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Collagen Dental Wound Dressings are indicated 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

Collagen Dental Wound Dressings are absorbent, porous, collagen matrices engineered from purified collagen derived from bovine dermis tissue. The Collagen Dental Wound Dressings are applied directly to the wound and protect the wound and delicate new tissue. Collagen Dental Wound Dressings can be removed, replaced or left in situ. If left in situ the dressings will be essentially resorbed in 30 days. Collagen Dental Wound Dressings are available in tape, sponge and plug form, and are supplied sterile, non-pyrogenic and for single use only.

The provided text describes a 510(k) premarket notification for "Collagen Dental Wound Dressings" (K152600). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a comparative effectiveness study or a comprehensive study with human readers.

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

1. Table of Acceptance Criteria and Reported Device Performance

Strict "acceptance criteria" as would be set for a clinical trial with specific performance metrics (e.g., sensitivity, specificity for diagnostic devices, or specific clinical outcomes for therapeutic devices) are not explicitly stated in this 510(k) summary. Instead, the focus is on demonstrating "substantial equivalence" of the Collagen Dental Wound Dressings to its predicate devices by comparing technical characteristics and showing similar in vitro and in vivo performance in non-clinical tests.

The criteria for demonstrating substantial equivalence are implicitly that the new device performs comparably to the predicate devices in various tests.

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

The "test set" in this context refers to the samples used in the non-clinical tests (e.g., materials for in vitro characterization, animals for biocompatibility and resorption studies). The document does not specify exact sample sizes for each test. For example:

• In vitro characterization: The number of samples for each test (Composition, Dimensions, Thickness, Density, Weight, Absorbency, pH, Hydrothermal transition temperature) is not specified.
• Biocompatibility:
  • Cytotoxicity: Not specified.
  • Sensitization: "Guinea Pig Maximization" – typically involves a group of guinea pigs, but the exact number is not stated.
  • Intracutaneous Reactivity: "Intracutaneous Study in Rabbits" – typically involves a group of rabbits, but the exact number is not stated.
  • Pyrogenicity: "USP (151) Rabbit Pyrogen Study" – typically involves a few rabbits (e.g., 3-8), but the exact number is not stated.
• Resorption study: "rat subcutaneous model" – typically involves a group of rats, but the exact number is not stated.
• Viral inactivation study: Not specified how many samples/batches were tested.

Data Provenance: The data comes from non-clinical laboratory studies (in vitro and in vivo animal models). The document does not mention any human data (retrospective or prospective) for these tests. The country of origin for these specific tests is not stated but implied to be part of the manufacturer's R&D process, likely within the USA given the submission to the FDA.

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

This information is not applicable as the document describes non-clinical testing. "Ground truth" established by human experts (e.g., radiologists, pathologists) is relevant for studies involving human data or diagnostic imaging. The "results" of these non-clinical tests are determined by standard laboratory methods and validated interpretations of those methods.

4. Adjudication Method for the Test Set

This information is not applicable for non-clinical laboratory testing. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies or studies evaluating diagnostic performance where independent reviewers assess cases, and discrepancies are resolved. The tests described here have objective outputs determined by the experimental protocols.

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. This type of study assesses the performance of human readers, sometimes with and without AI assistance, on a set of cases. The document describes a medical device (wound dressing) and its non-clinical characteristics, not a diagnostic or AI-enabled device requiring such a study.

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

No, this refers to a medical device, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is established by the results of the standardized scientific tests themselves (e.g., an in vitro lab test concludes "Non-cytotoxic," an animal study shows "No evidence of causing delayed dermal contact sensitization"). These are objective measurements and observations determined by established methodologies rather than expert consensus, pathology reports (from human patients), or clinical outcomes data.

8. The Sample Size for the Training Set

This refers to a training set for machine learning models. Since this document is for a physical medical device (collagen wound dressings) and not an AI/ML product, the concept of a "training set" is not applicable.

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

As there is no training set for an AI/ML model, this question is not applicable.

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Collagen Dental Wound Dressings 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

Collagen Dental Wound Dressings are absorbent, porous, collagen matrices engineered from highly purified type I collagen derived from porcine Achilles tendon. The Collagen Dental Wound Dressings are applied directly to the wound and protect the wound and delicate new tissue. Collagen Dental Wound Dressings are supplied sterile, non-pyrogenic, in various sizes, and for single use only.

This appears to be a 510(k) summary for a medical device (Collagen Dental Wound Dressings), which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, some of the requested information (like MMRC studies, sample sizes for test/training sets with ground truth, expert qualifications) is not typically detailed in this type of submission.

