Search Results

Silverseal® Wound Packing Strips with X-Static® are intended for the control of local wound bleeding and nasal hemorrhage, and to encourage draining by wicking fluids from a body cavity, infected area, or abscess, and to help remove necrotic tissue from ulcers or other infected wounds when used as a wet-to-dry packing.

SILVERSEAL® Wound Packing Strip with X-Static® is a flexible, non-adherent, protective dressing consisting of nylon fibers with a metallic silver surface. It is made of flexible, sterile, non-adherent fabric consisting of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1.5% silver oxide.

The provided text is a 510(k) summary for the SILVERSEAL® Wound Packing Strips with X-Static®. This type of document is for clearance of a medical device, and therefore focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a detailed clinical study with numerical thresholds.

As such, many of the requested categories for a rigorous study design (e.g., sample size for test set, number of experts, adjudication methods, multi-reader multi-case studies, effect size, training set details) are not applicable or not present in this type of submission. The primary "study" for a 510(k) is a comparison to a legally marketed predicate device.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission focused on substantial equivalence, there are no explicit numerical acceptance criteria described in the same way one might find in a clinical trial protocol (e.g., "sensitivity must be >90%"). Instead, the "acceptance criteria" are implied by demonstrating that the new device shares fundamental technological characteristics, intended use, and similar performance to the predicate devices.

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

• Test Set Sample Size: Not applicable. There was no specific "test set" of cases or patients in the sense of a clinical performance study with statistical endpoints. The evaluation was primarily based on material characterization and in vivo biocompatibility testing.
• Data Provenance: The biocompatibility tests were in vivo studies, likely conducted in animal models, but specific details on the "country of origin" or "retrospective/prospective" nature of patient data (which is not applicable here) are not provided.

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

• Not applicable. There was no "ground truth" established by experts for a test set of clinical cases. The evaluation involved laboratory testing and comparison to existing device classifications and intended uses.

4. Adjudication Method for the Test Set

• Not applicable. No adjudication method was used, as there was no clinical test set requiring expert review or consensus.

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 wound packing strip, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is irrelevant.

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

• The "ground truth" for the biocompatibility assessment was derived from standardized in vivo biological evaluations based on ISO 10993, rather than expert consensus, pathology, or outcomes data from human patients for performance claims.
• The "ground truth" for substantial equivalence relies on the established intended use, technological characteristics, and safety profile of the legally marketed predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device requiring a training set.

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

• Not applicable. No training set was used.

Ask a specific question about this device

For over-the-counter use, SILVERSEAL® Adhesive Strips with X-Static® may be used for: First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns. Under the supervision of a health care professional, SILVERSEAL® Adhesive Strips may be used for the management of: SILVERSEAL® Adhesive Strips with X-Static® are sterile, non-adherent dressings intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).

SILVERSEAL® Adhesive Strips with X-Station are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing abainst microbial contamination. The nylon fabric permits the passage of exygen and fluids to and from the wound. The surface of the nylon fibers in SILVERSEAL® Adhesive Strips with X-Static; consists or a thin layer of approximately 22. metallic silver containing approximately 1.5 silver oxide that provides effective protection of the dressing against microbial contamination. SILVERSEAL: Adhesive Strips are made of flexible, sterile, non-adherent fabric consisting of a knitted continuous nylon fiber substrate with 22% metallic silver surface containing approximately 1.58 silver oxide.

This 510(k) premarket notification for the SILVERSEAL® Adhesive Strip with X-Static® does not include acceptance criteria or a study proving that the device meets specific acceptance criteria in the way a clinical trial or performance study for a diagnostic device would.

Instead, the submission focuses on substantial equivalence to existing predicate devices. The performance data provided are biocompatibility tests, which are standard for medical devices that come into contact with the body.

Here's an breakdown based on the information provided, highlighting why some sections of your request cannot be fully addressed:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for this type of device (biocompatibility) are generally qualitative (e.g., "safe," "non-sensitizing") rather than quantitative performance metrics like sensitivity/specificity for a diagnostic device. The document states all tests were performed in accordance with ISO 10993 and indicated safety.

Explanation of Device Performance:

• Biocompatibility: The device was subjected to standard in vivo biocompatibility tests, including cytotoxicity, sensitization, and acute intracutaneous reactivity.
• Results: All tests were performed in accordance with ISO 10993 (Biological Evaluation of Medical Devices) by Nittin American Science Associates, Inc. (NAMSA). The studies indicated that SILVERSEAL® Adhesive Strips with X-Station are safe for their intended use.
• Microbial Contamination Protection (of dressing): The silver and silver oxide in the dressing provide "effective protection of the dressing against microbial contamination." This claim is based on "In Vitro studies" and has not been studied in a clinical setting. This is a functional claim for the dressing itself, not a direct patient outcome claim.

