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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 Polyaxial Hemispherical Spinal Screws are intended for posterior, noncervical pedicle and non-pedicle fixation 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

As a pedicle screw system the Polyaxial Hemispherical Spinal Screws are 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 rods, nuts and cross link members. (K990118, K013447 and K031290) It can be used for single or multiple level fixation. It also includes single and double hooks (K013444 and K013440) used for posterior, nonpedicle screw fixation of the noncervical spine, hook and sacral/iliac screw fixation to the noncervical spine and hook and sacral screw fixation to the T1-S1 spine.

The modification included in this submission is the addition of polyaxial hemispherical screws. These screws function in the same manner as the previously cleared hemispherical screws by insertion into the pedicle then placing an offset clamp over the screw with a rod that has been loaded into the clamp. A nut is them placed on the screw and tightened to secure the assembly. The new polyaxial screw allows the proximal portion of the screw to angulate in order to ease the assembly of the rod loaded clamps onto multiple screws that may not be axially aligned.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Polyaxial Hemispherical Spinal Screws:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided summary does not explicitly state a sample size for the test set. It mentions "Testing was performed per ATM F1717," which is a standard for pedicle screw spinal systems. This implies that the tests outlined in ASTM F1717 would have been conducted on a sufficient number of devices to demonstrate equivalence.

The data provenance is commercial, with the submitter being Scient'x, located in France. The testing would have been conducted by the manufacturer or a contracted lab in support of U.S. market clearance. The submission is retrospective in the sense that the testing was performed before the 510(k) submission.

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

This information is not applicable to this type of device submission. For a mechanical device like a spinal screw, the "ground truth" is established by adherence to a recognized international standard (ASTM F1717) and the physical properties of the materials and design, not by expert interpretation of data like in medical imaging.

4. Adjudication Method for the Test Set

This is not applicable to this type of mechanical testing. Adjudication methods like 2+1 or 3+1 are used for expert review of subjective data (e.g., medical images). The results of ASTM F1717 are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic or screening devices, particularly those involving human interpretation of data, and how an AI system might improve that human performance. This is a mechanical implant device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as this is a mechanical spinal implant, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the Polyaxial Hemispherical Spinal Screws relies on engineering specifications and recognized international standards (ASTM F1717). The comparison is made against the performance of a previously cleared predicate device that presumably also met these standards.

8. The Sample Size for the Training Set

This question is not applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set.

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

This question is not applicable. As explained above, there is no "training set" for this type of device.

Summary of the Study:

The "study" or rather, the non-clinical testing, performed to demonstrate the device meets acceptance criteria was based on ASTM F1717, a standard specification for spinal pedicle screw systems. The crucial aspect of the study was to show that the modified device (Polyaxial Hemispherical Spinal Screws) performed comparably to its predicate device (Scient'x ISOBAR Hemispherical Screw system). The specific performance metrics would have included various mechanical tests such as static and dynamic compression bending, torsion, axial pullout, implant-to-implant connection strength, corrosion resistance, and fatigue strength, as described in ASTM F1717. The acceptance criteria essentially were to meet or exceed the performance characteristics of the predicate device under these standardized conditions. The FDA's clearance (K051063) indicates that the agency found the results of this testing sufficient to establish substantial equivalence.

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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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