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The Rostan Scented and Unscented Biodegradable Plastic Applicator Tampons are inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Rostam plastic scented and unscented biodegradable applicator tampons are being submitted to obtain clearance for a new material applicator. They are menstrual tampons used to absorb menstrual fluid. These Tanıpons will be provided with 4 absorbencies, light, regular, super and super plus.

These Tampons are made from rayon and/or cotton (as the absorbent material) polymeric overwrap, cotton/polyester sewing thread and cotton cord.

The provided text is a 510(k) summary for a menstrual tampon device. It discusses the device's substantial equivalence to previously marketed tampons and includes information about performance testing related to biocompatibility and absorbency. However, it does not describe any acceptance criteria for an AI/ML powered device, nor does it detail a study that proves a device meets such criteria. Therefore, I cannot extract the requested information.

The document pertains to a traditional medical device (menstrual tampons) and not an AI/ML powered device. The questions in the prompt are specifically geared towards the evaluation of AI/ML medical devices.

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The Rostam Fragranced and Unfragranced Compact Applicator Tampons are inserted into the vagina and used to absorb menstrual or other vaginal discharge

Rostam plastic applicator tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, Light, regular and super. These Tampons are made from rayon and/or cotton polymeric overwrap and cotton cord. The materials used in these tampons are similar to those used in other legally marketed tampons.

The provided text is for a 510(k) summary for a medical device (tampons). The purpose of a 510(k) summary is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to detail comprehensive device-specific performance studies with specific acceptance criteria and detailed study designs as might be found for novel, higher-risk devices.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Repeated Insult Patch Test: 100 human subjects.
• Data Provenance: Not explicitly stated for all tests, but "review of existing toxicological data in the public literature" suggests some data is retrospective and potentially sourced broadly. The human patch test is prospective. No country of origin is specified.
• Syngyna Testing: No explicit sample size specified, as it's a standardized in vitro test.

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

• The document does not mention experts being used to establish "ground truth" in the context of diagnostic performance or clinical outcomes. The assessments are primarily for safety and absorbency, which are typically evaluated by laboratory analysis or clinical safety studies, not expert consensus on ground truth in a diagnostic sense. For the patch test, the evaluation would be performed by trained dermatologists or clinicians, but the number is not specified.

4. Adjudication Method for the Test Set:

• Not applicable/Not mentioned. Adjudication methods are typically relevant for studies where multiple readers assess cases against a predefined ground truth, which is not the primary focus here.

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

• No. This type of study is not relevant for tampons, as they are not diagnostic devices that involve human readers interpreting results.

6. Standalone Performance Study (Algorithm Only):

• No. This is not applicable. Tampons are not an algorithm-based device.

7. Type of Ground Truth Used:

• Biocompatibility/Safety: Historical testing data, literature review, and direct results (e.g., lack of significant skin reactions in the patch test).
• Absorbency: Standardized laboratory measurements (Syngyna test) which serve as the "ground truth" for absorbency.

8. Sample Size for the Training Set:

• Not applicable. As this device is not an AI/ML diagnostic or image interpretation device, there is no "training set." The reference to "historical data" and "public literature" for safety serves a similar purpose to a knowledge base, but not a supervised machine learning training set.

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

• Not applicable, as there is no training set as defined in an AI/ML context.

Summary of Approach:

The K096671 submission for Rostam tampons primarily relies on demonstrating substantial equivalence to a previously legally marketed device (Tampax Compak Pearl Scented and unscented Tampons). This means the focus is on showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.

The "studies" mentioned (Biocompatibility testing, Syngyna testing, Repeated Insult Patch Test) are primarily to confirm the safety and functional performance (absorbency) in a manner consistent with established standards for tampons and to demonstrate they meet the safety profile of predicate devices. The phrase "these Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons" is the overarching "acceptance criterion" met by the provided test results.

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Rostam Ltd. Fragranced and Unfragranced plastic applicator tampons are a plug of Cellulosic or synthetic material that is inserted into the vagina and used to apsorb menstrual or other vaginal discharge

Rostam plastic applicator tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided as two absorbencies, slender regular and light. These Tampons are made from rayon and/or cotton, polymeric overwrap and cotton cord. The materials used in these tampons are similar to those used in other legally marketed tampons.

This document is a 510(k) summary for Rostam Scented and Unscented Plastic Applicator Tampons, indicating the device's substantial equivalence to legally marketed predicate devices. It primarily focuses on the regulatory submission and does not contain detailed information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical trial or algorithm performance study would for, for instance, a medical imaging AI.

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

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

Based on the provided text, explicit acceptance criteria and corresponding reported device performance for specific quantitative metrics are not available. The submission focuses on substantial equivalence to existing legally marketed tampons rather than setting new quantitative performance benchmarks.

The document states:

• "The results of these tests demonstrate that these Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons."
• "Standard Syngyna testing confirmed the absorbency of these Tampons."

