOSAMA Reusable Applicator is a physical medical device (tampon applicator), not an AI diagnostic tool.

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

• No, a standalone algorithm performance study was not done. This device is not an algorithm or AI. The testing described focuses on the physical and biological safety and performance of the applicator itself.

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

• For Biocompatibility: The ground truth is based on established biological and toxicological standards and test methods (e.g., ISO 10993 series for cytotoxicity, sensitization, irritation) and their defined pass/fail criteria.
• For Bench Testing: The ground truth is established by engineering design specifications and performance requirements (e.g., specific force values for ejection, dimensional tolerances, durability cycles).
• For Reprocessing: The ground truth is based on micro-biological testing (e.g., reduction of bioburden) and visual inspection to ensure cleanliness and disinfection efficacy, validated against pre-defined criteria.

8. The sample size for the training set

• Not applicable. This device is not an AI model, 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 this device.

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The Unscented Menstrual Tampon is inserted into the vagina to absorb menstrual discharge.

The Unscented Menstrual Tampons are menstrual tampons used to absorb menstrual fluid. These tampons are provided in 4 absorbencies, light (≤ 6 grams absorbency), regular (6-9 grams), super (9-12 grams) and super plus (12-15 grams). These tampons include a pledget made from viscose and cotton as well as a polyester and polypropylene overwrap. The removal string is made of polypropylene yarn and cotton yarn. The applicator tubes are made of low density polyethylene (LDPE). The assembled tampon with applicator is wrapped in a printed polyethylene wrapper.

This document describes the premarket notification for an "Unscented Menstrual Tampon" (K232598) and states its substantial equivalence to a predicate device. It is important to note that this document is for a medical device (menstrual tampons), not an AI/ML powered device, so the requested information about AI model performance, multi-reader multi-case studies, and ground truth establishment from experts or pathology will not be present.

Based on the provided document, here's what can be extracted regarding acceptance criteria and performance:

The document explicitly states: "The performance tests were conducted to demonstrate the effectiveness of the subject device; all samples met the predefined acceptance criteria."

However, the specific numerical acceptance criteria for each test and the reported device performance are not explicitly detailed in a table format with specific values within this document. Instead, it lists the types of performance characteristics assessed and implies that the device met the criteria.

Here's a breakdown of the requested information based on the provided document, with explanations for what is not applicable or not explicitly stated:

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

While the document states that all acceptance criteria were met, it does not provide a table with specific numerical acceptance criteria and the corresponding reported values for the subject device. It only lists the types of tests performed.

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The Daye Tampons are indicated for insertion into the vagina to absorb menstrual discharge.

The Daye Tampons are unscented menstrual tampons consisting of an absorbent cotton pledget and a plastic (polyethylene) full-size applicator. The tampon pledget is made entirely of organic cotton, is fashioned with a W'wadding design and protective sleeve/overwrap. A withdrawal cord, made from mercerised organic cotton, is attached to the pledget. The Daye Tampons are available in regular (6-9 grams) and super (9-12 grams) absorbencies. The Daye Tampons and applicator are gamma irradiated in the finalpackaging. The Daye Tampons and applicators are repackaged together.

The provided document is a 510(k) summary for the Daye Tampon, which is a medical device, not an AI/ML powered diagnostic device. Therefore, the information required to answer the prompt regarding acceptance criteria and a study proving a device meets acceptance criteria using AI/ML specific methods is largely not present. The document focuses on demonstrating substantial equivalence to a predicate menstrual tampon based on performance characteristics, biocompatibility, and microbiology.

However, I can extract and restructure the available information to fit the spirit of the request, interpreting "device performance" in the context of a tampon and its established safety and effectiveness. I will explicitly state where the requested information is not applicable or not provided in the document.

Acceptance Criteria and Study for Daye Tampon (based on 510(k) Summary)

The Daye Tampon is a menstrual tampon, and its performance and safety are assessed against established regulatory standards and comparison to a legally marketed predicate device (Ontex W long plastic applicator Tampons, K162746). The "acceptance criteria" here are essentially the demonstration of substantial equivalence, ensuring the device is as safe and effective as the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the specific sample sizes for each test (e.g., number of tampons tested for absorbency, dimensions, etc.). It refers to "tests" being performed.
• Data Provenance: The study was conducted by Anne's Daye Ltd. The country of origin for the data is not specified, but the applicant's address is in London, UK. The studies are implicitly prospective in the sense that they are specifically performed for the purpose of this 510(k) submission to demonstrate compliance and substantial equivalence to the predicate where comparative testing was done (e.g., post-irradiation effects). For chemical residues and microbiology, leverage from the predicate device implies reliance on data previously generated for the predicate, which could have been retrospective for that predicate, but for the Daye Tampon submission, it's a forward-looking use of existing data.

