Precision Spine Navigation Instrumentation are intended to be used during the preparation and placement of Precision Spine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Precision Spine Navigation Instrumentation are specifically designed for use with the Medtronic Stealth Station 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 for the anatomy.

Device Description

Precision Spine Navigated Instruments are non-sterile, reusable instruments that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation® System to aid in implantation of associated Precision Spine screw implants. The instruments are manufactured from stainless steel per ASTM F899

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Precision Spine Navigation Instrumentation." It outlines the device's intended use and claims substantial equivalence to predicate devices, but it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria.

Specifically, the document is a regulatory submission rather than a research study report. It discusses the types of performance data collected (accuracy and precision testing per ASTM F2554-10, mating interface assessments, CMM inspection, instrument verification, and simulated use) but does not provide:

Specific acceptance criteria values.
Reported device performance values against those criteria.
Sample sizes for test sets (other than implying "simulated use" was done).
Provenance of data (country of origin, retrospective/prospective).
Number or qualifications of experts.
Adjudication methods.
Effect sizes for human readers with/without AI assistance (as this is not an AI device).
Standalone algorithm performance (as this is not an AI device).
Ground truth types with specifics.
Sample size for the training set (not applicable as it's not a machine learning device).
How ground truth for the training set was established (not applicable).

Therefore, I can only provide information based on what is present in the document, which is limited regarding a detailed study demonstrating acceptance criteria.

Based on the provided text, here is what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "Accuracy and Precision Testing of Navigation System per ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of computer Assisted Surgical Systems," and that "The accuracy and precision testing...was performed, per ASTM F2554-10." This ASTM standard defines methods for assessing accuracy, but the specific acceptance criteria (e.g., "accuracy must be within X mm") and the reported values achieved by the device are not detailed in this document. Therefore, a table with specific values cannot be created from this text.

Acceptance Criterion (Inferred from ASTM F2554-10)	Reported Device Performance (Not specified in document)
Positional Accuracy within defined limits	Details not provided
Orientation Accuracy within defined limits	Details not provided
Mating Interface Assessment (Proper fit/function)	Details not provided
CMM Inspection Tolerances	Details not provided
Instrument Verification (Functionality)	Details not provided
Simulated Use Performance	Details not provided

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated. The text mentions "The accuracy and precision testing...was performed" and "Simulated Use," implying a test set was used for these activities, but the number of tests or samples is not provided.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not specified. This device is an instrument for navigation, not an AI or diagnostic imaging device that typically requires expert-established ground truth in the same way. The testing mentioned appears to be engineering and performance verification.

4. Adjudication method for the test set:

Not applicable/Not specified.

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:

Not applicable. This device is "Navigation Instrumentation" and not an AI or diagnostic tool. It assists surgeons, but the documentation does not describe an MRMC study or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm-only device. It is a physical instrument used with an existing navigation system (Medtronic StealthStation System).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the performance tests mentioned (accuracy, precision, CMM inspection), the "ground truth" would likely be based on established engineering standards, calibration references, and design specifications. For example, CMM inspection measures against CAD models or specified tolerances. "Simulated Use" would likely have predefined successful outcomes. No "expert consensus," "pathology," or "outcomes data" in the diagnostic sense is described.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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September 27, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left is the Department of Health and Human Services logo, which is a stylized human figure. On the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Precision Spine % Ms. Meredith May Partnership Manager Empirical Consulting LLC 4628 Northpark Dr. Colorado Springs, Colorado 80918

Re: K181606

Trade/Device Name: Precision Spine Navigation Instrumentation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 4, 2019 Received: September 5, 2019

Dear Ms. 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/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.

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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4. INDICATIONS FOR USE STATEMENT

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

510(k) Number (if known) K181606 Device Name Precision Spine Navigation Instrumentation

Indications for Use (Describe)

Type of Use (Select one or both, as applicable) മ Prescription Use (Part 21 CFR 801 Subpart D) 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."

FORM FDA 3881 (7/17)

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5.510(K) SUMMARY

Submitter's Name:	Precision Spine
Submitter's Address:	2050 Executive DrivePearl, MS 39208
Submitter's Telephone:	973-455-7150
Contact Person:	Meredith L May RACEmpirical Consulting LLC719-337-7579
Date Summary was Prepared:	12 Jun 18
Trade or Proprietary Name:	Precision Spine Navigation Instrumentation
Common or Usual Name:	Orthopedic Stereotaxic Instrument
Classification:	Class II per 21 CFR §882.4560
Product Code:	OLO
Classification Panel:	Orthopedics

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

TECHNOLOGICAL CHARACTERISTICS

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Precision Spine Navigation Instrumentation is made from material that conforms to ASTM. 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
Structural support mechanism ●

Table 5-1 Predicate Devices

510kNumber	Trade or Proprietary or Model Name	Manufacturer	PredicateType
K153603	Alphatec Spine Navigation Instruments	Alphatec Spine, Inc.	Primary
K140454	Navigated CD HORIZON® SOLERA®Screwdrivers and Taps	Medtronic Sofamor Danek,USA Inc.	Additional
K121172	Reform Pedicle Screw System	Spinal USA	Reference
K173130	Reform® Midline Cortical Screw System	Precision Spine	Reference

Performance Data

The following testing was performed:

Accuracy and Precision Testing of Navigation System per ASTM F2554-10 Standard ● Practice for Measurement of Positional Accuracy of computer Assisted Surgical Systems
Mating Interface Assessments ●
CMM Inspection ●
Instrument Verification ●
o Simulated Use

The accuracy and precision testing of the position and orientation of the Precision Spine Navigation Instrumentation when used with Medtronic's O-Arm, StealthStation, and NavLock Spinal Instruments systems was performed, per ASTM F2554-10, Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Precision Spine Navigation 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).