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The Ellipse Residual Limb Lengthening System is indicated for lengthening of the residual limb of the femur.

The Ellipse Residual Limb Lengthening (RLL) System is composed of the intramedullary RLL Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The RLL Nail has a 14 mm diameter with a telescoping distal end. The telescoping end has a 100 mm stroke length, making the RLL Nail capable of a maximum distracted length of 230 mm. The RLL Nail utilizes one distal and one proximal locking screw to secure the implant to the bone. The RLL Nail is supplied sterile by gamma radiation while the locking screws and instruments are supplied non-sterile and must be sterilized prior to use. The nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The Ellipse RLL System is a non-weight bearing device.

The provided text describes a 510(k) premarket notification for the Ellipse Residual Limb Lengthening System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving that the device meets specific clinical acceptance criteria in terms of performance. The information provided heavily relies on non-clinical testing.

Therefore, many of the requested categories cannot be directly addressed from the given text, as they pertain to clinical performance studies.

Here's an analysis based on the information available:

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

The document does not explicitly state acceptance criteria in terms of clinical performance (e.g., success rate of limb lengthening, complication rates within a defined threshold). Instead, it focuses on demonstrating equivalence through mechanical and functional tests.

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

The document primarily refers to non-clinical mechanical and functional testing. For these tests, sample sizes are typically determined by the specific ISO/ASTM standards referenced, but are not explicitly stated in this summary. There is no mention of a clinical test set, country of origin, or whether it was retrospective/prospective.

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 is not applicable as no clinical test set requiring expert ground truth or assessment is described in this 510(k) summary. The testing described is non-clinical.

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

This is not applicable as no clinical test set requiring adjudication is 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 is not applicable. The device is an intramedullary limb lengthening system, not an AI or imaging diagnostic device.

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

This is not applicable. The device is a surgical implant system, not an algorithm.

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

For the non-clinical tests described, the "ground truth" is defined by the specifications and requirements of the referenced ASTM/ISO standards and the device's design specifications. For example, the "ground truth" for sterilization is achieving an SAL of 10-6 as per ISO 11137-2. For mechanical tests, it's meeting the load and torque requirements defined by ASTM F1264-03.

8. The sample size for the training set

This is not applicable as the device is a mechanical implant system, not a machine learning model that requires a training set.

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

This is not applicable for the reasons stated above.

Summary based on available information:

The provided text focuses on demonstrating the substantial equivalence of the Ellipse Residual Limb Lengthening System to a legally marketed predicate device (Ellipse PRECICE® Intramedullary Limb Lengthening System K141023) through a series of non-clinical tests. These tests cover mechanical properties, sterilization, functionality, and biocompatibility, aligning with relevant ASTM and ISO standards. The "acceptance criteria" are implicitly set by these standards and the equivalence to the predicate device. The document does not contain information about clinical performance studies, expert assessment, or AI-related evaluations.

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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 PRECICE System is indicated for limb lengthening of the tibia and femur.

The Ellipse PRECICE System is composed of the modified PRECICE nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The nail is available in tibia or femur models with various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The modified PRECICE nail is supplied sterile by gamma radiation while the locking screws and PRECICE specific accessories are supplied non-sterile and must be sterilized prior to use. The nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing.

This appears to be a 510(k) premarket notification for a medical device, specifically the Ellipse PRECICE® System, which is an intramedullary nail for limb lengthening. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing, rather than clinical studies involving human patients as one might find for a new drug or complex diagnostic AI.

Therefore, many of the requested categories related to clinical studies, such as "Sample size used for the test set," "Number of experts," "Adjudication method," "MRMC comparative effectiveness study," and "Standalone (i.e. algorithm only without human-in-the loop performance)" are not applicable to this type of device submission as described in the provided text.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of in vitro (benchtop) engineering and performance tests as outlined in the provided text. These tests are conducted according to recognized industry standards (ASTM F1264, ISO 11607-1, ISO 11137-2, ISO 10993-1) and internal functional verification protocols. The purpose of these tests is to demonstrate that the modified Ellipse PRECICE System performs equivalently or superiorly to its predicate device and meets established safety and performance specifications.

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

• Sample Size for Test Set: Not explicitly stated in terms of a "test set" as one would find in a clinical trial. For in vitro engineering tests, the sample size typically refers to the number of devices or components tested per condition. This information is not provided in the summary but would be detailed in the full test reports submitted to the FDA.
• Data Provenance: The data provenance is derived from in vitro laboratory testing conducted by Ellipse Technologies, Inc. There is no information regarding country of origin of data as it's not patient data. This is typically considered retrospective in the sense that the testing is performed on manufactured devices, not in a live patient setting.

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

• Not Applicable. For mechanical/functional testing of a medical device, "ground truth" is established by the specifications of the design, the chosen ASTM/ISO standards, and the capabilities of the testing equipment. There is no mention of human expert interpretation for establishing ground truth in these types of tests.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods are relevant for subjective human interpretations, especially in clinical or image-based studies. This submission focuses on objective, quantifiable engineering test results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is relevant for diagnostic imaging devices where multiple readers evaluate cases. This is a limb lengthening implant, and its performance is evaluated through engineering tests, not human reader interpretation of clinical cases.

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

• Not Applicable. This is a mechanical implant with an external remote controller, not an algorithm-driven diagnostic or therapeutic device. "Standalone performance" in this context refers to the device's ability to lengthen, and its mechanical integrity, which is assessed through the engineering tests.

7. The Type of Ground Truth Used:

• The "ground truth" for this device, in the context of the provided information, is based on:
  • Validated engineering standards (ASTM F1264, ISO 11607-1, ISO 11137-2, ISO 10993-1): These standards define performance expectations and testing methodologies.
  • Predicate device performance: The modified device must demonstrate substantial equivalence or improvement compared to the previously cleared predicate device.
  • Device design specifications: Internal specifications for strength, functionality, and biocompatibility.

8. The Sample Size for the Training Set:

• Not Applicable. This device does not use machine learning or AI, so there is no "training set." The development of the device is based on engineering design principles and material science, then validated through the specified in vitro tests.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.

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