Search Results

Under the supervision of a health care professional, Epicyn HydroGel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis. Epicyn HydroGel may be also used to relieve the pain of first and second degree burns. Epicyn HydroGel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Epicyn™ HydroGel is an emollient containing, non oily pH neutral hydrogel. The product is preserved with a unique mixture of hypochlorous acid and sodium hypochlorite generated through a proprietary process. The gel forms a protective barrier which retains moisture and provides relief of the burning and itching associated with various types of dermatoses including atopic dermatitis. The gel will be supplied in polyethylene terephthalate (PET) tube-bottles with polypropylene (PP) tamper resistant snap-top closure as described in Section 11.3.

The provided text is a 510(k) Premarket Notification for Epicyn™ HydroGel, a wound and burn hydrogel dressing. It focuses on demonstrating substantial equivalence to a predicate device and outlines safety testing. It does not present acceptance criteria for device performance, nor does it describe a study proving the device meets performance-based acceptance criteria.

Therefore, I cannot provide the requested information in the format specified because the document does not contain details about:

• Acceptance criteria for device performance: The document discusses "safety and effectiveness" and "functions as intended" but does not quantify performance metrics or acceptance thresholds.
• A study proving device meets acceptance criteria: The document refers to "in-vitro and in-vivo biocompatibility testing," "bench testing including bioburden, biocompatibility and animal testing," and "USP Antimicrobial Effectiveness Testing and Microbial Enumeration testing characterization studies." These are safety and characterization tests, not performance studies against specific acceptance criteria for the intended use (managing burning, itching, pain, and maintaining a moist wound environment).
• Sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set size, or ground truth for training set.

The document's primary argument for substantial equivalence is based on:

1. Same intended use as the predicate device (Sinclair Wound and Skin Emulsion, Atopiclair®).
2. Similar basic function and technological characteristics (clear, aqueous, emollient-containing, non-oily, pH neutral hydrogel for moisture control, wound exudate management, and barrier protection).
3. Safety established through biocompatibility, in-vitro cytotoxicity, and sensitization testing in animal species (ISO 10993-1 compliance).

The document states: "Performance Testing: Epicyn™ HydroGel has been subjected to in-vitro and in-vivo biocompatibility studies to demonstrate that the device is safe for the indications for use. Extensive bench testing including bioburden, biocompatibility and animal testing have been performed to support the safety and efficacy of the Epicyn™ HydroGel. Test results demonstrate that the gel functions as intended and without adverse effects." However, it does not elaborate on what "functions as intended" means in terms of specific performance metrics or how it was quantitatively measured.

Ask a specific question about this device

OTC: Microcyn Skin and Wound HydroGel is intended for use to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns. Microcyn is also indicated for the management of irritation and pain from minor sunburn. Professional Use: Under the supervision of a healthcare professional, Microcyn Skin and Wound HydroGel is intended for management of wounds including itch and painrelief associated with dermal irritation, sores, injuries and ulcers of dermal tissue. Microcyn Skin and Wound HydroGel is intended for use on first and second degree burns, exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.

Microcyn™ Skin and Wound HydroGel is a clear viscous, odoriess, aqueous hydrogel. The gel will be supplied in 2 oz polyethylene terephthalate bottles with polypropylene, tamper resistant caps as described in Section 11.3.

This looks like a 510(k) premarket notification for a medical device called Microcyn™ Skin and Wound HydroGel. This document is a submission to the FDA (Food and Drug Administration) to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, and therefore does not require a full Premarket Approval (PMA) process.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

This document describes a medical device (Microcyn™ Skin and Wound HydroGel) seeking 510(k) clearance, which is a process to demonstrate substantial equivalence to a predicate device. It is not a study that establishes acceptance criteria and proves performance in the way clinical trials for new drugs or more complex devices might. Instead, the "acceptance criteria" here are implicitly tied to the safety and functionality demonstrated by the predicate device and the general requirements for such wound dressings.

