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510(k) Data Aggregation
(61 days)
JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
The JTS® Extendible Distal Femoral Implant is intended to be used for cemented limb salvage procedures in paediatric (between the ages of 2 and 21) cases where radical resection and replacement of the distal femur is required with the following conditions:
- patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;
- surgical intervention for severe trauma, revision knee arthroplasties, failed previous prosthesis and/or oncology indications; and
- malignant diseases (e.g., osteogenic sarcoma).
The JTS® Extendible Distal Femoral Implant and its components are for single use only.
The JTS® Extendible Distal Femoral Implant is a patient specific system that is used to replace bone which is lacking or damaged or must be removed (e g., due to tumor). The device consists of components (defined below) which are available in a range of sizes depending on the size and needs of the patient. Every configuration includes a telescoping shaft with a gearbox, magnet, and extension screw assembly for extending the implant when required by the patient.
Components available in patient specific sizes:
- Femoral Telescoping Shaft
- Femoral Block
- Extension Screw
- Femoral Shaft
- Tibial configurations for knee joint including passive rotating hinge, rotating hinge (polyethylene), and metal cased tibia components
- Passive Bearing
- Tibial Passive Stem
- HA Coated Extra-cortical Plate that is integral to the Femoral Shaft
- Hydroxyapatite Collar that is integral to the Femoral Shaft
- Bumper Pad
- Bushes
- Axles
The specific design of the implant is based on the surgeon's description of the case and patient radiological information. The key dimensions for each JTS® Extendible Distal femoral Implant are derived from the generic device specifications and by taking measurements from the patient's X-rays and/or CT scans. The implant is designed and manufactured for each patient.
The JTS® External Drive Unit is used periodically to lengthen the prosthesis when the patient's limb length discrepancy needs to be addressed. The JTS® External Drive Unit creates a magnetic field which interacts with the magnet in the telescoping shaft to lengthen the implant.
The provided text is a 510(k) summary for the JTS® Extendible Distal Femoral Implant. This document focuses on establishing substantial equivalence to predicate devices for a medical implant.
Based on the content, this document does not describe a study involving performance metrics like sensitivity, specificity, accuracy, or reader improvement in an AI context. Instead, it discusses the technical characteristics, intended use, and substantial equivalence of a physical medical device.
Therefore, many of the requested categories related to AI/algorithm performance studies cannot be filled from the given text.
Here's a breakdown of what can be extracted and explanations for what cannot:
Acceptance Criteria and Device Performance (as described for a physical implant)
The document primarily focuses on establishing substantial equivalence to predicate devices rather than defining specific performance acceptance criteria for a new, standalone study of the device's functional performance in a clinical setting. The "performance" here refers to its design and intended use matching existing cleared devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: For cemented limb salvage in pediatric patients (2-21) with conditions like severe arthropathy, trauma, failed prostheses, or oncology indications (e.g., osteogenic sarcoma). | Meets Intended Use: The device states the same intended use as its predicate device (K092138). |
| Technological Characteristics: Similar components, telescoping shaft, gearbox, magnet, extension screw assembly, and patient-specific design based on radiological information. | Meets Technological Characteristics: The device has the same fundamental scientific technology as the predicate. Minor differences are additional optional knee configurations (fixed and rotating hinge tibial designs) and extra-small tibial components, which have themselves been cleared as part of other predicate devices (K120992, K121055, K121029). These do not alter the fundamental technology or raise new safety/effectiveness questions. |
| Principle of Operation: Telescoping shaft with a gearbox, magnet, and extension screw assembly; uses an external drive unit to create a magnetic field for lengthening. | Meets Principle of Operation: The device has similar principles of operation as its predicate device (K092138). |
| Safety and Effectiveness: Should not raise new questions of safety or effectiveness compared to predicate devices. | Meets Safety and Effectiveness: The modifications (additional knee configurations) are stated not to "alter the fundamental scientific technology of the JTS® device or raise any new questions of safety or effectiveness." |
Information Not Applicable / Not Available from the Provided Text:
The following requested items are specific to the evaluation of AI/algorithm performance and are not found in this 510(k) summary for a physical medical implant.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This document does not describe a clinical study for performance testing of an algorithm.
- 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): Not applicable. "Ground truth" in the AI sense is not established for this device.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text is a regulatory filing for a physical medical device (an extendable distal femoral implant), not for an artificial intelligence or algorithm-based device. Therefore, the detailed questions about AI performance studies, ground truth establishment, and expert involvement are not applicable to this document.
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