Search Results

The SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.

The SkinPen® Precision System consists of a microneedling pen handpiece (SkinPen® Precision) and a sterile needle cartridge (SkinPen® Precision Cartridge). The accessories are a charging base and a BioSheath. A SkinPen® Precision System treatment kit is provided separately and contains the following: SkinPen® Precision Cartridge: sterile, disposable needle cartridge. Not to be resterilized or reused. (K202243, Class 2, Regulation 878.4430, Product Code: QAI.); Lift HG: hydrogel wound dressing (without drugs and/or biologics), to protect against abrasion and friction during the microneedling procedure. May be applied to prevent skin from drying out post procedure. (Class I, 510(k) Exempt, Regulation 878.4022, Product code: NAE.); SkinPen® BioSheath: nonsterile, disposable cover for the microneedling pen handpiece to avoid contamination of the SkinPen® Precision.; Sani-Cloth AF3: Sanitizing cloth available for purchase along with device to sanitize between uses.

The provided FDA 510(k) clearance letter (K220506) for the SkinPen® Precision System does not contain information about acceptance criteria or a study proving the device meets acceptance criteria for its clinical indications (improving the appearance of wrinkles of the neck and facial acne scars).

The letter states, "No Clinical testing was conducted as part of this submission." This submission is a "Special 510(k)" for a modification to an already cleared device (K202243 SkinPen Precision System). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" would have been part of the original 510(k) for the predicate device, K202243, or a prior submission that established the clinical effectiveness for the indications for use.

Instead, this submission focuses on a non-clinical performance testing related to a change in the disinfecting cloth used with the device.

Here's a breakdown of the information that is present, in relation to your request, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• No clinical acceptance criteria or performance data are provided in this document for the indications of use (wrinkles of the neck, facial acne scars).
• Non-clinical (cleaning validation) acceptance criteria and performance:
  • Acceptance Criteria for Cleaning Validation: The goal was to confirm that the Sani-Cloth AF3 is sufficient for bacterial removal from the device even under worst-case contamination scenarios. The implicit acceptance criterion is that the bacteria are effectively removed.
  • Reported Device Performance (Cleaning Validation): "it was confirmed that the bacteria were removed from the device when cleaned with Sani-Cloth AF3... The new Sani-Cloth AF3 shows the same or improved results than the previously used Sani-Cloth HB."

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

• Clinical Test Set: Not applicable, as no clinical testing was performed for this submission.
• Non-clinical (Cleaning Validation) Test Set: The document describes "application of bacteria on the SkinPen device surface." The exact sample size (number of devices, number of wipes, etc.) is not explicitly stated, but it refers to "worst-case conditions."
• Data Provenance: Not explicitly stated, but likely conducted in a laboratory setting as part of the manufacturer's testing for regulatory submission.

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

• Clinical Test Set: Not applicable.
• Non-clinical (Cleaning Validation) Test Set: The "ground truth" here is the presence or absence of bacteria (before and after cleaning). This would be established by standard microbiological laboratory techniques, not by human experts in the context of clinical interpretation. The qualifications of the microbiologists or lab technicians are not provided.

4. Adjudication Method for the Test Set

• Clinical Test Set: Not applicable.
• Non-clinical (Cleaning Validation) Test Set: Not applicable in the sense of clinical adjudication. The result (bacteria removed or not) would be determined by laboratory assays.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs Without AI Assistance

• This device is a microneedling system, not an AI diagnostic or assistive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

• This device is a microneedling system, not an algorithm. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

• Clinical Ground Truth: For the clinical indications (wrinkles and acne scars), the ground truth for the original predicate device clearance would likely have been based on clinician assessments (e.g., blinded expert photographic evaluations, severity scales) and/or patient-reported outcomes. This document does not provide that information.
• Non-clinical (Cleaning Validation) Ground Truth: The ground truth for the cleaning validation was the microbiological assessment of bacterial presence/absence on the device surface.

8. The Sample Size for the Training Set

• Clinical Training Set: Not applicable, as no clinical studies were performed for this submission, and it's not an AI/model development submission.
• Non-clinical (Cleaning Validation) Training Set: Not applicable. This was a validation study, not a model training process.

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

• Not applicable for the reasons stated above.

