(233 days)
The Zimmer Biomet Universal Navigation System is indicated for use during the preparation and insertion of Zimmer Biomet screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These adaptors 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 skull, a long bone or vertebra can be identified relative to an acquired image: CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Zimmer Biomet Universal Navigation System includes Universal Adaptors that are intended to be used with instrumentation from Vitality Spinal Fixation System (including Vital Power Instrument System), Pathfinder NXT Minimally Invasive Pedicle Screw System, and Polaris Spinal Fixation System (including Cypher MIS Screw System) to facilitate preparation and insertion of Zimmer Biomet screws using navigation.
Due to the nature of the provided document, which is a 510(k) summary for a medical device and not a study detailing specific acceptance criteria and performance data in the typical sense of AI/ML device testing, many of the requested fields cannot be directly extracted or are not applicable.
The document describes the Zimmer Biomet Universal Navigation System, a stereotaxic instrument for spinal surgery. The performance data provided focuses on accuracy testing of the instruments in accordance with a particular ASTM standard, rather than clinical performance metrics often associated with AI/ML systems (e.g., sensitivity, specificity, AUC).
Here's a breakdown based on the available information:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for performance in the format of a table with numerical targets and reported values. Instead, it refers to validation activities and accuracy testing. The primary performance claim is related to accuracy as measured by a standard practice.
Implied Acceptance Criterion: The device should meet the performance requirements for accuracy as defined by ASTM F24554-18.
Here's a table based on the summary of performance data presented in the document:
| Acceptance Criteria Category | Specific Metric / Study | Reported Device Performance |
|---|---|---|
| Accuracy | Positional Accuracy according to ASTM F24554-18 Standard Practice For Measurement of Positional Accuracy of Computer Assisted Surgical Systems. | "Validation activities are used to confirm the instruments meet performance requirements, providing assurance of device performance for their intended use, similar to predicate systems." Specific numerical results are NOT provided in this 510(k) summary. |
Missing Information: Crucially, the specific numerical results of the accuracy testing are not included in this 510(k) summary. The document states that "validation activities ... confirm the instruments meet performance requirements," implying that the acceptance criteria were met, but the criteria themselves (e.g., "accuracy must be within X mm") and the measured performance (e.g., "accuracy achieved Y mm") are not detailed here.
Additional Requested Information (Based on Document Content)
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Sample sized used for the test set and the data provenance: Not explicitly stated. The testing mentioned in the document is "Accuracy testing of the Zimmer Biomet Universal Navigation System Instruments" in accordance with an ASTM standard. This likely refers to in-vitro/bench testing, not a clinical test set with patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" are not applicable here.
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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 applicable. This device is not an AI/ML diagnostic or predictive tool that relies on expert interpretation to establish ground truth in a test set. The validation is for the accuracy of navigation instruments, which is typically measured against physical standards or known positions.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the reasons mentioned above.
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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: Not applicable. This is not an AI-assisted diagnostic or interpretation device that would involve human readers or an MRMC study. It's a navigation system designed to aid surgeons in precisely locating anatomical structures.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The "accuracy testing" mentioned is likely a standalone performance assessment of the navigation system's instruments, independent of a human surgeon's interaction during a live procedure, but it's not an "AI algorithm" in the typical sense. It is testing the instrument's ability to accurately track or guide.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): For positional accuracy testing of a navigation system, the ground truth would typically be established by highly precise measurement devices or known physical reference points in a controlled laboratory setting, not expert consensus or pathology.
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The sample size for the training set: Not applicable. This device is not described as an AI/ML device that undergoes a "training" phase.
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How the ground truth for the training set was established: Not applicable for the reasons mentioned above.
Conclusion based on provided text:
The provided document is a 510(k) summary for a navigation system, not an AI/ML diagnostic or predictive device. As such, many of the questions related to AI/ML device testing methodologies (like training sets, expert adjudication of ground truth, MRMC studies) are not applicable to the information presented. The key performance aspect is the accuracy of the navigation instruments, which was validated according to a recognized ASTM standard, though specific numerical results of this validation are not included in the summary. The FDA deemed this sufficient for substantial equivalence.