Here's the breakdown based on the information provided, recognizing the nature of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a wound hydrogel, the "acceptance criteria" are primarily related to safety, biocompatibility, and functional equivalence to predicate devices, rather than specific performance metrics like sensitivity or specificity for an AI-powered diagnostic. The device's performance is demonstrated through in-vitro and in-vivo testing to show it is safe and functions as intended.

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

This document does not specify a "test set" in the context of a dataset for an AI algorithm. The testing described relates to biological and chemical properties of the hydrogel.

• Sample Size: Not specified for biocompatibility or other performance tests (e.g., how many animals were used, how many samples for in-vitro tests). It mentions "two species of animal" for sensitization testing, but not the number of animals per species.
• Data Provenance: The tests are in-vitro (lab-based) and in-vivo (animal studies, "two species of animal"). There is mention of "Clinical experience with the solution form of the product indicates the Microcyn™ Skin and Wound HydroGel is safe for its intended use," which suggests some human data exists for a previous version or related product, but no details are provided about this "clinical experience" for the hydrogel specifically. The focus for this 510(k) is heavily on bench and animal testing.

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

Not applicable in this context. This is a medical device (hydrogel), not an AI diagnostic algorithm that requires expert-established ground truth on a test set of images or patient data. The "ground truth" for these tests would be the established scientific methods and pass/fail criteria for biocompatibility, antimicrobial effectiveness, etc.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication" of expert opinions for a test set in the context of evaluating a wound hydrogel's physical and biological properties.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially imaging-based AI) to compare human reader performance with and without AI assistance. This document is for a wound dressing, which has a different evaluation paradigm.

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

No, this is not an AI algorithm. It's a wound hydrogel.

7. The Type of Ground Truth Used

The "ground truth" is established through:

• Standardized Biocompatibility Testing: According to ISO 10993 (cytotoxicity, sensitization).
• Standardized Antimicrobial Testing: USP Antimicrobial Effectiveness Testing .
• Bench Testing: To confirm properties like moisture absorption, exudate control, and physical characteristics.
• Animal Testing: For dermal irritation and sensitization in "two species of animal."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no "training set" in this submission.

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

Not applicable. As above, there is no training set for an AI algorithm.

Ask a specific question about this device

OTC: Oculus Puracyn™ Skin and Wound Cleanser with Preservatives is intended for OTC use for the management of skin abrasions. lacerations, minor irritations. cuts, and intact skin.

Professional Use: Oculus Puracyn™ Skin and Wound Cleanser with Preservatives is intended to be used by health care professionals in the management via debridement of wounds such as stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.

Oculus Puracyn™ Skin and Wound Cleanser with Preservatives is a clear hypotonic solution that aids in the mechanical removal of the debris and foreign material from the application site. Dirt debris and foreign material are mechanically removed by the action of the wound cleanser moving across the wound bed or application site with or without the assistance of a suitable wound dressing (i.e. gauze). The device also contains antimicrobial agents that inhibit the growth of microorganisms. Oculus Puracyn™ Skin and Wound Cleanser with Preservatives will be supplied in High Density Polyethylene (HDPE) bottles of various volumes with dosing inserts and caps as described in Section 11.3.

The provided text describes a 510(k) summary for the Oculus Puracyn™ Skin and Wound Cleanser with Preservatives. This is a medical device submission, and as such, the "acceptance criteria" and "device performance" are typically related to proving substantial equivalence to a predicate device and demonstrating safety and effectiveness through laboratory (in-vitro) and potentially animal (in-vivo) studies, rather than clinical studies with human readers or AI algorithms.

Therefore, many of the requested elements (like sample size for test set, number of experts, adjudication method, MRMC studies, standalone algorithm performance, and sample size for training set) are not applicable in this context.

