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The MAGEC® Spinal Bracing and Distraction System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal abnormalities (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 MAGEC Spinal Bracing and Distraction System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate NuVasive® and Armada® fixation components, or Stryker® Xia® fixation components (i.e. pedicle screws, hooks and/or connectors). The implanted MAGEC rod is used to brace the spine during growth to minimize the progression of scoliosis. The system includes a non-sterile hand held External Remote Controller (ERC or ERC 2) that is used periodically after implantation to non-invasively distract the implanted spinal rod. The titanium MAGEC rod includes an actuator portion that holds a small internal magnet. The magnet in the actuator can be turned non-invasively by use of the ERC, which is electrically powered. The hand held non-invasive ERC is placed over the patient's spine and then manually activated, which causes the magnet within the implanted MAGEC rod to rotate and distract. 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 sterile, single use device, which is used in the operating room to test the MAGEC rod prior to implantation. The MAGEC Manual Distractor used with the MAGEC System is made of Radel® and contains a rare-earth magnet. 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.

The provided document is a 510(k) summary for the MAGEC® Spinal Bracing and Distraction System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of acceptance criteria and device performance in the format requested.

Here's an attempt to extract and present the information based on the available text, noting where information is not explicitly provided in the standard AI/ML device study format.

Device Description:
The MAGEC® Spinal Bracing and Distraction System is comprised of a sterile single-use spinal rod (with an internal magnet for non-invasive distraction), and appropriate fixation components (pedicle screws, hooks, connectors). It also includes a non-sterile hand-held External Remote Controller (ERC) for non-invasive distraction, a MAGEC Manual Distractor for pre-implantation testing, and a MAGEC Wand Magnet Locator.

Indications for Use:
The MAGEC® Spinal Bracing and Distraction System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal abnormalities (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.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes non-clinical and clinical performance data in sections 7 and 8. The acceptance criteria for the non-clinical tests are implicitly that the device passes or meets the relevant standard. For the clinical study, the endpoints chosen represent the "performance" as observed in the study.

Non-Clinical Test Standards:
The document states that non-clinical testing was performed according to:

• ASTM F1717-14: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model (for Static Compression Bending, Static Torsion, Dynamic Compression Bending)
• ANSI/AAMI ST72:2011 – Bacterial Endotoxins – Test Methods, Routine Monitoring, and Alternatives to Batch Testing (for Pyrogenicity - LAL)

The reported performance for non-clinical tests is that the device meets the pyrogen limit specifications and that the tests were performed "to evaluate compatibility with the worst-case pedicle screw system" to establish substantial equivalence. Specific quantitative results for biomechanical tests are not provided in this summary.

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

The document describes a "retrospective clinical study" for the predicate MAGEC System.

• Sample Size: Not explicitly stated for the clinical study. It mentions children who had either a primary or revision spinal bracing procedure.
• Data Provenance: "evaluated outside the United States". The study was retrospective.

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

This information is typically not applicable or provided for clinical studies of this type (spinal implants assessing physical outcomes). The "ground truth" here is the actual patient outcomes as measured by various clinical parameters (Cobb angle, thoracic height, SAL, etc.) rather than expert consensus on, for example, image interpretation. The measurements would likely be taken by trained clinical staff.

4. Adjudication Method for the Test Set

Not applicable in the context of this type of clinical study where physical measurements and outcomes are the primary data points, rather than subjective interpretations requiring adjudication.

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

No, this was not an MRMC comparative effectiveness study to assess the impact of AI assistance on human readers. The clinical study evaluated the device's performance in patients compared to traditional growing rods conceptually, by demonstrating similar benefits without the need for repeat surgeries.

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

This question is not applicable as the MAGEC System is a medical device (spinal implant) and not an AI/ML diagnostic or therapeutic algorithm. Its "performance" is its physical function in the patient, not an algorithmic output.

7. The Type of Ground Truth Used

For the clinical study: Outcomes data as empirically measured from patients (e.g., Cobb angle, thoracic spine height increase, SAL, observation of surgical procedures).

8. The Sample Size for the Training Set

Not applicable. The MAGEC System is a physical medical device, not an AI/ML algorithm that requires a "training set." The clinical data described is for evaluating the predicate device's safety and probable benefit in a real-world setting.

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

Not applicable, as explained in point 8.

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