The Sculptor Robotic Guidance Arm (RGA) is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Sculptor RGA is indicated for use in unicompartmental knee replacement, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT-based model of the anatomy.

Device Description

Stanmore Implants Sculptor RGA utilizes a robotic arm to limit the surgeon's operation of a milling (cutting) tool to a safe area and a tracking arm to determine and monitor the location of the patient, providing dynamic referencing relative to the position of the robotic arm and the surgical plan; the device allows the surgeon to remove bone corresponding to the implant's shape as determined pre/intra operatively.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Sculptor Robotic Guidance Arm (RGA):

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not explicitly state quantitative acceptance criteria in a table format. Instead, it describes various verification and validation activities conducted to ensure the device's functionality, accuracy, and safety. The performance is reported in terms of successful verification and clinical radiographic outcomes.

Acceptance Criterion (Implicit)	Reported Device Performance
Non-Clinical Testing:
Electromagnetic Compatibility (EMC) and Electrical Safety	Testing performed and included in verification activities.
Software Control Verification and Validation	Verification of software flow, device safety, touch screen calibration, setup/shutdown procedures, individual hardware component function, correct interoperation of components, registration procedures, bone sculpting function, boundary data integrity, software thresholding, segmentation, data import, 3D model creation, joint/implant selection, landmarking, planning, workflow, patient file management, data integrity, backup, CD burning.
System Level Accuracy and Functionality (Sawbone models)	Evaluated setup, registration, and overall accuracy and functionality of the system in supporting unicondylar knee replacement.
Clinical Performance:
Accurate Bone Preparation for Unicompartmental Knee Replacement	Radiographic assessment confirmed the Sculptor accurately prepares the bone for unicompartmental knee replacement and validates the system's intended use.
Good Radiographic Outcomes with Implant Placement	Demonstrated good radiographic outcomes with respect to implant placement in a clinical study.

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

Test Set Description: The "clinical case series" serves as the primary test set for demonstrating clinical performance.
Sample Size: 35 patients (36 knees).
Data Provenance: Prospective, single-site, conducted in the United Kingdom.

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

Number of Experts: Two orthopedic surgeons.
Qualifications: "Orthopedic surgeons." No further details on years of experience or sub-specialty are provided in this document.

4. Adjudication Method for the Test Set:

Adjudication Method: Implicitly, a consensus or independent review model. "Assessments of lateral and A/P radiographs were performed by two orthopedic surgeons. Their analyses confirmed..." This suggests they both reviewed the radiographs and their analyses "confirmed" the findings, implying agreement or a common conclusion without explicitly stating a formal adjudication process like 2+1 or 3+1 voting. It doesn't indicate a disagreement resolution method if there was one.

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

MRMC Study: No, an MRMC comparative effectiveness study was not explicitly described.
Effect Size of Human Readers with/without AI: Not applicable, as no MRMC study comparing human readers with and without AI assistance was reported. The clinical study described is a single-arm series, focusing solely on the device's performance in preparing bone for implantation, without direct comparison to human readers or unassisted procedures.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

Standalone Performance: The Sculptor RGA is described as a "Robotic Guidance Arm" intended to "assist the surgeon." The entire description emphasizes its role as a tool for the surgeon, limiting the surgeon's operation and providing dynamic referencing. Therefore, the presented performance data, especially the clinical case series, inherently involves human-in-the-loop performance, as the surgeon is operating the milling tool guided by the robot. The non-clinical testing of software and hardware functions could be considered "standalone" in terms of verifying the system's internal accuracy, but not its clinical utility in isolation.

7. The Type of Ground Truth Used:

Clinical Ground Truth: Radiographic assessment of implant placement. For the clinical case series, "Assessments of lateral and A/P radiographs were performed by two orthopedic surgeons" to confirm accurate bone preparation and implant positioning.
Non-Clinical Ground Truth: For the non-clinical lab testing, Sawbone models were used, with the "true" or ideal preparation likely defined by the pre-operative planning and intended implant fit.

8. The Sample Size for the Training Set:

Training Set Sample Size: The document does not provide any explicit information about a training set or its sample size. This type of submission (510(k) for a robotic guidance system) often focuses more on functional verification and clinical validation rather than machine learning model training sets in the modern sense.

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

Training Set Ground Truth Establishment: As no training set information is provided, how its ground truth was established is not discussed in the document.

