(192 days)
BrainLAB VectorVision is intended to be an intraoperative image guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space either on a patient's preoperative image data being processed by a Vector vision workstation on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray, MR based model of the anatomy. The system aids the surgeon to accurately navigate a hip endoprothesis to the preoperatively or intraoperatively planned position.
Example orthopedic surgical procedures include but are not limited to:
Total Joint Replacement (TJR)
Revision surgery of TJR
Tumor resection and bone/joint reconstruction
BrainLAB VectorVision® Hip is intended to enable operational planning and navigation in orthopedic and surgical procedures. It links a surgical instrument, tracked by passive markers to virtual computer image space on a patient's preoperative image data or an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. Vector Vision® Hip uses the registered patient data to guide the cup reamer, cup inserter, stem rasp, bone saw and the implant to the planned position. If no implant data is available it is possible to provide information in order to define the implant and the bone orientation as defined by the operating surgeon.
VectorVision® Hip allows 3-dimensional reconstruction of the relevant mechanical axes and planes of femur and pelvis. VectorVision® Hip software has been designed to read in data and perform calculations based on the geometry of implants and instruments if provided by the implant manufacturer and offers to individually choose the type of implants and instruments. VectorVision® Hip software registers the patient data needed for prosthesis implantation using the CT free module. The system can be used for planning and navigating the surgery intraoperatively. Special landmarks and any other anatomical information referring to the patient data can be used additionally for surgery, the patient data is then provided by the CT data stored on a standard data storage media.
The provided text (K040368) is a 510(k) summary for the VectorVision® Hip system. It focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, study designs, sample sizes, or ground truth establishment typically found in performance studies for new medical devices.
Therefore, many of the requested details cannot be extracted directly from this document.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the 510(k) summary. A 510(k) often focuses on comparing the new device's features and intended use to a predicate device to argue for substantial equivalence, rather than presenting detailed performance study results against specific acceptance criteria.
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not provided. The document states that the device "has been verified and validated according to BrainLAB's procedures for product design and development," but no specific test set sample sizes are given for this validation.
- Data provenance: Not provided. No information about country of origin, or if data was retrospective or prospective, is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided.
5. 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:
- MRMC study: Not provided. This document does not describe an MRMC study. The VectorVision® Hip is described as an "intraoperative image guided localization system" that "aids the surgeon to accurately navigate a hip endoprothesis." It's not an AI-driven diagnostic tool where "human readers improve with AI vs without AI assistance" would typically be measured.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone performance: Not explicitly stated in the context of an "algorithm only" study. The device is described as an "intraoperative image guided localization system" that assists the surgeon. Its performance is inherently tied to human interaction (the surgeon using the system to navigate). The summary focuses on its function as a navigation aid.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided.
8. The sample size for the training set:
Not applicable/Not provided. This device is described as an image-guided surgery system, not a machine learning model that would typically have a "training set" in the sense of supervised learning. While it processes image data and creates 3D models, the core functionality is navigation and not predictive modeling based on a trained dataset.
9. How the ground truth for the training set was established:
Not applicable/Not provided. (See point 8).
Summary of what the document DOES state regarding verification and validation:
The document briefly mentions:
"VectorVision® Hip has been verified and validated according to BrainLAB's procedures for product design and development. This verification and validation demonstrated the safety and effectiveness of the system."
However, it does not elaborate on the specifics of these verification and validation activities, such as:
- What parameters were measured.
- What the quantitative acceptance criteria were.
- What the results of those measurements were.
- How ground truth was established for any performance testing.
- The exact study design or participant details.
This 510(k) submission primarily relies on demonstrating substantial equivalence to its predicate device (VectorVision® Hip K010602 and Vector Vision® CT-free Knee K021306) rather than providing extensive de novo performance study details.
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510 (k) Summary of Safety and Effectiveness for VectorVision® Hip (K040368)
Manufacturer:
| Address: | BrainLAB AG |
|---|---|
| Ammerthalstrasse 8 | |
| 85551 Heimstetten | |
| Germany | |
| Phone: +49 89 99 15 68 0 | |
| Fax: +49 89 99 15 68 33 | |
| Contact Person: | Mr. Rainer Birkenbach |
| Summary Date: | August 13, 2004 |
Device Name:
Trade name:
VectorVision® Hip
Common/Classific:stion Name:
VectorVision® Hip, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
Predicate Device Vector Vision® Hip (K010602)
Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II
intended Use:
BrainLAB VectorV sion is intended to be an intraoperative image guided localization system. It links a freehand probe, tr:cked by a passive marker sensor system to virtual computer image space either on a patients preoperat ve image data being processed by a Vector vision workstation or on an individual 3Dmodel of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray, MR based model of the anatomy. The system aids the surgeon to accuralely navigate a hip endoprothesis to the preoperatively or intraoperatively planned position.
