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Indications for Use (Describe)

Prescription Use

Collagen Wound Dressing is indicated for the management of exuding wounds including:

• Full thickness and partial thickness wounds
• Pressure and venous ulcers
• Ulcers caused by mixed vascular etiologies
• Diabetic ulcers
• Partial thickness burns
• Donor sites and other bleeding surface wounds
• Abrasions
• Traumatic wound healing by secondary intention
• Dehisced surgical incisions

Over-The-Counter Use

Intended for the management of minor cuts, minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns.

Collagen Wound Dressing is a wound care device composed of pure freeze-dried cross-linked bovine collagen. It is a sterile, absorbent, white, porous, topical wound dressing. As a primary wound dressing that can be cut to any size or be used in multi-layers to fit wound. It can also be used in combination with either occlusive or semi-occlusive secondary dressing. The product is biodegradable. Please reapply the dressing as needed based on the patient's wound healing situation.

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Helios Dermal Scaffold is intended for the management of wounds that include:

• Partial- and full- thickness wounds
• Pressure, diabetic, and venous ulcers
• Partial thickness burns
• Surgical wounds – donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
• Trauma wounds – abrasions, lacerations and skin tears
• Tunneled/undermined wounds
• Draining wounds

Helios Dermal Scaffold is an acellular dermal tissue matrix derived from fetal bovine dermis. The single-use device is supplied sterile and is provided in sheet form in a variety of sizes and configurations, including meshed, solid, and fenestrated designs ranging from 1.5 - 500 cm² to be trimmed by the surgeon to meet the individual patient's needs.

The provided FDA 510(k) clearance letter for the Helios Dermal Scaffold does not contain any information regarding acceptance criteria or the study details typically associated with AI/ML device performance validation.

This document is for a medical device (a dermal scaffold), which is a biological product, not a software or AI/ML-driven diagnostic device. The performance data section refers to physical and biological characteristics of the scaffold, such as:

• Device Characterization Testing: Dimensional verification, color and appearance, suture retention strength, acellularity (histology), collagen denaturation.
• Design Validations: Viral inactivation, sterilization.
• Biocompatibility
• Shelf-life
• Packaging testing

These tests are standard for biological and implantable materials, ensuring their physical integrity, safety, and compatibility with the human body. They do not involve AI/ML algorithms, image analysis, or diagnostic accuracy.

Therefore, it is not possible to extract the requested information (acceptance criteria, sample size, ground truth, expert opinions, MRMC studies, etc.) from this document, as those concepts are not applicable to the type of device described.

To answer your prompt with the requested information, the input document would need to be a 510(k) clearance letter for an AI/ML medical device, typically referencing a clinical study or performance study that evaluates diagnostic accuracy, sensitivity, specificity, or reader agreement.

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Kerecis® Marigen Wound Extra Autologous Hydration, Kerecis Silicone Autologous Hydration and Kerecis Parvus Autologous Hydration

Management of wounds including:

• Partial thickness wounds
• Full thickness wounds
• Pressure ulcers
• Venous ulcers
• Chronic vascular ulcers
• Diabetic ulcers
• Trauma wounds (abrasions, lacerations, partial thickness burns, skin tears)
• Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence)
• Draining wounds

All three subject devices of this bundled submission are part of a family of devices manufactured by Kerecis Limited. The subject devices can be seen in Table 1. They are lyophilized, terminally sterilized, fish skin medical devices comprised of biocompatible, resorbable fish skin (Wild North Atlantic Cod) for wound management. The devices are intended for single use only. The devices are applied to the wound bed to maintain a moist wound environment. The primary predicate device is Marigen Wound Extra (K190528) and the additional predicate devices are Kerecis Silicone (K213231), and Kerecis Parvus (K241080). Marigen Wound Extra is commercially available under the names Kerecis MariGen, Kerecis GraftGuide, and Kerecis SurgiClose. Kerecis Silicone is commercially available under the names Kerecis Shield and Kerecis SurgiClose Silicone. For clarity, this submission will refer to the devices under their commercially available names, except when specifically referring to the primary predicate device. This information is also shown in Table 1.
Although the subject devices differ from each other in terms of device indications and dimensional specifications, each one remains physically identical to its primary predicate device, both in design and packaging, as well as for indications for use. The only difference between each subject device and its respective primary predicate device is in the device labeling, with the subject devices having additional rehydration fluid options included in their instructions for use (IFUs).

