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The Stay Fresh Skin Fold Management Textile is a skin protectant intended to be used between skin folds and in other skin contact areas to provide moisture management and reduce friction. The Stay Fresh Skin Fold Management Textile contains hydrogen peroxide, which reduces bacterial populations in the fabric.

Stav Fresh Skin Fold Management Textile is a non-sterile skin protectant indicated for management of skin folds and other skin-to-skin contact areas, such as extremities, and is offered as a 25.4 cm x 365.8 cm fabric piece (other sizes may also be available). The device provides moisture management to keep skin dry and the device's low coefficient of friction reduces skin-to-skin friction. Stay Fresh Skin Fold Management Textile is a single patient use product that is custom cut from a multiuse package. Polyester fabrics are well known to wick moisture away from skin as well as provide a low friction surface.

The provided text describes a 510(k) summary for a medical device (Stay Fresh Skin Fold Management Textile) and associated FDA correspondence. However, it does not contain the detailed information requested regarding specific acceptance criteria, a study proving those criteria were met, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/algorithm-based device study.

The document states that the device was subjected to "extensive testing to assess the biocompatibility and the performance of the Stay Fresh Skin Fold Management Textile was shown to provide moisture management and antimicrobial properties." This is a general statement and does not provide the specifics of a study suitable for answering the questions.

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

Here's a breakdown of what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated in terms of specific quantitative thresholds for properties like moisture management or bacterial reduction.
• Reported Device Performance: The text generally states the device "was shown to provide moisture management and antimicrobial properties." No specific metrics or values are given.

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 mentioned.
• Data Provenance: 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)

• Not applicable as this is a textile product, not an AI/diagnostic device requiring expert ground truth in that sense. The "testing" mentioned doesn't involve medical image interpretation or similar.

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

• Not applicable for this type of device and testing.

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, this is not an AI/algorithm-based diagnostic device.

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

• No, this is not an AI/algorithm-based diagnostic device.

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

• For the "moisture management and antimicrobial properties" testing, the ground truth would likely be based on established laboratory methods and standards for measuring these properties (e.g., absorbency tests, microbiological assays). However, the specific methods are not detailed.

8. The sample size for the training set

• Not applicable, as this is not an AI/machine learning model.

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

• Not applicable, as this is not an AI/machine learning model.

Summary Table (with available information):

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InterDry Textile is a skin protectant indicated for management of skin folds and other skin-to-skin contact areas. InterDry Textile reduces microbial colonization in the fabric.

InterDry is a non-sterile skin protectant fabric with an antimicrobial silver complex. InterDry is a single patient use product that is custom cut from a multiuse package.

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

Device: InterDry

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify the sample sizes used for any of the performance tests (biocompatibility, antimicrobial effectiveness, physical property testing).

The data provenance (e.g., country of origin, retrospective or prospective) is also not mentioned in this document.

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

The document does not mention using experts to establish ground truth for this device's performance testing. The evaluation appears to be based on laboratory testing against established standards or direct comparison to predicate devices, rather than expert interpretation of clinical data points.

4. Adjudication Method:

Since no expert input is mentioned for establishing ground truth, there is no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not performed or mentioned in this document. The device is a "skin protectant" (medical fiber absorbent), and the nature of its testing (biocompatibility, antimicrobial, physical properties) does not typically involve human readers interpreting cases or AI assistance.

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

This question is not applicable as the InterDry is a physical medical device (textile) and not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant to this submission. The performance tests conducted are inherently "standalone" in the sense that they evaluate the device itself without human intervention in the primary measurement.

7. The Type of Ground Truth Used:

The ground truth for this device's performance is established through:

• Standardized Biocompatibility Tests: These tests have predefined endpoints and acceptance criteria based on established international standards (ISO).
• Antimicrobial Effectiveness Test Standards: These tests measure the device's ability to reduce microbial colonization according to established laboratory protocols.
• Physical Property Measurement Standards: Absorption, wicking, friction, and silver release are measured against defined quantitative standards or directly compared to the predicate device's measured properties to demonstrate substantial equivalence.

8. The Sample Size for the Training Set:

This question is not applicable as the InterDry is a physical medical device and not an AI algorithm that requires a "training set."

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

This question is not applicable as the InterDry is a physical medical device and not an AI algorithm.

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Walgreen's Personal Lubricating Jelly is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. It can ease insertion of rectal thermometers, enemas and tampons. This product is compatible with latex condoms.

