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The HILINE™ Fixation System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

· Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;

· Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis;

· Spinal degenerative surgery, as an adjunct to spinal fusions;

· Use with a posterior spinal instrumentation construct when ligament augmentation is needed.

The HILINE™ Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.

The HILINE™ Fixation System is a sublaminar fixation system consisting of bands and clamps to mate with 3.5-6.5mm diameter rods, and associated manual surgical instruments. The bands have a titanium anchor attachment on one end that is detached after insertion and is not intended to be implanted. HILINE™ implants are manufactured from polyethylene terephthalate (PET), titanium alloy, commercially pure titanium, stainless steel, or cobalt chromium molybdenum alloy.

The provided text is a 510(k) summary for the HILINE™ Fixation System, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices based on mechanical testing and material characteristics. The summary explicitly states:

"Performance data demonstrate substantial equivalence to the predicate devices."

However, the provided text does not contain the detailed information required to fill out the table regarding acceptance criteria, specific device performance metrics, or study design details for clinical or AI-related performance evaluations. The "Performance Data" section solely mentions mechanical testing in accordance with ASTM F1798. There is no indication of a study involving human readers, ground truth establishment by experts, or any AI component.

Therefore, several sections of your request cannot be fulfilled based on the given information.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The document states that mechanical testing (static and dynamic tension, band pull-through, rod push-through, and static component torsion) was conducted in accordance with ASTM F1798, and that the performance data demonstrated substantial equivalence to the predicate devices. However, it does not specify the numerical acceptance criteria or the specific numerical results of these tests.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical or human-involved test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.

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, an MRMC study was not done. The device description and performance data section do not mention any AI component or human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone algorithm study was not done. The device description and performance data section do not mention any AI component.

7. The type of ground truth used: Not applicable. No ground truth for an AI algorithm or diagnostic performance study is mentioned. The "ground truth" relevant here pertains to the physical properties and performance of the device under mechanical stress, which are assessed through standardized mechanical testing (ASTM F1798).

8. The sample size for the training set: Not applicable. No training set for an AI algorithm is mentioned.

9. How the ground truth for the training set was established: Not applicable. No training set for an AI algorithm is mentioned.

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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 Percusys® Plus Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Percusys® Plus Pedicle Screw System is a multiple component, posterior spinal fixation system which consists of pedicle screws and rods. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All implant components are made from titanium alloy (ASTM F136).

The Percusys® Plus Pedicle Screw System is provided in sterile form. All implants are intended for single use only.

This document is a 510(k) Premarket Notification from the FDA regarding the joimax GmbH's Percusys® Plus Pedicle Screw System. It is primarily concerned with establishing substantial equivalence to legally marketed predicate devices, not with clinical performance based on AI or advanced algorithms requiring extensive performance studies as outlined in the prompt's request.

Therefore, the requested information regarding acceptance criteria, training/test set sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and ground truth types is not present in this document. This typically applies to devices that rely on novel algorithms or AI for diagnosis or treatment.

The performance data provided for the Percusys® Plus Pedicle Screw System is mechanical in nature, focusing on the physical properties and stability of the pedicle screw system itself. The document states:

"The following performance data were provided in support of the substantial equivalence.

• Dynamic Axial Compression Bending (ASTM F1717)
• Dynamic Flexion Bending (ASTM F1798)
• Buckling Test
• Torsion Testing
  The Percusys® Plus Pedicle Screw System met all specified criteria and did not raise new safety or performance questions."

This indicates that the acceptance criteria for this device are based on meeting specific mechanical testing standards (ASTM F1717, ASTM F1798) and other physical tests (Buckling, Torsion). The "performance" here refers to the device's structural integrity and mechanical behavior, not its diagnostic or clinical efficacy in the context of AI assistance.

Therefore, I cannot provide the requested table and detailed study information because the provided text describes a mechanical device clearance based on substantial equivalence, not an AI-driven medical device requiring the type of performance study details you've asked for.

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The Invictus Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion 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 and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

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

The Invictus Spinal Fixation System is intended to be used with autograft and/or allograft.

The Invictus Spinal Fixation System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium (CP Ti Grade 2) per ASTM F67 and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus System consists of a variety of shapes and sizes of screws, hooks, rods, connectors, and cross-connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic. Iumbar and sacral spine.

The purpose of this submission is to add modular pedicle screws and rod connectors to the Invictus Spinal Fixation System.

The provided text describes a 510(k) premarket notification for the Invictus™ Spinal Fixation System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data, rather than clinical performance studies typically associated with AI/software devices. Therefore, the information requested regarding acceptance criteria, study design for proving it, sample sizes, expert ground truth, MRMC studies, standalone performance, and training data for AI/software is not applicable to this specific document.

The document pertains to a Class II medical device, specifically a thoracolumbosacral pedicle screw system, which is a physical implant. The approval is based on demonstrating the device's substantial equivalence to existing legally marketed predicate devices through material testing and mechanical performance, not through clinical or AI-based performance metrics.

Specifically addressing your numbered points based on the provided text:

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

   • Acceptance Criteria: The acceptance criteria are implicitly based on demonstrating performance comparable to the predicate devices as per industry standards for spinal fixation systems. The relevant ASTM (American Society for Testing and Materials) standards provide the framework for these criteria.
   • Reported Device Performance:

     Test Type	Standard	Reported Performance
     Static and dynamic axial compression	ASTM F1717	"The results demonstrate that the subject Invictus Spinal Fixation System is substantially equivalent to other predicate devices for nonclinical testing."
     Static torsion	ASTM F1717	"The results demonstrate that the subject Invictus Spinal Fixation System is substantially equivalent to other predicate devices for nonclinical testing."
     Static tulip pull-off (Fx)	ASTM F1798	"The results demonstrate that the subject Invictus Spinal Fixation System is substantially equivalent to other predicate devices for nonclinical testing."

   Note: The document does not provide specific numerical results of these tests, but rather states that the results demonstrate substantial equivalence.

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

   • Sample Size: Not specified in the document. For mechanical testing, sample sizes are typically determined by the relevant ASTM standard and statistical requirements for demonstrating equivalence, but not explicitly stated here.
   • Data Provenance: The data is generated from non-clinical laboratory testing of the physical device components. Not applicable to country of origin in the way it would be for patient data, nor is it retrospective or prospective in the clinical sense.

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

   • Not applicable. Ground truth as typically understood in AI/software evaluation (e.g., expert consensus on medical images) is not relevant for this type of mechanical device testing. The "ground truth" for these tests are the established scientific principles of material strength and mechanical integrity as defined by the ASTM standards.

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

   • Not applicable. This is not a clinical study involving human judgment.

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 non-clinical submission for a physical medical device, not an AI or software device.

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

   • Not applicable. This is a non-clinical submission for a physical medical device, not an AI or software device.

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

   • For this mechanical device, the "ground truth" is defined by the physical properties and mechanical performance requirements as per the relevant ASTM standards (F1717, F1798) to demonstrate safety and effectiveness comparable to predicate devices. There is no expert consensus on clinical data, pathology, or outcomes data used for the substantial equivalence determination for this device's performance.

8. The sample size for the training set

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

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

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

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