(30 days)
Medtronic Navigated Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems.
Navigated surgical instruments are specifically designed for use with the 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, long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses described on the label and the instruments.
Medtronic Navigated Reusable Instruments are spine preparation instruments made of high-grade stainless steel. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. Placing Medtronic single-use sterile spheres on each of the tracker passive stems allows a Medtronic computer-assisted surgery system such as the StealthStation™ Image Guidance System to track the instruments in the surgical field. An instrument may incorporate a measuring function which has uses as described on the label and the instrument. Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems.
The provided text describes a 510(k) premarket notification for the Anteralign™ Spinal System with Titan NanoLOCK™ Surface Technology Navigated Instruments. It's a submission for a medical device to the FDA, asserting substantial equivalence to a previously cleared predicate device.
The document focuses on demonstrating that the new device has identical intended use, fundamental scientific technology, sterilization method, materials, and compatibilities with the StealthStation™ System as the predicate devices.
Crucially, this document highlights performance testing in a general sense, but it does NOT provide the specific acceptance criteria or the detailed results (e.g., numerical performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) that would typically be found in a detailed study report for AI/ML device performance.
Therefore, I cannot fulfill most of your request directly from the provided text, as it doesn't contain the detailed data for an AI/ML study. The device itself is "Navigated Instruments," not an AI/ML algorithm that would typically undergo the kind of performance validation you've outlined.
However, I can extract what is present regarding "performance data" which refers to engineering/bench testing rather than clinical AI/ML performance.
Here's an attempt to answer based on the engineering/functionality testing mentioned, noting where the information for an AI/ML study is not present:
Based on the provided FDA 510(k) summary, the device is the Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments. This is a set of navigated surgical instruments intended for use with the StealthStation™ System. The summary focuses on demonstrating substantial equivalence to a predicate device through functional and engineering testing, rather than an AI/ML performance study as typically seen with diagnostic algorithms.
Therefore, the information regarding "acceptance criteria" and "device performance" in the context of an AI/ML model's diagnostic accuracy (e.g., sensitivity, specificity, AUC) is not present in this document. Instead, the document discusses functional performance testing to ensure the instruments work as intended with the navigation system.
Here's a breakdown based on the information provided, and where information for an AI/ML study is absent:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes "Performance Data" which refers to the validation of the instruments' functionality and compatibility, rather than AI/ML model performance metrics. Specific numerical acceptance criteria and reported numerical performance values are not provided for these tests.
| Test Title | Description | Acceptance Criteria (Not Detailed) | Reported Device Performance (Not Detailed) |
|---|---|---|---|
| Navigation Accuracy Analysis | Confirmed navigated instrument accuracy in both 2D and 3D space | Confirmed accuracy (Specific numerical criteria not provided) | Passed (Specific numerical results not provided) |
| Anatomical Simulated Use | Confirmed instrument functionality under expected use conditions | Confirmed functionality (Specific criteria not provided) | Passed (Details of how functionality was confirmed not provided) |
| Navigated Simulated Use | Confirmed navigation system functionality under expected use conditions | Confirmed functionality (Specific criteria not provided) | Passed (Details of how functionality was confirmed not provided) |
| CAD Model Evaluation | Verified that the CAD models are accurately reflected in the application software | Verified accurate reflection (Specific metrics/tolerances not provided) | Passed (Details of verification not provided) |
| Implant/Instrument Mating Conditions | Verified that the instruments can be assembled with the appropriate devices according to their intended use | Verified proper assembly (Specific criteria not provided) | Passed (Details of verification not provided) |
| Spine Tools Package Functional Testing | Verified that the Spine Tools package has met the required interface needs of the spine application software | Verified required interface needs met (Specific criteria not provided) | Passed (Details of verification not provided) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable / not provided as the validation described is for physical instruments and software compatibility, not an AI/ML model evaluated on a test set of patient data (e.g., images).
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable / not provided for the type of engineering/functional testing described. Ground truth as typically understood for an AI/ML clinical study (e.g., expert radiological review) is not part of this submission's performance data section.
4. Adjudication Method for the Test Set
This information is not applicable / not provided as there is no mention of a human-reviewed test set requiring adjudication in the context of typical AI/ML performance studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable / not provided. The document describes functional testing of surgical instruments and their compatibility with a navigation system, not a comparative effectiveness study involving human readers assisted by AI.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable / not provided. The device is an instrument, not a standalone AI algorithm. While it integrates with a "StealthStation™ System" (a navigation system), the performance evaluation described focuses on the instruments' functionality and compatibility, not a standalone AI algorithm performance.