While "equivalent in terms of safety and effectiveness" and "confirmed the absorbency" are positive statements, they don't provide a table of precise criteria or numerical performance data against those criteria.

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

The only specific test mentioned with a sample size is:

• Test: Repeated Insult Patch Test
• Sample Size: 100 human subjects
• Data Provenance: Not specified, but likely prospective given it's an "insult patch test" on human subjects. Country of origin not mentioned.

Other tests are alluded to (biocompatibility, safety evaluations, Syngyna testing) but without specific sample sizes or details on data provenance.

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 question is not applicable in the context of this device and testing. The "ground truth" concept, often used in AI or diagnostic device studies where expert consensus or pathology confirms a condition, does not apply directly to tampon safety and absorbency testing. The Repeated Insult Patch Test uses human subjects as direct biological indicators of irritation/sensitization, not as adjudicators of a "ground truth" diagnosis. Absorbency testing (Syngyna) uses a standardized in-vitro method, not expert judgment for ground truth.

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

Not applicable. As noted above, the testing methodologies (patch test, Syngyna) do not involve human adjudication in the sense of reviewing diagnostic 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 is a medical device for menstrual fluid absorption, not a diagnostic imaging or AI-assisted system. No MRMC studies or AI involvement is mentioned or relevant.

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

Not applicable. This is not an algorithm or AI device.

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

As explained previously, the concept of a "ground truth" in the diagnostic sense is not directly applicable here.

• For the Repeated Insult Patch Test, the "ground truth" is the observed skin reaction (or lack thereof) on the human subjects. This is a direct biological outcome.
• For Syngyna testing, the "ground truth" for absorbency is determined by the standardized in-vitro method, which measures fluid uptake.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. The materials and manufacturing processes are likely validated through standard engineering and quality control procedures, but not by training an algorithm.

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

Not applicable, as there is no training set for this type of device.

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As a Class II Device, the menstrual tampon is defined as follows: (21CFR884.5460 and 21CFR 884 5470).

Rostam Ltd. Fragranced plastic applicator tampons are a plug of Cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Rostam plastic applicator tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, regular, super and super plus.

These Tampons are made from rayon and/or cotton polymeric overwrap and cotton cord.

The materials used in these tampons are similar to those used in other legally marketed tampons.

The provided text describes a 510(k) premarket notification for Rostam Scented and Unscented Plastic Applicator Tampons. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the context of a new, complex medical device or AI system.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth types is not applicable to this submission.

Here's an attempt to extract relevant information and explain why other points are not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 100 human subjects for the Repeated Insult Patch Test.
• Data Provenance: Not explicitly stated, but the test was conducted to support a US FDA submission, implying the data would be expected to meet appropriate regulatory standards for validity. The exact country of origin for the subjects is not provided.
• Retrospective or Prospective: The "Repeated Insult Patch Test, 100 human subjects" is a prospective test.

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

• Not applicable in the context of this device. The "ground truth" for the patch test would be the observed skin reactions, assessed by a qualified medical professional (e.g., dermatologist), but the specific number or qualifications are not detailed in this summary. For absorbency, the "ground truth" is defined by the Syngyna test protocol.

4. Adjudication method for the test set

• Not applicable. This is not a study requiring adjudication of interpretations (like imaging studies). The Repeated Insult Patch Test involves direct observation and scoring of skin reactions.

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, a MRMC comparative effectiveness study was not done. This is a physical product (tampon), not an AI-powered diagnostic or interpretive device.

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

• No, "standalone performance" in the AI sense is not applicable. This is a physical product.

7. The type of ground truth used

• For biocompatibility: Historical data and existing toxicological literature.
• For absorbency: Standardized laboratory testing (Syngyna test) outcome.
• For allergenicity/irritation: Direct clinical observation of skin reactions in human subjects.

8. The sample size for the training set

• Not applicable. This is not a machine learning device, so there is no "training set." The "training" here refers to the development process of the product itself, which included historical biocompatibility data and standard material testing.

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

• Not applicable. Given this is not an AI/ML device, the concept of a "training set" with established ground truth is not relevant. The safety and effectiveness claims are based on material equivalence, standard physical testing, and prior human subject testing for irritation.

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The Rostam pH Tampon is a menstrual tampon for the absorption of menstrual fluid. The pH Tampon reduces the usual vaginal pH increase during menses.

The Rostam pH Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be marketed at the first stage in two absorbencies: regular and super. The Tampons reduce the usual vaginal pH increase during menses. These Tampons are made from rayon and cotton cord. The materials used in these tampons are similar to those used in other legally marketed tampons in the US, with the exception of an additive that is designed to reduce the usual increase in vaginal pH during menstruation.

The provided text describes a 510(k) summary for the Rostam pH Tampons. It outlines the device description, intended use, and non-clinical/clinical testing. However, it does not provide the specific details required to complete your request for acceptance criteria and the study proving the device meets those criteria.

