Search Results

LUOFUCON® Collagen Particles is intended for the management of wounds including:

• · Full thickness and partial thickness wounds
• · Pressure (stage I-IV) and venous ulcers
• · Ulcers caused by mixed vascular etiologies
• · Venous stasis and diabetic ulcers
• · 1st and superficial second-degree burns
• Cuts
• Abrasions
• · Surgical wounds

LUOFUCON® Collagen Particles is a native bovine collagen wound dressing that is sterile, white to off-white, absorbent and resorbable powder. LUOFUCON® Collagen Particles maintains a moist wound environment to support wound healing.
LUOFUCON® Collagen Particles can be applied to a wound either in the dry state or pre-hydrated with sterile saline, and can be used in conjunction with other suitable secondary dressings indicated for wound management. The device is intended for one time use.
LUOFUCON® Collagen Particles is sterilized and sold after sterilization by radiation using conditions validated following ISO 11137-2:2013.

This is a 510(k) Premarket Notification for a medical device (LUOFUCON® Collagen Particles, a collagen wound dressing) seeking substantial equivalence to a legally marketed predicate device. The information provided in this document focuses on demonstrating substantial equivalence for a collagen wound dressing, not an AI/Software as a Medical Device (SaMD).

Therefore, the specific criteria you've asked for, such as "acceptance criteria for an AI/SaMD study," "sample size for the test set," "number of experts for ground truth," "MRMC study," "standalone AI performance," and "training set details," are not applicable to this type of medical device submission.

This document demonstrates substantial equivalence through:

1. Comparison to a Predicate Device (K171645): Showing that the subject device has similar indications for use, technological characteristics (material, animal source, physical structure, biodegradability, mode of action), and manufacturing processes.

   • Acceptance Criteria: Substantial equivalence based on these comparisons.
   • Device Performance: The detailed comparison table (Table 1) outlines the similarities and minor differences. The document explicitly states: "LUOFUCON® Collagen Particles has the similar indications for use, and very similar technological characteristics to the predicate device(K171645). Both devices are 100% collagen and are designed as powder form, Tyvek packaging, single-use, sterile product. Their main production process includes drying, grinding, and irradiation sterilization. The subject and predicate devices employ the same mode of action in that both devices contain an absorbent nature that maintains a moist wound environment to support wound healing."

2. Non-Clinical Data/Information: Providing data on sterilization, shelf-life, biocompatibility, and performance bench tests to ensure safety and performance.

   • Acceptance Criteria: Meeting relevant ISO standards (ISO 11137-1/-2 for sterilization, ISO 10993-1 for biocompatibility, ISO 22442 for animal-derived materials safety) and demonstrating that the device meets performance requirements.
   • Device Performance:
     • Sterilization and Shelf-Life: "LUOFUCON® Collagen Particles is sterilized using Gamma radiation to a sterility assurance level of 10-6." and "a real-time aging test was conducted to demonstrate the shelf-life of LUOFUCON® Collagen Particles."
     • Biocompatibility: "The results showed that LUOFUCON® Collagen Particles meets biocompatibility requirements of the ISO 10993-1 standard and FDA Guidance, and it raised no new safety concerns for biocompatibility to the predicate device."
     • Performance Test-bench: "Test results confirm that the subject device meets all product performance requirements and demonstrates substantial equivalence to the predicate device." Specific tests conducted include: Appearance, Weight, Sieving rate, Loss on drying, Free swell absorption, pH value, Heavy metal, Hydroxyproline assay, Endotoxin content, Sterility, In-Vitro degradation.
     • Animal-Derived Materials Safety: "the requirements of safety is compliant with FDA quidance document-Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) and ISO 22442 standards."

In summary, for this specific submission of a collagen wound dressing, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device through detailed comparison and non-clinical testing, rather than performance metrics for an AI algorithm.

The document does not contain any information related to AI/SaMD testing, human reader studies, or ground truth establishment in the context of an AI system.

Ask a specific question about this device

HealiAid® Dental Collagen Wound Dressing is indicated for the management of oral wounds and sores, including:

1. Denture sores
2. Oral ulcers (non-infected or viral)
3. Periodontal surgical wounds
4. Extraction sites
5. Surgical wounds.
6. Traumatic wounds

The subject device is HealiAid® Dental Collagen Wound Dressing (HealiAid Dental) that is a white, porous, pliable and absorbable collagen wound dressing. HealiAid Dental is fabricated by fibrous collagen matrix purified from bovine Achilles tendons. HealiAid Dental is pliable and can be applied easily to oral wounds to protect the wound bed. The product is supplied in a sterile, nonpyrogenic package, and is indicated for single use only.

