Search Results

icotec Navigation Instruments are intended to be used during the preparation and placement of FDA-cleared icotec pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. These instruments are designed for use with stereotactic navigation system Medtronic StealthStation®, 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The purpose of this Traditional 510(k) is to seek marketing clearance for the VADER® Pedicle System Navigated Instruments.

icotec's VADER® Pedicle System Navigated Instruments are reusable instruments used for the preparation and placement of FDA-cleared icotec pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. These instruments are designed for use with navigation system Medtronic StealthStation® in combination with the Medtronic NavLock™ tracker and Medtronic SureTrak®II clamps and arrays.

The VADER® Pedicle System Navigated Instruments include awls, probes, taps, drivers and adapters. The VADER® Pedicle System Navigated Instruments are to be used with the FDAcleared icotec pedicle screws cleared under K222789. K200596. K193423 and K190545.

This document is a 510(k) Premarket Notification from the FDA regarding the VADER® Pedicle System Navigated Instruments. It confirms that the device is substantially equivalent to a predicate device and can be marketed.

However, the provided text does not contain the detailed information requested regarding acceptance criteria and the specifics of the study proving the device meets those criteria.

Here's what can be extracted and what is missing:

1. Table of acceptance criteria and reported device performance:

• Missing: The document only generally states that "Performance Testing" was conducted to "verify that the VADER® Pedicle System Navigated Instruments are appropriate for their intended use, to ensure functionality, accuracy and compatibility with the Medtronic StealthStation® System using the NavLock™ tracker and SureTrak®II clamps and arrays, and to demonstrate substantial equivalence to the predicate instruments." It does not provide specific quantitative acceptance criteria (e.g., accuracy thresholds, precision values) or their corresponding reported performance values.

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

• Missing: The document mentions "anatomical and navigated simulated use and accuracy and reliability testing" but does not specify the sample size of the test set (e.g., number of simulated procedures, number of anatomical models, number of measurements). It also does not provide data provenance (e.g., country of origin, retrospective or prospective).

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

• Missing: This information is not provided.

4. Adjudication method for the test set:

• Missing: This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

• Missing: The document does not describe an MRMC comparative effectiveness study where human readers improve with or without AI assistance. The device is a set of navigated instruments, not an AI diagnostic tool that assists human readers in interpreting data.

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

• Not applicable/Missing: The device is a set of navigated instruments for use during surgery with a navigation system (Medtronic StealthStation®), which inherently involves a human surgeon. It's not an algorithm that performs actions "standalone" without human interaction. The performance testing likely evaluated the accuracy and reliability of the instruments in conjunction with the navigation system and human use, not as a standalone algorithm.

7. The type of ground truth used:

• Missing: The document describes "anatomical and navigated simulated use" but does not explicitly state how ground truth was established for these tests (e.g., a "true" anatomical position determined by a gold standard method before navigation, or a reference measurement).

8. The sample size for the training set:

• Not applicable/Missing: The document describes a medical device (navigated instruments), not a software or AI model that typically has a training set. Therefore, there is no "training set" in the context of this device.

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

• Not applicable/Missing: Similar to point 8, there is no training set for this type of device.

Summary of what is provided:

• Device Name: VADER® Pedicle System Navigated Instruments
• Intended Use: To be used during the preparation and placement of FDA-cleared icotec pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. Designed for use with stereotactic navigation system Medtronic StealthStation®.
• Performance Testing Mentioned: "one-to-one dimensional comparison to demonstrate substantially equivalent geometry that is critical to navigation accuracy. Testing, including anatomical and navigated simulated use and accuracy and reliability testing, has been conducted to verify that the VADER® Pedicle System Navigated Instruments are appropriate for their intended use, to ensure functionality, accuracy and compatibility with the Medtronic StealthStation® System using the NavLock™ tracker and SureTrak®II clamps and arrays, and to demonstrate substantial equivalence to the predicate instruments."
• Conclusion: The device was demonstrated to be substantially equivalent to the predicate device (VERTICALE® Navigation Instruments, K223649) with respect to indications, design, and performance, based on the performance testing.

Ask a specific question about this device

The icotec Anterior Cervical Plate System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine (C2-T1) in whom life expectancy is of insufficient duration to permit achievement of fusion.

The icotec Anterior Cervical Plate System consists of plates and screws intended for use in anterior cervical fixation from C2 to T1. The system is developed to allow for conventional ventral approaches to the cervical spine. The icotec Anterior Cervical Plate System is available in various plate lengths and with selftapping screws for the specific adaption to the patient's anatomy. The icotec Anterior Cervical Plates are 18mm in width and come as 1- to 4-segmental implants with lengths ranging from 21 up to 94mm. The plates are precontoured to better fit patient anatomy. The screw holes in the plates are conical and threaded. The icotec ACP self-tapping screws are available in diameters of 4.0 and 4.25mm with lengths of 13 and 15mm. The fully threaded bone screws have threaded conical heads to firmly lock into the plate. The conical threaded screw heads are designed to block pullout while screw angulation in the cranial direction prevents screws from penetrating through the lower end plate of the vertebral body.

This document is a 510(k) premarket notification for a medical device, the icotec Anterior Cervical Plate System. It focuses on demonstrating substantial equivalence to predicate devices, rather than proving that the device meets specific performance criteria for an AI/ML product. Therefore, the requested information regarding acceptance criteria for AI/ML device performance, ground truth establishment, training sets, and MRMC studies is not present in this document.

The document details the device's indications for use, its description, and the predicate devices used for comparison. It also lists performance testing that was conducted, which primarily involves mechanical biocompatibility and structural integrity tests relevant to a spinal implant, not an AI/ML algorithm.

