Search Results

For the treatment of chronic venous insufficiency, lymphedema, edema of venous origin, post amputation, lymphatic obstruction and contusions.

Not Found

This document is a 510(k) clearance letter from the FDA for a device named "ATLANT'S." This type of document primarily confirms that a new medical device is "substantially equivalent" to a legally marketed predicate device, allowing it to be marketed. It does not typically contain detailed study data, acceptance criteria, or performance metrics in the way a clinical study report or a premarket approval (PMA) application would.

Therefore, most of the information requested in your prompt cannot be extracted from this document. The letter focuses on regulatory approval rather than a detailed technical performance evaluation.

Here's what can be extracted based on the provided text, and where gaps exist:

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

   • Not available in this document. This letter does not specify acceptance criteria for device performance nor does it report detailed performance metrics from a study. It only states that the device is "substantially equivalent" to a predicate device for its stated indications for use.

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

   • Not available in this document. No information on sample sizes, data provenance, or study design (retrospective/prospective) is provided.

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 available in this document. No details about experts, ground truth establishment, or their qualifications are included.

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

   • Not available in this document. No information on adjudication methods is present.

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 available in this document. This is a 510(k) for a device, not explicitly an AI-driven one (though the document is from 1998, well before the widespread use of AI in medical devices). No MRMC study details are provided.

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

   • Not available in this document. Not applicable as this is not an AI algorithm approval, and no standalone performance data is mentioned.

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

   • Not available in this document. The ground truth for any potential studies is not mentioned.

8. The sample size for the training set

   • Not available in this document. No information on a training set or its size is provided.

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

   • Not available in this document. No information on a training set or how its ground truth was established is provided.

In summary, this 510(k) clearance letter serves as regulatory approval based on "substantial equivalence" to a predicate device, rather than a detailed report of clinical study data or performance metrics. Therefore, the specific details regarding acceptance criteria, study design, expert involvement, and ground truth establishment are not present in this document.

Ask a specific question about this device