The provided text describes the regulatory clearance (510(k)) for the HealiAid® Dental Collagen Wound Dressing. This is a medical device, not an AI/ML software device, and therefore the concepts of acceptance criteria for AI performance metrics (like sensitivity, specificity, AUC), sample size for test sets, ground truth establishment by experts, adjudication methods, MRMC studies, or training sets are not applicable here.

Instead, the acceptance criteria for this medical device are related to its physical and biological properties, and its performance in pre-clinical studies to demonstrate substantial equivalence to a legally marketed predicate device.

Here's a breakdown of the information provided, framed to address the prompt's categories where applicable for a medical device without AI/ML components:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like wound dressings, "acceptance criteria" are typically defined by demonstrating compliance with established standards (like ISO 10993 for biocompatibility) and exhibiting comparable performance to predicate devices in pre-clinical tests.

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

• Test Set (Pre-clinical Studies): The document does not specify exact sample sizes for each pre-clinical test (e.g., number of animals for toxicity or implantation studies). These studies are typically conducted according to standardized protocols outlined in documents like ISO 10993, which define appropriate sample sizes for each test type.
• Data Provenance: The studies were pre-clinical (laboratory and animal studies) rather than human clinical trials. The bovine Achilles tendons are the source material.

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

• This is not applicable as the "ground truth" for this type of device is established through standardized laboratory tests and animal models, adhering to recognized international standards (e.g., ISO 10993, USP 151, ISO 22442). These tests have defined endpoints and criteria, and their interpretation is generally performed by qualified laboratory personnel following strict protocols, rather than a consensus of human "experts" evaluating an outcome like an image.

4. Adjudication Method for the Test Set

• Not applicable. The pre-clinical tests have objective measurements and pass/fail criteria based on established standards, not subjective assessments requiring adjudication.

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

• Not applicable. MRMC studies are specific to diagnostic devices (often imaging-based AI) where multiple human readers interpret cases, and their performance is compared with and without AI assistance. The HealiAid® Dental Collagen Wound Dressing is a therapeutic/wound management device, not a diagnostic one.

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

• Not applicable. This device is a physical wound dressing and does not involve an algorithm or AI functionality.

7. The Type of Ground Truth Used

• For the pre-clinical studies, the "ground truth" is established by the objective results of standardized biological and chemical tests (e.g., cell viability in cytotoxicity, presence/absence of mutagenic activity in genotoxicity, tissue reactions in implantation, absorption values, degradation rates). These are verifiable scientific outcomes, not interpretations of medical images or pathology.

8. The Sample Size for the Training Set

• Not applicable. This device does not use AI/ML and therefore does not have a "training set."

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

• Not applicable for the same reason as above.

Ask a specific question about this device

The 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

Collagen Wound Dressing is an advanced wound care device composed of pure freezedried cross-linked bovine collagen. It is a sterile, absorbent, white, porous, topical wound dressing. As a primary wound dressing, it 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.

The provided text does not describe a study that proves a device meets acceptance criteria for an AI/ML medical device. Instead, it is an FDA 510(k) clearance letter for a Collagen Wound Dressing, which is a physical medical device, not an AI/ML software.

The document discusses non-clinical data, performance tests (e.g., appearance, weight, absorption, pH, heavy metals, sterility, SEM, DSC, FTIR), biocompatibility, sterilization, and shelf-life studies. It explicitly states, "No clinical study is included in this submission."

Therefore, I cannot extract the information for an AI/ML medical device as requested, because the provided text is about a physical wound dressing and does not contain any details related to:

• Acceptance criteria for an AI/ML algorithm's performance (e.g., sensitivity, specificity, AUC)
• Sample sizes for test sets used in AI/ML validation
• Number/qualifications of experts for ground truth establishmen
• Adjudication methods
• MRMC studies
• Standalone algorithm performance
• Type of ground truth (e.g., pathology, outcomes data) in the context of an AI/ML model
• Training set details for an AI/ML model

The request's template is specifically designed for AI/ML device evaluations, which is not applicable to the content of this FDA clearance letter.

