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Silver Glucan Wound Dressing is an effective barrier to bacterial and candida penetration. The dressing may be use for partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, donor sites, and surgical wounds. Silver Glucan dressings may be used over partial thickness wounds, debrided wounds, and as a temporary covering for full thickness and grafted wounds.

Silver Glucan dressing consists of a nylon mesh coated with silver and oat glucan. The glucan facilitates the placement of the mesh and the silver protects the wound site from bacterial and yeast contamination.

The sterile, single use dressing will be sold in a variety of sizes ranging from 4" x 4" to 16" x 16" and rolls of 4" x 48".

This premarket notification (K050086) for Brennen Medical, Inc.'s Silver Glucan Wound Dressing does not contain detailed acceptance criteria or a dedicated study report proving the device meets specific performance metrics in the way modern medical device submissions typically do for AI/ML devices.

Instead, this 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, function, and intended use, and presents a list of general performance tests conducted. The "acceptance criteria" here are implied by the successful completion of these tests and the determination of substantial equivalence (rather than specific quantitative thresholds).

Therefore, I will extract the information available and note where specific details are not provided in this document format.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative thresholds for "acceptance criteria" (e.g., minimum tensile strength in Newtons, specific cytotoxicity scores, exact zone of inhibition measurements) are not detailed in this summary. The summary broadly states that the device "is both effective for its intended use and functions in a substantially equivalent manner to the predicate devices."

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

This 510(k) summary does not describe specific "test sets" in the context of an algorithm or AI model evaluation. The "studies" mentioned (Biocompatability, Animal Wound Healing, Silver Dissolution, Tensile Strength, Barrier Efficacy, Zone of Inhibition, Stability) are laboratory or animal-based performance tests, not clinical evaluations with human patient data or AI algorithm testing with a specific test set.

• Sample Size for Test Set: Not applicable/not specified for a "test set" in the context of an AI/ML device. The underlying details of the sample sizes for each specific performance study (e.g., number of animals in the wound healing study, number of samples for tensile strength) are not provided in this summary.
• Data Provenance: Not applicable/not specified for an AI/ML device test set. The provenance of the data for the performance studies (e.g., which lab conducted the tests, what species for animal studies) is not detailed.

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

This information is not applicable. This 510(k) pertains to a wound dressing, not an AI/ML diagnostic or prognostic device that would require expert-established ground truth on a test set. The listed studies are laboratory and preclinical performance tests.

4. Adjudication Method for the Test Set

This information is not applicable. There is no AI/ML test set requiring an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. This device is a wound dressing, not an imaging or diagnostic AI/ML system that would typically undergo such a study.

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

No, a standalone performance study (in the context of an algorithm) was not done. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance studies refers to the direct measurement or observation of the physical, chemical, or biological properties and effects of the wound dressing.

• Biocompatibility: In-vitro (cytotoxicity, sensitization assays) and in-vivo (irritation, sensitization on animals/humans) test results.
• Wound Healing: Clinical and histological assessment of wound closure, tissue regeneration, inflammation in an animal model.
• Silver Dissolution: Analytical chemistry measurements of silver release.
• Tensile Strength: Physical testing measurements of material strength.
• Barrier Efficacy: Microbiological challenge tests demonstrating reduction of bacterial/fungal penetration.
• Zone of Inhibition: Microbiological growth assays on agar plates.
• Stability Testing: Comparison of pre- and post-aging performance characteristics.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that is "trained."

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

Not applicable. This device is not an AI/ML algorithm that is "trained."

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For use in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female urinary incontinence resulting from urethral hypermobility or sphincter deficiency.

(Trade name) is a sterile, processed and treated porcine skin, which is intended for use in the reconstruction of soft tissue deficiencies.

The provided text does not contain the acceptance criteria or information about a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a surgical mesh, focusing on its substantial equivalence to predicate devices. It discusses:

• Device Name: Brennen Biosynthetic Surgical Mesh Matrix
• Indication for Use: Treatment of hernias and as a sling material for female urinary incontinence.
• Device Description: Sterile, processed, and treated porcine skin.
• Technological Characteristics and Performance: States that "The technological characteristics are the same or equivalent to the predicate device. Testing and review of the literature has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device."

Missing Information:
The document does not provide any specific details regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for either training or test sets. It merely asserts that "testing and review of the literature" was done to demonstrate substantial equivalence, but offers no specifics about these tests.

Therefore, I cannot populate the table or answer the specific questions based on the provided text.

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Glucamesh™/Glucatex™ Surgical Mesh is intended for the use as a prosthesis in general surgery for surgical treatment of abdominal wall reinforcement, hernia repairs, eventrations, rectal and genitourinary prolapse. The meshes are biocompatible and not biodegradable. The device is intended to be implanted by a qualified surgeon.

Glucatex mesh is constructed of polypropylene or polyester which is identical in composition to that used in Prolene Soft Mesh, Mersitence or Biomesh. The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth.

