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The MAGEC Spinal Bracing and Distraction System is indicated for skeletally immature patients with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) secondary to early-onset scoliosis 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 subject MAGEC Spinal Bracing and Distraction System has an identical design and principle of operation to the predicate design iterations cleared in the predicate Magec System (K201543, K161751, K140613). The subject system includes sterile single use MAGEC rods manufactured from Ti-6Al-4V, conforming to ASTM F136, along with various accessories including a sterile Rod Template and Manual Distractor, a non-sterile Wand Magnet Locator, and is compatible with a hand held External Remote Controller (ERC) 1 or 2. The MAGEC rod can be surgically implanted using appropriate NuVasive Reline 4.5-5.0 (Reline Small Stature or RSS) or Armada fixation components (i.e., pedicle screws, hooks and/or connectors). 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. Periodic distraction of the rod is performed to lengthen 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.

The provided text describes a 510(k) premarket notification for the MAGEC Spinal Bracing and Distraction System, focusing on expanding its indications for use. It primarily demonstrates substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in the typical sense of a diagnostic or AI device.

However, based on the information provided, we can infer "acceptance criteria" from the measured clinical outcomes that are presented to support the expanded indication. The device's performance is demonstrated through a retrospective registry study comparing clinical and radiographic data.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" with numerical thresholds as one might find for a new, novel device. Instead, the study aims to show that the performance of the MAGEC System in older skeletally immature patients (subject group) is comparable to its established performance in younger patients (predicate group). Therefore, the "acceptance criteria" are implicitly that the clinical outcomes in the subject group should not be worse than those in the predicate group, supporting substantial equivalence.

| Acceptance Criteria (Inferred from comparison) | Reported Device Performance (Subject Group 2: Age ≥10 years) | Reported Device Performance (Predicate Group 1: Age

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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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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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The Ellipse MAGEC 2 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 MAGEC 2 Spinal Bracing and Distraction System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate Stryker® Xia9 fixation components (i.e. Pedicle screws, hooks and/or connectors). The implanted MAGEC 2 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 noninvasively distract the implanted spinal rod. The titanium MAGEC 2 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 distract the MAGEC 2 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 2 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 2 rod prior to implantation. The MAGEC Manual Distractor used with the MAGEC 2 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 2 rod. The ERC is placed over this location on the child's back.

The provided document describes the FDA 510(k) clearance for the MAGEC 2 Spinal Bracing and Distraction System. This is a medical device designed to treat severe progressive spinal deformities in skeletally immature patients. The document focuses on demonstrating substantial equivalence to an existing predicate device (MAGEC Spinal Bracing and Distraction System, K140613), rather than outlining explicit acceptance criteria with numerical thresholds. Therefore, the "acceptance criteria" presented are implied by the comparison to the predicate and the general requirements for safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a medical device (spinal rod) and not a software algorithm with quantitative performance metrics like accuracy, sensitivity, or specificity, the "acceptance criteria" are related to mechanical performance, sterilization, and biocompatibility, as compared to the predicate device. The document states that the MAGEC 2 System is substantially equivalent to the predicate.

• Static Mechanical Testing (ASTM F1717-14)
• Dynamic Mechanical Testing (ASTM F1717-14)"
  "Results of these tests demonstrate that there are no new risks associated with the device and the device can be expected to perform in a manner substantially equivalent to the predicate." |
  | Wear Testing | "wear testing and particulate analysis according to the methods in the standards ASTM F2624 and ASTM F1877."
  "The specific non-clinical tests that have been performed in order to establish equivalence to the predicate device include:
• Wear Testing (ASTM F2624-12)"
  "Results of these tests demonstrate that there are no new risks associated with the device and the device can be expected to perform in a manner substantially equivalent to the predicate." |
  | Particulate Analysis | "wear testing and particulate analysis according to the methods in the standards ASTM F2624 and ASTM F1877."
  "The specific non-clinical tests that have been performed in order to establish equivalence to the predicate device include:
• Particulate Analysis (ASTM F1877-05)"
  "Results of these tests demonstrate that there are no new risks associated with the device and the device can be expected to perform in a manner substantially equivalent to the predicate." |
  | Sterilization Efficacy | "validation of the gamma radiation sterilization cycle in accordance with the VDmag 22 methodology as given in ISO 11137-2 to verify that the gamma radiation sterilization process provides a sterility assurance level of 10-6."
  "The specific non-clinical tests that have been performed in order to establish equivalence to the predicate device include:
• Sterilization Validation (ANSI/AAMI/ISO 11137-2)"
  "Results of these tests demonstrate that there are no new risks associated with the device and the device can be expected to perform in a manner substantially equivalent to the predicate." |
  | Biocompatibility | "The performance testing on the predicate device includes... biocompatibility in accordance with ISO 10993-1 for the intended use of the device." (Implied to be met for the new device as well due to material similarity and predicate equivalence.) |
  | Design Verification | "design verification and validation."
  "The specific non-clinical tests that have been performed in order to establish equivalence to the predicate device include:
• Design Verification" (Standard not specified for Design Verification itself, but related to other standards.)
  "Results of these tests demonstrate that there are no new risks associated with the device and the device can be expected to perform in a manner substantially equivalent to the predicate." |
  | Indications for Use Equivalence | "The MAGEC 2 System that is subject of this premarket notification and the predicate device have the same indications for use."
  "Substantial equivalence to the predicate device is based on indications for use..." |
  | Principles of Operation Equivalence | "Both the MAGEC 2 System and the predicate device are spinal rods that have adjustable length, and are implanted on the posterior spine using hooks or screws. Both devices operate on the same non-invasive distraction technology using the Ellipse External Remote Controller (ERC or ERC 2)."
  "Substantial equivalence to the predicate device is based on... principles of operation..." |
  | Technological Characteristics Equivalence | "The technological characteristics of the subject device and the predicate device are similar. Both systems are manufactured of the same biocompatible metals and supplied sterile by the same methods of gamma radiation. The differences between the two systems include the addition of a 6.0 mm diameter rod to the product offering, design modifications to remove structural welds and new design features."
  "Substantial equivalence to the predicate device is based on... technological characteristics..."
  "Results of these tests demonstrate that there are no new risks associated with the device and the device can be expected to perform in a manner substantially equivalent to the predicate." |
  | Similar Safety and Probable Benefit as Predicate Device | "Previous clinical performance data for the predicate MAGEC System is applicable to the MAGEC 2 System."
  "The safety and probable benefit of the predicate MAGEC System was evaluated outside the United States in a retrospective clinical study..." |