In summary, this document primarily outlines the regulatory clearance (510(k)) for a minor modification (change in disinfecting wipe) to an already cleared microneedling device. It does not provide the details of clinical acceptance criteria or studies proving clinical effectiveness, as those would have been part of the original clearance for the predicate device (K202243). The only "study" mentioned is a non-clinical cleaning validation.

Ask a specific question about this device

The SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.

The SkinPen® Precision System consists of a microneedling pen handpiece (SkinPen® Precision) and a sterile needle cartridge (SkinPen® Precision Cartridge). The accessories are a charging base and a BioSheath. A SkinPen® Precision System treatment kit is provided separately and contains the following: SkinPen® Precision Cartridge: sterile, disposable needle cartridge. Not to be resterilized or reused. Lift HG: hydrogel wound dressing (without drugs and/or biologics), to protect against abrasion and friction during the microneedling procedure. May be applied to prevent skin from drying out post procedure. SkinPen® BioSheath: nonsterile, disposable cover for the microneedling pen handpiece to avoid contamination of the SkinPen® Precision.

Here's a breakdown of the acceptance criteria and study details for the SkinPen Precision System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state formal "acceptance criteria" with numerical thresholds for performance. Instead, it describes "effectiveness endpoints" and presents study results that demonstrate the device's ability to improve the appearance of wrinkles on the neck. The implicit acceptance criterion is a statistically significant and clinically meaningful improvement in wrinkle appearance and positive patient satisfaction, as evidenced by the measured outcomes.

• 11.5% of subjects received a '2: much improved' grading.
• 31.5% of subjects received a '3: improved' grading.
• 57% received a '4: no change' grading. (Total of 43% showed improvement) |
  | Secondary Effectiveness: Subject's Global Aesthetic Improvement Scale (SGAIS) | Clinically meaningful proportion of subjects reporting "Improved," "Much Improved," or "Very Much Improved" ratings. | At 3 months post-treatment: 22 out of 32 subjects (68.8%) reported some percentage of improvement in the appearance of their wrinkles.
  (This suggests a high level of patient-perceived improvement). |
  | Secondary Effectiveness: Patient Satisfaction Questionnaire - Question 1 (Improvement noticed) | High percentage of subjects reporting "Yes" to noticing improvement in fine lines and wrinkles. | 1-Month Post-Treatment: 93.8% (30 out of 32) reported "Yes".
  3-Months Post-Treatment: 71.9% (23 out of 32) reported "Yes". (High initial and sustained patient perception of improvement). |
  | Secondary Effectiveness: Patient Satisfaction Questionnaire - Question 2 (Satisfaction) | High percentage of subjects reporting "Favorable" satisfaction. | 1-Month Post-Treatment: 87.5% (28 out of 32) reported "Favorable".
  3-Months Post-Treatment: 75.0% (24 out of 32) reported "Favorable". (High level of patient satisfaction). |
  | Secondary Effectiveness: Patient Satisfaction Questionnaire - Question 3 (Recommendation) | High percentage of subjects reporting "Yes" to recommending the treatment. | 1-Month Post-Treatment: 80.6% (25 out of 31) reported "Yes".
  3-Months Post-Treatment: 65.6% (21 out of 32) reported "Yes". (Strong willingness to recommend, though decreasing slightly over time). |
  | Safety Endpoint (Adverse Events) | Absence of serious device-related adverse events. | No adverse events related to the SkinPen Precision treatment were observed on the face and neck during the study. (Common transient treatment responses like dryness, redness, burning, itching, peeling, tenderness were reported, lasting 1-7 days). |

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

• Sample Size for Clinical Study (Test Set): 35 subjects initially enrolled (2 male, 33 female). The detailed demographic table (Table 1) shows N=32 for the reported results, implying 32 subjects completed the study protocol in some capacity for the neck wrinkle indication.
• Data Provenance: The study was a "single center study" (location not explicitly stated, but typically US-based for FDA submissions). It was a prospective clinical study conducted to specifically evaluate the device for the new indication (wrinkles on the neck).

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

• Number of Experts: Two separate independent blinded Board Certified Physicians.
• Qualifications of Experts: Board Certified Physicians. (No specific years of experience are mentioned).