Here's the information derived from the provided text, adapted for the nature of this medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable in the context of this device. The "test set" refers to microorganisms and animal subjects used in laboratory and animal studies, not human clinical participants for evaluating an AI algorithm.
  • For antimicrobial effectiveness, multiple strains of bacteria and fungi were tested as per USP and additional clinical relevance.
  • For biocompatibility, animal species were used for sensitization and irritation testing.
• Data Provenance: The studies were conducted in-vitro (laboratory) and in-vivo (animal) as a part of the device's premarket submission. The specific location or institution where these studies were performed is not detailed, nor is the country of origin explicitly stated, but it's part of a US FDA submission. The studies are prospective in the sense they were conducted specifically for this submission.

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

• Not applicable. "Ground truth" in this context refers to established scientific methods and standards (e.g., USP for antimicrobial effectiveness, ISO standards for biocompatibility) and the experimental results against those standards, rather than expert consensus on medical images or diagnoses. The studies are performed by qualified laboratory personnel following established protocols.

4. Adjudication method for the test set

• Not applicable. Adjudication is typically for resolving discrepancies in expert interpretations of clinical data. For laboratory and animal studies, results are typically determined by direct measurement or observation against defined scientific criteria.

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. This device is not an AI diagnostic tool and therefore MRMC studies are not relevant.

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

• Not applicable. This device is a solution for wound cleansing, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device can be understood as:

• Established Scientific Standards: Performance against recognized standards like USP Antimicrobial Effectiveness for microbiology.
• Biocompatibility Standards: Results of biocompatibility, cytotoxicity, and sensitization tests in animal models, demonstrating non-harmful interaction with biological systems.
• Chemical/Physical Properties: In-vitro demonstrations of mechanical removal action and stability over time.

8. The sample size for the training set

• Not applicable. There is no training set as this is not an AI/ML device.

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

• Not applicable. No training set was used.

Ask a specific question about this device

OTC: Oculus Microcyn™ Skin and Wound Gel is intended for over the counter use for minor skin abrasions, lacerations, minor irritations and intact skin.

Professional Use: Under the supervision of a healthcare professional, Oculus Microcyn™ Skin and Wound Gel is intended for exuding wounds such as leg ulcers, pressure ulcer, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.

Oculus Microcyn™ Skin and Wound Gel is a clear viscous, odorless, aqueous hydrogel. The gel will be supplied in 2 oz polyethylene terephthalate bottles with polypropylene disc top caps as described in Section 11.3

The provided text describes a 510(k) premarket notification for the Oculus Microcyn™ Skin and Wound Gel. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies with specific performance metrics against pre-defined acceptance criteria for a new AI or diagnostic device. Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for AI algorithms is not applicable to this document.

Here's an breakdown of the information that is available and a note on what is not:

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

• Acceptance Criteria: The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating safety and substantial equivalence to a predicate device through biocompatibility testing and manufacturing quality.

• Reported Device Performance:

  • Biocompatibility: "Oculus Microcyn™ Skin and Wound Gel has been subjected to in-vitro and in-vivo biocompatibility testing (cytotoxicity, dermal irritation and dermal sensitization)." These tests "demonstrate the Oculus Microcyn™ Skin and Wound Gel is a safe for use as temporary dressing when in contact with abraded, breached or compromised skin."
  • Antimicrobial Effectiveness: "USP Antimicrobial Effectiveness Testing was performed to support claims that the FAC inhibits contamination within the hydrogel." (No specific results are given beyond the claim of inhibition).
  • Stability: "Extrapolated results from ongoing stability studies support a product shelf life of 18 months."
  • Clinical Experience (Solution Form): "Clinical experience with the solution form of the product indicates the Oculus Microcyn™ Skin and Wound Gel is safe for its intended use." (This refers to a related product, not directly the gel).

  Table (Based on available information):

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 provided for the biocompatibility or antimicrobial effectiveness tests. The tests mentioned are laboratory-based and animal studies, not human clinical trials with "test sets" in the context of AI or diagnostic device evaluation.

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 as the submission is for a wound care product based on physical properties and biocompatibility, not for a diagnostic device requiring expert interpretation or ground truth establishment in the conventional sense.

