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The 3D SCOPE™ is designed to aid in visualization for general endoscopic and laparascopic procedures including general thoracic, and as an aid in visualization and examination of the evacuated cardiac chambers.

This 510(k) submission is for the addition of an indication for use of the currently marketed, cleared device 3D SCOPE™ Three Dimensional Medical Video System. 510(k) #: K923160. The primary application cleared for the AST 3D SCOPE™ is general endoscopic surgery and laproscopic procedures. This includes general thoracic procedures.

The provided text is a 510(k) summary for a medical device (3D SCOPE™) from 1996. It focuses on adding an indication for use ("examination of the evacuated cardiac chambers") to an already cleared device.

Crucially, the document explicitly states that "The device is not modified in any way except for the added indication for use." This implies that the device's performance, as proven by the original clearance (K923160), is considered sufficient for this new indication based on the device's established technological equivalency to its predicate.

Therefore, there is no new study described in this 510(k) summary demonstrating acceptance criteria for the new indication. The acceptance criteria and the study that proved them would have been part of the original 510(k) submission (K923160), which is not provided here.

Given the information provided, I cannot populate the requested table or answer most of the questions because the document does not describe a new study or new acceptance criteria for the device's performance related to its new indication. The clearance is based on the equivalency of the new indication to the previously cleared indications and the existing device's proven performance for those indications.

Here's what can be inferred or stated based on the provided text:

1. Table of acceptance criteria and reported device performance: Not applicable. No new acceptance criteria or new performance data are presented for the added indication. The device's performance for general endoscopic and laparoscopic procedures was accepted in the original 510(k) (K923160).
2. Sample size used for the test set and the data provenance: Not applicable. No new test set data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set data is presented.
4. Adjudication method for the test set: Not applicable. No new test set data is presented.
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 is a 1996 device; AI assistance for visual medical devices in the context of MRMC studies was not a standard or relevant evaluation method at that time.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm-only device; it's a visualization system for human use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this 510(k) submission.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set in the modern sense.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The 510(k) submission is for an expanded indication for use of an already cleared and unmodified device. Therefore, no new performance studies, acceptance criteria, or ground truth establishment methods are described within this specific document. The justification for clearance relies on the established substantial equivalence and performance of the device under its original clearance (K923160).

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