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Foryou NPWT NP32 Device is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material, and tissue debris.

Foryou NPWT NP32 Device is an AC-powered, portable suction pump with a back-up battery. The pump is used in combination with wound dressing kits, a bacteria filter, suction tubing, drainage tubing, and a disposable canister. Foryou NPWT NP32 Device is designed for hospital use only with specified wound dressing kits to deliver a recommended therapeutic range of -55mmHg of continuous or intermittent negative pressure wound therapy to the wound, which may promote wound healing through the removal of excess exudates, infectious material, and tissue debris by:

• preparing the wound bed for closure
• reducing edema
• promoting granulation tissue formation and perfusion
• removing exudate and infectious material

The wound dressing kits, bacteria filter, suction tubing, drainage tubing, and disposable carister are not included in the Forvou NPWT device package.

Here's a breakdown of the acceptance criteria and study information for the Foryou NPWT NP32 Device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The 510(k) summary for the Foryou NPWT NP32 Device primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and performance specifications. The "acceptance criteria" are implied by the device's ability to meet industry standards and demonstrate comparable performance to predicate devices without raising new safety or effectiveness concerns.

Table of Acceptance Criteria and Reported Device Performance:

Since this is a submission based on substantial equivalence, the "acceptance criteria" are often the performance characteristics of the predicate devices or compliance with recognized standards. The "reported device performance" refers to the Foryou NPWT NP32 Device's own specifications.

Study Details:

1. Sample size used for the test set and the data provenance:

   • The provided document does not specify a "test set" in the context of clinical or performance data involving human subjects. The non-clinical testing involved "bench testing using a mock wound model." The sample size for this mock wound model is not provided.
   • Data Provenance: The document does not provide information on country of origin or whether any data was retrospective or prospective, as it does not report on clinical studies with human participants. It focuses on bench testing and compliance with recognized standards.

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

   • This information is not applicable as there is no mention of a human-reviewed "test set" for ground truth establishment. The evaluation relies on engineering tests and compliance with standards.

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

   • This information is not applicable as there is no mention of a human-reviewed "test set" requiring adjudication.

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:

   • No, an MRMC comparative effectiveness study was not done. This device is a negative pressure wound therapy pump, not an AI-assisted diagnostic tool for human readers.

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

   • Yes, a form of standalone performance was assessed through non-clinical bench testing. The device's performance (e.g., maximum vacuum, battery life) was evaluated independently against specifications and predicate device characteristics, without human interaction in its core function assessment, beyond operating the test equipment.

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

   • For the non-clinical testing, the "ground truth" was established by engineering specifications, recognized industry standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 10993-5, -10), and the performance characteristics of legally marketed predicate devices. The device's performance was compared to these established benchmarks.

7. The sample size for the training set:

   • Not applicable. This document describes a medical device (a pump), not a machine learning or AI algorithm that would typically require a training set.

8. How the ground truth for the training set was established:

   • Not applicable. As above, there is no mention of a training set for an algorithm.

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