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The Carrington Wound Cleansers are surfactant wound cleansers intended for the removal of foreign material such as dirt and debris from dermal wounds. CarraKlenz is a wound cleanser that is indicated for high, medium, and low exudating wounds. UltraKlenz is a gentle wound cleanser which is used on intact skin.

The Carrington CarraKlenz Wound Cleansers are wound cleaning solutions that are intended for the cleansing and irrigation of dermal wounds. The Carrington Wound Cleansers work by mechanical action on the dermal wounds. The pressure of the liquid flowing onto the wound aids in the removal of the debris from the wound. The Carrington Wound Cleansers are offered in various bottle sizes.

The provided 510(k) summary (K022670) for Carrington Laboratories CarraKlenz and UltraKlenz Wound Cleansers does not contain any information regarding clinical studies, acceptance criteria, or performance data for the device.

This submission is a premarket notification (510(k)), which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical trial data or performance metrics against defined acceptance criteria. The core of this 510(k) is to assert that the CarraKlenz and UltraKlenz wound cleansers are "substantially equivalent" to existing, cleared predicate devices (Aliclenz Wound Cleanser K965120 and Derma Sciences Dermagran Wound Cleanser with Zinc K954743 and K945802).

Therefore, based solely on the provided document, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present. The submission focuses on substantial equivalence in terms of intended use, technological characteristics, and mechanism of action, not on specific performance metrics or acceptance criteria derived from a study.
2. Sample size used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method for the test set: No test set is 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, as this is a wound cleanser, not an AI-assisted diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical wound cleanser.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth is described.
8. The sample size for the training set: No training set is described.
9. How the ground truth for the training set was established: No training set or ground truth is described.

In summary, the 510(k) provided focuses on substantial equivalence claims rather than presenting primary clinical or performance study data against specific acceptance criteria. Such detailed performance data and study methodologies are typically required for different types of regulatory submissions or for devices with higher risk classifications or novel technology.

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Recommended for use in tooth extraction sites and management of alveolar osteitis (dry socket). The SaliCept Oral Patch is also intended for the management of all types of oral wounds, injuries and ulcers of the oral mucosa. The Salicept Oral Patch relieves pain by adhering to and protecting affected tissues from further irritation.

The SaliCept Oral Patch is a freeze-dried gel that contains Acemannan Hydrogel," a product obtained from the clear inner gel of Aloe vera L. Other ingredients include hydroxyethyl cellulose, polyvinylpyrrolidone, benzethonium chloride, simethicone. It is pliable, white to off-white, with a texture similar to that of finely woven cotton. The SaliCept Oral Patch is packaged in blister cards of six pledgets per card, two blister cards per carton, for a total of 12 pledgets per carton. Each pledget is approximately 1 cm in diameter and 0.5 cm thick.

This document describes the SaliCept Oral Patch and presents clinical data to support its intended use. However, it does not contain specific acceptance criteria for a device's performance in the typical sense of a regulatory submission (e.g., a specific sensitivity, specificity, or reduction percentage that must be met). Instead, the clinical studies cited demonstrate the patch's efficacy by showing statistically significant improvements in pain reduction and/or reduction in alveolar osteitis compared to control groups.

Therefore, I cannot directly fill in a table of "acceptance criteria" versus "reported device performance" as no explicit quantitative acceptance criteria are stated in the provided text for parameters like pain relief or AO incidence that would typically be seen in a device performance study for regulatory approval. The approval here is based on substantial equivalence and demonstration of safety and effectiveness through clinical trials.

Regarding the provided text, here's an analysis of the requested information:

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

As explained above, explicit numerical acceptance criteria are not provided in the document. The "acceptance criteria" are implicitly met by demonstrating statistically significant positive outcomes in the clinical trials, rendering the device "substantially equivalent" to predicate devices. The "reported device performance" is the statistically significant clinical benefit observed.

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

• Aphthous Ulcer Studies:
  • Study 1: 37 patients (either Orabase-Plain or SaliCept Oral Patch).
  • Study 2: 90 patients (Orabase-Plain, Carrington's Carrasyn Hydrogel Dressing, or SaliCept Oral Patch).
  • Study 3: 155 patients (SaliCept Oral Patch, cyanoacrylate bioadhesive, or negative control).
• Alveolar Osteitis Study:
  • Mandibular 3rd Molar Sites: 958 for SaliCept Oral Patch, 975 for Gelfoam.
  • All Extraction Sites: 1064 for SaliCept Oral Patch, 1031 for Gelfoam.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies are referred to as "clinical data" and "clinical trials," indicating they are prospective in nature, as they involve actively administering treatments and observing outcomes.

