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Collatek Foam 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

Collatekto Fourn is a sterile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. It is to be used to manage full and partial thickness wounds with moderate to heavy exudate. Collatek® Foam is composed of two scparate layers: a collagen matrix layer and a medical grade foam layer. Collatek Foam's collagen matrix layer is made from insoluble fibrous type I bovinc collagen derived from cowhide. Collatek@ Foam's foam layer is a medical grade polyurothane fourn. Collatek® Foam will be initially available in a 4"x 4" size pad, additional sizes may be introduced at a later time.

This 510(k) summary for the Collatek® Foam wound dressing does not describe a study involving performance acceptance criteria in the way a clinical trial or algorithm validation study would. Instead, it focuses on demonstrating substantial equivalence to predicate devices. Therefore, the device does not have explicit acceptance criteria or a study "proving" it meets those criteria in the traditional sense of a performance study.

Here's a breakdown based on the information provided, highlighting what is not applicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This submission does not describe a "test set" in the context of a clinical performance study with patient samples. The evidence relies on direct comparison to predicate devices and biocompatibility testing. The biocompatibility tests were likely performed on material samples, not patient data.

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

• Not Applicable. No test set with ground truth established by experts is described for performance evaluation.

4. Adjudication method for the test set

• Not Applicable. No test set with ground truth adjudication is described.

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 a wound dressing, not an AI-assisted diagnostic or imaging device, so MRMC studies and AI assistance are not relevant.

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

• Not Applicable. This is a physical medical device (wound dressing), not an algorithm or AI system.

7. The type of ground truth used

• Not Applicable. For the performance as a wound dressing, the "ground truth" for substantial equivalence is based on the established safety and effectiveness profile of the predicate devices, material properties, and proven biocompatibility and sterility. There isn't an "expert consensus," "pathology," or "outcomes data" specifically collected for this device's performance in a clinical study to establish a ground truth.

8. The sample size for the training set

• Not Applicable. This is not an AI or machine learning device requiring a training set.

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

• Not Applicable. This is not an AI or machine learning device requiring a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" or evidence provided is a demonstration of substantial equivalence to legally marketed predicate devices (VigiFOAM® and SkinTemp®) for the same intended use. This is common for 510(k) clearances, especially for devices where the technology is well-understood and similar alternatives exist.

The key elements used to "prove" substantial equivalence are:

• Comparison to Predicate Devices: A side-by-side comparison (Table 1-2.1.2 is mentioned but not provided in the excerpt) showing similarity in:
  • Indications for Use
  • Instructions for Use
  • Technological Characteristics (design, fluid handling)
  • Materials (constituents)
• Biocompatibility Testing: Performed by North American Science Associates, Inc. (NAMSA) in accordance with Good Laboratory Practices (GLP), demonstrating the device meets or exceeds FDA Blue Book Memorandum G95-1 and ISO 10993 requirements. This addresses safety.
• Sterility Validation: Confirmation that the sterilization process (electron beam) achieves a Sterility Assurance Level (SAL) of 10^-6 (implied) in accordance with ANSI/AAMI/ISO 11137-1994. This addresses sterility.

Essentially, the company is arguing that because their device is fundamentally the same as already cleared devices, and it passes standard safety and sterility tests, it is equally safe and effective.

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