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CoreLeader HEMO-Bandage is intended to be used as a topical dressing to temporarily control moderate to severe external bleeding resulted from traumatic or surgical wounds.

CoreLeader HEMO-Bandage is woven gauze made of chitosan fiber and rayon fiber. Chitosan is a type of organic polysaccharide carrying positively-charged ions. Appearing light yellow color and inheriting biodegradability and biocompatibility of chitosan. CoreLeader HEMO-Bandage achieves hemostasis by attracting erythrocytes to the injured sites and facilitates blood clot formation. CoreLeader HEMO-Bandage is sterilized by gamma-ray radiation to 10th SAL after packed in a foil bag. With the softness and flexibility, it is readily conformable to various wound shapes.

This document is a 510(k) summary for the CoreLeader HEMO-Bandage, a device intended to control bleeding. The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices. The study detailed focuses on non-clinical performance and safety rather than a clinical trial with human subjects for diagnostic accuracy.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria seem to be implicit in demonstrating equivalence to previously approved predicate devices, particularly regarding safety and certain aspects of performance. The performance data is presented in a table comparing the proposed device against predicate devices based on various tests.

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Bios King Biocellulose Film is indicated as a topical dressing to manage pressure sores, diabetic ulcers, 1st to 2nd degree burns and skin donor sites.

Bios King Biocellulose Film is made of bacterial synthesized cellulose mesh with a selectively permeable structure allowing water evaporation, and thus provides a moist but not damp environment for wound healing. Bios King Biocellulose Film is resistible to the tensile force generated from the wound handing. It can adhere to wound beds without fixation devices.

The provided document is a 510(k) summary for the Bios King Biocellulose Film, a topical wound dressing. It details the device's characteristics and its substantial equivalence to predicate devices, focusing primarily on non-clinical tests.

However, the document does not contain information about a study proving the device meets acceptance criteria related to typical clinical performance metrics for AI/ML medical devices, such as sensitivity, specificity, or reader performance in diagnostic tasks. The "device performance" described here refers to physical and biological properties of the wound dressing, not diagnostic accuracy.

Therefore, many of the requested fields cannot be answered from the provided text as they pertain to clinical studies involving AI in diagnostics.

Here's the information that can be extracted or deduced from the document regarding the device's non-clinical performance and acceptance criteria:

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

Regarding the Study (Non-clinical Tests):

The document describes several non-clinical tests conducted to validate the safety and efficacy of the Bios King Biocellulose Film. These are in-vitro or in-vivo animal/material tests, not human clinical trials for diagnostic performance.

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

• Sample Size: Not specified for each individual test. The tests are general biocompatibility, physical property, and sterility tests, often requiring specific numbers of samples or subjects (e.g., animals for skin irritation) as per the referenced ISO or ASTM standards, but these numbers are not detailed in the summary.
• Data Provenance: The document does not specify the country of origin for the test data, though the submitting company is from Taiwan. The tests are non-clinical in nature.

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. Ground truth in the context of expert consensus is not relevant for these types of non-clinical tests. Standards like ISO 10993 define methodologies and criteria for chemical, biological, and physical properties, often determined by laboratory analysis.

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

• Not applicable. Adjudication methods are typically used in clinical studies for diagnostic accuracy, not for non-clinical material property or biocompatibility tests.

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 topical wound dressing, not an AI/ML diagnostic algorithm. Therefore, an MRMC study is not relevant.

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

• Not applicable. This is not an AI/ML algorithm.

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

• The "ground truth" for the non-clinical tests is established by the specific methodologies and quantifiable outcomes defined in the referenced international standards (e.g., ISO 11137 for sterility, ISO 10993 for biocompatibility, ASTM E96-95 for moisture vapor transmission). These typically involve laboratory analyses, physical measurements, and biological assays against defined thresholds.

8. The sample size for the training set

• Not applicable. This is not an AI/ML algorithm; there is no "training set."

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

• Not applicable. No training set exists.

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Coreleader Hydro-clear is indicted for the management of 1st and 2nd degree burns, chronic ulcers, surgical wounds, skin graft and donor sites.

Patient with conditions listed below is considered appropriate for Over-The Counter Use (OTC): for the management of minor cuts, minor burns (1st degree burns), minor lacerations and minor cuts.

Coreleader Hydro-clear is a new product that is made of Hydrocolloid (Sodium carboxymethyl cellulose, Synthetic Elastomer, Tackifier Resins, Mineral Oil and Polyurethane film) by unique production process. With preferable liquid absorbsion ability, gas permeability and ability of water resistant, Hydro-clear is clear of adhesive onto wound, capable to absorb exudates, protect wound site and facilitates would healing process.

