(33 days)
CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System S8 (V1.2.0), 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel for use with CoreLink pedicle screw and sacroiliac screw systems. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.
The purpose of this submission is to add instruments to the previously cleared CoreLink Navigation Instruments set to offer navigation compatibility with additional CoreLink pedicle screws.
The provided text describes a 510(k) summary for CoreLink Navigation Instruments. This document does not contain information about an AI/ML powered device, but rather a set of non-sterile, reusable manual surgical instruments designed to interface with a navigation system. As such, the specific criteria requested for AI/ML powered devices, such as performance metrics like ROC curves, sensitivity, specificity, and detailed study designs involving AI performance, are not applicable here.
However, I can extract information related to the performance evaluation of the CoreLink Navigation Instruments based on the provided text.
Here's an analysis of the available information regarding acceptance criteria and performance:
1. A table of acceptance criteria and the reported device performance
The document mentions "Performance testing per ASTM F2554 has been conducted to evaluate positional accuracy of the CoreLink Navigation Instruments". It also states that "An engineering analysis has been performed to show that the subject instruments present no new worst case for positional accuracy and that the previous testing is representative of the subject instruments."
However, the specific acceptance criteria (e.g., a defined threshold for positional accuracy) and the quantitative reported device performance values are not explicitly stated in this summary. It only indicates that testing per a standard was conducted and an engineering analysis confirmed representativeness.
2. Sample size used for the test set and the data provenance
The document refers to "Performance testing per ASTM F2554". ASTM F2554 is a standard for "Standard Test Method for Positional Accuracy of Computer-Assisted Surgical Systems." This standard outlines methods for testing, but the specific sample size (e.g., number of tests, number of instruments tested) used in the CoreLink study is not provided in this summary.
Similarly, the data provenance (e.g., country of origin, retrospective/prospective) related to this performance testing is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is geared towards AI/ML device evaluations where expert consensus often establishes ground truth for image interpretation or diagnosis. For a surgical instrument like the CoreLink Navigation Instruments, "ground truth" would typically relate to physical measurements of accuracy. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense is not directly applicable. The ground truth would be established by the measurement methods defined in ASTM F2554, likely involving precision measurement instruments and qualified test operators, but specifics are not provided.
4. Adjudication method for the test set
Similarly, adjudication methods (like 2+1 or 3+1) are common in studies where multiple human readers assess medical data for diagnostic agreement. For performance testing of a physical instrument's accuracy, a formal adjudication method among experts is not typically used. The "ground truth" is based on the precision of the measurement system itself. Details of any such process are 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
An MRMC study is relevant for evaluating the impact of an AI system on human diagnosticians. Since the CoreLink Navigation Instruments are physical surgical tools and not an AI diagnostic system, an MRMC comparative effectiveness study in the context of "human readers improve with AI" is not applicable. The device aids surgeons in locating anatomical structures in spinal surgery with the Medtronic StealthStation® System, not in diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is also specific to AI/ML software. The CoreLink Navigation Instruments are physical instruments. Therefore, a standalone performance evaluation of an "algorithm only" is not applicable.
7. The type of ground truth used
As mentioned in point 3, for physical surgical instruments, ground truth for performance testing (e.g., positional accuracy) would typically be established through highly accurate physical measurement systems and methodologies, often prescribed by standards like ASTM F2554. This is distinct from "expert consensus, pathology, or outcomes data" which are common for diagnostic AI/ML systems. The specific type of ground truth measurement system used is not detailed beyond reference to ASTM F2554.
8. The sample size for the training set
This question refers to the training of an AI/ML model. Since the CoreLink Navigation Instruments are physical surgical tools and not an AI system, there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
As there is no training set for this device, how its ground truth was established is not applicable.
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May 2, 2023
CoreLink, LLC % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K230880
Trade/Device Name: CoreLink Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 30, 2023 Received: March 30, 2023
Dear Nathan Wright:
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
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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 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 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-S
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
Submission Number (if known)
Device Name
CoreLink Navigation Instruments
Indications for Use (Describe)
CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System S8 (V1.2.0), 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 vertebra, can be identified relative to a 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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510(K) SUMMARY K230880
| Submitter's Name: | CoreLink, LLC |
|---|---|
| Submitter's Address: | 2072 Fenton Logistics ParkSt. Louis, Missouri 63026 |
| Submitter's Telephone: | 888-349-7808 |
| Contact Person: | Nathan Wright MSEmpirical Technologies719-351-0248nwright@empiricaltech.com |
| Date Summary was Prepared: | May 1, 2023 |
| Trade or Proprietary Name: | CoreLink Navigation Instruments |
| Common Name: | Orthopedic Stereotaxic Instruments |
| Device Classification Name: | Stereotaxic Instrument |
| Classification & Regulation #: | Class II per 21 CFR §882.4560 |
| Product Code: | OLO |
| Classification Panel: | Orthopedic - Stereotaxic, Trauma, and Restorative Devices (DHT6C) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel for use with CoreLink pedicle screw and sacroiliac screw systems. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.
The purpose of this submission is to add instruments to the previously cleared CoreLink Navigation Instruments set to offer navigation compatibility with additional CoreLink pedicle screws.
INDICATIONS FOR USE
CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System S8 (V1.2.0), 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
- Indications for use ●
- . Materials of manufacture
- . Principles of operation
Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|---|---|---|---|
| K220973 | CoreLink Navigation Instruments | CoreLink, LLC | Primary |
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| K170679 | Medtronic Navigated Reusable Instruments | Medtronic Sofamor Danek | Additional |
|---|---|---|---|
| K221776 | Nextgen Pedicle Screw System | CoreLink, LLC | Additional |
Performance Data
Performance testing per ASTM F2554 has been conducted to evaluate positional accuracy of the CoreLink Navigation Instruments as submitted under previous submissions of the CoreLink Navigation Instruments (K220973, K212825). An engineering analysis has been performed to show that the subject instruments present no new worst case for positional accuracy and that the previous testing is representative of the subject instruments.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the CoreLink Navigation 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).