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

• Sample Size (Biocompatibility): Not specified in the provided document. Biocompatibility tests usually involve animal models (in vivo) or cell cultures (in vitro), with a specific number of subjects/samples depending on the ISO 10993 part being followed. The document only mentions "standard in vivo biocompatibility tests."
• Data Provenance: Not explicitly stated, but "Nittin American Science Associates, Inc. (NAMSA)" is a contract research organization (CRO) with a global presence, often performing tests in various locations.
• Retrospective or Prospective: Biocompatibility tests are typically prospective studies performed specifically for regulatory submission.

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

• Not applicable in this context. For biocompatibility testing, the "ground truth" is established by adherence to standardized protocols (ISO 10993) and established scientific methods, rather than expert consensus on complex diagnostic interpretations. The CRO (NAMSA) is implicitly qualified to perform these tests.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert image review or clinical outcome assessment in studies where human judgment is a primary input. Biocompatibility testing relies on objective, laboratory-based measurements and observations according to validated protocols.

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

• No. An MRMC study is not relevant for this device. These studies are typically performed for diagnostic imaging devices to evaluate how AI affects human reader performance.

6. If a Standalone Study Was Done

• Yes, in essence. The biocompatibility studies described are "standalone" in the sense that they evaluate the device's inherent safety properties without human intervention in the loop. The "In Vitro studies" for microbial protection are also standalone algorithm/device performance, though the details are not provided.
• "Algorithm only without human-in-the loop performance": This phrasing is more applicable to AI/software as a medical device. For a wound dressing, the "algorithm" is the physical/chemical properties of the dressing. Its performance (e.g., biocompatibility or antimicrobial action against the dressing itself) is assessed directly.

7. The Type of Ground Truth Used

• Biocompatibility: The "ground truth" is established by standardized biological responses observed in validated in vivo and in vitro models, as defined by ISO 10993. This is based on established scientific principles regarding material interaction with biological systems.
• Microbial Protection: The ground truth for the dressing's protection against microbial contamination is based on in vitro microbiological assays, which quantitatively measure microbial growth on the dressing material under controlled conditions. This is a form of laboratory-based evidence.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical wound dressing, not an AI algorithm that requires a "training set."

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

• Not applicable. As above, there is no "training set" for this type of device.

In summary, the 510(k) submission for the SILVERSEAL® Adhesive Strip with X-Static® relies on demonstrating substantial equivalence to predicate devices and proving biocompatibility through standard in vivo tests. It also mentions in vitro studies for protection against microbial contamination of the dressing itself. The performance data presented are not in the context of diagnostic AI algorithms, so many of the requested categories (like sample size for test/training sets, expert ground truth, adjudication, or MRMC studies) are not directly applicable or available in the provided text.

Ask a specific question about this device

SILVERSEAL® Orthotic Components with X-Static® are used as components on various orthotic devices intended for medical purposes that can be worn as a cervical collar or brace. The component comprises a knitted stockinette which is made of 90% cotton or polyester, and 10% X-Static®, which is 1.5% silver oxide. The component provides the skin with an antimicrobial barrier.

SILVERSEAL® Orthotic Components with X-Static® are made of flexible, non-adherent fabric consisting of a knitted or made or in fabric which is 90% cotton or polyester, and 10% of a continuous nylon fiber substrate with a metallic silver surface containing approximately 1.5% silver oxide.

The Noble Fiber Technologies, Inc. 510(k) submission for the SILVERSEAL® Orthotic Components with X-Static® does not include acceptance criteria or a study that evaluates device performance against specific efficacy endpoints in the same way a diagnostic or therapeutic device might. Instead, this submission focuses on biocompatibility and substantial equivalence to a predicate device.

Here's an breakdown of the relevant information provided:

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

This document does not present quantitative acceptance criteria or a performance table for efficacy. The "performance" assessment is based on biocompatibility and antimicrobial properties, which are discussed qualitatively.

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 that the device was "subjected to standard in vivo biocompatibility" tests, including sensitization, irritation, and acute in vivo blood incompatibility. However, it does not specify the sample size for these tests. It also does not explicitly state the country of origin of the data or whether the tests were prospective or retrospective, although biocompatibility testing is typically prospective. The testing was performed by "North American Science Associates, Inc. (NAMSA)."

