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The exsalt® SD7 Wound Dressing with Adhesive Backing is indicated for use in partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds. The exsalt® SD7 Wound Dressing with Adhesive Backing provides an antibacterial barrier that inhibits bacterial growth in the dressing pad for up to 7 days.

Exciton Technologies Inc. has developed the exSALT® technology, a proprietary chemical process, which deposits oxidized silver species onto a substrate; a non-woven polyester with a gray Delnet® HDPE mesh layer thermally laminated to one side (wound contact layer). The pad is backed with a clear polyurethane film with acrylate adhesive to hold the dressing in the exsalt® SD7 Wound Dressing with Adhesive Backing inhibits bacterial growth in the dressing pad. The concentration of the silver and oxidized silver species on the dressing pad is 0.4 mg/cm² (1.8%w/w). The exsalt® SD7 Wound Dressing with Adhesive Backing has been shown to be effective in vitro against Staphylococcus aureus. Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii for up to 7 days.

The provided text describes a Special 510(k) submission for the exsalt® SD7 Wound Dressing with Adhesive Backing, which is an modification of an already cleared device, exsalt® SD7 Wound Dressing (K103067). This type of submission generally focuses on demonstrating that the changes do not raise new questions of safety or effectiveness, often by comparing the modified device's performance to the predicate device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The submission explicitly states: "All performance characteristics of the exsalt® SD7 Wound Dressing with Adhesive Backing are the same as the predicate." This indicates that the primary study proving the device meets the acceptance criteria is a comparison to the predicate device (exsalt® SD7 Wound Dressing, K103067). The core argument is that, because the wound-contacting materials and the underlying technology are the same, and the modifications (addition of adhesive backing) do not impact the core performance aspects, the new device inherently meets the same performance standards as the predicate.

The document lists "The following performance tests were conducted on the exsalt® SD7 Wound Dressing". While it doesn't explicitly state new tests were conducted on the "exsalt® SD7 Wound Dressing with Adhesive Backing" for all these characteristics, the phrasing implies that these characteristics were evaluated for the predicate device, and the new device is deemed equivalent based on its identical core components. Biocompatibility testing was specifically performed on the adhesive backing component to ensure its safety.

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 for Test Set: Not specified for individual performance tests. The document refers to the predicate device's performance results as the basis for equivalence. For biocompatibility, the adhesive film was tested, but specific sample sizes are not given.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies are internal performance tests conducted by Exciton Technologies Inc. or their commissioned labs.

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)

• Number of Experts: Not applicable or specified. Performance testing for medical devices like wound dressings typically involves standardized laboratory methods, not expert consensus on interpretations.
• Qualifications of Experts: Not specified. Standard laboratory personnel or qualified technicians would perform these types of tests.

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

• Adjudication Method: Not applicable. This is not a study requiring human interpretation or adjudication of results in the way image analysis or clinical trials might. The performance tests are objective laboratory measurements.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices involving human interpretation, not for wound dressings.

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

• Standalone Performance: Not applicable. This device is a wound dressing, not an algorithm or AI system.

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

• Type of Ground Truth: The "ground truth" for the performance characteristics are established scientific and engineering standards and methods for testing wound dressings, and the performance of the previously cleared predicate device. For example:
  • Antibacterial Effectiveness: In vitro testing against specific bacterial strains.
  • Biocompatibility: Standardized tests (e.g., ISO 10993 series) for cytotoxicity, irritation, and sensitization.
  • Material properties: Standardized tests for silver content, pH, absorbency, etc.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device doesn't involve a machine learning algorithm or AI that requires a "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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The exsalt™ SD7 Wound Dressing is indicated for the management of partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.

Exciton Technologies Inc. has developed the exsalt™ technology, a proprietary chemical process, which deposits oxidized silver species onto a non-woven needled polyester coated with gray Delnet® HDPE mesh layers on both sides (STRATEX®). Silver in the exsalt™ SD7 Wound Dressing inhibits microbial growth in the dressing. The concentration of the silver and oxidized silver species on the dressing is 0.4 mg/cm² (2.5% w/w). The exsalt™ SD7 Wound Dressing has been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Enterococcus faecalis when they are in direct contact with the dressing. In addition, in vitro data have demonstrated that exsalt™ SD7 Wound Dressing maintains its antibacterial activity for up to 7 days against Pseudomonos aeruginosa and Staphylococcus aureus.

