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510(k) Data Aggregation
(90 days)
FITBONE(R) TAA
The WITTENSTEIN intens GmbH FITBONE® TAA intramedullary lengthening system is intended for limb lengthening of the femur and tibia.
The FITBONE®TA A intramedullary lengthening system is indicated for adult and pediatric (greater than 12 through 21 years of age) patients.
The FITBONE® TAA System is a fully implantable intramedullary lengthening device. Changes to the existing FITBONE® TAA (K163368) have been introduced to extend the current portfolio by new Subject FITBONE® TAA09 intramedullary lengthening nail model fixed to the bone by new Subject Locking Screws and a new Subject Receiver connected to the Subject nail by a bipolar feed line with new Subject external Retraction Control Set consisting of a control electronics with a Retraction Transmitter. New Subject surgical tools are provided to facilitate the surgical process.
The Subject FITBONE® TAA09 intramedullary lengthening nail model, line extension of the primary predicate FITBONE® TAA (Κ163368) models is implanted into the medullary canal of the femur or tibia. The nail is fixed to the bone by Locking Screws through longitudinal openings in the nail.
The Subject FITBONE® TAA09 intramedullary lengthening 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 Subject FITBONE® TAA09 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 of the nail 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 nail and Receiver are offered in sterile conditions and the Locking screws and non-implantable external electronic controlling components in non-sterile packaging configurations.
The Subject FITBONE® TAA09 nail model is fixed to the bone by Locking Screws, made from Stainless steel AISI 316LVM, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)".
Surgical procedures with the use of the Subject FITBONE® TAA09 model shall be performed with the support of orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. The surgical instruments offered by WITTENSTEIN intens GmbH as part of this submission under product code: LXH (21 CFR 888.4540).
The orthopedic instruments are made by medical grade stainless steel, Aluminum and Silicone.
The Subject FITBONE® TAA09 and the Subject external electronic controlling components are designed to be used in the operating theatre and home environment.
The FITBONE® TAA intramedullary lengthening system is intended for limb lengthening of the femur and tibia. It is indicated for adult and pediatric (greater than 12 through 21 years of age) patients.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on demonstrating substantial equivalence to a predicate device (FITBONE® TAA, K163368) and other similar devices, rather than establishing specific, quantified acceptance criteria for a new clinical performance study. The "Performance Analysis" section summarizes that the device performs "as well as or better than the predicate devices" based on various testing.
Therefore, the table below reflects what can be inferred as "acceptance criteria" based on the substantial equivalence argument, which inherently means meeting or exceeding the predicate's performance. Specific quantitative targets for clinical outcomes are not explicitly stated in this document.
| Acceptance Criterion (Inferred from Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Mechanical Performance: Biomechanical integrity (e.g., strength, durability, fatigue resistance) equivalent to or better than the predicate device. | "Results to support the determination of substantial equivalence from engineering, electrical, bench, human factors testing... confirm that Subject devices are as safe, as effective, and performs as well as or better than the predicate devices." (Implies successful completion of relevant mechanical tests) |
| Material Compatibility: Use of biocompatible materials equivalent to the predicate device. | "Material: are equivalent as the primary predicate." (Specifically mentions Stainless steel AISI 316LVM, according to ASTM F138-13) |
| Sterilization Efficacy: Sterilization method and effectiveness equivalent to the predicate device. | "Sterilization: identical method as the FITBONE® TAA- K163368." |
| Functional Equivalence: Powering, elongation, and control mechanisms are equivalent to or improve upon the predicate device's functionality. | "The Subject FITBONE® TAA09 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 of the nail is transmitted from the outside by placing the external Transmitter over the implanted Receiver..." (These describe the mechanism, equivalent to the predicate.) |
| Safety: No new or unresolved risks compared to the predicate device. | "No new risks associated to the Subject device compared to those of the additional predicate and the reference devices which have similar indications for use, anatomical sites and conditions of use." "Any potential hazards of the changes introduced... have been evaluated and controlled through Risk Management activities." |
| Intended Use & Indications: Identical to the predicate device. | "Intended use: identical to FITBONE® TAA K163368 and additional predicate" and "Indications for Use, Anatomical sites, operating principles and conditions of use are substantially equivalent to FITBONE® TAA K163368 and to the additional predicate." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance data, specifically engineering, electrical, bench, and human factors testing. It does not mention a test set from a clinical study with human subjects.
- Sample Size: Not applicable as no clinical test set is described. The performance assessment relies on engineering and bench testing, for which sample sizes (e.g., number of nails tested for fatigue) are not specified in this summary.
- Data Provenance: Not applicable as no clinical data (e.g., country of origin, retrospective/prospective) is associated with a "test set" in the context of this 510(k) summary. The testing appears to have been conducted by the manufacturer, WITTENSTEIN intens GmbH.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. As no clinical "test set" is described for algorithm evaluation, the concept of establishing ground truth by experts is not applicable to the data presented. The "ground truth" for the engineering and bench testing would be defined by established standards and internal validation protocols.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable as no clinical "test set" requiring expert adjudication is described in the document.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The submission is based on engineering, electrical, bench, and human factors testing to demonstrate substantial equivalence to a predicate device, not on a clinical effectiveness study involving human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is not applicable. The device, FITBONE® TAA, is an intramedullary lengthening system, a physical medical device, not an AI algorithm or software device. Therefore, a "standalone algorithm performance" study is not relevant.
7. The Type of Ground Truth Used
The "ground truth" in this submission is established through:
- Engineering Standards and Bench Testing Results: Compliance with established mechanical, material, and electrical performance standards (e.g., ASTM F138-13 for stainless steel). The performance of the predicate device also serves as a benchmark for equivalence.
- Risk Management Activities: Identification and control of potential hazards.
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (FITBONE® TAA, K163368) forms the basis for demonstrating substantial equivalence.
No pathology, expert consensus, or outcomes data from a new clinical study are used as ground truth for a test set in this 510(k) summary.
8. The Sample Size for the Training Set
This information is not applicable. The FITBONE® TAA is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The design and development of the device would involve engineering principles and prototypes, but not a data-based "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 this medical device submission.
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