(68 days)
The Navitrack® System - Partial Hip Resurfacing Universal is indicated for use as a stereotaxic instrument to assist in the positioning of partial hip resurfacing components.
It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist in precisely positioning hip femoral resurfacing components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.
The Navitrack® System – Partial Hip Resurfacing Universal system consists of software, a computer workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of partial hip resurfacing components.
Tracking devices are incorporated onto given surgical instruments and onto fixation bases attached to the femur by which the system tracks their relative locations and displays back to the user corresponding positional information intra-operatively to initially plan and then guide the positioning of the components.
The instruments that are tracked include a drill guide to help position the implant's system guide wire or pin that sets the central axis for the implants. The femoral reference geometries relative to which the guide wire location is to be positioned include representations of the femoral head and neck surfaces as rendered by clouds of points that are digitized by the user using the system.
In addition, the system also allows for specific implant models as obtained from the implant manufacturers to also be included in the system. In this mode, the system also displays the implant models relative to the bony geometries corresponding to the placement.
The provided text describes a 510(k) premarket notification for the Navitrack® System – Partial Hip Resurfacing Universal. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance data from a specific study demonstrating acceptance criteria.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and MRMC studies is not available in the provided document.
However, I can extract the available information and highlight what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (General Statement in the document) |
|---|---|
| Accuracy and performance for intended use (Inferred requirement, likely derived from predicate device performance) | "Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. These included tests and analyses to verify that the accuracy and performance of the system was adequate for its intended use, equivalently as in the Navitrack® predicates." |
| Specific quantitative accuracy thresholds (e.g., in mm or degrees for component placement) | Not provided. |
| Clinical outcomes or precision of component positioning in humans | Not provided. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions "Non-clinical tests" without detailing specific test sets, cases, or the number of components tested.
- Data Provenance: Not specified, but given the non-clinical nature of the tests, it would likely be laboratory or bench testing data rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable/Not specified. Since the tests were "non-clinical," traditional ground truth established by medical experts for a diagnostic or interventional outcome is not described. The "accuracy and performance" would likely be compared against a known physical reference or measurement in a laboratory setting.
4. Adjudication Method for the Test Set
- Not applicable/Not specified, as no expert review or adjudication process for a test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The document focuses on establishing substantial equivalence through non-clinical accuracy and performance tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- The device is a "computer controlled image-guidance system equipped with a three-dimensional tracking sub-system" intended to "assist the surgeon." The description of the device's function implies human-in-the-loop operation, as it "displays back to the user corresponding positional information intra-operatively to initially plan and then guide the positioning of the components." While "non-clinical tests" were done, it's not specified if these were purely standalone algorithmic evaluations or if they simulated the full human-in-the-loop workflow. However, the phrasing "accuracy and performance of the system was adequate for its intended use" suggests evaluating the device in its intended assistive role.
7. The Type of Ground Truth Used
- The document does not explicitly state the type of ground truth used. For "non-clinical tests" assessing "accuracy and performance" of a surgical navigation system, the ground truth would typically be established by high-precision measurement tools (e.g., CMM, optical trackers, or precise mechanical fixtures) against known geometric configurations or reference points in a laboratory setting. This would serve as the "true" position or alignment against which the system's measurements are compared.
8. The Sample Size for the Training Set
- Not applicable/Not specified. The document describes a "stereotaxic instrument" and "image-guidance system" which implies a rule-based or model-based system for tracking and display, rather than a machine learning model that requires a "training set" in the conventional sense. The "models" mentioned ("specific implant models... to also be included in the system") refer to CAD models of implants, not training data for an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not specified, as there is no mention of a training set for a machine learning model. The "ground truth" for the system's underlying operations (e.g., tracking accuracy, display fidelity) would be established by engineering specifications and metrology.
