(141 days)
The PRECICE Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femur.
The PRECICE Intramedullary Limb Lengthening System is composed of the PRECICE Nail (supplied sterile), locking screws, end cap, surgical instruments and an external remote controller (ERC, ERC2P, or ERC 3P). 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 PRECICE Nail is supplied sterile by gamma radiation while the locking screws and PRECICE surgical instruments are supplied non-sterile and must be sterilized prior to use.
The third generation External Remote Controller (ERC 3P) which is the subject of this premarket notification, is a non-invasive adjustment component of the system. The ERC 3P is an electrically powered handheld unit. The ERC 3P contains two large rare-earth magnets that are rotated using gears. After the PRECICE Nail has been implanted into the patient, the external device can be placed over the actuator portion of the nail and activated, the magnets within the ERC 3P rotate, which causes the magnet in the actuator portion of the PRECICE Nail to rotate, lengthening or shortening the nail. Periodic lengthening (typically daily) of the nail is performed after the implantation surgery to lengthen the limb. The ERC 3P also encompasses on-unit prescription programming. The distraction is confirmed in office using standard, routine x-ray of the limb. These office visits usually occur on a weekly basis. The principles of operation of the ERC 3P are the same as those of the ERC and ERC2P previously cleared.
This FDA_510k document describes the PRECICE Intramedullary Limb Lengthening System, specifically focusing on the new External Remote Controller (ERC 3P). The document primarily focuses on establishing substantial equivalence to previously cleared devices through design, in vitro testing, software validation, and usability/labeling readability evaluations. Therefore, the information provided does not fully align with the typical structure of a study proving a device meets specific acceptance criteria in terms of accuracy or efficacy, but rather demonstrating safety and performance equivalence.
Here's a breakdown of the requested information based on the provided text, with acknowledgments of what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of specific acceptance criteria for performance metrics related to limb lengthening accuracy, speed, or similar clinical outcomes as would be found in a study demonstrating efficacy. Instead, it lists various engineering and usability tests and standards used to demonstrate equivalence and safety of the ERC 3P.
| Test/Document Description | Applicable Test Standard | Purpose (Implied Acceptance) | Reported Performance / Outcome |
|---|---|---|---|
| Risk Management Report | EN ISO 14971: 2012 | Comprehensive risk assessment and mitigation | (Implied: Risks adequately identified and mitigated) |
| Electrical Safety | IEC 60601-1 (3rd edition): 2005 | Device electrical safety | (Implied: Meets electrical safety requirements) |
| Electromagnetic Compatibility and Interference | IEC 60601-1-2: 2014 | Device EMC/EMI compliance | (Implied: Meets EMC/EMI requirements) |
| Minimum rated voltage testing | N/A (Internal method) | Device functionality at minimum voltage | (Implied: Operates as intended at minimum voltage) |
| Shock and Vibration Testing | IEC 60601-1-11: 2015 | Device durability under shock/vibration (home use) | (Implied: Withstands specified shock/vibration for home use) |
| Ingress protection | N/A (Internal method; likely related to IEC 60601-1-11) | Protection against ingress of solids/liquids | (Implied: Meets ingress protection requirements for home use) |
| Usability evaluation | N/A (Internal method) | Ease of use and effectiveness for target users (patients) | "demonstrate its suitability for use by the proposed patient population in the home environment and in accordance with the indications." |
| Labeling Readability | N/A (Internal method) | Clarity and comprehension of device labeling | (Implied: Labeling is clear and understandable) |
| Software Validation | (Implied: Internal methods based on regulatory guidance) | Software functions as intended and is safe | (Implied: Software is validated) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Usability Study): 17 participants
- Data Provenance: The document does not explicitly state the country of origin for the usability study participants. It describes the study as being performed on a "representative population" and an "equivalent patient population," suggesting a prospective design within a clinical or simulated environment. It doesn't specify if it's retrospective or prospective, but usability studies are typically prospective.
- Other Testing: For the engineering tests (electrical safety, EMC, shock/vibration, etc.), the "sample size" is generally the device itself or a limited number of test units, which is standard for such evaluations. The data provenance would be from laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For the usability study, there isn't a "ground truth" established by experts in the context of diagnostic accuracy. Instead, the "truth" is the user experience and ability to perform tasks. Usability studies typically involve observers and evaluators, but they are not usually referred to as "experts" establishing a ground truth in the same way a radiologist establishes a diagnosis.
4. Adjudication Method for the Test Set
This information is not provided as it's not relevant to the nature of the usability study described. Adjudication methods (like 2+1, 3+1) are typically used in studies where multiple human readers independently interpret data (e.g., medical images) and their disagreements need to be resolved to establish a definitive ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not reported. The document focuses on demonstrating the substantial equivalence of the new ERC 3P to existing predicate devices (ERC and ERC2P) and confirming its safety and usability, not on comparing the efficacy of human readers with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device described is a medical hardware system (an intramedullary nail) with an external controller. It is not an AI algorithm or software-only device designed to standalone or diagnose. Therefore, a "standalone (algorithm only without human-in-the-loop performance)" study is not applicable and was not performed. The ERC 3P is a component that interacts directly with the patient and is operated by the patient.
7. The Type of Ground Truth Used
For the engineering tests, the "ground truth" is compliance with the specified standards (e.g., IEC 60601-1 for electrical safety). For the usability study, the "ground truth" is the successful and safe interaction of the participants with the device, and their ability to complete assigned tasks according to the device's intended use and design, as observed by the study team. It is not based on expert consensus, pathology, or outcomes data in a diagnostic sense.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The ERC 3P is a hardware device with software, not a machine learning model that requires a distinct "training set." Any internal software development or validation would involve standard software engineering practices, not a machine learning training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of machine learning. For software validation, the "ground truth" would be established by the software requirements and design specifications, verified through testing.
§ 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.