Ask a specific question about this device

SurgiAid® Collagen Wound Dressing is indicated for use in patients who have surgical wounds, donor sites/grafts, podiatric wound, wound dehiscence, traumatic wounds, abrasions, lacerations, partial thickness burns or skin tears. SurgiAid® Collagen Wound Dressing can be applied to wounds with depth less than 0.3 cm.

SurgiAid Collagen Wound Dressing (SurgiAid) is white, porous pliable and absorbable collagen wound dressing. It is fabricated by fibrous collagen matrix which is purified from bovine Achilles tendon. SurgiAid is pliable and can be applied easily to clean wound. The product is supplied in sterile, non-pyrogenic package, and is indicated for single use only.

The provided text describes a 510(k) submission for a medical device called "SurgiAid® Collagen Wound Dressing" (K223126). This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than a de novo approval requiring extensive clinical efficacy studies. Therefore, the "study" described and the "acceptance criteria" are primarily related to non-clinical performance data and comparison to the predicate device.

Here's an analysis of the requested information based on the provided text:

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

The document provides a comparison table (Table 1) between the subject device (K223126), the predicate device (K100927), and a reference device (K122325). The acceptance criteria are implied by the "Comparison" column, which states "Identical to Predicate Device" or similar, indicating that the subject device's performance should match that of the predicate. For specifications (dimensions), the acceptance is that the new sizes "fall within the size range of the reference device."

The Study that Proves the Device Meets the Acceptance Criteria:

The "study" here is a series of non-clinical tests and a comparison to the predicate device to demonstrate substantial equivalence, rather than a clinical trial.

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 discusses non-clinical performance and material characteristics.

• Sample size: The specific sample sizes for each non-clinical test (e.g., how many dressings were tested for water absorption, porosity, sterilization validation, etc.) are not explicitly provided in the summary.
• Data provenance: The document states the manufacturer is Maxigen Biotech Inc. in Taoyuan City, Taiwan. The non-clinical tests would have been conducted by or for this manufacturer. It does not specify whether these tests were performed in Taiwan or elsewhere. The data is "retrospective" in the sense that the new device's characteristics were compared to already established characteristics of the predicate and reference devices, and tested against established standards (ISO10993, etc.). These are typically laboratory tests, not patient data trials.

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)

This question is not applicable to this type of submission. The "ground truth" for non-clinical performance data (e.g., water absorption, porosity, biocompatibility) is established according to recognized international standards (e.g., ISO 10993 for biocompatibility) and validated laboratory methods. It does not involve expert consensus on medical images or clinical outcomes.

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

This question is not applicable. Adjudication methods are typically used in clinical trials involving subjective interpretation of data (like imaging studies where multiple readers agree/disagree on a finding). For non-clinical tests, results are typically quantitative and objective measurements against predefined criteria/standards.

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

This question is not applicable. An MRMC study is relevant for diagnostic devices, especially those incorporating AI, where human readers interpret medical images. This document describes a collagen wound dressing, which is a therapeutic device, and does not mention any AI component or diagnostic function.

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 physical wound dressing, not an algorithm or software.

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

For the non-clinical tests:

• Standards/Specifications: The "ground truth" for characteristics like water absorption, porosity, density, sterilization, packaging integrity, and biocompatibility is based on established international standards (e.g., ISO10993-1:2018) and predefined acceptance criteria derived from the predicate device's performance and general recognized medical device safety and efficacy principles.
• Predicate Device Data: The performance of the predicate device (K100927) serves as a key "ground truth" for comparison to establish substantial equivalence.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of this 510(k) submission for a wound dressing. Training sets are used in machine learning for AI algorithms.

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

This question is not applicable as there is no training set.

Ask a specific question about this device

LUOFUCON® Collagen Wound Dressing is intended for the management of wounds including: full thickness and partial thickness wounds, pressure ulcers, ulcers, ulcers caused by mixed vascular etiologies, diabetic ulcers, partial thickness burns, donor sites and other bleeding surface wounds, abrasions, traumatic wounds healing by secondary intention, dehisced surgical incisions.

The dressing can be cut to the exact size of the wound, and can be used in multiple layers.

LUOFUCON® Collagen Wound Dressing is comprised of a porous matrix of cross-linked bovine collagen. LUOFUCON® Collagen Wound Dressing is a sterile, single use, white or off-white, pliable, absorbent and biodegradable wound dressing.

