(192 days)
The CTL Amedica Navigation Instrument System is intended to be used during the preparation and placement of CTL Amedica screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The CTL Amedica Navigation Instrument System is specifically designed for use with the Medtronic 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 vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
The CTL Amedica Navigation Instrument System are manual surgical instruments for use with the Medtronic® StealthStation™ Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of this navigation system provides the surgeon access to real-time, multiplane 3D images (and 2D images) providing confirmation of hardware placement.
The Navigation Instruments include the following:
- Drivers
- Taps
- Awls
- Probes
Use of the Navigated Instrument System is limited to Taps ranging in sizes from 4.5mm to 8.5mm in diameter. The Navigation Instruments are to be used with the following CTL Amedica Systems but not limited to:
- RAPHAELTM Pedicle Screw System Family
- PICASSO II™ MIS Spinal System Family
- TAURUS™ Pedicle Screw System Family
The CTL Amedica Navigation Instruments are designed for use only with the hardware and software of the Medtronic StealthStation Navigation System.
The CTL Amedica Navigation Instruments are manufactured from Stainless Steel and Aluminum. All of these materials conform to ASTM F899.
The provided text describes the CTL Amedica Navigation Instrument System, but it does not contain any specific numerical acceptance criteria or performance results from a study that proves the device meets those criteria.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices (K172115 and K153442) for 510(k) clearance. This means the manufacturer is asserting their device is as safe and effective as a legally marketed device, rather than providing new, independent performance metrics against specific acceptance thresholds.
Therefore, many of the requested sections regarding detailed study information cannot be answered from the provided document.
Here's a breakdown of what can be inferred or explicitly stated based on the text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicit: The document does not state specific numerical acceptance criteria (e.g., accuracy +/- X mm, or specific pass/fail rates). The criteria are implicitly tied to the performance of the predicate devices. | Compatibility, Accuracy, Function, and Performance: The non-clinical testing demonstrated that the subject instruments registered successfully with the StealthStation system and are substantially equivalent to the predicate devices with regards to compatibility, accuracy, function, and performance in a simulated surgical navigation use environment. |
Study Information (Based on the provided text):
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "all subject instruments" for compatibility testing and "both the predicate devices and subject devices" for dimensional analysis, but no specific count is given for the test set.
- Data Provenance: Not explicitly stated, but the testing was conducted as part of the regulatory submission process for the CTL Amedica Navigation Instrument System, implying it was conducted by or for the manufacturer. It is a non-clinical, controlled environment (simulated surgical navigation use environment) rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. The ground truth in this non-clinical testing appears to be based on engineering analysis, dimensional comparisons, and the successful registration and function with the predicate Medtronic StealthStation system. There is no mention of human experts establishing a 'ground truth' for specific anatomical localization or diagnostic outcomes.
4. Adjudication method for the test set
- Not Applicable/Not Specified. Since there's no mention of human experts establishing ground truth or evaluating outcomes in a subjective manner, an adjudication method like 2+1 or 3+1 is not relevant to the described testing.
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
- No. The document explicitly states "Clinical Tests: o N/A". This is a premarket notification for a medical instrument system, not an AI-powered diagnostic device, and therefore this type of study is not applicable or performed as part of this submission. The device is an instrument used with a navigation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Partially. The testing described is primarily standalone device performance (how the instruments themselves function with the navigation system). It's "algorithm only" in the sense that the instruments interface with the "Medtronic StealthStation System" software, and their compatibility/accuracy with that system's function is assessed. However, this is not an "AI algorithm" in the typical sense of a diagnostic or predictive model. The assessment of "accuracy, function and performance in a simulated surgical navigation use environment" primarily focuses on the instrument's interaction with the navigation system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this non-clinical testing is based on:
- Successful registration and compatibility with the Medtronic StealthStation system.
- Dimensional measurements and geometrical comparisons against predicate devices (for dimensional comparison and rigidity).
- Expected function and performance in a simulated environment as defined by the capabilities of the StealthStation system and the purpose of the surgical instruments.
- Essentially, the ground truth is the expected engineering and functional performance when integrated with the existing, cleared navigation system.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set in the conventional sense. The device is a set of physical surgical instruments.
9. How the ground truth for the training set was established
- Not Applicable. (See point 8)
§ 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).