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The Kalitec Navigated Instrument System is indicated for use during the preparation and placement of screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Kalitec Navigated Instruments System reusable instruments are specifically designed for use with the Medtronic Navigation StealthStation System which are 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 vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. Use of the Kalitec Navigated Instruments is limited to use only with Kalitec pedicle screw systems.

The Kalitec Navigated Instrument System is comprised of nonsterile, reusable instruments, including probes, taps, and drivers that can be operated manually. These instruments are designed to function with the Medtronic StealthStation® S8(v2.0.1-7) System, in combination with the Medtronic NavLock™ tracker and Medtronic SureTrak®Il clamps and arrays to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures for preparation and placement of Kalitec polyaxial screws.

Here's a breakdown of the acceptance criteria and study information for the Kalitec Navigated Instrument System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "side-by-side testing," but does not specify the sample size for the test set (i.e., how many instruments were tested or how many measurements were taken).

The data provenance is not explicitly stated beyond being part of a non-clinical test conducted by Kalitec Direct, LLC. It is a retrospective study as it's a submission for a 510(k) premarket notification.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This study appears to be a technical performance validation against a standard (ASTM F2554) and a predicate device, rather than an evaluation requiring expert clinical interpretation to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. As this was a technical performance validation, there would not typically be an adjudication method in the sense of resolving discrepancies between expert opinions. The performance was measured against the ASTM standard and the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study described is a non-clinical performance validation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence. The study focuses on the "dimensional accuracy" of the "Kalitec Navigated Instrument System" in conjunction with the Medtronic StealthStation® System. This is a technical performance assessment of the device itself, rather than an evaluation of human performance with or without the device. While a human surgeon would ultimately use the instruments, the test described is about the instrument's accuracy, not a surgeon's performance using it.

7. The Type of Ground Truth Used

The "ground truth" for the test set was:

• Dimensional accuracy as defined by ASTM F2554. This is a recognized standard for evaluating dimensional accuracy.
• Performance of the legally marketed predicate device (Medtronic® StealthStation® system and predicate device). The Kalitec system's performance was compared to this established benchmark.

8. The Sample Size for the Training Set

Not applicable. This device is a navigated instrument system, not an AI/ML algorithm that requires a training set in the typical sense. The device's functionality is based on its mechanical design and interaction with the navigation system, not on learning from a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

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The Navigated Instrument System is indicated for use during the preparation and placement of Orthofix screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Navigated Instrument System reusable instruments are specifically designed for use with the Brainlab Vector Vision system and the Medtronic StealthStation System which are 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 for the anatomy.

Use of the Navigated Instrument System is limited to use only with the Firebird Spinal Fixation System / Phoenix MIS Spinal Fixation Systems.

The Navigated Instrument System is comprised of manual surgical instruments for use with the Brainlab VectorVision System and 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 these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement. Use of the Navigated Instrument System is limited to Taps ranging in sizes of 4.5mm to 8.5mm and bone screws ranging from 4.5mm to 8.5mm with length ranging from 25mm to 55mm.

The Navigated Instrument System Medtronic and Brainlab compatible instruments are comprised of Bone Awl, Bone Taps, Bone Probes and a variety of Screw Drivers.

The provided text, a 510(k) summary for the Orthofix Navigated Instrument System, describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical performance data. However, it does not contain a detailed study report that includes specific acceptance criteria and reported device performance in a table format, nor does it provide details on sample sizes, provenance, expert qualifications, or adjudication methods.

Here's an analysis of what information is available and what is missing, based on your request:

1. A table of acceptance criteria and the reported device performance

• Missing. The document states "Engineering analysis and performance data demonstrate that the subject Navigated Instruments are substantially equivalent to the predicate devices in compatibility, accuracy, function and performance." It also mentions "accuracy and performance testing...in a simulated surgical navigation use environment." However, it does not provide a table outlining specific acceptance criteria (e.g., "Accuracy within X mm") or the numerical results achieved by the device against those criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Missing. The document mentions "physical testing with all Navigated Instrument System Screwdrivers" but does not specify the sample size for this test set or the provenance of any data used (e.g., if it was from a specific country, or if it was retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Missing. Given that this is a non-clinical evaluation for navigation instruments, the "ground truth" would likely relate to objective measurements of accuracy and compatibility rather than expert interpretation of medical images or outcomes. There is no mention of experts establishing a ground truth for a test set in the traditional sense of clinical studies.

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

• Not applicable / Missing. Adjudication methods are typically used in studies involving human interpretation or subjective assessments where discrepancies need to be resolved. This document describes an engineering analysis and physical testing, so an adjudication method is not relevant.

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 "Navigated Instrument System" used with existing navigation systems (BrainLab VectorVision and Medtronic StealthStation). It is a physical instrument for surgical guidance, not an AI or imaging diagnostic tool that would involve "human readers" or AI assistance in image interpretation. Therefore, an MRMC study is not relevant to this device.

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

• Not applicable. This is a system of physical instruments, not an algorithm. The performance evaluation is related to the physical instruments' compatibility, accuracy, and function within established navigation systems, which inherently involve a "human-in-the-loop" (the surgeon).

