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.

Device Description

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.

AI/ML Overview

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.

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.

Summary

{0}------------------------------------------------

January 19, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

IlluminOss Medical, Inc. Robert Rabiner Chief Technical Officer 993 Waterman Avenue East Providence, Rhode Island 02914

Re: K233436

Trade/Device Name: IlluminOss Photodynamic Bone Stabilization System Regulation Number: 21 CFR 888.3023 Regulation Name: In vivo cured intramedullary fixation rod Regulatory Class: Class II Product Code: QAD Dated: December 20, 2023 Received: December 20, 2023

Dear Robert Rabiner:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

{1}------------------------------------------------

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv. Joseph P. Russell -S

Digitally signed by Joseph P. Russell -S Date: 2024.01.19 14:42:04 -05'00'

for: Farzana Sharmin, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K233436

Device Name

IlluminOss Photodynamic Bone Stabilization System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Manufacturer:	IlluminOss Medical, Inc.993 Waterman AvenueEast Providence, RI 02914Phone: 401.714.0008
Contact:	Mr. Robert RabinerChief Technical OfficerIlluminOss Medical, Inc.993 Waterman AvenueEast Providence, RI 02914Phone: 401.714.0008 x207rrabiner@illuminoss.com
Date Prepared:	October 12, 2023
Device Trade Name:Classification:Class:Product Code:	IlluminOss Photodynamic Bone Stabilization System21 CFR 888.3023. In vivo cured intramedullary fixation rodClass IIQAD (Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, LightActivated)

Predicate Device:

K202887 - IlluminOss Photodynamic Bone Stabilization System.

Indications for Use:

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, 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 System may be used in the femur and tibia to provide supplemental fixation to an anatomically appropriate FDA-cleared fracture fixation system.

Device Description:

Technological Similarities/Differences:

The subject device introduces modifications to the light system and packaging configurations.

{4}------------------------------------------------

K233436 Page 2 of 2

The modified light system includes a Lightsource with:

. A High Power (HP) LED light source to cure the implant; This replaces a metal halide bulb.
. Updated Light Fiber interface to attach the fiber directly to the LED Lightsource; This replaces an intermediary liquid lightguide that connected the Light Fiber to the Lightbox.
. A Radio Frequency Identification (RFID) system to set the light exposure time; This replaces a mechanically inserted timer key card.
. An LCD display screen as the main user interface; This replaces manual switches, foot pedal, and indicator lights for the use and activation of the system.

The modified packaging includes:

A tray to hold multiple disposable system components in one pouch; This replaces individually ● packaged disposable system components packaged separately using the same packaging materials and sterilization method.
. A tray to hold multiple vials of the photodynamic (light cured) monomer in one pouch; This replaces individually packaged vials using the same packaging materials, sterilization method, and aseptic fill process.

Performance Testing Summary:

The technological characteristics of the subject device that differ from the predicate are supported by verification activities.

The modified light system is supported by:

Functional Testing
. Software Testing
Electrical Safety Testing
Electromagnetic Compatibility Testing
Human Factors and Usability Testing
Shipping / Environmental Storage and Testing
. Implant Performance Testing

The modified packaging is supported by:

Sterility Testing
Packaging Performance Testing ●
Shipping Testing ●

Substantial Equivalence:

The subject device and predicate device maintain the same intended use and differ only in technological characteristics. The light system and packaging configurations have been modified but perform similarly to the predicate while the in vivo cured implant is unchanged. The technological differences are all supported by verification activities and demonstrate that the device functions as intended. These differences in technological characteristics do not raise different questions of safety and effectiveness. Thus, it can be determined that the subject device is substantially equivalent to the predicate.

Regulation Number and Section

§ 888.3023 In vivo cured intramedullary fixation rod.

(a)
Identification. An in vivo cured intramedullary fixation rod is a prescription implanted device consisting of a balloon that is inserted into the medullary canal of long bones for the fixation of fractures. The balloon is infused with, and completely encapsulates, a liquid monomer that is exposed to a curing agent which polymerizes the monomer within the balloon creating a hardened rigid structure.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Mechanical testing must be conducted on the final device to assess burst, abrasion, bending, and torsion in static and dynamic conditions.
(ii) Mechanical testing must demonstrate the integrity of the balloon including testing for leaks, ruptures, and release of cured/uncured material.
(iii) Performance testing must demonstrate that the device can be inserted and removed.
(iv) Performance testing must demonstrate the ability, in the event of a leak, to remove the uncured material from its in vivo location.
(v) Performance testing must demonstrate the reliability and accuracy of the curing method used.
(vi) Thermal safety testing must be conducted to evaluate the temperature rise during curing.
(2) Electrical safety, electromagnetic compatibility (EMC) testing, and electromagnetic interference (EMI) testing must be conducted for all electrical components.
(3) All patient-contacting components must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility and pyrogenicity of patient contacting components of the device that are provided sterile.
(5) Performance data must validate the reprocessing instructions for any reusable components or instruments.
(6) Performance data must support the shelf life of the system by demonstrating continued sterility, package integrity, and system functionality over the established shelf life.
(7) Technological characterization of the device must include materials, curing agents, and a description of the operating principles of the device, including the delivery system and devices which initiate the curing process.
(8) Labeling must include the following:
(i) A detailed summary of the device technical parameters.
(ii) Information describing all materials of the device.
(iii) Information describing how to perform the procedure and use the device, including the delivery system and devices which initiate the curing process, as well as how to remove the device and any uncured materials.
(iv) A shelf life.
(v) Validated methods and instructions for reprocessing any reusable components or instruments.