(66 days)
The TOTAL KNEE SURGETICS NAVIGATION SYSTEM is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for : . Total Knee Arthroplasty
As the equivalent Surgetics ORTHO KNEELOGICS Navigation System, the TOTAL KNEE SURGETICS 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 registration - TOTAL KNEE SURGETICS software . The main modifications to the predicate device concern the internal architecture of the software, allowing more easily to integrate new implants and to better adapt the workflow to different surgical techniques. New instruments adapted to new implants are also incorporated.
The provided text for the TOTAL KNEE SURGETICS Navigation System does not contain specific acceptance criteria or a detailed study report with quantitative performance metrics. Instead, it makes a general statement about performance testing and substantial equivalence to a predicate device.
Here's an analysis based on the given information, highlighting what is and is not present:
Acceptance Criteria and Device Performance:
The document states: "Analyses show that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate device." However, no specific accuracy metrics (e.g., in millimeters, degrees of rotation) or performance thresholds (acceptance criteria) are provided in the document. Therefore, a table of acceptance criteria and reported device performance cannot be generated from this text.
Study Details:
The document mentions "Performance Testing" but does not provide a detailed study design or results.
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified.
- Data Provenance: The testing was "non clinical setting (bench testing, specimen)". No country of origin is mentioned for the data, and it was not human patient data (retrospective or prospective).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not specified. The document does not describe the establishment of a ground truth by experts for the test set.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
-
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:
- A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The device is a surgical navigation system, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The performance testing mentioned was "non clinical setting (bench testing, specimen)." This implies a standalone evaluation of the system's accuracy in a controlled environment, likely without human surgical intervention as part of the test (though it's intended for use with human surgeons). The document states, "Analyses show that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate device." This indicates a standalone assessment was performed to compare it with the predicate device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. Given it was "bench testing, specimen," the ground truth would likely involve highly precise measurements against known physical standards or anatomical landmarks on the specimens using a highly accurate reference system, but the document does not detail this.
-
The sample size for the training set:
- Not applicable/Not specified. This is a navigation system, not a machine learning model that typically requires a discrete training set in the sense of a diagnostic AI. The software modifications concern "internal architecture," "integrating new implants," and "adapting the workflow to different surgical techniques," rather than training a predictive algorithm with a large dataset.
-
How the ground truth for the training set was established:
- Not applicable/Not specified. (See point 7).
Summary of what is present:
- Device Type: Surgical navigation system (TOTAL KNEE SURGETICS Navigation System).
- Intended Use: Aid surgeons in locating anatomical structures and aligning endoprostheses during Total Knee Arthroplasty.
- Testing Conducted: Non-clinical bench testing on specimens.
- Conclusion: Accuracy and performance were "adequate for its intended use and not reduced in comparison to the predicate device."
- Predicate Device: Surgetics ORTHO KNEELOGICS Navigation System (K031196).
- Modifications from Predicate: Internal software architecture for easier integration of new implants and adaptation of workflow, new instruments for new implants.
In essence, the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, and while it mentions performance testing, it does not provide the granular data or criteria usually expected in a detailed study report for acceptance criteria. The FDA's acceptance of the 510(k) implies that the provided (but non-public) testing information was sufficient for their "substantial equivalence" determination.
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510(k) Summary
for
TOTAL KNEE SURGETICS Navigation System
1. Submitter Name and Address:
APR 1 0 2006
Praxim "Le Grand Sablon" 4, Avenue de l'Obiou 38 700 La Tronche France
Contact Name: Mady BATAILH Telephone: (0033) 4 76 54 95 03
Date Prepared: January, XX 2006
2. Device Name:
Proprietary Name: TOTAL KNEE SURGETICS Navigation System Common/Usual Name: Image guided surgical navigation system Classification Name: Computed tomography x-ray system (accessory)
3. Equivalent to:
K031196 - Surgetics ORTHO KNEELOGICS Navigation System
4. Intended Use:
The TOTAL KNEE SURGETICS NAVIGATION SYSTEM is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.
It is specifically indicated for :
- . Total Knee Arthroplasty
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5. Device Description:
As the equivalent Surgetics ORTHO KNEELOGICS Navigation System, the TOTAL KNEE SURGETICS 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 registration
- TOTAL KNEE SURGETICS software .
The main modifications to the predicate device concern the internal architecture of the software, allowing more easily to integrate new implants and to better adapt the workflow to different surgical techniques. New instruments adapted to new implants are also incorporated.
6. Technological Characteristics and Substantial Equivalence
The underlying technology of the TOTAL KNEE SURGETICS Navigation System is the same as for the predicate device. The system is based on the same operating principle and control mechanism to provide the user with the same kind of information and guidance for the same surgery. The main changes with respect to the predicate device concern software and engineering modifications with regard to easy integration of new implants (modularization). In addition, the software was modified in order to allow easier adaptation of the workflow to the characteristics of each implant and to different surgical techniques. New navigated instruments have been developed also with respect to easier integration of new implants.
7. Performance Testing
The Surgetics TOTAL KNEE SURGETICS Navigation System was tested in a non clinical setting (bench testing, specimen) to assess that no new safety and efficiency issues were raised in the device. Analyses show that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate device. In conclusion the TOTAL KNEE SURGETICS Navigation System is substantially equivalent to the Surgetics ORTHO KNEELOGICS Navigation System.
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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: K060282
Trade/Device Name: TOTAL KNEE SURGETICS Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: March 13, 2006 Received: March 16, 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, 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
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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 yours,
Mark N. Mullan
Mark N. Melkarson 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): K060282
Device Name: TOTAL KNEE SURGETICS Navigation System
Indications for Use:
The TOTAL KNEE SURGETICS Navigation System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning and the endoprostheses with the anatomical structures.
It is specifically indicated for :
Total Knee Arthroplasty .
Prescription Use
(Part 21 CFR 801 Subpart D)
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 (DRH Officer Sign-Off Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices
| Additional information K060282TOTAL KNEE SURGETICS | March 13, 2006 | CONFIDENTIAL |
|---|---|---|
| -------------------------------------------------------- | ---------------- | -------------- |
| 510(k) Number | K060282 |
|---|---|
| --------------- | --------- |
§ 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).