Walgreen's Personal Lubricating Jelly is a non-sterile, aqueous based personal lubricant designed to supplement the body's own natural lubrication fluids. It is specifically formulated to be a clear, nonirritating, non-greasy, gel-like liquid and is compatible for use with or without a condom during intimate sexual activity as evidenced by condom compatibility test results. Walgreen's Personal Lubricating Jelly is a water-based personal lubricant containing chlorhexidine digluconate and methylparaben as preservatives in a vehicle for glucono delta lactone, glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water. This product is designed in LDPE tube w/ plastic flip-top cap.

The Walgreen's Personal Lubricating Jelly is a personal lubricant. The provided information does not describe an AI/ML device, therefore, the requested information on studies, test sets, ground truth, and training sets is not applicable.

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)

Not applicable. The submission is for a medical device (personal lubricant) and not an AI/ML device that would typically involve test sets or data provenance in this context. The product was tested by independent laboratories, but specific sample sizes and data provenance for these tests are not provided in the summary.

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. The submission is for a medical device (personal lubricant) and not an AI/ML device. Ground truth as typically understood for AI/ML validation is not relevant here.

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

Not applicable. This is not an AI/ML device.

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/ML device.

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

Not applicable. This is not an AI/ML device.

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

Not applicable. The assessment relied on laboratory testing for condom compatibility, biocompatibility, and preservative effectiveness, and comparison of chemical ingredients and intended use to a predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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InterDry Textile with Silver is a skin protectant indicated for management of skin folds and other skin-to-skin contact areas. InterDry Textile with Silver reduces microbial colonization in the fabric.

Interdry Textile with Silver is a non-sterile skin protectant comprised of polyester knit textile substrate indicated for management of skin folds and other skin-to-skin contact areas and is offered as a 25.4 cm x 365.8 cm fabric piece, although other sizes may be available. The device provides moisture management to keep skin dry and the device's low coefficient of friction reduces skin-to-skin friction. Interdry Textile with Silver is a single patient use product that is custom cut from a multiuse package.

The provided text describes a 510(k) summary for the "Interdry Textile with Silver" device, which is a skin protectant. The performance testing section mentions "Biocompatibility testing" and "Antimicrobial testing". However, it does not provide detailed acceptance criteria with specific numerical targets, nor does it present a detailed study with a defined sample size, ground truth, or statistical analysis in the way typically expected for an AI/ML device.

It's important to note that K061615 is for a medical textile, not an AI/ML device. Therefore, the questions about AI/ML specific criteria (e.g., test set sample size, experts for ground truth, MRMC study, training set size) are not applicable to this submission. The "study" mentioned here refers to standard biocompatibility and antimicrobial efficacy tests for a medical textile.

Here's an attempt to answer the questions based on the available information, noting the limitations due to the nature of the device:

Acceptance Criteria and Device Performance for Interdry Textile with Silver (K061615)

This 510(k) submission is for a medical textile, not an AI/ML device. Therefore, many of the requested details, particularly those related to machine learning model evaluation, are not applicable. The reported performance relates to the physical and biological characteristics of the textile.

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

Note: Specific numerical acceptance criteria for biocompatibility and antimicrobial tests are not provided in this summary. These would typically be detailed in the full submission, referencing standards like ISO 10993 for biocompatibility and specific microbiological test standards.

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

• Sample Size for Test Set: Not explicitly stated. For biocompatibility tests, sample sizes are dictated by the specific ISO 10993 test methods (e.g., animal tests, in-vitro cell cultures). For antimicrobial testing, sample sizes are typically small, involving various microbial strains and replicates.
• Data Provenance: Not explicitly stated but inferred to be laboratory-generated data from testing performed to industry standards. This is likely prospective testing conducted in controlled environments. Country of origin not specified.

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

• This question is not applicable to this type of device. "Ground truth" in the context of biocompatibility and antimicrobial testing is established by standard laboratory protocols and expert interpretation of results, not by a consensus of medical experts reviewing patient data. The "experts" would be the scientists and toxicologists performing and interpreting the laboratory tests according to established scientific principles and standards.

4. Adjudication method for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to clinical outcome or image interpretation studies. For laboratory tests, results are interpreted based on predefined criteria in the test standard, often without external adjudication beyond internal quality control and peer review of results.

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/ML device.

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

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

7. The type of ground truth used

• Ground Truth for Biocompatibility: Established by adherence to standardized testing protocols (e.g., ISO 10993 series for cytotoxicity, sensitization, irritation) and comparison against established biological reactivity scales. The "truth" is whether the material elicits a harmful biological response above acceptable thresholds.
• Ground Truth for Antimicrobial Efficacy: Established by quantitative microbiological assays that measure the reduction in microbial counts when in contact with the material, compared to control samples. The "truth" is the measured inhibition or kill rate of specific microorganisms.

8. The sample size for the training set

• Not applicable. There is no AI/ML model to train for this device.

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

• Not applicable. There is no AI/ML model to train for this device.

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