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The NIDO™ 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The NIDO™ Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

The NIDO™ Pedicle Screw System Cannulated/Fenestrated Screws are intended to be used with saline and radiopaque dye.

The NIDO™ Pedicle Screw System is a modular head, multiple component posterior spinal fixation system which consists of subject modular pedicle screw tulips, and rod connectors manufactured from Titanium alloy Ti-6Al-4V per ASTM F136.

The subject pedicle screws are available in solid and cannulated/fenestrated configurations in various sizes to match patient anatomy. The fenestrated/cannulated screws are cannulated for use over a guidewire; they are fenestrated to allow the surgeon to apply a radiopaque dye or saline solution. The fenestrated/cannulated screws are not intended to allow for the use of bone cement. Screw tulips are available in standard, extended tab and closed styles, with a universal locking cap to lock the construct. Rod connectors are provided in domino, lateral and tulip styles.

The subject components are intended for use with previously cleared rods and crosslinks connectors from the primary predicate Cosmolock Pedicle Screw System.

This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, the NIDO™ Pedicle Screw System. It determines the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document states: "No clinical studies were necessary to demonstrate substantial equivalence."

This means that the information requested regarding acceptance criteria, device performance from a clinical study, sample sizes for test sets, expert consensus, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for test/training sets cannot be provided from this document.

The device's substantial equivalence was determined based on non-clinical testing (mechanical tests) and comparison of technological characteristics (material, design, manufacturing process, indications for use) to predicate devices. Therefore, the requested clinical performance data and study details are not present.

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The ARx Illiac Spinal Screw System, is intended for posterior pedicle screw fixation of the non-cervical posterior spine (T1 to S2/ilium) in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis . It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When used as a posterior spine thoracic/lumbar system, the ARx Illiac Spinal Screw System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures and spinal deformity (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (pseudarthrosis), (6) spinal stenosis, (7) spondylolisthesis.

In order to achieve additional levels of fixation in skeletally mature patients, the ARx Illiac Spinal Screw System 5.5/6.0 rod system may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm rod.

The ARx Illiac Spinal Screw System consists of screws and longitudinal rods intended to provide temporary stabilization and immobilization following surgery to fuse a portion of the thoracic, lumbar, and/or sacral spine. The ARx Illiac Spinal Screw System consists of an assortment of rods and screws. The bone screw, head, and taper lock are assembled together during manufacturing to create the ARX Illiac Spinal Screw System screw assembly component. The ARx Illiac Spinal Screw System implant components are made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 and Cobalt Chrome (Co-28Cr-6Mo) as described by ASTM F1537. Do not use any of the ARx Illiac Spinal Screw System components with the components from any other system or manufacturer.

This document is a 510(k) premarket notification for the "ARx Illiac Spinal Screw System," a medical device used for spinal fixation. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through mechanical performance testing.

Here's the breakdown of the requested information, which can be extracted directly from the provided text:

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

The document states that the testing was performed "to demonstrate substantially equivalent mechanical performance as compared to the Life Spine Arx (K200070)." This implies that the acceptance criteria for the ARx Illiac Spinal Screw System were to meet or exceed the performance of the predicate device (Life Spine Arx, K200070) for each tested parameter. Specific quantitative acceptance criteria are not provided in this summary, but the type of tests performed are mentioned:

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

The document does not specify the exact sample size used for the mechanical testing (e.g., number of screws, rods, or test constructs). It also does not explicitly state the provenance of the data (country of origin, retrospective or prospective). However, as this is a medical device approval in the U.S., it can be inferred that the testing was conducted to U.S. regulatory standards and likely performed by the manufacturer or a contracted lab. The data is generated from mechanical testing, not patient data.

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

This information is not applicable to this type of device and study. The "ground truth" for mechanical testing is established by standardized test methods (ASTM F1717 & F1798) and objective measurements using calibrated equipment, not by human experts interpreting results.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically associated with human interpretation tasks (e.g., medical image reading) where there might be subjectivity or disagreement. Mechanical testing is objective and quantitative.

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

An MRMC comparative effectiveness study was not done. This study focuses on the mechanical performance of a spinal implant, not on the effectiveness of an AI-assisted diagnostic or interpretative tool.

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

A standalone performance study was not done. This is not an AI algorithm.

7. The type of ground truth used

The ground truth used for this study is mechanical test standards and objective measurements. Specifically, the performance of the ARx Illiac Spinal Screw System was compared directly against the mechanical performance of the predicate device (Life Spine Arx, K200070) as measured by established ASTM standards (ASTM F1717 & F1798).

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of mechanical performance testing for spinal implants. This is not a machine learning or AI device.

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

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

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The Zavation System is intended to provide immobilization and stabilization of spinal segments in sketally mature patients as an adjunct to fusion in the tollowing 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); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

The Zavation Spinal System is comprised of polyaxial pedicle screws, rods, and rod connectors. The Zavation Spinal System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters. The rods are available in straight and prelordosed (curved) configurations. The system has variable length cross connectors, offsets, and connectors.

This document is a 510(k) premarket notification for the Zavation Spinal System. It is primarily a regulatory submission for a medical device and therefore does not contain information about an AI/ML device, its acceptance criteria, or a study proving it meets them.

The document describes a spinal fixation system, which is a physical implant used in spinal surgery. The performance data section refers to "biomechanical testing including static compression bending and torsion, and dynamic compression bending were performed according to ASTM F1717 on a worst-case construct. Axial and torsional grip of rod connectors was tested according to ASTM F1798." These are standard mechanical engineering tests for implants to ensure their structural integrity and performance, not statistical or clinical studies for an AI/ML device.

Therefore, I cannot provide the requested information as it is not present in the provided text.

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