(57 days)
The WITTENSTEIN intens GmbH FITBONE® TAA intramedullary lengthening system is intended for limb lengthening of the femur and tibia.
The FITBONE® TAA system is a fully implantable intramedullary lengthening device. The FITBONE® TAA intramedullary lengthening system consists of an intramedullary lengthening nail connected to a receiver by a bipolar feed line, locking screws and an external Control Set consisting of a control electronics with a transmitter. The surgical tools and additional components are provided to facilitate the surgical process.
The FITBONE® TAA intramedullary lengthening nail is implanted into the medullary canal of the femur or tibia. The nail is connected to the bone by locking screws through longitudinal openings in the nail.
The nail consists of a telescoping system that allows it to expand. It is powered by hermetically enclosed electromagnetic motor which draws the telescope apart, during which the extension is externally steered via electronic impulses. The FITBONE® TAA intramedullary lengthening nail elongation is propelled by a highly sensitive gear and spindle mechanism which converts the rotation of the motor into an axial movement with high force.
The energy needed for the distraction process is transmitted from the outside by placing the external transmitter over the implanted receiver which is placed in the subcutaneous tissue during FITBONE® surgery. The energy transmission will be triggered by pressing the "Patient" button on the control electronics by the patient. There is no transcutaneous contact between the implanted intramedullary nail and the outer surface of the patient's body.
The provided submission is for a medical device (intramedullary lengthening system) and does not describe an AI/ML powered device or study. Therefore, the questions related to acceptance criteria and studies for AI/ML performance metrics are not applicable.
The document discusses the substantial equivalence of the FITBONE® TAA intramedullary lengthening system to predicate devices. The "performance testing" described in the document refers to the mechanical and safety performance of the hardware device, not the performance of an algorithm.
Here's an overview of the "Performance Testing" section relevant to the physical device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions "Performance Testing" (Section I) and lists specific tests performed. However, it does not provide a table with explicit "acceptance criteria" values alongside "reported device performance" values. Instead, it states that "The results of testing demonstrate that the WITTENSTEIN intens GmbH FITBONE® TAA intramedullary lengthening system...is substantially equivalent to the predicate devices." This implies that the device met the performance requirements established for equivalence.
The tests conducted are:
| Test Description | Applicable test standard |
|---|---|
| Sterilization validation | ISO 14937 |
| Biocompatibility testing | ISO 10993 |
| Pyrogenicity testing | ISO 10993-11 |
| FITBONE® Control Set: Electrical safety testing | IEC 60601-1 |
| FITBONE® Control Set: Electromagnetic interference and compatibility testing | IEC 60601-1-2 |
| FITBONE® Control Set: Home Use | IEC 60601-1-11 |
| FITBONE® Control Set: Usability | IEC 60601-1-6 |
| Locking screw: Bending fatigue testing of IMFD Locking Screws | ASTM F 1264-03 |
| Locking screw: Torsional properties | ASTM F543-13 |
| Locking screw: Driving torque | ASTM F543-13 |
| Implantable rod: Static 4-point bend test | ASTM F1264-03 |
| Implantable rod: Fatigue 4-point bend test | ASTM F1264-03 |
| Implantable rod: Torque to failure | ASTM F1264-03 |
| Shelf Life Validation: Requirements for materials, sterile barrier systems and packaging systems | ISO 11607-1 |
| System functionality test | n/a |
| Risk management | ISO 14971 |
The following questions are not applicable as the device is a physical intramedullary lengthening system, not an AI/ML-based diagnostic or prognostic tool.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- 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)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
§ 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.