(30 days)
IlluminOss Photodynamic Bone Stabilization System (PBSS) is indicated for use in skeletally mature patients in the treatment of traumatic, fragility, pathological, and impending pathological fractures of the humerus, radius, and ulna.
The IlluminOss Photodynamic Bone Stabilization System provides an important treatment option in the fixation and stabilization of fractures through a minimally invasive procedure. The system uses a catheter to deploy an inflatable, noncompliant, thin wall PET balloon into the medullary canal of the bone across the fracture site. The balloon is infused using a standard 20cc syringe with a photodynamic (light cured) monomer that causes the balloon to slowly expand and fill the intramedullary canal of the fractured bone. Activation of the light system allows for visible spectrum light to be delivered through a radially emitting light pipe that is temporarily positioned into a central lumen of the catheter that runs the length of the balloon. With this design, the liquid monomer within the balloon is exposed to light along the entire length of the balloon during the curing process. The purpose of this Special 510(k) is to add smaller, intermediate, and larger sizes of the implant, an intermediate size of the Sheath/Dilator Set, and a smaller size of the Delivery Set.
The provided text is a 510(k) summary for a medical device (IlluminOss Photodynamic Bone Stabilization System) and does not describe an AI medical device. Therefore, the questions related to acceptance criteria, ground truth, expert opinions, sample sizes for AI training/test sets, and MRMC studies are not applicable.
The document discusses performance testing for physical characteristics of the device, rather than algorithmic performance.
Here's a breakdown of the relevant information provided for the physical device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes the testing and states that the "modified IlluminOss Photodynamic Bone Stabilization System met the pre-determined acceptance criteria for the verification activities" for the following:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability of new device sizes to withstand pressures during monomer infusion. | Demonstrated successfully. |
| Sufficient curing of monomer within given cure time for new implant sizes, providing adequate mechanical strength. | Demonstrated successfully. |
| Adequate tensile characteristics of the balloon catheter bond. | Demonstrated successfully. |
| Light pipe does not break upon removal and can sufficiently cure the monomer. | Demonstrated successfully. |
2. Sample size used for the test set and the data provenance: Not applicable for an AI device. The testing described is for the physical device components (e.g., pressure resistance, material strength, curing effectiveness).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an AI device.
4. Adjudication method for the test set: Not applicable for an AI device. The evaluation is based on engineering and material performance tests.
5. 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, as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI device.
7. The type of ground truth used: For the physical device, the "ground truth" would be the established engineering specifications and material properties. For example, "sufficient mechanical strength" is a ground truth based on predefined biomechanical requirements.
8. The sample size for the training set: Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.
§ 888.3023 In vivo cured intramedullary fixation rod.
(a)
Identification. An in vivo cured intramedullary fixation rod is a prescription implanted device consisting of a balloon that is inserted into the medullary canal of long bones for the fixation of fractures. The balloon is infused with, and completely encapsulates, a liquid monomer that is exposed to a curing agent which polymerizes the monomer within the balloon creating a hardened rigid structure.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Mechanical testing must be conducted on the final device to assess burst, abrasion, bending, and torsion in static and dynamic conditions.
(ii) Mechanical testing must demonstrate the integrity of the balloon including testing for leaks, ruptures, and release of cured/uncured material.
(iii) Performance testing must demonstrate that the device can be inserted and removed.
(iv) Performance testing must demonstrate the ability, in the event of a leak, to remove the uncured material from its in vivo location.
(v) Performance testing must demonstrate the reliability and accuracy of the curing method used.
(vi) Thermal safety testing must be conducted to evaluate the temperature rise during curing.
(2) Electrical safety, electromagnetic compatibility (EMC) testing, and electromagnetic interference (EMI) testing must be conducted for all electrical components.
(3) All patient-contacting components must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility and pyrogenicity of patient contacting components of the device that are provided sterile.
(5) Performance data must validate the reprocessing instructions for any reusable components or instruments.
(6) Performance data must support the shelf life of the system by demonstrating continued sterility, package integrity, and system functionality over the established shelf life.
(7) Technological characterization of the device must include materials, curing agents, and a description of the operating principles of the device, including the delivery system and devices which initiate the curing process.
(8) Labeling must include the following:
(i) A detailed summary of the device technical parameters.
(ii) Information describing all materials of the device.
(iii) Information describing how to perform the procedure and use the device, including the delivery system and devices which initiate the curing process, as well as how to remove the device and any uncured materials.
(iv) A shelf life.
(v) Validated methods and instructions for reprocessing any reusable components or instruments.