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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, ulna, clavicle, pelvis, fibula, metacarpals, and phalanges. The IlluminOss Photodynamic Bone Stabilization System can also be used in conjunction with FDAcleared fracture fixation systems to provide supplemental fixation in these anatomic sites. The IlluminOss System may be used in the femur and tibia to provide supplemental fixation to an anatomically appropriate FDA-cleared fracture fixation system.

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 system is currently indicated for use in the humerus, radius, ulna, clavicle, metacarpal, metatarsal, phalanges, ulna, fibula, and anterior ring of the pelvis. The purpose of this Special 510(k) is to expand the indications of the IlluminOss Photodynamic Bone Stabilization System (PBSS) to include use in the femur and tibia in conjunction with FDA-cleared fracture fixation systems.

The provided text describes the IlluminOss Photodynamic Bone Stabilization System (PBSS) and its expanded indications for use. However, it does not contain the specific details about acceptance criteria, a comparative study with a test set, ground truth establishment, or human reader performance that would typically be found in a detailed study report.

Based on the information provided in the 510(k) summary:

1. A table of acceptance criteria and the reported device performance

   Acceptance Criteria	Reported Device Performance
   Improves pull-out strength	Device demonstrated statistically significantly higher screw pull-out loads compared to when the IlluminOss device is not used.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
   The document does not specify the sample size for the test set or data provenance (country of origin, retrospective/prospective). It generally refers to "samples" being tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
   This information is not provided in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
   This information is not provided in the document.

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
   A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted, as this device is a physical medical device (bone stabilization system), not an AI algorithm for diagnostic imaging.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
   This question is not applicable as the device is a physical bone stabilization system, not an algorithm. However, performance testing of the device itself (standalone) was conducted, focusing on its mechanical properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
   The "ground truth" in this context is likely derived from mechanical testing data (e.g., direct measurements of pull-out strength in a laboratory setting) rather than clinical expert consensus or pathology, as the study focuses on the device's mechanical performance in supplemental fixation.

8. The sample size for the training set
   This information is not provided. It's important to note that for a physical device undergoing mechanical testing, the concept of a "training set" as understood in machine learning is generally not applicable. Instead, there would be samples used for initial design verification and validation testing.

9. How the ground truth for the training set was established
   Not applicable, as a "training set" in the machine learning sense is not relevant here. For the mechanical testing performed, the "ground truth" (i.e., the actual pull-out strength for a given construct) would have been established through direct experimental measurement in a controlled laboratory environment.

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