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The ISOBAR Spinal System is intended to provide immobilization and stabilization 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; scoliosis; spinal tumor; and failed previous fusion.

As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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 solid fusion.

The Semi-Rigid Rod and Dual Dampener Rod should only be used at levels (one and two levels, respectively) that will be fused.

The ISOBAR Spinal System consists of pedicle screws, rigid rods and crosslink members (K990118, K013444, K020245, K031290 and K051063), semi-rigid rods (K991326) and hooks (K013440 & 013447). The Isobar Semi-rigid Dual Dampener Rod is an addition to the ISOBAR Spinal System family. The semi-rigid rod allows a very small amount of compression, torsion and bending. The components in this submission are fabricated from Ti6A14V alloy, conforming to ASTM F136 and ISO 5832-3, which is known to be biocompatible.

The provided text is a 510(k) summary for the "ISOBAR Spinal System." It details the device's indications for use, description, and states its substantial equivalence to predicate devices. However, it does not contain the specific information required to answer your questions regarding acceptance criteria, study details, sample sizes, expert involvement, or grand truth establishment for performance evaluation.

Here's an explanation of why the requested information is not present in the given document:

• Acceptance Criteria and Reported Device Performance: The document only states that "Testing performed indicates the ISOBAR Spinal System is substantially equivalent to predicate devices." It does not provide specific acceptance criteria (e.g., specific thresholds for mechanical strength, fatigue life) or the quantitative results of the tests performed against such criteria.
• Sample Size for Test Set and Data Provenance: This document is a regulatory submission for a spinal implant system. Performance testing for such devices typically involves benchtop mechanical testing (e.g., fatigue, static strength), not studies on human data or medical images. Therefore, concepts like "test set," "data provenance," or "country of origin of the data" in the context of medical imaging or clinical study data do not apply here. The "sample size" would refer to the number of devices or components tested mechanically, which is not disclosed.
• Number of Experts and Qualifications: As the evaluation is based on mechanical performance and substantial equivalence to predicate devices, there isn't a need for medical experts to establish "ground truth" or to adjudicate observations in the way they would for, say, an AI-powered diagnostic device analyzing medical images.
• Adjudication Method: Not applicable for a mechanical device substantial equivalence submission.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is used for diagnostic devices, particularly those involving human interpretation of medical data, to assess how a new technology (like AI) affects reader performance.
• Standalone Performance: While the device is "standalone" in the sense that it's an implantable device, the concept of "algorithm only without human-in-the-loop performance" is typically relevant to AI/ML software devices.
• Type of Ground Truth: The "ground truth" for a spinal implant system's performance would generally be established by adherence to recognized ASTM or ISO standards for mechanical testing (e.g., fatigue strength, pull-out strength). The document only mentions conformity to ASTM F136 and ISO 5832-3 for material properties, but not specific performance test standards or their results.
• Sample Size for Training Set: Not applicable. This pertains to AI/ML models.
• How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document is a 510(k) summary primarily focused on demonstrating substantial equivalence to predicate devices based on indications for use, design, function, and materials, rather than detailed performance study results against specific acceptance criteria. For mechanical devices like spinal implants, "performance standards" typically refer to adherence to recognized test methods and successful completion of those tests, rather than clinical studies with human participants. The document indicates that testing was performed to show substantial equivalence, but it does not elaborate on the specific tests, their results, or the acceptance criteria used.

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The MX Monoaxial Pedicle Screw is a pedicle screw system intended to provide immobilization and stabilization 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system the MX Monoaxial Pedicle Screws are 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.

The MX Monoaxial Pedicle Screw consists of pedicle screws and rods. Pedicle screws are inserted into the pedicles of the vertebrae and are available in two diameters (Ø5.5 and Ø6.2mm) and in lengths ranging from 30mm to 55mm. A rod is then placed through the screws. The rods are available in lengths ranging from 45-600mm. Two rod loading configurations are available. A closed screw is similar to the predicate screw with the head of the screw enlarged and the rod is slid through an opening in the head. A side loading configuration is similar to the closed screw except that there is an opening in the side of the screw head and the rod slid into this opening.

The document you provided is a 510(k) summary for the Scient'x MX Monoaxial Pedicle Screw. This document describes a medical device (a pedicle screw system) and its substantial equivalence to a predicate device, based on nonclinical testing.

