Search Results

Rx

Management of partial and full thickness wounds including stage I - IV pressure ulcers, ulcers caused by mixed vascular etiologies, Diabetic skin ulcers, 1st and 2nd degree burns, post-surgical incisions, graft sites, lacerations, skin tears, cuts and abrasions.

OTC

Management of minor wounds including minor cuts, abrasions, lacerations and burns.

The Field Shield Wound Dressing is a spray on hydrogel wound dressing that hydrates, seals and protects dermal injuries to create and maintain a moist wound environment. A moist wound environment is known to be conducive to the wound healing process. It is a hydrophilic system containing a polyacrylate polymer matrix with silver hydrosol and lidocaine. The dressing donates moisture to a wound and maintains a moist environment. When applied to the liquid device donates moisture to the wound then sets into a thin, pliable, transparent film barrier over the surface of the wound. The film is capable of setting over intact and compromised skin surfaces. The device is intended for use for up to 30 days. with reapplication recommended every 24 to 72 hours. The device contains silver hydrosol that may inhibit the growth of microorganisms such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant strains of MRSA and VRE, as well as fungi such as Candida albicans and Candida auris within the dressing. Additionally, the dressing contains lidocaine as a topical anesthetic. Clinical evaluation showed that the Lidocaine can reduce pain within 30 minutes after application; long-term pain reduction has not been evaluated. Field Shield® Wound Dressing is intended for both Prescription and over the counter (OTC) indications for use.

The provided document describes the KeriCure Inc.'s Field Shield Wound Dressing, an unclassified device. The information focuses on demonstrating its substantial equivalence to predicate devices, particularly regarding safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative thresholds for the Field Shield Wound Dressing. Instead, the document focuses on demonstrating that the device meets safety and performance standards equivalent to predicate devices, particularly through various types of testing. The reported device performance is outlined in the "Summary of Performance Testing" table.

Ask a specific question about this device

Prescription: LUOFUCON® Silver Wound Gel is under the medical supervision of a healthcare professional for the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.

OTC: LUOFUCON® Silver Antimicrobial Wound Gel is indicated for the topical management of minor cuts, minor lacerations and minor burns.

LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is a sterile, water-based amorphous gel composed of hydrophilic polymer and silver compound. The gel helps to maintain a moist wound environment. The silver compound acts as a preservative to inhibit the growth of microorganisms in the gel during shelf storage.

LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is supplied in a tube (collapsible, polypropylene tube, sealed on one end and fitted with a screw cap on the other end).

The provided document is a 510(k) summary for the LUOFUCON® Silver Wound Gel / LUOFUCON® Silver Antimicrobial Wound Gel. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

Based on the content, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with numerical targets for clinical performance metrics (like sensitivity, specificity, accuracy) that would be common for AI/diagnostic devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing various physical, chemical, and biological properties, as well as general performance attributes relevant to wound care gels.

The table below summarizes the comparative data presented, which implicitly serves as "acceptance criteria" by showing the subject device is comparable to the predicate/reference devices for key properties and performance aspects.

The document states: "Performance tests were conducted to demonstrate that the subject device is as effective as its predicate device." The "acceptance criteria" for these performance tests are implicitly met if the test results demonstrate comparable performance attributes to the predicate/reference devices, supporting the claim of substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not detail specific sample sizes for the performance tests listed (Appearance, Fluid Affinity, Loss on Drying, pH Value, Preservative Effectiveness). These are typically bench tests or in vitro studies, not requiring human patient test sets.

For the Animal Study (Porcine Wound Healing Study):

• Sample Size: Not explicitly stated.
• Data Provenance: Not explicitly stated (e.g., country or retrospective/prospective). This was an animal study, not human clinical data.

For Clinical Studies:

• Sample Size: "No clinical study was conducted."
• Data Provenance: Not applicable, as no human clinical data was used for direct performance evaluation of this device.

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)

This information is not applicable to this submission. The device is a wound care gel, not an AI or diagnostic medical device that requires expert adjudication for a test set. The efficacy (or non-inhibition of wound healing) was assessed in an animal model and through comparative performance testing.