4. Adjudication Method for the Test Set

• The document states that the G. Lemperle Wrinkle Scale and Clinician's Global Aesthetic Improvement Assessment were "graded by two blinded graders." It does not specify an adjudication method such as 2+1, 3+1, or any other consensus mechanism if the two graders disagreed. It only reports the results based on these two independent blinded assessments.

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 was not done. This study evaluates the direct clinical effectiveness of a physical microneedling device for aesthetic improvement, not an AI-assisted diagnostic or interpretative tool for human readers. Therefore, the concept of human reader improvement with/without AI assistance is not applicable here.

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

• No, this is not an algorithm. The SkinPen Precision System is a physical microneedling device. The study evaluates the device's direct effect on patients, interpreted by human clinicians for efficacy and safety.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for evaluating the device's effectiveness was primarily based on:
  • Expert Assessment: Graded by two independent, blinded Board Certified Physicians using standardized aesthetic scales (G. Lemperle Wrinkle Scale, Clinician's Global Aesthetic Improvement Assessment) based on digital images. This leans towards expert consensus if their results were combined or averaged, though the method isn't detailed.
  • Patient-Reported Outcomes/Subjective Assessment: Subject Global Aesthetic Improvement Scale and Patient Satisfaction Questionnaires provided outcomes data directly from the subjects.
  • Safety Data: Monitoring of adverse events and subject safety diaries also contributed to the overall outcomes data.

8. The Sample Size for the Training Set

• This clinical study was conducted to support the safety and effectiveness of the SkinPen Precision System for the treatment of wrinkles on the neck. This appears to be a pivotal clinical trial for the new indication, meaning it serves as the primary evidence for this specific claim, not a "training set" for an algorithm. There is no mention of a separate training set for an algorithm as the device itself is not an algorithm.
• The document mentions a previous clinical study for acne scars (DEN160029) but does not provide details about its sample size in this submission.

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

• As this is not an AI/algorithm-driven device with a training set, the concept of establishing ground truth for a training set does not apply. The "ground truth" for establishing the device's efficacy and safety for its intended use was derived directly from the prospective clinical study as outlined in section 7.

Ask a specific question about this device

SkinPen® Precision System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older.

The SkinPen® Precision System consists of a microneedling pen handpiece (SkinPen Precision) and a sterile needle cartridge (SkinPen Precision Cartridge). The accessories are a charging base and a BioSheath. A SkinPen Precision System treatment kit is provided separately and contains the following:

• SkinPen Precision Cartridge: sterile, disposable needle cartridge. Not to be . resterilized or reused.
• . SkinPen BioSheath: nonsterile, disposable cover for the microneedling pen handpiece to avoid contamination of the SkinPen Precision
• . Lift HG: hydrogel wound dressing (without drugs and/or biologics) to protect against abrasion and friction during the microneedling procedure. May be applied to prevent skin from drying out post procedure

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

SkinPen Precision System: Acceptance Criteria and Performance Study

The SkinPen Precision System is a microneedling device intended to improve the appearance of facial acne scars in adults aged 22 years or older. The regulatory information outlines various non-clinical and clinical studies conducted to ensure its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for clinical effectiveness in a singular table, but rather presents performance goals through the clinical study outcomes. The regulatory framework defines special controls that serve as acceptance criteria for safety and performance aspects.

Here's an interpretation combining the clinical effectiveness results and the special controls as acceptance criteria:

Note: This table synthesizes information. The original document does not explicitly present clinical "acceptance criteria" but rather states the results and concludes that the probable benefits outweigh the probable risks.

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

• Sample Size for Test Set:
  • Clinical Study (Effectiveness): 20 subjects treated with the SkinPen Precision System.
  • Clinical Study (Safety - includes prototype): 41 subjects (20 SkinPen Precision, 21 prototype device).
• Data Provenance: The general location of the clinical study is not explicitly stated as a country but it was a "single center" study. The method was prospective (clinical study conducted to evaluate safety and effectiveness).

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

• Number of Experts: 2 blinded evaluators.
• Qualifications of Experts: Board Certified Dermatologists. Specific experience (e.g., 10 years) is not provided.

4. Adjudication Method for the Test Set

The document states, "2 blinded evaluators would evaluate images after completion of the clinical study." It does not specify an adjudication method like 2+1 or 3+1 if their ratings differed. It implies both evaluators independently graded the images.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus those without AI assistance was not done. This study focused on the device's effectiveness on subjects, with expert graders evaluating subject images, not evaluating AI performance or AI-assisted human performance.

