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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 Aladyn Rigid Spine Plate 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 Aladyn Rigid Spine Plate is 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 spinc (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Aladyn Rigid Spine Plates, pedicle screws and a polyaxial nut. It is a modification to the plates and nuts of the ISOLOCK Pedicle Screw System (K990721) and uses the same hemispherical screws of the ISOBAR system (K990118). Pedicle screws are inserted into the vertebrae. An Aladyn plate is placed over the screws. The rigid plates are available in six multi-hole lengths. The construct is then scurely fixed with nuts. The implantation steps of the Aladyn are the SOLOCK Plate system. The only difference is that there are no washers used with the Aladyn plate.

The hemispherical screws come in two diameters (6.2mm and in lengths ranging from 38mm to 50mm. There is also a polyaxial nut available.

The provided text describes the "Aladyn Rigid Spine Plate," a pedicle screw system. However, it does not contain information about acceptance criteria, the specific study design to prove device performance against those criteria, or details regarding sample sizes, expert ground truth establishment, or clinical effectiveness studies.

The document primarily focuses on:

• Device Description: What the device is, its components, and modifications from previous devices.
• Intended Use/Indications for Use: The medical conditions and patient populations for which the device is intended.
• Nonclinical Tests: A very brief statement that "Testing was performed per ASTM F1717. Results were comparable with other devices on the ISOLOCK and ISOBAR Pedicle Screw Systems."

Therefore, I cannot populate the requested table or provide detailed answers to most of the study-related questions based on the input text.

Here's a breakdown of what can be inferred from the text, and where information is missing:

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

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

• Sample Size (Test Set): Not mentioned. ASTM F1717 specifies testing procedures for specific numbers of constructs.
• Data Provenance: Not mentioned (implied to be laboratory testing of the device itself, not human data).
• Retrospective or Prospective: Not applicable, as this refers to mechanical device testing, not clinical studies.

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)

• Number of Experts: Not applicable. Ground truth in this context would be derived from engineering specifications and standardized test methods (like ASTM F1717), not expert interpretation of clinical data.
• Qualifications of Experts: Not applicable.

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

• Not applicable. This refers to consensus-building amongst experts for clinical ground truth, not mechanical testing.

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

• MRMC Study: No. This device is a mechanical implant; it does not involve AI or human readers for diagnostic interpretation.

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

• No. This relates to AI algorithms, not a mechanical spinal implant.

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

• The "ground truth" for this device's performance is based on engineering specifications and standardized material/mechanical testing protocols (specifically ASTM F1717).

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. This device is not an AI algorithm that requires a training set. The "training" for a mechanical device comes from design, material selection, and manufacturing processes, guided by engineering principles.

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

• Not applicable. Again, this concept pertains to AI algorithms. For a mechanical device, performance is established through adherence to design specifications and subsequent validation via testing.

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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 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 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.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the ISOBAR Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history patient history and radiographic studies), deformities (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

The ISOBAR Spinal System consists of pedicle screws, rods, nuts, crosslink members and hooks. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

The provided document is a 510(k) summary for the ISOBAR Spinal System Additional Components. This document pertains to a medical device (pedicle screw spinal system) and its mechanical performance, not an AI/ML-based device. Therefore, many of the requested elements for AI/ML device studies (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable or cannot be extracted from this type of documentation.

However, I can extract the acceptance criteria and the study performed based on the information provided, focusing on the mechanical aspects of the device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the document. Testing according to ASTM F1717-96 would involve a specific number of samples, but this summary does not provide that detail.
• Data Provenance: The testing was "performed according to ASTM F1717-96." This implies laboratory testing of the physical device components. Data provenance in terms of country of origin or retrospective/prospective is not applicable for this mechanical testing.

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

• Not applicable. This is mechanical performance testing against an engineering standard, not clinical data requiring expert human review or ground truth establishment.

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

• Not applicable. This refers to consensus methods for clinical assessment, which is not relevant for mechanical testing.

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 medical device for spinal fixation, not an AI-based diagnostic or assistive technology.

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

• Not applicable. This is not an algorithm.

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

• The "ground truth" for this device's performance is compliance with the ASTM F1717-96 standard for static and fatigue compression testing, and the ASTM F136 standard for material composition. These are engineering standards, not clinical ground truths.

8. The sample size for the training set:

• Not applicable. This is mechanical performance testing, not an AI/ML model that requires a training set.

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

• Not applicable. There is no training set for this type of device and study.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study performed to demonstrate the device meets acceptance criteria involved mechanical testing of the ISOBAR Spinal System Additional Components. The specific standard cited for this testing is ASTM F1717-96, which covers static and fatigue compression testing of metallic spinal implant ensembles. Additionally, the material used, titanium alloy (Ti-6Al-4V), was confirmed to conform to ASTM F136, a standard specification for wrought titanium-6aluminum-4vanadium alloy for surgical implant applications.

The 510(k) submission states that these tests were "performed according to" the specified standards. This implies that the device and its components successfully met the performance requirements and material specifications outlined in those ASTM standards, thus establishing its substantial equivalence to predicate devices (Moss Miami Polyaxial Screw and ISOBAR U-Line Spinal System) that also rely on compliance with such standards for their mechanical integrity. The document does not provide a detailed report of the exact numerical results or the pass/fail thresholds for these tests, as is typical for a 510(k) summary which focuses on demonstrating substantial equivalence rather than a full engineering report.

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