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

The document does not explicitly state a new test set sample size for the MAGEC 2 System for clinical performance. Instead, it relies on the clinical performance data of the predicate MAGEC System.

• Sample Size: Not specified for the predicate device's clinical study beyond "children."
• Data Provenance: "evaluated outside the United States in a retrospective clinical study."

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

This information is not provided in the document. The clinical study for the predicate device is described as a "retrospective clinical study," which would typically involve reviewing patient records, imaging, and outcomes. The "ground truth" for success in this context would be based on objective measurements (Cobb angle, thoracic spine height, SAL) and patient outcomes. It does not mention expert adjudication for establishing ground truth in the same way an AI diagnostic device would.

4. Adjudication Method for the Test Set

Not applicable/not specified. The clinical study was retrospective, relying on medical records and measurements.

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 device is a surgically implanted spinal rod system, not an AI-assisted diagnostic tool for human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the predicate device's clinical study, the ground truth for "safety and probable benefit" was based on:

• Outcomes Data: Cobb angle correction, thoracic spine height increase, improvement in space available for lung (SAL), coronal and sagittal balance, reduction in the number of subsequent surgical procedures, and weight gain.
• Expert Clinical Assessment (Implied): While not explicitly stated as "expert consensus," the evaluation of these parameters and overall patient outcomes would inherently involve clinical expertise.

For the non-clinical tests of the MAGEC 2 System, the "ground truth" was established by conformance to established ASTM and ISO standards for mechanical performance, wear, particulate analysis, and sterilization.

8. The Sample Size for the Training Set

Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable for the same reason as above.

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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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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 MAGEC Spinal Bracing and Distraction System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate Stryker® Xia9 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. The 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 shorten.

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.

The provided documentation does not contain detailed acceptance criteria or a comprehensive study that proves a device meets specific acceptance criteria in the typical format of a clinical or performance study for a diagnostic or AI-powered device.

Instead, the document is a 510(k) summary for the MAGEC® Spinal Bracing and Distraction System, which is a medical device for treating severe spinal deformities in skeletally immature patients. The purpose of this 510(k) submission is to demonstrate substantial equivalence to a previously cleared predicate device, not to establish performance against new, specific acceptance criteria for a novel device.

The "acceptance criteria" presented here are inferred from the need to show substantial equivalence, primarily through mechanical testing and a comparison of clinical outcomes to those expected from growing rods.

Here's an attempt to extract the requested information based on the provided text, recognizing that it may not perfectly fit the structure of a typical AI/diagnostic device performance study:

Acceptance Criteria and Device Performance Study for MAGEC® Spinal Bracing and Distraction System (K140613)

The device, the MAGEC® Spinal Bracing and Distraction System, is demonstrated to be substantially equivalent to a predicate device (MAGEC Spinal Bracing and Distraction System, K140178) by showing similar indications for use, principles of operation, technological characteristics, and comparable performance through non-clinical testing and a retrospective clinical study of the predicate device.

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implied by the performance of the predicate device and the new device's ability to meet those standards.

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

• Test Set (Clinical Data for Predicate): The document mentions a "retrospective clinical study for children" that evaluated the predicate MAGEC System. The exact sample size (N) is not specified in the provided text.
• Data Provenance: The retrospective clinical study was conducted outside the United States.

