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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the COLORADO™ II Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal turnor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the COLORADO™ II Spinal System is also indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the COLORADO™ II Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used as an anterolateral thoracic/lumbar system, the COLORADO™ II Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The COLORADO™ II Spinal System consists of a variety of rods, hooks, screws, plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

COLORADO™ II Spinal System implant components are fabricated from stainless steel conforming to ASTM F138 or ISO 5832-1 or ISO 5832-9. Alternatively, the implant components may be manufactured from titanium alloy conforming to ASTM F-136 titanium alloy, or ISO 5832-3 and may be sold sterile or non-sterile. Stainless steel implants are not to be used with titanium alloy implants in a spinal construct.

The provided text is a 510(k) summary for the COLORADO™ II Spinal System. This document details the device's description, indications for use, and a statement of substantial equivalence to other legally marketed devices.

However, the 510(k) summary does not contain information about acceptance criteria, detailed device performance metrics, or specific study designs (like sample sizes, ground truth establishment, or expert involvement) that would be expected for a clinical or AI-based device study.

Instead, the document states: "Mechanical testing data were provided or referenced to demonstrate substantial equivalence." This implies that the device's performance was evaluated against a predicate device based on mechanical properties rather than clinical outcomes or diagnostic accuracy.

Therefore, I cannot provide the requested information for an AI/clinical study as it is not present in the provided text. The device's approval is based on demonstrating "substantial equivalence" through mechanical testing, not a study evaluating its performance against specific acceptance criteria in a clinical setting with human readers or AI.

If this were an AI-based device, the 510(k) summary would include sections describing a clinical study, reader study, or similar performance evaluation. Since it's a spinal system (an implantable medical device), the focus is on mechanical and materials safety and equivalence.

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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the COLORADO™ II Spinal System Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the COLORADO™ II Spinal System is also indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the COLORADO™ II Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The COLORADO™ II Spinal System consists of a variety of rods, hooks, screws, plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

The provided text is a 510(k) premarket notification for the COLORADO™ II Spinal System, indicating that the device's substantial equivalence was demonstrated through "Mechanical testing data were provided or referenced to demonstrate substantial equivalence."

This type of submission typically relies on comparing the new device's design and mechanical properties to a legally marketed predicate device, rather than clinical studies involving human subjects in the same way an AI-powered diagnostic device would. Therefore, most of the detailed information requested regarding clinical study design, acceptance criteria, multi-reader multi-case studies, or ground truth establishment is not present or applicable to this type of device submission.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

For a 510(k) submission like this, the "acceptance criteria" are implicitly met if the mechanical testing demonstrates that the new device performs equivalently or better than the predicate device for its intended use. Performance is typically assessed through engineering tests (e.g., strength, fatigue, stiffness) rather than clinical outcomes.

Study Details (Applicable to Mechanical Testing for Substantial Equivalence):

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

• Sample size: Not specified in the provided text. Mechanical testing would involve a certain number of device components or constructs tested to failure or under specific conditions.
• Data provenance: Not explicitly stated, but mechanical testing data would typically be generated in a lab setting, either by the manufacturer or a third-party testing facility. The country of origin is not specified but based on the company's location (Memphis, TN, USA) it is likely US-based.

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

• Not applicable in the context of mechanical testing for substantial equivalence. "Ground truth" in this context would refer to established engineering standards or the performance of predicate devices, not expert human interpretation.

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

• Not applicable. Mechanical testing results are typically quantitative and objective measurements against established engineering limits or predicate device performance, not subjective interpretations requiring adjudication.

4. 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 implant, not an AI-powered diagnostic device.

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

• Not applicable. This is a spinal implant, not an AI-powered diagnostic device.

6. The type of ground truth used:

• For mechanical testing, the "ground truth" would be established engineering standards, material properties, and the known performance specifications of predicate devices.

7. The sample size for the training set:

• Not applicable in the context of device approval through substantial equivalence via mechanical testing. There is no "training set" in the machine learning sense.

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

• Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (spinal implant) seeking approval based on substantial equivalence to predicate devices through mechanical testing. It is fundamentally different from the regulatory pathway for AI/ML-based diagnostic software, which would require extensive clinical validation as detailed in your prompt questions.

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