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The device is intended for the management of minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns.

CoMatryx OTC Collagen Wound Dressing is a native bovine Type I Collagen which, when applied to a wound surface in powder or pad form, absorbs wound fluid and maintains a moist wound environment. The CoMatryx OTC powder and pads are provided sterile in the following configurations:

• . 1 gram powder in 1 pouch
• 2"x2," 3"x4," and 8"x12" pad in pouch

The provided text describes a 510(k) premarket notification for a medical device called "CoMatryx OTC Collagen Wound Dressing." This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a PMA.

Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details are not applicable (N/A) in the context of this 510(k) submission.

Here's why and what information is provided:

• 510(k) Substantial Equivalence: The primary goal of a 510(k) is to show that a new device is "substantially equivalent" to a predicate device already on the market. This often means demonstrating similar technological characteristics, intended use, and performance, with little to no new safety or effectiveness concerns. It does not typically involve the rigorous performance studies, human-in-the-loop assessments, or detailed ground truth establishment associated with AI/ML device approvals or PMAs.
• Focus on Bench Testing and Biocompatibility: For devices like wound dressings, the evidence typically relies on bench testing (e.g., sterilization, shelf life, physical properties) and biocompatibility testing, rather than studies involving human readers or complex algorithms.

Based on the provided document, here's what can be extracted and why the requested information is N/A:

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

Instead, the document highlights parameters compared to the predicate device:

The conclusion states: "Comatryx OTC Collagen Wound Dressings are identical to the predicate device except for the indications for use; therefore, testing from K171645 applies to this device." This implies that prior testing for the predicate device (K171645) supported its safety and effectiveness, and since the current device is "identical except for indications," that prior testing is considered sufficient.

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

• Sample Size: N/A - No clinical "test set" in the context of an AI/ML or comparative clinical performance study is described. The relevant data for a wound dressing is likely bench testing (sterilization, physical properties, biocompatibility).
• Data Provenance: N/A - Not applicable for this type of 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)

• N/A - Not applicable. This type of ground truth establishment by experts is relevant for diagnostic devices, particularly those involving image interpretation (e.g., radiology AI). This wound dressing device does not involve such an assessment.

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

• N/A - Not applicable. No expert adjudication process is described or required for this type of device submission.

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

• N/A - Not applicable. This device is a collagen wound dressing, not an AI-assisted diagnostic tool.

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

• N/A - Not applicable. This device is not an algorithm.

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

• N/A - Not applicable. The "ground truth" for a wound dressing focuses on its material properties, biological compatibility, and ability to maintain a moist wound environment, typically demonstrated through in vitro and in vivo (animal, not human clinical trials unless specifically deemed necessary for a novel claim) testing, rather than clinical outcomes data or expert consensus on interpretations. The submission relies on "comparison of the composition, technological characteristics, intended use and biocompatibility test results" to a predicate.

8. The sample size for the training set

• N/A - Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

• N/A - Not applicable. As above, this device is not an AI/ML algorithm.

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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.

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For Over-the-Counter Use: For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.

For Prescription Use: For moistening absorbent wound dressings and for moistening, debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.

The Sterile Water and Sterile Normal Saline devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile normal saline for irrigation and meets the requirements of USP . The devices are offered in 100 mL, 250 mL and 500 mL bottles and 120 mL cups

The provided text describes a 510(k) premarket notification for "USP Sterile Water" and "USP Sterile Normal Saline (0.9% Sodium Chloride)." This document is a regulatory submission for medical devices, primarily focusing on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies against specific acceptance criteria.

As such, the document does not contain the detailed information requested regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set or its provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
• Standalone (algorithm-only) performance.
• Type of ground truth used.
• Sample size for a training set.
• How ground truth for the training set was established.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (K083042, Sterile Water and Sterile Normal Saline from Nurse Assist, Inc.) based on:

• Intended Use: The device shares the same intended uses as the predicate, which includes moistening absorbent wound dressings, cleaning minor cuts/burns/abrasions/irritations (OTC use), and moistening/debriding/cleaning acute/chronic dermal lesions and device irrigation (Prescription Use).
• Technological Characteristics: The devices have the same technological characteristics (sterile water or sterile normal saline meeting USP and providing mechanical action for cleaning).
• Mechanism of Action: The mechanism of action is identical – mechanical action of fluid for removing foreign objects.
• Composition: Supplied sterile in containers of identical composition.
• Biocompatibility Testing: The devices were tested according to ISO 10993 standards and found to be non-cytotoxic, non-irritating, and non-sensitizing, with results similar to those reported for the predicate devices.

Conclusion:

The submission concludes that "Based on a comparison of composition, technological characteristics, intended use and biocompatibility test results, we conclude that Sterile Normal Saline perform at least as well as the predicate devices. Sterile Water and Sterile Normal Saline are therefore considered to be substantially equivalent to the above-mentioned predicate devices."

Therefore, for this specific submission, the "acceptance criteria" revolve around demonstrating comparable characteristics and safety to a legally marketed predicate device, rather than quantitative performance metrics against pre-defined clinical thresholds typically seen for more complex diagnostic or therapeutic devices. The "study" that proves the device meets "acceptance criteria" (i.e., substantial equivalence) consists of the comparative analysis described above and the biocompatibility testing.

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