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

• Inferred, but not explicitly stated. For an "accuracy and performance testing...in a simulated surgical navigation use environment," the ground truth would likely be established through precise measurements of the instrument's tip position relative to a known target or planned trajectory, validated by high-precision measurement systems (e.g., optical trackers, coordinate measuring machines). The inherent "ground truth" for compatibility would be successful functional integration with the navigation systems and the specific screws. However, the document does not explicitly describe the "type of ground truth" in detail.

8. The sample size for the training set

• Not applicable. This device is a physical instrument system. It does not involve machine learning or AI models that require a "training set" of data.

9. How the ground truth for the training set was established

• Not applicable. As there is no training set mentioned, this information is not relevant.

Summary of what is available from the text:

• Device Name: Navigated Instrument System
• Purpose of Evaluation: To demonstrate substantial equivalence to predicate devices (K153442, K070106, K162921) regarding "compatibility, accuracy, function and performance."
• Testing Information:
  • "Engineering analysis and performance data"
  • "Dimensional measurements of both the predicate devices and subject devices and geometrical comparisons to currently marketed Orthofix Instruments."
  • "Validation testing includes physical testing with all Navigated Instrument System Screwdrivers..."
  • "...to ensure compatibility with the system software and 1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment."
• Systems used for compatibility testing: Medtronic StealthStation S7 Orange, Violet, and Gray Navlock Tracker, Medtronic Navigation Instrument Driver, Navlock Reference Frame, and Navigated CD Horizon Solera Operative Technique; Brainlab VectorVision System.

In conclusion, while the document asserts that testing was performed to demonstrate substantial equivalence in compatibility, accuracy, function, and performance, it lacks the specific quantitative details, study methodologies, and explicit acceptance criteria that your request requires. The information provided is at a high-level summary suitable for a 510(k) submission, not a detailed study report.

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The Navigated Instrument System is indicated for use during the preparation and placement of Orthofix screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Navigated Instruments are specifically designed for use with the BrainLab Vector Vision system and the Medronic StealthStation System which are 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 for the anatomy.

The Navigated Instrument System is comprised of manual surgical instruments for use with the BrainLab VectorVision System and 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 these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement. Use of the Navigated Instrument System is limited to Taps ranging in sizes of 4.5mm to 8.5mm and bone screws ranging from 4.5mm to 8.5mm with length ranging from 25mm to 55mm.

The Navigated Instrument System Medtronic compatible instruments are comprised of Bone Awl, Bone Taps, and Bone Probes only.

The Navigated Instrument System BrainLab compatible instruments are comprised of Bone Awl. Bone Taps, Bone Probes and a variety of Screw Drivers.

The provided text is a 510(k) summary for a medical device called the "Navigated Instrument System." This document aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove a device meets specific performance acceptance criteria through clinical studies in the typical sense (e.g., diagnostic accuracy on a test set).

Here's an attempt to answer your questions based on the available information, noting that much of it is not explicitly stated in this type of regulatory document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed performance results in the format of a table. Instead, it makes a general statement about substantial equivalence based on "compatibility, accuracy, function and performance."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Engineering analysis and performance data" and "non-clinical test." This implies in-vitro or bench testing rather than studies involving patient data. Therefore:

• Sample size for the test set: Not specified, but likely refers to a set of instruments/fixtures used for bench testing, not human subjects or patient data.
• Data provenance: Not explicitly stated, but given it's a 510(k) submission from Orthofix Inc. in Lewisville, Texas, the testing was likely conducted in the US or by an affiliated entity. The data would be non-clinical/bench testing data, not clinical in retrospect or prospect.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable or not provided in the context of this 510(k) summary. "Ground truth" in this context would typically refer to clinical data or expert consensus on diagnoses, which is not what was used given the "engineering analysis and performance data" for a surgical instrument system. The ground truth for bench testing would be defined by metrology standards or physical measurements.

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

Not applicable or not provided. This usually refers to how disagreements among expert readers are resolved in diagnostic image interpretation studies. Since this device relates to surgical instrumentation and its performance was assessed via engineering analysis, such a method would not be used.

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. This is a surgical instrument system, not an AI-powered diagnostic device. Therefore, an MRMC study assessing human reader improvement with AI assistance is not relevant and was not performed.

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

Not applicable. This device is an instrument system, not an algorithm. Its function is to assist a human surgeon. Standalone performance as an algorithm would not be relevant.

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

The ground truth for the "engineering analysis and performance data" would be based on physical measurements and engineering specifications. For example, the accuracy of instrument tip localization might be verified against known physical coordinates or measurements of a phantom. It is not clinical ground truth like pathology reports or patient outcomes.

8. The sample size for the training set

The concept of a "training set" is primarily relevant for machine learning or AI models. This device is a traditional mechanical/navigated instrument system. Therefore, there is no training set in the AI sense. The "training" for the system would involve calibration procedures and design verification.

9. How the ground truth for the training set was established

As there is no training set in the AI context, this question is not applicable. The design and performance were validated against engineering principles and predicate device characteristics.

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