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InnovaBurn™ 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 (donor sites/ grafts, post Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, and skin tears), partial-thickness second degree burns, and draining wounds.

The device is intended for one-time use.

InnovaBurn™ is a decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue. Triad processes the tissue into the ECM topical wound covering. InnovaBurn" is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulfated glycosaminoglycans. The wound dressing is provided in sheets that are approximately 40-100 microns thick in sizes greater than 5 x 5cm (25cm2) up to 20 x 20cm (400cm2). They are provided as single-use, sterile wound coverings.

The provided document is a 510(k) summary for the InnovaBurn™ device and does not contain detailed acceptance criteria or a study proving that the device meets specific performance criteria through a clinical trial or a formal statistical study with a specific sample size. Instead, it relies on substantial equivalence to a predicate device.

Here's a breakdown of the information available based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or performance metrics for InnovaBurn™ that would typically be found in a clinical study report (e.g., sensitivity, specificity, accuracy).

Instead, it relies on the following:

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

• Test Set Sample Size: Not applicable. The document describes a bench testing and substantial equivalence comparison rather than a clinical study with a "test set" of patient data. Performance data from the predicate device (InnovaMatrix® K193552) was leveraged.
• Data Provenance: Not applicable in the context of a clinical test set. The data presented is from laboratory testing and analytical comparisons, primarily performed on the predicate device.

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

Not applicable. This information is relevant for studies involving human interpretation or clinical data for ground truth establishment. This submission relies on analytical and bench testing performed in a laboratory setting.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set with human adjudication is mentioned.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on regulatory approval based on substantial equivalence, not on comparing human reader performance with or without AI assistance.

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

Not applicable. InnovaBurn™ is a physical medical device (collagen wound dressing), not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims is derived from analytical testing results against established biocompatibility, safety, and compositional standards, and the documented characteristics and performance of the predicate device. For instance, biocompatibility involves comparing test results to predetermined acceptable limits.

8. The Sample Size for the Training Set

Not applicable. InnovaBurn™ is a physical medical device, not an AI model, so there is no "training set."

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

Not applicable for the same reason as above.

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InnovaMatrix PD 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 (donor sites/grafts, post Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, and skin tears), draining wounds, and partial-thickness burns. The device is intended for one-time use.

InnovaMatrix® PD is a powder manufactured from the decellularized extracellular matrix (ECM) derived from porcine placental tissue harvested according to Good Manufacturing Practices. Further treatment and final sterilization yield a particulate device prepared for the management of wounds. The particulate is meant to be deployed by the user to manage wounds of the types outlined in the Indications for Use of the device. InnovaMatrix® PD is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulfated glycosaminoglycans. The wound dressing is provided in a particulate form as a single-use, sterile wound covering.

This document is a 510(k) Summary for the InnovaMatrix PD device, a collagen wound dressing. It details the device's characteristics, intended use, and comparison to predicate devices to demonstrate substantial equivalence to a legally marketed device.

Here's an analysis of the provided text in relation to your request about acceptance criteria and study proving the device meets them:

Crucially, this document (a 510(k) Summary) focuses on demonstrating "substantial equivalence" of a new medical device to a legally marketed predicate device. This process typically relies heavily on comparing technological characteristics and non-clinical performance data to show the new device is as safe and effective as the predicate.

It does NOT describe a study with "acceptance criteria" for a device's performance in a clinical setting in the way you've outlined (e.g., diagnostic accuracy metrics like sensitivity, specificity, or human reader improvement with AI assistance). These types of detailed performance studies are commonly seen for diagnostic devices or AI/ML-driven software, not typically for wound dressings demonstrating substantial equivalence.

Therefore, I cannot provide all the requested information as it is not contained within this type of regulatory submission. However, I can extract what is present and clarify what is absent.

Based on the provided text, here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document implies acceptance criteria by performing specific non-clinical tests and concluding that the device is "substantially equivalent" to predicate devices. However, explicit numerical performance targets (e.g., "Device must achieve X sensitivity") are not stated. The "performance data" section lists the types of tests performed to mitigate risks, not specific performance metrics against pre-defined criteria.
• Reported Device Performance: Instead of explicit performance metrics, the document reports that the conducted tests support the conclusion of substantial equivalence. For example, Biocompatibility Testing was performed, and the implication is that the results were acceptable.
  Table (Inferred based on non-clinical testing performed):

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

• Sample Size for Test Set: Not specified for any of the non-clinical tests.
• Data Provenance: Not specified. The document does not mention the country of origin of data or whether it was retrospective/prospective. This is typical for non-clinical lab testing.

3. Number of Experts and Qualifications for Ground Truth

• This concept does not apply to this type of submission. "Ground truth" established by experts (e.g., radiologists for image analysis) is applicable to studies of diagnostic accuracy or AI performance where expert interpretation is the reference standard. This document focuses on material properties, manufacturing controls, and physical/chemical performance of a wound dressing. "Physician Usability Testing" involved physicians, but their role was to assess usability, not to establish a "ground truth" for a performance metric.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are for reconciling differences in expert interpretations, which is not relevant to the non-clinical testing described here.

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

• Not applicable. This device is a wound dressing, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, MRMC studies evaluating human reader performance with/without AI assistance are not relevant or performed for this product.

6. Standalone (Algorithm Only) Performance

• Not applicable. This is a physical wound dressing, not an algorithm or software.

7. Type of Ground Truth Used

• Not applicable in the conventional sense of clinical ground truth. The "ground truth" for the non-clinical tests performed is typically defined by established laboratory standards, specifications, and regulatory requirements (e.g., ISO standards for biocompatibility, USP for endotoxins, validated test methods for particle size).

8. Sample Size for the Training Set

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

9. How Ground Truth for Training Set Was Established

• Not applicable.

