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The MLM Biologics bio-ConneKt Wound Matrix is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including:

• · Partial and full thickness wounds
• · Draining wounds
• Tunneling wounds
• Pressure sores/ulcers
• Venous ulcers
• · Chronic vascular ulcers
• Diabetic ulcer
  · Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears)
  · Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, podiatric wounds, dehisced surgical incisions)

The bio-ConneKt Wound Matrix is a sterile, conformable and porous wound dressing made of reconstituted collagen derived from equine tendon. It is chemically crosslinked to provide resistance to enzymatic degradation. The dressing is provided sterile for single use only.

The provided document describes the 510(k) summary for the bio-ConneKt Wound Matrix, which is a medical device. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving a device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or reader improvement in an AI context.

Therefore, many of the requested items related to an AI device's performance study (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment) are not applicable to this document. This document details a collagen-based wound dressing, not an AI or diagnostic device.

Here's an analysis based on the information available in the provided text, addressing the applicable points:

Acceptance Criteria and Study for bio-ConneKt Wound Matrix (K140456)

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are primarily related to demonstrating substantial equivalence to existing predicate devices, particularly regarding safety and effectiveness, rather than meeting specific quantifiable performance metrics in a clinical trial. The performance reported focuses on non-clinical testing.

• Categorization: surface device, breached/compromised surface, >30 days contact duration.
• Tests included: cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity (acute, sub-acute, sub-chronic), genotoxicity.
• All GLP testing met criteria for biocompatibility.
• Results of an appropriate implantation study support biocompatibility as compared to a predicate device control. |
  | Sterility | - Radiation (E-beam) sterilized.
• Provides a sterility assurance level (SAL) of 10⁻⁶. |
  | Technological Characteristics (Material & Design Similarity) | - Made of Type I collagen from equine tendon, chemically crosslinked, sterile.
• Similar in materials and design to predicate devices.
• Differences from predicates (e.g., crosslinking presence, animal origin, specific components) were reviewed and determined to raise no concerns regarding potential safety or effectiveness. |
  | Indications for Use Similarity | - Indications for use are consistent with those of the predicate devices for local management of moderately to heavily exuding wounds (e.g., partial/full thickness wounds, ulcers, trauma wounds, surgical wounds).
• Found to be substantially equivalent in indications for use. |

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

• Sample Size for Test Set: Not applicable. No clinical "test set" in the context of an AI device's performance evaluation was used. The evaluation relied on non-clinical (laboratory/bench) testing.
• Data Provenance: Not applicable for clinical data. Non-clinical biocompatibility and sterility testing data were generated internally by MLM Biologics Inc. or contracted labs.

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

• Not applicable. No human expert review was involved in establishing a "ground truth" for a diagnostic or AI performance evaluation. The evaluation focused on physical and biological properties.

4. Adjudication Method for the Test Set

• Not applicable. No adjudication method for a test set was described.

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

• No. An MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging or AI interpretation devices, which the bio-ConneKt Wound Matrix is not.

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.

7. The Type of Ground Truth Used

• Not applicable for clinical ground truth. The "ground truth" for this device's evaluation came from established scientific methods for material characterization, biocompatibility testing (in vitro and in vivo animal studies for implantation), and sterility testing (e.g., SAL determination). These are objective measurements rather than expert consensus on clinical cases or pathology.

8. The Sample Size for the Training Set

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

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

• Not applicable. This question pertains to AI development, which does not apply to the bio-ConneKt Wound Matrix.

Summary of Device Evaluation Approach:

The submission for the bio-ConneKt Wound Matrix (K140456) is a 510(k) premarket notification, which aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. For this type of device (a wound dressing), the primary evidence provided is non-clinical testing:

• Biocompatibility testing: Conducted under GLP according to ISO 10993 standards, including various toxicity and reactivity tests. An implantation study was also performed.
• Sterilization validation: Demonstrated a Sterility Assurance Level (SAL) of 10⁻⁶.
• Technological characteristics comparison: Analysis of material composition (Type I collagen, equine tendon, crosslinking) and design compared to predicate devices.

The conclusion drawn by MLM Biologics, and concurred by the FDA (as indicated by the 510(k) clearance letter), is that the bio-ConneKt Wound Matrix is "as safe, as effective and performs as well as or better than the predicate devices" based on these non-clinical tests. No clinical testing was performed or required for this submission.

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