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K Number
K173338
Device Name
Navigated INFINITY™ Instruments
Manufacturer
Medtronic Sofamor Danek USA, Inc.
Date Cleared
2018-01-18

(87 days)

Product Code
OLO
Regulation Number
882.4560
Type
Traditional
Panel
OR
Reference & Predicate Devices
K163375,K111520,K123270,K050438,K170011,K124004,K143628
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Medtronic Navigated Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic 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. Medtronic Navigated Instruments are also compatible with the IPC® POWEREASE® System.

Device Description

The Navigated INFINITY™ Instruments are non-sterile, reusable and single use instruments that can be operated manually or under power. These instruments are intended to be used when implanting components of the INFINITY™ OCT System. The Navigated INFINITY™ Instruments are also compatible with the StealthStation® and IPC® POWEREASE® Systems.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Navigated INFINITY™ Instruments":

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report for new device approval. As such, the information provided for some of your requested points is limited or not applicable in the context of a 510(k).

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)Reported Device Performance
Maintain Navigation AccuracyNavigation Accuracy Analysis Confirmed navigated instrument accuracy
Instrument Functionality under Expected Use ConditionsAnatomical Simulated Use Confirmed instrument functionality under expected use conditions
Navigation System Functionality under Expected Use ConditionsNavigation Simulated Use Confirmed navigation system functionality under expected use conditions
Accurate Reflection of CAD Models in Application SoftwareCAD Model Evaluation Verified that the CAD models are accurately reflected in the application software
Proper Mating of Instruments with Appropriate DevicesImplant/Instrument Mating Conditions Verified that the instruments can be assembled with the appropriate devices according to their intended use
Spine Tools Package Meets Interface Needs of Spine Application SoftwareSpine Tools Package Functional Testing Verified that the Spine Tools package has met the required interface needs of the spine application software

Study Details

  1. Sample size used for the test set and the data provenance:

    • Sample Size: The document does not specify the sample size (e.g., number of instruments tested, number of simulated cases) for any of the performance tests.
    • Data Provenance: Not specified. Given the nature of a 510(k) and the types of tests listed (simulated use, accuracy analysis, CAD evaluation, functional testing), it is highly probable that the data provenance is retrospective (using internal testing data) and likely in-house laboratory or engineering testing, rather than clinical data from a specific country of origin.

  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • This information is not provided in the document. For the types of engineering and functional tests described (e.g., navigation accuracy, instrument functionality, CAD evaluation), "ground truth" would likely be established through engineering specifications, validated measurement systems, and perhaps expert observation from R&D engineers, rather than clinical experts like radiologists.

  3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • This information is not provided and is unlikely to be relevant for the non-clinical, performance-based tests described in the 510(k) summary. Adjudication methods like 2+1 are typically used for clinical endpoints, especially in image interpretation.

  4. 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, an MRMC comparative effectiveness study was not done. The device (Navigated INFINITY™ Instruments) is a surgical navigation instrument, not an AI-powered diagnostic or assistive tool for "human readers." Therefore, this type of study and its associated effect size are not applicable.

  5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • The term "standalone" and "algorithm only" are typically used for AI/software devices. This device is a physical surgical instrument that works with existing navigation systems (StealthStation™ System, IPC® POWEREASE® System). The performance tests listed (e.g., Navigation Accuracy Analysis, Anatomical Simulated Use) assess the instrument's accuracy and functionality within the intended surgical navigation system, which inherently involves human interaction (the surgeon). Therefore, a "standalone algorithm only" performance is not applicable in the context of this device.

  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • For the tests described:
      • Navigation Accuracy Analysis: Ground truth would likely be established through pre-defined engineering specifications and validated measurement systems (e.g., comparing navigated position to physically measured, known positions).
      • Functional/Simulated Use Tests: Ground truth would be defined by the device's design specifications and intended functionality (i.e., whether it performs as designed under various conditions).
      • CAD Model Evaluation: Ground truth would be the original CAD models themselves and the expectation of their accurate representation in the software.
      • No expert consensus, pathology, or outcomes data is explicitly mentioned or seems relevant for these specific engineering tests.

  7. The sample size for the training set:

    • This question is not applicable. The "Navigated INFINITY™ Instruments" are physical surgical instruments, not a machine learning model that requires a training set. The underlying navigation systems (StealthStation™) might have calibration data or algorithms, but the instruments themselves do not have a "training set" in the sense of AI.

  8. How the ground truth for the training set was established:

    • This question is not applicable as there is no "training set" for these physical instruments.

§ 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).