(84 days)
FitboneTM Trochanteric is indicated for limb lengthening of the femur. FitboneTM Trochanteric is indicated for adult and pediatric (greater than 12 through 21 years of age) patients.
FitboneTM Trochanteric is a fully implantable intramedullary lengthening nail and accessories. The subject Fitbone Trochanteric consists of the implantable intramedullary lengthening nail and accessories (Locking screws, Trial nails K-wire and Convenience kits). The subject device is implanted into the medullary canal of the femur and connected to the primary predicate intracutaneous Receiver (K203399) by a bipolar feed line. The external FITBONE Control Set is the same as previously cleared for the reference device Fitbone TAA (K203399) and consists of a control electronics station and transmitter. The power required for the distraction process is controlled by hermetically enclosed motor which draws the telescope apart. The electro-magnetic field sent from the Transmitter to the Receiver is converted in the Receiver into DC-Voltage to supply the motor of the subject Fitbone Trochanteric Nails with voltage, when actioned. The subject Fitbone Trochanteric Nails are available in two different diameter models (D09mm, D11mm), different lengths and lengthening capabilities. The subject nail is anchored to the bone by locking screws. The locking screws to be used with the subject nails are the same as cleared for the primary predicate Fitbone Trochanteric (K233867). Trial nails accessories are available for each variant of the Fitbone Trochanteric nails and are used to simulate the shape of the implant. The Fitbone Trochanteric nail and K-wire are provided in sterile conditions only. The trial nails are provided in non-sterile version only. The locking screws are available in both sterile and non-sterile versions. The subject Fitbone Trochanteric Nails and their accessories are made from implant grade stainless steel 1.4441 (AISI 316LVM) and Silicone Nusilmed.
The provided document is an FDA 510(k) clearance letter for the FitboneTM Trochanteric, an intramedullary fixation rod used for limb lengthening. This type of device is classified as a Class II medical device. The document focuses on demonstrating substantial equivalence to a predicate device through engineering and mechanical testing, rather than clinical studies involving human efficacy data. Therefore, many of the requested elements pertaining to clinical study design, such as human reader performance, ground truth establishment for a training set, and multi-reader multi-case studies, are not applicable here.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are established through comparison to a predicate device and bench testing against recognized standards. The "performance" described primarily refers to mechanical properties.
| Acceptance Criteria / Characteristic | Reported Device Performance (Subject Device) |
|---|---|
| Intended Use & Indications for Use | "Fitbone™ Trochanteric is indicated for limb lengthening of the femur. Fitbone Trochanteric is indicated for adult and pediatric (greater than 12 through 21 years of age) patients." (Identical to predicate) |
| Anatomical Sites | Femur (Identical to predicate) |
| Intended Environment | Clinic or Home environment (Identical to predicate) |
| Nail Material | Implant Grade Stainless Steel (1.4441, AISI 316LVM) and Silicone Nusilmed (Identical to predicate) |
| Nail Size Range | 217-357mm in length; 9 and 11mm diameters. |
| Maximum Distraction Possible | From 40mm (with nail length 217mm) to 80mm (with longer nails) (Equivalent to predicate) |
| Tail Nail Geometry | 2 holes (vs. 3 holes for predicate, assessed via bench testing) |
| Method of Distraction/Energy Source | Internal motor electro-magnetically induced by an external transmitter with signal received through a receiver placed just under skin (Identical to predicate) |
| Sterilization Method | Gas Plasma (Identical to predicate) |
| Static Cantilever Bending Test | Not explicitly quantified, but stated to "prove substantial equivalency with predicate devices" and "demonstrated not to raise different questions of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a "sample size" in terms of patient data for a test set, as this was not a clinical study assessing patient outcomes. The testing described is bench testing (mechanical testing). For mechanical testing, samples of the physical device would be tested. The number of such samples is not explicitly stated but would typically involve multiple units for each configuration tested.
- Data Provenance: The data provenance is from bench testing conducted on the subject device, its primary predicate (K233867), and reference devices (K203399, K220234). This testing would have been done in a laboratory setting, likely at the manufacturer's facility or a third-party testing lab. The origin of the device is Italy (Orthofix S.r.l.). The data is prospective in the sense that the tests were conducted specifically for this submission to evaluate the design change.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of this 510(k), is established through engineering specifications, material standards (e.g., ASTM F138-13), and validated mechanical testing methodologies, rather than human expert interpretation of clinical data.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is used for diagnostic devices where human readers interpret medical images or data, and an AI would assist in that interpretation. The FitboneTM Trochanteric is an implantable intramedullary lengthening nail, not a diagnostic AI software.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The FitboneTM Trochanteric is a physical medical device, not a software algorithm or AI. Its function is mechanical distraction, controlled by an external unit, but it does not have a "standalone algorithm" performance to report in this context.
7. Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is based on engineering specifications, material properties, and established mechanical testing standards. The primary method for establishing substantial equivalence involves comparing these aspects to a legally marketed predicate device and demonstrating that any differences do not raise new questions of safety or effectiveness.
8. Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of AI or machine learning. The device's design and materials are based on established engineering principles and prior device history, not on learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.