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The Ellipse MAGEC® Spinal Bracing and Distraction System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth.

The Ellipse Technologies, Inc. MAGEC Spinal Bracing and Distraction System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate Stryker® Xia® fixation components (i.e. Pedicle screws, hooks and/or connectors). The system includes a non-sterile hand held External Remote Controller (ERC) that is used at various times after implant to non-invasively lengthen or shorten the implanted spinal rod. The implanted spinal rod is used to brace the spine during growth to minimize the progression of scoliosis. The titanium rod includes an actuator portion that holds a small internal magnet in the actuator can be turned non-invasively by use of the ERC. Rotation of the magnet causes the MAGEC rod to be lengthened or shortened.

The hand held non-invasive ERC is electrically powered. The ERC is placed over the patient's spine and then manually activated, which causes the implanted magnet to rotate and either lengthen or shorten the rod. Periodic lengthening of the rod is performed to distract the spine and to provide adequate bracing during growth to minimize the progression of scoliosis. Once the physician determines that the implant has achieved its intended use and is no longer required, the implant is explanted. Additional accessories for the MAGEC System include the MAGEC Manual Distractor and the MAGEC Wand Magnet Locator. The MAGEC Manual Distractor is a sterilizable, single use device, which is used in the operating room to test the device prior to implantation. The MAGEC Wand Magnet Locator is a non-sterile device which is used during the distraction procedure to locate the magnet within the MAGEC rod. The ERC is placed over this location on the child's back during a distraction procedure.

The provided document is a 510(k) summary for the Ellipse MAGEC® Spinal Bracing and Distraction System, focusing on the inclusion of a second-generation External Remote Controller (ERC 2). The submission aims to demonstrate substantial equivalence to a previously cleared MAGEC System (K140178).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, or precision). Instead, it relies on demonstrating that the ERC 2 performs equivalently to its predicate device through design functionality, safety, and compatibility testing. The "reported device performance" is essentially the successful completion of these tests, showing the ERC 2 meets the standards set for medical devices of its type and performs as intended.

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

The document mentions "in vitro evaluations" and "non-clinical testing" for the ERC 2. It does not specify a "test set" in the context of patient data or clinical trials with a defined sample size. The testing described is primarily engineering and performance verification of the device components.

For the clinical performance data, the document states: "The retrospective clinical study performed on the MAGEC System and previously submitted is also applicable to the ERC 2 and this submission."

• Sample Size: Not specified in the provided text.
• Data Provenance: Retrospective, as explicitly stated. The country of origin is not mentioned.

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

This information is not applicable and not provided. The non-clinical testing for the ERC 2 focuses on engineering specifications and safety standards, not on diagnostic accuracy requiring expert interpretation of results. The previous retrospective clinical study supporting the MAGEC system (not the ERC 2 specifically) would have involved clinical assessments, but details on ground truth establishment and expert involvement are not in this document.

4. Adjudication Method for the Test Set:

Not applicable and not provided, as the testing described for the ERC 2 doesn't pertain to diagnostic accuracy where adjudication of expert opinions would be relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study is not mentioned in the context of this 510(k) submission. This submission focuses on the safety and performance of a device component (ERC 2) and its substantial equivalence to a predicate, not on the comparative effectiveness of human readers with or without AI assistance.

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

This is not applicable to the device described. The MAGEC system is a physical implant and an external controller (ERC 2), not a standalone algorithm. The ERC 2 is a human-operated device used to interact with the implanted rod.

7. The Type of Ground Truth Used:

For the non-clinical testing of the ERC 2 (electrical, EMC, design verification, software validation), the "ground truth" is defined by the relevant engineering standards (EN ISO 14971, IEC 60601-1, IEC 60601-1-2) and FDA guidance for software. The device's performance against these established benchmarks serves as the "truth." For the retrospective clinical study mentioned, the type of ground truth used is not specified in this document, but would typically involve clinical outcomes or expert diagnoses.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. The ERC 2 is a hardware device with embedded software, not a machine learning model that requires a "training set" in the conventional sense of AI development.

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

Not applicable, as there is no "training set" in the context of an AI/ML model for this device.

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