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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 Tosama Biobased Applicator Tube Menstrual Tampon is intended for insertion into the absorption of menstrual or other vaginal discharge.

The device will be offered as a traditional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator comprised of biobased plastic. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in three absorbencies: Regular, Super, and Super Plus.

This document is a 510(k) premarket notification for a medical device (a menstrual tampon) and primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of a novel AI/software-as-a-medical-device (SaMD) or diagnostic device that would typically involve acceptance criteria related to accuracy, sensitivity, and specificity, and the elements of an MRMC study.

Therefore, the requested information regarding AI/SaMD performance metrics (such as a table of acceptance criteria for device performance, ground truth establishment, expert adjudication, MRMC studies, training/test set details, etc.) is not applicable to this document.

However, the document does contain "acceptance criteria" in the context of non-clinical testing for the physical and biological properties of the tampon. I can extract that information.

Here's a breakdown of the information that is available in the provided text, adapted to the closest relevant sections of your request:

Study on Device Meeting Acceptance Criteria (Non-Clinical)

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

The document states: "The results of these tests met pre-defined acceptance criteria as applicable and are acceptable." It does not provide the specific numerical acceptance criteria or the numerical results for each test. However, it lists the types of tests performed.

Note: The specific numerical "pre-defined acceptance criteria" for each test (e.g., minimum pull-out strength, maximum microbial counts) are not provided in this document.

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: Not explicitly stated for each test. The testing was conducted on "All materials used in the construction of Tosama Biobased Applicator Tube Menstrual Tampons as well as complete devices" and "each absorbency level of the complete finished device." This implies a sufficient number of samples were tested to demonstrate compliance, but the exact number isn't quantified.
• Data Provenance: Not explicitly stated, but given the company (Tosama, d.o.o.) is based in Slovenia, EU, it's highly probable the testing was conducted in Europe. The data refers to non-clinical lab testing. These would be prospective experimental tests conducted for regulatory submission.

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

• This is not applicable as this is a physical/biological product validation, not a diagnostic device involving expert human interpretation for "ground truth." The ground truth for these tests is established by quantifiable physical, chemical, and biological measurements following established standards (e.g., ISO, FDA guidance).

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

• Not applicable for non-clinical lab testing. The results are based on objective measurements against pre-defined standards.

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

• Not applicable. This is not an AI/SaMD device.

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

• Not applicable. This is not an AI/SaMD device.

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

• The "ground truth" for the non-clinical tests is established by objective laboratory measurements against recognized international standards and FDA guidance. Examples include:
  • Quantifiable values from biocompatibility assays (e.g., cell viability).
  • Microbial counts from culture methods.
  • Measured absorbency in grams.
  • Physical dimensions in millimeters/grams.
  • Measured force for withdrawal cord pull-out strength.

8. The sample size for the training set

• Not applicable. This is not an AI/SaMD device requiring a training set.

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

• Not applicable. This is not an AI/SaMD device requiring a training set.

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The Tosama 100% Organic Cotton Menstrual Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

The device will be offered as a traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in three absorbencies: Regular, Super, and Super Plus.

This document is a 510(k) premarket notification for a menstrual tampon. It is not a study about an AI-powered medical device. Therefore, it does not contain the information required to answer your request regarding acceptance criteria and a study proving a device meets them for an AI device.

The document discusses the substantial equivalence of the "Tosama 100% Organic Cotton Menstrual Tampon" to a predicate device (Naturalena 100% Cotton Tampon). It outlines the general safety and effectiveness of the traditional medical device through non-clinical testing.

Here's why the requested information cannot be provided from this document:

1. Nature of the Device: The device described is a physical menstrual tampon, not an AI-powered software or system.
2. Type of Study: The document refers to "non-clinical data" and "testing" (chemical, microbiological, biocompatibility, efficacy) for the tampon, which are standard for physical medical devices to demonstrate safety and effectiveness. It does not describe a clinical study of an AI algorithm's performance.
3. Missing AI-Specific Information: There is no mention of algorithms, machine learning, AI assistance, human readers, ground truth establishment by experts, or training/test sets in the context of AI.

The requested information is specific to the development and validation of AI/ML-based medical devices, which are not covered by this submission for a menstrual tampon.

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The Tosama 100% Cotton Tampon is intended for insertion into the vagina for absorption of menstrual or other vaginal discharge.

The device will be offered as a traditional unscented menstrual 100% cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in three absorbencies: Regular, Super, and Super Plus.

The provided document describes a medical device (Tosama 100% Cotton Menstrual Tampon) and its substantial equivalence to predicate devices, rather than an AI-powered diagnostic tool. Therefore, many of the requested categories for acceptance criteria and study design (such as Number of experts used to establish the ground truth, Adjudication method, MRMC comparative effectiveness study, Standalone performance, Type of ground truth, and Sample size for the training set and Ground truth for training set) are not applicable.

However, I can extract information related to the device's performance, the tests conducted, and the basis for its equivalence.

Here's the information derived from the provided text, adapted to the closest relevant categories:

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

The document doesn't explicitly state "acceptance criteria" but lists various physical and functional specifications for the tampon, along with reported values for the Tosama 100% Cotton Menstrual Tampon and the predicate devices. The study objective was to demonstrate substantial equivalence, meaning the Tosama device performs within the same established ranges as the predicates.

The "study that proves the device meets the acceptance criteria" is described as a non-clinical data summary. This non-clinical data was used for substantial equivalence determination to predicate devices already on the market.