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

Not applicable. This was a clinical outcomes study, not a study requiring expert consensus for ground truth on an AI or diagnostic device. The outcomes (e.g., Cobb angle, TBH) are typically measured objectively based on medical imaging and patient records.

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

Not applicable. This was a clinical outcomes study, not a study requiring adjudication of expert interpretations.

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 is not an AI-assisted diagnostic device, but a physical medical implant.

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

Not applicable. This is not an AI or algorithm-based device.

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

For the human clinical performance portion (retrospective study of the predicate): Outcomes data (e.g., Cobb angle correction, thoracic spine height increase, SAL improvement, reduction in subsequent surgeries, weight gain) based on clinical measurements and patient records.

For the non-clinical testing: Physical measurements and engineering standards (e.g., ASTM F1717 for mechanical tests, ISO standards for biocompatibility and sterilization).

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device that requires a training set.

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

Not applicable. This is not an AI or machine learning device.

Ask a specific question about this device

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 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 (Ti-6Al-4V ASTM F136) 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. Rotation of the magnet causes the MAGEC rod to be lengthened or shorten.

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.

The provided text describes the MAGEC® Spinal Bracing and Distraction System and its premarket notification (K140178) to the FDA. The submission focuses on establishing substantial equivalence to a predicate device, the Harrington Rod System, rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the context of a diagnostic AI product.

Therefore, much of the requested information (acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance with specific metrics like sensitivity/specificity, and detailed ground truth establishment for training) cannot be extracted from the provided document as it pertains to a mechanical medical device rather than a diagnostic AI.

However, I can extract information related to the device's performance evaluation.

Here's the information that can be extracted and a clear statement about what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of numerically defined acceptance criteria for a diagnostic AI product. Instead, it describes performance in terms of mechanical and clinical outcomes for a spinal bracing system.

• Shelf Life Packaging Validation (ISO 11607-1): Performed.
• Sterilization (ANSI/AAMI/ISO 11137-2): "Verification that the gamma radiation sterilization process provides a sterility assurance level of 10-6."
• Biocompatibility (ISO 10993-1): Performed.
• Device functionality and verification: Performed.
• Electrical Safety (IEC 60601-1): Performed.
• Electrical Interference and Compatibility (EMC/EMI) (EN 60601-1-2): Performed.
• Magnetic Field Safety (ICNIRP 2009): Performed.
• Software (FDA Guidance (May 11, 2005)): Performed. |
  | In Vivo (Animal) Study | Safe and efficient non-invasive distraction of the spine in an animal model. | - Porcine Model (9 male Yucatan pigs): "Results of the in vivo porcine study demonstrates that the MAGEC System is safe and provides an efficient means of non-invasive distraction of the spine. No complications from distraction occurred." Attempted and actual distraction were recorded. |
  | Clinical Performance | Safety and probable benefit, including deformity correction, continued growth, and reduced need for subsequent surgical procedures, similar to traditional growing rods. | - Retrospective clinical study (outside US): "The results of the clinical study showed the MAGEC System provides the benefits of spinal deformity correction and continued growth, similar to that for traditional growing rods, without the need for regular surgical lengthening procedures in these children."
• Specific endpoints assessed: Cobb angle correction, thoracic spine height increase, improvement in space available for lung (SAL), coronal and sagittal balance, reduction in number of subsequent surgical procedures, and weight gain.
• Demonstrated ability for non-invasive adjustment to lengthen the implanted rod, allowing continued spinal growth and increased Thoracic Spine Height. |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size:
  • In Vivo (Animal) Study: 9 male Yucatan pigs (randomly assigned to two groups: 1 (MAGEC rod) and 2 (sham)).
  • Clinical Study: Not explicitly stated, but described as a "retrospective clinical study for children who had either a primary or revision spinal bracing procedure using the MAGEC System."
• Data Provenance:
  • In Vivo Study: Porcine model (animal study).
  • Clinical Study: "evaluated outside the United States" (retrospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The studies performed were primarily in vivo animal studies and a retrospective clinical study focusing on device performance and clinical outcomes, not on establishing ground truth for a diagnostic AI.

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

This information is not provided as it is not relevant to the type of device and studies described.

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

This information is not provided as it is not relevant to the type of device (spinal bracing system) and evaluation presented. It's a study design typically used for diagnostic imaging AI.

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

This information is not provided as it is not relevant to the type of device described, which is a physical, implantable medical device, not a standalone diagnostic algorithm.

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

• Non-Clinical and In Vivo Studies: Ground truth was based on physical measurements, functional specifications, and observation of physiological responses (e.g., distraction achieved, lack of complications) in controlled experimental settings.
• Clinical Performance Data: Ground truth or "probable benefit" was assessed based on clinical outcomes data such as 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.

8. The sample size for the training set

This information is not provided as there is no mention of a "training set" in the context of an AI/algorithm-based device. The device is mechanical with non-invasive magnetic actuation.

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

This information is not provided as there's no training set for an AI in this context.

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