The provided FDA 510(k) clearance letter and summary describe the acceptance criteria and a study to prove the device meets these criteria. However, it's important to note that this submission is for a modification to an existing device (Kerecis Marigen Wound Extra, Kerecis Silicone, Kerecis Parvus) and not for an entirely novel device. The modification specifically addresses the inclusion of additional rehydration fluids. Therefore, the "study" is focused on verifying the device's performance with these new rehydration fluids, rather than establishing initial clinical effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the device's performance with the original rehydration fluid (saline) and the need for the device to perform comparably with the new rehydration fluids. The performance is assessed through specific bench tests.

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

The document does not explicitly state the sample size for the rehydration and suture retention tests. It mentions "bench testing" was performed.

Data provenance: Not explicitly stated, but bench testing typically involves laboratory-controlled conditions. It is not patient data from a specific country, nor is it referred to as retrospective or prospective in a clinical trial sense.

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

This type of information (expert consensus for ground truth) is typically associated with clinical studies or diagnostic device clearances where a "truth" is established through expert review of patient data (e.g., radiologist opinions on images). Since this submission focuses on bench testing for a modification to rehydration fluids, this information is not relevant or provided. The "ground truth" here is the prior established performance of the predicate device under saline rehydration.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are relevant for studies involving human interpretation or clinical endpoints. As this submission describes bench testing for material and process compatibility, an adjudication method is not applicable and therefore not provided.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic devices where multiple readers evaluate cases to assess performance with and without AI assistance. This submission is for wound dressings and focuses on physical and biological compatibility with different rehydration fluids.

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

This question is not applicable. The device is a wound dressing, not a software algorithm or an AI-based system. Therefore, there is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

For the specific tests conducted for this modification (rehydration and suture retention with new fluids), the ground truth is implicitly the established performance characteristics of the predicate device when rehydrated with saline. The goal of the new tests was to show that these characteristics are maintained or are comparable when using lactated Ringer's solution and autologous body fluids.

8. The Sample Size for the Training Set

This concept is not applicable as this is not a machine learning or AI device. The "training set" for a traditional medical device would refer to the data used to design and develop the device prior to its initial submission. The summary doesn't provide this detail for the original device development, only that performance testing was "leveraged from the Kerecis primary predicate devices."

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

Again, "training set" and its "ground truth" are terms typically used in AI/ML contexts. For a medical device like a wound dressing, the "ground truth" during initial development (analogous to a training phase) would involve extensive material testing, biocompatibility studies, mechanical property evaluations, and potentially pre-clinical and clinical studies to establish its safety and effectiveness for wound management. The summary indicates that for this modification, the ground truth is based on the previously established performance of the predicate devices.

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Collymer Self-Assembling Scaffold is intended 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-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds.

Collymer Self-Assembling Scaffold is a wound management device composed of a purified, self-assembling (scaffold-forming) collagen derived from porcine dermis. This two-part device consists of a collagen solution and a self-assembly reagent. Combining the two solutions initiates collagen self-assembly. The resulting collagen scaffold is suitable for cellularization and vascularization, providing a moist wound environment.

The provided FDA 510(k) Clearance Letter for the GeniPhys Collymer Self-Assembling Scaffold (K250329) does not include information about any clinical studies or the performance of a device based on acceptance criteria.

The clearance letter explicitly states:
"Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of Collymer Self-Assembling Scaffold to the predicate device."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as no such clinical study data is presented in this document.

The document focuses on demonstrating substantial equivalence through:

• Comparison of Indications for Use and Technological Characteristics to a predicate device (Integra Flowable Wound Matrix, K072113) and several reference devices.
• Non-Clinical Testing: Biocompatibility assessments, viral inactivation studies, sterility assessments, shipping studies, and stability evaluations. For these non-clinical tests, it is stated that "All results met the acceptance criteria" or "The acceptance criteria were met," but the specific numerical acceptance criteria themselves are not detailed, nor are the specific performance results beyond a qualitative statement of meeting the criteria.

To directly answer your specific points based on the provided document:

1. A table of acceptance criteria and the reported device performance: This information is not explicitly provided in the document for any clinical performance. For non-clinical tests, only a qualitative statement that acceptance criteria were met is given.
2. Sample sizes used for the test set and the data provenance: Not applicable as no clinical test set is described. For non-clinical tests, sample sizes are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set is described.
4. Adjudication method for the test set: Not applicable as no clinical test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, the document states clinical testing was not necessary.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (wound scaffold), not a software algorithm.
7. The type of ground truth used: Not applicable as no clinical study or test set with a "ground truth" (in the context of AI/diagnostic device performance) is described.
8. The sample size for the training set: Not applicable, as the document refers to a physical device and not a machine learning model that would have a training set.
9. How the ground truth for the training set was established: Not applicable, as no training set is described.