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

• Not Applicable. This device is a menstrual tampon, not an AI/ML diagnostic system requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" here is defined by established regulatory standards (e.g., 21 CFR 801.430 for absorbency, ISO standards for biocompatibility) and direct physical/chemical measurements.

4. Adjudication Method for the Test Set

• Not Applicable. As this is not an AI/ML diagnostic study involving human readers and interpretations, an adjudication method for a test set is not relevant. Tests are performed according to established methods (e.g., Syngyna method, ISO 10993).

5. MRMC Comparative Effectiveness Study

• Not Applicable. This is not an AI/ML diagnostic device, and thus, no Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. There are no human readers assisting with an AI to improve performance.

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

• Not Applicable. This is not an AI or algorithm-based device. Its performance is inherent to its physical and chemical properties.

7. Type of Ground Truth Used

• The "ground truth" for this device is based on:
  • Regulatory Standards: Specific performance requirements defined by FDA regulations (e.g., 21 CFR 801.430 for absorbency ranges).
  • International Standards: Biological evaluation standards (ISO 10993 series) for biocompatibility.
  • Direct Measurement & Empirical Testing: Objective measurements of physical dimensions, strength, and laboratory tests for fiber loss, absorbency, and dissolution.
  • Comparison to Predicate: Establishing equivalence to the performance and safety characteristics of a legally marketed predicate device.

8. Sample Size for the Training Set

• Not Applicable. As this is not an AI/ML device, there is no "training set."

9. How Ground Truth for the Training Set Was Established

• Not Applicable. There is no training set as it's not an AI/ML device.

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The tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

The organic cotton tampon and viscose tampon are traditional unscented menstrual tampons. Except for the raw materials, they share the same design. The organic cotton tampon and viscose tampon, both have two types i.e., digital tampon and applicator tampon. The tampon applicator is available in two colors - milky and pink. Each device consists of a tampon, including an absorbent 100% organic cotton or 100% viscose pledget ("absorbent core") surrounded by polyethylene and polyethylene terephthalate overwrap ("security veil"), a 100% organic cotton or polyester and cotton removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The applicator is made of polyethylene and polypropylene. The tampon is of the traditional cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion. Both, organic cotton tampon and viscose tampon, are provided in 4 absorbencies: light (≤6g), regular (69g), super (912g) and super plus (12~15g). Each device is individually wrapped in a polyethylene/nonwoven laminated film or cellophane film and packaged in sealed multi-unit containers for retail sale. It is provided non-sterile and for single use only.

The provided text is a 510(k) Summary for a medical device (tampon). It details performance testing, biocompatibility testing, and microbiology testing, but does not describe an AI/ML-based device or a study that uses AI/ML.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and studies that prove an AI device meets those criteria.

The information typically provided in such a document for a traditional medical device (like a tampon) focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized standards and guidance, not on AI/ML performance metrics.

Specifically, the document states:

• No AI: The device is an "Organic cotton tampon" and "Viscose tampon," with no mention of AI or machine learning.
• No clinical study: "No clinical study is included in this submission."
• Non-clinical testing only: The document summarizes "Non-clinical Testing" including performance, biocompatibility, and microbiology tests.

If you have a document describing an AI/ML medical device, please provide that, and I would be happy to analyze it according to your requested criteria.

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Sequel tampon with plastic applicator is an unscented tampon provided with a plastic applicator used for easing the placement of the tampon correctly into the vagina. The Sequel tampon is inserted into the vagina and used to absorb menstrual or other vaginal discharge.

The Sequel Tampon with Plastic applicator are menstrual tampons used to absorb menstrual fluid. These Tampons are available in Regular absorbency (6-9 grams). These Tampons are made from rayon fibers and a polyethylene/polyester overwrap in which a cotton/polyester withdrawal cord is inserted. The applicator is a compact style polyethylene applicator with cylindrical barrel with a plunger. The assembled tampon with applicator is wrapped in a printed polypropylene wrapper. The tampon and applicator are single-use and non-sterile.

This document describes the premarket notification (510(k)) for the Sequel Tampon with Plastic applicator. It is a Class II device, regulated under 21 CFR § 884.5470 (Unscented menstrual tampon), with product code HEB. The predicate device is the "Interlude and Private Label Unscented 3-piece compact applicator tampon (K173225)."

The document focuses on demonstrating substantial equivalence to the predicate device, primarily through performance testing and comparison of technological characteristics. This document describes a medical device clearance, not a digital health/AI product. Therefore, the questions related to AI/MRMC studies, expert ground truth, and training sets are not applicable.