When the wound dressing absorbs wound exudate or sterile water, LUOFUCON® Collagen Wound Dressing transforms into a soft, conformable gel sheet, maintains a moist wound environment, to protect the wound and support natural healing.

LUOFUCON® Collagen Wound Dressing can be used as a primary wound dressing in direct contact with the wound, or be used in combination with other suitable secondary dressings. The dressing can be cut to the exact size of the wound, and can be used in multiple layers.

LUOFUCON® Collagen Wound Dressing is sterilized and sold after sterilization by radiation using conditions validated following ISO 11137-2:2013.

The provided text is a 510(k) summary for the LUOFUCON® Collagen Wound Dressing, which is a medical device intended for wound management. The document states that the device is substantially equivalent to a predicate device (Medline Collagen Wound Dressing, K060456).

The document does not describe a study in the context of comparing the device to human readers or an AI algorithm, but rather a set of bench tests and biocompatibility tests to demonstrate safety and effectiveness for its intended use, and to prove substantial equivalence to a predicate device. This is typical for a 510(k) submission for a wound dressing, which is not an AI-powered diagnostic device.

Therefore, many of the requested fields are not applicable to the information provided in this document.

Here's a breakdown based on the available information:

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

The document does not explicitly state "acceptance criteria" as numerical thresholds for specific performance metrics. Instead, it states that "the subject device meets all product performance requirements for the intended use and demonstrates substantial equivalence to the predicate device."

However, we can infer some "performance requirements" that were tested:

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

Not applicable in the context of an AI/human reader study. The document refers to "non-clinical data and performance data" and "bench tests" performed on the device itself. Specific sample sizes for these tests (e.g., number of dressings tested for tensile strength) are not provided in this summary.

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

Not applicable. There is no mention of a test set with ground truth established by experts, as this is not an AI diagnostic device.

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. This is not an AI-powered device.

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

Not applicable. This is not an AI-powered device.

7. The type of ground truth used

Not applicable. The "ground truth" here is the physical, chemical, biological, and safety characteristics of the device being evaluated against established standards and the characteristics of the predicate device. For example, for sterility, the ground truth is "sterile at SAL 10^-6". For biocompatibility, the ground truth is "meeting ISO 10993-1 requirements".

8. The sample size for the training set

Not applicable. There is no "training set" in the context of a machine learning model for this medical device submission.

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

Not applicable.

Ask a specific question about this device

Fibrillar Collagen Wound Dressing is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding.

Fibrillar Collagen Wound Dressing may be used for the management of exudating wounds such as:

• Pressure ulcers
• Venous stasis ulcers
• Diabetic ulcers
• Acute wounds, for example trauma and surgical wounds
• Partial-thickness burns

The Fibrillar Collagen Wound Dressing is an absorbent microfibrillar collagen matrix intended for the management of moderately to heavily exudating wounds and the control of minor bleeding. When interacting with the wound fluid, the product immediately begins to absorb the exudates. The Fibrillar Collagen Wound Dressing is applied directly to the secreting wound and protects the wound bed and delicate new tissue. In addition, the product, being comprised of microfibrillar collagen, has intrinsic hemostatic properties, which can be used to control minor bleeding.

The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.

This document does not contain an AI/ML device, and therefore does not have acceptance criteria or study information relevant to AI/ML performance. Instead, it is a 510(k) premarket notification for a Fibrillar Collagen Wound Dressing, claiming substantial equivalence to a predicate device.

The document discusses:

• Regulatory information: FDA approval, regulatory class, product code, general controls, and compliance with various parts of the Code of Federal Regulations.
• Indications for Use: For the management of moderately to heavily exudating wounds and control of minor bleeding, applicable to pressure ulcers, venous stasis ulcers, diabetic ulcers, acute wounds (trauma, surgical), and partial-thickness burns.
• Device Description: An absorbent microfibrillar collagen matrix that absorbs exudates, protects the wound bed, and has intrinsic hemostatic properties.
• Comparison to Predicate Device (K030921): Shows identical indications for use, material (collagen), biocompatibility, sterility, pyrogenicity, and single-use/reuse characteristics.
• Nonclinical Tests: The submission included summary-level information demonstrating compliance with design controls and risk analysis. Specific tests mentioned are:
  • Cytotoxicity (L929 MEM Elution, ISO 10993-5)
  • Sensitization (Guinea Pig Maximization, ISO 10993-10)
  • Intracutaneous Reactivity (Rabbits, ISO 10993-10)
  • Acute Systemic Toxicity (Mice, ISO 10993-11)
  • Pyrogenicity (Rabbit Pyrogen Study, USP )
  • Additional in-vivo implantation and subchronic toxicity testing of the predicate device was leveraged.
• Conclusion: The device is substantially equivalent to its legally marketed predicate based on the design control process and non-clinical studies.