In summary, this 510(k) clearance relied on substantial equivalence to a predicate device and extensive non-clinical testing, rather than a clinical study demonstrating performance against specific acceptance criteria.

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CollOvine™ Wound Dressing is indicated for the management of exuding wounds including:

• full-thickness & partial-thickness wounds
• pressure ulcers
• venous ulcers
• ulcers caused by mixed vascular etiologies
• diabetic ulcers
• superficial second-degree burns
• donor sites and other bleeding surface wounds
• abrasions
• traumatic wounds healing by secondary intention
• dehisced surgical incisions

CollOvine Wound Dressing is a sterile advanced wound care device composed of medical grade ovine collagen. CollOvine Wound Dressing is soft, absorbent, and readily conforms to the wound bed. CollOvine Wound Dressing is available in multiple sizes; 1"x1", 2"x2" and 4"x4". CollOvine wound dressing is intended to maintain the moist microenvironment. CollOvine Wound Dressing is a primary wound dressing that can be cut with sterile scissors to ensure good contact with the wound bed. CollOvine Wound Dressing should be used with suitable non-occlusive absorbent secondary dressing and secured with standard non-irritating fixations such as medical grade tape or semi-occlusive dressing as appropriate. CollOvine Wound Dressing is a primary dressing, to maintain the required moist wound bed environment. CollOvine Wound Dressing is soft and pliable. The ovine collagen for CollOvine Wound dressing is obtained from sheep in compliance with ISO22442, including controls of animal tissue sourcing, collection, storage and viral inactivation.

The provided FDA 510(k) clearance letter for the CollOvine™ Wound Dressing does not contain any information about acceptance criteria or a study that proves the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (Fibracol Plus Collagen wound dressing with Alginate) based on non-clinical testing in a side-by-side comparison.

Therefore, I cannot fulfill your request for the specific details you've asked for, as they are not present in the provided text.

Here is a breakdown of what is contained in the document related to testing, and why it doesn't align with your request for acceptance criteria and a study proving device performance:

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

• Not present. The document lists the Indications for Use for both the CollOvine Wound Dressing and the predicate device, showing they are identical. It also presents a "Technological Comparison" table that details attributes like classification, product code, regulatory class, indications for use, manufacturer, material, origin, device characteristics, biocompatibility, reusability, and sterilization method. This table focuses on comparing attributes rather than defining performance acceptance criteria or reporting specific performance metrics against those criteria. The “Device Characteristics” for both are simply listed as “Collagen” and “Collagen with 10% calcium alginate” respectively, which is a material description, not a performance metric.

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

• Not present. The document describes non-clinical biocompatibility testing (Acute systemic toxicity, Primary skin irritation, Dermal sensitization, Pyrogenicity, Subacute Systemic toxicity, Subcutaneous implant, In vitro Cytotoxicity, Chemical Characterization, Toxicological Risk assessment). For these tests, sample sizes and data provenance are not provided. These are generally standard biological safety tests, not clinical performance studies.

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 present. This information is typically relevant for studies involving human assessment or interpretation (e.g., radiology AI devices). This is not applicable to the non-clinical biocompatibility and physiochemical testing described.

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

• Not present. Adjudication methods are typically used in clinical studies where expert consensus is needed. This is not mentioned for the non-clinical 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 present. An MRMC study is a type of clinical study, often used for diagnostic devices involving human interpretation (like AI in radiology). The document describes a wound dressing, and the testing conducted is non-clinical.

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

• Not present. This concept is specific to AI or software-as-a-medical-device (SaMD). The CollOvine Wound Dressing is a physical product, not an algorithm.

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

• Not present. For the non-clinical biocompatibility tests, "ground truth" would be established by the results of standardized biological assays comparing the device's effects to known safety profiles or controls. For pH and absorbency tests, the "ground truth" is the measured physical property itself, compared to the predicate. No expert consensus or pathology is mentioned.

8. The sample size for the training set

• Not present. Training sets are relevant for AI/machine learning models. This is a physical wound dressing device.

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

• Not present. As above, not relevant for this type of device.

Summary of what the document does provide regarding testing:

• Study Objective (Implied): To demonstrate substantial equivalence to the predicate device (Fibracol Plus Collagen wound dressing with Alginate, K982597) through non-clinical testing.
• Tests Performed:
  • Biocompatibility testing in compliance with ISO 10993 Part 1 Biological Evaluation of Medical Devices, including:
    • Acute systemic toxicity (in mice)
    • Primary skin irritation (in rabbits)
    • Dermal sensitization (in Guinea pigs)
    • Pyrogenicity (in rabbits)
    • Subacute Systemic toxicity (in rats; 30 days intraperitoneal route)
    • Subcutaneous implant (in rats, 1-week and 4-weeks)
    • In vitro Cytotoxicity (Direct cell contact)
    • Chemical Characterization
    • Toxicological Risk assessment
  • pH and absorbency testing (results stated as "found to be similar to that of the primary predicate Fibracol Plus wound dressing").
• Conclusion: Based on the non-clinical testing, CollOvine wound dressing is substantially equivalent to the predicate device.

