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Non-Adherent Antimicrobial Alginate Dressing is an effective barrier to bacterial penetration. The barrier functions of the dressing may help reduce infection in moderate to heavily exuding partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor sites, traumatic and surgical wounds.

Non-Adherent Antimicrobial Wound Dressing is indicated for external use only.

Non-Adherent Antimicrobial Alginate Dressing is a sterile, non woven pad composed of a high G (guluronic acid) alginate, carboxymethy)cellulose (CMC) and silver coated nylon fibres, laminated to a perforated, non-adherent ethylene methyl acrylate (EMA) wound contact layer. The dressing absorbs exudate and allows intact removal, whilst maintaining a moist wound environment. A moist wound environment is optimal for wound healing. The silver ions within the dressing protects the dressing from bacterial contamination. Odor reduction results from the antibacterial effect.

This document is a 510(k) premarket notification for a medical device modification, specifically for Advanced Medical Solutions Limited's Non-Adherent Antimicrobial Alginate Dressing. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for de novo acceptance criteria for a new AI/software device.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning AI or software performance.

Here's why and what information is available:

• Device Type: The device is a wound dressing, a physical medical product, not an AI or software device.
• Purpose of Submission: This is a 510(k) modification for a PHYSICAL device (adding a perforated, non-adherent wound contact layer). The primary goal is to show "substantial equivalence" to existing, legally marketed predicate devices, not to establish new performance criteria for a novel AI.
• Study Types Mentioned: The document refers to:
  • Biocompatibility testing: In compliance with BS EN ISO 10993-1.
  • Sterilization validation: In compliance with ISO 11137 standards.
  • Performance testing and antimicrobial activity: Stated to be substantially equivalent to predicate devices.
    These are standard tests for physical medical devices and do not involve AI performance metrics, sample sizes for AI test sets, expert ground truth, or MRMC studies.

Based on the provided text, I cannot complete the table or answer the questions regarding acceptance criteria and an AI study.

The prompt's specific questions are geared towards the evaluation of AI/software as a medical device (SaMD) or AI-enabled medical devices, which typically involve metrics like sensitivity, specificity, AUC, human reader improvement, and detailed ground truth establishment. This document does not pertain to such a device or evaluation.

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The Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including:

• Post-operative wounds .
• . Trauma wounds
• . Leq Ulcers
• Pressure Ulcers .
• Diabetic Ulcers .
• Graft and donor sites .

Silver Alginate II Dressing is indicated for external use only

The dressing is a sterile, non-woven pad composed of a high G (guluronic acid) calcium alginate, carboxymethylcellulose (CMC) and ionic silver, which absorbs wound exudate and releases silver ions in the presence of wound fluid. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal.

The silver ions protect the dressing from a broad spectrum of microorganisms over a period of up to four (4) days, based on in vitro laboratory testing. Odour reduction results from the antibacterial effect in the dressing.

The dressing is an effective barrier to penetration by microorganisms.

The dressing has a off-white appearance, and is available in various sizes (5cm x 5cm, 10cm x 10cm, 15cm x 15cm, 10cm x 20cm flat dressings; 2.7cm x 30cm, and 3cm x 44cm flat rope dressings; and 30cm x 2g rope dressings). The flat dressings are packaged in pouches, and the flat rope and rope dressings are packaged in a blister pack.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Silver Alginate II Dressing.

This submission is a 510(k) for a medical device (wound dressing), which primarily demonstrates substantial equivalence to existing predicate devices rather than proving a novel therapeutic effect or clinical outcome through extensive clinical trials. Therefore, the "acceptance criteria" and "study" described are focused on demonstrating that the new device performs similarly to or meets the established characteristics of the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify sample sizes for any of the in vitro tests. The data provenance is stated as "in vitro laboratory testing" conducted by Advanced Medical Solutions Ltd. (England). This indicates the data is from an in vitro (laboratory) setting and not from human clinical trials. It is retrospective in the sense that the testing was completed before the 510(k) submission.

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

This type of information is not applicable to this 510(k) submission. The "ground truth" for demonstrating substantial equivalence of a wound dressing is based on established performance characteristics and standardized in vitro testing methods (e.g., ISO standards, antimicrobial efficacy tests). It does not involve expert consensus on the device's performance in a clinical scenario, as would be the case for a diagnostic AI device.