The provided document is a 510(k) Summary for the Coreleader Hydro-clear Hydrocolloid Wound Dressing. It describes the device, its intended use, and compares its technological characteristics to a predicate device. However, it does not contain information about a study that assesses the device's performance against acceptance criteria in the context of an AI/algorithm-driven medical device.

The "Technological Characteristics" section lists physical properties like thickness, peeling adhesion, holding power, elongation, and tensile strength. These are likely engineering specifications, not clinical performance metrics derived from a study on patient outcomes or AI accuracy.

Therefore, most of the requested information regarding study details, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document, as it pertains to the regulatory submission of a physical wound dressing, not an AI-enabled diagnostic or therapeutic tool.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes "Technological Characteristics" which serve as specifications for the wound dressing. While these are not explicitly presented as "acceptance criteria" in the context of a clinical study or AI performance evaluation, they represent the product's measured physical properties.

Note: The document implies these characteristics are comparable to the predicate device, but specific acceptance criteria (e.g., "must be greater than X" or "within Y range") are not explicitly stated for each characteristic.

The following information cannot be found in the provided document:

• 2. Sample size used for the test set and the data provenance: This document is for a physical wound dressing, not an AI/algorithm device that would have a "test set" of data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI device is based on expert labels or pathology, which is not part of this submission for a wound dressing.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable. This is for an AI-assisted diagnostic.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a wound dressing for its characteristics listed.
• 8. The sample size for the training set: Not applicable to a wound dressing.
• 9. How the ground truth for the training set was established: Not applicable to a wound dressing.

In summary: The provided document describes the physical and chemical properties of a wound dressing for regulatory approval. It does not concern an AI/algorithm-driven device and therefore lacks all the study-related details typically required for such a device.

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Coreleader Colla-Algi Fiber Dressing is indicated for management of exuding wounds including:

• Full-thickness and partial-thickness wounds .
• Pressure ulcers .
• Venous ulcers
• Ulcers caused by mixed vascular etiologies .
• Diabetic ulcers ●
• Second-degree burns ●
• Donor sites and other bleeding surface wounds ●
• Abrasions
• Traumatic wounds healing by secondary intention .
• Dehisced surgical incisions .

Coreleader Colla-Alig Fiber Dressing with Alginate is wound care dressing with 10% collagen composition. Colla-Alig Fiber Wound Dressing with Alginate combines with exudate to maintain a moist wound environment. The moist environment provided by the Colla-algi fibers may provide an environment favorable to the wound healing process. It is non-adherent, removes easily and leaves wound free of fiber. It maintains initial integrity when wet. Soft, conformable sheet can be cut to fit any size wound. Coreleader Colla-Algi Fiber Dressing with Alginate is an advanced wound care device composed of collagen and calcium alginate fibers. Its unique combination of natural biopolymers created by Wet-Spinning process combines the structure support of collagen and gel forming properties of alginates into a sterile, soft, absorbent. conformable topical wound dressing. The dressing is manufactured from bovine collage and medical grade alginate.

This document concerns a 510(k) submission for a topical wound dressing, the Coreleader Colla-Algi Fiber. The 510(k) process is for demonstrating substantial equivalence to a predicate device, not for proving device performance against specific acceptance criteria through a clinical study in the way a PMA (Premarket Approval) would.

Therefore, the provided text does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets them.

Specifically:

1. Table of acceptance criteria and reported device performance: Not present. The document focuses on establishing substantial equivalence to existing predicate devices.
2. Sample size, test set data provenance: Not present. Clinical studies with test sets are not described.
3. Number of experts and qualifications for ground truth: Not present. Ground truth establishment for a clinical study is not described.
4. Adjudication method: Not present.
5. MRMC comparative effectiveness study: Not present. This type of study is more common for imaging or diagnostic AI devices.
6. Standalone (algorithm only) performance: Not applicable. This is a physical wound dressing, not an algorithm.
7. Type of ground truth used: Not present.
8. Sample size for training set: Not applicable and not present. This is not an AI/ML device.
9. How ground truth for training set was established: Not applicable and not present.

The document describes the device, its intended use, and indicates that biocompatibility studies have demonstrated the Coreleader Colla-Algi Fiber Dressing to be non-irritating, non-sensitizing, and non-cytotoxic. However, it does not provide details about these studies (e.g., sample sizes, specific criteria, results documentation) beyond this summary statement.