6. Standalone (Algorithm Only) Performance Study

This device is a physical microneedling system, not an AI algorithm. Therefore, no standalone (algorithm only) performance study was conducted. The performance studies were for the physical device itself.

7. Type of Ground Truth Used (for Clinical Effectiveness)

The ground truth for clinical effectiveness was established by expert consensus (two blinded dermatologists) grading digital images of facial acne scars using the "Acne Scar Assessment Scale" and the "Clinician's Global Aesthetic Improvement Assessment (CGAIS)". The Acne Scar Assessment Scale was also stated to be a "validated scale." Patient-reported outcomes (Self-assessed Scar Improvement Scale, Subject Global Aesthetic Improvement Scale, Patient Satisfaction Questionnaire) were also collected as secondary endpoints.

8. Sample Size for the Training Set

This report does not describe a machine learning algorithm that requires a "training set." The clinical study data was used to demonstrate the device's performance, not to train an AI model.

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

As noted above, there was no training set in the context of an AI/ML algorithm. The clinical data was used for direct evaluation of the device.

Ask a specific question about this device

PerioPatch is intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa, including stomatitis, minor chaffing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery. PerioPatch operates to relieve pain by adhering to and protecting affected tissues from further irritation, thereby allowing healing.

PerioPatch is a hydrogel wound dressing for use in the oral cavity. It is a hydrogel with an occlusive ethyl cellulose backing to support and help the hydrogel conform to the wound, thereby providing protection and coverage to the wound. The dressing is made entirely of GRAS natural ingredients, commonly used in ingested products, which absorb moisture and become a hydrogel. These materials adhere to the wound for up to 5-6 hours. The patch is self-adhesive after contact with moist tissue and provides an absorptive and flexible barrier over the affected area and as such protects the inflamed areas and lesions in the mouth from contact with the rest of the oral environment, thereby preventing irritation and painful aggravation of the affected area.

The provided 510(k) summary for the PerioPatch does not contain information regarding objective acceptance criteria or a study designed to demonstrate device performance against such criteria.

The document primarily focuses on establishing "substantial equivalence" to a predicate device, which is a common pathway for 510(k) clearances. Substantial equivalence is determined by comparing the new device to a legally marketed predicate device based on intended use, technological characteristics, and performance. In this case, the performance aspect is described in general terms, highlighting the similar hydrophilic characteristics and self-adhesive nature upon contact with moisture.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Specifically, the following information is not available in the document:

• A table of acceptance criteria and the reported device performance: No specific performance metrics or thresholds are mentioned.
• Sample size used for the test set and the data provenance: There is no mention of a test set, clinical trial, or any quantitative testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not relevant in an application focused on substantial equivalence through comparison of characteristics rather than a new performance study.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no test set or clinical study is described.
• 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 concept is entirely irrelevant to a wound dressing device described here.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is described as no performance study was conducted.
• The sample size for the training set: Not applicable as this is not an AI/ML device, and no training data for a model is mentioned.
• How the ground truth for the training set was established: Not applicable.

The conclusion states: "The evaluation of PerioPatch does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device." This indicates that the regulatory decision was made based on the comparison of the device's characteristics and intended use to an existing, cleared device, rather than on new performance studies with objective acceptance criteria.

Ask a specific question about this device

BariRep's intended use is to manage minor burns, minor abrasions, minor cuts and minor lacerations.

BariRep is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for over-the-counter use. The product is formulated as an oil-inwater emulsion containing a cross-linked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of BariRep is composed of glyceride, squalane, lecithin, and fatty acids.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.

Instead, the document is a 510(k) summary for a medical device called BariRep. This summary is part of the process for seeking FDA clearance for a new medical device by demonstrating its "substantial equivalence" to a predicate device already on the market.