Example orthopedic surgical procedures include but are not limited to:
Total Joint Replacement (TJR) Revision surgery of TJR Tumor resection and bone/joint reconstruction
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Device Description:
Device Description.
BrainLAB VectorV sion® Hip is intended to enable operational planning and navigation in orthopedic and Brainced vectory sion "The Is inched to bhable passive markers to virtual computer image space on an ilt lifes a surgical mistrument, traokou by ilohino passed on a patients preoperative image data or midwiddler SD-modil of the patient 3 band, while bone sufface. Vector Vision of Hip uses the registered generated through acquinny multiple lanathans the cup reamer, cup inserter, stem rasp, bone saw and the implant to the planned position. If no implant data is available it is possible to provide information in order implant to the plainted position. If he implant and the bone orientation as defined by the operating surgeon.
VectorVision® Hip allows 3-dimensional reconstruction of the relevant mechanical axes and planes of femur vector vision " hip allows of almendiation" Hip software has been designed to read in data and pervis and to:).ment of the implanter manufacturer and offers to individually choose the of miplants and tonio if provided by the ctorVision® Hip software registers the patient data needed for prosulesis uning :ach Surgery. The Toster New within the CT free module. The system can be used to planning and navillating the Surgery intre Sperial of William of the landman and any and generally and too "onemations as overing to the patient data can be used additionally for surgery, the patient data is then provided by the CT data stored on a standard data storage media.
Substantial equiv alence:
Substantial Cquit Inonoor
VectorVision® Hip has been verified and validated according to BrainLAB's procedures for product design violor video. This has bettle and effectiveness of the system. The information and devolopmont. The valication was found to be substantially equivalent with predicate devices such as the 510(k)-clearance of:
- VectorVision® Hip (K 010602) -
- Vector Vision® CT-free Knee (K 021306) -
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of a caduceus, which is a symbol often associated with healthcare and medicine. The caduceus in the logo is composed of three wavy lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2004
Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Ammerthalstrasse 8 Heimstetten Germany 85551
Re: K040368
Trade/Device Name: VectorVision® Hip 3.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: June 23, 2004 Received: June 28, 2004
Dear Mr. Birkenbach:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed 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 commerce prior to May 20, 1978, tive eccordance with the provisions of the Federal Food. Drug. de vices that have been recidentive require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mereleve, mains of the Act include requirements for annual registration, listing of general controlly profitering 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 If your device is olasbirred (overal 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 I lease be advised that the researce complies with other requirements of the Act that I 127 Has made a and regulations administered by other Federal agencies. You must or any I edena satisfer and see is 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 foruit in the quant) of the (Sections 531-542 of the Act): 21 CFR 1000-1050.
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Page 2 - Mr. Rainer Birkenbach
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow You to oegin mailing of substantial equivalence of your device to a legally premarket notification. The 717A midning of the more of the and thus, permits your device to proceed to the market.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acrite for your as 1) 594-4659. Also, please note the regulation entitled, Colliation of Compullios as (ot (on the motification" (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 your responser 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,
Miriam C. Provost
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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| 510(k) Number (if known): | K040368 |
|---|---|
| Device Name: | VectorVision ® Hip |
Indications For Use:
BrainLAB VectorVision is intended to be an intraoperative image guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space either on a patient's preoperative image data being processed by a Vector vision workstation on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray, MR based model of the anatomy. The system aids the surgeon to accurately navigate a hip endoprothesis to the preoperatively or intraoperatively planned position.
Example orthopedic surgical procedures include but are not limited to:
Total Joint Replacement (TJR)
Revision surgery of TJR
Tumor resection and bone/joint reconstruction
| Prescription Use(Per 21 CFR 801.109) | X | OR | Over-The-Counter Use ______ |
|---|---|---|---|
| ------------------------------------------ | --- | ---- | ----------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C Provost
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K040368
§ 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).