Ask a specific question about this device

CoMatryx Collagen Wound Dressing may be used in the management of partial and full thickness wounds, pressure (stage I-IV) and venous ulcers, ulcers caused by mixed vascular etiologies, venous stasis and diabetic ulcers, 1st and 2nd degree burns, cuts, abrasions, and surgical wounds.

Collagen Wound Dressing, a native bovine Type I Collagen which, when applied to a wound surface, absorbs wound fluid and maintains a moist wound environment in the management of wound healing. The CoMatryx Collagen Wound Dressing is provided sterile in the following patient ready configurations:

• 10 gram Bottle
• 1 gram Vial
• 1 gram pouch

Acceptance Criteria and Device Performance Study for CoMatryx Collagen Wound Dressing

This document analyzes the acceptance criteria and the study performed to demonstrate the substantial equivalence of the CoMatryx Collagen Wound Dressing, as described in the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are based on demonstrating substantial equivalence to the predicate device, CollaTek Powder (now Medifil II Particles). The performance data primarily relies on direct comparison of characteristics and functional testing against specified parameters.

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state a specific "test set" in the context of a dataset for an AI device. Instead, the "testing" involves a series of laboratory and animal studies to demonstrate the device's characteristics and safety.

• Sample Size for Biocompatibility Tests: The document does not specify the exact number of samples used for each in vitro biocompatibility test (Cytotoxicity, Sensitization Guinea Pig, Intracutaneous Irritation Test, Acute Systemic Toxicity).
• Sample Size for Physical/Chemical Characterization: The number of samples for each physical and chemical characteristic (e.g., Water Absorption Capacity, Moisture Content, pH, IR Spectroscopy, SDS-PAGE) is not explicitly stated. These are typically performed on a statistically relevant number of production lots.
• Sample Size for Wound Healing Study: The document refers to "a Wound Healing Study" conducted on "porcine wounds." However, the exact number of porcine subjects or wounds used in this study is not provided.
• Data Provenance: The studies appear to be prospective in nature, conducted specifically for the 510(k) submission. The location of the studies is not explicitly mentioned, but "Alamo Labs, Inc." is named for the SDS-PAGE analysis, suggesting a US-based laboratory.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable as the device is a wound dressing, not an AI/diagnostic device that requires expert-established ground truth for a test set. The "ground truth" for this type of device is established through laboratory test methods and animal studies demonstrating physical, chemical, and biological properties.

4. Adjudication Method

This section is not applicable as there is no mention of a human-read diagnostic test set requiring adjudication in this 510(k) submission.

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

This section is not applicable. The device is a wound dressing, not a diagnostic AI system, so an MRMC comparative effectiveness study is not relevant to its regulatory approval.

6. Standalone (Algorithm Only) Performance Study

This section is not applicable. The device is a physical wound dressing and does not involve an algorithm or AI component.

7. Type of Ground Truth Used

The "ground truth" for the CoMatryx Collagen Wound Dressing is established through:

• Comparative Analysis: Direct comparison of the device's physical, chemical, and functional characteristics against a legally marketed predicate device (CollaTek Powder/Medifil II Particles).
• Laboratory Testing: Adherence to established scientific and regulatory standards for material characterization (e.g., IR Spectroscopy, SDS-PAGE, pH, moisture content, water absorption).
• Biocompatibility Testing: Adherence to ISO 10993 standards.
• Animal Outcomes Data: The "Wound Healing Study" on porcine wounds provides outcomes data for the cellular response to the dressing and its impact on the healing process, particularly in addressing initial in vitro cytotoxicity concerns.

8. Sample Size for the Training Set

This section is not applicable as the device is a physical wound dressing and does not involve a "training set" for an algorithm.

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

This section is not applicable for the same reason as point 8.

