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The ULTRA Silver Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).

The ULTRA Silver Dressings are sterile, single-use wound care dressings for use in moist wound management. The dressings are comprised of 4 layers, each performing a specific function; an occlusive synthetic top layer, a polyurethane foam layer, a hot-melt adhesive and a layer of a silver-containing knitted composite fabric.

The provided text is a 510(k) premarket notification for the ULTRA Silver Dressing, and it does not describe an AI medical device. Therefore, the requested information regarding acceptance criteria for an AI device, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document.

The document discusses the substantial equivalence of the ULTRA Silver Dressing to a predicate device (AFM Ultra Ag Dressings) based on non-clinical performance testing.

Here's what can be extracted regarding the device performance and supporting studies, though it does not align with the AI device criteria requested:

Device: ULTRA Silver Dressing (Wound Dressing)

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state acceptance criteria in a numerical or statistical sense for wound dressings as one might for an AI device's performance metrics (e.g., sensitivity, specificity). Instead, it relies on demonstrating that the modified device, with changes to non-patient contacting layers, performs equivalently to the predicate device in terms of established performance categories.

Study Description:

The study proving the device meets the "acceptance criteria" (understood as demonstrating substantial equivalence to the predicate device) is a "Summary of Non-Clinical Performance Testing."

Relevant Sections from the document:

• Section 7: SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
  "Validation activities to support the use of the ULTRA Silver Dressings consisted of four main elements:

  • Biocompatibility Testing
  • Validation of Antimicrobial Effectiveness
  • Sterility Validation
  • Fluid Management Performance
    Testing of the ULTRA Silver Dressings has demonstrated that the wound dressing fulfills prospectively defined performance criteria and that the modification system meets user needs."

• Section 8: SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
  "No clinical testing was conducted to support this submission."

• Section 10: CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
  "The similarities in intended use, operational characteristics, and functional technological characteristics between the proposed ULTRA Silver Dressings and the predicate AFM Ultra Ag Dressings lead to a conclusion of substantial equivalence between the proposed and predicate device."

Regarding the specific questions tailored for AI devices (which are not applicable here):

2. Sample sizes used for the test set and the data provenance: Not applicable. This is a non-clinical device test, not an AI model evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth in the AI sense is established.
4. Adjudication method: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable. The "ground truth" here is the performance of the predicate device and established standards for wound dressing properties.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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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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Low Adherent AFM Ag Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic). The Low Adherent AFM Ag Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.

The Low Adherent AFM Ag Dressings are sterile, single-use wound care dressings for use in moist wound management. The dressings are designed to contact the wound as a primary dressing and permit the passage of fluids. The dressings provide a protective environment for the wound and an effective protection against microbial contamination in the dressing. The devices are effective antimicrobial barrier dressings against both Gram-positive and Gram-negative bacteria, including the following organisms: methicillin-resistant Staphylococcus aureus (MRSA). methicillin- resistant Staphylococcus epidermidis (MRSE), vancomycin-resistant Enterococcus faecalis (VRE), Pseudomonas aeruginosa, and Acinetobacter baumannii.

The provided text does not describe a study that proves the device meets specific acceptance criteria in the context of typical medical device performance studies for diagnostic or therapeutic efficacy.

Instead, this document is a 510(k) Summary for a wound dressing, which focuses on substantial equivalence to a previously cleared predicate device. The "performance testing" mentioned is for validation activities rather than a comparative effectiveness or standalone performance study in the way one might expect for a diagnostic AI device.

Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth, and expert involvement are not applicable or cannot be extracted from this specific document.

Here's an attempt to answer the questions based on the available information, highlighting where the information is missing or not relevant to the requested structure:

Acceptance Criteria and Device Performance Study for Low Adherent AFM Ag Dressings

The provided 510(k) Summary for the Low Adherent AFM Ag Dressings describes validation activities to support the modified device, rather than a study with explicit acceptance criteria and device performance metrics as would typically be presented for a diagnostic or AI-driven device.

The core of this submission is to demonstrate substantial equivalence to a predicate device (Milliken Silver Wound Dressing, K051445) and to confirm that the modification (addition of a low adherent wound contact layer) does not affect safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Precise quantitative acceptance criteria (e.g., specific cytotoxicity thresholds, minimum microbial reduction percentages, or sterility assurance levels as defined in standards) are not detailed in this summary. The "reported device performance" is described qualitatively as "validation conducted" and meeting "prospectively defined performance criteria."

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

This document does not describe a "test set" in the context of a performance study for a diagnostic or therapeutic effect. The validation activities (biocompatibility, antimicrobial effectiveness, sterility) typically involve standardized laboratory tests, for which sample sizes are determined by the specific test methods and regulatory standards (e.g., ISO, ASTM). The document does not provide these sample sizes or data provenance (country, retrospective/prospective) for these lab tests.

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

Not applicable. The validation activities for a wound dressing (biocompatibility, antimicrobial effectiveness, sterility) do not involve expert-established "ground truth" in the way a diagnostic imaging study would. Standardized laboratory methods and controls are used.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication is described or relevant for these types of validation tests.

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

No. An MRMC comparative effectiveness study is not relevant for a wound dressing and was not conducted or mentioned in this 510(k) summary. This type of study is typically for diagnostic devices, especially those involving human interpretation of data (e.g., radiology AI).

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

Not applicable. This device is a physical wound dressing, not an algorithm or AI system.

7. The Type of Ground Truth Used

The concept of "ground truth" as pathology or outcomes data is not directly applicable here. For the described validation activities:

• Biocompatibility: Ground truth is established by standardized material safety tests and comparison to established safe materials or acceptable toxicity limits (e.g., ISO 10993 standards).
• Antimicrobial Effectiveness: Ground truth is established by laboratory cultures and validated methods for measuring microbial reduction or inhibition (e.g., ATCC strains, established protocols).
• Sterility: Ground truth is established by validated sterilization processes and sterility testing (e.g., USP guidelines, ISO 11137).

8. The Sample Size for the Training Set

Not applicable. This device is a physical wound dressing and does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As there is no training set, this question is not relevant.

Summary of Device Rationale from the Document:

The 510(k) describes a modification to an already cleared predicate device (Milliken Silver Wound Dressing K051445). The modification is the "addition of a low adherent wound contact layer." The key argument for substantial equivalence is that this modification is "minor and does not affect safety and effectiveness of the device." The "performance testing" (biocompatibility, antimicrobial effectiveness, sterility validation) was conducted to confirm that the modified device continues to meet expected performance criteria, implying these tests re-verified the properties of the device post-modification without necessarily presenting a new comparative efficacy study.

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