The VIPER PRIME navigated inserter is a navigated instrument for insertion of VIPER PRIME screws in open or percutaneous procedures. The VIPER PRIME navigated inserter is indicated for use in spinal surgical procedures, in which:

use of the VIPER System is indicated,
use of stereotactic surgery may be appropriate, and
where reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system which includes universal tracking arrays supplied by the navigation manufacturer.

These procedures include but are not limited to spinal fusion. The VIPER PRIME navigated inserter requires manual calibration.

Device Description

The VIPER PRIME™ navigated inserter is a reusable manual screwdriver for insertion of the VIPER PRIME screws of the VIPER System in open and percutaneous procedures. The VIPER PRIME navigated inserter also features attachment sites for universal tracking arrays supplied by the navigation manufacturer to enable use with the respective spine navigation system. The VIPER PRIME navigated inserter must be manually calibrated with the third-party navigation system.

AI/ML Overview

This document is not about an AI/ML powered device, but rather a navigated inserter for spinal surgery. Therefore, the questions related to AI/ML specific concepts like training sets, ground truth establishment for training, MRMC studies, and effect size of human reader improvement with AI assistance are not applicable.

However, I can extract information related to the device's acceptance criteria and the study proving it meets these criteria based on the provided text.

Based on the provided text for the VIPER PRIME navigated inserter, the primary method for demonstrating acceptable performance is through non-clinical sawbones testing. The document does not provide a formal table of acceptance criteria with specific numerical thresholds, nor does it detail a comparative study with a "reported device performance" against explicit criteria beyond general confirmation of function.

Here's an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table with quantitative acceptance criteria and corresponding reported performance metrics. Instead, the performance evaluation is described qualitatively as "confirm[ing] device performance for the intended use."

The study confirmed the following functions:

Acceptance Criteria (Implicit): The device should successfully allow for:
- Assembly with third-party universal tracking arrays.
- Manual calibration with the third-party navigation system.
- Navigated insertion of VIPER PRIME screws in a sawbones model.
- Final screw position in the software should be verifiable by a second imaging modality.
Reported Device Performance (Qualitative): The non-clinical sawbones testing "confirmed device performance for the intended use" by demonstrating successful assembly, manual calibration, and navigated insertion of screws, with verification of screw position using a second imaging modality.

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

Sample Size: The document only states "non-clinical sawbones testing" and "insertion of VIPER PRIME screws in a sawbones model." It does not specify the number of sawbones models used, the number of screws inserted, or the number of trials performed.
Data Provenance:
- Country of Origin: Not specified, but given the submission is to the FDA in the USA, the testing would likely adhere to US regulatory standards.
- Retrospective or Prospective: This was likely a prospective study designed to demonstrate performance for regulatory submission.

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

The document does not mention the use of human experts to establish "ground truth" for the test set in the way one might for an AI/ML diagnostic device (e.g., radiologist reads).
The ground truth in this context appears to be the physical confirmation of the screw's final position via a second imaging modality. It is implied that the test was performed by qualified individuals, but their specific roles or qualifications (e.g., orthopedic surgeons, engineers) are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable in the context of this device. There is no mention of consensus reading or multi-reader adjudication for establishing ground truth, as the "ground truth" is the physical location of the screw confirmed by imaging.

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 a surgical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader improvement with/without AI assistance was not performed.

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

Not applicable. This is a hardware device requiring human interaction and navigation system input. There is no standalone algorithm to evaluate.

