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Theae dressings are intended for use as a primary dressing in the management of medium to heavy draining wounds such as minor burne, abrasions and lacerations. These dressings may also be used under the care of a health tare professional for wounds such as surgical incisions, skin grafts, and dermal ulcers.

The proposed Kendall Curity Non-Adhering Dressing is a sterile, single-use, dressing consisting of cellulose acetate fabric impregnated with a specially formulated petrolatum emulsion. It is packaged in clear polyester pouches and is available in 3" x 3", 3" x 8", 3" x 16" and 14" x 4 yds sizes.

Here's an analysis of the provided text regarding the Kendall Curity Non-Adhering Dressing, focusing on the absence of acceptance criteria and a study proving their fulfillment:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no table of acceptance criteria or reported device performance in the provided document. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative performance metrics against pre-defined acceptance criteria.

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

No information regarding a "test set" in the context of evaluating performance against acceptance criteria is provided. The document refers to "Biocompatibility testing," but doesn't specify sample sizes, data provenance (e.g., country of origin), or whether it was retrospective or prospective.

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

This information is not applicable or available in the provided document. The submission type (510(k) for a non-adhering wound dressing) does not typically involve the establishment of ground truth by clinical experts in the way AI or diagnostic device studies would. The assessment revolves around material composition and intended use equivalence.

4. Adjudication Method for the Test Set:

This information is not applicable or available as there is no described test set or clinical performance evaluation involving adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC comparative effectiveness study was done or reported. The 510(k) submission for this type of device does not typically require an MRMC study. The focus is on product comparison to a predicate device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This information is not applicable as the device is not an algorithm or AI-driven system. It is a physical wound dressing.

7. The Type of Ground Truth Used:

Ground truth in the typical sense (expert consensus, pathology, outcomes data) is not applicable for this device submission. The primary "truth" being established is the safety and effectiveness through substantial equivalence to a legally marketed predicate device, based on material composition and intended use. The biocompatibility testing implies adherence to established safety standards, which can be seen as a form of "ground truth" derived from scientific principles, but not clinical outcomes in the same way.

8. The Sample Size for the Training Set:

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reason as above.

Summary of Device Submission Type and Relevance:

The provided document is a 510(k) Pre-Market Notification for a wound dressing. This regulatory pathway primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves:

• Comparison of Technical Characteristics: Showing similar materials, design, energy (if applicable), and intended use.
• Performance Data (often non-clinical): Such as biocompatibility, sterility, and physical properties, to ensure the new device performs as safely and effectively as the predicate.
• Clinical Data (rarely required for 510(k)s for simple devices like dressings): Unless the device has novel technology, a new intended use, or raises new safety/effectiveness questions not addressed by a predicate.

In this specific case, the submission relies on:

• Substantial Equivalence: To the Johnson & Johnson Medical, Inc., Adaptic® Non-Adhering Dressing based on similar materials and intended use.
• Biocompatibility Testing: Based on ISO 10993 standards and FDA guidelines (memorandum G95-1). This testing aims to ensure the materials used are not toxic or irritating to the human body, which is a key safety aspect.

The absence of detailed quantitative acceptance criteria and a "study that proves the device meets the acceptance criteria" in the way one might expect for an AI or diagnostic device is consistent with the nature of a 510(k) submission for a non-adhering wound dressing in 1997. The "proof" lies in the demonstration of substantial equivalence and adherence to general safety standards (like biocompatibility).

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