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):

The document does not specify the number or qualifications of experts for establishing ground truth. For these clinical studies, the "ground truth" typically relies on patient-reported outcomes (pain scores) and clinical diagnosis/observation of conditions (aphthous ulcers, alveolar osteitis) by the treating clinicians involved in the trials. The studies cite publications from individuals such as "Plemons J, Rees T, Binnie W, Wright J," who are likely dental/oral health professionals, but their specific expert qualifications are not detailed in this summary.

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

The document does not describe any specific adjudication method for the test set data. Clinical trials typically involve standardized protocols for assessment, but explicit multi-reader adjudication is not mentioned.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes a medical device (oral patch) for direct patient application, not an AI diagnostic tool that assists human readers/clinicians. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

Not applicable. This device is a physical product (oral patch) intended for direct patient application, not a diagnostic algorithm.

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

The ground truth used is primarily patient-reported outcomes data (pain relief) and clinical outcomes data (incidence of alveolar osteitis, presence/absence of aphthous ulcers), as assessed during the clinical trials.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

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

Not applicable. As a physical medical device, there is no "training set" or a need to establish ground truth for it.

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The Carrington Laboratories Caraloe Oral Rinse provides fast pain relief and is recommended for the conning of a lives of oral wounds, mouth sore injuries and ulcers of the oral mucosa, including canker son s and traumatic ulcers such as those caused by braces and ill-fitting dentures. Safe if swallowed

Caraloe Oral Rinse

This document is a 510(k) clearance letter from the FDA for the Carrington Laboratories Caraloe Oral Rinse, dated December 10, 1998. It primarily addresses the regulatory status and allowed labeling claims for the device. As such, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document lacks the following information which would be necessary to answer the prompt directly:

• A table of acceptance criteria and the reported device performance: This document states the device is "substantially equivalent" but does not define specific performance metrics or acceptance thresholds.
• Sample size used for the test set and the data provenance: There is no mention of any specific test set, its size, or its origin.
• Number of experts used to establish the ground truth for the test set and their qualifications: No information about expert review or ground truth establishment is provided.
• Adjudication method for the test set: Not applicable as no test set is described.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
• If a standalone study was done: The document describes regulatory clearance, not a standalone performance study in the context of an algorithm.
• The type of ground truth used: Not applicable as no ground truth is described.
• The sample size for the training set: There is no mention of a training set as this is about a medical device, not an AI/algorithm.
• How the ground truth for the training set was established: Not applicable.

Instead, the document focuses on:

• Indications for Use: "The Carrington Laboratories Caraloe Oral Rinse provides fast pain relief and is recommended for the conning of a lives of oral wounds, mouth sore injuries and ulcers of the oral mucosa, including canker son s and traumatic ulcers such as those caused by braces and ill-fitting dentures." (There appears to be a typo "conning of a lives" which likely meant "comforting of").
• Regulatory Class: Unclassified
• Product Code: MGQ
• Limitations on Labeling: The device may not be labeled for use on third-degree burns, as having an accelerating effect on wound healing, as a long-term/permanent/no-change dressing/artificial skin, or as a treatment/cure for any type of wound.
• Basis for Clearance: Substantial equivalence to devices marketed prior to May 28, 1976.

Therefore, I cannot provide the requested table and study details based on the provided text.

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RadiaCare™ Oral Wound Rinse is a wound dressing designed for the management of oral mucositis/stomatitis.

RadiaCare™ Oral Wound Rinse is a wound dressing designed for the management of oral mucositis/stomatitis. The oral wound rinse is equivalent to the predicate device, Carrasyn® Oral Wound Dressing. Determination if substantial equivalence for this device was based on descriptive information about the design, materials and intended use of the device. The ingredients used in RadiaCare™ Oral Wound Rinse are the same as used in Carrasyn Oral Wound Dressing or are food-grade materials.

The provided document describes the RadiaCare™ Oral Wound Rinse and its substantial equivalence to the predicate device, Carrasyn® Oral Wound Dressing. The acceptance criteria and supporting studies are presented in relation to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the RadiaCare™ Oral Wound Rinse is equivalent to the predicate device, Carrasyn® Oral Wound Dressing, and its substantial equivalence is based on descriptive information about design, materials, and intended use. The performance data for RadiaCare™ itself is limited to a pilot study on two patients, which reported pain relief. The primary evidence for performance and safety relies on the studies conducted on the predicate device, Carrasyn® Oral Wound Dressing.