The core of this 510(k) submission is the claim of "substantial equivalence" to predicate devices, meaning it is as safe and effective as existing legally marketed devices. The FDA's letter (pages 2-3) confirms this determination.

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Coreleader Scar-D Silicone Sheeting is intended for use: for the management of closed hypertrophic and keloid scars.

Coreleader Scar-D silicone sheeting is a thin, soft and self-adhesive sheet made from medical grade silicone with a PU Foam/PU non-woven film backing paper and a non-silicone polyester release paper. It is able to hold moisture with adequate pressure on the scar. The sheets are rectangular and come in four sizes, 5 cm x 8 cm, 5 cm x 20 cm, 2.5 cm x 100 cm and 5 cm x 100 cm. They are approximately 0.6 mm thick. The sheet maybe cut or trimmed to the desired shape or size prior to placement on the scar. The sheets are not for use on an open wound, are not sterile but can be washed.

The provided text is a 510(k) summary for the "Coreleader Scar-D Silicone Sheeting." This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from this document.

The document primarily describes the device's characteristics, intended use, and states that it is substantially equivalent to two predicate devices (BIODERMIS CORP., K003948, EPI-DERM SILICONE GEL SHEETING and SMITH & NEPHEW UNITED, INC., K935803, CICA-CARE SILICONE GEL SHEET). It does not contain information about a specific study designed to prove the device meets pre-defined acceptance criteria for its performance.

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Coreleader Hemo-Pad is a dressing indicated for topical wound management and for the external topical temporary control of moderate to severe bleeding. The dressing is indicated for the following wounds: abrasions, lacerations, skin surface puncture sites for vascular procedures (arteries and veins)

The Coreleader Hemo-Fiber wound dressing is made from poly-D-glucosamine and poly-N-acetylglucosamine derived from chitosan. The Coreleader Hemo-Fiber is a soft, non-woven topical pad for hemostasis and wound care. The natural biological property of this material carries cation (positively charged ion) that helps to stop external hemorrhage, and the Coreleader Hemo-Fiber wound dressing absorbs the wound exudates to form a hydrogel while providing protection layer layer for an optimal wound-healing environment. Coreleader Hemo-Pad is a sterile topical hemostasis pad, packed in a foil pouch and sterilized by gamma-ray radiation to a 10to SAL.

This is a 510(k) summary for a medical device called "Coreleader Hemo-Pad." 510(k) submissions, particularly older ones, often focus on substantial equivalence to a predicate device rather than presenting detailed standalone performance studies with specific acceptance criteria in the manner one might find for a novel AI/software medical device.

Based on the provided document, here's an attempt to answer your questions, with the caveat that detailed performance study methodology and acceptance criteria as you've outlined for AI/software devices are largely absent from this type of regulatory submission for a physical wound dressing:

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

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in terms of metrics like sensitivity, specificity, accuracy, etc., which are common for AI/software-based devices. Its focus is on establishing substantial equivalence to predicate devices (CLO-SURPLUS P.A.D., ChitoSeal, T-PAD) based on intended use, technological characteristics, and safety/effectiveness.

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

The document does not mention any specific "test set" in the context of a performance study like those for AI/software devices. There is no information provided regarding the sample size of any study, data provenance (country of origin), or whether any data used was retrospective or prospective.

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)

No information is provided regarding the use of experts to establish a "ground truth" for a test set. This type of review is not typically part of a 510(k) for a physical wound dressing.

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

No information is provided regarding an adjudication method, as no "test set" and ground truth establishment process are 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

No such study was done or is referenced. This type of study (MRMC, human readers, AI assistance) is completely irrelevant to a physical wound dressing like the Coreleader Hemo-Pad.

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

A standalone performance study for an algorithm is not applicable, as this is a physical medical device (a wound dressing), not an algorithm or AI.

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

The concept of "ground truth" as relevant to AI/software performance evaluation is not applicable here. The safety and effectiveness of the device are implied by its substantial equivalence to legally marketed predicate devices, which would have undergone their own prior evaluations (e.g., biocompatibility testing, perhaps some animal or limited human trials demonstrating hemostasis, but not in the detailed statistical performance metrics of current AI studies). The document refers to "safety and use of chitosan [being] published by researchers over a period of decades," implying reliance on existing scientific literature rather than a new ground truth establishment for this specific device.

8. The sample size for the training set

No "training set" is mentioned or applicable, as this is not an AI/machine learning device.

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

Not applicable as there is no training set and no AI/machine learning component.

