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Under the supervision of a healthcare professional, Titan Ag 200 may be used for the management of:

• Wounds with moderate to heavy exudate. ●
• Partial thickness burns. ●
• Leg ulcers, pressure ulcers and diabetic ulcers.
• Surgical wounds (e.g. post-operative, wounds left to heal by secondary intent and ● donor/graft sites).
• . Traumatic wounds (e.g. abrasions and lacerations).
• Wounds prone to bleeding such as wounds that have been mechanically or surgically ● debrided or donor sites .

Titan Ag 200 Wound Dressing is a soft, conformable non-woven fabric made from a blend of cellulose fiber(s) impreqnated with metallic silver (in the form of silver nano-particles), sodium carboxymethyl cellulose fibres and strengthening cellulose fiber(s). The ionic silver released into the wound dressing when in contact with wound exudate or blood has an antibacterial effect on wound bacteria held within the dressing, preventing it from being colonized. The structure of the dressing remains intact through the gel formation. Debris and any bacteria absorbed in the wound exudate and retained within the dressing are removed when the dressing is changed.

The provided text describes the Titan Ag 200 wound dressing and its substantial equivalence to the predicate device, Aquacel Ag Extra (K121275). Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on "Equivalent" and "Similar" in the context of this document: The document explicitly states that "Statistical analysis of the difference in results obtained for silver release over 7 days for the subject and predicate devices was statistically insignificant. Therefore the devices are deemed to have equivalent silver release." This suggests that "similar" or "equivalent" in this context means statistically comparable performance that meets the safety and effectiveness requirements.

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

The document does not explicitly state the sample sizes for the various performance tests (e.g., number of dressings tested for silver release, absorbency, or wet tensile strength).

• Data Provenance: The studies are described as non-clinical performance data, indicating they were conducted in a laboratory setting. There is also mention of a porcine wound healing study, which would be an in vivo animal study. The document does not specify the country of origin for these specific tests, but the submitting company is based in the United Kingdom.

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. The ground truth for performance testing is typically established by adhering to recognized international standards and test methods (e.g., AATCC 100 for antibacterial efficacy, British Pharmacopoeia for absorbency, ISO 10993 for biocompatibility). These standards define the methodology and acceptance criteria, rather than relying on expert consensus for each individual test result within the submission.

4. Adjudication Method for the Test Set

This information is not applicable in the context of the performance testing described. The tests are objective measurements against established standards, not subjective assessments requiring adjudication by multiple readers.

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

No, an MRMC comparative effectiveness study involving human readers is not described in this document. The studies focus on the physical and biological performance of the wound dressing itself, not on human interpretation or effectiveness with and without AI assistance. This device is a wound dressing, not an AI-powered diagnostic or therapeutic device.

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

No, a standalone algorithm performance study was not done. This document pertains to a physical medical device (wound dressing), not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance tests were based on:

• Standardized test methods and predetermined acceptance criteria: For silver release, absorbency, antibacterial activity, wet tensile strength, sterilization validation, and packaging integrity. These are objective measures against predefined thresholds.
• Biological evaluation standards (ISO 10993 series) and FDA guidance: For biocompatibility. This involves a battery of tests to assess different biological responses.
• Comparison to a legally marketed predicate device: The performance of the Titan Ag 200 was directly compared to the Aquacel Ag Extra (K121275) to demonstrate substantial equivalence.
• Porcine wound healing study: This is an in vivo animal model used to assess the device's effect on the wound healing process.

8. The Sample Size for the Training Set

This information is not applicable as this document describes a physical medical device (wound dressing) and its performance testing, not a machine learning or AI algorithm that requires a training set.

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

This information is not applicable as this document describes a physical medical device (wound dressing) and its performance testing, not a machine learning or AI algorithm that requires a training set.

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SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritations of the skin.

SynePure is a biocompatible, cleansing solution that is intended for rinsing and cleansing dermal wounds through irrigation. The solution is preserved and provided in flexible low density polyethylene (LDPE) bottles with a nozzle spray top to allow for easy delivery of a stream of liquid to remove dirt, debris and contamination from a wound. A screw cap is used to secure the device when not in use. The cap/bottle assembly is sealed with a strip to indicate tampering.

The wound cleanser is supplied as 125mL single-use or 250mL multiple-use bottle. The mechanical action of fluid moving across the wound provides for the mechanism of action to aid in the removal of foreign objects, such as dirt and debris, from the wound.

This document is a 510(k) premarket notification for a medical device (SynePure Wound Cleanser). It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria and results typical for a completely novel device or an AI/software as a medical device (SaMD).

Therefore, much of the requested information regarding acceptance criteria, study design for ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training set details for AI/SaMD is not applicable to this document. This document describes a relatively simple wound cleanser, not an AI-powered diagnostic or predictive tool.

Here's a breakdown of the available information based on your request:

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

Based on the document, two performance data points are mentioned, which could be interpreted as meeting certain criteria. However, explicit numerical acceptance criteria are not stated.

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 Performance Data (Spray Duration, Solution Delivered): Not specified.
• Sample Size for Biocompatibility Testing: Not specified for individual tests. For acute systemic toxicity, it mentions "all animals," implying a group of animals, but the exact number is not given.
• Data Provenance: Not specified. The testing was done by Synedgen, Inc.

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

• Not Applicable. This device is a physical wound cleanser, not an AI or diagnostic tool that relies on expert interpretation for ground truth. Biocompatibility testing follows established protocols and laboratory readouts rather than expert consensus on interpretations of images or data.

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

• Not Applicable. See point 3.

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 device.

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

• Not Applicable. This is not an AI device.

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

• For the physical performance tests (spray duration, solution delivery), the ground truth is likely direct measurement and observation against a defined threshold.
• For biocompatibility, the ground truth is established through standardized laboratory assays (e.g., cell cultures for cytotoxicity, animal models for sensitization and systemic toxicity) which yield objective results based on predefined biological endpoints.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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CELOX Antibacterial Trauma Gauze is indicated for temporary external use to control moderate to severe bleeding.

CELOX Antibacterial Trauma Gauze may be used for the management of partial and full thickness wounds 1st and 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology and pressure ulcers/sores (partial and full thickness), surgical wounds and donor sites.

CELOX Antibacterial Trauma Gauze (Silver containing Antibacterial Dressing) is a soft, sterile, non-woven gauze dressing. This dressing is composed of Chitosan, Chitosan derivatives and structural woven gauze materials with the addition of Ionic Silver. The silver ions present in the dressing help to inhibit bacterial growth in the dressing. The dressing absorbs high amounts of wound fluid and bacteria, conforms to the wound surface, maintains a moist and creates a soft, cohesive gel that aids in the removal of non-viable tissue (autolytic debridement). The moist wound healing environment and the ability to inhibit bacterial growth in the dressing provided by the CELOX Antibacterial Gauze support the body's healing process.

This document is a 510(k) summary for the CELOX Antibacterial Trauma Gauze. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance data.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information cannot be extracted directly from this document.

The document primarily states that the device is substantially equivalent to a predicate device (AQUANOVA Ag K100693 and CELOX Trauma Gauze K0917953) because it shares similar raw materials, manufacturing route, intended use, indications, product design, composition, and processing. The main difference highlighted is the addition of ionic silver as an antibacterial agent.

It also mentions that the product was "evaluated through standard biocompatibility tests (ISO 10993) and antimicrobial testing with appropriate organisms." However, it does not provide the specific acceptance criteria for these tests or the detailed results of the evaluations.

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