Here's what the document does say about the device and its assessment:

• Device Name: BariRep
• Common Name: Hydrogel wound dressing
• Intended Use: To manage minor burns, minor abrasions, minor cuts and minor lacerations.
• Predicate Device: Cleared under K083721, approved January 08, 2009.
• Technological Comparison: The device is stated to be "identical in formulation, specifications and performance characteristics" to the predicate device. The only change mentioned is that it is being presented for over-the-counter use.
• Non-Clinical Performance Data: "N/A" (Not Applicable)
• Conclusion: "The product's ingredients and performance characteristics have remained unchanged and are therefore, identical to the predicate. Tests and performance data are not applicable as the product remains safe, effective and substantially equivalent to the predicate. Over the counter use will not result in any increased risk to the patient."

Critically, this document explicitly states that "Tests and performance data are not applicable." This means no study was conducted or presented to demonstrate the device's performance against specific acceptance criteria, as its clearance was based on its substantial equivalence to an already approved device.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance (since none were established or tested).
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details (since no non-clinical or clinical studies were performed for this submission).

Ask a specific question about this device

Tropazone CR is for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 200 degree burns, including sunburns, and radiation dermatitis.

Tropazone CR is a non-sterile, semi-viscous emulsion intended for topical application. It is presented as a prescription medication, requiring a physician's diagnosis of disease state prior to use. This product is formulated as an oil-in-water emulsion containing moisturizing ingredients to keep the area moist. The oil composition of Tropazone CR is composed of mineral oil, lecithin, fatty acids and a silicon-based organic polymer.

This document describes the premarket notification (510(k)) for Tropazone CR, a hydrogel wound dressing. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided in this document are based on demonstrating substantial equivalence to predicate devices, focusing on technological characteristics and safety. The performance is assessed through specific tests to show the device is non-irritating and non-sensitizing, and that it meets cytotoxicity standards.

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

• Human Subjects (Biocompatibility - Irritation/Sensitization):
  • Sample Size: 50 human subjects.
  • Data Provenance: Not explicitly stated (e.g., country of origin, ethnicity). It is a prospective study.
• L929 Agar Overlay Cytotoxicity Study:
  • Sample Size: Not applicable in the same way as human subjects. This is an in vitro test using L929 cells.
  • Data Provenance: In vitro laboratory study.

The document does not specify geographical origin but indicates these are studies conducted to support the 510(k) submission, implying they were performed for this purpose (prospective relative to the submission).

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

• For human patch testing: The document does not specify the number or qualifications of experts involved in establishing the "ground truth" (i.e., assessing the skin reactions). Typically, board-certified dermatologists or allergists would conduct and interpret such studies.
• For cytotoxicity testing: Similarly, the document does not specify experts. These are standardized laboratory tests, where "ground truth" is established by adherence to ISO and USP protocols and interpretation by qualified laboratory personnel.

4. Adjudication Method

Not applicable. These studies are clinical (human patch test) and lab-based (cytotoxicity) tests that follow established protocols, not typically requiring adjudication in the context of expert review of images or diagnoses.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a hydrogel wound dressing, not an imaging or diagnostic device that would typically involve human readers interpreting data with and without AI assistance. The studies performed are focused on biocompatibility and physicochemical equivalence.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

No, a standalone (algorithm only) performance study was not conducted. This is a medical device (a wound dressing), not an algorithm or AI system.

7. Type of Ground Truth Used

• For human patch testing: The ground truth is generally considered to be the observed physiological reaction of the human skin (e.g., erythema, edema) as assessed by a trained professional following a standardized scoring system.
• For cytotoxicity testing: The ground truth is the in vitro cellular response to the device extract, measured against established criteria within the ISO 10993-5 and USP 23 standards.

8. Sample Size for the Training Set

Not applicable. This device is a wound dressing, not an algorithm that requires a training set. The studies performed are for safety and performance testing, not for training AI models.

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

Not applicable, as no training set was used.

Ask a specific question about this device

Stage I - IV Pressure ulcers Venous stasis ulcers Vehous stasio aread by mixed vascular etiologies Diabetic skin ulcers . First and second degree burns Post-surgical incisions Cuts and abrasions

AmeriGel® Wound Dressing PLUS is a hydrogel that maintains a moist environment to support wound healing. We added 4% Lidocaine HCL to the formulation in our predicate device, AmeriGel® Wound Dressing. AmeriGel® Wound Dressing has been on the market for many years. With so many painful wounds, particularly venous stasis ulcers, we wanted to offer a wound gel that would help reduce the discomfort patients feel. Since AmeriGel® Wound Dressing has been doing so well for all these years, adding the 4% Lidocaine to the Polyethylene glycol (PEG) base will finally provide relief for those patients with painful wounds. When the Lidocaine was added to our formulation of Oakin (oak extract), Meadowsweet extract, water and Zinc acetate, the physical properties remained at a pH range of 7.0 - 7.2. Lidocaine HCL is well known to be GRASE (Generally regarded as safe and effective) and AmeriGel® Wound Dressing is also well known to be safe and effective, the combination of chemicals were found compatible, safe and effective.