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

The “test set” here refers to the subjects in the clinical trials for the predicate device, Carrasyn® Oral Wound Dressing.

• Study 1 (Randomized, double-blind, active-controlled):
  • Sample Size: 60 healthy volunteer patients.
  • Breakdown: 30 patients treated with Carrasyn® Oral Wound Dressing, 30 patients treated with a control.
  • Data Provenance: Not explicitly stated, but implied to be prospective clinical trials as subjects were treated and observed. No country of origin is mentioned.
• Study 2 (Open-label, uncontrolled):
  • Sample Size: 30 healthy volunteer patients.
  • Data Provenance: Not explicitly stated, implied to be a prospective clinical trial. No country of origin is mentioned.

Pilot Study for RadiaCare™ Oral Wound Rinse:

• Sample Size: 2 cancer patients with oral mucositis/stomatitis.
• Data Provenance: Implied to be a prospective pilot study. No country of origin is mentioned.

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

The studies described involve patient-reported outcomes (discomfort, adverse events), rather than expert assessment of primary endpoints like diagnosis or classification.

• For discomfort, patients kept a diary.
• For adverse events, patients completed an adverse report form.

Therefore, there were no external experts used to establish a "ground truth" in the traditional sense of a diagnostic or classification study. The ground truth for effectiveness was direct patient reporting of sensation (discomfort/pain relief).

4. Adjudication Method for the Test Set

The studies did not involve an adjudication panel for evaluating outcomes.

• Patient discomfort was self-reported via a diary.
• Adverse events were self-reported via an adverse report form.
• Healing was observed, but the method of assessment (e.g., by a clinician, patient, or both) is not detailed beyond "treatment was continued until the oral ulcers were healed."

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

No, an MRMC comparative effectiveness study was not done. The studies were clinical trials comparing the device to a control (Study 1) or observing its effects (Study 2) directly on patients, focusing on patient-reported outcomes.

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

This is not applicable as the device is an oral wound rinse, not an algorithm or AI-based system. Therefore, standalone performance (in the context of AI) is not relevant.

7. The Type of Ground Truth Used

The ground truth for the effectiveness endpoints (reduction in discomfort) was patient-reported outcomes. For safety, the ground truth was patient-reported adverse events and observation that "no adverse events were reported."

8. The Sample Size for the Training Set

This is not applicable as the studies described are clinical trials for a medical device (an oral wound rinse), not an AI algorithm that requires a training set. The term "training set" is relevant for machine learning models.

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

This is not applicable for the same reasons as #8.

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Carrasyn wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are designed to be used in conjunction with an appropriate cover dressing and are intended for the management of wounds.

Carrasyn wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are designed to be used in conjunction with an appropriate cover dressing and are intended for the management of wounds.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CARRINGTO device (Carrasyn® Hydrogel Wound Dressing):

It's important to note that the provided text is a 510(k) Premarket Notification summary from 1998. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving de novo safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) or for novel high-risk devices today. Therefore, the "studies" described are more akin to pilot or observational studies rather than rigorous, controlled clinical trials.

Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantifiable acceptance criteria (e.g., "device must achieve 80% sensitivity for X condition" or "wound healing rate must be Y%"). Instead, it describes general findings regarding acceptability and effectiveness.

Study Details

Given the context of a 1998 510(k) for a wound dressing, the "studies" mentioned are quite limited compared to modern standards for AI/medical device performance evaluation.

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

   • Test Set Sample Size: 4 patients with radiation dermatitis and 30 patients with diabetic ulcers. (Total: 34 patients).
   • Data Provenance: The text does not specify the country of origin. It describes "clinical experience to date" and "these studies," implying they were conducted by or for Carrington Laboratories. It refers to these as "two studies." Given the context, these are prospective observational studies or case series, not randomized controlled trials.

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

   • The text does not specify the number of experts or their qualifications for establishing ground truth in clinical outcomes. It implies a clinical assessment was made, likely by the treating clinicians ("clinicians" are mentioned in evaluating acceptability).

3. Adjudication method for the test set:

   • Not specified. The text does not describe any formal adjudication process for clinical outcomes.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. This type of study is entirely irrelevant for a hydrogel wound dressing undergoing a 510(k) submission in 1998. MRMC studies are typically for diagnostic imaging interpretation devices involving multiple readers.

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

   • No. This is a physical wound dressing, not an AI algorithm.

6. The type of ground truth used:

   • Clinical observation and assessment: For the clinical studies, the "ground truth" was based on clinical assessment of wound healing, skin appearance, wound environment, and patient/clinician acceptability over time by treating medical personnel. For the biocompatibility studies, the ground truth was based on the results of standardized animal model tests (e.g., observing for irritation).