The document states: "These tests, together with clinical evaluations, demonstrated that the tampon with additive is appropriate for its intended use." This is a general statement of compliance, but it lacks the quantitative results or specific criteria usually found in a detailed study report.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered based on the provided information:

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

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 specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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 specified.

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

• Not specified. The document mentions "clinical evaluations" but does not detail the methodology.

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 as the device is a menstrual tampon, not an AI-powered diagnostic tool requiring human readability studies. The document does not mention any MRMC study.

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

• Not applicable as the device is a menstrual tampon.

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

• The implicit "ground truth" relates to the tampon's ability to "reduce the usual vaginal pH increase during menses" and its safety profile (irritation, sensitization, TSS-1 testing). The exact methodology for establishing the reduction in pH is not detailed, nor is the specific "ground truth" definition for the clinical evaluations mentioned.

8. The sample size for the training set

• Not applicable/Not specified. The clinical evaluations mentioned are likely for verifying safety and performance, not for training a model.

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

• Not applicable/Not specified.

Summary of available information:

The provided document, a 510(k) summary, focuses on demonstrating substantial equivalence to predicate devices and adherence to regulatory standards for safety and general performance. It lists various preclinical toxicology tests and states that "clinical evaluations" were performed to show the device is appropriate for its intended use, specifically highlighting its ability to "reduce the usual vaginal pH increase during menses." However, it does not offer the granular detail of specific acceptance criteria, study sizes, methodologies, or quantitative performance metrics that would be found in a full study report or a more detailed section on clinical test results.

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Rostam Ltd fragranced plastic applicator tampons are a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Rostam plastic applicators are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 5 absorbencies, junior (MINI), regular, slender regular, super and super plus. These Tampons are made from rayon and cotton and cotton cord. The material used in these tampons are similar to those used in other legally marketed tampons.

This document describes ROSTAM Ltd Plastic Applicator Fragranced Tampons. Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set (Clinical Testing):
  • Sample Size: 100 human subjects for the Repeated Insult Patch Test.
  • Data Provenance: Not explicitly stated (e.g., country of origin) but "human subjects" implies prospective clinical testing.
• Training Set: Not applicable. This submission does not involve a machine learning algorithm with a training set.
• Other Testing:
  • Biocompatibility and Safety Evaluations: "Historically carried out." No specific sample size or provenance given in this document.
  • Syngyna Testing: Confirmed absorbency. This is an in vitro test, so human sample size is not applicable.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. The tests described (biocompatibility, absorbency, patch test) rely on laboratory measurements and clinical observations, not expert consensus for establishing ground truth in the way a diagnostic imaging study would.

4. Adjudication Method for Test Set

Not applicable. The tests described do not lend themselves to an adjudication method typically used for subjective assessments or classifications. The "Repeated Insult Patch Test" involves clinical observation of skin reactions, but an adjudication method for reconciling differing interpretations by experts is not mentioned.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical product (tampon), not a diagnostic imaging or AI-assisted device that would typically involve human readers interpreting cases.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. This device is a physical product, not an algorithm.

7. Type of Ground Truth Used

• Biocompatibility/Safety: Likely based on standardized assays and historical data/toxicological literature.
• Absorbency: Measured objectively using the "Standard Syngyna testing" (an in vitro laboratory method).
• Repeated Insult Patch Test: Clinical observation of skin reactions (e.g., redness, swelling, itching) in human subjects following repeated exposure to the product. The ground truth would be the presence or absence, and severity, of these reactions.
• Overall Equivalence: Based on comparison of materials, design, and performance data (biocompatibility, absorbency) against a legally marketed predicate device.

8. Sample Size for the Training Set

Not applicable. This submission does not involve a machine learning algorithm with a training set.

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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As a Class II device, the menstrual tampon is defined as follows: (21 CFR 884.5460 and 21 CFR 884.5470) Rostam applicator tampons are made of cellulosic or synthetic material that is inserted ire the vagina and used to absorb menstrual or other discharge.

Rostam Interlude Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be marketed in three absorbencies: regular, super and super plus. These Tampons are made from rayon and cotton and cotton cord. The material used in these tampons are similar to those used in other legally marketed tampons in the US.

The provided text is a 510(k) summary for Rostam Interlude Plastic Applicator Tampons. It describes the device, its intended use, and substantial equivalence to legally marketed predicate devices. However, this document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, or comparative effectiveness studies.

The document indicates "Assessment of Performance Standards: Not Applicable" and states "Non-Clinical Testing: Biocompatibility testing and safety evaluations of tampon components were historically carried out. The results of these tests demonstrate that these Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons. Standard Syngyna testing confirmed the absorbency of these Tampons."

This indicates that the device's performance was not evaluated against specific, new quantifiable acceptance criteria, but rather its equivalence to existing predicate devices was established based on historical testing and standard absorbency tests (Syngyna).

Therefore, as per the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and study details.

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Ask a specific question about this device

Ask a specific question about this device