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

The ground truth was established by physical verification of the final screw position using a second imaging modality after insertion in a sawbones model. This is a form of objective measurement/outcomes data within the controlled test environment.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable. There is no training set for this device.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Medos International, SARL % Laura Bleyendaal Senior Regulatory Affairs Specialist DePuy Synthes 325 Paramount Drive Raynham, Massachusetts 02767

September 14, 2017

Re: K170937

Trade/Device Name: VIPER PRIME navigated inserter Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 5, 2017 Received: May 8, 2017

Dear Laura Bleyendaal:

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. 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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K170937

Device Name VIPER PRIME™ navigated inserter

Indications for Use (Describe)

The VIPER PRIME navigated inserter is a navigated instrument for insertion of VIPER PRIME screws in open or percutaneous procedures. The VIPER PRIME navigated inserter is inspinal surgical procedures, in which:

· use of the VIPER System is indicated,

· use of stereotactic surgery may be appropriate, and

· where reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system which includes universal tracking arrays supplied by the navigation manufacturer. These procedures include but are not limited to spinal fusion. The VIPER PRIME navigated inserter requires manual calibration.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

A. Submitter Information

510(k) Sponsor:	Medos International, SARL
Contact Person:	Laura BleyendaalDePuy Synthes325 Paramount DriveRaynham, MA 02767
Telephone number:Fax number:Email:	(508) 828-3267(508) 828-3797Lbleyend@its.jnj.com
Date Prepared	September 13, 2017
Device Name
Trade/Proprietary Name:	VIPER PRIME™ navigated inserter
Common/Usual Name:	Orthopedic stereotaxic instrument
Device Classificationand Regulation:	Class II per 21 CFR § 882.4560

Classification Product and Panel OLO; Orthopedic Code:

D. Predicate Device Name

Primary Predicate Device: Synthes Navigable Pedicle Preparation Instruments (K122211)

Reference Devices: Stryker SpineMap® 3D Navigation System (K141941) Medtronic StealthStation『System (K133444) Brainlab (K070106)

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E. Device Description

F. Indications for Use

use of the VIPER System is indicated,
use of stereotactic surgery may be appropriate, and
where reference to a rigid anatomical structure, such as the pelvis or a ● vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system which includes universal tracking arrays supplied by the navigation manufacturer.

These procedures include but are not limited to spinal fusion. The VIPER PRIME navigated inserter requires manual calibration.

G. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use

The technological characteristics, including materials, design and performance of the VIPER PRIME navigated inserter are consistent with those of the primary predicate device. In brief, both the primary predicate and subject devices are indicated for use in open or percutaneous spinal surgical procedures in which the use of stereotactic surgery may be appropriate. The Synthes Navigable Pedicle Preparation instruments include awls, probes, taps, screwdrivers, a dilator, a guide tube and a pedicle access cannula while the VIPER PRIME navigated inserter is a screwdriver. The Synthes Navigable Pedicle Preparation instruments are manufactured from surgical grade metals, silicone and polyetheretherketone (PEEK), while the VIPER PRIME navigated inserter is manufactured from stainless steel, titanium alloy (Ti-6Al-4V) and polyphenylsulfone (RADEL"). Both the Synthes Navigable Pedicle Preparation instruments and VIPER PRIME navigated inserter feature attachment sites for universal tracking arrays supplied by the navigation manufacturer to enable use with the respective spine navigation system. The VIPER PRIME navigated inserter requires manual calibration and similarly, the Synthes

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Navigable Pedicle Preparation instruments include instruments which may be manually calibrated with the spine navigation systems.

H. Materials

The VIPER PRIME navigated inserter is manufactured from stainless steel, titanium alloy (Ti-6Al-4V) and RADEL .

l. Performance Data

Non-clinical sawbones testing was conducted to confirm device performance for the intended use. The testing consisted of assembly of the VIPER PRIME navigated inserter with the third party universal tracking arrays, manual calibration and navigated insertion of VIPER PRIME screws in a sawbones model. Final screw position in the software was confirmed using a second imaging modality.

J. Conclusion

The indications for use and intended use of the VIPER PRIME navigated inserter are consistent with those of the primary predicate device. The technological characteristics of the VIPER PRIME navigated inserter in terms of design, materials and performance are consistent with those of the predicate device. The VIPER PRIME navigated inserter is substantially equivalent to the primary 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).