(158 days)
Vital Navigation instruments are to be used during the preparation and placement of Vital and Vitality screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Vital Navigation instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
The Vital Navigation System is comprised of nonsterile, reusable instruments including awls, probes, taps, and drivers that can be operated manually. These instruments are intended to be used with the Medtronic Synergy™ Experience StealthStation® System to assist surgeons in precisely locating anatomical structures in either open or minimally invasive procedures for preparation and placement of Vital and Vitality screws. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.
The provided document is a 510(k) clearance letter for the Zimmer Biomet Vital Navigation System. It primarily outlines the regulatory approval for a medical device and its intended use, rather than detailing a study focused on the performance of an AI/algorithm against acceptance criteria.
The document discusses "accuracy testing of the stereotactic instruments" and cites ASTM F2554-18, which is a standard practice for measuring positional accuracy of computer-assisted surgical systems. This testing is for the hardware (instruments used in conjunction with the Medtronic StealthStation System), not an AI or algorithmic component that would require a study with human readers or AI-specific performance metrics like sensitivity, specificity, or AUC.
Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, and ground truth for training sets, are not applicable or not present in this regulatory clearance letter because the device is a set of physical surgical instruments, not an AI or software algorithm.
Here's a breakdown of the relevant information that can be extracted, and where the document is silent on AI/algorithmic performance:
Device: Vital Navigation System (non-sterile, reusable instruments: awls, probes, taps, drivers)
Function: To be used with the Medtronic StealthStation System to assist surgeons in precisely locating anatomical structures for placement of Vital and Vitality screws during spinal surgery.
1. A table of acceptance criteria and the reported device performance
Based on the document, the device's performance is tied to "accuracy testing" of its stereotactic instruments. The acceptance criteria are implicitly that the device "functioned as intended" and "demonstrated substantial equivalence" to predicate devices, particularly regarding positional accuracy. Specific numerical acceptance criteria for accuracy are not provided in this summary document, nor are specific numerical results.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Positional Accuracy (per ASTM F2554-18 - details not specified in document) | "In all instances, the proposed instrument system functioned as intended and demonstrated substantial equivalence to the predicate device(s)." |
| Safety and Effectiveness | "The assessment concluded that the use of the proposed stereotactic instruments for the implantation of Vital and Vitality screws are safe and effective for use." |
Note: This is an approval for physical instruments, not an AI system. The "performance" refers to the mechanical and operational accuracy of the instruments, not an algorithm's diagnostic or predictive capabilities.
2. Sample sized used for the test set and the data provenance
- Not Applicable/Not Provided for AI study. The document only mentions "accuracy testing" of the instruments per ASTM standards. It does not disclose the sample size (e.g., number of tests, number of cases/patients) or data provenance (e.g., country of origin, retrospective/prospective nature) for the engineering verification testing. This information would typically be detailed in the test reports, which are not part of the 510(k) summary provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This information is relevant for studies involving human interpretation or AI performance where expert ground truth is established. The device discussed here is a set of surgical instruments evaluated for mechanical/positional accuracy, not for diagnostic performance requiring expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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
- No. This is a hardware device (surgical instruments), not an AI assistance system for human readers. Therefore, an MRMC comparative effectiveness study is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. The device is a set of surgical instruments; there is no standalone algorithm. Its function is to assist in real-time surgical navigation when used with the Medtronic StealthStation System.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering/Physical Measurement: For the "accuracy testing" of the stereotactic instruments, the ground truth would have been established through precise engineering measurements of positional accuracy, likely using calibrated tools and fixtures as prescribed by ASTM F2554-18. It would not involve expert consensus on medical images or pathology.
8. The sample size for the training set
- Not Applicable. This device did not involve machine learning or a "training set" in the context of an AI algorithm. Its performance is based on its mechanical design and precise manufacturing.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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December 2, 2019
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Zimmer Biomet Spine, Inc. Alex Pawlowski Regulatory Affairs Senior Specialist 10225 Westminster Drive Westminster, Colorado 80021
Re: K191722
Trade/Device Name: Vital Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 31, 2019 Received: November 1, 2019
Dear Alex Pawlowski:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191722
Device Name Vital Navigation System
Indications for Use (Describe)
Vital Navigation instruments are to be used during the preparation and placement of Vital and Vitality screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Vital Navigation instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image contains the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is in a dark gray color.
K191722
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Preparation Date | June 26, 2019 |
|---|---|
| Applicant/Sponsor | Zimmer Biomet Spine, Inc.10225 Westmoor Dr.Westminster, CO 80021 |
| Contact Person | Alex PawlowskiRegulatory Affairs Senior SpecialistPhone: 303-533-1062Fax: 303-501-8444 |
| Alternate Contact | Ted KuhnRegulatory Affairs Associate DirectorPhone: 720-469-5055Fax: 303-501-8444 |
| Trade Name | Vital Navigation System |
| Common Name | Stereotaxic Instrument |
| Device Class | Class II |
| Classification Name | OLO - Orthopedic Stereotaxic Instrument (21 CFR 882.4560) |
Device Description & Technological Characteristics:
Orthopedic
The Vital Navigation System is comprised of nonsterile, reusable instruments including awls, probes, taps, and drivers that can be operated manually. These instruments are intended to be used with the Medtronic Synergy™ Experience StealthStation® System to assist surgeons in precisely locating anatomical structures in either open or minimally invasive procedures for preparation and placement of Vital and Vitality screws. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.
Device Panel
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Image /page/4/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is in a dark gray color, contrasting with the white background.
Intended Use / Indications for Use:
Vital Navigation System Instruments are to be used during the preparation and placement of Vital and Vitality screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Vital Navigation System Instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Summary of Technological Characteristics:
The technological characteristics of the subject Vital Navigation System components remain the same as, or similar to, the predicate Orthofix Navigated Instrument System (K172115) in regards to intended use, indications for use, design, manufacturing methods, fundamental technology, and operational principles. The purpose of this submission is to seek clearance for the release of stereotactic instruments for the implantation of Vital and Vitality screws, which utilize the existing Medtronic StealthStation system.
Summary of Performance Data:
To support substantial equivalence, accuracy testing of the stereotactic instruments of the subject Vital Navigation System were assessed and tested appropriately in accordance with ASTM standards. The assessment concluded that the use of the proposed stereotactic instruments for the implantation of Vital and Vitality screws are safe and effective for use. Performance testing included tests per ASTM F2554-18 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems. In all instances, the proposed instrument system functioned as intended and demonstrated substantial equivalence to the predicate device(s).
Predicate Devices:
Primary Predicate: Orthofix Navigated Instrument System (K172115)
Additional Predicates: Medtronic StealthStation (K140454)
Substantial Equivalence Conclusion:
The Vital Navigation System is substantially equivalent to the predicate system as a spinal fixation device in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, sterility, and operational principles. Furthermore, accuracy testing and other supporting information sufficiently demonstrate the substantial equivalence of the subject components to the Navigated Instrument System which has been cleared for stereotactic guidance during orthopedic surgery procedures. Based on this information, the subject device does not raise any new issues regarding the safety or efficacy when compared to its predicates.
§ 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).