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Non-Woven dressing impregnated with Sodium Chloride is intended for use on moderately to heavily exudating wounds. The dressing will absorb exudate and maintain a moist hypertonic environment when applied to the wound. A moist wound environment will support autolytic debridement of the wound. The dressing is appropriate for the following indications:minor cuts, minor burns and minor lacerations. Under the guidance of a heatth care professional, "AbsorbaSalt" Cotton Gauze Packing is also indicated for surgical incisions and excisions, venous stasis ulcers, pressure ulcers and decubitus ulcers.

Device Description

Dumex Pak-its Non-Woven Dressing Impregnated with Sodium Chloride

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Dumex Pak-its Non-Woven Dressing:

Based on the provided document, which is a 510(k) premarket notification letter from the FDA, the information requested about acceptance criteria and a study proving device performance is not explicitly available in this format.

The document primarily focuses on:

Confirming "substantial equivalence" of the device to existing predicate devices. This means the FDA has determined the new device is as safe and effective as a legally marketed device that was on the market before May 28, 1976, or has been reclassified.
Stating specific limitations on labeling claims for the device (e.g., no claims of accelerating wound healing, no claims for third-degree burns).
Outlining general regulatory requirements for the device.
Listing the "Indications for Use."

A 510(k) submission typically includes data to support substantial equivalence, which might involve performance data. However, the FDA letter itself is a summary of the regulatory decision, not the full performance study report. Therefore, I cannot extract the detailed study information you requested directly from these pages.

However, I can infer some aspects and highlight what information is missing based on your request categories:

Here's an attempt to fill out the table, acknowledging that most of the requested detail is not present in the provided FDA letter:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred/Not Explicit)	Reported Device Performance (Inferred/Not Explicit)
Safety	Non-toxic, non-irritating, biocompatible.	Assumed to meet safety profile similar to predicate; no adverse events reported in summary.
Effectiveness (Indications)	Ability to absorb exudate, maintain moist hypertonic environment, support autolytic debridement.	Assumed to exhibit these properties for minor cuts, minor burns, minor lacerations, surgical incisions/excisions, venous stasis ulcers, pressure ulcers, and decubitus ulcers. Performance is "substantially equivalent" to predicate.
Material Properties	Absorbency, tensile strength (for dressing).	Not specified, but implied to be comparable to predicate.
Sterility	Must be sterile (for wound care).	Not explicitly stated, but implied for medical dressing.
Labeling Compliance	Adherence to specific FDA labeling restrictions.	Explicitly outlined as restrictions in the letter (e.g., no 3rd-degree burn claims, no accelerated healing claims).
Substantial Equivalence	Device is as safe and effective as a legally marketed predicate device.	FDA determined the device is substantially equivalent to existing predicate(s).

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

Sample Size: Not specified in the provided document.
Data Provenance: Not specified. It's likely from a combination of bench testing, possibly some preclinical data, and comparison to existing predicate devices. Whether it's retrospective or prospective is not mentioned.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. For substantial equivalence, the "experts" are often the manufacturers providing data, and FDA reviewers.

4. Adjudication method for the test set

Not specified.

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

MRMC Study: Unlikely to be applicable. This device is a wound dressing, not an imaging AI diagnostic tool. Therefore, MRMC studies and "human readers improve with AI" metrics are not relevant in this context.

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

Not applicable as this is a physical medical device (wound dressing), not an algorithm or AI system.

7. The type of ground truth used

For a physical device like a wound dressing, "ground truth" would typically refer to objective measures of performance (e.g., absorbency tests, biocompatibility tests, clinical outcomes in trials if clinical data was part of the submission), and comparison to the performance of predicate devices. The letter indicates that the device's performance is assumed to be equivalent to the predicate.

8. The sample size for the training set

Not applicable to this type of device and submission (no "training set" in the AI/ML sense).

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

Not applicable to this type of device and submission.

Summary of missing information:

The provided document is an FDA clearance letter for a 510(k) submission. It confirms regulatory clearance based on "substantial equivalence" to a predicate device and outlines labeling restrictions. It does not contain the detailed study design, specific performance metrics, sample sizes, or expert review processes that would be submitted by the manufacturer to the FDA as part of the 510(k) application itself. To get that level of detail, one would need access to the full 510(k) submission report, which is usually hundreds or thousands of pages long.

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