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510(k) Data Aggregation
(74 days)
TrueLok Elevate is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities. The TrueLok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.
The subject TrueLok Elevate is an external fixation component system (including its accessories) to be used with the Orthofix TrueLok family, for which Orthofix identified as a predicate device TrueLok Hexapod System (TL-HEX) V2.0 (K170650). The subject device consists in a further series of elements for external fixation added to the Orthofix TrueLok family with the aim of supporting the Orthofix TrueLok external fixator systems family falling within the indications for use of the more extensive, cleared indications for use of the chosen predicate device, for the specific use in bone transport treatment.
The subject TrueLok Elevate is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities.
The TrueLok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.
The subject device is constituted by an external fixator and related accessories (half pins, k-wires, drill positioning guide, template and template inserts and convenience kits).
The technique for the use of the subject device consists in fixing two half pins on the first cortical of the bone segment that the surgeon decided to transport, and two half pins on both cortexes of the bone.
The positioning of the half pins is driven by a template.
During the treatment, through the knob present on the device, the bone segment is gradually pulled outward by the patient/caregiver to laterally transport the bone segment.
The subject device, as the predicate, will be implanted only by Healthcare Professionals (HCP), with full awareness of the appropriate orthopedic procedures (including application and removal), in the operating theatre only. The distraction of the limb will be activated in home by the patient/caregiver or in clinic theatre by the HCP. Treatment activation for pediatric patients in the home environment may require the assistance of a caregiver.
The Orthofix TrueLok™ Elevate is an external fixation component system intended for the treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities in adult and pediatric patients (greater than 2 through 21 years of age).
Here's an analysis of the acceptance criteria and the study performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific pass/fail acceptance criteria values for the mechanical tests conducted. Instead, it describes comparative testing against predicate or reference devices to demonstrate similarity in performance. The assessment for each technological characteristic indicates that "no different questions have been raised" or that the subject device's indications fall within the predicate's, suggesting that the goal was to demonstrate equivalence rather than meeting pre-defined numerical thresholds for acceptance.
| Test Description | Reported Device Performance |
|---|---|
| External Frame: | |
| Static axial stiffness test (according to ASTM F1541-17 Annex 7) | Performed for subject TrueLok Elevate external fixator. Performance was compared with reference device True/Lok Monolateral/Bilateral Fixator (K941048). The implicit acceptance criterion is that its stiffness is comparable or superior to the reference device, ensuring similar mechanical behavior. |
| Slipping torque on connectors test (according to ASTM F1541-17 Annex 2) | Performed for subject TrueLok Elevate external fixator. Performance was compared with reference device True/Lok Monolateral/Bilateral Fixator (K941048). The implicit acceptance criterion is that its slipping torque is comparable or superior to the reference device, ensuring secure connection and stability. |
| Half Pins: | |
| Static 4-point bending evaluation | Performed for subject half pins of TrueLok Elevate. Performance was compared to the predicate device Orthofix TrueLok Hexapod System (K170650). The implicit acceptance criterion is that its bending strength is comparable or superior to the predicate device, ensuring similar structural integrity. |
| Torsional strength evaluation | Performed for subject half pins of TrueLok Elevate. Performance was compared to the predicate device TrueLok Hexapod System (K170650). The implicit acceptance criterion is that its torsional strength is comparable or superior to the predicate device, ensuring similar resistance to twisting forces. |
| Overall Assessment: | The conclusions state: "Based upon substantial equivalences in: intended use, patient population, site of application, conditions of use, operating principles, and the non-clinical performance data, the subject TrueLok™ Elevate has been shown to be substantially equivalent to the legally marketed predicate device (K170650)." This indicates the device met the implicit acceptance criterion of performing comparably to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the mechanical tests (e.g., number of external fixators or half pins tested).
The provenance of the data is not specified regarding country of origin or whether it was retrospective or prospective, as these were bench tests performed on devices rather than patient data.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable to this type of submission. The ground truth for mechanical performance is established through standardized testing protocols (e.g., ASTM standards) and comparisons to previously cleared predicate devices, not through expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
This information is not applicable to this type of submission as the mechanical tests are objectively measured, not subject to subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not performed. This type of study is typically relevant for AI/imaging devices where human reader performance is being evaluated with and without AI assistance. The TrueLok™ Elevate is a physical external fixation system.
6. Standalone (Algorithm Only) Performance Study
A standalone study was not performed, as the device is a physical medical device, not a software algorithm.
7. Type of Ground Truth Used
The ground truth used for demonstrating performance was based on objective mechanical measurements conducted in accordance with recognized industry standards (e.g., ASTM F1541-17) and comparisons to the established performance characteristics of legally marketed predicate devices. The "truth" is that the new device's mechanical properties fall within acceptable limits or are comparable to those of the predicate, as determined by these tests.
8. Sample Size for the Training Set
This information is not applicable. The TrueLok™ Elevate is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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(245 days)
"FITBONE Transport and Lengthening system" is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, malunions, non-unions, or bone transport of the long bones. The "FITBONE Transport and Lengthening system" is indicated for adult only.
The subject “FITBONE® Transport and Lengthening System” consists of the implantable intramedullary transport or lengthening nail and its trial nail accessories. The Subject device is implanted into the medullary canal of the femur or tibia and connected to the additional predicate intracutaneous Receiver by a bipolar feed line. The external FITBONE Control Set is identical to that previously cleared for the additional predicate Fitbone TAA device (K203399) and consists of a control electronics station and transmitter. There are no changes to this previously cleared Control Sets and Receiver as a result of this submission. 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 FITBONE Transport and Lengthening Nail with voltage, when actioned. The subject nail is anchored to the bone by locking screws through medial-lateral and AP holes in the nail depending on the configuration holes in the nail. 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 surgery. There is no transcutaneous contact between the implanted intramedullary nail and the outer surface of the patient's body. The subject trial nails accessories are available for each size model of the FITBONE Transport (TN) and FITBONE Transport or Lengthening (TLN) nails and are used to simulate the shape of the implant. The subject nails and trial nails are provided in sterile conditions only and are made from, as follows: • Nail: implant grade stainless steel 1.4441, according to ASTM F138- 13 "Standard Specification for Wrought 18Chromium-14Nickel- 2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)", and Silicone Nusilmed (NuSil MED-4870, NuSil MED- 1511, Nusil MED 4750). • Trial nail: implant grade stainless steel 1.4441, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel- 2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)" and ASTM F899-20 Standard Specification for Wrought Stainless Steels for Surgical Instruments For the implantation and removal of the subject device the same instruments of the additional predicate Fitbone TAA (K203399) may be used.
The provided text is a 510(k) summary for a medical device (FITBONE® Transport and Lengthening System). It details the device's indications for use, technological characteristics, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-based medical device.
The document describes mechanical testing (bench testing) to demonstrate the equivalence of the subject device to its predicates for physical attributes like bending, fatigue, and torsional strength, and current consumption of the motor. This is typical for implantable mechanical devices.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device, including details about sample sizes, data provenance, expert qualifications, ground truth establishment, or MRMC studies, as these concepts are not applicable to the content provided in the input text.
The document discusses performance in terms of mechanical and functional equivalence of a physical medical device, not the performance of an AI/ML algorithm.
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