The DigiMatch™ ROBODOC® 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 intra-operative 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 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™ ROBODOC® Surgical System consists of the 510(k)-cleared (K960685) ORTHODOC® Preoperative Planning Workstation (ORTHODOC), and a Robot composed of an electromechanical arm, electronics control cabinet, display monitor and miscellaneous accessories (ROBODOC). The System (ORTHODOC and ROBODOC) is a threedimensional graphical preoperative planner and implementation tool and is indicated as an alternative to template planning and manual broaching for treatment of patients who require primary total hip arthroplasty (THA). The ORTHODOC component of the System allows a surgeon to preoperatively assess a patient's femoral anatomy and state of hip disease, select an optimally sized femoral stem implant from a library of prostheses, and determine where the implant should be positioned within the femur. Then ROBODOC component of the System, under direct control by the surgeon, will precisely implement the preoperative plan.

AI/ML Overview

The provided text describes the DigiMatch™ ROBODOC® Surgical System and its premarket notification (K072629) to the FDA. However, the document does not explicitly state specific quantitative acceptance criteria for performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices and proving safety and efficacy through various studies.

The closest to "acceptance criteria" is the demonstration of "equivalence in Harris Hip Scores" in the clinical trials, implying that the device's performance should be at least as good as manual methods in this regard. The non-clinical studies focus on accuracy and biological response.

Here's a breakdown of the requested information based on the provided text, with caveats where information is not explicitly stated:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Accuracy of Femur Cutting (Non-clinical)	ROBODOC was more accurate than manual broaching in the cadaver study and animal study.
Gaps between Implant and Bone (Non-clinical)	Significant reduction in gaps between the implant and bone with ROBODOC compared to manual broaching in the cadaver study. In the animal study, ROBODOC showed better apposition of implants with cortical and cancellous bone.
Bone Integrity/Damage (Non-clinical)	Animal study revealed many instances of fracture or osteotomy in the control group (manual) compared to none in the ROBODOC group. ROBODOC group had more consistent cortical bone continuity.
Clinical Efficacy (Harris Hip Scores)	Equivalence in Harris Hip Scores was demonstrated between the ROBODOC group and the manual control group in both the First and Second U.S. Trials.
Precise and Reliable Implantation of Preoperative Plan	Demonstrated in the First U.S. Trial through fit and alignment of the femoral implant.
Safety	Confirmed as safe and effective through the First and Second U.S. Trials, as well as non-clinical studies (e.g., absence of fractures/osteotomies in the animal study and histological findings related to bone integrity). The FDA's substantial equivalence determination implies it meets safety benchmarks comparable to predicate devices.
Substantial Equivalence to Predicate Devices	The device was determined to be substantially equivalent to Voyager/Tactile Guidance System - CT (K052851), Frameless Neuromate (K991081), and da Vinci Surgical System (K043153) based on technological characteristics and principles of operation (Table 1) and confirmed by the FDA's 510(k) clearance letter.

Study Details:

Sample Size used for the test set and the data provenance:
- Cadaver Study: Sample size not specified. Data provenance: Not explicitly stated, but typically cadaver studies are conducted in a controlled lab environment.
- Animal Study: 20 male greyhounds. Data provenance: Not explicitly stated, but typically animal studies are conducted in a controlled lab environment.
- First U.S. Trial (Clinical): Sample size for ROBODOC group and manual control group not specified. Data provenance: U.S., prospective clinical trial.
- Second U.S. Trial (Clinical): Sample size for ROBODOC group and manual control group not specified. Data provenance: U.S., prospective clinical trial (IDE # G000071).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number of experts or their qualifications for establishing ground truth for any of the studies (cadaver, animal, or clinical). For clinical trials, "Harris Hip Scores" are typically evaluated by orthopedic surgeons or trained clinicians. Histological examinations would involve pathologists.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not specify any adjudication methods (e.g., 2+1, 3+1 consensus) for establishing ground truth in any of the studies.
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:
No, an MRMC study was NOT done. The studies described compare the robotic system (ROBODOC) to manual techniques for hip arthroplasty, not human readers with or without AI assistance in an imaging interpretation context. The device is a surgical system that implements a plan, not an AI diagnostic tool that assists human interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, in essence, the "ROBODOC" component operates in a standalone manner in terms of implementing the presurgical plan. The document states: "The ROBODOC component of the System, under direct control by the surgeon, will precisely implement the preoperative plan." While under "direct control by the surgeon," the precision and execution of the plan by the robot itself is an algorithmic function. The performance of the robotic cutting was evaluated against manual cutting in cadaver and animal studies, and clinicallly, its implementation of the plan led to equivalent Harris Hip Scores.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cadaver Study: "Accuracy of cutting the femur" and "measurement of the gap between the bone and implant." Implies objective measurements.
- Animal Study: "Accuracy of cutting the femur," "histological examinations of the cavity/implant interface" (pathology), and observation of "fracture or osteotomy."
- Clinical Studies (First & Second U.S. Trials): "Fit and alignment of the femoral implant" (likely based on imaging and surgical assessment) and "Harris Hip Scores" (patient-reported outcomes and clinical assessment of hip function).
The sample size for the training set:
The document does not specify any separate "training set" for the DigiMatch™ ROBODOC® Surgical System. The device's "training" and validation would have occurred during its development and prior testing, which is not detailed here. The studies mentioned (cadaver, animal, clinical) serve as validation/test sets to demonstrate safety and effectiveness for regulatory approval.
How the ground truth for the training set was established:
As no specific "training set" is described for the device's algorithmic development, this information is not available in the provided text. The ORTHODOC component is described as being "510(k)-cleared (K960685)," indicating prior regulatory review, but details of its development and ground truth establishment are not in this K072629 summary.

