Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a robotic surgical system for hip arthroplasty that uses diagnostic images for planning and provides orientation during surgery. It focuses on precise bone preparation as an alternative to manual techniques. There is no mention of AI or ML in the intended use, device description, or performance studies. The system appears to be based on pre-programmed instructions derived from the diagnostic images and surgical plan, rather than adaptive or learning algorithms.

Therapeutic

Yes
The device is described as an "implementation tool" and "robotic surgical tool" that "precisely implements the presurgical software plan" and makes "precision bone preparation possible before and during THA surgical procedures." These functions directly contribute to the treatment of a patient's condition, specifically in total hip arthroplasty (THA).

Diagnostic

No

The device description clearly states it is a "three-dimensional, graphical, preoperative planner and implementation tool" and an "alternative to manual template planning, broaching, and reaming techniques for the preparation of bone". While it uses diagnostic images for planning, its primary function is not to diagnose conditions but to assist in surgical procedures.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of both the ORTHODOC® Preoperative Planning Workstation (software) and ROBODOC®, a robotic system composed of an electromechanical arm, electronics control cabinet, computer, display monitor, and miscellaneous accessories. This indicates significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Device Function: The DigiMatch™ ROBODOC®/ORTHODOC® Encore Surgical System is a surgical planning and implementation tool. It uses diagnostic images (CT scans) to plan a surgical procedure and then a robotic arm to execute that plan on the patient's bone during surgery.
No Specimen Analysis: The device does not analyze any specimens taken from the patient's body. It works directly with the patient's anatomy based on imaging data.

Therefore, its function falls under the category of a surgical planning and execution system, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DigiMatch™ ROBODOC®/ORTHODOC® Encore Surgical System is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.

The preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).

The DigiMatch™ ROBODOC®/ORTHODOC® Encore Surgical System is indicated for orthopedic procedures in which the broaching/reaming in primary total hip arthroplasty (THA) may be considered to be safe and effective and where references to rigid anatomical structures may be made.

Product codes

OJP, HAW

Device Description

The DigiMatch™ ORTHODOC®/ROBODOC® Encore System is a three-dimensional, graphical, preoperative planner and implementation tool for treatment of patients who require a total hip arthroplasty (THA) procedure. This device is intended as an alternative to manual template planning, broaching, and reaming techniques for the preparation of bone for patients requiring a THA procedure. The system consists of the ORTHODOC® Preoperative Planning Workstation and ROBODOC® , a robotic system composed of an electromechanical arm, electronics control cabinet, computer, display monitor, and miscellaneous accessories such as cutters, drapes, irrigation sets, probes, and markers. ORTHODOC® and ROBODOC® when used according to the instructions for use, make precision bone preparation possible before and during THA surgical procedures ..

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT Scan

Anatomical Site

Femoral canal (for primary total hip arthroplasty)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physician / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The DigiMatch™ ORTHODOC®/ROBODOC® Encore Surgical System has been evaluated with non-clinical performance testing for the following modifications and or improvements:

ORTHODOC® host computer and operating system .
ORTHODOC® addition of CT file complete/size check ●
ORTHODOC®/ROBODOC® elimination of pin patient/robot registration .
ORTHODOC®/ROBODOC® THA/TKA (non-USA only) factory setting .
·ROBODOC® Two-Pin Registration Recovery .
Osteotomy demarcation .
ROBODOC® electromechanical arm .
ORTHODOC®/ROBODOC® error message colors .
. ROBODOC® bearing sleeve
. ROBODOC® Smart Bone Motion Monitor (BMM)
ROBODOC® Percutaneous Probe .
Change of Irrigation Set Length and Manufacturer .

Bench and simulated use tests included functional software testing for the ORTHODOC® Surgical Planning Workstation hardware, software, and user interface, and hardware, functional software, user interface, instrument/tool and sterile disposable accessory testing and simulated clinical use of new and changed instrument/tools for the DigiMatch™ ORTHODOC®/ROBODOC® Encore Surgical System.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K072629

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).

Summary

0

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Curexo Technology Corp. Submitter Name: 47320 Mission Falls Court Fremont, CA 94539 Submitter Address : Glen Emelock Contact Person: Phone Number: (510) 249-2300 Fax Number: (510) 249-2396 Date Prepared: January, 2014 DigiMatch™ ORTHODOC®/ROBODOC® Encore Surgical System Device Trade Name: Stereotaxic Instrument Device Common Name: Orthopedic Computer Controlled Surgical System, OJP, HAW Classification Name: Regulation Number: 21 CFR 882.4560 DigiMatch™ ROBODOC® Surgical System, K072629 Predicate device: Not previously marketed in the USA Reason for submission:

Device Description:

The DigiMatch™ ORTHODOC®/ROBODOC® Encore System is a three-dimensional, graphical, preoperative planner and implementation tool for treatment of patients who require a total hip arthroplasty (THA) procedure. This device is intended as an alternative to manual template planning, broaching, and reaming techniques for the preparation of bone for patients requiring a THA procedure. The system consists of the ORTHODOC® Preoperative Planning Workstation and ROBODOC® , a robotic system composed of an electromechanical arm, electronics control cabinet, computer, display monitor, and miscellaneous accessories such as cutters, drapes, irrigation sets, probes, and markers. ORTHODOC® and ROBODOC® when used according to the instructions for use, make precision bone preparation possible before and during THA surgical procedures ..