Here's a breakdown of the acceptance criteria and study information for the exsalt™ SD7 Wound Dressing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes for each in-vitro test (e.g., how many dressings tested per bacterial strain, or how many iterations for physical tests). It only states that "in vitro data have demonstrated..."
• Data Provenance: The studies were in vitro (laboratory-based) and conducted by the manufacturer, Exciton Technologies Inc., based in Canada. Given the context of a premarket notification, these are prospective studies conducted to support the device's claims.

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

• This information is not provided in the document. For in-vitro studies, ground truth is typically established by the scientific methodology itself (e.g., bacterial count reduction based on established laboratory protocols), rather than by expert consensus on individual "cases."

4. Adjudication Method for the Test Set

• This information is not applicable as the studies described are in-vitro efficacy and physical performance tests, not human-reader-based assessments requiring adjudication.

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, an MRMC comparative effectiveness study was not done. This device is a wound dressing, and the studies described are primarily in-vitro performance and biocompatibility assessments, not studies involving AI-assisted human readers.

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 and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• The ground truth for the performance tests (e.g., antimicrobial activity, physical properties) was established through laboratory-based, scientific measurement and observation using validated protocols (e.g., bacterial culture methods for antimicrobial efficacy, standardized tests for absorptive capacity). For biocompatibility, it was based on standardized biological reactivity tests.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve machine learning or AI models, therefore there is no "training set."

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

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

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The exSALT ™ SD7 Wound Dressing is indicated for the management of partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.

The exSALT™ SD7 Wound Dressing consists of 2 outer layers of HDPE with an inner layer of absorbent polyester, all coated with silver. The dressing is available in various sizes and can be cut to size. Silver in the exSALT™ SD7 Wound Dressing kills bacteria which are in direct contact with the dressing.

This document describes Exciton Technologies Inc.'s 510(k) submission for the exSALT™ SD7 Wound Dressing, seeking substantial equivalence to the Acticoat® 7 Dressing. The study focuses on comparing the technological characteristics and performance data between the two devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify exact sample sizes for each test conducted. It states that "the results of physical, efficacy, and biocompatibility testing" were used for comparison. The data provenance is not explicitly mentioned (e.g., country of origin). The studies appear to be retrospective in the sense that they are laboratory tests performed to compare the new device against an existing predicate, rather than new clinical trials as part of a prospective study.

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

The document does not mention the use of experts or a ground truth established by experts for the test set. The "ground truth" for this type of device comparison is based on standardized laboratory testing methods for physical, efficacy, and biocompatibility properties, with the predicate device serving as the benchmark.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned, as the data are laboratory measurements and comparisons to a predicate device's established performance, rather than human expert assessments.

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 typically used for diagnostic imaging devices where human readers interpret results, and an AI's impact on their performance is being evaluated. This document concerns a wound dressing, and the evaluation is based on laboratory performance metrics.

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

The entire evaluation is effectively a "standalone" performance assessment of the device's physical, chemical, and biological properties in a laboratory setting, without human-in-the-loop interaction in its performance evaluation. The device itself is not an algorithm, but a physical product.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is implicitly based on established benchmark performance of the predicate device (Acticoat® 7 Dressing) and internationally recognized standards for testing physical properties, antimicrobial efficacy, and biocompatibility. For instance:

• Physical properties: Measured parameters like absorptive capacity, moisture content, etc., are inherent properties of the material.
• Antimicrobial efficacy: Laboratory tests against specific bacteria (e.g., Pseudomonas aeruginosa, Staphylococcus aureus) providing quantitative kill rates.
• Biocompatibility: Standardized in vitro and in vivo tests for toxicity, irritation, and sensitization.

8. The Sample Size for the Training Set:

This question is not applicable. Wound dressings are physical medical devices, not AI/ML algorithms that require training sets of data.

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

This question is not applicable, as there is no training set for this device.

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