(245 days)
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
| Acceptance Criteria Category | Specific Test/Evaluation | Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|---|---|
| Safety & Performance | Risk Management Report | EN ISO 14971 compliance | Risk analysis performed; results included in submission. |
| Electrical Safety | IEC 60601-1 (3rd edition) compliance | Testing demonstrated compliance. | |
| Electromagnetic Compatibility and Interference | IEC 60601-1-2 compliance | Testing demonstrated compliance. | |
| Minimum Rated Voltage Testing | Device functions as intended at minimum rated voltage | Testing performed to establish equivalence. | |
| Shock and Vibration Testing | Device maintains integrity and function under specified conditions | Testing performed in accordance with IEC 60601-1-11; demonstrated equivalence. | |
| Ingress Protection | Device meets specified IP rating for home use environment | Testing performed in accordance with IEC 60601-1-11; demonstrated equivalence. | |
| Usability | Usability Evaluation | Device is suitable for use by target population in home environment; user interfaces and ergonomic handling are improved/suitable compared to predicate. | Usability study undertaken on 15 participants showed suitability for use by proposed patient population in the home environment and in accordance with indications. |
| Labeling | Labeling Readability | Labeling is clear and understandable. | Evaluation performed; results included in submission. |
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.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.