(245 days)
The OrthoPilot® Next Generation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to position endoprosthesis in arthroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for endacement surgery (such as total knee, revision knee, unicondylar knee, and total hip systems) and provides intraoperative measurement. It indicates angles and positions for implant placement.
Aesculap's OrthoPilot® Next Generation is a computer assisted surgical navigation system that uses proprietary software to provide anatomical information to a surgeon. The hardware in the system consists of the following primary components: stereotaxic camera, computer (w/ monitors), rigid bodies (transmitters), passive markers, power supply, various tagged instruments, an ultrasound module, transport cart and stand. The computer accepts input from the transmitters on the rigid bodies either mounted to the patients bones or mobile to palpate anatomical landmarks in conjunction with a camera to monitor the spatial location of the transmitters in relation to each other and/or instruments. The computer can also accept spatial input for anatomical landmarks from an ultrasound unit. The software modules for the OrthoPilot Next Generation consist of modules for both a knee suite and a hip suite.
The provided text is a 510(k) summary for the "Aesculap OrthoPilot Next Generation" surgical navigation system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of diagnostic or interpretive performance.
Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy, human reader improvement with AI) cannot be extracted from this document, as it describes a computer-assisted surgical navigation system and not an AI-driven diagnostic device.
However, I can extract information related to the device's performance data based on the context of a surgical navigation system, which focuses on verification and validation of changes to the device.
Here's what can be gathered:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of specific quantitative acceptance criteria (e.g., error margins in millimeters or degrees for navigation) and corresponding reported device performance. Instead, it mentions that the device was verified and validated for certain aspects.
| Acceptance Criterion (Abstracted from 'Performance Data' section) | Reported Device Performance |
|---|---|
| Sterilization | Verified and validated (details not provided) |
| Shelf Life | Verified and validated (details not provided) |
| Navigation Performance | Verified and validated (details not provided) |
| Software Acceptance Tests | Verified and validated (details not provided) |
| Software Life Cycle Testing | Verified and validated (details not provided) |
| Compliance with International Standards | Complies with IEC 60601-1, IEC 62304, ISO 14971 (stated) |
2. Sample size used for the test set and the data provenance
The document does not detail specific "test sets" in the diagnostic sense, nor does it provide sample sizes (e.g., number of procedures, patients, or data points) for the verification and validation activities mentioned. Data provenance (country of origin, retrospective/prospective) is also not discussed. The performance data refers to testing conducted on the device components and software.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The device is a surgical navigation system, and "ground truth" for its performance would likely be related to precision and accuracy measurements in a lab or cadaveric setting, not expert consensus on diagnostic images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable and not provided.
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
Not applicable and not provided. This device is not an AI-driven diagnostic tool to assist human readers. It is a computer-assisted surgical navigation system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept doesn't directly apply here in the context of a diagnostic algorithm. The device, being a surgical navigation system, works with human surgeons in the loop. Its "standalone performance" would be its inherent accuracy and precision in guiding instruments, which is what "navigation performance" verification and validation would cover. However, specific details of this testing are not given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of "ground truth" for the verification and validation of the navigation system's performance. For a surgical navigation system, "ground truth" would typically involve highly precise measurements of physical placement, angles, or trajectories compared to ideal or calibrated values. This might be established through metrology equipment or other highly accurate measurement systems in a controlled environment.
8. The sample size for the training set
Not applicable and not provided. This document does not describe an AI/machine learning model that requires a training set. The software is proprietary and provides anatomical information to the surgeon.
9. How the ground truth for the training set was established
Not applicable and not provided, as there is no mention of a training set for an AI/ML model.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2015
AESCULAP IMPLANT SYSTEMS, LLC Ms. Julie Tom Wing Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K141694
Trade/Device Name: Aesculap OrthoPilot Next Generation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: January 27, 2015 Received: January 28, 2015
Dear Ms. Wing:
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 - Ms. Julie Tom Wing
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/Resourcesfor You/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.
Mark N. Melkerson -S
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 (if known) K141694
Device Name Aesculap OrthoPilot Next Generation
Indications for Use (Describe)
The OrthoPilot® Next Generation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to position endoprosthesis in arthroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for endacement surgery (such as total knee, revision knee, unicondylar knee, and total hip systems) and provides intraoperative measurement. It indicates angles and positions for implant placement.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
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B. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Aesculap OrthoPilot Next Generation
January 27, 2015
| COMPANY: | Aesculap® Implant Systems, LLC3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 300567331 |
|---|---|
| CONTACT: | Julie Tom Wing610-984-9147 (phone)610-791-6882 (fax)Julie.TomWing@aesculap.com |
| DEVICE | |
| TRADE NAME: | Aesculap OrthoPilot Next Generation |
| COMMON NAME: | Surgical Navigation Platform |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | OLO |
| REGULATION NUMBER: | 882.4560 |
Orthopedic
SUBSTANTIAL EQUIVALENCE
CLASSIFICATION NAME:
REVIEW PANEL:
Aesculap® Implant Systems, L.L.C. believes the introduction of alternate marker spheres, a camera update and software integration of OrthoPilot® Next Generation navigation system remains substantially equivalent to the currently marketed OrthoPilot Next Generation system previously cleared in 510(K) K090375.
Orthopedic Stereotaxic Instrument
DEVICE DESCRIPTION
Aesculap's OrthoPilot® Next Generation is a computer assisted surgical navigation system that uses proprietary software to provide anatomical information to a surgeon. The hardware in the system consists of the following primary components: stereotaxic camera, computer (w/ monitors), rigid bodies (transmitters), passive markers, power supply, various tagged instruments, an ultrasound module, transport cart and stand. The computer accepts input from the transmitters on the rigid bodies either mounted to the patients bones or mobile to palpate anatomical landmarks in conjunction with a camera to monitor the spatial location of the transmitters in relation to each other and/or instruments. The computer can also accept spatial input for anatomical landmarks from an ultrasound unit. The software modules for the OrthoPilot Next Generation consist of modules for both a knee suite and a hip suite.
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INDICATIONS FOR USE
The OrthoPilor® Next Generation Platform is a system for computer-aided navigation of surqical instruments. Its purpose is to position endoprosthesis in the patient. It aids the surgeon in accurately positioning the cutting quides, drills and reamers for endoprosthesis replacement surgery (such as total knee, revision knee, unicondylar knee, and total hip systems) and provides intraoperative measurements of bone alignment. It indicates angles and positions for implant placement.
TECHNOLOGICAL CHARACTERISTICS (Compared to the Predicate)
OrthoPilot® Next Generation navigation system was cleared under K090375. The intended use and fundamental scientific technology of the OrthoPilot® Next Generation Navigation system remain unchanged. The only difference is a design modification of the passive marker spheres and it's integration with the current software modules.
PERFORMANCE DATA
OrthoPilot® Next Generation system was developed in accordance with 'General Principles of Software Final Guidance for Industry and FDA Staff; 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' and Aesculap's procedures.
As a result of the risk assessment, design modification of the marker spheres and it's integration with the current software modules was verified and validated via sterilization; shelf life; navigation performance; software acceptance tests and software life cycle testing.
In addition, Aesculap's OrthoPilot® Next Generation navigation platform complies with the following internationally recognized standards:
| IEC 60601-1 | International Electrotechnical Commission Medical Electrical EquipmentPart 1: General Requirements for Basic Safety and EssentialPerformance |
|---|---|
| IEC 62304 | International Electrotechnical Commission Medical Device Software –Software Life Cycle Processes |
| ISO 14971 | International Standards Organization Medical Devices – Application ofRisk Management to Medical Devices |
§ 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).