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

This information is not applicable. As mentioned above, this is not an AI/diagnostic device that relies on expert adjudication for ground truth.

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. An MRMC study is relevant for AI/diagnostic imaging devices. This submission concerns a wound care gel.

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

This information is not applicable. This question refers to AI algorithm performance.

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

For the various performance tests (Appearance, Fluid Affinity, Loss on Drying, pH Value, Preservative Effectiveness):

• Ground Truth: These properties are determined through standardized laboratory testing methods (e.g., EN 13726-1, USP , USP , USP ). The "ground truth" is the quantitative or qualitative result obtained from these validated methods.

For the Biocompatibility Testing:

• Ground Truth: Compliance with ISO 10993 standards. The "ground truth" is the biological response (or lack thereof) observed in standardized in vitro and in vivo biocompatibility tests, interpreted by toxicologists or biologists.

For the Animal Study (Porcine Wound Healing Study):

• Ground Truth: Histological and macroscopic assessment of wound healing, and observation for adverse biological reactions. This ground truth is established by veterinary pathologists or researchers.

8. The sample size for the training set

This information is not applicable. This device is not an AI algorithm and therefore does not have a "training set."

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

This information is not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it.

Ask a specific question about this device

Atteris Antimicrobial Barrier Film Dressing is intended for application to minor wounds and damaged skin as a liquid, film forming barrier, which creates a waterproof, film dressing, protecting the wound or damaged skin.

Atteris™ Antimicrobial Barrier Film Dressing is a polymeric solution which forms a uniform film when applied to minor wounds and damaged skin. The product is dispersed in a unique non-cytotoxic, non-stinging solution via a standard 28 mL pump spray bottle. The product is biocompatible, non-stinging, fast drying, and has low friction. Antimicrobial Barrier Film Dressing protects minor wounds and damaged skin by providing a secure, breathable, waterproof barrier to external contaminates. The film dressing is colorless, transparent, and possesses good oxygen and moisture vapor permeability. The antimicrobial PHMB at a concentration of 0.001% w/w is added to the product as a preservative to inhibit the growth of microorganisms within the product.

The provided document is a 510(k) premarket notification for the "Atteris Antimicrobial Barrier Film Dressing" and focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove a device meets specific acceptance criteria in the context of AI/machine learning performance.

Therefore, most of the requested information regarding AI/ML study design (sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the provided "Performance Testing" section.

Acceptance Criteria and Reported Device Performance

Answers to other questions based on the provided document:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The document describes in-vitro lab testing, not a clinical study with a "test set" of patients/data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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/ML device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" or reference standards for the performance tests were established using recognized international standards and methods, specifically:
   • USP 51 for antimicrobial effectiveness.
   • ISO 10993 parts 1, 5, and 10 for biocompatibility.
7. The sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a medical device (a film dressing) and its performance is evaluated through standard laboratory and biocompatibility testing, not through AI/ML performance studies.

Ask a specific question about this device

The AGX Wound Wash Skin and Wound Cleanser is indicated for Over the Counter Use -For normal skin and minor wounds, minor burns, abraded skin, and irritated areas. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing solution.

The AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser is Indicated for Prescription Use -To cleanse, moisten and irrigate skin and dermal lesions; Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing solution.

AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and the AGX Wound Wash Skin and Wound Cleanser are cleansing solutions intended for the external cleansing of skin and wounds. The mechanical action of the fluid moving across the skin or wound surface provides the mechanism of action and aids in the removal of foreign objects such as dirt and debris. The AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and the AGX Wound Wash Skin and Wound Cleanser are identical devices. The only difference is that the AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser is for prescription use and the AGX Wound Wash Skin and Wound Cleanser is for Over-the-Counter Use.