Ask a specific question about this device

Dental Collagen Wound Dressings (NovaTape and NovaPlug) are intended for the management of oral wounds and sores, including:

• · Denture sores
• · Oral Ulcers (non-infected or viral)
• · Periodontal surgical wounds
• · Suture sites
• · Burns
• · Extraction sites
• · Surgical wounds
• Traumatic wounds

Dental Collagen Wound Dressings are soft, white to off-white, resorbable collagen dressings produced from cross-linked, purified collagen derived from bovine hide. The thickness and pore structure of the device allow it to absorb fluids and blood at the defect site. Dental Collagen Wound Dressings are supplied sterile, non-pyrogenic, and are for single use only.

This document is a 510(k) summary for NovaBone Products, LLC's Dental Collagen Wound Dressing (NovaTape and NovaPlug), seeking substantial equivalence to a legally marketed predicate device. The information provided is for regulatory clearance and focuses on demonstrating equivalence, rather than establishing new performance criteria for a novel device. As such, the structure of the provided text does not directly align with a typical acceptance criteria study for a novel device.

However, based on the provided text, I can extract and infer information to address your request in the context of demonstrating substantial equivalence to a predicate device.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k), the "acceptance criteria" is essentially demonstrating equivalence to the predicate device in key areas. The "reported device performance" refers to how NovaTape/NovaPlug compares to the predicate.

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

The primary "test set" for performance equivalence was an animal study:

• Sample Size: The document does not explicitly state the number of animals (minipigs) used in the study. It refers to a "porcine (minipig) model."
• Data Provenance: The study was an animal study (in vivo) conducted in compliance with GLP regulation (21 CFR Part 58). The country of origin is not specified, but GLP compliance implies a controlled, prospective study environment.

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

• The document does not mention the use of human experts to establish ground truth in the context of an animal study for performance assessment. The "ground truth" for the animal study was based on histological findings and observations of local reaction and material absorption, likely assessed by veterinary pathologists or similar specialists. However, their specific number or detailed qualifications are not provided.

4. Adjudication Method for the Test Set

• Again, as the study is an animal performance study focused on histological and observational comparison, a human-reader adjudication method (like 2+1, 3+1) is not typically applicable or described here. The evaluation of histological findings would be performed by trained professionals following established pathology protocols.

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

• No, an MRMC comparative effectiveness study was not done. This device is a physical wound dressing, not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

• Not applicable. As stated above, this is a physical medical device (wound dressing), not an algorithm or AI.

7. The Type of Ground Truth Used

• For the animal performance study: The ground truth was established through histological findings and direct observation of local tissue reaction and material absorption in the minipig model. This is a form of biological/pathological ground truth.
• For biocompatibility: Ground truth was established through standardized in vitro and in vivo biocompatibility tests in accordance with ISO 10993.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/machine learning model, so there is no "training set." The development of the device would involve materials science and engineering principles, not data training.

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

• Not applicable. (See point 8).

In summary, this 510(k) emphasizes demonstrating that the NovaTape/NovaPlug device is substantially equivalent to a predicate device, focusing on a robust comparison of materials, intended use, and performance in an animal model and biocompatibility testing, rather than establishing novel performance criteria with human subject data.

Ask a specific question about this device

CollaFirm Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including; pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular origin, venous ulcers, donor and graft sites, abrasions, traumatic wounds healing by secondary intention, dehisced surgical wounds, first and second degree burns. For Prescription use

CollaFirm Collagen Wound Dressing, a highly purified porcine Type I, collagen wound dressing which, when applied to a wound surface, absorbs wound fluid and maintains a moist wound environment in the management of wound healing. The CollaFirm Collagen Wound Dressing is provided in a patient ready, one (1) gram, envelop.

This document describes the 510(k) submission for the CollaFirm Collagen Wound Dressing. As such, it is not a study proving device performance against acceptance criteria in the manner of an AI/ML device. Instead, it demonstrates substantial equivalence to predicate devices through non-clinical testing and shared technological characteristics and intended use.

Here's an breakdown of the information based on the provided text, addressing your questions where applicable to a non-AI/ML device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of medical device (collagen wound dressing), the "acceptance criteria" are typically the standards and tests performed to demonstrate safety, effectiveness, and substantial equivalence to existing predicate devices.

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

This document does not specify "sample sizes" in the context of a "test set" as would be relevant for an AI/ML device. The "testing" here refers to non-clinical laboratory tests performed on the device material itself. The provenance of this data is from controlled laboratory experiments, not patient data in the sense of a clinical trial or AI model evaluation.