Here's an analysis based on the provided text, addressing the points where applicable:

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

The document does not present a formal "acceptance criteria" table in the way one would for a quantifiable performance claim (e.g., sensitivity/specificity for a diagnostic device). Instead, it lists performance characteristics assessed according to FDA guidance documents for menstrual tampons. The "reported device performance" is a statement that the device met these criteria.

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

The document does not specify quantitative sample sizes for each test (e.g., number of tampons tested for absorbency, or number of biological samples for biocompatibility). It simply states that "The test results show the tampon..." met the criteria.

Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned, as these are primarily laboratory-based performance and biocompatibility tests rather than clinical studies.

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

Not applicable. This is a medical device clearance based on laboratory and material performance testing, not on expert-adjudicated clinical ground truth like an AI diagnostic algorithm.

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

Not applicable. There is no clinical test set requiring adjudication in the context of this 510(k) submission.

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 (tampon), not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for this device's performance is established by standardized laboratory methods and biocompatibility assays, as deemed appropriate by the FDA guidance documents for menstrual tampons. For example:

• Absorbency: Measured according to 21 CFR 801.430.
• Biocompatibility: Assessed using ISO 10993 standards and established toxicological endpoints.
• Microbial Testing: Standardized tests for growth of Staphylococcus aureus, TSST-1 production, and impact on vaginal microflora.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. This is a physical medical device.

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U by Kotex® Click® Unscented Menstrual Tampon is an unscented tampon inserted into the vagina to absorb menstrual fluid.

The U by Kotex® Click® Unscented Menstrual Tampon is a conventional unscented menstrual tampon consisting of an absorbent pledget and a telescoping three-piece plastic applicator. The device will be manufactured in Regular, Super, and Super Plus absorbencies. The absorbent pledget consists of an absorbent core of radially wound rayon ribbon compressed into a grooved cylinder with a rounded, bullet-like tip, a non-woven overwrap cover, and a rayon-polyester blend withdrawal string. The three-piece applicator consists of an outer insertion tube (barrel) with a textured grip and formed with a closed, rounded tip in a petal-like design, a clear middle telescopic tube (telescope), and an elongated insertion tube (plunger). Each tampon is individually sealed in a plastic film primary wrapper and then packaged in sealed multi-unit containers for retail sale.

The document describes a 510(k) submission for a medical device, which generally means comparing a new device to a legally marketed predicate device to demonstrate substantial equivalence. For this type of submission, extensive acceptance criteria and detailed clinical studies as might be found for novel technologies are often not present in the same format. Instead, the focus is on showing that the modified device performs as safely and effectively as the predicate.

Based on the provided text, here's a breakdown of the requested information:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance for a test set. Instead, it states that the device was assessed against various standards and guidance documents. The "Performance" column in Table 05-02 indicates the outcome of the tests, rather than specific numerical acceptance criteria. Similarly, for other performance characteristics, the document states they "were assessed in accordance with the 2005 FDA guidance document," implying compliance with the requirements within that guidance, but without listing specific numerical targets.

However, we can infer some "performance" outcomes from the biocompatibility tests:

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

The document states, "No clinical tests were performed as part of this device modification." Therefore, there is no clinical test set, sample size, or specific data provenance (country, retrospective/prospective) for clinical performance in the traditional sense. The performance data discussed relates to non-clinical laboratory testing. The document does not specify sample sizes for these non-clinical tests (e.g., how many tampons were tested for absorbency, string strength, etc.).

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

Not applicable. Since no clinical tests were performed and no human interpretation of data for diagnostic purposes is relevant to this device, no "experts" in the context of establishing ground truth for a test set are mentioned. The testing was conducted against regulatory standards and guidelines by presumably qualified laboratory personnel.

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

Not applicable. This device is a menstrual tampon, and the performance assessment is based on physical and chemical properties and biocompatibility, not on a diagnostic interpretation requiring adjudication of results from multiple readers.

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

Not applicable. This device is a menstrual tampon and does not involve AI or human readers for diagnostic purposes.

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

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

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

For the non-clinical tests, the "ground truth" is defined by the established regulatory standards and guidance documents (e.g., ISO 10993 series for biocompatibility, 2005 FDA guidance for tampons for performance characteristics). Compliance with these standards indicates acceptable performance. There isn't a "ground truth" derived from expert consensus, pathology, or outcomes data in the typical sense applied to diagnostic devices.

8. The sample size for the training set

Not applicable. This is a 510(k) submission for a physical medical device, not an AI or machine learning device requiring a training set.

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

Not applicable for the reason mentioned above.

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