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The MIST Therapy System produces a low energy ultrasound-generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.

MIST Therapy System is a non-contact, low-energy ultrasound device, which utilizes continuous ultrasonic energy to atomize saline and deliver a continuous mist to the treatment site to promote wound healing.

The provided text describes a Premarket Notification (510(k)) Summary for the MIST Therapy™ System 5.1, seeking clearance from the FDA. This summary focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific performance acceptance criteria through a dedicated study with quantified metrics.

Therefore, many of the requested details about acceptance criteria, specific study results, sample sizes for test/training sets, expert qualifications, and adjudication methods are not present in the provided document, as the 510(k) approval process for this type of device often relies on demonstrating equivalence through design, materials, and function, supported by a summary of clinical evidence rather than a de novo performance study with pre-defined acceptance criteria.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:

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

No explicit acceptance criteria with numerical targets are provided in the document. The "Testing Summary" broadly states that "All study results supported the conclusion that the MIST Therapy System promotes wound healing." This is a qualitative statement of performance rather than a specific quantitative metric against an acceptance criterion.

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

• Sample Size for Test Set: Not specified. The document mentions "numerous preclinical, animal, and human clinical studies" but does not provide details on sample sizes for these studies.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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 and not specified. The studies mentioned relate to wound healing, which would likely involve clinical assessments by healthcare professionals, but the document does not detail how "ground truth" was established, nor the number or qualifications of experts.

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

Not applicable and 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

Not applicable. This device is an ultrasonic wound cleaning device, not an AI-assisted diagnostic or imaging tool. Therefore, MRMC studies and "human readers with/without AI assistance" are not relevant to this product.

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

Not applicable. This is a physical device used for treatment, not an algorithm.

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

The "Testing Summary" refers to "preclinical, animal, and human clinical studies." For human clinical studies, "wound healing" would likely be assessed through observable clinical outcomes (e.g., wound size reduction, removal of slough/fibrin/exudates, reduction of bacteria). The specific methods for establishing this "ground truth" (e.g., specific clinical assessments, photographic evidence, microbial cultures) are not detailed.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/machine learning algorithm that requires a "training set."

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

Not applicable.

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