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Non-cervical spinal fixation devices intended for posterior, 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); turnor; pseudoarthrosis; and failed previous fusion.

Non-cervical pedicle screw fixation 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 LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (1,3 to sacrum ) with removal of the implants after the attainment of a solid fusion.

The Range Spinal System is a top-loading, multiple component, posterior system which consists of pedicle screws, rods, hooks, and transverse connectors. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials: The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards,

Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the thoracic, lumbar and / or sacral spine.

The medical device being described is the Range Spinal System.

Here's an analysis of the provided text regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

Design Features and Sizing: The design features and sizing of components must be substantially the same as predicate systems, implying that it fits within established anatomical and surgical norms for spinal fixation.

Material Composition: Must be manufactured from FDA-recognized materials for spinal implants (specifically Ti6Al-4V ELI alloy per ASTM and ISO standards).

Intended Use: The device must be indicated for the same intended uses as legally marketed predicate devices, encompassing various spinal conditions requiring fixation (e.g., degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion, and severe spondylolisthesis at L5-S1 for pedicle screw fixation). | Mechanical/Biomechanical Performance: "The Range Spinal System was biomechanically tested and compared to the predicate systems and other currently marketed systems and performed equal to or better than these systems in ASTM testing to F1717."

Design Features and Sizing: "The design features and sizing of the components were also compared and the Range Spinal System found to be substantially the same as these systems."

Material Composition: "It is manufactured from the same FDA recognized materials [Ti6Al-4V ELI alloy per ASTM and ISO standards]."

Intended Use: "It is indicated for the same intended uses as these systems." (The specific indications are listed in section 5 of the 510(k) summary and reiterated in the Indications for Use document.) |

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

The provided text does not specify a sample size for a "test set" in the context of clinical data or patient outcomes. The evaluation is primarily based on biomechanical testing against established ASTM standards and comparison to predicate devices, and not on a clinical trial with a defined patient test set.

The data provenance is related to the biomechanical testing results of the Range Spinal System itself, compared against predicate devices. It is therefore prospective in the sense that the new device was tested, but the comparison is against established, already-marketed devices. The country of origin for the data is not specified, but the testing was done according to ASTM standards, which are international.

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 document. The "ground truth" for this medical device's acceptance is based on adherence to biomechanical performance standards (ASTM F1717) and substantial equivalence to legally marketed predicate devices in terms of design, materials, and intended use. There is no mention of expert consensus on patient data or clinical outcomes being used to establish ground truth in this submission.

4. Adjudication Method for the Test Set

This information is not applicable as there is no human-adjudicated "test set" described in the context of clinical performance or diagnostic accuracy. The evaluation revolves around engineering and material properties, and comparison to predicate devices.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and their performance is compared with and without AI assistance. The Range Spinal System is an implantable spinal fixation device, not a diagnostic tool requiring interpretation by human readers.

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

N/A. This question is primarily relevant to AI/diagnostic algorithms. The Range Spinal System is a physical medical implant. The determination of its performance is through physical testing (biomechanical) and comparison to existing physical devices, not through an algorithm operating in isolation.

7. The Type of Ground Truth Used

The "ground truth" for the Range Spinal System's substantial equivalence determination is based on:

• Biomechanical performance standards: Compliance with ASTM F1717.
• Material standards: Use of Ti6Al-4V ELI alloy per ASTM and ISO standards.
• Comparison to predicate devices: Demonstration of "substantially the same" design, function, material, and intended use as other legally marketed spinal systems.

There is no mention of pathology, expert consensus on clinical cases, or outcomes data being used as ground truth for this 510(k) submission.

8. The Sample Size for the Training Set

This information is not applicable. The Range Spinal System is a physical medical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable as there is no training set for this device.

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