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510(k) Data Aggregation
(141 days)
The IlluminOss Photodynamic Bone Stabilization System 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 can also be used in conjunction with an FDA-cleared fracture fixation system to provide supplemental fixation in the humerus, radius, and ulna. It is also indicated for use in skeletally mature patients in the treatment of the pelvis, clavicle, metacarpals, metatarsals, and phalanges.
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 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 fiber 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 510(k) is to add smaller, and intermediate sizes of the implant and expand the indications for use to include the pelvis, clavicle, metacarpals, metatarsals, and phalanges.
The provided text is a 510(k) summary for the IlluminOss Photodynamic Bone Stabilization System, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than conducting a detailed study with specific acceptance criteria and performance metrics for an AI-powered diagnostic device.
Therefore, much of the information requested in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) is not applicable to this type of device and document.
However, I can extract the relevant "acceptance criteria" (in terms of performance testing) and "reported device performance" as described within the limited context of this 510(k) submission.
Here's the information gleaned from the provided text, focusing on the available performance testing summary, keeping in mind that this is not a study proving AI acceptance criteria:
1. A table of (implied) acceptance criteria and the reported device performance
| Acceptance Criteria (Implied from Performance Testing) | Reported Device Performance |
|---|---|
| 1. Device is of sufficient strength upon curing for the new indications (pelvis, clavicle, metacarpals, metatarsals, and phalanges). (This implies structural integrity and load-bearing capacity meet pre-defined thresholds for these anatomical sites) | 1. "Testing to demonstrate that the devices is of sufficient strength upon curing for the indications in the pelvis, clavicle, metacarpals, metatarsals, and phalanges." (The document states this testing was done, implying successful demonstration to meet clearance requirements.) |
| 2. New device sizes (smaller and intermediate implants) can withstand the pressures necessary to complete the infusion process with the liquid monomer without failure. (This implies pressure resistance and integrity during inflation.) | 2. "Testing to demonstrate that the new device sizes could withstand the pressures necessary to complete the infusion process with the liquid monomer." (The document states this testing was done, implying successful demonstration to meet clearance requirements.) |
| 3. Monomer sufficiently cures during the given cure time for the new implant sizes, providing sufficient mechanical strength. (This implies adequate polymerization and resulting biomechanical properties within the specified operational parameters.) | 3. "Testing to demonstrate that monomer sufficiently cures during the given cure time for the new implant sizes, providing sufficient mechanical strength." (The document states this testing was done, implying successful demonstration to meet clearance requirements.) |
| Overall substantial equivalence: The modified IlluminOss PBSS is substantially equivalent to predicate devices with respect to indications, design, function, and performance. (This is the overarching "acceptance criterion" for 510(k) clearance, demonstrated via the sum of all testing and comparisons.) | "The subject device was demonstrated to be substantially equivalent to the predicates cited above with respect to indications, design, function, and performance." |
| "The IlluminOss PBSS device is substantially equivalent to the previously cleared devices with respect to its indications for use, design, function, and performance." (This is the conclusion based on the performed evaluations.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document describes general performance testing but does not detail the specific sample sizes, methodologies, or data provenance (e.g., animal models, cadaveric testing, in vitro simulations) for each test.
3. 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)
This information is not applicable and therefore not provided. The IlluminOss Photodynamic Bone Stabilization System is a physical medical device for fracture stabilization, not an AI diagnostic tool requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for its performance would be derived from engineering standards, biomechanical testing, and material science properties, not expert consensus on diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 refer to how discrepant interpretations by multiple experts are resolved in diagnostic ground truth establishment, which is not relevant for this device.
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
This information is not applicable and therefore not provided. An MRMC study is performed to evaluate the diagnostic performance of human readers, typically with and without AI assistance, which is not relevant for a fracture stabilization device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and therefore not provided. Standalone performance refers to the diagnostic accuracy of an AI algorithm operating without human intervention, which is not relevant for a fracture stabilization device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a device like the IlluminOss PBSS, the "ground truth" for the performance testing would be based on:
- Engineering standards: Adherence to relevant ASTM/ISO standards for medical devices and orthopedic implants.
- Biomechanical testing: Mechanical properties (e.g., strength, stiffness, fatigue life) measured against established thresholds for bone stabilization.
- Material properties: Chemical and physical properties of the monomer and balloon material meeting specifications.
- Curing kinetics: Demonstration that the polymerization process completes within specified timeframes and achieves desired material strength.
The summary describes that "Testing to demonstrate that the devices is of sufficient strength upon curing..." and "Testing to demonstrate that monomer sufficiently cures...providing sufficient mechanical strength" was performed, indicating these types of technical data serve as the "ground truth" for device function.
8. The sample size for the training set
This information is not applicable and therefore not provided. The IlluminOss PBSS is a physical medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided, as there is no training set for this device.
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