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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 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.

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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 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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