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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 surgiclly implanted using appropriate 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 nonsterile 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 actuator can be turned noninvasively 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 implanted magnet to rotate and distract the MAGEC rod. 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 text is a 510(k) summary for the MAGEC® Spinal Bracing and Distraction System, focusing on a labeling revision from MR Unsafe to MR Conditional. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for software or AI-enabled medical devices.

Instead, the document details a comparison to a predicate device and non-clinical testing performed to establish MRI compatibility for the device itself. There is no mention of an algorithm or AI component in this specific submission.

Therefore, many of the requested categories about acceptance criteria, AI performance, ground truth, and human reader studies are not applicable to the information contained in this document.

However, I can extract the information relevant to the device's substantial equivalence and the testing related to its regulatory submission for the hardware component of the MAGEC System.

Based on the provided document, here is the information that can be extracted:

1. Table of Acceptance Criteria (for MRI Compatibility) and Reported Device Performance:

Explanation: The "acceptance criteria" here are implicitly defined by the ASTM standards for MRI compatibility and the FDA guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment (12/11/2014)". The reported performance is that the testing indicated MR Conditional labeling is appropriate according to these standards and guidance.

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

• Test Set (for MRI compatibility): "Test samples were provided in the final manufactured condition." The exact number of samples is not specified, but it refers to manufactured units of the MAGEC rod.
• Data Provenance: Not explicitly stated for the MRI compatibility testing, but it would be from in-house or contracted lab testing of the physical device.

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

• Not applicable. This testing is for the physical device's MRI compatibility, not an AI or diagnostic algorithm requiring expert ground truth.

4. Adjudication method for the test set:

• Not applicable. This testing is for the physical device's MRI compatibility, not an AI or diagnostic algorithm requiring adjudication.

5. 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 submission concerns a physical medical device (spinal bracing system), not an AI or diagnostic algorithm.

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

• Not applicable. This submission concerns a physical medical device (spinal bracing system), not an AI or diagnostic algorithm.

7. The type of ground truth used:

• For MRI Compatibility: The "ground truth" is defined by the physical properties of the device and its interaction with an MRI environment, as measured against the specified ASTM standards and FDA guidance.
• For Clinical Efficacy (referenced from predicate): The clinical study endpoints for the predicate device included: Cobb angle correction, thoracic spine height increase, improvement in space available for lung (SAL), coronal and sagittal balance, reduction in subsequent surgical procedures, and weight gain. These are objective clinical measurements and patient outcomes.

8. The sample size for the training set:

• Not applicable. This submission is about a physical medical device, not an AI model.

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

• Not applicable. This submission is about a physical medical device, not an AI model.

Additional Information from the document:

• Clinical Performance Data (referenced from predicate): A retrospective clinical study was conducted for the predicate MAGEC System outside the United States. This study evaluated children who had either a primary or revision spinal bracing procedure using the MAGEC System. The study showed benefits similar to traditional growing rods without the need for regular surgical lengthenings.
• The current submission (K160352) is identical to the predicate device (K150885) in terms of indications for use, principles of operation, and technological characteristics. The only purpose of this specific premarket notification is to revise the labeling from MR Unsafe to MR Conditional based on the non-clinical MRI compatibility testing.

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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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