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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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