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510(k) Data Aggregation
(98 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, ulvis, fibula, metacarpals, metatarsals, and phalanges. The IlluminOss Photodynamic Bone Stabilization System can also be used in conjunction with FDA-cleared fracture fixation systems to provide supplemental fixation in thes. 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 provided text is a 510(k) summary for the IlluminOss Photodynamic Bone Stabilization System. It describes the device, its indications for use, and how it compares to a predicate device. The information necessary to fully answer your request regarding acceptance criteria and the study that proves the device meets those criteria is not explicitly detailed in the provided text.
Specifically, the document states: "The technological characteristics of the subject device that differ from the predicate are supported by verification activities." It then lists types of testing performed (Functional Testing, Software Testing, Electrical Safety Testing, Electromagnetic Compatibility Testing, Human Factors and Usability Testing, Shipping / Environmental Storage and Testing, Implant Performance Testing for the light system, and Sterility Testing, Packaging Performance Testing, Shipping Testing for the packaging).
However, the specific "acceptance criteria" (i.e., quantitative performance thresholds that the device must meet, such as a specific accuracy rate or predefined ranges for measurements) for these tests are not provided in this summary. Likewise, the detailed "study" that proves these criteria are met is not a comprehensive report here, but rather a list of verification activities.
Therefore, many of the requested details cannot be extracted directly from this document. I will provide the information that is available and indicate where the requested information is not present.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document lists types of tests performed for the modified light system and packaging configurations, such as "Functional Testing," "Software Testing," "Electrical Safety Testing," etc. However, it does not specify the quantitative or qualitative acceptance criteria for these tests, nor does it provide a summary of the numerical device performance against any such criteria. It generally states that "The technological differences are all supported by verification activities and demonstrate that the device functions as intended." | Not explicitly detailed in the document. The document states that the testing "demonstrate[s] that the device functions as intended" and that it "perform similarly to the predicate." No specific metrics or results are given. |
2. Sample size 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 document. The document lists "verification activities" but does not detail the sample sizes, data provenance, or whether the studies were retrospective or prospective.
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 provided in the document. The nature of the device (a bone stabilization system) suggests that "ground truth" might be established through engineering specifications, biomechanical testing, or clinical outcomes rather than expert consensus on diagnostic images. However, no details are given.
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
An MRMC study is typically associated with diagnostic imaging devices or AI-assisted diagnostic tools. This device is a bone stabilization system; therefore, an MRMC study is not applicable and was not mentioned or performed. The device is a physical implant system, not a diagnostic imaging aid.
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 photodynamic bone stabilization system, not a software algorithm or AI. The "light system" has software components, but the performance testing mentioned (e.g., Software Testing) is about the functionality of the device's control software, not a standalone AI diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for each verification activity. For "Implant Performance Testing," the ground truth would typically be established through biomechanical testing standards and engineering specifications to ensure the implant meets strength, durability, and biological compatibility requirements. For "Electrical Safety Testing" and "Electromagnetic Compatibility Testing," the ground truth would be established by relevant national and international safety standards. For "Sterility Testing" and "Packaging Performance Testing," ground truth would be based on established regulatory standards for medical device sterilization and packaging integrity.
8. The sample size for the training set
This question is not applicable as the device is a physical bone stabilization system, not an AI or machine learning model that requires a training set. The "Software Testing" referred to is for the device's operational software, not an AI component.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated in point 8.
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