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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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(29 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, 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:
-
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. -
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. -
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. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document. -
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. -
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. -
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. -
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. -
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
(30 days)
The IlluminOss Photodynamic Bone Stabilization System is in skeletally mature patients in the treatment of traumatic, fragility, pathological, and impending pathological fractures of the humerus, radius, pelvis, 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 these anatomic sites.
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, and anterior ring of the pelvic. The purpose of this Special 510(k) is to expand the indications for use to include the fibula.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the IlluminOss Photodynamic Bone Stabilization System.
It includes:
- Device Name and Regulation Information: IlluminOss Photodynamic Bone Stabilization System, regulated as an in vivo cured intramedullary fixation rod (21 CFR 888.3023).
- Clearance Date and Reference Number: August 13, 2020, K201961.
- Indications for Use: Treatment of traumatic, fragility, pathological, and impending pathological fractures of humerus, radius, pelvis, fibula, metacarpals, metatarsals, and phalanges, and as supplemental fixation.
- Predicate Device Information: The device is deemed substantially equivalent to the Synthes Elastic Intramedullary Nail System (K081452). A previously cleared IlluminOss system (K200295) is also referenced for expanding indications to the fibula.
- Device Description: Details on how the system works (inflatable PET balloon, photodynamic monomer, light curing).
- Performance Testing Summary (brief): States that testing demonstrates "sufficient strength upon curing for the fibular indications."
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details on sample size, data provenance, number/qualifications of experts, or adjudication methods for any test set or ground truth establishment.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Specific types of ground truth used (e.g., pathology, outcomes data).
- Training set size or how its ground truth was established.
Therefore, I cannot fulfill your request for this specific information based on the provided text.
Ask a specific question about this device
(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.
Ask a specific question about this device
(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.
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(115 days)
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