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The ISOLA® Growing Spine System is indicated for patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The ISOLA® Growing Spine System may be used with any cleared traditional ISOLA® Spine System 3/16 inch rod constructs.

The EXPEDIUM® Growing Spine System is indicated for patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The EXPEDIUM® Growing System may be used with any cleared traditional 4.5 and 5.5 EXPEDIUM® Spine Systems. The EXPEDIUM® Growing Spine System is not intended to be used with 4.0mm diameter screws.

The ISOLA and EXPEDIUM Growing Spine Systems consist of an assortment of connectors designed to convert a traditional fusion construct into a non-fusion growth enabling construct that can be surgically lengthened on a periodic basis as the patient grows. The ISOLA and EXPEDIUM Growing Spine Systems' components are manufactured from titanium alloy and stainless steel and are designed to interact with constructs consisting of rods ranging in diameter from 4.5 to 5.5mm, hooks, screws, offset connectors, and cross connectors. The ISOLA and EXPEDIUM Growing Spine Systems are intended for use only with ISOLA (3/16 inch rod diameter) and EXPEDIUM Spinal Systems (4.5 and 5.5mm rod diameter) fusion constructs for cleared pediatric use.

This document describes the ISOLA® and EXPEDIUM® Growing Spine Systems which are surgical devices, not AI/ML software. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies for AI/ML performance is not applicable to this submission.

The provided document, K141509, is a 510(k) premarket notification for medical devices. The relevant performance data for this type of device typically involves mechanical and material testing, not clinical studies in the context of AI/ML performance.

However, based on the information provided in the document, here's what can be extracted regarding the device's assessment:

1. Acceptance Criteria and Reported Device Performance:

The document broadly states that "Performance data per ASTM F 1717 (static and dynamic compression bending and static torsion) were submitted to characterize the subject ISOLA and EXPEDIUM Growing Spine Systems components addressed in this notification."

• Acceptance Criteria (Implied): The acceptance criteria are implicitly based on meeting the standards outlined in ASTM F 1717 for static and dynamic compression bending and static torsion for spinal implant constructs. These standards define the mechanical properties and performance expectations for such devices. Specific numerical thresholds or pass/fail criteria are not detailed in this summary but would have been part of the full submission to the FDA.
• Reported Device Performance: The summary concludes that "Both the Performance Testing and Substantial Equivalence Justification demonstrate that the proposed device is substantially equivalent to the predicate devices." This indicates that the device met the performance requirements of ASTM F 1717 and demonstrated performance comparable to its predicate devices.

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

• Test Set: Not applicable in the context of AI/ML. For mechanical testing, the "sample size" would refer to the number of device components or constructs subjected to testing. This information is not provided in this summary but would be detailed in the full test reports.
• Data Provenance: Not applicable in the context of AI/ML. Mechanical test data is typically generated in a lab setting, not from patient data, and is therefore not "retrospective or prospective" in the medical study sense.

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

• Not applicable. "Ground truth" in the AI/ML sense (e.g., expert labels on medical images) is not relevant for the mechanical testing of a surgical implant.

4. Adjudication Method for the Test Set:

• Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This is not an AI/ML device.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study:

• Not applicable. This is not an AI/ML device.

7. Type of Ground Truth Used:

• Not applicable for AI/ML. For mechanical performance, the "ground truth" is defined by the objective physical measurements and engineering specifications outlined in the ASTM F 1717 standard.

8. Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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