DTRAX Spinal System is a set of instruments indicated to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.

Device Description

The DTRAX® Spinal System is a set of surgical instruments indicated for performing posterior cervical fusion. The instruments will be supplied sterile and single use only. The system consists of a facet joint access tool, lateral mass decortication trephine, mallet, cannula, decortication rasp, decortication burr, and tamp. In combination, these instruments allow the user to access the posterior cervical spine to perform posterior cervical fusion by decortication of bone surfaces, including the posterior lateral mass and facet joints, combined with application of autograft or allograft.

AI/ML Overview

The provided text describes the 510(k) submission for the DTRAX® Spinal System, a set of surgical instruments. The information focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and adherence to consensus standards. It does not contain the kind of detailed information about acceptance criteria and clinical study results (like MRMC studies, human reader improvement with AI assistance, ground truth establishment for training and test sets, etc.) that would be present for an AI/ML medical device.

Therefore, many of the requested details cannot be extracted from this document, as it pertains to a mechanical surgical instrument system, not an AI/ML medical device.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

Acceptance Criteria and Device Performance

The document does not explicitly present acceptance criteria in a table format with reported performance against specific metrics in the way one would see for an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, it states that "Non-clinical testing has demonstrated the DTRAX® Spinal System meets the performance requirements to safely distribute and use in accordance with the Indication for Use."

The performance assessment is described as:

Acceptance Criteria (Implied)	Reported Device Performance
Ability to perform posterior cervical fusion in cadavers.	"Simulated use cadaveric testing demonstrated the instruments can be used to perform posterior cervical fusion in patients with cervical degenerative disc disease."
Safety and efficacy of instruments; strength/integrity for impaction, insertion, removal, rotational loads.	"The bench testing demonstrated the safety and efficacy of the instruments and the strength and integrity to resist impaction, insertion, removal, and rotational loads to perform the stated intend use."
Compliance with specific FDA recognized consensus standards.	"Additionally, the DTRAX® Spinal System demonstrated that it is in compliance with the following FDA consensus standards:" (A list of 9 ISO/ASTM/ANSI standards related to sterilization, packaging, biological evaluation, and material properties is provided.) The implication is that the device met the requirements of these standards.

Study Details (as inferable from a non-AI/ML device submission)

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a numerical 'sample size' for a test set in the context of clinical images or patient data. The testing involved "simulated use cadaveric testing" and "bench testing." The number of cadavers or test repetitions is not specified.
- Data Provenance: The cadaveric testing implies a source of human cadavers (country of origin not specified). Bench testing is in-laboratory. The studies were non-clinical.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not present. This type of ground truth establishment is typically for AI/ML devices analyzing medical images. For a surgical instrument, performance is assessed through mechanical testing and cadaveric simulations, not through expert reading of results in the same way.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not present. Adjudication methods are relevant for interpretation of medical images or clinical outcomes, not for the mechanical performance of surgical tools.
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 is relevant for AI-assisted diagnostic devices. This document describes a surgical instrument, not an AI device, so no such study was conducted or reported.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual surgical instrument and does not involve an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the cadaveric testing, the "ground truth" was likely the successful completion of the surgical procedure and assessment of bone decortication/fusion preparation.
- For bench testing, the "ground truth" was meeting engineering specifications for strength, integrity, and compliance with recognized standards.
The sample size for the training set:
- Not applicable / Not present. This document describes a non-AI/ML medical device. "Training set" is a concept for machine learning algorithm development, which is not relevant here.
How the ground truth for the training set was established:
- Not applicable / Not present. As there is no AI/ML component, there is no training set or associated ground truth establishment process in the context of machine learning.

Summary

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May 18, 2018

Providence Medical Technology, Inc. Edward Liou Chief Operating Officer 3857 Hopyard Rd. Suite 300 Pleasanton, California 94588

Re: K180876

Trade/Device Name: DTRAX Spinal System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: April 2, 2018 Received: April 3, 2018

Dear Edward Liou:

We have reviewed vour 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 of medical device-related adverse events) (21 CFR 803); good

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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.

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.

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, Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K180876

Device Name DTRAX® Spinal System

Indications for Use (Describe)

DTRAX Spinal System is a set of instruments indicated to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.

