The use of the ROI Fusion Rods and Plates are generally indicated for the reduction and fixation of fractures appropriate for the size of the devices. They are indicated for use in the internal fixation of fractures, boney fusion, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies).

Device Description

The ROI Rods and Plates are utilized similar to screws in treating fractures, non-unions and fusions. The rods come in a variety of diameters and lengths. The plates are available in various widths, lengths and thicknesses. Both the rods and plates have fins to aid in resisting rotation or movement. The rods and plates are made from titanium alloy ((T1-6A1-4V ELI, ASTM F136 or Ti 3Al2.5V, ASTM B348 Grade 9) or CP titanium. The bodies are plasma spray coated with commercially pure titanium

AI/ML Overview

This 510(k) submission (K051309) for the ROI Fusion Rods & Plates does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in submissions for AI/ML-driven medical devices.

Instead, this submission follows the traditional pathway for a medical device by demonstrating substantial equivalence to legally marketed predicate devices. The "study" here refers to nonclinical tests performed to show that the new device is functionally, materially, and in terms of indications similar to existing devices.

Therefore, the requested information elements related to AI/ML device performance (like sample size, experts, adjudication, MRMC studies, standalone performance, and training set details) are not applicable to this document.

Here's an attempt to answer the questions based on the provided text, while highlighting the non-applicability of certain AI/ML-centric questions:

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

Acceptance Criteria (Implied)	Reported Device Performance (Nonclinical Tests)
Material composition equivalent to predicate devices	Made from titanium alloy (T1-6A1-4V ELI, ASTM F136 or Ti 3Al2.5V, ASTM B348 Grade 9) or CP titanium, with plasma spray coating of commercially pure titanium. This is similar to materials used in predicate devices.
Functional similarity to predicate devices	Utilized similar to screws in treating fractures, non-unions, and fusions. Rods and plates have fins to aid in resisting rotation or movement, similar to predicate functions.
Indicated uses align with predicate devices	Indicated for the reduction and fixation of fractures, internal fixation of fractures, boney fusion, non-unions, and reconstructive procedures where reduction and fixation of bone fragments are required (e.g., osteotomies). These indications are in line with predicate devices.

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 applicable as the submission relies on demonstrating substantial equivalence through nonclinical testing (material, functional, and indications comparison), not through clinical trial data or performance testing on a specific "test set" in the context of AI/ML.

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. The "ground truth" for this type of device is established through engineering and material standards, and comparison to existing, legally marketed devices. It does not involve expert image interpretation or diagnostic ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are relevant for clinical studies, especially those involving expert review of diagnostic or prognostic outcomes, which is not the case here.

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. MRMC studies are specific to evaluating AI-assisted diagnostic or interpretative devices, which the ROI Fusion Rods & Plates are not.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This device is a bone fixation implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is based on established engineering principles, material standards (e.g., ASTM F136, ASTM B348 Grade 9), and the proven safety and effectiveness of the legally marketed predicate devices. The substantial equivalence argument relies on showing that the new device conforms to these established standards and practices.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

This information is not applicable. There is no "training set" as this is not an AI/ML device.

Summary

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JUI I 1 2005

K051309 f

510(k) Summary ROI Fusion Rods & Plates

Date	May 16, 2005
Submitter	Reiley Orthopaedics, Inc.PO Box 129,Ross, CA 80301
Contact person	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199
Trade Name	ROI Fusion Rods & Plates
Common name	Bone screwBone plate
Classification name	Smooth or threaded metallic bone fixation fastenerClass II per 21 CFR section 888.3040Single/multiple component metallic bone fixation appliances andaccessoriesClass II per 21 CFR section 888.3030
Product Code	HWCHRS
Equivalent Device	Osteomed Cannulated Screw System (K010783)Acumed Acutrak screws (K930834/K944330

Device Description

Intended Use

Summary Nonclinical Tests

The ROI Rods and Plates are similar in function, material and indications to the Osteomed Cannulated Screw System (K010783) and Acumed Acutrak screws (K930834/K944330).

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JUL 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Riley Orthopaedics Incorporated C/o Mr. J.D. Webb Orthomedix Group Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K051309 Trade/Device Name: ROI Fusion Rods and Plates Regulation Number: 21 CFR 888.3030, 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HWC Dated: May 16, 2005 Received: May 19, 2005

Dear Mr. Webb:

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 (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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. J.D. Webb

This letter will allow you to begin marketing your device as described in your Section 510(k) rmovices notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

iriam C. Provost

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ROI Fusion Rods and Plates

Indications for Use:

The use of the ROI Fusion Rods and Plates are generally indicated for the reduction and The use of the rees appropriate for the size of the devices. They are indicated for use in the internal fixation of fractures, boney fusion, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies).

Prescription Use _ X_ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost
(Division Sign 23)

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.