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TALIDERM™ is intended for use under the direction of a healthcare professional.

TALIDERM™ is indicated for the management of wounds including: Diabetic ulcers Venous ulcers Pressure wounds Ulcers caused by mixed vascular etiologies Full thickness and partial thickness wounds Second degree burns Surgical wounds-donor sites/grafts, post-mohr's surgery, and other bleeding surface wounds Abrasions Traumatic wounds healing by secondary intention Dehisced surgical wounds.

TALIDERM™ is a sterile primary wound dressing comprised of shortened fibers of poly-N-acetyl glucosamine, isolated from microalgae.

This document is a 510(k) summary for a medical device called TALIDERM™, a wound dressing. It declares substantial equivalence to predicate devices based on biocompatibility and performance characteristics. However, it does not include detailed acceptance criteria or a study that proves the device meets those criteria, as typically found in clinical trial reports for devices that require them.

Here's an analysis of why the requested information cannot be fully provided based solely on the provided text, and what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria or quantitative performance metrics for TALIDERM™. Instead, it states:

• "Results of scientific testing have ensured that the material is biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use."
• "Non-clinical testing was conducted. Animal testing was performed to simulate clinical conditions with no adverse effects noted."
• "Clinical evidence further supported the safety and performance of TALIDERM™."

These are general statements affirming that testing was done and the outcomes were positive, but they do not define specific, measurable acceptance criteria (e.g., "wound closure rate > X%", "infection rate < Y%") or provide the actual numerical results against such criteria.

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

The document mentions "Clinical evidence further supported the safety and performance of TALIDERM™" but does not specify the sample size for any clinical or test set. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not mention the use of experts to establish ground truth. It refers to "clinical evidence," but the specifics of how that evidence was generated, reviewed, or validated by experts are absent.

4. Adjudication Method:

Since there's no mention of experts or a formal review of test set data, there is no information on adjudication methods such as 2+1 or 3+1.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC study involves multiple human readers evaluating cases, often with and without AI assistance, to measure the impact of the AI. This document pertains to a wound dressing, not an AI/diagnostic device. Therefore, it is highly unlikely and not mentioned that an MRMC comparative effectiveness study was done for TALIDERM™.

6. Standalone Performance Study (Algorithm Only):

TALIDERM™ is a physical wound dressing, not an algorithm or software. Therefore, the concept of a "standalone algorithm only performance" study is not applicable to this device.

7. Type of Ground Truth Used:

The document vaguely refers to "Clinical evidence" and "Animal testing." For a wound dressing, the ground truth for safety and performance would typically involve clinical outcomes data (e.g., wound healing rates, infection rates, adverse events) and observed effects in animal models. However, the specific methodology for establishing this ground truth is not detailed.

8. Sample Size for the Training Set:

Since this is a physical wound dressing and not an AI/machine learning device, the concept of a "training set" in the context of statistical model development is not applicable. The document does not provide sample sizes for any studies that would be analogous to a training set.

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

Again, as this is not an AI/machine learning device, the concept of establishing ground truth for a training set is not applicable.

Summary of what can be extracted and what is missing:

This 510(k) summary explains that TALIDERM™ is a sterile primary wound dressing. The claim for substantial equivalence is based on "indication for use, biocompatibility and performance characteristics."

• Acceptance Criteria & Performance: Not explicitly stated with quantitative metrics. General statements indicate biocompatibility, appropriate physical properties, and safety/performance supported by non-clinical (animal) and clinical evidence, with "no new adverse effects" and "no adverse effects noted" in animal testing.
• Sample Size (Test Set): Not provided.
• Data Provenance: Not provided.
• Experts for Ground Truth: Not mentioned.
• Adjudication Method: Not applicable/mentioned.
• MRMC Study: Not applicable/mentioned.
• Standalone Performance Study: Not applicable/mentioned.
• Type of Ground Truth: Implied to be clinical outcomes and animal model observations, but not detailed.
• Sample Size (Training Set): Not applicable/mentioned.
• Ground Truth Establishment (Training Set): Not applicable/mentioned.

In conclusion, this 510(k) summary is a regulatory document affirming substantial equivalence based on a high-level review of various tests. It does not contain the detailed study information (specific acceptance criteria, sample sizes, expert involvement, or ground truth methodologies) one would expect from a clinical trial report or a submission for an AI-powered device.

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