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

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

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Section 6. 510(k) Summary

510(k) Owner:	Providence Medical Technology, Inc.3875 Hopyard Rd., Suite 300Pleasanton, CA 94588T: 415-923-9376F: 415-923-9377
Contact Person:	Edward LiouEmail: ed@providencemt.comT: 415-754-8593
Date Summary Prepared:	May 16th, 2018
Trade Name:	DTRAX® Spinal System
Common Name:	Arthroscopic Accessories
Device Classification Regulation:	21 CFR 888.1100
Device Product Code & Panel:	HRXOrthopaedic and Rehabilitation Devices Panel
Primary Predicate Device:	Vertos Medical, Inc. Vertos Medical mild® Device Kit (K093062)
Reference Devices:	Dyonics, Inc. The Arthrofile (K812506)Transcorp, Inc. Transcorp Spinal Access System (K113352)Aesculap, Inc. Hi Line XS disposable Rosen Burr III (Class I exempt)Medtronic Cervical FacetLift ID/S Instruments (Class I exempt)

Device Information

A. Device Description

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DTRAX® Spinal SystemCatalog# DX-22-100
1	PT-01-100	Access Chisel
2	PD-34-100	Access Chisel Handle
3	PD-05-200	Decortication Trephine
4	PD-04-000	Guide Tube
5	PD-02-101	Decortication Rasp
6	PD-02-300	Decortication Burr
7	PD-12-000	Bone Graft Tamp
8	PD-05-004	Fork Mallet

B. Indications for Use

DTRAX® Spinal System is a set of instruments indicated to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.

C. Summary of Technological Characteristics

The fundamental operational principles, surgical approach, design, materials, and performance of the DTRAX® Spinal System and the predicate device are essentially the same. Therefore, the technological characteristics of the DTRAX® Spinal System do not raise any new safety and effectiveness questions not addressed in the predicate device.

D. Summary of Performance Testing

Non-clinical testing has demonstrated the DTRAX® Spinal System meets the performance requirements to safely distribute and use in accordance with the Indication for Use.

Premarket Notification

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Simulated use cadaveric testing demonstrated the instruments can be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.
The bench testing demonstrated the safety and efficacy of the instruments and the strength . and integrity to resist impaction, insertion, removal, and rotational loads to perform the stated intend use.
Additionally, the DTRAX® Spinal System demonstrated that it is in compliance with the following FDA consensus standards:
- FDA Recognition Number 14-428: ISO 11137-1 First Edition 2006-04-15 Sterilization о Of Health Care Products - Radiation - Part 1: Requirements For Development, Validation And Routine Control Of A Sterilization Process For Medical Devices [Including: Amendment 1 (2013)]
- FDA Recognition Number 14-438: ISO 11137-2 Third Edition 2013-06-01 Sterilization o Of Medical Devices - Microbiological Methods - Part 2: Tests Of Sterility Performed In The Definition, Validation And Maintenance Of A Sterilization Process
- FDA Recognition Number 14-407: ISO 11737-1 Second Edition 2006-04-01 o Sterilization of Medical Devices – Microbiological Methods – Part 1: Determination of a Population of Microorganisms on Products
- o FDA Recognition Number 14-287: ISO 11737-2: 2009/(R) 2014 Sterilization of medical devices – Microbiological methods – Part 2: Tests of Sterility Performed in the Definition, Validation and Maintenance of Sterilization Process.
- FDA Recognition Number 14-457: ISO 11607-1:2006/(R)2010 Packaging For o Terminally Sterilized Medical Devices - Part 1: Requirements For Materials, Sterile Barrier Systems And Packaging [Including: Amendment 1 (2014)]
- FDA Recognition Number 14-458: ISO 11607-2:2006/(R)2010 Packaging for o Terminally Sterilized Medical Devices – Part 2: Validation Requirements for Forming, Sealing and Assembly Processes [Including: Amendment 1 (2014)
- O FDA Recognition Number 2-156: ANSI AAMI ISO10993-1:2009/(R)2013 Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process
- FDA Recognition Number 8-344: ISO 7153-1 Second Edition 1991-04-01 Surgical o Instruments -- Metallic Materials -- Part 1: Stainless Steel [Including: Amendment 1 (1999)]
- FDA Recognition Number 8-343: ASTM F899-12b Standard Specification for Wrought o Stainless Steels for Surgical Instruments

E. Basis of Substantial Equivalence

The DTRAX® Spinal System is substantially equivalent compared to the cleared primary predicate device, Vertos Medical, Inc., Vertos Medical Mild® Device Kit (K093062) and the reference devices, on the basis the devices have the same technological characteristics, similar design features, same materials and principles of operation. Performance data demonstrate that the DTRAX® Spinal System is as safe and effective as the predicate devices.

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.