In essence, the document serves as a regulatory clearance (510(k)) based on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical, benchtop, and biocompatibility studies, rather than a clinical performance study with predefined acceptance criteria for patient outcomes.

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DermiSphere™ hDRT hydrogel Dermal Regeneration Template is a wound dressing indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second degree burns, skin tears) and draining wounds. This device is intended for one-time use.

DermiSphere™ hDRT hydrogel Dermal Regeneration Template is an advanced wound dressing comprised of crosslinked bovine collagen microspheres embedded in bovine collagen hydrogel matrix. This composite biodegradable wound dressing provides a scaffold for native tissue cellular invasion and capillary growth.

The provided text does not contain information about acceptance criteria and the study that proves the device meets them. The text primarily focuses on the FDA's clearance of the DermiSphere™ hDRT (K241904) as substantially equivalent to a predicate device (Avagen Matrix Wound Dressing, K022127).

It mentions:

• Biocompatibility testing
• Bench testing including dimensions, drapability, and pyrogenicity.

However, it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication methods.
5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Information about standalone (algorithm only) performance studies.
7. The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The conclusion states that nonclinical tests demonstrated substantial equivalence, with safety and effectiveness demonstrated through bench testing, biocompatibility, and comparison to the predicate device. However, the specifics of these tests and their results against predefined acceptance criteria, as requested, are not detailed in this document.

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Bovine Dermis Collagen Dermal Matrix is indicated for the management of wounds, including:

• . Full thickness and Partial thickness wounds
• . Chronic wounds (e.g. pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers)
• . Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
• . Trauma wounds (abrasions, lacerations, and skin tears)
• Draining wounds
• Partial thickness burns

Bovine Dermis Collagen Dermal Matrix is an absorbent, porous, collagen matrix engineered from purified collagen derived from bovine dermal tissue. Bovine Dermal Matrix should be applied directly to the wound, covering the entire wound surface.
Bovine Dermis Collagen Dermal Matrix is supplied sterile, non-pyrogenic and for single use only.

The Collagen Matrix, Inc. Bovine Dermis Collagen Dermal Matrix (K243071) is a medical device. The provided text outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence for regulatory purposes.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a go/no-go fashion with numerical targets for clinical performance. Instead, it compares the subject device to predicate devices across various technical characteristics. The implicit acceptance criterion is that the subject device's performance is either equivalent to or better than the predicate devices, or that any differences do not raise new questions of safety or effectiveness.

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

• Test Set Sample Size: The document does not specify a "test set" in the context of clinical or performance data with a specific number of cases or patients. The studies described are in vitro characterization tests, biocompatibility tests, and a viral inactivation study. These are conducted on samples of the device itself or in laboratory settings, not on patient data.
• Data Provenance: Not applicable in the context of clinical patient data. The studies are laboratory-based and conducted on the manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. The studies are not clinical studies requiring expert ground truth for interpretation of patient data. They are lab tests for material properties, biological safety, and viral inactivation.

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

Not applicable. This pertains to clinical studies involving human readers and adjudicated outcomes, which are 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. The document describes laboratory-based testing of a dermal matrix, not a diagnostic AI device requiring human reader analysis.

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

Not applicable. This pertains to AI algorithm performance studies, which are not described here.

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

Not applicable in the human clinical sense. For the in vitro tests (Absorbency, pH, Thermal Transition Temperature, Density, Crosslinking Agent Residual Content, Pyrogenicity), the "ground truth" would be established by validated analytical methods and reference standards. For biocompatibility, it would be based on established international standards (e.g., ISO 10993 series) and their respective endpoints. For viral inactivation, it would be based on virological assays.

8. The sample size for the training set:

Not applicable. This device is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set.

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BIOBRANE Dressings are indicated for:

• Covering clean partial thickness burn wounds
• Split thickness donor sites

BIOBRANE Glove is indicated for:

• Covering clean partial thickness burn wounds of the hand.

BIOBRANE Dressing and BIOBRANE Glove are wound dressings made from an ultrathin, semipermeable, perforated silicone membrane that is mechanically bonded to a flexible knitted tri-filament nylon fabric. Denatured porcine dermal collagen is bonded to the silicone-nylon membrane to provide a flexible and conformable dressing with adherence properties and a hydrophilic surface.

