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Foryou NPWT Dressing Kit is intended to be used with Foryou NPWT Device to manage wounds through removal of fluids, and the NPWT system is indicated for patients who would benefit from a suction device, particularly as it may promote wound healing by removal of fluids, excess exudate, infectious material, and tissue debris. Foryou NPWT Dressing Kit is indicated for use in patients with the following wounds: traumatic, dehisced wounds, partial-thickness burns, chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers, acute wounds, flaps and grafts.

Foryou NPWT Dressing Kit is the wound dressing kit to be used with Foryou NPWT Device for negative pressure wound therapy. It consists of three key components: the foam dressing, the tube unit, and the transparent film. The components are kitted into medical pouch and sterilized, or individually packaged and sterilized. Foryou NPWT Dressing Kit is single-use and sterile. It is available in different sizes: small, medium, large and extra large. The foam dressing should not be used for more than 24 hours and should be replaced with other dressings compatible with Foryou NPWT pump as stated in the Foryou NPWT pump labeling.

The provided text describes a 510(k) premarket notification for a medical device, the "Foryou NPWT Dressing Kit." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical data often seen with novel Class III devices or those requiring a de novo classification.

Therefore, the information you're requesting regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, particularly in the context of an AI/ML device, is largely not present in this document. This document focuses on demonstrating that the new device performs similarly to an existing one through non-clinical performance and biocompatibility testing.

Here's a breakdown of why your specific questions cannot be fully answered by the provided text:

• This is not an AI/ML device. The device described is a Negative Pressure Wound Therapy (NPWT) Dressing Kit, which is a physical consumable for wound management.
• The submission is a 510(k). For 510(k) clearances, the primary goal is to show substantial equivalence to a predicate device. This often involves performance testing (non-clinical) and comparison of specifications, rather than full-blown clinical trials or detailed AI model validation studies.
• Clinical tests were explicitly stated as NOT performed. (Section 10)

However, I can extract the information that is available related to acceptance criteria and performance, translating it to your requested table structure where possible, and explain what is missing.

Acceptance Criteria and Reported Device Performance (as inferred for a non-AI medical device 510(k))

For a physical device like a wound dressing kit, "acceptance criteria" primarily relate to product specifications, safety (biocompatibility, sterility), and core functional performance (e.g., ability to conduct pressure, remove exudate). These are typically verified through bench testing.

Information NOT Present in the Document (and why, given it's a 510(k) for a physical device, not AI)

Given this is a 510(k) for a physical medical device (NPWT dressing kit) and explicitly states "Clinical tests were not performed" (Section 10), the following information relevant to AI/ML device studies would not be found:

1. Sample size used for the test set and the data provenance: Not applicable in the context of an AI model's test set. The "test set" here refers to physical samples for engineering/bench tests. Data provenance (country of origin, retrospective/prospective) is typically for patient data used in clinical studies, which were not performed.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance tests would be established by validated measurement standards and equipment, not human expert consensus.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for performance bench testing results.
4. 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, as this is not an AI-assisted device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, ground truth for performance relates to physical measurements and material properties confirmed by laboratory testing (e.g., pressure values, material composition analysis, sterility validation).
7. The sample size for the training set: Not applicable, as there is no AI model.
8. How the ground truth for the training set was established: Not applicable, as there is no AI model.

In summary: The provided FDA document is a 510(k) clearance letter and summary for a physical medical device (NPWT dressing kit). It demonstrates substantial equivalence primarily through non-clinical performance and safety testing, not through clinical trials or the type of AI/ML performance studies you are asking about.

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Carilex VT Dressing Kits is intended to be used with the Carilex VT device (S1 series) to manage wounds through removal of fluids, and the NPWT system is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of fluids, excess exudates, infectious material, and tissue debris.

The Carilex VT Dressing Kits is indicated for use for patients with the following wounds:

• Traumatic
• Dehisced wounds
• Partial-thickness burns
• Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers
• Acute wounds
• Flaps and grafts

Carilex VT Dressing Kits is the wound dressing to be used with the Carilex VT suction pumps for negative pressure wound therapy. This single-use dressing is manufactured using a reticulated flexible polyether and polyurethane hydrophobic material, housed in a medical grade peel pouch, and sterilized by Ethylene Oxide. The Carilex VT Dressing Kits is available in three sizes; 1) small 2) medium and 3) large

The provided text describes the Carilex VT Dressing Kits (K172725) and its equivalence to a predicate device, the DeRoyal Foam Kits (K112458). The document focuses on regulatory approval and substantial equivalence based on non-clinical tests.

Acceptance Criteria and Device Performance:

The document doesn't explicitly list "acceptance criteria" in a typical quantitative sense (e.g., sensitivity, specificity for an AI device). Instead, it states that the dressing kits met "all pre-determined acceptance criteria and passed the tests" during performance/comparison testing against the predicate device. These criteria would likely be related to the physical and functional performance of the dressing kits in managing wounds through fluid removal, as described in their intended use.

The "reported device performance" is implicitly that it performs comparably to the predicate device, thereby demonstrating substantial equivalence. The "Technological Comparison to Predicate Devices" table (pages 4-5) highlights the similarities across various attributes:

1. Table of Acceptance Criteria and Reported Device Performance (Implied):

Missing Information:

The provided document is a 510(k) summary for a medical device (wound dressing kits), not an AI/software device. Therefore, many of the requested details, such as sample sizes, ground truth establishment methods, expert qualifications, and MRMC study specifics, are not applicable to this type of submission and are not present in the document.

Here's why and what can be gleaned:

2. Sample size used for the test set and the data provenance: Not applicable. This refers to performance testing of the physical medical device and its components, not data-driven AI. The "test set" would be the manufactured dressing kits themselves subjected to various physical and chemical tests (e.g., sterilization validation, material testing, fluid absorption/removal efficiency, biocompatibility). The document mentions "Performance/Comparison Testing of VT Dressing Kits with the predicate" and "The biocompatibility tests were performed with the final finished form of VT Dressing Kits." No details on the exact sample sizes of physical units tested or data provenance (country of origin, retrospective/prospective) are provided, as these are typically part of internal technical reports referenced in the 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI (e.g., image annotations by radiologists) is not relevant here. The "ground truth" for this device would be established engineering and scientific standards for material properties, sterility, and device function.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This relates to expert consensus for AI ground truth.

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 for AI-assisted diagnostic or interpretive devices.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is for AI algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this physical device relies on established engineering and medical standards for material properties, sterility, and functional performance. Things like ISO 10993 (biocompatibility) are the "ground truth" against which the device is measured.

8. The sample size for the training set: Not applicable. There is no AI model or algorithm being "trained" for this physical device.

9. How the ground truth for the training set was established: Not applicable.

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