Therefore, there is no information present in this document about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic accuracy studies. The document focuses on the mechanical and material aspects of the device in comparison to an already approved device.

Here's why the requested information is absent and what is provided:

• Acceptance Criteria/Reported Device Performance (Table): Not applicable. This device is a physical implant, and its "performance" is evaluated through mechanical testing, not diagnostic metrics like sensitivity, specificity, or AUC. The document states "Testing was performed per ASTM F1717 and is comparable to the predicate device." This is the core of their performance claim.

• Sample Size for Test Set and Data Provenance: Not applicable. There is no "test set" of patient data in the context of an AI/ML algorithm or diagnostic study. The testing refers to biomechanical tests on the screws themselves.

• Number of Experts and Qualifications: Not applicable. No human experts were involved in establishing ground truth for evaluating a diagnostic algorithm.

• Adjudication Method: Not applicable.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not a diagnostic imaging or AI-assisted device.

• Standalone Performance: Not applicable. The device itself is a physical implant; it doesn't have "standalone algorithm performance."

• Type of Ground Truth: Not applicable. There's no ground truth in the sense of a medical diagnosis. The ground truth for this type of device is compliance with mechanical standards (e.g., breaking strength, fatigue life).

• Sample Size for Training Set: Not applicable. This is a physical device, not an AI model.

• How Ground Truth for Training Set Was Established: Not applicable.

What the document does tell us about performance and acceptance criteria:

• Acceptance Criteria (Implicit): The implicit acceptance criteria are that the MX Monoaxial Pedicle Screw performs comparably to the predicate device (Scient'x Closed Pedicle Screw system, K020245) according to specific ASTM standards.
• Study Proving Device Meets Acceptance Criteria: The study involved "Nonclinical Tests" performed "per ASTM F1717." This standard (ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) specifies mechanical test methods for spinal implants. The document asserts that the results of these mechanical tests demonstrate comparability to the predicate device.

In summary, the provided text is for a physical medical device (pedicle screws) and not for an AI/ML diagnostic system. Therefore, the specific questions regarding AI/ML study design and performance metrics are not applicable and cannot be answered from this document.

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The EASYS Transverse Connection used with the ISOBAR Spinal System is intended for posterior, nonpedicle screw fixation of the noncervical spine/hook and sacral/iliac screw fixation to the noncervical spine/hook and sacral screw fixation to the T1-S1 spine.

Indications for use include:

• 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
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• tumor
• pseudoarthrosis
• failed previous fusion

The ISOBAR Spinal System is a pedicle screw system 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.

The ISOBAR Spinal System is a pedicle screw system intended to provide immobilization and stabilization 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal tumor, and failed previous fusion (pseudarthrosis).

The ISOBAR Spine System is a pedicle screw system 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 or sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusions.

As a pedicle screw system the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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.

The ISOBAR Spinal System consists of monoaxial and polyaxial pedicle screws (K990118, K013447 and K020245) rods, nuts and cross link members. It can be used for single or multiple level fixation. It also included single and double hooks (K013444 and K013440) used for posterior, nonpedicle screw fixation of the noncervical spine/hook and sacral/illiac screw fixation to the noncervical spine/hook and sacral screw fixation to the T1-S1 spine.

All components are manufactured from titanium alloy (Ti-6AI-4V) that conforms to ASTM F136.

The additional component that is the subject of this Special 510(k) submission is the EASYS Transverse Connection. Its purpose is to provide rigidity to the spinal construct similar to the crosslink cleared on K990118. It consists of a cross bar and two self locking jumper consists of a clamp and tightening screw.

The EASYS Transverse Connection is a component intended to provide rigidity to a spinal construct, similar to a previously cleared crosslink for the ISOBAR Spinal System.

The device's acceptance criteria and the study proving it meets these criteria are described as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. The study involved a comparison of mechanical properties, not a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The study was a non-clinical mechanical test.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The study was a non-clinical mechanical test.

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 mechanical device, not an AI or imaging device requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used: The ground truth was based on the mechanical strength of the predicate device's crosslink as measured by ASTM 1717.

8. The sample size for the training set: Not applicable. This is a non-clinical mechanical test, not a machine learning study with a training set.

9. How the ground truth for the training set was established: Not applicable.

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