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The QUARTEX™ Occipito-Cervico-Thoracic Spinal System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These implants are also 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. In order to achieve additional levels of fixation, rods may be connected to occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.2mm to 6.5mm, using corresponding connectors.

Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX™, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These 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.

The QUARTEX™ Occipito-Cervico-Thoracic Spinal System includes 3.5mm-4.0mm jointed, straight and pre-bent rods, tapered rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, in-line connectors, rod-to-rod connectors, rod extension clamps, QUARTEX™ H-LINK™ integrated rod, and occipital plates and screws. The implants are composed of titanium alloy, stainless steel, or cobalt chromium molybdenum (CoCr) alloy.

QUARTEX™ constructs may be connected to stabilization systems including ELLIPSE®, PROTEX® CT, PROTEX®, CREO®, REVERE®, or BEACON® Systems using corresponding connectors. The QUARTEX™ System includes manual surgical instruments.

Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX™, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System.

The provided text does not contain information about the acceptance criteria and study proving a device meets these criteria in the context of an Artificial Intelligence (AI) or machine learning device. The document is an FDA 510(k) clearance letter for a QUARTEX™ Occipito-Cervico-Thoracic Spinal System and Globus Navigation Instruments.

This document focuses on the mechanical and material equivalence of a surgical spinal system to previously cleared predicate devices. It discusses:

• Device Name: QUARTEXTM Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
• Regulation Number: 21 CFR 888.3075 (Posterior Cervical Screw System)
• Regulatory Class: Class II
• Product Code: NKG, KWP, OLO
• Indications for Use: Stabilization of spinal segments, assistance in locating anatomical structures during spinal surgery.
• Performance Data: Mechanical testing (static and dynamic compression bending, static interconnection testing) in accordance with ASTM F1717, ASTM F1798, and FDA guidance. Bacterial endotoxin testing (BET) per ANSI/AAMI ST-72:2011.
• Basis of Substantial Equivalence: Similar technical characteristics, performance, material composition, function, and intended use to predicate devices.

Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details (such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) because this information is not present in the provided document.

The document describes material and mechanical testing for a physical surgical implant and navigation instruments, not an AI/ML diagnostic or prognostic device.

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The QUARTEX™ Occipito-Cervico-Thoracic Spinal System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); turnors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These implants are also 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 turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, rods may be connected to occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.2mm to 6.5mm, using corresponding connectors.

Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX, CREO, REVERE, REVOLVE, ELLIPSE, and PROTEX CT Stabilization Systems) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medronic 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.

The QUARTEX™ Occipito-Cervico-Thoracic Spinal System consists of 3.5mm-4.0mm jointed, straight and pre-bent rods, tapered rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, in-line connectors, rod-to-rod connectors, rod extension clamps, QUARTEX™ H-LINK™ Integrated Rod and occipital plates. The implants are composed of titanium alloy (per ASTM F136, F1472, or F1295), stainless steel (per ASTM F138) or cobalt chromium molybdenum alloy (CoCr) (per ASTM F1537).

QUARTEX™ constructs may be connected to stabilization systems including ELLIPSE®, PROTEX® CT, PROTEX® , CREO®, REVERE®, or BEACON® Systems using corresponding connectors.

The QUARTEX™ System include manual surgical instruments manufactured from stainless steel, as specified in ASTM F899. Globus Navigation Instruments are nonsterile, reusable instruments that can be operated manually and are intended to be used with the Medtronic StealthStation® System.

This document is a 510(k) premarket notification decision letter from the FDA regarding the QUARTEX™ Occipito-Cervico-Thoracic Spinal System and Globus Navigation Instruments. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain the specific acceptance criteria or details of a study that proves the device meets those criteria in the way you've outlined for performance studies (e.g., sensitivity, specificity, sample sizes, expert qualifications, etc.).

The document primarily focuses on regulatory clearance based on substantial equivalence, which is often established through comparison to predicate devices, rather than comprehensive performance studies with specific statistical endpoints like those for AI/diagnostic devices.

Here's a breakdown of what can be extracted and what is missing from the provided text based on your request:

Information Present in the Document:

• Device Names: QUARTEX™ Occipito-Cervico-Thoracic Spinal System and Globus Navigation Instruments.
• Purpose of Submission: Request clearance for these devices for use with the Medtronic StealthStation® System.
• Device Description:
  • QUARTEX™ System: Consists of rods, screws, hooks, caps, connectors, and plates made of titanium alloy, stainless steel, or cobalt chromium molybdenum alloy. Manual surgical instruments are made of stainless steel.
  • Globus Navigation Instruments: Nonsterile, reusable instruments for use with Medtronic StealthStation® System.
• Indications for Use: Very detailed for both the spinal system (immobilization and stabilization for various spinal instabilities, fractures, deformities, tumors, degenerative diseases) and the navigation instruments (assisting surgeons in precisely locating anatomical structures during spinal surgery).
• Predicate Devices:
  • QUARTEX™ System: Primary predicate: ELLIPSE® OCT Spinal System (K150552). Additional predicates: Synapse OCT System (K142838), H-LINK™ Integrated Rod (K073517), PROTEX CT® (K050391).
  • Globus Navigation Instruments: Additional predicate: Globus Navigation Instruments (K153203).
• Basis of Substantial Equivalence: The subject devices perform as well as or better than the predicate devices with respect to technical characteristics, performance, and intended use.
• Performance Data Mentioned: "Performance of the QUARTEX™ Occipito-Cervico-Thoracic Spinal System was evaluated in accordance with ASTM F1717, ASTM F2706, and the 'Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s,' May 3, 2004. Performance data demonstrate substantial equivalence to the predicate devices. A comparative analysis was provided for the Globus Navigation Instruments and its predicate device. Bacterial endotoxin testing was also provided."

Missing Information (based on your specific request for AI/diagnostic device performance studies):

The document does not provide the following specific details typically found in acceptance criteria and performance study reports for AI/diagnostic devices:

1. A table of acceptance criteria and the reported device performance: This document states performance data demonstrated "substantial equivalence" to predicate devices, but it does not list specific numerical performance metrics (e.g., sensitivity, specificity, accuracy, precision, recall) or the thresholds for those metrics (acceptance criteria). The performance evaluation mentioned refers to adherence to ASTM standards and FDA guidance for spinal systems, which are largely mechanical and materials testing standards, not clinical performance metrics for an AI algorithm.
2. Sample size used for the test set and the data provenance: Not mentioned. The "performance data" refers to engineering and mechanical testing, not a clinical test set of patients/images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or mentioned. The device is a spinal implant system and navigation instruments, not an AI diagnostic tool requiring expert ground truth for image interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or mentioned.
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 is not an AI diagnostic device for human readers. It's a surgical implant and navigation system. The navigation instruments assist the surgeon, but the document doesn't detail a study measuring improvement in surgeon performance with vs. without the navigation system in a quantitative MRMC-like approach. It only states the instruments are "intended to assist the surgeon."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The "Globus Navigation Instruments" are tools used by a human surgeon, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/diagnostic device. The "ground truth" for the spinal system would be its mechanical integrity, biocompatibility, and intended function as demonstrated through engineering tests and comparison to predicates.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary:

This FDA document is a clearance letter for a medical device (spinal implant system and navigation instruments) based on substantial equivalence. It confirms regulatory compliance but does not provide the kind of detailed performance study information, acceptance criteria, or ground truth establishment relevant to an AI or diagnostic imaging device that you requested. The "performance data" mentioned refers to engineering and biocompatibility testing, not clinical diagnostic accuracy metrics.

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