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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 an implantable intramedullary rod ("Distracting Rod"), locking screws, an external remote controller (ERC), and surgical implantation tools and accessories. The modular implantable rod is available in different configurations, lengths, and diameters to accommodate a variety of patient anatomies. Likewise, the locking screws are available in two different diameters and a variety of lengths from 20 mm to 75 mm increments. The distracting rod is a modular system that includes the PRECICE Actuator component and various configurations of PRECICE Extension Rods. The PRECICE Actuator includes an enclosed rare earth magnet, telescoping lead screw/nut assembly and gearing. The second generation External Remote Controller (ERC 2P) which is the subject of this premarket notification, is a non-invasive adjustment component of the system. The ERC 2P is an electrically powered handheld unit. The ERC 2P contains two large rareearth magnets that are rotated using gears. After the rod has been implanted into the patient, the external device can be placed over the actuator portion of the implant and activated. When activated, the magnets within the ERC 2P rotate, which causes the magnet in the implantable device to rotate, lengthening or shortening the rod. Periodic lengthening (typically daily) of the rod is performed after the primary implantation surgery to lengthen the limb. The physician writes the patient prescription on an SD card which is placed in the ERC 2P. The distraction is confirmed in office using standard, routine x-ray of the limb. These office visits usually occur on a weekly basis.

The provided document, K131490, describes the Ellipse PRECICE® System, specifically focusing on the second-generation External Remote Controller (ERC 2P). This submission aims to demonstrate substantial equivalence to previously cleared devices (K101997 and K113219) rather than introducing a new clinical indication or demonstrating a novel clinical performance through a standalone study.

Therefore, the acceptance criteria and study details discussed below are primarily focused on the usability, safety, and performance of the ERC 2P in demonstrating equivalence to its predicate, not on the clinical effectiveness of the limb lengthening system itself.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Usability Study: 15 participants.
• Data Provenance: The document does not explicitly state the country of origin for the usability study participants. Given the company (Ellipse Technologies, Incorporated) is based in Irvine, California, USA, and the submission is to the FDA, it is highly probable the study participants were from the USA or North America. The study was prospective for the usability evaluation, as it was specifically undertaken to evaluate the ERC 2P. Other tests (electrical safety, EMC, etc.) are laboratory-based and not patient-data dependent in this context.

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

For this type of submission (focused on a new controller for an existing system), "ground truth" isn't typically established by medical experts in the way it would be for a diagnostic AI algorithm.

• Usability Study: The "ground truth" for the usability study was the observed performance and feedback from the 15 participants using the ERC 2P in a simulated home environment, evaluated against pre-defined usability tasks and criteria. The document states a "representative population" was used, which implies users matching the demographic and cognitive profile of the actual patient users.
• Other Tests (Safety, Performance): The "ground truth" for these tests (e.g., electrical safety, EMC, shock/vibration) is defined by the standards themselves (e.g., IEC 60601-1). The "experts" involved would be qualified test engineers and technicians performing the tests and interpreting the results against established regulatory standards.

4. Adjudication Method for the Test Set

Not applicable in the typical sense for this submission.

• For the usability study, the "adjudication" would involve human factors specialists or researchers observing participant interactions, collecting quantitative and qualitative data (e.g., task completion rates, errors, subjective feedback), and interpreting this data against usability goals. There isn't a "2+1" or "3+1" medical expert adjudication method described or typically used for usability studies of this nature.
• For laboratory tests, compliance with standards is usually a pass/fail determination, sometimes with detailed reports and expert review of those reports by test house engineers or regulatory affairs professionals, but not "adjudication" in the multi-reader sense.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.

This submission is for a new version of an external controller for a mechanical medical device, not a diagnostic imaging AI algorithm. Therefore, improving human reader performance with or without AI assistance is not relevant to this device's function or the scope of this 510(k) submission.

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

Not applicable in the context of an "algorithm only" performance.

The device (ERC 2P) is an interactive electromechanical device. While it has embedded software and a camera to assist alignment, its primary function is to enable the patient to non-invasively lengthen the implantable rod under physician prescription. Its performance is inherently "human-in-the-loop" due to the user activating it and ensuring proper alignment. The usability study evaluated this human-in-the-loop performance.

