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The CarboClear Pedicle Screw System is 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The CarboClear Pedicle Screw System is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants.

The CarboClear implants include pedicle screws, rods and locking elements. The implants are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell.

The implants are supplied sterile, and are intended for single use.

I am sorry, but based on the provided document, I cannot extract the specific details about the acceptance criteria, the study that proves the device meets the acceptance criteria, or most of the other requested information (sample size, expert qualifications, adjudication method, MRMC study, standalone performance, training set details).

This document is a 510(k) summary for a medical device (CarboClear® Pedicle Screw System), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results in the format you've requested.

Here's what I can tell you from the document:

• Device: CarboClear® Pedicle Screw System
• Purpose: To restore the integrity of the spinal column in patients with advanced-stage tumors involving the thoracic and lumbar spine.
• Performance Data: "Performance characteristics included static and dynamic tests according to ASTM F 1717, and tests according to ASTM F 1798, ASTM F 2193, ASTM F 543; as well as fatigue lateral bending-axial rotation test and rod creep test. The test results are comparable to those of predicate devices, as applicable, demonstrating that the device is safe and effective for its intended use."
• Clinical Data: "Clinical data for the CarboClear System was presented for the target population specified in the indications for use statement, and supports the safety and effectiveness of the device."

However, the document does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information about standalone (algorithm-only) performance (this is a hardware device, not an AI algorithm).
7. The type of ground truth used (beyond general "clinical data").
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This type of information would typically be found in a more detailed clinical study report, which is not part of this 510(k) summary.

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The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications;

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: Trauma ( i.e. fracture or dislocation ): spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of 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.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: 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; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Everest Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

The purpose of this 510(k) submission is to add minimally invasive implants.

Here's an analysis of the provided text regarding the Everest Spinal System, focusing on acceptance criteria and the study proving device performance:

Summary of Acceptance Criteria and Device Performance for the Everest Spinal System

It's important to note that the provided document is a 510(k) summary for a spinal fixation system, and not a diagnostic AI device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are geared towards mechanical and design equivalence to predicate devices, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC which are typical for AI-powered diagnostic tools.

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

Given this is a mechanical testing and design comparison, the concept of a "test set" and "data provenance" (country of origin, retrospective/prospective) as understood for AI/diagnostic studies is not directly applicable.

• Test Set Sample Size: The document does not specify a numerical sample size for the mechanical tests. It would typically involve a certain number of devices or components tested according to ASTM F1717.
• Data Provenance: Not applicable in the context of mechanical testing. The testing would be conducted in a laboratory environment following standardized procedures.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This category is not applicable for the Everest Spinal System 510(k) summary. "Ground truth" in this context refers to an objective standard, which for mechanical performance is established by the ASTM F1717 standard itself and the measured physical properties of the tested devices, not expert human assessment.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts in diagnostic studies. Here, the "truth" is determined by direct mechanical measurements against a standard.

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 device is a surgical implant, not an AI-assisted diagnostic tool. Therefore, MRMC studies for human reader performance with or without AI assistance are irrelevant.

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

Not applicable. The Everest Spinal System is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Mechanical Measurement Results: Directly measured values from static compression, static torsion, and dynamic compression tests performed according to ASTM F1717.
• Predicate Device Performance: The accepted performance characteristics of the legally marketed predicate devices (K2M Everest Spinal System, K2M Range Spinal System, NuVasive SpherX, Globus Resolve). The new device's performance is compared against these established benchmarks.
• Design and Sizing Equivalence: Direct comparison of the physical design and dimensions of the new components to those of the predicate devices.
• Material Standards: Compliance with ASTM and ISO standards for Titanium Alloy and Cobalt Chrome.

8. The Sample Size for the Training Set

Not applicable. As this is a physical medical device undergoing mechanical testing and design comparison, there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this type of device submission.

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The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples, all of which are cleared for the following indications:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the LS-S 1 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.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DDD ) (defined as back pain of discogenic origin with degencration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fision.

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

The provided document is a 510(k) premarket notification for the Range Spinal System: Mesa Modifications. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials. Therefore, the information typically requested regarding acceptance criteria, study data, sample sizes, expert involvement, and ground truth establishment for AI/diagnostic devices will not be present in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Test Set Sample Size: Not applicable. The submission relies on mechanical testing of components, not human test subjects or clinical data in the context of diagnostic performance. The sample size for the mechanical tests (e.g., number of screws or rods tested) is not specified in this summary.
• Data Provenance: Not applicable in the context of clinical data. The data provenance is from laboratory mechanical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. Ground truth as typically understood for diagnostic or AI devices (e.g., expert consensus on medical images) is not relevant for this type of mechanical device submission and testing. The "ground truth" here is compliance with ASTM standards and comparison to a predicate device's mechanical properties.

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

• Not applicable. This is not a clinical study involving human readers or interpretation of results that would require an adjudication method.

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 fixation system, not an AI or diagnostic device designed to assist human readers.

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

• Not applicable. This refers to an AI/algorithm's performance, which is not relevant to this device.

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

• The "ground truth" in this context is the established performance characteristics and mechanical properties of the legally marketed predicate devices, and the compliance with established ASTM standards (like F1717) for mechanical testing.

8. The sample size for the training set:

• Not applicable. This submission does not involve machine learning or AI models with training sets.

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

• Not applicable. There is no training set mentioned in this submission.

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