Here's an analysis of the provided information regarding the GlucaMesh and Glucatex (Polypropylene/Polyester) Mesh, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Study Information (Based on the provided K021835 documentation):

The provided documentation describes a 510(k) Premarket Notification for the GlucaMesh/Glucatex Surgical Mesh. This regulatory pathway primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials for de novo approval.

Here's a breakdown of the study aspects based on the given text:

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

• Sample Size for Test Set: Not applicable (N/A) in the context of a clinical test set. The submission refers to "Sufficient bench testing" and a comparison of technological characteristics to predicate devices. There is no mention of a clinical test set of patients or data in the provided documents.
• Data Provenance: The primary data provenance is bench testing and comparison to the known characteristics of predicate devices. There is no mention of a specific country of origin, nor whether any human data (if collected) was retrospective or prospective.

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

• Not applicable (N/A). There is no mention of a test set requiring expert ground truth in the provided summary. The substantial equivalence determination is based on a comparison of technical characteristics and intended use to established predicate devices.

4. Adjudication Method for the Test Set:

• Not applicable (N/A). No clinical test set or expert adjudication is described in the provided documents.

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 is not mentioned as part of this 510(k) submission. This type of study is typically associated with AI-driven diagnostic or screening devices, which is not the nature of a surgical mesh.

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

• No. This device is a surgical mesh, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used:

• The "ground truth" in this context is the established physical and material characteristics, performance, and clinical history of the predicate devices (Prolene Soft, Mersilene, Biomesh), combined with the results of bench testing for the GlucaMesh/Glucatex. The substantial equivalence argument serves as the "truth" for regulatory purposes here.

8. The Sample Size for the Training Set:

• Not applicable (N/A). There is no "training set" in the context of an AI/machine learning model for this surgical mesh submission. The development relies on established engineering principles, material science, and comparison to existing devices.

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

• Not applicable (N/A). As there is no training set for an AI model, this question does not apply.

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Brennen Beta Glucan Gel may be used to aid in the management of superficial and partial thickness burns; pressure ulcers (stages I-IV); venous, diabetic, and arterial ulcers; donor graft sites; superficial through full thickness wounds such as surgical wounds, minor abrasions and lacerations; and irritations of the skin.

Brennen Glucan Gel provides a moist environment which supports in the autolytic debridement of wounds with scattered areas of necrosis and slough.

Brennen Medical Beta Glucan Gel

Unfortunately, the provided text is a 510(k) clearance letter from the FDA for a medical device called "Brennen Medical Beta Glucan Gel." This letter grants clearance for the device to be marketed based on substantial equivalence to a predicate device, but it does not contain the detailed study results, acceptance criteria, or performance data that would be necessary to answer your request.

The FDA 510(k) process primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive new clinical trials with predefined acceptance criteria and performance reports in the same way a PMA (Premarket Approval) submission would.

Therefore, I cannot extract the information you've requested from these documents. The provided text only states:

• Device Name: Brennen Medical Beta Glucan Gel
• Regulatory Clearance: 510(k) clearance (K982825)
• Indications for Use: To aid in the management of superficial and partial thickness burns; pressure ulcers (stages I-IV); venous, diabetic, and arterial ulcers; donor graft sites; superficial through full thickness wounds such as surgical wounds, minor abrasions and lacerations; and irritations of the skin. It provides a moist environment which supports in the autolytic debridement of wounds with scattered areas of necrosis and slough.
• Limitations on Labeling: Not for third-degree burns, no claims of accelerating wound healing, not a long-term/permanent/artificial skin dressing, not a treatment or cure.

To get the information you asked for (acceptance criteria and detailed study data), you would typically need to consult the original 510(k) submission summary, which sometimes contains more detail on performance studies (though often not as extensive as a PMA). This information is not present in the brief FDA clearance letter.

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The Brennen Biosynthetic Surgical Mesh is indicated in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female winary incontinence resulting from urethral hypermobility or sphincter deficiency.

Brennen Biosynthetic Surgical Mesh Matrix

I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for a surgical mesh, focusing on regulatory aspects, indications for use, and legal compliance. It does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

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MacroPro Cream may be used to aid in the management of superficial and partial thickness burns; pressure ulcers (stages I-IV); venous, diabetic, and arterial ulcers; donor graph sites; superficial through full thickness wounds such as surgical wounds, minor abrasions and lacerations; and irritations of the skin.

MacroPro Cream provides a moist environment which supports in the autolytic debridement of wounds with scattered areas of necrosis and slough.

For external use only. Do not use on patients with known allergies to plants such as gum oat.

Brennen Medical Beta Glucan Cream, "MacroPro"

This document is a Premarket Notification (510(k)) decision letter from the FDA for the "Brennen Medical Beta Glucan Cream, 'MacroPro'". It focuses on regulatory approval and substantial equivalence, not on the performance of the device against specific acceptance criteria from a clinical study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted from the provided text. The document does not describe any specific performance criteria, a study design, sample sizes, expert qualifications, or ground truth establishment related to the device's efficacy or safety. It primarily outlines the allowed indications for use and disclaimers for labeling.

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