(90 days)
The Orthopilot® HTO module is designed to assist an orthopedic surgeon to navigate the two bone cuts to form the wedge for correction of the leg axis.
Orthopilot® HTO (High Tibia Osteotomy) module uses transmitters that are mounted to the patients bones, or are flexible to palpate landmarks and a camera to monitor the spatial location of those transmitters in relation to each other and the medical instruments. These locations are used to locate the centers of rotation of the femur head, ankle and knee. These measurements allow for greater accuracy than mechanical methods of ascertaining cutting angles. The HTO module is only a tool to navigate the instruments for the bone cuts. It is not linked to any specific implant.
The provided document is a 510(k) summary for the Aesculap Orthopilot® HTO module, indicating its purpose is to gain marketing clearance. However, it explicitly states there are no performance standards for such devices and references conformity to applicable ASTM and ISO standards generally. No specific acceptance criteria or detailed study results are included in this document to demonstrate the device meets any particular performance criteria.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document primarily focuses on establishing substantial equivalence to existing devices (Orthopilot® 2 Navigation Platform, Kinamed Orthopilot®, Stryker Navigation System-Knee Module, Brainlab Vector Vision Knee) rather than presenting a detailed performance study with specific metrics and acceptance criteria.
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JUL 2 5 2002
Page 1 of 2
C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS [in Accordance with SMDA of 1990]
Aesculap Orthopilot® HTO module
April 22, 2002
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Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034
Establishment Registration Number: 2916714 -
CONTACT: Georg Keller, Regulatory Affairs Manager 800/258-1946 x 5073 (phone) 610/791-6882 (fax)
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Orthopilot® HTO module TRADE NAME:
COMMON NAME: Orthopilot® 2 Navigation Platform
DEVICE CLASS: Class II
PRODUCT CODE: HAW
CLASSIFICATION: 21 CFR Section 882.4560: Stereotaxic Instrument.
REVIEW PANEL: Neurology
INDICATIONS FOR USE
The Orthopilot® HTO module is designed to assist an orthopedic surgeon to navigate the two bone cuts to form the wedge for correction of the leg axis.
DEVICE DESCRIPTION
Orthopilot® HTO (High Tibia Osteotomy) module uses transmitters that are mounted to the patients bones, or are flexible to palpate landmarks and a camera to monitor the spatial location of those transmitters in relation to each other and the medical instruments. These locations are used to locate the centers of rotation of the femur head, ankle and knee. These measurements allow for greater accuracy than mechanical methods of ascertaining cutting angles. The HTO module is only a tool to navigate the instruments for the bone cuts. It is not linked to any specific implant.
PURPOSE FOR SUBMISSION
The purpose for this submission is to gain marketing clearance for the Aesculap Orthopilot® HTO module.
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PERFORMANCE DATA
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The Orthopilot® HTO module conforms to applicable ASTM and ISO standards.
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Orthopilot® HTO module is essentially identical to the Orthopilot® 2 Navigation Platform (subjected K013569), Kinamed Orthopilot® (K003347), Stryker Navigation System-Knee Module (K010204), Brainlab Vector Vision Knee (K010612).
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JUL 2 5 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aesculap, Inc. Mr. Georg Keller Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K021327 Trade Name: Orthopilot® HTO Module Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 23, 2002 Received: April 26, 2002
Dear Mr. Keller:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. Georg Keller
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 a legally 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, (Misbranding by reference to premarket notification( (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 6382041 or (301) 4436597 or at its Internet address HYPERLINK http://www.fda.gov/cdrh/dsma/dsmamain.html http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Stupt Plurdu
Celia M. Witten, Ph.D., M.D.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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B. INDICATIONS FOR USE STATEMENT
Page 1 of 1
KOLIB21 510(k) Number:
Orthopilot® HTO module Device Name:
Indication for Use:
The Orthopilot® HTO module is designed to assist an orthopedic surgeon to navigate the two bone cuts to form the wedge for correction of the leg axis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| 510(k) Number | K021327 |
|---|---|
| Prescription Use (per 21 CFR 801.109) | or Over-the-Counter Use |
§ 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).