R&R EXTERNAL FIXATION SYSTEM by R&R MEDICAL, INC.

The R&R Ring Fixator and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction or bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The R&R Ring Fixator is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.

The R&R Unilateral Fixator is indicated for stabilizing various fractures including open and/or comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metacarpal, metatarsal, ulnar, and calcaneal bones.

Device Description

The R&R Ring Fixator assembly consists of three basic types of elements: 1) bone anchorage elements, 2) bridge elements, and 3) connection elements. The Ring Fixator design allows freedom of pin placement, ease of assembly and stable fixation of bone fragments with the possibility of axial loading of the extremity and immediate range of motion of all adjacent joints.

Bone anchorage elements include pins and wires. Bridge elements include rings or arches and extensions. Connection elements include struts, nuts and bolts, wire fixation bolts and pin clamps.

The R&R Unilateral Mini Fixator is a stable solution for fractures and for lengthening of small bones. The system allows precise, controlled compression / distraction and early weight bearing, The articulating pin clamps allow adjustment around three axes and linear translation so that it can be used for comminuted intra-articular fractures, joint stiffness, or arthrodesis of the foot or hand. The fixator design enables pins to be located in multi-planar arrangements, allowing the frame to be built around the fractures in the hand or foot.

AI/ML Overview

The provided text is a 510(k) summary for the R&R External Fixation System, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria and device performance results as would be typical for a software or AI/ML device.

Therefore, many of the requested categories for describing acceptance criteria and study details are not directly applicable to this type of regulatory submission. The 510(k) process for this device relies on demonstrating that the new device has "the same intended use as legally marketed predicate device(s) and the same technological characteristics as the predicate device(s), OR the same intended use as legally marketed predicate device(s) and different technological characteristics than the predicate device(s) and information submitted by the 510(k) submitter does not raise new questions of safety and effectiveness." It is not about meeting specific performance metrics from a controlled study with predefined acceptance criteria in the manner of an AI/ML device.

Here's an attempt to address the request based on the available information, noting where the information is absent due to the nature of the document:

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

This information is not present in the provided 510(k) summary. The summary focuses on comparing the new device's features and intended use to predicate devices, not on presenting specific performance data against predefined acceptance criteria for a study.

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 present. The 510(k) summary does not describe a clinical study with a test set of data.

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 present. No such ground truth establishment process for a test set is described.

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

This information is not present. No adjudication method for a test set is described.

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 present. The R&R External Fixation System is a physical medical device (an external fixator), not an AI/ML device, so an MRMC study related to "human readers improving with AI" is not applicable.

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

This information is not present. As it's a physical device, this concept is not applicable.

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

This information is not present. No ground truth for a study is described. Regulatory clearance for this type of device often relies on mechanical testing, biocompatibility testing, and comparison to predicate devices, rather than clinical studies requiring "ground truth" as might be understood for diagnostic AI.

8. The sample size for the training set

This information is not present. No training set is described as this is not an AI/ML device.

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

This information is not present. No training set or associated ground truth establishment is described.

Summary of Relevant Information from the K052005 510(k) Summary:

While the detailed study information you're asking for isn't in this document, here's what the 510(k) does provide regarding the device and its regulatory clearance:

Device: R&R External Fixation System (Ring Fixator and Unilateral Mini Fixator)
Intended Use: For various orthopedic applications including fracture fixation, limb lengthening, and deformity correction of long bones (tibia, fibula, femur, humerus, radius, ulna) and small bones (metacarpal, metatarsal, ulnar, calcaneal).
Classification: Class II, Product Code KTT (Single/multiple component metallic bone fixation appliances and accessories).
Equivalent Devices (Predicates):
- True/Lok Monolateral/Bilaterial (Applied Osteo Systems, K941048)
- DFS® MiniFixator (EBI, K951357/K970290)
- Small Bone External Fixation System (Acumed)
Regulatory Basis: The FDA reviewed the 510(k) submission and determined the device is "substantially equivalent" to the predicate devices for its stated indications for use. This determination means the device does not raise new questions of safety and effectiveness compared to existing, legally marketed devices.
Approval Date: September 6, 2005.

The 510(k) process for this type of device typically involves demonstrating that the new device has similar design, materials, and mechanical properties to predicates, and that any differences do not raise new safety or effectiveness concerns, often supported by design comparisons, risk analysis, and non-clinical performance testing (e.g., fatigue, static strength, and biocompatibility testing) rather than clinical studies with "test sets" and "ground truths" as described for AI devices.

Summary

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510(k) Summary R&R External Fixator System

K05 2005

Date	July 20, 2005
Submitter	R&R Medical, Inc.2225 Park Place DriveSlatington, Pa. 18080
Contact person	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199
Trade Name	R&R External Fixation System
Common name	External fixation frame
Classification name	Single/multiple component metallic bone fixation appliances and accessoriesClass II per 21 CFR section 888.3030
Product Code	KTT
Equivalent Device	True/Lok Monolateral/Bilaterial (Applied Osteo Systems, K941048)DFS® MiniFixator (EBI, K951357/K970290)Small Bone External Fixation System (Acumed)

Device Description

Bone anchorage elements include pins and wires. Bridge elements include rings or arches and extensions. Connection elements include struts, nuts and bolts, wire fixation bolts and pin clamps.

Intended Use

The R&R Ring Fixator and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal distraction, correction or bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The R&R Ring Fixator is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

Public Health Service

SEP - 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

R & R Medical, Inc. c/o J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K052005 R092009
Trade/Device Name: R & R External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: July 20, 2005 Received: July 25, 2005

Dear J.D. Webb:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Security (10(x) prematic is substantially equivalent (for the indications
referenced above and have determined the device is substantially interstate referenced above and nave determined the arrood at devices marketed in interstate for use stated in the encrosure) to regary manceded provice Amendments, or to commerce prior to May 28, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance was as a proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previous of the Act . The and Cosment Act (Act) that do not require approvine as a controls provisions of the Act. The Act. The You may, merelove, market the devices, subject to the go
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the Fist listed on and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it if your device is classifica (see above) me existing major regulations affecting your device can
may be subject to such additional controls. Existing major regal consected t may be subject to such additional controls. Extrong might of the 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 be found in the Ood of I satist one one --------------------------------------------------------------------------------------------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a buccession a suith other requirements of the Act
that FDA has made a determination that your device complies with other may that FDA has made a dolorimiation administered by other Federal agencies. You must or any Federal statutes and regulations administers. of economics, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sets CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 app 1950 form in the quality systems (QD) regalaren (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - J.D. Webb

This letter will allow you to begin marketing your device as described in your Section 510(k) I his icter wifi anow you to ogin maing of substantial equivalence of your device to a legally prematicated predicated. The PDF interness to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acroliance at (240) 276-0120. Also, please note the regulation entitled, Connact the Office of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small biller general informational 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/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson రార 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: R&R External Fixation System

Indications for Use:

Prescription Use _ X_ Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number_Kos2005

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.