(783 days)
The Surgetics ORTHO KNEELOGICS Navigation System is intended for use during stereotactic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for assisting the surgeon during:
- Anterior Cruciate Ligament (ACL) surgery by estimating anisometry of potential insertion points based on a digitized anatomical model
- Total Knee Arthroplasty with ZIMMER NEXGEN implant
- UniKnee Arthroplasty with BIOMET OXFORD Phase III implant
The Surgetics ORTHO KNEELOGICS Navigation System (ORTHO KNEELOGICS) 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 registration
- ORTHO KNEELOGICS Navigation applications software
The provided text describes the Surgetics ORTHO KNEELOGICS Navigation System. Here's an analysis of the acceptance criteria and study information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety | Compliance with electrical safety standards |
| Electromagnetic Compatibility | Compliance with electromagnetic compatibility standards |
| Accuracy (Phantom Testing) | Summaries of accuracy testing provided |
| Accuracy (Specimen Bench Testing) | Summaries of specimen bench testing results provided |
| Clinical Study | Summaries of a clinical study provided |
| Substantial Equivalence to Predicate Devices (BrainLab Vector Vision CT-Free (K021306) and OrthoSoft Navitrack System-Optical TKR CT-Less (K021760)) | "The ORTHO KNEELOGICS and the predicate systems all acquire positional data by tracking reflective markers and digitizing the relative locations of anatomical landmarks, and then use this data to display virtual 3D images used for subsequent planning and navigation during surgery. The three systems can all be used with different manufacturer's implant components." |
Critique: The provided document states that "summaries of accuracy testing using phantoms and specimen bench testing and results of a clinical study were provided," but it does not specify the numerical acceptance criteria (e.g., "accuracy within X mm") or detailed performance data (e.g., "achieved X mm accuracy"). Therefore, while the types of tests performed are mentioned, the actual quantitative criteria and the numerical results matching those criteria are not present in this excerpt. The substantial equivalence argument serves as a form of "acceptance criteria" related to technological characteristics.
2. Sample Size for the Test Set and Data Provenance
The document mentions "results of a clinical study were provided" but does not specify the sample size used for the test set (number of patients or cases) for the clinical study or the phantom/specimen testing.
Data Provenance: Not explicitly stated. The submitter is from France ("Praxim 'Le Grand Sablon' 4, Avenue de l'Obiou 38 700 La Tronche France"), suggesting the possibility of data originating from France or Europe, but this is not confirmed. The document does not specify if the clinical data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used to establish ground truth for the test set or their specific qualifications.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth in the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss any effect size of how much human readers improve with AI vs. without AI assistance. The device is a navigation system used by a surgeon, not an AI diagnostic tool for human readers.
6. Standalone Performance Study
The accuracy testing on "phantoms and specimen bench testing" and the "clinical study" are likely standalone performance studies, as they aim to evaluate the device's accuracy and performance. However, the document does not explicitly label them as "standalone" studies or differentiate them from studies involving human interaction beyond the surgeon's use of the navigation system as intended.
7. Type of Ground Truth Used
The document mentions "accuracy testing using phantoms and specimen bench testing," which implies that the ground truth for these tests would be known true values or measurements derived from precise physical models (phantoms) or anatomical specimens. For the "clinical study," the type of ground truth is not explicitly stated but would typically involve intraoperative measurements, postoperative imaging, or clinical outcomes to assess the accuracy of the navigation system's guidance.
8. Sample Size for the Training Set
The document does not provide any information regarding a "training set" or its sample size. This device is described as an image-guided surgical navigation system that "acquires positional data by tracking reflective markers and digitizing the relative locations of anatomical landmarks," implying it's based on real-time positional data and anatomical models rather than a machine learning model that would require a distinct training set.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or implied for a machine learning model, the document does not describe how ground truth for a training set was established.
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JUN 7 - 2005
K 03//96
510(k) Summary
for
Surgetics ORTHO KNEELOGICS Navigation System
Submitter Name and Address 1.
