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Biatain® Silicone Ag is intended to provide a moist wound environment and exudate management of acute and chronic wounds.

Biatain® Silicone Ag is indicated for the management of exuding leg and foot ulcers, diabetic foot ulcers, superficial and partial thickness burns, donor sites, and, traumatic and post-operative wounds.

The device is available as sterile, single use only. The device is intended to provide a moist environment and exudate management of acute and chronic wounds. The device maintains a moist wound providing the optimal environment for wound healing.

The device consists of:

• Polyurethane (PU) top film - a 25 um semi-permeable barrier, printed with grey dots.
• . Absorbing pad - composed of a 3.0 mm PU foam containing an anti-bacterial silver complex (silver sodium hydrogen zirconium phosphate).
• Silicone adhesive bi-layer composed of a middle PU film . with a silicone adhesive gel. The PU top film and the middle PU film are laminated together at the border.
• . Protective film - composed of three or five parts; the center part and the remaining side parts.

The device:

• . contains a silver compound (silver sodium hydrogen zirconium phosphate). In vitro testing demonstrated that Biatain® Silicone Ag has an antimicrobial effect in the dressing against the following strains of 3 gram positive bacteria, 3 gram negative bacteria, 1 yeast, and 1 mold: Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Proteus mirabilis, Klebsiella pneumoniae, Escherichia coli, Aspergillus brasiliensis and Meyerozyma guilliermondii. The dressing sustains antimicrobial activity for up to 7 days.
  The device may be used in hospitals, healthcare facilities, and home care.

Sterilized using ethylene oxide (EO).

Prescription Use Only.

The provided document is a 510(k) Premarket Notification from the FDA for a wound dressing called Biatain® Silicone Ag. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing clinical studies to prove effectiveness.

Therefore, the document does not contain information about acceptance criteria for an AI/CADe device, nor does it describe a study proving the device meets such criteria. The acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment are all relevant to the evaluation of AI/CADe systems, but are not applicable to the information contained within this 510(k) submission for a wound dressing.

The document describes material properties, sterilization methods, and antimicrobial effectiveness of the wound dressing itself, not an AI system.

However, I can extract the performance data and "acceptance criteria" (which are actually performance specifications) relevant to the wound dressing as described in the document, and then explain why this information doesn't fit the template for an AI/CADe device.

Based on the provided document, here's information related to the Biatain® Silicone Ag wound dressing, organized to address your request as much as possible, while clarifying its irrelevance to AI/CADe devices:

This device is a wound dressing, not an AI/CADe system. Therefore, the questions related to AI/CADe device performance (e.g., sample size for test/training sets, expert involvement, MRMC studies, standalone algorithm performance) are not applicable to this 510(k) submission.

The acceptance criteria listed below are for the physical and biological properties of the wound dressing and its components, not for the performance of an artificial intelligence algorithm in diagnosing or detecting medical conditions.

1. Table of Acceptance Criteria and the Reported Device Performance (for the Biatain® Silicone Ag Wound Dressing):

Statement from the document: "All tests passed the pre-determined acceptance criteria."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not applicable as the document describes performance testing of a physical medical device (wound dressing), not an AI/CADe system. The performance tests were likely conducted on specific numbers of dressing samples in a laboratory setting, but this is not equivalent to a "test set" for an AI model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. Ground truth, in the context of an AI/CADe system, refers to definitive labels or diagnoses provided by experts (e.g., radiologists interpreting images, pathologists analyzing tissue). For a wound dressing, "ground truth" would refer to the accurate measurement of physical properties, adhesion, or microbiological action in a lab, not expert consensus on interpretations.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are used to resolve discrepancies in expert interpretations for AI ground truth labeling.

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 information is not applicable. MRMC studies are designed to evaluate the impact of AI on human reader performance in diagnostic tasks. This document concerns a wound dressing, not a diagnostic AI tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This refers to the performance of an AI algorithm intrinsically, without human intervention.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the wound dressing, the "ground truth" for these tests are laboratory measurements and adherence to established international and national standards (e.g., ASTM, EN, ISO) for material properties, sterility, and antimicrobial effectiveness. This is based on objective scientific measurement rather than clinical outcomes or expert interpretation of diagnostic data.

