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The ConvaTec Nonwoven Pad is intended for use in the management of moderately to heavily exudating acute and chronic wounds. The dressing is indicated for minor lacerations and minor burns. Under the guidance of a healthcare professional, the dressing is also indicated for biopsies, open and closed surgical incisions and excisions, pressure ulcers, diabetic ulcers and leg ulcers such as venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology.

Nonwoven Pad is a sterile, absorbent pad dressing intended for use in the management of moderately to heavily exudating acute and chronic wounds. The dressing is indicated for minor abrasions, minor lacerations and minor burns. Under the guidance of a healthcare professional, the dressing is also indicated for biopsies, open and closed surgical incisions, pressure ulcers, diabetic ulcers and leg ulcers such as venous stasis ulcers, arterial ulcers of mixed aetiology. Nonwoven Pad absorbs wound exudate. The hydrophobic layer minimizes strike through of exudate and ensures distribution of the fluid throughout the dressing.

The provided text describes basic conformity testing for a medical device (Nonwoven Pad) for a 510(k) submission, not a study involving AI or complex statistical analysis for performance metrics as you've outlined in your request. Therefore, most of the information required for your output (like acceptance criteria for AI, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) is not present in the given document.

However, I can extract the relevant information that is available regarding acceptance criteria and the "study" that proves the device meets them, keeping in mind the limitations of the input text.

Here's a summary of what's available and an explanation of why other requested fields cannot be filled:

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

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

   • Sample Size: Not specified.
   • Data Provenance: Not specified, but implied to be from laboratory bench testing.

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)

   • Not applicable. This device does not involve expert interpretation or AI. The tests are physical/chemical.

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

   • Not applicable. This device does not involve expert interpretation.

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

   • No. This is not an AI device.

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

   • No. This is not an AI device.

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

   • The "ground truth" for the comparative bench testing was likely the performance of the predicate device (TENDERSORB® WET PRUF® Abd Pad) for characteristics like absorbency and preventing strike-through.
   • The "ground truth" for biocompatibility was established through ISO 10993 Part I "Biological Evaluation of Medical Devices" standards.

8. The sample size for the training set

   • Not applicable. This device does not involve a "training set" in the context of machine learning.

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

   • Not applicable. This device does not involve a "training set."

Summary of the Study (as described in the text):

The "study" refers to a series of tests conducted to demonstrate the safety and effectiveness of the Nonwoven Pad, primarily through substantial equivalence to a predicate device.

• Bench Testing: Comparative bench testing was performed between the Nonwoven Pad and the predicate device, TENDERSORB® WET PRUF® Abd Pad. The purpose was to show equivalence in intended use, design, and function. The results indicated that "the two products to be equivalent." Specific metrics like absorbency or strike-through minimization are mentioned as functions of the device, implying these were likely part of the bench tests, though no specific numerical results or methodologies beyond a general statement of equivalence are provided.
• Biocompatibility Testing: The device underwent biocompatibility testing according to ISO 10993 Part I "Biological Evaluation of Medical Devices" with an FDA modified matrix. The results "demonstrate that Nonwoven Pad is considered to be non-toxic," and these tests were conducted under Good Laboratory Practices (GLP).

Conclusion on Meeting Acceptance Criteria:

Based on the provided text, the device met its acceptance criteria by demonstrating:

1. Substantial Equivalence to a legally marketed predicate device (Kendall's TENDERSORB® WET PRUF® Abd Pad) through comparative bench testing for intended use, design, and function.
2. Biocompatibility by passing tests conducted under ISO 10993 Part I and being deemed non-toxic.

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