The solution consists of deionized water containing 10ppm silver. The silver is from American Biotech Labs and is the same silver used in ABL Medical's Wound Dressing hydrogel devices cleared in K140483, K092826 and K082333. The silver acts as a preservative that may help inhibit the growth of microorganisms within the solution while in storage which was established through testing in accordance with USP and was shown to inhibit the growth of microorganisms such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae. MRSA, VRE, as well as fungi such as Candida albicans and aspergillus niger.

This document pertains to the 510(k) premarket notification for a medical device (AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and AGX Wound Wash Skin and Wound Cleanser), which is a wound cleansing solution, not an AI or imaging device. Therefore, the questions about acceptance criteria for AI models, such as sample size for test sets, expert ground truth establishment, MRMC studies, and training set details, are not applicable to this document.

The document discusses the substantial equivalence of the proposed wound wash devices to a predicate device (Silvaklenz Antibacterial Silver Skin & Wound Cleanser, K063069).

Here's an analysis of the "acceptance criteria" and "study" as they apply to this medical device submission:

Acceptance Criteria and Reported Device Performance (as inferred from the document)

For this type of device (wound wash), "acceptance criteria" are not framed in terms of precision, recall, or AUC like they would be for an AI model. Instead, they are related to safety, functionality, and equivalence to a legally marketed predicate device. The "study" mentioned here is primarily through verification, comparative, biocompatibility, antimicrobial effectiveness, and stability testing.

Table of Acceptance Criteria and Reported Device Performance (as relevant for a wound wash)

• Indications for Use: Nearly identical for OTC and Prescription uses, aiding in removal of oils, dirt, debris, and cleansing various wounds/irritations.
• Packaging: Identical (2oz, 4oz, 8oz, 16oz spray/squeeze bottles).
• Sterile when used: Both "No."
• Mechanism of Action: Stated as "mechanical action of the fluid moving across the skin or wound surface."
• Differences Addressed: The primary difference is the "Ingredients" (10ppm silver in deionized water vs. surfactant, cocamidopropyl betaine, silver). The document argues this difference "does not affect the safety of the device as evidenced by the biocompatibility testing and antimicrobial effectiveness testing which is the same testing that was performed on the predicate device" and "does not affect the effectiveness... based on the fact that the mechanism of action for both... is as a wound wash provided by the mechanical action of the fluid." |
  | Biocompatibility/Safety | Device must be biocompatible for patient contact (limited exposure, breached/compromised surfaces). | Biocompatibility Testing: The device passed tests according to ISO 10993 standards:
• Cytotoxicity (ISO 10993-5:2009)
• Irritation (ISO 10993-10:2010)
• Sensitization (ISO 10993-10:2010)
  These are standard tests for patient-contacting medical devices. |
  | Antimicrobial Effectiveness (as preservative) | The silver component effectively inhibits microbial growth within the solution during storage. | Antimicrobial Effectiveness Testing: "The silver acts as a preservative that may help inhibit the growth of microorganisms within the solution while in storage which was established through testing in accordance with USP and was shown to inhibit the growth of microorganisms such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, MRSA, VRE, as well as fungi such as Candida albicans and aspergillus niger." |
  | Stability/Shelf Life | Device maintains specifications over its claimed shelf life. | Stability Testing: "Stability testing was performed on real time aged samples to establish a shelf life of 3 years. The testing demonstrated that the wound wash maintains its specifications over the three year shelf life." |

Inapplicable Questions (as this is not an AI/imaging device submission):

2. Sample sized used for the test set and the data provenance: N/A - No "test set" in the AI sense. Testing refers to laboratory and bench testing of the physical product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A - "Ground truth" in this context refers to established scientific/medical principles for biocompatibility, antimicrobial preservation, and the physical/chemical properties of the solution.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A
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: N/A - Not an AI device assessing images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A - Not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A - Ground truth here is based on chemical/biological test standards (e.g., ISO 10993 for biocompatibility, USP for antimicrobial effectiveness) and comparison to the predicate device's established safety and effectiveness profile.
8. The sample size for the training set: N/A - No training set.
9. How the ground truth for the training set was established: N/A - No training set.

Ask a specific question about this device