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Silony Medical Navigation Instruments are intended to be used during the preparation and placement of VERTICALE® pedicle screws during spinal surgery to assist the surgeon in precise 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.

Silony Medical's VERTICALE® navigation instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System is designed to assist surgeons in the precise localization of anatomical structures, preparation and placement of pedicle screw implants during spinal procedures.

The VERTICALE® Navigation Instruments include awls, probes, taps, drivers and inserts. The VERTICALE® Navigation Instruments are to be used with the VERTICALE® Posterior Spinal Fixation System cleared under K171421.

All instruments are made of stainless steel per ASTM F899. The VERTICALE Navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic StealthStation Navigation System hardware and software.

The provided text does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The submission (K223649) is for VERTICALE® Navigation Instruments, which are physical surgical instruments used with a stereotactic navigation system, not an AI or algorithm-based device.

Therefore, the information requested in the prompt, such as acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not applicable to this medical device submission.

The "Performance Data" section (page 5) refers to testing performed per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems." This standard is for evaluating the accuracy of surgical navigation systems, and the submitter states that these data are applicable because the new instruments complement existing ones and a technical evaluation confirmed compatibility and functionality. The relevant performance for this device is its navigational accuracy and compatibility with the Medtronic StealthStation®, not an AI-driven diagnostic or prognostic capability.

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The DeGen Medical Navigated Instrumentation is intended to be used during the preparation and placement of DeGen Medical F 1 MPS and E3 MIS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. DeGen Medical Navigated Instrumentation is specifically designed for use with the Medtronic 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 of the anatomy.

The DeGen Navigated Instrumentation is nonsterile, reusable drivers that are intended to be used with the Medtronic StealthStation® Application 1.2.0 (1.2.0-20) and are manufactured from stainless steel per ASTM F899.

I'm sorry, but this document does not contain the detailed information necessary to answer your request about the acceptance criteria and the study proving the device meets those criteria. Specifically, the document is a 510(k) clearance letter and summary, which confirms regulatory clearance but does not include:

• A table of acceptance criteria and reported device performance. The document mentions "Anatomical simulated use and navigation accuracy" as a non-clinical test, but no specific performance metrics or acceptance thresholds are provided.
• The sample size used for the test set or its provenance.
• The number and qualifications of experts used to establish ground truth.
• The adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of human improvement with AI assistance.
• Whether standalone (algorithm only) performance was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.), though it implies simulated use.
• The sample size for the training set.
• How the ground truth for the training set was established.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on intended use, indications for use, design, function, technology, and non-clinical tests (dimensional analysis and anatomical simulated use/navigation accuracy). It concludes that the device is "as safe and effective" as the predicate based on these comparisons, but does not provide the specific performance data you are looking for.

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NuVasive® Navigation Instruments are intended to be used during the preparation and placement of NuVasive screws (Armada, Reline, Precept, MAS PLIF, and VuePoint fixation systems) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. NuVasive® Navigation Instruments are 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 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.

NuVasive Navigation Instruments are manual, non-sterile, re-usable, surgical instruments intended for use with Medtronic StealthStation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of NuVasive screws during spinal surgery.

The document provided does not contain a study that proves the device meets specific acceptance criteria in terms of reported device performance based on quantitative metrics. The FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria.

The "Performance Data" section (G) on page 4 mentions "Accuracy testing," "Compatibility testing," and "Performance testing" were performed, and concludes that "results demonstrate that the subject NuVasive Navigation Instruments are substantially equivalent to the predicate." However, it does not provide details about the specific acceptance criteria for these tests, the reported performance metrics, the sample sizes, data provenance, ground truth establishment, or any information related to expert involvement or comparative effectiveness.

Therefore, I cannot provide the requested information from the given document as it is not present.

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The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fosion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion. With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

IPC® System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

The IPC®POWEREASE® System is indicated for drilling, tapping and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.

1. The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The subject devices include: Taps Screw Drivers The subject CD HORIZON® Spinal System device will be available in similar sizes as the predicate systems.
2. IPC® POWEREASE® System. The CD HORIZON® reusable instruments (subject taps and screw drivers) are compatible with Medtronic's IPC® POWEREASE® System, and are spine preparation instruments which are manufactured from materials commonly used in orthopedic procedures which meet available national or international standards specifications. The subject taps and drivers may be connected to the POWEREASE® Driver or used manually if desired. These instruments are also compatible with various Medtronic spinal implant systems.

This document does not contain information about the acceptance criteria and a study proving a device meets acceptance criteria in the context of diagnostic or screening performance.

Instead, this document is a 510(k) premarket notification summary for the CD HORIZON® Spinal System and the IPC® POWEREASE® System. It focuses on demonstrating substantial equivalence to predicate devices.

Here's what the document does provide in relation to product validation:

1. Acceptance Criteria and Reported Device Performance:

The document describes performance data related to biocompatibility and mechanical testing for the CD HORIZON® Spinal System devices (taps and drivers) in combination with the IPC® POWEREASE® System.

• Biocompatibility:

  • Acceptance Criteria (implied): The devices must be safe for body contact for up to 24 hours, in accordance with "FDA's Draft Guidance for Industry and FDA Staff 'Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'". They are manufactured from medical grade stainless steel (ASTM F899).
  • Reported Device Performance: "Medical grade stainless steel has a long history of safe and effective use in spinal surgery and biocompatibility testing is not required and no testing was conducted." The material choice is the proof of meeting the (implied) acceptance criteria.

• Mechanical Testing:

  • Acceptance Criteria (implied): The devices must demonstrate substantial equivalence to predicate devices and not represent a "new worst case" as per "Guidance for Industry and FDA Staff -Spinal System 510(k)'s".
  • Reported Device Performance: "It was determined that subject devices do not represent a new worst case. Engineering rationales were used to demonstrate substantial equivalence." No specific quantitative metrics or results from mechanical tests are provided in this summary, only the conclusion that they met the criteria through engineering rationales.

The other points you requested are not applicable or not explicitly detailed in this 510(k) summary because it's not a study evaluating diagnostic or screening performance of an AI/ML device.

Here's why these points are not present:

• 2. Sample sized used for the test set and the data provenance: Not applicable. This is not a study with a 'test set' in the sense of clinical data for diagnostic performance.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. There's no ground truth establishment for diagnostic purposes here.
• 4. Adjudication method: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not a comparative effectiveness study involving human readers or AI assistance.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an instrument used by a human surgeon.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device with a training set.
• 9. How the ground truth for the training set was established: Not applicable.

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