This document (K092086) is a 510(k) summary for a medical device called "AmeriGel® Wound Dressing PLUS." It primarily focuses on demonstrating substantial equivalence to existing predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria in a quantitative sense.

Therefore, many of the requested sections regarding acceptance criteria, study performance, sample sizes, expert ground truth, adjudication, and comparative effectiveness studies are not applicable or not provided in the given document. This is common for 510(k) submissions, especially for devices undergoing minor modifications (like adding an existing drug component to a previously cleared base).

Here's a breakdown based on the information available:

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

• Not explicitly provided as a quantitative table.
• The acceptance criteria for this 510(k) submission are implicitly based on demonstrating that the new device, AmeriGel® Wound Dressing PLUS, performs at least as well as, and is as safe and effective as, its predicate devices (AmeriGel® Wound Dressing and Regenecare® Wound Gel).
• The reported "performance" is primarily a claim of substantial equivalence supported by the fact that:
  • The formulation is identical to AmeriGel® Wound Dressing, except for the addition of 4% Lidocaine HCL.
  • Lidocaine HCL is "well known to be GRASE (Generally regarded as safe and effective)."
  • AmeriGel® Wound Dressing is "well known to be safe and effective" and has been marketed for almost ten years without adverse events.
  • Physical properties (pH range of 7.0 - 7.2) remained compatible after adding Lidocaine.
  • Biocompatibility was previously established for AmeriGel® Wound Dressing (dermal irritation test on rabbits, sensitization test on guinea pigs, in-vitro cytotoxicity test).

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

• Not applicable / Not provided. No specific "test set" in the context of a performance study with a sample size is mentioned in this 510(k) summary. The submission relies on the established safety and efficacy of its components and predicate devices.

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. No expert review committee or ground truth establishment relevant to an AI/diagnostic device performance study is described. The "ground truth" here is the established safety and efficacy of the individual components (Lidocaine HCL, AmeriGel® Wound Dressing).

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

• Not applicable / Not provided. No adjudication method is mentioned as there was no specific performance study requiring such a process.

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 a medicated wound gel, not an AI or diagnostic imaging device. Therefore, no MRMC study or AI assistance is relevant.

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

• Not applicable. This device is a medicated wound gel, not an algorithm.

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

• The "ground truth" for this submission is based on:
  • Prior regulatory classifications and approvals: Lidocaine HCL is GRASE (Generally Regarded As Safe and Effective).
  • Long-standing market history and absence of adverse events: AmeriGel® Wound Dressing has been on the market for almost ten years without reported adverse events, providing real-world outcomes data as evidence of its safety and effectiveness.
  • Bench testing: Biocompatibility tests (dermal irritation, sensitization, in-vitro cytotoxicity) performed previously on the predicate device.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

• Not applicable. No training set exists for this type of device.

In summary:

This 510(k) relies on demonstrating substantial equivalence to predicate devices and the established safety and efficacy of its components, rather than presenting a de novo clinical study with quantitative performance metrics for "acceptance criteria" in the way one might expect for a novel diagnostic or AI device. The "study" proving the device meets criteria is implicitly the regulatory history and proven safety record of the existing ingredients and base product.

Ask a specific question about this device

Zenieva is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Zenieva is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requires a physician diagnosis of disease state) use. The product is formulated as an oil-in-water emulsion containing a cross-linked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of Zenieva is composed of glyceride, squalane, lecithin, and fatty acids.

The provided document, K083721 for Zenieva Hydrogel Wound Dressing, does not contain the kind of detailed study information typically associated with AI/ML-based medical devices or comparative effectiveness studies involving human readers.

This submission is for a hydrogel wound dressing, a Class I non-exempt device. The context indicates it's a modification to an already cleared device, and the primary assessment is for substantial equivalence to a predicate device. The information provided heavily emphasizes the physical and chemical properties remaining unchanged.

