Trauma, including spinal fractures and/or dislocations;
Spondylolisthesis;
Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity: and
Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radios and/ or (b) degenerative disease of the facets with instability.
The ALLY™ Facet Screws provide temporary stabilization as an adjunct to spinal fusion.

Device Description

The ALLY™ Facet Screws are permanent implant devices manufactured from Titanium-6AL-4V ELI. The device is available in a variety of diameters and lengths to accommodate patient anatomy. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved. The device is supplied sterile and single-use only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ALLY™ Facet Screws. This document focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and performance testing. It does not contain information typically found in a study proving a device meets acceptance criteria related to AI/ML performance.

Instead, the document details bench testing for a medical implant (facet screws) to demonstrate its mechanical properties and safety.

Here's an analysis based on the provided text, while noting the absence of AI/ML-specific study details:

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

The document states: "In all instances, the ALLY™ Facet Screws functioned as intended and met all pre-determined acceptance criteria. Bench testing results of the ALLY™ Facet Screws exceeded those of the predicate Spartan S Facet System."

While the specific numerical acceptance criteria values for each test are not explicitly provided, the document implies that such criteria exist and were met or exceeded. The tests performed are listed as:

Acceptance Criteria (Implied)	Reported Device Performance
Met pre-determined criteria for Static and Dynamic Cantilever Bending per ASTM F2193-14	ALLY™ Facet Screws functioned as intended and met all pre-determined acceptance criteria. Bench testing results exceeded those of the predicate Spartan S Facet System.
Met pre-determined criteria for Static Torsion Testing per ASTM F543-13	ALLY™ Facet Screws functioned as intended and met all pre-determined acceptance criteria. Bench testing results exceeded those of the predicate Spartan S Facet System.
Met pre-determined criteria for Static Pull-Out Testing per ASTM F543-13	ALLY™ Facet Screws functioned as intended and met all pre-determined acceptance criteria. Bench testing results exceeded those of the predicate Spartan S Facet System.
Met pre-determined criteria for Drive Torque per ASTM F543-13	ALLY™ Facet Screws functioned as intended and met all pre-determined acceptance criteria. Bench testing results exceeded those of the predicate Spartan S Facet System.
Met pyrogenicity criteria (e.g., Endotoxin limit of <20EU/Device) per FDA Guidance Documents and USP <85>	Pyrogenicity Testing was conducted in compliance, and Bacterial Endotoxin Testing (BET) was used to achieve the Endotoxin limit of <20EU/Device.

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

Sample Size: Not specified in the provided text. The document refers to "bench testing," which typically involves a specific number of manufactured devices or components for mechanical and biological evaluation.
Data Provenance: Not specified, but generally, such bench testing is conducted in-house by the manufacturer (Providence Medical Technology, Inc., located in Walnut Creek, California, USA) or at a contracted testing laboratory. The testing is prospective in the sense that physical tests are performed on the device prototypes/samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the provided document. The "ground truth" for mechanical testing is established by engineering principles, recognized ASTM standards, and bio-compatibility testing methods, not by expert medical interpretation. Pyrogenicity testing relies on laboratory standards like USP <85>.

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

Not applicable. Mechanical and biological testing results are typically objective measurements with pass/fail criteria based on standards, not subjective assessments requiring adjudication by multiple experts.

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 is a medical device (facet screws), not an AI/ML diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant to this submission.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for this device's performance evaluation is based on:

Established ASTM (American Society for Testing and Materials) standards for mechanical properties (e.g., F2193-14 for spinal fixation components, F543-13 for metallic bone screws).
FDA guidance documents and pharmacopeial standards (USP <85>) for biological safety (pyrogenicity/endotoxin testing).
These standards define the expected performance benchmarks.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable for the same reason as above.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and an abstract symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The abstract symbol is a stylized representation of a human figure, composed of three overlapping profiles facing to the right.

