(174 days)
The SNN Scout is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head. It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations of the spine. The SNN Scout is contraindicated for patients suspected of having Creutzfeld-Jacob's disease if adequate sterilization of the instruments cannot be assured.
The passive sensor feature is an addition to the SNN Scout image-guided surgical system. This feature is designed to improve the ergonomics of the user/device interaction by eliminating the cable connections between the tracked surgical instruments and the computer workstation.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
Unfortunately, the provided text does not contain a table of acceptance criteria or specific reported device performance metrics for the SNN Scout image-guided surgical system, particularly regarding the passive sensor feature. The document is primarily a 510(k) summary and an FDA clearance letter, which focuses on substantial equivalence to a predicate device rather than detailed performance specifications.
The 510(k) summary states: "The intended use and technological characteristics of the SNN Scout image-guided device including the passive sensor feature are substantially equivalent, in the opinion of I.S.G. Technologies, to those of the predicate device and do not pose any new issues of safety and effectiveness." This implies that the device is deemed acceptable because it performs comparably to an already cleared device, but it doesn't provide the specific performance criteria or results.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not disclose any information about the sample size used for a test set, nor does it mention data provenance (e.g., country of origin, retrospective/prospective study design). This type of detail is typically found in a more comprehensive clinical study report, which is not part of this 510(k) summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided text does not mention any experts used to establish ground truth or their qualifications. As no specific performance study results for the SNN Scout are presented, there is no discussion of how ground truth might have been established for such a study.
4. Adjudication Method for the Test Set
The provided text does not describe any adjudication method as there is no mention of a specific test set or performance evaluation in the clinical sense.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. There is no discussion of human reader performance, with or without AI assistance, or any effect size.
6. Standalone (Algorithm Only) Performance Study
The provided text does not specifically describe a standalone (algorithm only) performance study. The device is an "image-guided surgical system" that includes a "passive sensor feature" to improve ergonomics. While its functionality relies on technology, the document focuses on its substantial equivalence to a predicate device rather than a detailed, quantitative standalone performance evaluation of an algorithm.
7. Type of Ground Truth Used
The provided text does not specify the type of ground truth used. Given the nature of the device (image-guided surgical system), if performance were evaluated, ground truth would likely be established through surgical outcomes, anatomical verification during surgery, or possibly highly accurate imaging modalities as a reference. However, these details are not present.
8. Sample Size for the Training Set
The provided text does not mention a training set sample size. This device documentation does not describe a machine learning model where a distinct training set would be explicitly referenced.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the provided text does not describe how ground truth for a training set was established.
Summary of Missing Information:
It's crucial to understand that 510(k) summaries, especially from 1998, often focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed, quantitative clinical study results with specific acceptance criteria and performance metrics as might be found in a modern premarket approval (PMA) application or a more recent 510(k) for an AI/ML powered device. The information provided heavily emphasizes the "substantially equivalent" argument from ISG Technologies.
§ 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).