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 information is not provided. Biocompatibility testing typically involves laboratory professionals and toxicologists, but no details on "experts" or their qualifications for establishing ground truth are given in this K051256 summary.

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

This information is not provided. Adjudication methods are not typically relevant for standard biocompatibility testing. The assessment of biocompatibility usually relies on established laboratory protocols and interpretation of results against predetermined biological endpoints.

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. This device is a component of an orthotic, and its performance evaluation is based on biocompatibility and antimicrobial properties, not on diagnostic or therapeutic effectiveness requiring human reader-dependent interpretation or AI assistance.

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

This is not applicable. This device is not an algorithm or AI system. Its performance relates to material properties and biological interaction.

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

The ground truth for biocompatibility testing is based on established biological endpoints and toxicological principles, as defined by international standards (ISO 10995, likely a typo for ISO 10993 which is for Biological Evaluation of Medical Devices). This involves evaluating for adverse biological reactions such as irritation, sensitization, and specific toxic effects, usually observed in animal models (in vivo) or in vitro cell cultures.

8. The sample size for the training set:

This is not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

This is not applicable. As mentioned above, there is no training set for this type of device.

Ask a specific question about this device

For over-the-counter use, Silverseal® Wound Contact Dressing with X-Static® may be used for first aid management of minor abrasions, cuts, scrapes, scalds and burns.

Under the supervision of a health care professional, Silverseal® Contact Wound Dressing may be used for the management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).

SILVERSEAL® Burn Contact Wound Dressings with X-Static® are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination.

The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in SILVERSEAL® Contact Wound Dressings with X-Static® consists of a thin layer of metallic silver containing approximately 1.5% silver oxide that provides effective protection of the dressing against microbial contamination.

SILVERSEAL® Contact Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1.5% silver oxide.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SILVERSEAL® Burn Glove with X-Static® and related dressings:

No acceptance criteria or study demonstrating performance against such criteria are explicitly provided in this 510(k) summary.

The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and biocompatibility.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does NOT explicitly state any acceptance criteria for device performance (e.g., specific percentages for infection reduction, healing rates, or other clinical outcomes).

Instead, the "performance" discussed is related to biocompatibility and protection against microbial contamination of the dressing itself.

• Protection Against Microbial Contamination (of the dressing): The silver content provides effective protection of the dressing against microbial contamination (based on in vitro studies). |

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

• Test Set for Biocompatibility: The sample size for the in vivo biocompatibility tests (cytotoxicity, sensitization, acute intracutaneous reactivity) is not specified.
• Data Provenance: The biocompatibility tests were performed by North American Science Associates, Inc. (NAMSA), which is a common contract research organization for medical device testing. The country of origin for the data is implicitly the USA, where NAMSA operates. These tests are typically prospective in nature, conducted specifically for the submission.

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

Not applicable.

• For biocompatibility tests, "ground truth" is typically established by laboratory standards and protocols (e.g., observing for specific cellular reactions, skin reactions) rather than expert consensus on a clinical outcome.
• There is no mention of a human-centric "test set" requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable.

As there is no "test set" requiring human interpretation or clinical judgment in the traditional sense for efficacy or diagnostic performance, no adjudication method is mentioned. Biocompatibility results are typically objective measurements or observations against established standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done.

The document explicitly states: "All claims are the result of In Vitro studies and have not been studied in a clinical setting." This confirms that no clinical studies comparing the device's effectiveness, either with or without AI assistance, were performed.

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

Not Applicable, and no such study was performed.

This is a medical dressing, not an algorithm or AI device. Therefore, the concept of "standalone algorithm performance" does not apply. The performance evaluation was focused on materials, biocompatibility, and antimicrobial properties of the dressing itself.

7. The Type of Ground Truth Used

• Biocompatibility: The "ground truth" for biocompatibility was established through performance against standardized laboratory protocols and observations for cytotoxicity, sensitization, and acute intracutaneous reactivity, as defined by ISO 10993.
• Antimicrobial properties (of the dressing): The "ground truth" for protection against microbial contamination of the dressing was established through in vitro studies, which involve lab-based testing of the material's ability to inhibit microbial growth.

8. The Sample Size for the Training Set

Not applicable.

This product is a medical dressing, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of AI model development.

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

Not applicable.

As there is no AI algorithm or "training set," there is no ground truth established in this context.

Ask a specific question about this device

Ask a specific question about this device