(15 days)
The Leksell® SurgiPlan with AtlasSpace™ is intended for use in planning invasive intra-cranial stereotactic surgical procedures.
The Leksell® SurgiPlan with AtlasSpace is intended for use in planning invasive intra-cranial stereotactic procedures. The Leksell SurgiPlan was cleared for commercial distribution under K943468 on January 20, 1995. The purpose of this special premarket 510(k) notification is to describe the addition of the AtlasSpace software module. The AtlasSpace module is a second generation computerized brain atlas, ased on three orthogonal series of the Schaltenbrand-Wahren atlas. The SurgiPlan System has not changed in its functionality or its indications for use. As a result of the addition of the AtlasSpace, the SurgiPlan software and instruction manuals have been updated.
The provided document is limited in the detail required to thoroughly describe acceptance criteria and a study proving device performance as it's a 510(k) summary from 2001. The document is primarily focused on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.
However, based on the available information, here's what can be inferred and presented:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the Leksell® SurgiPlan with AtlasSpace™ does not explicitly state quantitative acceptance criteria or a specific table-formatted performance report. Instead, it makes a general statement about performance testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device performs as intended for planning invasive intra-cranial stereotactic procedures, with the added AtlasSpace module functioning correctly. | "All results of testing and software evaluation were found to be acceptable. The Leksell® SurgiPlan with AtlasSpace performed as intended." |
| Functionality and indications for use remain unchanged from the predicate Leksell® SurgiPlan. | Stated that "The SurgiPlan System has not changed in its functionality or its indications for use." and "The functionality and the indications for use have not changed with the proposed modifications." |
| The AtlasSpace software module is equivalent to the brain atlas in the Radionics AtlasPlan™ predicate device. | "The addition of the brain atlas software module is equivalent to the brain atlas found in the Radionics AtlasPlan predicate device." |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for any test set or the data provenance. It vaguely refers to "performance testing" and "software evaluation."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document.
4. Adjudication method for the test set
This information is not provided in the document.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in this 510(k) summary. The device's clearance predates widespread AI integration in medical devices and the focus here is on adding a digital atlas, not an AI-driven interpretive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the Leksell® SurgiPlan with AtlasSpace™ as a planning tool that overlays atlas contours on patient images. This implies it's an assistive tool intended for human-in-the-loop use, not an algorithm operating in a standalone capacity for diagnosis or intervention. No standalone performance study is mentioned.
7. The type of ground truth used
The document does not explicitly state the type of ground truth used for any testing. Given the nature of a brain atlas and a stereotactic planning system, the "ground truth" for evaluating the AtlasSpace module would likely relate to the accuracy of anatomical mapping and the correspondence of the atlas to patient-specific imaging, potentially validated against known anatomical landmarks or surgical outcomes, but this is speculative as the document is silent on this.
8. The sample size for the training set
No information about a training set is provided. The AtlasSpace module is described as a "second generation computerized brain atlas, based on three orthogonal series of the Schaltenbrand-Wahren atlas," implying it's a pre-computed anatomical reference rather than a machine learning model developed with a training set.
9. How the ground truth for the training set was established
Since no training set is mentioned (see point 8), there is no information on how its ground truth was established. The "ground truth" for the AtlasSpace module itself would be the accuracy and anatomical correctness of the underlying Schaltenbrand-Wahren atlas data, which is a published anatomical reference.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).