(111 days)
The Surgetics ORTHO OSTEOLOGICS navigation system is an optically based surgical navigation system. It is intended for use as an aid to the surgeon in tracking bone structures and instruments on a 3D model of the patient's bone which is generated through acquiring multiple landmarks. The system is indicated to assist a surgeon to control the lower limb axis during osteotomy procedures.
Examples of orthopedic surgical procedures include, but are not limited to: Open wedge osteotomy for the lower limb Closed wedge osteotomy for the lower limb
The Surgetics ORTHO OSTEOLOGICS Navigation System consists of the following major components and subsystems:
- The Surgetics Station, consisting of a mobile computer system and an optical . localizer
- Ancillary instruments and reflective markers used for reference and . calibration.
- HTO Monitoring Software for, but not limited to open and closed wedge . osteotomy for the lower limb
The provided text describes performance testing for the Surgetics ORTHO OSTEOLOGICS navigation system, focusing on its accuracy.
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly refers to "summaries of accuracy testing" but does not explicitly state specific numerical acceptance criteria for accuracy, nor does it provide the exact reported performance values in a table format. It simply states that "summaries of accuracy testing using phantoms, specimen bench testing, and clinical experience with the system were provided."
Without explicit acceptance criteria in the document, I cannot create such a table.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "accuracy testing using phantoms, specimen bench testing, and clinical experience," implying a test set was used, but the size of these sets is not provided.
- Data Provenance: Not explicitly stated. The manufacturer is based in France ("Praxim "Le Grand Sablon" 4, Avenue de l'Obiou 38 700 La Tronche France"), suggesting the testing may have occurred there or in other countries, but this is not specified. It is likely prospective as it involves new testing for the device's clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not explicitly stated. The document mentions "clinical experience," which implies input from medical professionals (surgeons), but the exact number or their specific qualifications (e.g., years of experience, specialty) are not provided.
4. Adjudication Method for the Test Set:
Not explicitly stated. There is no mention of any specific adjudication method (e.g., 2+1, 3+1, none) used for interpreting the test results or establishing ground truth.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
Not explicitly stated. The document does not mention an MRMC comparative effectiveness study involving human readers with and without AI assistance, nor does it report any effect size. The system is a surgical navigation aid, not primarily an interpretative AI tool for diagnostic images.
6. Standalone Performance:
Yes, a standalone performance assessment was conducted. The "accuracy testing using phantoms, specimen bench testing" refers to evaluating the algorithm's performance in a controlled environment, which constitutes standalone (algorithm only) testing. The system's purpose is to provide navigation guidance, and its accuracy in doing so is a measure of its standalone performance.
7. Type of Ground Truth Used:
The ground truth for the standalone testing would likely be:
- Phantom Data: Precisely known measurements/geometries on the phantom as the ground truth against which the system's measurements are compared.
- Specimen Bench Testing: Likely involved comparing the system's measurements/tracking against a known gold standard (e.g., high-precision manual measurements or other validated measurement systems) on cadaveric or animal specimens.
- Clinical Experience: While not detailed, "clinical experience" would typically involve surgeons using the system and assessing its practical accuracy and utility during actual procedures, likely against their surgical judgment and possibly intraoperative imaging or direct measurements.
8. Sample Size for the Training Set:
Not explicitly stated. The document does not provide any information regarding the training set size or methodology for the development of the navigation system's algorithms.
9. How Ground Truth for the Training Set Was Established:
Not explicitly stated. Since training set details are omitted, the method for establishing ground truth for any potential training data is also not provided.
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APR 1 0 2006
053542
510(k) Summary
for Surgetics ORTHO OSTEOLOGICS navigation system
1. Submitter Name and Address
Praxim "Le Grand Sablon" 4, Avenue de l'Obiou 38 700 La Tronche France
Contact Name: Stéphane Lavallée Telephone: 33-4 76 54 95 03
Date Prepared: November 15th, 2005
2. Device Name
| Proprietary Name: | SURGETICS ORTHO OSTEOLOGICS NAVIGATIONSYSTEM |
|---|---|
| Common/Usual Name: | Image guided surgical navigation system |
| Classification Name: | Stereotaxic Instrument: 21 CFR 882.4560, Class II |
3. Predicate Device
PRAXIM - Surgetics ORTHO KNEELOGICS navigation system (K 031196) BrainLab -- VectorVision® Osteotomy (K 042513)
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4. Intended Use
The Surgetics ORTHO OSTEOLOGICS navigation system is an optically based surgical navigation system. It is intended for use as an aid to the surgeon in tracking bone structures and instruments on a 3D model of the patient's bone which is generated through acquiring multiple landmarks. The system is indicated to assist a surgeon to control the lower limb axis during osteotomy procedures.
Examples of orthopedic surgical procedures include, but are not limited to:
Open wedge osteotomy for the lower limb
Closed wedge osteotomy for the lower limb
5. Device Description
.
The Surgetics ORTHO OSTEOLOGICS Navigation System consists of the following major components and subsystems:
- The Surgetics Station, consisting of a mobile computer system and an optical . localizer
- Ancillary instruments and reflective markers used for reference and . calibration.
- HTO Monitoring Software for, but not limited to open and closed wedge . osteotomy for the lower limb
6. Technological Characteristics and Substantial Equivalence
The Surgetics ORTHO OSTEOLOGICS Navigation System is substantially equivalent to other stereotaxic instruments that have been cleared for use in spine, orthopedic and traumatology surgery, including the BrainLab Vector Vision Osteotomy and the PRAXIM - Surgetics ORTHO KNEELOGICS navigation The ORTHO OSTEOLOGICS and the predicate systems all acquire system. positional data by tracking reflective markers and digitizing the relative locations of anatomical landmarks, to aid the surgeon in linear procedures. It allows the surgeon to locate surgical instruments' tip and direction (e.g. screwdriver, awl). The system uses an infrared camera for localization and guidance of surgical instruments during the procedure.
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7. Performance Testing
The Surgetics ORTHO OSTEOLOGICS Navigation System was tested for compliance with electrical safety and electromagnetic compatibility standards. In addition, summaries of accuracy testing using phantoms, specimen bench testing, and clinical experience with the system were provided.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2006
Praxim S.A. c/o Medical Device Consultants, Inc. Mr. Randy Veale 49 Plain Street North Attleboro, Massachusetts 02760
Re: K053542
Trade/Device Name: Ortho Osteologics navigation system Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: February 27, 2006 Received: March 6, 2006
Dear Mr. Veale:
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. Iisting 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
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Page 2 - Mr. Randy Veale
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. 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
sincerely yours,
demee
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): K053542
Device Name: Surgetics ORTHO OSTEOLOGICS navigation system
Indications for Use:
The Surgetics ORTHO OSTEOLOGICS navigation system is an optically based surgical navigation system. It is intended for use as an aid to the surgeon in tracking bone structures and instruments on a 3D model of the patient's bone which is generated through acquiring multiple landmarks. The system is indicated to assist a surgeon to control the lower limb axis during osteotomy procedures.
Examples of orthopedic surgical procedures include, but are not limited to: Open wedge osteotomy for the lower limb Closed wedge osteotomy for the lower limb
Prescription Use (Part 21 CFR 801 Subpart D)
Surgetics ORTHO OSTEOLOGIOS ) Number
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) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | |
| Additional information K053542February 27, 2006 | CONFIDENTIAL |
§ 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).