7. Type of Ground Truth Used
For the described functional tests, "ground truth" would be established by engineering specifications, successful physical mating, accurate measurements, and correct software rendering. This is distinct from clinical ground truth (e.g., pathology, follow-up outcomes, expert consensus on patient data) relevant for AI/ML diagnostic or prognostic algorithms.
8. Sample Size for the Training Set
This information is not applicable / not provided. There is no mention of a "training set" as this is not an AI/ML model for which training data would be used to develop.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable / not provided as there is no training set for an AI/ML model involved.
In summary: The provided FDA 510(k) document pertains to navigated surgical instruments and their functional validation, not to an AI/ML algorithm requiring a clinical performance study with detailed metrics on diagnostic accuracy, reader performance, or clinical ground truth. The "Performance Data" section lists engineering and functional tests to confirm the device's operation and compatibility, but it does not specify numerical acceptance criteria or detailed results.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
May 25, 2022
Medtronic Sofamor Danek USA, Inc. Elizabeth Hamilton Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K221180
Trade/Device Name: Anteralign™ Spinal System with Titan NanoLOCK™ Surface Technology Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 21, 2022 Received: April 25, 2022
Dear Elizabeth Hamilton:
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
{1}------------------------------------------------
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,
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K221180
Device Name
Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments
Indications for Use (Describe)
Medtronic Navigated Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems.
Navigated surgical instruments are specifically designed for use with the 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, long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses described on the label and the instruments.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) SUMMARY MEDTRONIC Sofamor Danek 20 April 2022
| Submitter: | Medtronic Sofamor Danek, USA Inc. |
|---|---|
| 1800 Pyramid Place | |
| Memphis, Tennessee 38132 | |
| Telephone: (901)399-3395 | |
| Fax: (901) 346-9738 | |
| Contact Person | Elizabeth Hamilton |
| Sr. Regulatory Affairs Specialist | |
| Email : elizabeth.c.hamilton@medtronic.com | |
| Alternate Contact: | Raphael McInnis |
| Sr. Regulatory Affairs Manager | |
| Email : raphael.mcinniss@medtronic.com | |
| Date Prepared: | 20 April 2022 |
| Name of Device | Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface |
| Technology Navigated Instruments | |
| Common Name | Navigated Instruments |
| Classification Name | Stereotaxic Instruments (21 CFR 882.4560) |
| Regulatory Class | Class II |
| Product Code | OLO |
| Predicate Devices | Primary Predicate -Anteralign™ TL Spinal System with Titan |
| nanoLOCK™ Surface Technology Navigated Instruments | |
| (K212524, S.E. 12/08/2021) |
{4}------------------------------------------------
Description of Device
Medtronic Navigated Reusable Instruments are spine preparation instruments made of high-grade stainless steel. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. Placing Medtronic single-use sterile spheres on each of the tracker passive stems allows a Medtronic computer-assisted surgery system such as the StealthStation™ Image Guidance System to track the instruments in the surgical field. An instrument may incorporate a measuring function which has uses as described on the label and the instrument. Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems.
Indications for Use
Medtronic Navigated Manual Reusable Instruments for Use with StealthStation™ System
Medtronic Navigated Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems.
Navigated surgical instruments are specifically designed for use with the 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, long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses described on the label and the instruments.
Comparison of Technological Characteristics with Predicate Devices
{5}------------------------------------------------
The subject Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments have an identical intended use, fundamental scientific technology, sterilization method, materials, and compatibilities with StealthStation™ System as the recently cleared predicate devices listed above. Please refer to the substantial equivalence section of this submission for more details.
Performance Data
Testing was rationalized or completed new to ensure the functionality and compatibility of the subject instruments when used with StealthStation™ System. The following table summarizes the performance testing that was rationalized or completed:
| Test | Description |
|---|---|
| Navigation Accuracy Analysis | Confirmed navigated instrumentaccuracy in both 2D and 3D space |
| Anatomical Simulated Use | Confirmed instrument functionalityunderexpected use conditions |
| Navigated Simulated Use | Confirmed navigation systemfunctionalityunder expected use conditions |
| CAD Model Evaluation | Verified that the CAD models areaccurately reflected in the applicationsoftware |
| Implant/ Instrument Mating Conditions | Verified that the instruments can beassembled with the appropriate devicesaccording to their intended use |
| Spine Tools Package Functional Testing | Verified that the Spine Tools packagehasmet the required interface needs of thespine application software |
{6}------------------------------------------------
Conclusion
Based on the information contained in this submission, Medtronic believes that the subject instruments are substantially equivalent to the predicate device.
§ 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).