Therefore, most of the requested information regarding acceptance criteria derived from a study, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as would apply to a diagnostic or AI-powered device, is not applicable or available in this document.

Here is a breakdown based on the information provided, highlighting where the requested details are absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable/Not Provided. This document describes a modification to a hydrogel wound dressing, not a diagnostic device involving a test set of data. The "performance testing" mentioned is likely related to the physical or chemical properties of the dressing itself (e.g., pH, viscosity, stability), not clinical data from patients in the manner of an AI/ML or diagnostic study.

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

• Not Applicable/Not Provided. Ground truth as understood for diagnostic or AI/ML devices is not relevant for this type of product and submission.

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

• Not Applicable/Not Provided. Adjudication methods are specific to studies involving expert review of cases, which is not described here.

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 a hydrogel wound dressing, not an AI/ML device. An MRMC study is not relevant.

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

• No. This is a hydrogel wound dressing, not an algorithm or AI device.

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

• Not Applicable. The "ground truth" for this submission revolves around the chemical composition and physical properties of the dressing aligning with its predicate and previously cleared version, and confirming no compromise to safety or efficacy. This is assessed via "Performance testing for Zenieva" which implies laboratory tests, not clinical "ground truth" for diagnosis.

8. The sample size for the training set:

• Not Applicable/Not Provided. This device does not involve a training set as it's not an AI/ML algorithm.

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

• Not Applicable/Not Provided. As above, no training set or relevant ground truth for such a set.

Summary of the Study (as described in the document):

The "study" described in the 510(k) summary is rather a verification process for a modification to an existing Class I device (Zenieva Hydrogel Wound Dressing, previously cleared under K082865).

• Objective: To demonstrate that the modified Zenieva product remains substantially equivalent to its predicate device despite a change (the nature of which is not explicitly detailed but implied to be minor as it doesn't affect core properties).
• Methodology: "Performance testing for Zenieva was conducted and assessed." This testing was then "compared to the approved device." The specific tests are not enumerated, but given the product type, they would likely involve:
  • Stability testing (shelf life, environmental resilience)
  • Chemical characterization (to confirm unchanged composition)
  • pH, viscosity, spreadability (physical properties relevant to hydrogels)
  • Biocompatibility (if any new materials were introduced, though the document states "modification to Zenieva does not change the chemical composition").
• Conclusion: The tests indicated that "the modification was determined to be a satisfactory change with no compromise in the safety or efficacy of the product." The product's "ingredients and performance characteristics have remained unchanged."

In essence, this is a regulatory submission for a minor change to a non-AI medical device, focusing on bench testing and comparison to established parameters rather than a clinical study with patient data and expert review.

Ask a specific question about this device

Zenieva is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Zenieva is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requires a physician diagnosis of disease state) use. The product is formulated as an oil-in-water emulsion containing a crosslinked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of Zenieva is composed of glyceride, squalane, lecithin, and fatty acids.

The provided document is a 510(k) summary for a hydrogel wound dressing called "Zenieva." It details a submission for a modification to an already cleared device (K073246).

The key takeaway from the document regarding acceptance criteria and studies is that no new performance data or studies were conducted or required for this particular submission. The modification was solely a labeling change to add a contraindication. Therefore, the device is considered to meet acceptance criteria because its core composition, intended use, and technological characteristics remain unchanged from the previously cleared device.

Here's how the information requested applies to this specific submission:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   No new acceptance criteria were established or evaluated. The submission is for a labeling change to an already cleared device. The product's ingredients and performance characteristics are stated to have remained unchanged from the previously cleared predicate device (K073246).	Not Applicable (N/A). No new performance data was generated or required as the device itself was not modified.

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

   • N/A. No new test set or performance study was conducted. The submission is for a labeling change to an already cleared device.

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

   • N/A. No new ground truth establishment was required as no new performance study was conducted.

4. Adjudication Method for the Test Set:

   • N/A. No new test set or adjudication was required.

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

   • No. An MRMC study was not done. The device is a hydrogel wound dressing, not an AI-assisted diagnostic tool.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Study:

   • No. This is a medical device (hydrogel wound dressing), not an algorithm.