Summary

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510(k) Summary

· ・・・・

JAN 1 1 2013

Preparation Date	9 January 2013
Applicant/Sponsor	Stanmore Implants Worldwide Ltd210 Centennial AvenueCentennial ParkElstreeWD6 3SJPhone: +44 (0) 20 8238 6503Facsimile: +44 (0) 20 8954 0351
Contact Person:	Jon ChartersDirector of Regulatory affairsStanmore Implants Worldwide Ltd.+44 (0) 20 8238-6500
Prepared by:	Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street, NW, 12th FloorWashington, DC 2005202.552.5800 (phone)202.552.5789 (fax)
Trade Name:	Sculptor Robotic Guidance Arm (RGA)
Common Name:	Orthopedic Stereotaxic Instrument
Classification:	21 CFR 882.4560
Class	II
Product Code	OLO
Indications for Use	The Sculptor Robotic Guidance Arm (RGA) is intended to assist thesurgeon in providing software-defined spatial boundariesfororientation and reference information to anatomical structures duringorthopedic procedures.The Sculptor RGA is indicated for use in unicompartmental kneereplacement, in which the use of stereotactic surgery may beappropriate, and where reference to rigid anatomical bony structurescan be identified relative to a CT-based model of the anatomy.
Device Description:	Stanmore Implants Sculptor RGA utilizes a robotic arm to limit thesurgeon's operation of a milling (cutting) tool to a safe area and atracking arm to determine and monitor the location of the patient,providing dynamic referencing relative to the position of the roboticarm and the surgical plan; the device allows the surgeon to removebone corresponding to the implant's shape as determined pre/intra operatively.

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Predicate Devices

Technological Characteristics Compared to Predicate Device The Sculptor RGA is substantially equivalent to MAKO Surgical's Robotic Arm Interactive Orthopaedic System (K093425).

TechnologicalCharacteristics	Stanmore SculptorRGA	MAKO SurgicalRIO (K093425)
Major Components	Robotic arm,tracking arm, drillsystem, TouchScreen Monitor	Guidance module,robotic arm, camerastand, drill system
Tools/Accessories	Cutting toolsBone interlock fortracking	Various probes,arrays tracked byoptical camera
Images Used	CT	CT

Performance Data:

Non Clinical Testing

Performance testing of the Sculptor RGA included the FDA recommended Electromagnetic Compatibility and Electrical Safety testing, and verification and validation testing for a software controlled device. Verification testing was performed to verify the Sculptor RGA registration process, software flow, and device safety. The following activities were verified:

Touch screen calibration t
. Software and hardware setup and shutdown procedures
Individual hardware component function (e.g., Sculptor Arm, . Tracking Arm)
· Correct interoperation of components
Registration procedures .
Bone sculpting function and boundary data integrity .
. Software thresholding, segmentation, data import, 3D model creation, joint and implant selection, landmarking, frames of reference, planning, workflow, patient file management, data integrity and backup, and CD burning
System run-through .

System level verification and validation testing was performed in the laboratory using Sawbone models to evaluate setup, registration, and overall accuracy and functionality of the system in supporting unicondylar knee replacement.

Clinical Case Series

Results from a prospective, single site, clinical case series of patients undergoing primary unicompartmental knee arthroplasty with a diagnosis of osteoarthritis demonstrate the ability of the Sculptor RGA to prepare the tibia and femur for accurate positioning of the components of a unicompartmental knee system. The case series involved 35 patients (36 knees) and included a radiographic assessment of implant placement. Oxford Knee Score outcomes, and quality of life assessment.

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Assessments of lateral and A/P radiographs were performed by two orthopedic surgeons. Their analyses confirmed that the Sculptor accurately prepares the bone for unicompartmental knee replacement and validate the system's intended use.

Testing performed on this device indicates that the Sculptor RGA is Substantial substantially equivalent to the predicate device. Performance testing Equivalence: of the Sculptor RGA included the FDA recommended verification and validation testing. System level verification and validation testing was performed in the laboratory using Sawbone models to evaluate setup, registration, and overall accuracy and functionality of the system in supporting unicondylar knee replacement. A prospective, single arm clinical study conducted in the United Kingdom demonstrated good radiographic outcomes with respect to implant placement when the Sculptor RGA was used to prepare the bone for implantation.

The Sculptor RGA is shown to be substantially equivalent to Conclusion previously cleared devices with respect to its intended use, indications for use, technological characteristics, and performance characteristics.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of what appears to be a caduceus, a symbol often associated with healthcare.

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

Stanmore Implants Worldwide, Limited % Musculoskeletal Clinical Regular Advisers, LLC Ms. Hollace Saas Rhodes 1331 H. Street Northwest, 12th Floor Washington. District of Columbia 20005

Re: K121765

Trade/Device Name: Sculptor Robotic Guidance Arm (RGA) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: December 21, 2012 Received: December 26, 2012

Dear Ms. Rhodes:

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

January 11, 2013

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Page 2 - Ms. Hollace Saas Rhodes

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Peter D.,Rumm -S

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

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K121765

Device Name: Sculptor Robotic Guidance Arm (RGA)

Indications for Use:

Prescription Use_ X

AND/ OR

Over-The-Counter Use

(Per 21 CFR 801 Subpart D)

(Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dwight Yen 2013.01.11 11:03:00 -05'00'

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K121765

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).