• Sample Size for Test Set: Not applicable in the context of typical AI/ML device evaluation. The "sample" is the manufactured device material used for the specified laboratory tests (e.g., cytotoxicity, irritation, sensitization, sterility, pyrogenicity, stability). The specific number of samples tested for each assay is not detailed in this summary but would be part of the full test reports.
• Data Provenance: The tests were conducted in accordance with ISO standards and USP (United States Pharmacopeia) for sterility. This indicates the testing was performed in a laboratory setting. Country of origin for data is not explicitly stated but would typically be from accredited testing facilities. The data is non-clinical/pre-clinical.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. For this type of device submission, there is no "ground truth" in the sense of medical image interpretation or disease diagnosis established by experts. Substantial equivalence relies on comparing the device's characteristics and performance to established standards and predicate devices.

4. Adjudication Method

Not applicable. There is no adjudication method needed for establishing ground truth, as the ground truth concept (expert consensus in diagnostic tasks) does not apply here. The evaluation relies on standardized laboratory tests and comparison to predicate devices, which are objective measurements or assessments.

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 done. The document explicitly states: "CollaFirm Collagen Wound Dressing has not been studied in a clinical setting." This type of study would involve human readers (e.g., clinicians) evaluating cases, which is typically for AI-assisted diagnostic or prognostic tools.

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

No, a standalone performance study (algorithm only) was not done. This is not an AI/ML device, so concepts like "algorithm only" or "human-in-the-loop" are not relevant. The device is a physical wound dressing.

7. The Type of Ground Truth Used

Not applicable in the context of AI/ML. For this submission, "ground truth" is established through:

• Standardized laboratory tests: E.g., ISO standards for biocompatibility (cytotoxicity, irritation, sensitization), USP for sterility, LAL for pyrogenicity. The results of these tests, against predetermined pass/fail criteria, serve as empirical evidence.
• Comparison to predicate devices: The "ground truth" for substantial equivalence often involves demonstrating that the new device's properties and performance are comparable to (or within acceptable limits of) legally marketed predicate devices that have already been deemed safe and effective by the FDA. The amino acid analysis is an example of this.

8. The Sample Size for the Training Set

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

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

Not applicable. This is not an AI/ML device, so there is no "training set" or "ground truth for the training set."

Ask a specific question about this device

Collagen Wound Dressing is intended use for management of partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, tunneled / undermined wounds, surgical wound (donor sites / grafts, post-moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), draining wounds.

Collagen Wound Dressing (Absorbable Collagen Membrane) is a sterile, pliable porous and dense wound dressing made of highly purified collagen derived from porcine skin. It is crosslinked using 1-ethyl-3-(3-dimethyl aminopropyl) carbodiimide (EDC) for the resistance to enzymatic degradation. Collagen Wound Dressing is completely absorbable and highly biocompatible. Collagen Wound Dressing is composed of porous sponge layer for the wound surface and dense film layer for protecting wound from outside.

1. Acceptance Criteria and Reported Device Performance

This submission is for a Collagen Wound Dressing and does not involve an AI/ML device. The "acceptance criteria" and "reported device performance" are framed in terms of biocompatibility and substantial equivalence to a predicate device, rather than diagnostic accuracy metrics.

Note: This device is a medical wound dressing and not an AI/ML diagnostic or assistive device. Therefore, several of the requested categories related to AI/ML studies are not applicable to this submission.

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

No clinical testing was performed for this submission. The evaluation was based on non-clinical testing for biocompatibility and comparison to a predicate device. Therefore, there is no "test set" in the context of an AI/ML algorithm evaluation.

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

Not applicable, as no test set requiring expert ground truth for an AI/ML algorithm was used.

4. Adjudication Method for the Test Set:

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

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

No MRMC study was conducted. This device is a wound dressing, not an AI assistance tool for human readers.

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

Not applicable, as this is a physical medical device and not an algorithm.

7. Type of Ground Truth Used:

For the non-clinical testing, the "ground truth" was established by adherence to recognized international standards and analytical methods:

• Biocompatibility: Adherence to ISO 10993-1 requirements.
• Purity and Identity: Confirmed by SDS-PAGE analysis.
• Viral Inactivation and Removal: Confirmed by specific testing for these properties.

For substantial equivalence, the "ground truth" was the characteristics and performance of the legally marketed predicate device, TheraForm™ Standard / Sheet (K090812).

8. Sample Size for the Training Set:

Not applicable, as this is not an AI/ML model that requires a training set.

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

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

Ask a specific question about this device