(126 days)
Selective dissection and fragmentation of tissue, wound debridement (acute and chronic wounds, burns, diseased or necrotic tissue), and cleansing irrigation of the site for the removal of debris, exudates, fragments, and other matter.
The AR1000 system uses ultrasound for selective tissue dissection and fragmentation and saline for irrigation of the wound bed over course of treatment.
The provided text is a 510(k) summary for the AR1000 Ultrasonic Wound Therapy System. It details the device description, intended use, and comparison to predicate devices. However, it does not include information about acceptance criteria, study design, sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or results of MRMC or standalone studies.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance.
- Sample sized used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
- If a standalone study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document primarily focuses on demonstrating substantial equivalence to existing devices based on technical characteristics and intended use, rather than presenting clinical study results with specific performance metrics and acceptance criteria.
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