Summary

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Summary of Safety and Effectiveness K072629

AUG - 6 2008

Submitter:	Integrated Surgical Systems, Inc.
Address:	1433 N. Market Blvd., #1, Sacramento, CA 95834 USA
Phone Number:	916-285-9943
Fax Number:	916-575-7918
Contact Person:	Russ Hibbert
Date Submitted:	September 7, 2007
Trade Name:	DigiMatch™ ROBODOC® Surgical System
Common Name:	Stereotaxic Instrument
Device Classification;	Class II
Regulation Number:	21 CFR 882.4560

Substantial Equivalence Claim

The DigiMatch™ ROBODOC® Surgical System is substantially equivalent to the Voyager/Tactile Guidance System -- CT (K052851), the Frameless Neuromate (K991081) and the da Vinci Surgical System (K043153).

Device Description

Indications for Use / Intended Use Statement

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Summary of Safety and Effectiveness K072629

Comparison of Technological Characteristics and Principles of Operation

Table 1 provides a comparison of technological characteristics and principles of operation between the DigiMatch™ ROBODOC® Surgical System and its predicate devices, the Voyager/Tactile Guidance System - CT, the Frameless Neuromate and the da Vinci Surgical System.

Comparison of Technological Characteristics and Principles of Operation Table 1

	Patient	Pre-	Surgical Plan	Machine	Patient/Robot	Robot
	Image	Surgical	Data	Instructions	Registration	Electromechanic
	Data	Plan			Requirement	al Arm(s)
DigiMatch™ROBODOC®Surgical System	YesCT Scan	Yespre-surgery	Yeshigh leveloperative plan	Yesrobotic armsdriven byvalidated controlsoftware andhardware	Yespoint to surfaceregistration	YesRobot with singleelectromechanicalarm and endeffector implementcontrol fileinstructions
VoyagerTactile GuidanceSystem - CT(K052851)	YesCT Scan	Yespre-surgery	Yeshigh leveloperative plan	Yesrobotic armsdriven byvalidated controlsoftware andhardware	Yessurface tosurfaceregistration	YesRobot with singleelectromechanicalarm and endeffector implementcontrol fileinstructions
FramelessNeuromate(K991081)	YesCT Scan	Yespre-surgery	Yeshigh leveloperative plan	Yesrobotic armsdriven byvalidated controlsoftware andhardware	Yesfiducial markerregistration	YesRobot with singleelectromechanicalarm and endeffector implementcontrol fileinstructions
da Vinci®Surgical System(K043153)	Novisual image	Nointra-surgery	Nocontrol filedeveloped inreal time duringsurgery	Yesrobotic armsdriven byvalidated controlsoftware andhardware	Yesvisualregistration	YesRobot withmultipleelectromechanicalarms and endeffector implementcontrol fileinstructions

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Summary of Safety and Effectiveness K072629

Summary of Performance Testing

ISS has completed bench, animal, cadaver and clinical testing that assess the safety and efficacy of the ROBODOC System.

Nonclinical Studies

Nonclinical cadaver and animal studies provide an accurate means of determining cavity accuracy and placement. The value of such studies is that they allow a measurement of the gap between the bone and implant. They also permit histological examinations of the cavity/implant interface, which has value in determining whether the implant apposition within the cavity is sufficiently narrow.

Cadaver Study

The cadaver study compared the accuracy of cutting the femur with the ROBODOC versus manual broaching. The results showed that the ROBODOC was more accurate than manual broaching and led to significantly reduced gaps between the implant and bone.

Animal Study

The animal study, involving 20 male greyhounds, also supports the conclusion that the ROBODOC is more accurate than manual broaching in cutting the femur. Histological examination revealed many instances of fracture or osteotomy in the control group, compared to none in the ROBODOC group. In addition, histological examination revealed that the ROBODOC group had more consistent cortical bone continuity, better apposition of implants with cortical and cancellous bone, and appeared to have less cancellous bone hypertrophy.

Clinical Studies

The First U.S. Trial (G920035) was conducted using the "pin-based" technology, which required three locator (fiduciary) pins to register the robotic device to the patient. The primary endpoints of efficacy that demonstrated precise and reliable implantation of the preoperative plan were fit and alignment of the femoral implant. Primary clinical efficacy was demonstrated showing equivalence in Harris Hip Scores between the ROBODOC group and the manual control group.

The Second U.S. Trial (IDE # G000071) was undertaken with the "pinless" DigiMatch™ ROBODOC® Surgical System. The DigiMatch™ technology modified the ROBODOC System so as not to require pre-operative placement of fiduciary pins. The data from this trial also confirmed the safety and efficacy of the ROBODOC System. As with the First IDE Trial, primary clinical efficacy was demonstrated showing equivalence in Harris Hip Scores between the ROBODOC group and the manual control group.

Conclusion

The DigiMatch™ ROBODOC® Surgical System, which is substantially equivalent to the Voyager/Tactile Guidance System - CT, the Frameless Neuromate and the da Vinci Surgical System, has been shown to be safe and effective for its intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 6 2008

Intergrated Surgical Systems, Inc. % Mr. Russ Hibbert Director, Clinical & Regulatory Affairs 1433 N. Market Boulevard #1 Sacramento, California 95834

Re: K072629

Trade/Device Name: DigiMatch™ ROBODOC® Surgical System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: OJP, HAW Dated: March 31, 2008 Received: April 3, 2008

Dear Mr. Hibbert:

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. Russ Hibbert

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10gally 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarlet, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Mullison

Mark N. Melkerson 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): Unknown at this time K072629

Device Name: DigiMatch™ ROBODOC® Surgical System

Indications for Use:

The DigiMatch™ ROBODOC® 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Wilkerson

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

Page 1 of I

510(k) Number K0 to

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).