Here's an attempt to extract and infer the information based on the provided text:

Acceptance Criteria and Device Performance Study

The primary study conducted to assess the Collagen Dental Wound Dressings was a comparison to predicate devices through in vitro and in vivo (biocompatibility) tests, along with referencing the clinical history of the predicate devices. The device's performance is demonstrated by its substantial equivalence to the legally marketed predicate devices, Collacare Dental (K110388) and Collagen Wound Dressing - Oral (K040403).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the context of a traditional clinical study with a "test set" of patients/samples designed to evaluate performance against specific endpoints in humans. The "tests" here refer to in vitro and in vivo (animal or lab) studies.
• Data Provenance: The studies were non-clinical (in vitro and in vivo biocompatibility, viral inactivation). The clinical history of the predicate devices was referenced, implying retrospective use of existing clinical data from those older devices. The country of origin for the non-clinical studies is not specified but would likely be the manufacturing or testing facilities used by Collagen Matrix, Inc. in the US.

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

• This is not applicable as there was no traditional clinical "test set" with human data requiring expert ground truth establishment for this 510(k) submission. The evaluation relied on non-clinical data and comparison to existing predicate devices.

4. Adjudication Method for the Test Set

• Not applicable, as there was no clinical test set requiring adjudication of findings.

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

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical tests were performed on the product, however clinical history of the predicate device was referenced in the submission."

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, not a software algorithm, so the concept of an "algorithm only" performance study does not apply.

7. The Type of Ground Truth Used

• For the non-clinical studies (in vitro and in vivo biocompatibility, viral inactivation), the "ground truth" was established by the scientific and regulatory standards (e.g., ISO 10993-1, FDA Blue Book Memorandum G95-1) and the successful completion of the tests according to established protocols.
• For the equivalence claim, the "ground truth" was the established safety and effectiveness profile of the legally marketed predicate devices, as evidenced by their clinical history.

8. The Sample Size for the Training Set

• Not applicable. There was no "training set" in the context of an AI/algorithm.

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

• Not applicable. There was no "training set."

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Collagen Dental Sponge Membranes are intended for use in patients with moderate to Sollagen Bontal disease as a resorbable material for placement in periodontal defects to aid in wound healing post periodontal surgery.

Description of the Dore." Conagen Domar Sponge recemsnufactured from crosslinked type I collagen derived from bovine Achilles tendon. The product is supplied sterile, non-pyrogenic, and for single use only.

This submission (K033729) is for a Collagen Dental Sponge Membrane, a medical device. The provided documents are a 510(k) Summary of Safety and Effectiveness and the FDA's decision letter. These documents do not contain information about acceptance criteria or a study proving that the device meets them in the way typically expected for performance claims (e.g., sensitivity, specificity, accuracy for an AI/diagnostic device).

Instead, this submission is for a material (Collagen Dental Sponge Membranes) and focuses on demonstrating substantial equivalence to predicate devices by assessing its safety and technical characteristics. The "acceptance criteria" here are implicitly the regulatory requirements for showing substantial equivalence.

Here's how to interpret the available information in the context of your request:

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

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

This information is not provided in the document. For device submissions focused on substantial equivalence based on material properties and biocompatibility, human clinical "test sets" in the context of diagnostic performance are typically not required unless there are novel claims or significant differences from predicates. The "test set" here refers to the samples used for the ISO 10993-1 testing.

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 information is not provided. The "ground truth" for biocompatibility testing (ISO 10993-1) is established by the standardized test methods themselves, which are performed by trained laboratory personnel. There is no mention of clinical experts establishing ground truth for a test set in this context.

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

This information is not provided. Adjudication methods are typically relevant for clinical studies involving human interpretation or subjective outcomes, which are not detailed 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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which this Collagen Dental Sponge Membrane is not.

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

No, a standalone algorithm performance study was not done. This device is a bio-material, not an algorithm.

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

For the safety evaluation, the "ground truth" was established by standardized laboratory testing protocols (ISO 10993-1) for biocompatibility. These tests assess parameters like cytotoxicity, sensitization, irritation, etc., against predefined pass/fail criteria within the standard.

8. The sample size for the training set

This information is not provided. "Training set" is a concept for machine learning models, which is not applicable to this device submission.

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

This information is not applicable as there is no training set for an algorithm.

In Summary:

The provided documents describe a 510(k) submission for a Collagen Dental Sponge Membrane. The "study" referenced is the biocompatibility testing according to ISO 10993-1, which serves as the evidence for the device's safety. The "acceptance criteria" are the predefined pass/fail thresholds within these ISO standards. The overall goal of the submission is to demonstrate substantial equivalence to existing predicate devices, rather than to prove performance against clinical outcome metrics through a typical clinical trial with human subjects. Thus, many of the questions related to AI/diagnostic device evaluation are not applicable here.

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