- Praxim "Le Grand Sablon" 4, Avenue de l'Obiou 38 700 La Tronche France
Contact Name: Stéphane Lavallée 33-4 76 54 95 03 Telephone:
Date Prepared: April 28, 2005
Device Name 2.
Surgetics ORTHO KNEELOGICS Navigation System Proprietary Name: Common/Usual Name: Image guided surgical navigation system Computed tomography x-ray system (accessory) Classification Name:
3. Predicate Device
BrainLab Vector Vision CT-Free (K021306) OrthoSoft Navitrack System-Optical TKR CT-Less (K021760)
4. Intended Use
The Surgetics ORTHO KNEELOGICS Navigation System is intended for use during stereotactic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for assisting the surgeon during:
- Anterior Cruciate Ligament (ACL) surgery by estimating anisometry of . potential insertion points based on a digitized anatomical model
- Total Knee Arthroplasty with ZIMMER NEXGEN implant .
- UniKnee Arthroplasty with BIOMET OXFORD Phase III implant .
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5. Device Description
Surgetics ORTHO KNEELOGICS Navigation System (ORTHO The KNEELOGICS) 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 . registration
- . ORTHO KNEELOGICS Navigation applications software
6. Technological Characteristics and Substantial Equivalence
The Surgetics ORTHO KNEELOGICS Navigation System is substantially equivalent to other stereotaxic instruments that have been cleared for use in knee surgery without CT imaging, including the BrainLab Vector Vision CT-Free (K021306) and the OrthoSoft Navitrack System-Optical TKR CT-Less (K021760). The ORTHO KNEELOGICS and the predicate systems all acquire positional data by tracking reflective markers and digitizing the relative locations of anatomical landmarks, and then use this data to display virtual 3D images used for subsequent planning and navigation during surgery. The three systems can all be used with different manufacturer's implant components.
7. Performance Testing
The Surgetics ORTHO KNEELOGICS Navigation System was tested for compliance with electrical safety and electromagnetic compatibility standards. In addition, summaries of accuracy testing using phantoms and specimen bench testing and results of a clinical study were provided.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a symbol on the right and text on the left. The symbol is three curved shapes that resemble human profiles. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 7 - 2005
Praxim C/o Ms. Sheila Hemeon-Heyer, J.D., RAC Medical Device Consultants Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K031196
Trade/Device Name: Surgetics ORTHO KNEELOGICS Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 28, 2005 Received: April 29, 2005
Dear Ms. Hemeon-Heyer:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your bector of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, de nees that hat to been roll tequire approval of a premarket approval application (PMA). and Cosmetic Free, market the device, subject to the general controls provisions of the Act. The 1 ou may, merelore, market of the Act include requirements for annual registration, listing of general controls provisions of vactice, 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 it indy be subject to back as a 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 i lease be devilsed that I Dr i issum that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I occrained and 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 form in the qualisms of trol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Ms. Sheila Hemeon-Heyer, J.D., RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mainening of substantial equivalence of your device to a legally premarket notification: "The PDT Intently sification 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 II you desire specific advice ion your at (240) 276-0120 . Also, please note the regulation entitled, Comacs the Office of Compuners (set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
signature
Miriam C. Provost, Ph.D. Acting 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: K031196
Device Name: Surgetics ORTHO KNEELOGICS Navigation System
Indications for Use:
The Surgetics ORTHO KNEELOGICS Navigation System is intended for use during stereotactic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for assisting the surgeon during:
- · Anterior Cruciate Ligament (ACL) surgery by estimating anisometry of potential insertion points based on a digitized anatomical model
- Total Knee Arthroplasty with ZIMMER NEXGEN implant
- UniKnee Arthroplasty with BIOMET OXFORD Phase III implant
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Euchth
ivision Sign-Off) Division Sign-On)
Division of General, Restorative
Oivision of General, Revices Division of Gical Devices
510(k) Number K031196
April 28, 2005
§ 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).