The PMT Facet Screw is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The PMT Facet Screw is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1. The PMT Facet Screw is indicated for treatment of any or all of the following:

Pseudoarthrosis and failed previous fusion
Spondylolisthesis
Spondylolysis
Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies
Degeneration of the facets with instability; and
Fracture
The PMT Facet Screw is intended for conventional or tissue-sparing surgical placement.

Device Description

The PMT Facet Screw is available in fully threaded configurations with diameters of 3.5 mm, 3.75 mm and 4.0 mm and lengths of 13 mm to 25 mm (in 2 mm increments). The PMT Facet Screw is constructed of Titanium-6 Aluminum- 4 Vanadium ELI alloy (conforming to ASTM F136-13) and supplied sterile for single use only.

AI/ML Overview

The provided text describes the 510(k) summary for the PMT Facet Screw and details the performance testing conducted to demonstrate its substantial equivalence to predicate devices. It does not describe an AI/ML powered device, but rather a medical implant. As such, information regarding AI/ML-specific acceptance criteria, the study proving the device meets those criteria, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable or available in this document.

However, based on the provided text, I can extract information relevant to the non-AI device's performance testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "In all instances, the PMT Facet Screw functioned as intended and met all pre-determined acceptance criteria and do not raise new issues of safety or effectiveness; thus demonstrating that the PMT Screw is substantially equivalent to the legally marketed predicate device."

While specific numerical acceptance criteria for each test (e.g., minimum bending strength, torque values) are not explicitly detailed in the provided text, the successful completion of the tests against established ASTM standards and FDA guidance implicitly defines these criteria.

Test Type	Standard / Guidance	Acceptance Criteria	Reported Device Performance
Static and Dynamic Cantilever Bending	ASTM F2193-14 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System	Met requirements specified in ASTM F2193-14 for spinal skeletal fixation components (not explicitly detailed in text).	Functioned as intended, met all pre-determined acceptance criteria.
Static Torsion Testing	ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws	Met requirements specified in ASTM F543-17 for metallic medical bone screws (not explicitly detailed in text).	Functioned as intended, met all pre-determined acceptance criteria.
Static Pull-Out Testing	ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws	Met requirements specified in ASTM F543-17 for metallic medical bone screws (not explicitly detailed in text).	Functioned as intended, met all pre-determined acceptance criteria.
Drive Torque	ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws	Met requirements specified in ASTM F543-17 for metallic medical bone screws (not explicitly detailed in text).	Functioned as intended, met all pre-determined acceptance criteria.
Pyrogenicity Testing	"Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and FDA Staff"	Met pyrogenicity requirements outlined in FDA guidance (not explicitly detailed in text).	Functioned as intended, met all pre-determined acceptance criteria.
	"Pyrogen and Endotoxins Testing: Questions and Answers"	Met pyrogenicity requirements outlined in FDA guidance (not explicitly detailed in text).	Functioned as intended, met all pre-determined acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify the sample sizes used for each of the mechanical performance tests (e.g., number of screws tested for bending, torsion, pull-out, or drive torque). It also does not mention data provenance as these are laboratory-based physical tests, not clinical data.

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

Not applicable. The "ground truth" for the performance testing of this medical device is based on established engineering standards (ASTM) and regulatory guidance, not expert interpretation of clinical data in the traditional sense. These tests are objective measurements of physical properties.

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

Not applicable. This is not a study involving human adjudication of results, but rather objective mechanical and biological compatibility testing against predefined specifications.

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 implant, not an AI-powered diagnostic tool, and therefore MRMC studies are irrelevant here.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for the performance tests are the specifications and requirements defined by the referenced ASTM standards (F2193-14, F543-17) and FDA guidance documents for sterility and pyrogenicity. These are objective engineering and biological safety criteria.

8. The sample size for the training set:

Not applicable. There is no training set for a non-AI mechanical device.

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

Not applicable. There is no training set for a non-AI mechanical device.

Summary

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October 11, 2019

Providence Medical Technology, Inc. Janie Mandrusov, Ph.D. Vice President, Clinical and Regulatory Affairs 3875 Hopyard Road, Suite 300 Pleasanton, California 94588

Re: K183589

Trade/Device Name: PMT Facet Screw Regulatory Class: Unclassified Product Code: MRW Dated: September 20, 2019 Received: September 20, 2019

Dear Dr. Mandrusov:

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 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)

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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,

Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183589

Device Name PMT Facet Screw

Indications for Use (Describe)

The PMT Facet Screw is intended to spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet joint, and into the pedicle. The PMT Facet Screw is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1. The PMT Facet Screw is indicated for treatment of any or all of the following:

Pseudoarthrosis and failed previous fusion

1. Spondylolisthesis
1. Spondylolysis

Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies

1. Degeneration of the facets with instability; and

Fracture

The PMT Facet Screw is intended for conventional or tissue-sparing surgical placement.

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)

|XJ Prescription Use (Part 21 CFR

Cunter Use (21 CFR 801 Subbart Ci

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510(k) SUMMARY

Providence Medical Technology, Inc.'s PMT Facet Screw

Date Prepared:	September 20, 2019
Company:	Providence Medical Technology, Inc.3875 Hopyard Rd., Suite 300Pleasanton, CA 94588
Contact Person:	Janie MandrusovPhone:415.301.3128Facsimile:415.923.9377
Trade Name:	PMT Facet Screw
Common Name:	Facet Screw
ClassificationName:	System, Facet Screw Spinal Device
Product Code,Class:	MRW, Unclassified
Predicate Devices:

Primary Predicate: NuVasive Triad Facet Screw System (K020411, cleared 3/12/2012)

Additional Predicate: Venus Facet Screw System (K120340, cleared 10/19/12)

Indications for Use:

1. Pseudoarthrosis and failed previous fusion
1. Spondylolisthesis
1. Spondylolysis

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1. Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies
న్. Degeneration of the facets with instability; and
1. Fracture

The PMT Facet Screw is intended for conventional or tissue-sparing surgical placement.

Technological Characteristics:

Performance Testing

The following testing was performed using the subject device:

Static and Dynamic Cantilever Bending

ASTM F2193-14 Standard Specifications and Test Methods for Components . Used in the Surgical Fixation of the Spinal Skeletal System

Static Torsion Testing

ASTM F543-17 Standard Specification and Test Methods for Metallic Medical . Bone Screws

Static Pull-Out Testing

· ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws

Drive Torque

· ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws
In addition, the following testing was performed:

Pyrogenicity Testing

· Pyrogenicity Testing was conducted in compliance with the FDA Guidance Documents listed below:
- "Submission and Review of Sterility Information in Premarket o Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff"

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o "Pyrogen and Endotoxins Testing: Questions and Answers"

In all instances, the PMT Facet Screw functioned as intended and met all pre-determined acceptance criteria and do not raise new issues of safety or effectiveness; thus demonstrating that the PMT Screw is substantially equivalent to the legally marketed predicate device.

No clinical testing was deemed necessary to support substantial equivalence.

Substantial Equivalence

The PMT Facet Screw has the same indication for use, technological characteristics, and principles of operation as the predicate device. The successful completion of the performance testing further supports the subject PMT Facet Screw's substantial equivalence to the predicate device. No issues of safety or effectiveness are raised by the PMT Facet Screw.

Regulation Number and Section

N/A