7. The sample size for the training set:

   • Not applicable. This device is a physical hydrogel wound dressing, not an AI model requiring a training set. The "clinical experience" described is a small pilot/observational evaluation rather than a dataset to train an algorithm.

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

   • Not applicable. See point 7.

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Carrasyn™ wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are intended for the management of wounds.

Carrasyn™ wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are intended for the management of wounds.

The provided document describes the safety and effectiveness of Carrington's Carrasyn® wound dressings. It primarily focuses on demonstrating biocompatibility and some clinical observations. However, it does not include detailed acceptance criteria or a study designed to rigorously prove that the device meets specific performance metrics in the way that would typically be expected for a diagnostic or AI-based device's acceptance criteria.

The information provided is more akin to a 510(k) premarket notification summary for a medical device, which generally focuses on demonstrating substantial equivalence to a predicate device and outlining safety and efficacy through biocompatibility and some clinical experience.

Given this, I will interpret "acceptance criteria" as the overall goal of demonstrating safety and effectiveness as outlined in the summary, and "reported device performance" as the outcomes of the studies described.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Primary Dermal Irritation testing: Demonstrated not to be a primary dermal irritant.
• Primary Eye Irritation testing: Demonstrated not to be a primary eye irritant. |
  | Safety: Device does not cause adverse events. | Clinical Experience (Radiation Dermatitis & Diabetic Ulcers): No mention of adverse events.
  Clinical Trial (Aphthous Ulcers - Carrington Patch™):
• Randomized, double-blind study: No adverse events reported.
• Open-label study: No adverse events reported. |
  | Effectiveness: Improves wound healing/manages wounds as intended. | Clinical Experience (Radiation Dermatitis & Diabetic Ulcers): Evaluated "acceptability... to clinicians, to wound and skin appearance, and to the wound healing environment." Concluded to be "safe and effective for their intended use." |
  | Effectiveness: Reduces discomfort (specifically for aphthous ulcers). | Clinical Trial (Aphthous Ulcers - Carrington Patch™):
• Randomized, double-blind study: Found to "reduce discomfort."
• Open-label study: Found to "significantly reduce discomfort within 2 minutes." |

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

Due to the nature of the device (wound dressing, not AI/diagnostic), the concept of a "test set" in the context of an AI model doesn't directly apply. The document describes clinical studies that serve as evidence of safety and effectiveness.

• Clinical Experience (Radiation Dermatitis & Diabetic Ulcers):
  • Sample Size: 4 patients with radiation dermatitis, 30 patients with diabetic ulcers.
  • Data Provenance: Not specified, but generally implies a prospective clinical observation.
• The Carrington™ Patch - Randomized, Double-Blind Study (Aphthous Ulcers):
  • Sample Size: 60 healthy volunteer patients (30 in treatment group, 30 in control group).
  • Data Provenance: Not specified, but implies a prospective clinical trial.
• The Carrington™ Patch - Open-Label Study (Aphthous Ulcers):
  • Sample Size: 30 healthy volunteer patients.
  • Data Provenance: Not specified, but implies a prospective clinical trial.

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

• Biocompatibility Studies: These were laboratory tests conforming to GLP regulations using animal models. The "ground truth" (i.e., irritation levels) would be established by trained technicians/toxicologists following standard protocols. Specific numbers or qualifications are not provided but are inherent in GLP compliance.
• Clinical Experience (Radiation Dermatitis & Diabetic Ulcers): "Clinicians" were involved in evaluating acceptability and wound healing. The number and specific qualifications (e.g., dermatologists, wound care specialists) are not specified.
• Clinical Trials (Aphthous Ulcers): Patients themselves provided input on discomfort via diaries and adverse event reports. Clinicians would have conducted assessments but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• Biocompatibility Studies: Not applicable in the sense of expert adjudication. Results were objectively measured based on irritation scores.
• Clinical Experience (Radiation Dermatitis & Diabetic Ulcers): Adjudication method not described. It appears to be clinician observation without a formal multi-reader adjudication process.
• Clinical Trials (Aphthous Ulcers): Patient diaries and adverse event reports were primary data sources. Clinicians would have overseen the study, but a specific adjudication method for their observations is not detailed. The randomized double-blind nature of one study partially addresses bias for the discomfort assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document does not describe human readers interpreting images or data with and without AI assistance. This device is a wound dressing, not an AI diagnostic tool.