8. The sample size for the training set:
This information is not applicable. This device is a physical product, not an AI model requiring a training set.

9. How the ground truth for the training set was established:
This information is not applicable. No training set exists for this type of device.

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Biatain Silicone Ag Foam Dressings are indicated for use in the management of moderately to highly exuding leg ulcers and pressure sores. The dressing can also be used for 2nd degree burns, donor sites, post operative wounds and skin abrasions.

Biatain Silicone Ag Foam Dressings are wound dressings for exuding wounds with delayed healing due to bacteria or where there is a risk of infection. Biatain Ag Foam Dressings consist of a Top film (Printed high moisture-permeable barrier polyurethane (PU) film); a Center part (Soft, absorbing polyurethane (PU) antimicrobial foam (same Biatain Ag foam from Coloplast cleared via K100218) pads adhered to the top film with hot melt acrylic adhesive to avoid delamination when wet); a Border part (Perforated laminate of acrylic adhesive/melt blown polyurethane film/silicone adhesive, where the acrylic adhesive adheres to the top film, and the silicone adhesive is for skin adherence); and a Release liner: 3-part release liner that covers both center and border part. The foam contains silver, which is released upon contact with wound exudate. The dressings are available in different sizes. The dressing is square-shaped with rounded corners. Foam thickness is 3 mm. Biatain Silicone Ag foam dressing is protected with semi-permeable film backings that are waterproof and provide bacterial barriers. The dressings are individually-packed in a pouch: All dressings are sterile and are for single use only.

This 510(k) summary describes a medical device, the Biatain Silicone Ag Foam Dressing, which is a topical wound dressing. The submission aims to demonstrate substantial equivalence to a predicate device rather than providing a study on novel performance claims. As such, the information you've requested regarding acceptance criteria and a study proving those criteria (which are typically associated with AI/ML device performance or new functional claims) is not directly applicable to this type of submission.

Specifically:

• No new performance claims: The document states that "Substantial equivalency is supported by bench testing compared to the predicate device and biocompatibility testing performed on the subject device." There are no explicit acceptance criteria for diagnostic accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/ML systems or novel diagnostic/therapeutic functions.
• Focus on substantial equivalence: The core of this 510(k) is to demonstrate that the new device (Biatain Silicone Ag Foam Dressings) is "substantially equivalent in performance, indications, design and materials" to a legally marketed predicate device (Coloplast's Biatain Ag Adhesive Dressings, cleared under K100218). This means the focus is on showing the new device is as safe and effective as the existing one, not on proving new levels of performance against specific clinical benchmarks.

Therefore, many of the requested categories are not relevant to this specific premarket notification:

1. Table of acceptance criteria and reported device performance: Not applicable. The document does not define specific performance acceptance criteria or report performance metrics in the way an AI/ML device or a device with new functional claims would. The "performance" being assessed here is largely about equivalence in material properties and physical characteristics demonstrated through bench testing.
2. Sample size for test set and data provenance: No "test set" in the context of clinical performance evaluation (e.g., patient data for diagnostic accuracy) is mentioned. Bench testing data is used.
3. Number of experts used to establish ground truth & qualifications: Not applicable. There is no ground truth establishment in the diagnostic sense.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable. This is a wound dressing, not an AI-assisted diagnostic tool.
6. Standalone performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for training set: Not applicable. This is not an AI/ML device requiring a training set.
9. How ground truth for training set was established: Not applicable.

Summary of relevant information from the provided text:

• Device: Biatain Silicone Ag Foam Dressings
• Claim: Substantial Equivalence to predicate device (Biatain Ag Adhesive Dressings, K100218).
• Support for claim: Bench testing (comparing material properties, design, and performance characteristics to the predicate) and biocompatibility testing.
• Indications for Use: Management of moderately to highly exuding leg ulcers and pressure sores. Also for 2nd degree burns, donor sites, post-operative wounds, and skin abrasions.

To answer your request based on the provided text, the response must reflect that these specific questions are not addressed in this type of 510(k) submission which focuses on substantial equivalence rather than novel performance claims against specific clinical outcomes or diagnostic accuracy.

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