7. The Type of Ground Truth Used

• For safety and performance tests (electrical, EMC, shock/vibration, ingress protection): Compliance with recognized international standards (e.g., IEC 60601 series) served as the ground truth.
• For the usability evaluation: The ground truth was based on observed user performance, task completion, error rates, and subjective user feedback against pre-defined usability goals and criteria.

8. The Sample Size for the Training Set

Not applicable.

Because this is a submission for a hardware device (an external controller) with embedded software, not a machine learning or AI algorithm in the contemporary sense that would require a "training set" of data to learn from. The software in the ERC 2P is deterministic and programmed, not "trained."

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

Not applicable. (See answer to #8). There was no "training set" in the context of machine learning. The device was developed and tested against engineering specifications, risk analyses, and recognized standards.

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The Ellipse Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femurs.

The Ellipse PRECICE Intramedullary Limb Lengthening System is composed of a modular implantable intramedullary rod ("Distracting Rod"), locking screws, an external remote controller (ERC), and surgical implantation tools and accessories. The modular implantable rod is available in different configurations, lengths, and diameters to accommodate a variety of patient anatomies. Likewise, the locking screws are available in two different diameters and a variety of lengths from 20 mm to 75 mm in 5 mm increments. The distracting rod is a modular system that includes the PRECICE Actuator component and various configurations of PRECICE Extension Rods. The PRECICE Actuator includes an enclosed rare earth magnet, telescoping lead screw/nut assembly and gearing. The PRECICE Actuator is supplied sterile by gamma sterilization while the PRECICE IMLL Extension Rods, locking screws, and reusable accessories are supplied non-sterile and must be sterilized prior to use. The External Remote Controller (ERC) is a non-invasive adjustment component of the system. The ERC is electrically powered and is used for non-invasive lengthening of the implanted rod. The ERC can be used by the physician or by the patient in the home environment to perform lengthening.

Here's a breakdown of the acceptance criteria and study information for the Ellipse PRECICE Intramedullary Limb Lengthening System, based on the provided text:

Key Finding: This 510(k) submission (K113219) is primarily focused on the Home Use of the External Remote Controller (ERC) by the patient and claims substantial equivalence to a previously cleared device (K101997). Therefore, the "acceptance criteria" and "study" largely revolve around the usability and safety of the ERC in a home setting.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for device performance (e.g., specific accuracy metrics for limb lengthening). Instead, the acceptance is based on demonstrating the ERC's suitability and safety for home use through various tests and a usability evaluation, establishing substantial equivalence to the predicate device.

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

• Sample Size for Usability Study: 30 subjects.
• Data Provenance: The document does not specify the country of origin for the usability study data. It also does not explicitly state if the study was retrospective or prospective, but a usability evaluation on "subjects" typically implies a prospective study.

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

Not applicable for this submission. The "ground truth" for the usability study would be the participants' ability to safely and effectively use the ERC in a simulated home environment, as assessed by evaluators, rather than expert interpretation of medical images or data. No mention of "experts" in this context is made beyond the manufacturer's internal team conducting the evaluation.

4. Adjudication Method for the Test Set

Not applicable in the sense of expert consensus for medical data. The usability study would have its own methodology for evaluating participant performance and feedback, but it's not described as an "adjudication method" involving independent experts for ground truth.

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 mechanical limb lengthening system with an external controller, not an AI-powered diagnostic or assistive tool for human readers (e.g., radiologists).

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

This question is not directly applicable. The "standalone" component here is the ERC itself. The usability study is evaluating the human using the ERC for "human-in-the-loop performance" in a home setting. The device's primary function (limb lengthening) is mechanical and controlled by the ERC, so the concept of an "algorithm only" performance separate from the human interaction with the ERC doesn't fit this device type.

7. The Type of Ground Truth Used

For the usability evaluation, the "ground truth" would be the direct observation of users interacting with the ERC and their ability to successfully and safely operate it according to instructions, as well as their subjective feedback. This falls under usability data/user performance data. For the other technical tests (voltage, shock, ingress protection), the "ground truth" is adherence to and successful completion of the specified IEC standards.

8. The Sample Size for the Training Set

No training set is mentioned or applicable in the context of this 510(k) submission, which focuses on hardware and a usability study, not on developing a machine learning algorithm.

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

Not applicable, as there is no training set for an algorithm.

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