Search Results

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.

Ask a specific question about this device

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

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.

Ask a specific question about this device

Ask a specific question about this device

The IlluminOss Photodynamic Bone Stabilization System (PBSS) is indicated for skeletally mature patients in the treatment of impending and actual pathological fractures of the humerus, radius, and ulna, from metastatic bone disease.

The IlluminOss Photodynamic Bone Stabilization System (PBSS) is intended to be used in the fixation and stabilization of actual and impending pathological fractures of the humerus, radius, and ulna 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 within a central lumen of the catheter that runs the length of the balloon. The liquid monomer within the balloon is exposed to light along the entire length of the balloon during the curing process. Curing (and hardening) occurs only when the photo initiator within the monomer is exposed to a specific frequency of light causing rapid polymerization of the monomer resulting in a solid intramedullary (IM) rod. The time to cure the IM rod depends on the size of the balloon used to stabilize the fracture. A Timer Kev, included within each balloon catheter kit, determines the time the light source is activated during the curing process to ensure the appropriate cure time is used for each balloon size.

The IlluminOss Photodynamic Bone Stabilization System (PBSS) is indicated for skeletally mature patients in the treatment of impending and actual pathological fractures of the humerus, radius, and ulna, from metastatic bone disease.

Here's an overview of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document extensively details various tests and their acceptance criteria for the IlluminOss PBSS. Many of these relate to direct physical and chemical properties of the device components. The clinical study also had specific efficacy and safety endpoints.

Due to the volume of detailed bench testing, the table below will focus on the clinical efficacy and safety endpoints, as well as a selection of representative non-clinical acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size (Clinical Study): 81 subjects.
• Data Provenance:
  • Country of Origin: The IDE clinical study was a multi-center study conducted at 13 sites, presumably in the United States, given it was an Investigational Device Exemption (IDE) study within the US regulatory framework.
  • Retrospective or Prospective: The IDE clinical study was a prospective study. It also compared its results to historically controlled (literature-based) data for its non-inferiority assessment. An earlier EU Registry Study (135 bones in 132 subjects) was also mentioned, which collected data prospectively (standard of care demographic and fracture-related data for adverse device effects), but not as a formal clinical trial for this De Novo submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For the clinical study, ground truth was based on patient-reported outcomes (VAS pain, MSTS functional score, etc.), radiographic evaluations, and adverse event reporting.

• Number of Experts: Not explicitly stated as a specific number of independent experts providing a "ground truth" adjudication for each case. Outcomes were measured by study personnel and clinical investigators at the participating sites.
• Qualifications of Experts: Clinical Investigators at the 13 multi-center sites would be qualified physicians and surgeons involved in the treatment of patients with pathological fractures and musculoskeletal oncology. The radiographic evaluations for primary safety endpoints (device fracture, migrations, mal-alignment, or loss of reduction or fixation) would have been performed by qualified radiologists or orthopedic surgeons.

4. Adjudication Method for the Test Set

For the clinical study, the adjudication method involved:

• Pain and Function: Patient-reported outcome measures (PROMs) like VAS and MSTS scores were collected directly from subjects.
• Safety Endpoints: Assessment of major device-related adverse events, additional surgical interventions, and radiographic evaluations. The "radiographic evaluations" likely involved clinical investigators reviewing images, but a multi-reader adjudication process (e.g., 2+1 or 3+1) is not explicitly described for these. Adverse events would typically be classified and confirmed by the study investigators and potentially reviewed by an independent Clinical Events Committee (CEC), but this is not detailed in the provided text.

For non-clinical bench testing, the "ground truth" was established by comparing test results against predefined engineering and performance standards/criteria (e.g., ISO, ASTM, internal specifications).

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
• This device is an implantable medical device for fracture stabilization, not an AI diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply to this submission.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-loop Performance) Was Done

• No, a standalone (algorithm only) performance study was not done.
• Again, this is a physical medical device, not a software algorithm or AI. Its performance is demonstrated through bench testing (mechanical properties, curing, etc.) and clinical outcomes in patients.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the clinical study of the IlluminOss PBSS, the ground truth was primarily based on:

• Patient-Reported Outcomes (PROs): VAS pain scores, MSTS functional scores, QLQ-BM22 pain and functional interference, pain at palpation, analgesic use, and ability to perform Activities of Daily Living (ADLs).
• Clinical Outcomes/Safety Data: Incidence of adverse events, need for additional surgical interventions, and radiographic evidence of device fracture, migration, mal-alignment, or loss of reduction or fixation.
• Comparison to Historical Controls: The efficacy endpoints used historical literature as a "reference" for non-inferiority comparisons, which can be interpreted as a form of expert consensus or aggregated outcomes data from prior studies.

For non-clinical bench studies, the ground truth was based on:

• Established Test Standards: Adherence to ISO, ASTM, and other recognized engineering standards and internal specifications (e.g., Shore D Hardness, burst pressure, tensile strength limits, EMC compliance).
• Animal Studies: Observed biological reactions (e.g., tissue necrosis due to exothermic reaction) and successful implantation/removal in cadaveric models.

8. The Sample Size for the Training Set

The concept of a "training set" primarily applies to machine learning algorithms.

• For the clinical study, a training set in the AI sense is not applicable as it was a traditional clinical trial.
• For bench testing, there isn't a "training set" in the machine learning sense. Instead, product development and iterative design likely involved numerous prototypes and tests to optimize the device's performance before formal validation testing. The "Timer Key" development for cure times could be seen as an optimization based on prior experimentation for different balloon sizes.

9. How the Ground Truth for the Training Set Was Established

As noted above, a "training set" as understood in AI/ML is not directly applicable here. The "ground truth" for the development and optimization of the device (leading to its final design that then underwent formal testing) would have been established through a combination of:

• Engineering Principles and Materials Science: Basic understanding of polymer chemistry, mechanics, and biocompatibility.
• Pre-clinical Research and Development: Iterative design, prototyping, and testing in laboratory settings to meet desired performance characteristics, often guided by
  standards and clinical needs.
• Biocompatibility Testing: According to ISO 10993 series for an implanted device.
• Previous Experience/Literature: The very existence of similar legally marketed devices and the EU Registry study provided context and informed the design and expected performance, forming a basis for "what good looks like."

Ask a specific question about this device