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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the DigiMatch™ ORTHODOC®/ROBODOC® Encore Surgical System, a robotic system for Total Hip Arthroplasty (THA). This submission focuses on demonstrating substantial equivalence to a predicate device (DigiMatch™ ROBODOC® Surgical System, K072629) rather than establishing novel performance metrics or conducting a new clinical study. Therefore, some of the requested information, such as detailed quantitative acceptance criteria for a new device's performance, a standalone algorithm study, or a multi-reader, multi-case study, is not explicitly provided in the summary.

However, based on the information available, here's a breakdown of the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on demonstrating substantial equivalence to the predicate device, meaning the new device performs at least as well as, and presents no new safety or effectiveness concerns compared to, the predicate. The "performance" is implicitly that the modified features function as intended and do not degrade the overall system's safety or effectiveness.

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance (Implied)
Technological Characteristics & Principles of Operation	- Similar intended use and indications. - Similar technological characteristics (e.g., CT scan input, presurgical planning, robotic arm driven by validated software, point-to-surface registration).	- The table clearly shows identical technological characteristics and principles of operation between the new device and the predicate. - "Any minor differences...raise no new questions of safety or effectiveness nor change the device's intended therapeutic effect."
Performance Data	- Modifications and improvements do not adversely affect safety or effectiveness. - Functional verification of software and hardware. - Simulated clinical use performs as expected.	- Non-clinical performance testing for specific modifications (e.g., ORTHODOC® host computer, CT file checks, elimination of pin patient/robot registration, ROBODOC® electromechanical arm, Smart Bone Motion Monitor, etc.). - Bench and simulated use tests conducted, including functional software testing and simulated clinical use.
Safety and Effectiveness	- No new questions of safety or effectiveness.	- Implicitly confirmed by the FDA's substantial equivalence determination.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the traditional sense of a patient-based clinical study for performance evaluation against a gold standard for a diagnostic or AI device. Instead, the testing described is primarily non-clinical performance testing and simulated use tests.

Sample Size: Not applicable in terms of patient numbers for a test set. The "samples" would be the modified components, software modules, and system configurations that underwent bench and simulated use tests. The number of such items or test runs is not specified.
Data Provenance: Not applicable in terms of country of origin or retrospective/prospective for patient data. The testing was laboratory-based, focusing on the functionality of the device's modifications.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the summary. For non-clinical, bench, and simulated use testing, "ground truth" would likely be defined by engineering specifications, software design documents, and expected performance under controlled conditions, rather than expert-established ground truth from medical data.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable for non-clinical and simulated use testing as described. Adjudication methods (like 2+1 or 3+1) are typically reserved for clinical studies where multiple human readers assess medical images or findings to establish a consensus ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this summary. The submission is focused on demonstrating substantial equivalence of a modified surgical robotic system, not on assessing the improvement in human reader performance with or without AI assistance.

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

The device is a robotic surgical system that works with human intervention (under the direction of the surgeon). While the ORTHODOC® planning software and ROBODOC® robotic arm have algorithms, the performance evaluation described is for the integrated system, including its hardware, software, and simulated use. Therefore, a standalone "algorithm only" performance study in the context of, for example, a diagnostic AI device is not applicable or reported here. The "algorithm" here controls a physical robot and forms part of a surgical aid, not an independent diagnostic tool.

7. The Type of Ground Truth Used

For the non-clinical and simulated use testing, the "ground truth" would be based on:

Engineering specifications and design requirements: Ensuring that modified components meet their intended design outputs.
Functional correctness: Verifying that software and hardware perform as programmed and expected during various operational scenarios simulated in the lab.
Expected outcomes of simulated clinical scenarios: Ensuring the robotic system accurately plans and executes simulated bone preparations within specified tolerances.

This is distinct from "expert consensus," "pathology," or "outcomes data" which are typically used for diagnostic or predictive AI devices involving patient data.

8. The Sample Size for the Training Set

This information is not provided. The document describes modifications to an existing system, rather than the development of a new AI model that requires a "training set" in the machine learning sense. The "training" for such a system would typically refer to the extensive development and validation cycles of the underlying control software and robotic components, not a patient data training set.

9. How the Ground Truth for the Training Set was Established

As no "training set" in the machine learning context is mentioned, the method for establishing its ground truth is not applicable or discussed. The "ground truth" for the development of the surgical system (both the predicate and the modified version) would be established through principles of mechanical engineering, software engineering, and surgical accuracy requirements, validated through extensive bench testing and cadaver studies (though not explicitly detailed in this summary).

Summary

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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:

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 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.

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Device	Patient Image Data	PresurgicalPlan	SurgicalPlan Data	MachineInstructions	Patient/RobotRegistrationRequirement	RobotElectromechanicalArm
DigiMatch™ROBODOC®Surgical System	Yes, CT Scan	Yes,Presurgery	Yes, highleveloperativeplan	Yes, RoboticArm drivenby validatedcontrolsoftware andhardware	Yes, point tosurfaceregistration	Yes, robot withsingleelectromechanicalarm and endeffector implementcontrol fileinstructions
DigiMatch™ROBODOC®/ORTHODOC®Encore SurgicalSystem	Yes, CT Scan	Yes,Presurgery	Yes, highleveloperativeplan	Yes, RoboticArm drivenby validatedcontrolsoftware andhardware	Yes, point tosurfaceregistration	Yes, robot withsingleelectromechanicalarm and endeffector implementcontrol fileinstructions

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.

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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

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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

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Indications for Use

510(k) Number: K140038

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

Indications For Use:

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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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).