7. Type of Ground Truth Used:

   • N/A. No new ground truth was established for this specific submission as there were no new performance studies. The substantial equivalence for the original device would have been based on appropriate clinical or non-clinical data for a hydrogel wound dressing.

8. Sample Size for the Training Set:

   • N/A. This is a medical device, not a machine learning algorithm requiring a training set.

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

   • N/A. Not applicable, as there is no training set for this type of medical device.

Summary Explanation:

The 510(k) submission K082865 for "Zenieva" is a resubmission or modification of a previously cleared device (K073246). The core of this submission is a labeling change to add a contraindication for one of the ingredients. The document explicitly states:

• "The proposed modification to Zenieva does not change the chemical composition, intended indications for use, physical properties, or claims."
• "Research has shown that a labeling change - adding a contraindication for one of the ingredients - is necessary. This is adding safety to the product."
• "The product's ingredients and performance characteristics have remained unchanged. Tests and performance data are not applicable: research has shown that adding a contraindication statement for an ingredient is necessary. The product itself is not being modified; we are putting the appropriate measures in place to increase the product's safety."

Therefore, the device meets its acceptance criteria by demonstrating that the modification itself (labeling change) does not alter the fundamental safety and effectiveness of the device as previously established by the original clearance. No new studies were required or conducted for this specific 510(k) submission K082865 because the device's performance characteristics remain identical to the predicate device.

Ask a specific question about this device

Zenieva is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Zenieva is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requires a physician diagnosis of disease state) use. The product is formulated as an oil-in-water emulsion containing a crosslinked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of Zenieva is composed of glyceride, squalane, lecithin, and fatty acids.

This submission describes Zenieva, a hydrogel wound dressing, and its substantial equivalence to the predicate device, MimyXTM cream (K041342). The provided text focuses on the device's composition, intended use, and non-clinical performance data, as well as the FDA's clearance letter.

Device Acceptance Criteria and Performance

The acceptance criteria for Zenieva are based on demonstrating substantial equivalence to the predicate device, MimyXTM cream. The study presented is a non-clinical performance evaluation, which aims to show that Zenieva performs similarly to the predicate and meets safety standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The provided summary does not detail the sample sizes for the in vitro cytotoxicity, skin sensitization, and primary skin irritation tests. It states that Zenieva was tested as a "surface device" with "limited contact duration (24 hours) on breached surfaces." The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin, but it is implied to be from testing conducted by Gorbec Pharmaceutical Services Inc. to support this 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

This submission does not involve clinical studies with human assessors establishing ground truth for performance metrics in a typical sense (e.g., image interpretation). Instead, the "ground truth" for the non-clinical tests (cytotoxicity, sensitization, irritation) would be established by the results of standardized laboratory assays, interpreted by qualified laboratory personnel and toxicologists. The specific number and qualifications of experts for interpreting these non-clinical tests are not detailed in the provided document.

4. Adjudication Method for the Test Set

Not applicable. The non-clinical tests (cytotoxicity, sensitization, irritation) are typically objective laboratory assays with predefined endpoints, rather than requiring expert consensus or adjudication on subjective interpretations for a "test set" in the context of diagnostic or treatment efficacy.

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

No. This document describes a 510(k) submission for a hydrogel wound dressing, not an AI-assisted diagnostic or treatment device that would typically involve a MRMC study. Therefore, no effect size for human readers with and without AI assistance is reported.

6. Standalone Performance Study

Yes, in a sense. The non-clinical performance tests (cytotoxicity, skin sensitization, primary skin irritation) assess the intrinsic biological safety of the device (Zenieva) in isolation, without human-in-the-loop performance influencing the assay results. The device's "performance" in this context is its safety profile.

7. Type of Ground Truth Used

The ground truth used for these non-clinical tests is based on standardized laboratory assay results and regulatory definitions for toxicity, sensitization, and irritation. For example, a "non-toxic" finding is based on the cellular response in a cytotoxicity assay meeting predefined criteria, rather than expert consensus on a clinical outcome or pathology.

8. Sample Size for the Training Set

Not applicable. This device is a medical product (hydrogel wound dressing) and not an algorithm or AI model that requires a training set.

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

Not applicable, as there is no training set for this type of medical device submission.

Ask a specific question about this device