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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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The ELLIPSE® Occipito-Cervico-Thoracic Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft, for stabilization of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following conditions: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine.

The ELLIPSE® Occipito-Cervico-Thoracic Spinal System 3.5mm rods can also be linked to rod systems ranging in diameter from 3.2mm to 6.5mm, including the PROTEX® CT or PROTEX®, REVERE®, or BEACON® Stabilization Systems, using corresponding connectors.

The ELLIPSE® Occipito-Cervico-Thoracic Spinal System consists of 3.5mm jointed, straight and pre-bent rods, tapered rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, in-line connectors, rodto-rod connectors, rod extension clamps and occipital plates. CAPITOL ™ screws and rods are also available as components of the ELLIPSE® system. The implants are composed of titanium alloy (per ASTM F136, F1472, or F1295), stainless steel (per ASTM F138) or cobalt chromium molybdenum allov (CoCr) (per ASTM F1537). Due to the risk of galvanic corrosion following implantation. titanium alloy or CoCr implants should not be connected to stainless steel implants.

The provided text describes a 510(k) submission for the ELLIPSE® Occipito-Cervico-Thoracic Spinal System, specifically for additional implants. This document details the device, its intended use, and the performance data that demonstrates its substantial equivalence to predicate devices, rather than a clinical study evaluating the device against specific acceptance criteria for a diagnostic or AI-driven system.

Therefore, many of the requested categories in your prompt are not applicable to this type of medical device submission (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size).

However, I can extract the information relevant to the performance data provided:

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

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

• Sample Size: Not specified in the document. Mechanical testing typically uses predefined samples for each test type, but the exact numbers are not reported here.
• Data Provenance: Not applicable in the context of mechanical testing. The "data" are the results of physical tests conducted on the device components.

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

• This is not applicable as the "ground truth" for mechanical performance is established by standardized test methods and physical measurements, not by expert consensus on clinical data.

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

• Not applicable as this is not a diagnostic device relying on expert adjudication.

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 a spinal implant system, not a diagnostic imaging or AI system intended to assist human readers.

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used

• The "ground truth" for mechanical testing is defined by the objective physical measurements obtained from tests conducted according to recognized industry standards (ASTM F1717, ASTM F1798) and FDA guidance for spinal systems.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as Mechanical testing.

• Tests Conducted: Static and dynamic compression bending (in accordance with ASTM F1717), static torsion (in accordance with ASTM F1798), and axial gripping capacity (in accordance with the "Guidance for Industry and FDA Staff. Guidance for Spinal System 510(k)s," May 3, 2004).
• Conclusion: "Performance data demonstrate substantial equivalence to the predicate devices." The document states that the ELLIPSE® Additional Implants "are as safe, as effective, and perform as well as or better than the predicate devices."
• Predicate Devices: ELLIPSE® Occipito-Cervico-Thoracic Spinal System (K090565 & K110963), PROTEX® CT Cervicothoracic Spinal System (K050391 & K081906), REVERE® Stabilization System (K061202 & K122226), Blackstone™ Ascent® Posterior Occipital Cervico-Thoracic System (K080394).

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