Summary regarding the 510(k) submission and your questions:

The provided document is a 510(k) summary for a physical medical device (wound dressing) and is focused on demonstrating substantial equivalence to existing predicate devices. The framework you've provided for evaluating acceptance criteria and study designs is highly relevant to AI/Machine Learning-based medical devices and software, which require rigorous statistical performance analysis and often human reader studies.

For a physical device like the Coreleader Hemo-Pad, the "proof" often lies in:

• Bench testing: Demonstrating material properties, absorption, sterility, biocompatibility.
• Performance testing: Potentially in-vitro or in-vivo (animal) models to show hemostatic capabilities (e.g., time to hemostasis, blood loss reduction), but these are usually not detailed with specific "acceptance criteria" in the same way as an AI's diagnostic performance.
• Comparisons to predicate devices: Showing that the new device has similar technological characteristics and performs comparably to devices already on the market that have been deemed safe and effective.
• Scientific literature: Referencing established knowledge about the materials used (chitosan in this case) to support claims of biocompatibility, biodegradability, hemostatic, and anti-infectional activity.

The 510(k) summary provided does not contain the level of detail regarding performance studies, sample sizes, expert ground truth, or adjudication methods that would be expected for an AI/software device.

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The following conditions are considered appropriate for OTC use by the lay person: Coreleader AlgiPlaster is indicated for the management minor abrasions, minor cuts and minor lacerations.

The following conditions are considered appropriate for Prescription Use under the supervision of a licensed healthcare provider: Coreleader AlgiPlaster is indicated as a primary dressing for the management of exuding wounds, including acute wounds such as abrasions, lacerations and post-surgical wounds.

Coreleader AlgiPlaster is composed of Alginate fiber and combined with the thin polyurethane membrane coated with a layer of an acrylic adhesive. The dressing combination, which is permeable to both water vapor and oxygen, is impermeable to micro-organisms and once in position, it provides an effective barrier to external contamination, and producing a moist environment at the surface of the wound by reducing water vapor loss from the exposed tissue. The moist environment provided by the alginate fibers may provide an environment favorable to the wound healing process. Coreleader AlgiPlaster is a sterile topical wound dressing, packed in individual pouch and sterilized by r-ray radiation to a 106 SAL.

The provided text is a 510(k) summary for a wound dressing, the Coreleader AlgiPlaster. It describes the device, its intended use, technological features, and compares it to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/ML-based medical devices.

The submission is for a medical device that falls under the "Unclassified" category, meaning it does not require a PMA (Premarket Approval) and is subject to general controls. The review process outlined in the document confirms that the device is "substantially equivalent" to legally marketed predicate devices. This substantial equivalence is based on the device's technological characteristics and intended use being similar to existing cleared devices, rather than on a performance study against specific acceptance criteria for a new clinical claim.

Therefore, I cannot provide the requested table and study details because the provided document does not contain this information. The K102942 submission is not an AI/ML device and thus does not include the typical elements of an AI/ML device submission such as test sets, ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies.

The document is a traditional 510(k) submission for a wound dressing and focuses on demonstrating substantial equivalence to predicate devices based on physical and functional characteristics, biocompatibility, and intended use.

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Coreleader Colla-Pad Wound Dressing is indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/ undermined wounds, surgical wounds, (donor sites/grafts, post-Mohs surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds.

Coreleader Colla-Pad is comprised of a porous matrix of cross-linked bovine collagen. Colla-Pad is made of highly absorbent material that converts to a soft, gel sheet that stays in intimate contact with the wound bed as it absorbs exudate t. The moisture held around the wound by Colla-Pad could provide a favorable wound healing environment. Coreleader Colla-Pad is easy to cut and apply. Cut to fit any size of acute or chronic wounds with light to heavy exudate. Coreleader Colla-Pad is a sterile topical wound dressing, packed in a foil pouch and a foil package and sterilized by r-ray radiation to a 10to SAL.

The provided text is a 510(k) summary for the Coreleader Colla-Pad, a collagen wound dressing. This document confirms the device's substantial equivalence to predicate devices for its intended use. However, it does not contain information about acceptance criteria, device performance studies, or clinical trial data as typically requested for AI/software devices.

The document discusses the device description, intended use, technological characteristics, and biocompatibility testing. The biocompatibility section mentions ISO 10993-11 for systemic toxicity, blood analysis, and histological analysis showing no inflammation reaction in test animals, but this is a safety assessment, not a performance study comparing the device against specific acceptance criteria for efficacy.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample sized used for the test set and the data provenance: Not applicable as a performance study with a test set is not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/software device.
7. The type of ground truth used: Not applicable, as performance efficacy is not detailed.
8. The sample size for the training set: Not applicable, as this is not an AI/software device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/software device.

