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The MAGEC® System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (e.g., Cobb andle of 30 dearees 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® System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate NuVasive® Reline®, Reline 4.5-5.0 (Reline Small Stature) or Armada® 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) 1 or 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 implanted magnet to rotate and either distract or retract the 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, MAGEC Rod Template, 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 Rod Template is a sterile, single-use accessory used for intraoperative planning of the surgical procedure. 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 previously implanted in a patient.

The purpose of this premarket notification is to implement assembly process changes and a design change to the MAGEC Rod cleared in K171791 to address the Field Safety Notice and Product Recall issued on February 13, 2020 for the MAGEC X device (FDA Recall Number Z-1898-2020 and Recall Event ID 85495).

The provided text is a 510(k) summary for the NuVasive MAGEC® System, which is a spinal rod system designed for skeletally immature patients with severe progressive spinal deformities. The submission aims to demonstrate substantial equivalence to previously cleared MAGEC systems.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for device performance in terms of specific thresholds for outcomes (e.g., minimum distraction force, maximum bending, etc.) that the device needed to meet. Instead, it refers to performance testing against established ASTM standards and internal verification for distraction/retraction. The general "acceptance criteria" can be inferred as demonstrating substantial equivalence to the predicate devices through successful completion of the listed nonclinical tests.

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

The document only mentions "nonclinical testing" and lists standards for mechanical testing. It does not provide details on the sample size for these tests (e.g., number of rods tested for bending, torsion, etc.). The data provenance is also not specified beyond being "nonclinical testing." It does not involve human data, so terms like "country of origin" or "retrospective/prospective" are not applicable in this context.

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

This information is not applicable. The testing described is nonclinical mechanical testing, not clinical studies requiring expert review or ground truth establishment in a diagnostic context.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable as the testing is nonclinical mechanical testing and does not involve human assessment or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The submission focuses on nonclinical testing for substantial equivalence of a medical device (spinal rod system), not on diagnostic performance or human reader improvement with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The MAGEC System is a physical medical device (spinal rod and external controller), not an algorithm or AI system. Its performance is related to mechanical properties and functional reliability, not algorithmic accuracy.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the nonclinical tests is established by the specifications and acceptance limits defined within the referenced ASTM standards (e.g., specific forces, deflections, cycles, or distraction distances). The device is expected to meet or exceed the performance of the predicate and comply with these mechanical standards.

8. The Sample Size for the Training Set

This information is not applicable. The MAGEC System is a physical device, not an AI/ML 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 a physical medical device.

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The MAGEC® 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 MAGEC System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate NuVasive® Reline® 4.5-5.0 (Reline Small Stature) or Armada® 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) 1 or 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 implanted magnet to rotate and either distract or retract the 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, MAGEC Rod Template, 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 Rod Template is a sterile, single-use accessory used for intraoperative planning of the surgical procedure. 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 previously implanted in a patient.

The provided documents describe the MAGEC® System, a non-fusion growing rod system for pediatric spinal deformities. The information included focuses on the FDA 510(k) submission for this device, which aims to demonstrate substantial equivalence to previously cleared predicate devices.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Important Note: The provided document is a 510(k) summary, which is typically a high-level overview. It often summarizes the conclusions of testing rather than providing detailed raw data or specific numerical acceptance limits for each test. For a full understanding of the acceptance criteria, one would need to review the complete testing protocols and reports submitted to the FDA, which are not included here.

Study Information

Based on the provided text, the following information can be extracted or inferred:

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

   • Sample Size: The document does not specify the sample sizes (number of devices or tests performed) for the mechanical (static and dynamic) or pyrogenicity tests. It only lists the types of tests.
   • Data Provenance: The studies were nonclinical (bench testing) performed by the manufacturer, NuVasive Specialized Orthopedics, Incorporated. The country of origin for the data is not explicitly stated but would presumably be the US where NuVasive is located. These are not clinical studies with human subjects or retrospective/prospective human data.

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

   • Not Applicable. This was a nonclinical, bench-testing study to evaluate mechanical and biological safety (pyrogenicity) properties, not a study involving human readers or expert evaluation of images/data for ground truth establishment.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. Adjudication methods are typically relevant for clinical studies where multiple experts assess cases and their agreement or disagreement needs to be resolved. This document describes nonclinical engineering and safety testing.

4. 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:

   • No. An MRMC study was not done. This device is a surgical implant system, not an AI-powered diagnostic or assistive tool.

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

   • Not Applicable. This device is a physical medical device (implant and external controller), not an algorithm or AI system.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Engineering Standards and Safety Limits. The "ground truth" for the nonclinical tests were the specifications and criteria defined by the relevant ASTM and ANSI/AAMI standards (e.g., ASTM F1717-15 for spinal implant constructs, ANSI/AAMI ST72 for bacterial endotoxins). For "substantial equivalence," the performance of the device was compared directly to that of the predicate device, implying the predicate's performance served as a benchmark for acceptable "truth."

7. The sample size for the training set:

   • Not Applicable. This is not a machine learning or AI device, so there is no "training set."

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

   • Not Applicable. As there is no training set for an AI/ML algorithm.

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