Here's a breakdown of the information that is available, and why the requested AI/ML specific information is absent:

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

• Acceptance Criteria (Mechanical/Biocompatibility): The document states that "The nonclinical tests performed by the company, including static compression, static torsion and dynamic compression per ASTM F1717, met the pre-defined acceptance criteria." However, the specific numerical acceptance criteria (e.g., minimum load bearing capacity, maximum displacement) are not provided in this summary.
• Reported Device Performance (Mechanical/Biocompatibility): Similarly, the actual numerical results of these tests are not reported in this summary, only the qualitative statement that they "met the pre-defined acceptance criteria."

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

• Not Applicable for this type of device: This information typically pertains to clinical studies for AI/ML devices or drugs. For this mechanical implant, "sample size" would refer to the number of devices tested for mechanical properties, which is not detailed in this summary. There is no "data provenance" in the sense of patient data for an AI/ML algorithm.

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: Ground truth establishment by experts is a concept for AI/ML model validation, not for the mechanical testing of a spinal plate.

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

• Not Applicable: Adjudication methods are used in clinical trials or AI/ML evaluations to resolve disagreements among readers/experts. This is not relevant to mechanical 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

• Not Applicable: MRMC studies are used to evaluate diagnostic performance, especially for AI/ML algorithms assisting human readers. This device is a mechanical implant, not a diagnostic AI/ML tool.

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

• Not Applicable: This refers to the performance of an AI/ML algorithm in isolation. This device is a physical implant.

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

• Not Applicable (for AI/ML context): For mechanical testing, the "ground truth" would be engineering specifications and ASTM standards.

8. The sample size for the training set

• Not Applicable: There is no AI/ML model being trained for this device.

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

• Not Applicable: There is no AI/ML model being trained for this device.

In summary, the provided document is a regulatory submission for a physical medical device (spinal implant) demonstrating substantial equivalence based on mechanical and biocompatibility testing, not an AI/ML diagnostic or therapeutic device. Therefore, the questions related to AI/ML specific acceptance criteria, study methodologies, and ground truth establishment are not addressed in this document.

Ask a specific question about this device

Cervical

KONG®-C VBR System devices are intended for use in the cervical spine (from C2 to T1) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. KONG®-C VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.

These implants may be used with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. These implants are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

Thoracolumbar

KONG®-TL VBR System devices are intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). When used in the thoracolumbar spine, the KONG®-TL VBR System is intended to be used with FDA-cleared supplemental fixation appropriate for the implanted level, including icotec Pedicle Screw Systems.

These implants may be used with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. These implants are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The KONG®-TL VBR System and the KONG®-C VBR System are vertebral body replacement systems designed to improve the stability of the cervical and thoracolumbar spine. The devices are manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/ PEEK. BlackArmor®) and incorporate a rough titanium coating (Ti-TT®). The devices are intended to be used with supplemental spinal fixation.

Each implant is provided sterile and is available in an assortment of heights, footprints, and lordosis angles to accommodate patient anatomy.

This document is a 510(k) summary for the KONG®-TL VBR System and KONG®-C VBR System, which are vertebral body replacement systems. It describes the device, its indications for use, and a summary of performance testing to establish substantial equivalence to predicate devices.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present "acceptance criteria" in a typical quantitative sense (e.g., target accuracy, sensitivity/specificity values). Instead, the performance testing aims to demonstrate substantial equivalence to legally marketed predicate devices by conforming to established ASTM standards for various mechanical properties. The "reported device performance" are the results from these tests, which were deemed sufficient to show equivalence.

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

The document describes non-clinical mechanical performance testing. This typically involves physical samples of the medical device or its components.

• Sample Size: Not explicitly stated in terms of a numerical count of tested devices. It refers to "worst-case construct" for expulsion testing, implying selection based on anticipated highest stress. For other tests, it's implied that a statistically relevant number of samples were tested to meet ASTM standard requirements, but the exact number is not provided in this summary.
• Data Provenance: The tests are non-clinical (benchtop, laboratory testing) performed by "the company" (icotec ag). Since it's mechanical testing of the device itself, there is no patient data or "country of origin of the data" in the sense of clinical study demographics.

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

This question is not applicable. The study is a non-clinical mechanical performance test, not a clinical study involving diagnosis or interpretation by experts. The "ground truth" here is compliance with engineering standards and mechanical integrity, not medical findings.

4. Adjudication Method for the Test Set:

This question is not applicable. There is no expert adjudication needed for non-clinical mechanical testing. The results are typically objectively measured and compared against standard specifications.

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

No, an MRMC comparative effectiveness study was not done. This submission focuses on non-clinical mechanical performance testing to demonstrate substantial equivalence to predicate devices, not on a clinical comparison involving human readers or AI assistance.

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

No, this question is not applicable. The device (KONG®-TL VBR System and KONG®-C VBR System) is a physical medical implant, not an AI algorithm or software device.

7. The Type of Ground Truth Used:

The "ground truth" for this non-clinical performance evaluation is based on established engineering standards (ASTM F2077, ASTM F2267) and the mechanical properties and performance of legally marketed predicate devices. The testing aims to show that the subject device performs similarly or meets the safety and effectiveness requirements defined by these standards, thereby demonstrating substantial equivalence.

8. The Sample Size for the Training Set:

This question is not applicable. Since the device is a physical implant and the study is non-clinical mechanical testing, there is no "training set" in the context of an algorithm or statistical model.

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

This question is not applicable as there is no "training set" for this type of device and study.

Ask a specific question about this device