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

Not applicable. The device is a physical wound dressing, not an algorithm.

7. The Type of Ground Truth Used

• Biocompatibility Studies: Objective measurements of dermal and ocular irritation in animal models.
• Clinical Experience (Radiation Dermatitis & Diabetic Ulcers): Clinician observations and assessments of wound/skin appearance and healing environment. Patient acceptability. This is a form of expert clinical assessment.
• Clinical Trials (Aphthous Ulcers):
  • Discomfort: Patient-reported outcome (via diary), which is a subjective but direct measure of a patient's experience.
  • Adverse Events: Patient-reported and clinically observed events.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/ML device, there is no "training set" in the conventional sense. The "training" for the device's formulation likely involved laboratory research and development, but not data-driven machine learning.

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

Not applicable, as there is no training set for an AI/ML model for this device. The development process for the dressing would have involved standard chemical and material science techniques, preclinical testing, and potentially iterative formulation based on performance in those settings.

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Not Found

Carrasyn™ wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are designed to be used in conjunction with an appropriate cover dressing

The provided text does not contain information about specific acceptance criteria, device performance metrics, or a formal study designed to "prove" the device meets such criteria in terms of quantitative measures like sensitivity, specificity, or accuracy.

The text describes:

• Device: Carrasyn™ Hydrogel Wound Dressings.
• Purpose of filing: Standardization and clarification of previously cleared indications for labeling.
• Safety assessment: Biocompatibility tests (Primary Dermal Irritation, Primary Eye Irritation) in animal models, conducted under GLP regulations. These tests demonstrated the dressings are not primary dermal or eye irritants.
• Clinical Experience: Two observational studies (not formal clinical trials with specific endpoints or acceptance criteria to evaluate device performance) involving:
  • Four patients with radiation dermatitis.
  • 30 patients with diabetic ulcers (Grades III or IV, treated for 10 weeks).
• Outcomes of clinical experience: These studies "evaluated the acceptability of Carrasyn™ Hydrogel Wound Dressing to both the patients and clinicians, to wound and skin appearance, and to the wound healing environment." They "concluded that Carrasyn™ wound dressings are safe and effective for their intended use."

Therefore, I cannot populate the requested table or answer most of the questions as the information is not present in the provided document sections. The document focuses on safety testing (biocompatibility) and reporting on limited clinical experience for labeling purposes, rather than a study designed to establish quantitative performance metrics against acceptance criteria.

Here's how I would attempt to answer based only on the provided text, while acknowledging the severe limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" above are inferred from the types of evaluations mentioned ("evaluated the acceptability," "concluded that Carrasyn™ wound dressings are safe and effective"). No specific quantitative thresholds or predefined success criteria are provided in the text.

Summary of Study Information (Based on provided text):

• No formal study with defined quantitative acceptance criteria to prove device performance was described in the provided text. The clinical "studies" mentioned were observational and focused on acceptability and qualitative outcomes.

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

• Test Set Sample Size:
  • For biocompatibility tests: "standard animal models" (specific number not given).
  • For clinical experience: 4 patients with radiation dermatitis, 30 patients with diabetic ulcers (total 34 patients).
• Data Provenance: Not explicitly stated, but clinical experience likely from the US where the sponsor is located. Type: Retrospective or prospective is not specified for the clinical experience, but it seems to describe observed outcomes. Biocompatibility tests were prospective animal studies.

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

• Biocompatibility: Likely conducted by laboratory technicians and assessed by toxicologists/pathologists as per GLP, but specific numbers and qualifications are not mentioned.
• Clinical Experience: "clinicians" (plural) are mentioned as evaluators, but the specific number or their qualifications (e.g., dermatologists, wound care specialists) are not provided. The term "experts" is not explicitly used.

4. Adjudication method for the test set:

• Not specified for either the biocompatibility tests or the clinical experience.

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 type of study (MRMC with AI assistance) is not mentioned in the provided text. The device is a wound dressing, not an AI diagnostic tool.

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

• No. Not applicable as this is a physical wound dressing, not a software algorithm.

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

• Biocompatibility: Scientific standards for primary dermal and eye irritation (observed biological reactions in animal models).
• Clinical Experience: Clinician and patient observations/feedback on acceptability, wound and skin appearance, and wound healing environment. This could be considered a form of "outcomes data" or expert observation, but not formal "ground truth" for a performance metric.

8. The sample size for the training set:

• Not applicable/Not provided. There is no mention of machine learning or an AI algorithm that would require a dedicated training set.

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

• Not applicable/Not provided (see point 8).

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