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SEP 1 9 2007
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS NAVITRACK® SYSTEM - PARTIAL HIP RESURFACING UNIVERSAL
KO71929
Applicant: ORTHOsoft Inc. 75 Queen Street, suite 3300 Montreal, Quebec Canada, H3C 2N6 Tel.: 514 861 4074 Fax: 514 866 2197
Contact Person: Christopher McLean
Date Summary Prepared: July 12, 2007
Device Trade Name: Navitrack System - Partial Hip Resurfacing Universal
Device Classification Name: Stereotaxic Instrument (84 HAW); 21 CFR § 882.4560
Predicate Devices:
-
- Vectorvision Hip SR; from Brainlab, AG; 510(k) # K063028
-
- Navitrack System -- Total Hip Replacement CT-Free; from Orthosoft Inc.; 510(k) # K032917
-
- Navitrack® System -- OS Knee Universal; from Orthosoft Inc; 510(k) # K060336
Device Description:
The Navitrack® System – Partial Hip Resurfacing Universal system consists of software, a computer workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of partial hip resurfacing components.
Tracking devices are incorporated onto given surgical instruments and onto fixation bases attached to the femur by which the system tracks their relative locations and displays back to the user corresponding positional information intra-operatively to initially plan and then guide the positioning of the components.
The instruments that are tracked include a drill guide to help position the implant's system guide wire or pin that sets the central axis for the implants. The femoral reference geometries relative to which the guide wire location is to be positioned include representations of the femoral head and neck surfaces as rendered by clouds of points that are digitized by the user using the system.
In addition, the system also allows for specific implant models as obtained from the implant manufacturers to also be included in the system. In this mode, the system also displays the implant models relative to the bony geometries corresponding to the placement.
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Indications for Use / Intended Use:
The Navitrack® System - Partial Hip Resurfacing Universal is indicated for use as a stereotaxic instrument to assist in the positioning of partial hip resurfacing components.
It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist in precisely positioning hip femoral resurfacing components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.
Technological Comparisons to the Predicates:
The fundamental scientific technology of the predicates is unchanged. The main operating principle and control mechanism are maintained in the proposed device to similarly provide image guidance assistance in the placement of orthopedic implants.
Secondary software and instrument engineering changes were incorporated to the Navitrack® THR CT-Free and OS Knee Universal predicates for the design of the proposed system according to the requirements for the placement of partial hip resurfacing components as compared to the total hip and total knee components of the predicates. The computer system and the tracking system were unchanged.
The proposed system was also compared to the Vectorvision Hip SR from Brainlab as a predicate and was found to have the same general intended use and indication for use, and utilizes the same main technology.
Performance Data:
Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. These included tests and analyses to verify that the accuracy and performance of the system was adequate for its intended use, equivalently as in the Navitrack® predicates.
Conclusion:
The information and data provided in this 510(k) Premarket Notification established that the Navitrack System - Partial Hip Resurfacing Universal device is substantially equivalent to the predicates.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Orthosoft, Inc. % Christopher McLean, Eng. Regulatory Affairs & Quality Management Director 75, Queen Street, Suite 3300 Montréal, Quebec Canada H3C 2N6
SEP 1 9 2007
Re: K071929
Trade/Device Name: Navitrack® Partial Hip Resurfacing - Universal Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: July 12, 2007 Received: July 13, 2007
Dear Mr. McLean:
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 - Christopher McLean, Eng.
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 Pari 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark H. Melkerson
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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510(k) Number: |(07 |929
Device Name: Navitrack® Partial Hip Resurfacing - Universal
Indications for Use:
The Navitrack® Partial Hip Resurfacing - Universal is indicated for use as a stereotaxic instrument to assist in the positioning of partial hip resurfacing components.
It is a computer controlled image-guidance system equipped with a threedimensional tracking sub-system. It is intended to assist in precisely positioning hip femoral resurfacing components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.
Prescription Use (per 21CFR 801.109)
OR
Over-the-Counter Use
Concurrence of DRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
K07 1929
510(k) Number
§ 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).