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October 24, 2019
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Zimmer Biomet Spine, Inc. Alex Pawlowski Regulatory Affairs Senior Specialist 10225 Westmoor Drive Westminster, Colorado 80021
Re: K190556
Trade/Device Name: Zimmer Biomet Universal Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: July 26, 2019 Received: July 29, 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/cfpmp/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 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
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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 medical devices and radiation-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,
For, 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) K190556
Device Name Zimmer Biomet Universal Navigation System
Indications for Use (Describe)
The Zimmer Biomet Universal Navigation System is indicated for use during the preparation and insertion of Zimmer Biomet screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These adaptors 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 skull, a long bone or vertebra can be identified relative to an acquired image: CT or MR based model, fluoroscopy images, or digitized landmarks of 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 shows the logo for Zimmer Biomet. The logo consists of a circular icon with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The icon and text are in a matching color, which appears to be a shade of blue.
K190556
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 | July 26, 2019 |
|---|---|
| Applicant/Sponsor | Zimmer Biomet Spine, Inc.10225 Westmoor Dr.Westminster, CO 80021 |
| Contact Person | Alex PawlowskiRegulatory Affairs Senior SpecialistPhone: 303-553-1062Ted KuhnRegulatory Affairs Associate DirectorPhone: 303-501-8549 |
| Trade Name | Zimmer Biomet Universal Navigation System |
| Common Name | Stereotaxic Instrument |
| Device Class | Class II |
| Classification Name | OLO - Orthopedic Stereotaxic Instrument (21 CFR 882.4560) |
| Device Panel | Orthopedic |
| Primary Predicate | K122211 Synthes Navigable Pedicle Preparation Instruments |
| Secondary Predicate | K133444 Medtronic StealthStation |
| Reference Devices | K132884 Pathfinder NXT Spine SystemK151974 Polaris Spinal Fixation SystemK171907 Vitality Spinal Fixation SystemK172275 Vitality+ Power Instrument System, Vitality Spinal FixationSystem |
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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 words "ZIMMER BIOMET" in a simple, sans-serif font. The text is in a dark gray or black color, providing a clear contrast against a white background.
Device Description & Technological Characteristics:
The Zimmer Biomet Universal Navigation System includes Universal Adaptors that are intended to be used with instrumentation from Vitality Spinal Fixation System (including Vital Power Instrument System), Pathfinder NXT Minimally Invasive Pedicle Screw System, and Polaris Spinal Fixation System (including Cypher MIS Screw System) to facilitate preparation and insertion of Zimmer Biomet screws using navigation.
Intended Use / Indications for Use:
The Zimmer Biomet Universal Navigation System is indicated for use during the preparation and insertion of Zimmer Biomet screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The universal adaptors 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 pelvis or vertebra, can be identified relative to an acquired image: CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Summary of Technological Characteristics:
The technological characteristics of the subject Zimmer Biomet Universal Navigation System components remain the same as, or similar to, the predicates in regards to intended use, indications for use, design, manufacturing methods, materials, and operational principles. The purpose of this submission is to seek clearance to introduce new adaptors designed to interface with the already-Cleared surgical navigation system, Medtronic StealthStation System using the Medtronic SureTrak II instruments and already-Cleared pedicle screw preparation and insertion instruments to facilitate preparation and insertion of Zimmer Biomet screws using navigation.
Summary of Performance Data:
Validation activities are used to confirm the instruments meet performance requirements, providing assurance of device performance for their intended use, similar to predicate systems. Accuracy testing of the Zimmer Biomet Universal Navigation System Instruments was performed in accordance with ASTM F24554-18 Standard Practice For Measurement of Positional Accuracy of Computer Assisted Surgical Systems. Clinical data was not needed for the Zimmer Biomet Universal Navigation System.
Substantial Equivalence Conclusion:
The Zimmer Biomet Universal Navigation System is substantially equivalent to the predicate system in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, materials and operational principles. Furthermore, validation testing and other supporting information sufficiently demonstrate the substantial equivalence of the subject components. 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).