The 510(k) submission primarily focuses on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety (biocompatibility) compared to existing legally marketed devices, rather than presenting a detailed clinical performance study with specific acceptance criteria.

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The following indications for use of the product should be managed under the supervision of a health care professional:

Coreleader Algi-Fiber wound dressing is indicated as a primary dressing for the management of moderate to heavily exuding wounds, partial and full thickness wounds including chronic wounds such as leg ulcers, pressure sores and acute wounds such as donor sites, abrasions, lacerations and post-surgical wounds.

The following conditions are considered appropriate for OTC use by the lay person:

• · Coreleader Algi-Fiber wound dressing is indicated as a primary dressing for the management of minor exuding wounds such as minor abrasions, minor lacerations and minor post-surgical wounds.

Coreleader Algi-Fiber wound dressing is composed of calcium alginate fiber. It is softness and therefore Coreleader Algi-Fiber wound dressing is suitable for wound surface regardless the location, size, sinus and depth of a patient. Due to its highly hydrophilic property, the Coreleader Algi-Fiber wound dressing absorbs the wound exudates to form a hydrogel protection layer. The Coreleader Algi-Fiber wound dressing is biocompatibility. It has been tested and shown on accumulative effects, no evidence of delay hypersensitivity · non-cytotoxicity and is non-irritant. Coreleader Algi-Fiber is a sterile topical wound dressing, packed in individual pouch and sterilized by r-ray radiation to a 10° SAL.

The provided text describes a wound dressing device and its substantial equivalence to predicate devices, focusing on its physical properties, intended use, and biocompatibility. However, it does not include acceptance criteria for a device's performance that would typically be evaluated through a clinical study (e.g., sensitivity, specificity, accuracy for a diagnostic device, or a specific functional outcome for a therapeutic device).

Therefore, a table of acceptance criteria and reported device performance, information about sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth types cannot be extracted from this document. This document is a 510(k) Summary for a medical device (Coreleader Algi-Fiber Wound Dressing), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results with specific acceptance criteria as one would find for an AI-powered diagnostic or similar complex device.

Here's an analysis of what can be extracted:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Comparison):

The table provided in the document compares the proposed device (Coreleader Algi-Fiber Wound Dressing) with a predicate device (Comfeel SeaSorb Dressing) across several attributes to establish substantial equivalence.

Study Details (Limited Information for this Type of Device Submission):

• Sample Size for the Test Set and Data Provenance: Not applicable/not provided for performance evaluation in this 510(k) summary. The submission focuses on substantial equivalence based on product characteristics and previous testing data (e.g., biocompatibility testing).
• Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable/not provided. Biocompatibility testing results are typically from laboratory analyses, not expert consensus on clinical cases.
• Adjudication Method: Not applicable/not provided.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, this type of study is not mentioned as it's not relevant for this class of wound dressing.
• Standalone Performance (Algorithm Only): Not applicable. This is a physical wound dressing, not an algorithm.
• Type of Ground Truth Used: For biocompatibility, the "ground truth" would be established by standardized in vitro and in vivo biological tests (e.g., ISO 10993 series for cytotoxicity, irritation, sensitization). The document states the device "has been tested and shown on accumulative effects, no evidence of delay hypersensitivity · non-cytotoxicity and is non-irritant."
• Sample Size for the Training Set: Not applicable/not provided.
• How the Ground Truth for the Training Set Was Established: Not applicable/not provided.

Summary of Device and Evidence Presented:

The Coreleader Algi-Fiber Wound Dressing gained acceptance by demonstrating substantial equivalence to legally marketed predicate devices (CALGON VESTAL DIV., K910059, KALTOSTAT WOUND DRESSING and COLOPLAST CORP., K983519, COMFEEL SEASORB DRESSING). The evidence for this equivalence relies on direct comparison of material composition (calcium alginate fiber vs. calcium sodium alginate xerogel), intended use, single-use nature, sterilization methods, packaging, and critically, biocompatibility.

The biocompatibility of the Coreleader Algi-Fiber Wound Dressing was tested and shown to meet the standards of being non-hypersensitive, non-cytotoxic, and non-irritant. While no specific study names or detailed results are provided in this summary, the statement "It has been tested and shown on accumulative effects, no evidence of delay hypersensitivity · non-cytotoxicity and is non-irritant" confirms that the necessary biological evaluation tests were performed and passed. This type of submission does not typically include detailed clinical trial data or performance metrics beyond the basic safety and functional comparisons required to demonstrate substantial equivalence to an existing device.

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