Summary of what the document does provide regarding "acceptance":

The document effectively describes the regulatory acceptance process for a medical device through the 510(k) pathway, which primarily involves demonstrating substantial equivalence to an existing predicate device. The "acceptance criteria" here are that the new device (InnovaMatrix PD) must be as safe and effective as the predicate device (Cook® ECM Powder), despite minor differences in technological characteristics (e.g., raw material source, sterilization method, form factor).

The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing listed in Section 7. These tests were performed to address any potential risks introduced by changes from the predicate or reference devices. The successful completion of these tests, combined with the comparison of technological characteristics, forms the basis for the FDA's determination of substantial equivalence and subsequent market clearance. The "proof" is the FDA's clearance letter itself, stating they "have determined the device is substantially equivalent."

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InnovaMatrix™ FS 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, second-degree burns and skin tears) and draining wounds.

The device is intended for one-time use.

InnovaMatrix™ FS is a decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue. Triad processes the tissue into the ECM topical wound covering. InnovaMatrix™ FS is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulfated glycosaminoglycans. The wound dressing is provided in fenestrated sheets that are approximately 40-100 microns thick in sizes ranging from 2 x 2cm to 5 x 5cm. They are provided as single-use, sterile wound coverings.

This is a 510(k) premarket notification for a medical device called InnovaMatrix™ FS. The document describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria, a scientific study detailing device performance against those criteria, or information on specific statistical metrics (e.g., sensitivity, specificity, AUC) normally associated with AI/algorithm performance studies.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared device (InnovaMatrix™ K193552) and mentions verification testing to ensure certain characteristics. The primary change in the InnovaMatrix™ FS is the addition of fenestrations.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth for AI performance are not available in this regulatory submission.

Here's what can be extracted based on the provided text, while explicitly noting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific numerical values or ranges for "specified values" (e.g., for bioburden, endotoxin, water absorption capacity) are not provided in this document. The "acceptance criterion for the verification activity" for fenestrations is also not detailed.

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

This document describes verification testing and design controls for the modified device (InnovaMatrix™ FS), not a clinical or AI performance study with a "test set" in the typical sense.

• Sample Size for Test Set: Not applicable in the context of an AI/algorithm performance study. The document mentions "verification testing" for characteristics like bioburden, endotoxin, and water absorption, but does not provide sample sizes for these tests.
• Data Provenance: Not applicable for an AI/algorithm performance study. The data for verification testing would likely be from laboratory tests performed by the manufacturer.

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

Not applicable. This is not an AI/algorithm performance study that relies on expert interpretation to establish ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication method as this is not an AI/algorithm performance study.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a collagen wound dressing, not an AI software device.

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

No, a standalone (algorithm only) performance study was not done. InnovaMatrix™ FS is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to established laboratory standards and specifications for material characteristics (bioburden, endotoxin, water absorption capacity) and manufacturing/design output (fenestrations). It is not pathology, outcomes data, or expert consensus in an observational or diagnostic sense. The ground truth for proving substantial equivalence relies on comparison to the predicate device and established safety/performance parameters for similar products.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm, so there is no "training set."

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

Not applicable. There is no "training set" or corresponding ground truth establishment methodology.

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InnovaMatrix™ 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 (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, seconddegree burns and skin tears) and draining wounds.

The device is intended for one-time use.

InnovaMatrix™ is a decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue. Triad processes the tissue into the ECM topical wound covering.

InnovaMatrix™ is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulfated glycosaminoglycans.

The wound dressing is provided in sheets that are approximately 40-100 microns thick in sizes ranging from 1 x 1cm to 5 x 5cm. They are provided as single-use, sterile wound coverings.

The provided text is a 510(k) summary for the InnovaMatrix™ device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving effectiveness through clinical trials with specific acceptance criteria as would be required for a novel device or a PMA.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the way a clinical trial for a new diagnostic algorithm or treatment efficacy would. Specifically, it does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a "test set" in the context of an AI/diagnostic algorithm study.
• Information about expert ground truth establishment (number of experts, qualifications, adjudication method).
• Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
• Standalone performance data for an algorithm.
• Specific "ground truth" types (pathology, outcomes data) for clinical efficacy.
• Training set sample size or how ground truth was established for a training set.

Instead, the study presented in this document is a substantial equivalence demonstration based on:

1. Biocompatibility Testing: Evaluating the safety profile of InnovaMatrix™ with various in vitro and in vivo tests (cytotoxicity, skin sensitization, intracutaneous reactivity, acute/subacute/subchronic systemic toxicity, implantation, genotoxicity, material-mediated pyrogenicity). The conclusion drawn is that the biocompatibility profile is comparable to the predicate device.
2. Laboratory Testing: Analysis of the physical and chemical properties of the device (cell debris, collagen/elastin/etc. analysis, endotoxin, residual moisture, water absorption, tensile strength, viral inactivation, shelf life, heavy metals). These tests aim to characterize the material and ensure it meets relevant standards.
3. Clinical Testing (Human Repeat Insult Patch Testing and Skin Prick Testing): These are safety tests to assess allergic/irritant potential, not efficacy studies.
   • Human Repeat Insult Patch Testing: 58 subjects completed, no reactions.
   • Skin Prick Testing: 23 subjects completed, 22 showed no reactions, 1 had a low-grade positive reaction that resolved.

Key takeaway: The provided information is about demonstrating the safety and similar technological characteristics of a wound dressing to an existing device, not about proving performance against specific acceptance criteria in a study format typically associated with AI or diagnostic device performance evaluation.

If this were a study proving the device meets acceptance criteria for a diagnostic AI, the structure and content would be vastly different, focusing on metrics like sensitivity, specificity, AUC, human-AI collaboration impact, etc.

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