(59 days)
The navigated instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as a skull, a long bone, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
When used with a Medtronic StealthStation™ Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery.
The Spinous Process Clamps are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. The subject devices are designed for use with the StealthStation™ System and are intended to be reusable.
The provided text describes a 510(k) premarket notification for a medical device, the StealthStation™ Spinous Process Clamps. This document outlines the device's characteristics, intended use, and a comparison to a predicate device, along with a summary of performance testing.
However, the document does not describe an AI/ML-driven device or a study involving "human readers" improving with "AI vs without AI assistance." It pertains to a physical stereotaxic instrument used in spinal surgery for rigid attachment to a patient's anatomy for navigation.
Therefore, many of the specifics requested in your prompt (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth for AI, training set details) are not applicable to this type of medical device submission.
The document discusses performance testing relevant to a mechanical device, such as functional verification, useful life testing, navigation accuracy testing, and packaging verification, as well as biological endpoint testing. These tests are to ensure the device's safety and effectiveness as a physical surgical tool and reference system, not as an AI diagnostic or assistive tool.
To answer your prompt, I will extract the information that is present and explicitly state when information is not applicable given the nature of the device.
Acceptance Criteria and Device Performance for Medtronic StealthStation™ Spinous Process Clamps
The device in question, the StealthStation™ Spinous Process Clamps, is a physical stereotaxic instrument, not an AI/ML-driven device. Therefore, the "acceptance criteria" and "study" described in the provided text relate to the mechanical and biological performance of this instrument, not to the performance of an AI algorithm or its impact on human reader performance.
The "studies" are performance tests designed to demonstrate the device's substantial equivalence to a predicate device and its safety and effectiveness for its intended use as a surgical instrument.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of quantitative acceptance criteria with corresponding performance metrics like those typically seen for AI/ML device validations (e.g., sensitivity, specificity, AUC thresholds). Instead, the performance testing described is qualitative or refers to compliance with established standards for mechanical and biological safety.
| Category | Acceptance Criteria (Implied / Stated Objective) | Reported Device Performance (Summary) |
|---|---|---|
| Functional | Device satisfies functional requirements. | Functional Verification confirms the design satisfies functional requirements. |
| Useful Life | Device operates normally throughout its useful life. | Useful Life Testing confirms normal operation throughout its useful life. |
| Navigational Accuracy | Robustness and navigational accuracy are verified. | Navigation Accuracy Testing verifies robustness and navigational accuracy. |
| Packaging Integrity | Device can withstand ship testing per ASTM D4169 and ISTA 2A. | Packaging Verification confirms packaging withstands ship testing per ASTM D4169 and ISTA 2A. |
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-irritating, non-toxic, non-pyrogenic; negligible risk of adverse biological effects to patients. | Biological endpoint testing (per ISO 10993-1:2018) indicates non-cytotoxic, non-sensitizing, non-irritating, non-toxic, and non-pyrogenic. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a "sample size" in the context of patient data or algorithm testing. The performance testing likely involved a limited number of physical devices (e.g., clamps) for mechanical and biological evaluations. This is not a data-driven AI model.
- Data Provenance: Not applicable. The "data" comes from physical testing of the device, not from patient medical records or imaging scans. The testing would have occurred in a laboratory or manufacturing environment.
- Retrospective/Prospective: Not applicable. The testing is a controlled, experimental assessment of the device's physical properties and performance, not a study on historical or future patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This section is relevant for AI/ML applications where expert labeling is used to create ground truth for image classification, segmentation, etc. For a mechanical device, "ground truth" relates to engineering specifications, physical measurements, and compliance with industry standards, which are evaluated by engineers and technical specialists, not typically "experts" in the context of medical image interpretation.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (e.g., 2+1, 3+1 consensus) are used in studies involving human interpretation of complex medical data, especially for establishing ground truth in AI model development. This device's testing involves objective engineering and biological assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is specific to evaluating the impact of an AI algorithm on human reader performance, usually in diagnostics. This device is a physical surgical instrument, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, not applicable. This concept pertains to the performance of an AI algorithm by itself. The StealthStation™ Spinous Process Clamps are physical devices that are used with a navigation system and by a human surgeon. Their performance is inherently related to their physical interaction and functionality for surgical navigation.
7. The Type of Ground Truth Used
- Engineering Specifications and Standardized Test Methods: For functional verification, useful life, packaging, and navigational accuracy, the "ground truth" would be the pre-defined engineering specifications, design requirements, and objective measurements obtained using established test methodologies (e.g., ASTM, ISTA, internal quality standards).
- ISO 10993-1:2018 Standards: For biocompatibility, the ground truth is established by the accepted biological safety endpoints and testing protocols outlined in the ISO 10993 series of standards.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply.
§ 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).