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

• Sample Size: Not explicitly stated for each test, but it is implied that representative samples of the Tosama 100% Cotton Menstrual Tampon and its components were tested.
• Data Provenance: The manufacturer is TOSAMA, d.o.o. from Slovenia, EU. The testing appears to have been conducted by or for the manufacturer. The data is likely prospective, as it relates to testing the specific device for regulatory submission.

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

Not applicable. This is a physical and chemical testing study for a medical device, not an AI-powered diagnostic tool requiring expert ground truth for interpretation.

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

Not applicable. This is a physical and chemical testing study, not based on human review/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

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device. The device itself is a standalone medical product.

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

The "ground truth" in this context refers to established test methodologies and results for similar predicate devices, and the physical, chemical, and microbiological properties of the materials and finished product. Testing followed "recommended requirements."

• Chemical Analysis: Tests for pesticide, dioxin, heavy metal, phthalate, and PCB residues.
• Microbiological Testing: Enumeration per USP /, Toxic Shock Syndrome Toxin-1 production, vaginal microflora growth alteration, and S. aureus growth enhancement.
• Biocompatibility Testing: In vitro cytotoxicity, intracutaneous and vaginal irritation, sensitization, and acute systemic toxicity.
• Efficacy Testing: Syngina absorbency, fiber loss, withdrawal cord pull-out resistance, and tampon integrity.
• Physical Characteristics: Length, diameter, mass, withdrawal cord length, applicator dimensions.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no "training set."

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

Not applicable. There is no training set as it is not an AI device.

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The Lil-lets tampons (both types) are unscented tampons for:
• Women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge.
• The plastic applicator is for easing the placement of the tampon correctly into the vagina (only the Lil-lets Silk Comfort Compact Plastic Applicator Tampon).

Lil-lets tampons are used to absorb menstrual fluid. Lil-lets series tampons come with a plastic applicator and without a plastic applicator in sizes: Lite, Regular, Super, Super plus and Ultra. Lil-lets tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.

The provided 510(k) summary (K120481) for the Lil-lets Silk Comfort Compact Plastic Applicator Tampon & Lil-lets Non-Applicator Tampon describes pre-clinical testing to demonstrate substantial equivalence to a predicate device, MAXIM Plastic Applicator and Non Applicator Tampons (K080775). However, it does not contain a comprehensive study proving that the device meets specific acceptance criteria in the manner typically described for clinical studies of new medical devices with defined performance metrics, patient populations, and statistical analysis.

Instead, the summary focuses on non-clinical tests to ensure safety and equivalence based on existing standards and knowledge of the predicate device. The "acceptance criteria" are implied by adherence to these standards and by demonstrating that the Lil-lets tampons do not present new questions of safety or effectiveness.

Here's a breakdown of the information based on the provided text, using the requested format where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

• Alter the growth of normal vaginal microflora (Zone of inhibition)
• Increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1) | (Not explicitly stated as "met" or specific results, but the submission implies these were assessed and deemed acceptable for substantial equivalence. The overall conclusion states substantial equivalence.) |
  | Syngyna Testing | Adherence to 21 CFR 801.430(f)(2) to verify absorbency ranges as specified in the regulation. Tampons must be labeled in accordance with required ranges. | "Syngyna testing was conducted in accordance to 21 CFR 801.430(f)(2) to verify that the subject tampons met absorbency ranges as specified in the regulation. The tampons are labeled in accordance to required ranges." (This directly states the criteria were met.) |
  | Physical and Chemical Tests | Internal methods for:
• Fibre loss test
• Stability of digital tampons
• Withdrawal cord attachment test
• Expulsion force of applicator tampons | (Not explicitly stated as "met" or specific results, but the submission implies these were assessed and deemed acceptable for substantial equivalence. The overall conclusion states substantial equivalence.) |
  | Technological Characteristics | No differences from the technical characteristics of the substantially equivalent predicate devices (MAXIM tampons under K080775), differing only in dimensions across sizes (Lite, Regular, Super, Super plus, Ultra). The tampons contain commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string. | "There are no differences between the technical characteristics of the Lil-lets tampons and the predicate characteristics of the substantially equivalent devices MAXIM tampons under K080775. All sizes... have the same characteristics; they differ only in dimensions." |

Detailed Study Information:

This document is a 510(k) summary focused on demonstrating substantial equivalence for tampons, not a report of a traditional clinical performance study for a novel device. Therefore, many of the requested points do not apply or are not explicitly detailed in the provided text, as the regulatory pathway chosen (510(k)) relies heavily on comparing technical and safety characteristics to a legally marketed predicate device.

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 does not specify general "test set" sample sizes or data provenance in the context of a clinical study.
• For Syngyna testing, it states "Syngyna testing was conducted," but does not provide the number of tampons tested. This is a bench test performed in a lab, not on human subjects.
• For Microbiology and Physical/Chemical tests, no sample sizes are provided for individual tests.
• Data provenance for these non-clinical tests would likely be the manufacturing site or a contract lab performing the tests, which is in Slovenia, given the submitter's address.

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

• Not applicable in this context. "Ground truth" in the sense of expert consensus for diagnostic performance is not relevant to non-clinical tests of tampon safety and absorbency. Expertise is implied by adherence to regulatory standards and testing methodologies by competent personnel.

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

• Not applicable. This concept is for clinical studies involving human interpretation or challenging outcomes.

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 tampon, not an AI-assisted diagnostic tool or an imaging device.

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

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

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

• The "ground truth" for these non-clinical tests would be the established regulatory standards and validated test methodologies themselves (e.g., 21 CFR 801.430(f)(2) for absorbency, specific microbiological assays, internal physical testing protocols).
• For biocompatibility, the ground truth is the accepted safety profile of the predicate device's materials.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of such a device and its regulatory submission.

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

• Not applicable.

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