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

February 16, 2017

Providence Medical Technology, Inc. Mr. Edward Liou Chief Operating Officer 1331 North California Boulevard, Suite 320 Walnut Creek, California 94596

Re: K163374

Trade/Device Name: ALLYTM Facet Screws Regulatory Class: Unclassified Product Code: MRW Dated: January 17, 2017 Received: January 19, 2017

Dear Mr. Liou:

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 devicerelated 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.

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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 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 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) K163374

Device Name ALLY™ Facet Screws

Indications for Use (Describe)

The ALLY™ Facet Screws are indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:

Trauma, including spinal fractures and/or dislocations;
Spondylolisthesis;
Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity: and
Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radios and/ or (b) degenerative disease of the facets with instability.

The ALLY™ Facet Screws provide temporary stabilization as an adjunct to spinal fusion.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CER 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY

Providence Medical Technology, Inc.'s ALLY™ Facet Screws

Date Prepared:	February 8, 2017
Company:	Providence Medical Technology, Inc.1331 N. California Blvd., Suite 320Walnut Creek, CA 94596
Contact Person:	Edward LiouPhone: 415.923.9376Facsimile: 415.923.9377
Trade Name:	ALLY™ Facet Screws
Common Name:	Facet screw
ClassificationName:	System, Facet Screw Spinal Device
Product Code,Class:	MRW, Unclassified
Predicate Devices:
Primary Predicate: SpartanS3 Facet System (K092568, cleared 11/17/09)(This device has not been subject to recall.)
Additional Predicates:	Venus Facet Screw System (K120340, cleared 10/19/12)Facet Fixx (K131417, cleared 7/12/13)

Indications for Use:

The ALLY™ Facet Screws are indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:

1. Trauma, including spinal fractures and/or dislocations;
1. Spondylolisthesis;
1. Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity;
1. Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient

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history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

The ALLY™ Facet Screws provide temporary stabilization as an adjunct to spinal fusion.

Device Description

Technological Characteristics.

The ALLY™ Facet Screws have technical characteristics similar to the predicate devices. See table below for a comparison of technical attributes.

Technological Characteristics
ALLY™ Facet Screws(Subject Device)	Spartan S³ Facet System(Predicate Device)
Single use only implant	Same
Supplied sterile, individually packaged	Same
Implant material is 6Al-4V Titanium conforming toASTM F136	Same
Fully threaded and lag versions	Same
Self-drilling and self-tapping	Same

Performance Testing

The following testing was performed using the subject device and results were compared to those of the predicate 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

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ASTM F543-13 Standard Specification and Test Methods for Metallic Medical ● Bone Screws

Static Pull-Out Testing

· ASTM F543-13 Standard Specification and Test Methods for Metallic Medical Bone Screws

Drive Torque

ASTM F543-13 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"
- "Pyrogen and Endotoxins Testing: Questions and Answers" O
- Bacterial endotoxin testing (BET) as specified in USP <85> is used for o pyrogenicity testing to achieve the Endotoxin limit of <20EU/Device.

In all instances, the ALLY™ Facet Screws functioned as intended and met all pre-determined acceptance criteria. Bench testing results of the ALLY™ Facet Screws exceeded those of the predicate Spartan S Facet System. Therefore, the performance characteristics of the ALLYIM Facet Screws are substantially equivalent to those of the Spartan S Facet System.

Substantial Equivalence

The ALLY™ Facet Screws (subject device) are substantially equivalent to the Spartan S Facet System (predicate device cleared under K092568). When compared to the predicate device, the ALLYTM Facet Screws have the same:

indication for use;
implant material (Ti 6Al-4V ELI);
o design characteristics (fully threaded and lag versions);
o operating principle; and
o insertion method (via posterior spine).

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The subject devices are offered in a larger size range than that of the predicate device however, the ALLY™ Facet Screws are offered in the same size range as that of the reference devices. In addition, the Spartan S Facet System is cannulated while the ALLY™ Facet Screws are not. This difference does not affect the outer thread features of the subject device and thus the functional differences between the two devices are considered very minor. These minor differences between the ALLY™ Facet Screws and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the ALLY™ Facet Screws are substantially equivalent to the Spartan S3 Facet System.

Regulation Number and Section

N/A