(206 days)
The WayPoint™ Stercotactic System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microclectrodes, stimulating electrodes, or other instruments in the brain or nervous system.
The WayPoint™ Stereotactic System. (WPS System) accurately locates and rigidly supports neurosurgical or other surgical instruments relative to specific anatomical structures or targets, thus facilitating microelectrode recording, stimulation, data collection, device implantation and other surgical procedures. The WPS System provides patient-customized stereotactic fixtures designed to be secured on skull-based anchor mounting sets to hold and align surgical instruments with patient anatomy and to allow selected targets to be reached with sub-millimeter accuracy. The WPS System consists of several components that work together to become a stereotactic system. These components are:
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- the WayPoint™ Stereotactic Anchor System:
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- the WayPoint™ Stereotactic Platform Adapter:
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- Device mounting hardware for the Platform; and,
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- WayPoint™ compatible Planning software such as:
- a. WayPoint™ Planner; or,
- b. VoXim®Planning software.
The WayPoint™ Stereotactic Anchor/Locator System provides tools and components for the temporary implantation of anchors to be used as reference points and mounting sets for the surgical procedure. The WPS System software designs a Stereotactic Platform Adapter that will mount to the WayPoint™ Stereotactic Anchor System. For each surgical instrument or device to be mounted to the Stereotactic Platform Adapter, suitable hardware is provided to act as a secure interface and allow flexibility in targeting, if required. The two existing software components of the WPS System (WayPoint™ Planner and VoXim® microTargeting™ Planning software) provide tools to create a Stereotactic Platform Adapter from scanned patient images.
The provided document describes the WayPoint™ Stereotactic System and references performance data to support its substantial equivalence claim. However, it does not explicitly state acceptance criteria or provide a detailed study report that includes all the requested information for acceptance criteria and device performance in a structured format.
The document summarizes performance data rather than presenting it in detail.
Here's an attempt to extract the relevant information based only on the provided text, while also highlighting what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly stated in predefined numerical targets (e.g., "accuracy > X mm") | Phantom-based study: Stereotactic Platform Adapter produced by the WPS System is accurate to a submillimetric level. |
| Not explicitly stated in predefined numerical targets | Intraoperative comparison study: Accuracies comparable to those of conventional frames when comparing intraoperative stereotactic coordinates of an implant to its position in postoperative CT images. |
| Not explicitly stated in predefined numerical targets | Preoperative target selection/final placement verification study: Error measurements comparable to those for the same procedure as described by other groups using a standard stereotactic frame. |
Missing from the table: Specific numerical acceptance criteria (e.g., "Accuracy must be within 0.5 mm") are not provided. The reported performance is qualitative ("submillimetric," "comparable").
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified. The document states "phantom- and imaging-based studies were conducted," but does not give the number of phantoms, images, or cases used in these studies.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not specified.
- The 510(k) submission is from FHC, Inc. in Bowdoin, Maine, USA.
- It is not stated whether the studies were prospective or retrospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: Not explicitly stated or described. The document mentions "accuracies comparable to those of conventional frames" and "error measurements were comparable to those for the same procedure as described by other groups using a standard stereotactic frame," which implies a comparison, but it does not detail a formal MRMC study design comparing human readers with and without AI assistance to determine an "effect size." The device itself is a stereotactic system, not an AI for human reader assistance in diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: The description of the phantom-based study ("Stereotactic Platform Adapter produced by the WPS System is accurate to a submillimetric level") can be interpreted as a standalone performance assessment of the system's physical and software-driven accuracy in a controlled environment. The "imaging-based studies" comparing coordinates and error measurements also relate to the system's standalone performance in achieving target accuracy.
7. Type of Ground Truth Used
- For Phantom-based study: Likely the known physical dimensions and target locations of the phantom, measured with a high-precision reference system. This would be known physical truth.
- For Imaging-based studies:
- Comparison of "intraoperative stereotactic coordinates of an implant to its position in postoperative CT images" suggests comparing the device's predicted/achieved coordinates with the actual, visible position on a postoperative imaging modality (CT), which serves as the ground truth for actual placement.
- Comparison of "preoperative target selection and final placement verification based on CT images" also implies using CT images as the basis for both planning and verifying outcomes.
8. Sample Size for the Training Set
- Training Set Sample Size: Not specified. The document describes the system's performance but does not provide details on the development or training of any software components within the WPS System, nor does it refer to separate "training" and "test" sets in the context of machine learning model development. This device predates widespread explicit mention of training sets for AI in 510(k) summaries.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not specified, as training set details are absent.
§ 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).