This document is a 510(k) K242146 premarket notification for the BIOBRANE Dressing and BIOBRANE Glove. It asserts substantial equivalence to the predicate device BIOBRANE II (K901369).

Here's an analysis of the provided information relating to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide a table of acceptance criteria with specific performance metrics such as sensitivity, specificity, accuracy, or any quantitative measures for the device's diagnostic or predictive capabilities. This is likely because the device is a wound dressing, not a diagnostic AI/ML device.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through shared characteristics and verification tests. The "acceptance criteria" can be inferred as successful completion of these tests and demonstration that the device's characteristics are similar to the predicate.

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

The document explicitly states: "No clinical data is relied upon in this submission to determine substantial equivalence."

Therefore:

• Sample size for the test set: Not applicable, as no clinical test set was used for substantial equivalence determination.
• Data provenance: Not applicable. The evaluation was based on non-clinical (bench) testing and comparison of technological characteristics.

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

Not applicable, as no clinical test set with a ground truth established by experts was used. The substantial equivalence was based on non-clinical data and direct comparison to a predicate device.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or relied upon. This is a wound dressing, not an AI/ML diagnostic device where such studies are typical.

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

Not applicable. This device is a wound dressing, not an algorithm or software-only device.

7. The Type of Ground Truth Used

Not applicable, as no clinical data or ground truth in the context of diagnostic performance was used. The "ground truth" for this submission is implicitly the established safety and efficacy profile of the legally marketed predicate device (BIOBRANE II, K901369) and the physical/chemical properties assessed through bench testing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set or ground truth for training.

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Corplex P/Theracor P/Allacor P is indicated for use in the management of the following wounds:

• · Partial and full-thickness wounds
• Pressure ulcers
• Venous ulcers
• · Diabetic ulcers
• · Chronic vascular ulcers
• · Tunneled/undermined wounds
• · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
• · Trauma wounds (abrasions, lacerations, partial-thickness burns, and skin tears)
• · Draining wounds

Corplex P/Theracor P/Allacor P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P/Theracor P/Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.

The provided text describes a 510(k) premarket notification for a medical device called Corplex P/Theracor P/Allacor P. It states that the device is identical to its predicate device (K231325) in most aspects, with a minor modification being the addition of an 8 cc configuration. The document explicitly states that this modification does not raise new questions of safety or effectiveness and therefore, no new clinical testing, biocompatibility testing, or extensive performance studies were required to demonstrate substantial equivalence.

Instead, the submission relies on the established performance of the predicate device and verification testing related to the minor design change.

Therefore, many of the requested details about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth establishment, which are typically associated with performance studies, are not explicitly present in this summary document because such extensive studies were deemed unnecessary for this 510(k) submission.

Here's an attempt to answer your questions based on the provided text, indicating where information is not available due to the nature of this submission:

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

The document does not explicitly state acceptance criteria in a quantitative format for all characteristics. Instead, it relies on the device being "identical" or having "same" or "does not raise new questions of safety and effectiveness" compared to the predicate device. For the one specific test mentioned (Bioburden Testing), the outcome is a simple "PASS".

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 primarily relies on the substantial equivalence to a predicate device (K231325). For the specific modification (8 cc configuration), verification testing was performed.

• Test Set Sample Size: Not specified for the bioburden testing or other verification tests mentioned. The document states "Testing was performed based on the risk assessment for the proposed change using the same methods used to support the clearance of the predicate device."
• Data Provenance: Not explicitly stated. Given it's a 510(k) submission to the US FDA by a US-based company (StimLabs, LLC, Roswell, Georgia), the data is most likely from the US, and refers to prior data from the predicate device. It is not a clinical study, so terms like "retrospective" or "prospective" are not applicable to the verification testing conducted for this submission. The predicate device's data would have been part of its original 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This submission is for a material device, not an AI or diagnostic device that requires expert ground truth for image interpretation or similar tasks. The "ground truth" for the characteristics listed would be defined by standard laboratory testing methodologies and specifications.

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

Not applicable. The verification testing mentioned (e.g., bioburden) involves laboratory results rather than expert adjudication of interpretations.

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 wound dressing made from human umbilical cord extracellular matrix, not an AI or diagnostic device.

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

No. This is a physical medical device, not an algorithm.

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

For the verification testing related to the new device, the ground truth would be defined by standard laboratory test results and established acceptance criteria for physical and chemical properties (e.g., bioburden levels, particle size distribution, moisture content, collagen content, endotoxin levels). For the predicate substantial equivalence, the "ground truth" refers to the established safety and effectiveness of the existing legally marketed device.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

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