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

• This information is not applicable for the reasons stated above.

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 type of study is not applicable as the device is a wound care gel, not an AI-assisted diagnostic or imaging product.

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

• This is not applicable as the device is a physical product (wound gel), not an algorithm.

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

• The "ground truth" for this device is based on standardized laboratory and animal testing protocols for biocompatibility (e.g., ISO 10993, USP) and antimicrobial effectiveness. For demonstrating substantial equivalence, the "ground truth" is also the characteristics and intended use of the legally marketed predicate device.

8. The sample size for the training set

• This information is not applicable as this is not an AI/machine learning device. The "training set" concept does not apply.

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

• This information is not applicable as this is not an AI/machine learning device.

Ask a specific question about this device

Dermacyn™ Wound Care is intended for moistening absorbent wound dressings and for debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, statis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin.

Dermacyn™ is intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.

The subject device is a wound cleansing solution that is intended for the moistening and debriding of dermal wounds. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. The subject device is offered in various bottle sizes with and without a trigger spray.

This premarket notification (K060113) for Dermacyn™ Wound Care does not contain the detailed information necessary to complete most of the requested sections regarding acceptance criteria and study data. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with acceptance criteria.

However, based on the provided text, I can infer the acceptance criteria relate to the device being substantially equivalent to the predicate devices (Allclenz™ Cleanser and CarraKlenz Wound Cleanser) in terms of function, intended use, and safety, as demonstrated through non-clinical testing.

Here's a breakdown of what can be extracted and what cannot:

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

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

• Not provided. The document states "Non-clinical testing was conducted" but gives no details about sample sizes, study design (retrospective/prospective), or data provenance.

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)

• Not applicable / Not provided. This device is a wound cleanser, and the "testing" mentioned is non-clinical, likely bench testing for safety and performance (e.g., microbial efficacy, chemical composition, biocompatibility). It does not appear to involve human interpretation or a "ground truth" established by clinical experts in the way AI/diagnostic devices would.

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

• Not applicable / Not provided. 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

• No. This is not an AI or diagnostic device, so an MRMC study is not relevant or mentioned.

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

• Not applicable. This product is a physical wound cleanser, not an algorithm.

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

• Not applicable / Not provided. For non-clinical testing of a wound cleanser, "ground truth" would relate to accepted standards for biocompatibility (e.g., ISO standards), chemical composition validation, or efficacy against specific microorganisms in a lab setting, rather than clinical outcomes or diagnostic accuracy. The document doesn't detail these specific ground truths.

8. The sample size for the training set

• Not applicable / Not provided. This is not a machine learning device, so there is no training set in the conventional sense.

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

• Not applicable / Not provided. See point 8.

Ask a specific question about this device

Dermacyn™ Wound Cleanser is intended for moistening and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, statis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin.

The subject device is a wound cleansing solution that is intended for the cleansing of dermal wounds. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. The subject device is offered in various bottle sizes.

The provided text is a 510(k) summary for the Dermacyn™ Wound Cleanser. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed studies with acceptance criteria and performance metrics in the way a clinical trial for a new drug or a novel AI software would.

Therefore, the document does not contain the specific information requested regarding acceptance criteria and performance studies in the context of device performance, test sets, expert adjudication, or AI assistance.

Here's a breakdown of why the requested information is absent based on the provided text:

1. Acceptance Criteria and Reported Device Performance: Not applicable in this context. The 510(k) summary focuses on demonstrating that the device is "substantially equivalent" to existing products, not on meeting specific performance criteria related to accuracy, sensitivity, or other typical metrics for a diagnostic or AI device. It mentions "Non-clinical testing was conducted to confirm the safe and effective performance," but it doesn't quantify or specify acceptance criteria for these tests. The "performance" assessment is comparative, showing it performs similarly to predicate devices.

   • Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided. The summary states "Non-clinical testing was conducted to confirm the safe and effective performance of Dermacyn™ Wound Cleanser. Pre-clinical testing also demonstrated the biocompatibility of the subject device." However, no quantifiable acceptance criteria or reported numerical performance metrics are given.