4. Adjudication Method for the Test Set

This is not applicable. The "adjudication method" refers to how discrepancies in expert opinions are resolved, typically in a clinical study context. Since the testing described is in vitro and based on measurable performance characteristics, there is no expert adjudication process in this context.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Silver Alginate II Dressing is a therapeutic wound dressing, and its performance is evaluated through in vitro tests and comparison to predicate devices, not by human reader interpretation.

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

This question is not applicable as the Silver Alginate II Dressing is a physical medical device (wound dressing), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" doesn't apply.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established by:

• Established performance characteristics of predicate devices: The new device's performance (absorbency, silver release, antimicrobial activity) is compared to that of the already legally marketed predicate devices.
• Standardized in vitro testing methodologies: Biocompatibility is assessed against BS EN ISO 10993-1 requirements. Antimicrobial activity and other key performance characteristics would have been evaluated using recognized laboratory methods.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of this 510(k) submission for a wound dressing. Training sets are relevant for machine learning algorithms.

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

This question is not applicable for the same reasons as #8.

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Advanced Medical Solutions Ltd's Antimicrobial Alginate. Dressing is an effective barrier to bacterial penetration, The barrier functions of the dressing may help reduce infection in moderate to heavily exuding partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, donor sites, traumatic and surgical wounds.

Advanced Medical Solutions Ltd's Antimicrobial Alginate Dressing is a sterile, non-woven pad composed of a high G (quluronic acid) alginate, carboxymethylcellulose (CMC) and silver coated nylon fibres. The sustained release of silver creates a favourable environment by protecting the dressing from bacterial contamination. The dressing absorbs exudate, maintains a moist wound healing environment and allows intact removal. The dressing has a light grey appearance, and is available in various sizes (5cm x 5cm, 11cm x 11cm, 10cm x 20cm flat dressings and 2.5cm x 30.5cm rope). The flat dressings are packaged in pouches, and the rope is packaged in a blister pack.

This document describes the 510(k) summary for Advanced Medical Solutions Ltd's Antimicrobial Alginate Dressing. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, device performance metrics (accuracy, sensitivity, specificity, AUC), or details of a study with sample sizes, ground truth establishment, or expert qualifications for performance evaluation.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (K002896 Acticoat Calcium Alginate Dressing) based on similarities in:

• Materials (calcium alginate and silver)
• Intended use and indications for use
• Product description and functional characteristics (absorbent, sterile, sustained silver release, antimicrobial effect, barrier to bacterial penetration, maintains moist wound environment, intact removal, similar dressing change frequency)
• Biocompatibility (demonstrated in accordance with BSENISO 10993-1)
• Sterilization method (gamma irradiation)
• Contraindications
• Product sizes and variants

The document states: "Additional in vitro testing has demonstrated that the performance characteristics of the dressing are substantially equivalent to the predicate device." However, it does not provide specific performance metrics or detailed results from this in vitro testing, nor does it detail a clinical study with the requested elements.

Therefore, I cannot populate the table or answer most of the questions as the provided text does not contain that specific information.

Summary of available information regarding performance and studies:

1. A table of acceptance criteria and the reported device performance:
   Not provided in the document. The document focuses on demonstrating substantial equivalence rather than reporting specific performance metrics against set acceptance criteria for metrics like accuracy, sensitivity, specificity, or AUC.

2. Sample size used for the test set and the data provenance:
   Not provided. The document mentions "Additional in vitro testing" but does not detail sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable, as no human-in-the-loop study with a test set requiring expert ground truth is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   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. This device is an antimicrobial dressing, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   The document mentions "Additional in vitro testing has demonstrated that the performance characteristics of the dressing are substantially equivalent to the predicate device." This suggests some form of standalone testing was performed to compare its characteristics to the predicate, but no specific performance metrics like those for an algorithm are detailed. The device is a physical dressing, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not explicitly stated for the "in vitro testing." Given the nature of an antimicrobial dressing, ground truth would likely relate to microbiological growth inhibition, fluid absorption, or silver release rates, rather than expert consensus on images or pathology.

8. The sample size for the training set:
   Not applicable, as this is not an AI/ML device with a training set in the conventional sense.

9. How the ground truth for the training set was established:
   Not applicable.

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