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Leksell SurgiPlan® is intended for use in planning invasive intracranial stereotactic surgical procedures.

Leksell SurgiPlan® is an advanced image-based neurosurgical planning software, specifically designed for Leksell Stereotactic System®.

The provided text for K080250 is a 510(k) summary for the Leksell SurgiPlan® device. This document focuses on demonstrating substantial equivalence to a predicate device (an earlier version of Leksell SurgiPlan® with 510(k) # K033340).

The 510(k) summary does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the way a clinical performance study would. The primary mechanism for clearance in this case is a demonstration of substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device.

Therefore, many of the requested details (sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are generally not part of a 510(k) submission based on substantial equivalence to a previously cleared similar device, unless significant changes in technology or indications warrant a new clinical study.

Based on the provided text, here's what can be extracted and what cannot:

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

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of a clinical study or performance testing with specific metrics. The device's "performance" is implicitly deemed equivalent to the predicate device.

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

None of the above information is present in the provided 510(k) summary.

The document states:

• "The functionality for the Leksell SurgiPlan® is equivalent to its predicate device the Leksell SurgiPlan® (K033340) in safety and effectiveness. The fundamental technical characteristics are the same to those of the predicate device."

This statement is the core of the submission, asserting that because the new device is fundamentally the same as its cleared predecessor, it is also safe and effective without requiring new clinical performance data to demonstrate this. For a software device, "technical characteristics" often refer to aspects like software architecture, algorithms, user interface, and overall system design. The implication is that since these are the same, or negligibly different, the performance is also considered equivalent.

In summary, this 510(k) submission for Leksell SurgiPlan® relies on substantial equivalence to a predicate device (K033340) rather than presenting new performance data from a specific study with defined acceptance criteria and detailed methodology as requested in your prompt.

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