(126 days)
Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated and with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:
• the use of EXPEDIUM 4.5, EXPEDIUM 6.35, VIPER 2, VIPER SAI, EXPEDIUM VERSE, VIPER PRIME (without stylet control), SYMPHONY OCT and the TriALTIS Spine System is indicated,
· the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as the pelvis or a vertebra, can be identified relative to the acquired image (CT. MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.
The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only.
Navigation Enabled Instruments are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUM™ 4.5, EXPEDIUM™ 5.5, EXPEDIUM™ 6.35, VIPER™ 2, VIPER™ SAI, VIPER PRIME™, EXPEDIUM VERSE™, SYMPHONY™ OCT and TriALTIS™ screws, in either open or percutaneous procedures. The Navigation Enabled Instruments include drills, taps and screwdrivers and can be operated manually or under power. These instruments are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the Medtronic StealthStation navigation system and associated tracking arrays.
This document is a 510(k) premarket notification for the "TriALTIS Navigation Enabled Instruments". It's a regulatory submission to the FDA, not a study report detailing AI/algorithm performance. Therefore, most of the information requested in your prompt (acceptance criteria for AI, study details like sample size, ground truth, expert adjudication, MRMC studies, standalone performance, training set details) is not present in this document.
The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices. It describes the physical device, its intended use, and confirms that its technological characteristics (design, materials, performance) are consistent with the predicates.
Here's a breakdown of what can and cannot be answered from the provided text:
Information NOT available in this document regarding AI/algorithm performance:
- 1. A table of acceptance criteria and the reported device performance (for an AI/algorithm): This document does not describe performance metrics or acceptance criteria for an AI or algorithm. It's for a physical medical instrument.
- 2. Sample size used for the test set and the data provenance: Not applicable, as there's no AI algorithm being tested in the traditional sense.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is a navigation instrument, not an AI diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
What the document does provide, related to its "performance" (as a physical device):
The document mentions "Performance Data" in Section I, but this refers to engineering analyses and compatibility testing for the physical instrument, not an AI algorithm.
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Acceptance Criteria Mentioned (for the physical instrument's performance):
- Rigidity of Connections and Instrument During Use
- Instrument Verification
- Accuracy Verification
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Study described that proves the device meets these criteria:
- Type of Study: "A dimensional comparison and engineering analysis demonstrates that the TriALTIS Navigation Enabled Instrument meet performance requirements..."
- Compatibility Testing: "Compatibility testing was performed with Medtronic StealthStation System S8 using StealthStation Spine Software Version 1.2.0 (1.2.0-20) using automatic intraoperative 3D Scan on an OARM Imaging System according to set up and installation instructions outlined in Medtronic's StealthStation S8 Spine with O-arm and 3D Fluoro Imaging Pocket Guide."
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Sample Size: Not specified for the engineering analysis or compatibility testing in terms of "cases" or "patients." It's likely component-level testing or a few test runs with the integrated system.
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Data Provenance: Not explicitly stated (e.g., country of origin), but it would be laboratory/engineering test data.
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Ground Truth: For a physical instrument, ground truth would be established through engineering specifications, calibrated measurement tools, and functional success/failure in controlled test environments. This isn't the same as clinical diagnostic ground truth.
In essence, the prompt's questions are designed for a submission involving an AI/Machine Learning device, whereas this document pertains to a physical surgical navigation instrument.
§ 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).