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For Plastic and Reconstructive Surgery* * This product is available by prescription only.

Softform® Implant Soft Tissuc Augmentation Tube with Insertion Tool - Size Modifications

{
"1. A table of acceptance criteria and the reported device performance": "The provided text is an FDA 510(k) clearance letter and an 'Indications for Use' page. It does not contain information about specific acceptance criteria or detailed device performance metrics. Its purpose is to declare substantial equivalence to a predicate device and outline the approved indications for use.",
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The provided document does not contain information about a test set sample size or data provenance. This type of detail is typically found in the 510(k) submission itself, not in the clearance letter or indications for use.",
"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)": "The provided document does not contain information about experts used to establish ground truth or their qualifications. This is not typically part of an FDA clearance letter.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "The provided document does not contain information about an adjudication method for a test set. This detail would be found in the device's validation study, not in the regulatory clearance.",
"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": "The provided document does not contain information about a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes related to human-AI collaboration. This type of study is more common for diagnostic AI tools, which doesn't seem to be the primary function of the 'Softform® Implant' mentioned.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "The provided document does not contain information about a standalone algorithm performance study. The device, 'Softform® Implant', is described as a 'Soft Tissue Augmentation Tube with Insertion Tool', suggesting it's a physical implant and not an algorithm-based device requiring standalone performance evaluation.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The provided document does not contain information about the type of ground truth used. As a medical implant, 'ground truth' for its safety and effectiveness would likely come from pre-clinical testing, clinical trials, and material properties, rather than expert consensus on image interpretation or pathology in the context of an algorithm.",
"8. The sample size for the training set": "The provided document does not contain information about a training set sample size. Given the nature of the device ('Softform® Implant' - a soft tissue augmentation tube), it is highly unlikely that an AI training set would be relevant or discussed in its regulatory clearance.",
"9. How the ground truth for the training set was established": "The provided document does not contain information about how ground truth for a training set was established. As noted above, this device does not appear to be an AI/algorithm-based device for which a training set and its associated ground truth would be relevant."
}

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