(353 days)
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.
| Acceptance Criteria Category/Test | Reported Device Performance/Outcome |
|---|---|
| Usability for Home Use | Usability evaluation performed on 30 subjects in an equivalent patient population demonstrated its suitability for use in the proposed patient population and in accordance with the indications. |
| Risk Management | Risk Management Report (EN ISO 14971:2007 compliant) for device specific to home use. Results are accepted. |
| Minimum Rated Voltage Testing | Performed in accordance with IEC 60601-1-11:2010. Results are accepted. |
| Shock and Vibration Testing | Performed in accordance with IEC 60601-1-11:2010. Results are accepted. |
| Ingress Protection Testing | Performed in accordance with IEC 60601-1-11:2010. Results are accepted. |
| Substantial Equivalence | The device is deemed substantially equivalent to the predicate (K101997) due to similar indications for use, designs, in vitro testing, and usability evaluations, particularly regarding the Home Use of the ERC. |
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.
§ 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.