(29 days)
The Leksell® Image Guidance Surgical System (LIGS) is intended for use in cranial and spinal neurosurgical procedures to provide image guidance based on preoperative images which are visualized interactively with the aid of surgical tools.
The Leksell® Image Guidance Surgical System (LIGS) is intended for use in cranial and spinal neurosurgical procedures to provide image guidance based on preoperative images which are visualized interactively with the aid of surgical tools. The LIGS System was cleared for commercial distribution under K973684 on March 31, 1998. The purpose of this special premarket 510(k) notification is to describe the changes in product specifications and system modifications. The LIGS System has not changed in its functionality or its indications for use. Technological enhancements have been made to the ViewScope/Elekta Insight Localization System and Surgical Tools. As a result of these enhancements, the software and instruction manuals have also been updated.
Here’s an analysis of the acceptance criteria and the study information based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Product Accuracy and Repeatability | Found to be acceptable |
| Performed as intended | Performed as intended |
Note: The document provides very generalized statements regarding acceptance criteria and performance. Specific numerical criteria or detailed performance metrics are not given.
Study Details
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Sample size used for the test set and data provenance:
- Sample Size: Not specified. The study involved "simulated cranial and spinal models," but the number of models or tests conducted is not mentioned.
- Data Provenance: The study was conducted on "simulated cranial and spinal models," indicating it's an in-house performance test rather than using patient data (retrospective or prospective). The country of origin for the data is implicitly Sweden, as the company Elekta Instruments, AB, is based in Stockholm, Sweden, and likely conducted their own testing.
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Number of experts used to establish the ground truth for the test set and their qualifications:
- This information is not provided in the document. The study was a technical performance test on simulated models, not a diagnostic study requiring expert human interpretation of images to establish ground truth.
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Adjudication method for the test set:
- This information is not provided. Given it was a technical performance test on simulated models, an adjudication method for human experts is not applicable.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, an effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The device in question is a surgical image guidance system, not an AI diagnostic tool that assists human readers in interpreting images. Therefore, the concept of improving human reader performance with AI assistance is not applicable to this device and its reported study.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance test was done. The "performance testing on simulated cranial and spinal models was conducted for product accuracy and repeatability" describes the standalone performance of the Leksell® Image Guidance Surgical System itself, without necessarily involving a human operator beyond initiating the tests and collecting data. The system's ability to provide image guidance and its localization technology were evaluated directly.
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The type of ground truth used:
- The ground truth for the performance test would have been engineering specifications or known measurements on the simulated cranial and spinal models. For example, for "accuracy," the system's measurements would be compared against the precisely known real-world coordinates or distances within the simulated models.
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The sample size for the training set:
- This information is not applicable/not provided. The Leksell® Image Guidance Surgical System is a navigation system, not an AI/machine learning algorithm that requires a "training set" in the conventional sense for image recognition or diagnostic tasks. Its functionality is based on established physics principles for localization and display, not learned patterns from data.
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How the ground truth for the training set was established:
- This information is not applicable/not provided for the same reasons as #7.
§ 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).