Intended Use:

The DigiMatch™ ROBODOC®/ORTHODOC® Encore Surgical System is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide onentation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.

The preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).

The DigiMatch™ ROBODC®/ORTHODOO® Encore Surgical System is indicated for orthopedic procedures in which the broaching/reaming in primary total hip arthroplasty (THA) may be considered to be safe and effective and where references to rigid anatomical structures may be made.

Predicate Device:

The DigiMatch™ ORTHODOC®/ROBODOC® Encore Surgical System is substantially equivalent to the DigiMatch™ ROBODOC® Surgical System, K072629.

Comparison of Technological Characteristics and Principles of Operation:

The DigiMatch™ ORTHODOC®IROBODOC® Encore Surgical System is similar to the legally marketed device listed oreviously in that they share intended use and indications, technological characteristics, principles of operation and performance data as the predicate device.

Table 1 provides a comparison of technological characteristics and principles of operation between the DigiMatch™ ORTHODOC®/ROBODOC® Encore Surgical System and its predicate device.

1

| Device | Patient Image Data | Presurgical
Plan | Surgical
Plan Data | Machine
Instructions | Patient/Robot
Registration
Requirement | Robot
Electromechanical
Arm |
|-------------------------------------------------------------------|--------------------|---------------------|-----------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| DigiMatch™
ROBODOC®
Surgical System | Yes, CT Scan | Yes,
Presurgery | Yes, high
level
operative
plan | Yes, Robotic
Arm driven
by validated
control
software and
hardware | Yes, point to
surface
registration | Yes, robot with
single
electromechanical
arm and end
effector implement
control file
instructions |
| DigiMatch™
ROBODOC®/
ORTHODOC®
Encore Surgical
System | Yes, CT Scan | Yes,
Presurgery | Yes, high
level
operative
plan | Yes, Robotic
Arm driven
by validated
control
software and
hardware | Yes, point to
surface
registration | Yes, robot with
single
electromechanical
arm and end
effector implement
control file
instructions |

Table 1: Comparison of Technological Characteristics and Principles of Operation

Any minor differences between the DigiMatch™ ORTHODOC®/ROBODOC® Encore Surgical System and its predicate device raise no new questions of safety or effectiveness nor change the device's intended therapeutic effect in comparison to its predicate.

Performance Data:

The DigiMatch™ ORTHODOC®/ROBODOC® Encore Surgical System has been evaluated with non-clinical performance testing for the following modifications and or improvements:

ORTHODOC® host computer and operating system .
ORTHODOC® addition of CT file complete/size check ●
ORTHODOC®/ROBODOC® elimination of pin patient/robot registration .
ORTHODOC®/ROBODOC® THA/TKA (non-USA only) factory setting .
·ROBODOC® Two-Pin Registration Recovery .
Osteotomy demarcation .
ROBODOC® electromechanical arm .
ORTHODOC®/ROBODOC® error message colors .
. ROBODOC® bearing sleeve
. ROBODOC® Smart Bone Motion Monitor (BMM)
ROBODOC® Percutaneous Probe .
Change of Irrigation Set Length and Manufacturer .

Bench and simulated use tests included functional software testing for the ORTHODOC® Surgical Planning Workstation hardware, software, and user interface, and hardware, functional software, user interface, instrument/tool and sterile disposable accessory testing and simulated clinical use of new and changed instrument/tools for the DigiMatch™ ORTHODOC®/ROBODOC® Encore Surgical System.

Conclusion

In conclusion, based on the intended use, indications for use, technological characteristics, and performance data, the DigMatch™ ORTHODOC®/ROBODOC® Encore Surgical System is substantially equivalent (SE) to the DigiMatch™ ROBODOC® Surgical System, K072629 predicate device.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 27, 2014

Curexo Technology Corporation % Glen Emelock The CRO Group, Incorporated 32 Harrison Street Melrose, Massachusetts 02176

Re: K140038

Trade/Device Name: DigiMatch™ ORTHODOC® ROBODOC® Encore Surgical System Regulation Number: 21 CFR 882.4560 Regulatory Class: Class II Product Code: OJP, HAW Dated: February 25, 2014 Received: February 26, 2014

Dear Mr. Emelock:

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. 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.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

3

Page 2 - Mr. Glen Emelock

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours,

Lori A. Wiggins

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

Indications for Use

510(k) Number: K140038

Device Name: DigiMatch™ ORTHODOC® / ROBODOC® Encore Surgical System

Indications For Use:

The DigiMatch™ ROBODOC®/ORTHODOC® Encore Surgical System is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.

The preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).

The DigiMatch™ ROBODOC®/ORTHODOC® Encore Surgical System is indicated for orthopedic procedures in which the broaching/reaming in primary total hip arthroplasty (THA) may be considered to be safe and effective and where references to rigid anatomical structures may be made.

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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