The Choice Spine Navigation reusable instruments are intended to be used during preparation and placement of Choice Spine Lancer™ and Thunderbolt™ system screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Choice Spine Navigation reusable 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 skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Device Description

The Choice Spine Navigation instruments are non-sterile, reusable instruments designed to function with the Medtronic® StealthStation® System and SureTrak® II System. The Choice Spine Navigation instruments are for use with Choice Spine pedicle screw systems, specifically, the Lancer™ and Thunderbolt™ Pedicle Screw Systems. The instruments are manufactured from medical grade titanium and stainless steel.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Choice Spine Navigation System." This submission focuses on establishing substantial equivalence to a predicate device, rather than proving the device's absolute performance against a set of de novo acceptance criteria through extensive clinical studies, as might be required for a PMA or novel device.

The context of a 510(k) submission means the "device performance" and "acceptance criteria" are viewed through the lens of demonstrating equivalence to a legally marketed predicate. Therefore, the "study" proving it meets acceptance criteria is primarily an engineering and non-clinical performance assessment against a recognized standard (ASTM F2554-10).

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for a 510(k) is substantial equivalence to a predicate device. This is demonstrated by showing that the new device has "nearly identical technological characteristics" and that any minor differences "do not raise any new issues of safety and effectiveness."

The specific performance testing mentioned is for positional accuracy, as this is a critical function of a surgical navigation system.

Acceptance Criterion (Implicit for Substantial Equivalence via 510(k))	Reported Device Performance
Overall Safety & Effectiveness	"The overall technology characteristics and performance data lead to the conclusion that the Navigation System is substantially equivalent to the predicate device."
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, identical Indications for Use, Principle of Operation, Technical Characteristics including Sterility, Interfacing, Sizes).
Positional Accuracy (specific to navigation systems)	"The Navigation System has been tested per ASTM F2554-10, 'Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems.'""The results of this non-clinical testing show that performance of the Navigation System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." (No specific numerical accuracy values are provided in this summary document.)
Material Compatibility	The only difference cited is the use of additional materials (Radel, Ketaspire KT-820 CF30, Ti-6Al-4V per ASTM F136, and PTFE) in addition to stainless steel. The implication is that these materials are deemed safe and do not raise new safety concerns.

Important Note: The provided text is a summarization for FDA submission. It generally does not include the detailed numerical results from performance tests; instead, it states the conclusion that the performance was "sufficient for its intended use" and "substantially equivalent." Full test reports would contain the exact measurements.

Additional Information on the Study (Based on 510(k) Context)

Given this is a 510(k) submission, the "study" proving the device meets acceptance criteria is primarily a non-clinical performance study and comparison to predicates.

Sample sizes used for the test set and the data provenance:
- The document explicitly states "non-clinical testing" and references ASTM F2554-10. This standard typically involves laboratory-based measurements rather than human patient data.
- Therefore, the "test set" would consist of physical test setups or mock anatomy used to measure positional accuracy according to the ASTM standard.
- No specific sample size for "cases" is mentioned, as it's not a clinical study on patients. The "sample size" would relate to the number of measurements taken during the laboratory testing according to the standard.
- Data Provenance: The testing was conducted by Choice Spine, LP., based in the USA. It's non-clinical/bench testing, not retrospective or prospective patient data from specific countries.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For non-clinical performance testing like positional accuracy per ASTM F2554-10, expert consensus in the form of physical measurement standards and calibrated equipment establishes the "ground truth." There are no human experts adjudicating clinical images or outcomes.
- The "experts" involved would be engineers and technicians trained in metrology and the use of the specified testing equipment (e.g., optical tracking systems, coordinate measuring machines) to perform the measurements according to the standard. Their qualifications would be in engineering and quality assurance/testing.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in this context. Adjudication methods like 2+1 or 3+1 are used for human expert interpretation of clinical data (e.g., medical images) to establish a consensus ground truth.
- For non-clinical performance testing, the "ground truth" is derived from calibrated measurement devices and the precise execution of a standardized testing protocol (ASTM F2554-10). The results are quantitative measurements.
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, an MRMC study was not conducted for this submission.
- This device is a surgical navigation system, not an AI-assisted diagnostic imaging device. Its function is to guide physical instruments in real-time during surgery, not to interpret images or assist "human readers" in a diagnostic context.
- Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this device's intended use and assessment.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself is standalone in its measurement capability, but its intended use is inherently human-in-the-loop, assisting a surgeon.
- The "performance" tested (positional accuracy) reflects the algorithm's ability to track and display positions accurately. This test is a standalone assessment of the system's mechanical and computational accuracy, independent of a specific surgical procedure or patient.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the positional accuracy testing is based on metrological standards and precise physical measurements obtained from calibrated equipment according to ASTM F2554-10.
- It is not expert consensus on clinical findings, pathology, or patient outcomes data.
The sample size for the training set:
- Not applicable. This device is hardware and software for surgical navigation. It's not described as an AI/machine learning device that requires a "training set" of data in the typical sense (e.g., for image classification or prediction).
- Its functionality is based on established engineering principles (e.g., optical tracking, coordinate systems) and algorithms, not data-driven machine learning models that learn from a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of machine learning for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

January 8, 2019

Choice Spine, LP. % Meredith May Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K182721

Trade/Device Name: Choice Spine Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 19, 2018 Received: December 20, 2018

Dear Meredith May:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement on last page.
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Indications for Use
510(k) Number (if known)	K182721
Device Name	Choice Spine Navigation System
Indications for Use (Describe)

The Choice Spine Navigation reusable instruments are intended to be used during preparation
and placement of Choice Spine Lancer™ and Thunderbolt™ system screws during spinal
surgery to assist the surgeon in precisely locating anatomical structures in either open or
minimally invasive procedures. The Choice Spine Navigation reusable 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 skull, a long bone, or 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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Submitter's Name	Choice Spine, LP.
Submitter's Address	400 Erin Dr.Knoxville, TN 37919
Submitter's Phone	865.246.3333
Contact Person	Meredith Lee MayEmpirical Consulting719.337.7579mmay@empiricalconsulting.com
Date Summary wasPrepared	03 January 2019
Trade or Proprietary Name	Choice Spine Navigation System
Common or Usual Name	Orthopedic Stereotaxic Instrument
Classification	Class II per 21 CFR §882.4560
Product Code	OLO
Classification Panel	Orthopedic

510(K) SUMMARY

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The indications for use for the Choice Spine Navigation is similar to that of the predicate devices noted in Table 5-1: Predicate Devices.

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:

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Indications for Use ●
Principle of Operation ●
Technical Characteristics
- Sterility o
- Interfacing о
- Sizes O

The only difference between the subject and predicate device is the subject device utilizes different materials than the predicate device, which manufactured only from stainless steels. In addition to stainless steel, the subject device has Radel, Ketaspire KT-820 CF30, Ti-6Al-4V per ASTM F136 and PTFE.

Table 5-1: Predicate Devices

510k Number	Trade or Proprietary orModel Name	Manufacturer	Predicate Type
K150231	Navigated Disc PrepInstruments	Medtronic	Primary
K132049	Thunderbolt and LancerPedicle Screw System	Choice Spine,LP	Additional
K124004	Navigated CD HORIZON®SOLERATMScrewdrivers, CDHORIZON® SOLERATMTaps, CD HORIZON®SOLERATMIliac Taps and CDHORIZON® LEGACY™Taps	MedtronicNavigation, Inc	Reference

Performance Data

The Navigation System has been tested per ASTM F2554-10, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems".

The results of this non-clinical testing show that performance of the Navigation System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and performance data lead to the conclusion that the Navigation System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).