2. Sample Size and Data Provenance for Test Set: This kind of information is generally not included in a 510(k) summary for a wound cleanser. The "testing" mentioned is likely related to manufacturing quality, sterility, shelf-life, and biocompatibility, not a clinical "test set" in the sense of a medical imaging or AI device.

3. Number of Experts and Qualifications: Not applicable. The "ground truth" concept, as used in the context of expert review for medical devices or AI, does not apply to a physical wound cleanser. The "truth" here would be its chemical and physical properties and its effect on wounds, which are assessed through laboratory and possibly limited preclinical studies, not expert consensus on interpretations.

4. Adjudication Method: Not applicable for the reasons mentioned above. There's no interpretive "ground truth" that needs adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is relevant for diagnostic devices where human readers interpret medical data (e.g., radiologists reading images) and AI might assist them. A wound cleanser does not involve human interpretation in this manner.

6. Standalone Performance: While the wound cleanser operates "stand-alone" in its intended use, the concept of "standalone performance" in the context of device evaluation usually refers to an algorithm's performance without human intervention, which is not relevant here. The device itself is standalone.

7. Type of Ground Truth Used: The "ground truth" for a wound cleanser would be its physical and chemical properties and its biological effects (e.g., sterilization effectiveness, irritation potential, wound healing mechanisms), established through laboratory assays and possibly animal models, rather than expert consensus, pathology, or outcomes data in humans for substantial equivalence. The document indicates "Pre-clinical testing also demonstrated the biocompatibility of the subject device."

8. Sample Size for Training Set: Not applicable. There is no AI component or machine learning model being "trained."

9. How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided 510(k) document is for a non-AI, non-diagnostic medical device. The regulatory pathway for such devices focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and safety data (e.g., biocompatibility) rather than detailed clinical performance studies with acceptance criteria, test sets, and expert adjudication, which are more typical for novel diagnostic or AI-powered devices.

Ask a specific question about this device

Dermacyn™ Wound Dressing is intended for use in moistening and lubricating absorbent wound dressings for traumatic wounds, cuts, abrasions and minor burns.

The subject device is an 8 ounce polyethylene bottle containing Dermacyn™ Wound Care Dressing intended for multi-use.

This document describes the 510(k) summary for the Dermacyn™ Wound Dressing (K041161). It is a medical device application that establishes substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics.

Here's an analysis based on the provided text, addressing the requested points where applicable:

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

This 510(k) summary does not present specific quantitative acceptance criteria or performance metrics in the way a clinical study for a novel device would. Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device.

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

• Test Set Sample Size: Not applicable. This document refers to "non-clinical testing" and "preclinical testing" but does not detail the sample sizes for these tests. There's no mention of a human "test set" in the context of a clinical performance study.
• Data Provenance: Not specified, but given the nature of non-clinical and preclinical testing, it would typically be laboratory-based rather than patient data.

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)

Not applicable. This is not a study that involves expert review or ground truth establishment in the context of diagnostic accuracy or equivalent performance. The evaluation is based on scientific testing related to the product's formulation and biocompatibility, as compared to a predicate.

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

Not applicable. There is no human "test set" or adjudication process described.

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 device is not an AI-powered diagnostic or assistive tool, nor does the document describe a comparative effectiveness study involving human readers.

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

Not applicable. This device is a topical solution, not an algorithm.

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

Not applicable. The "ground truth" here is the established safety and effectiveness of the traditional sterile saline wound dressing, to which the new device is compared in terms of its properties and intended use. The non-clinical and preclinical tests would have generated data on properties like sterility, pH, antimicrobial activity (if applicable, though not explicitly stated as a primary function here), and biocompatibility, using established laboratory methods.

8. The sample size for the training set

Not applicable. There is no machine learning or AI component that would require a training set.

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

Not applicable.

Ask a specific question about this device