DePuy Synthes Spine Dens Access System is comprised of screws and instruments. The screws are available in multiple lengths and will be offered non-sterile. The screws feature self-drilling, self-tapping tips, reverse cutting flutes and cancellous threads.

AI/ML Overview

The K132910 submission describes the DePuy Synthes Spine Dens Access System, a bone fixation fastener intended for fracture fixation of small bones and small bone fragments, including odontoid fractures. The submission relies on mechanical testing to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the provided information:

Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in a quantitative table. Instead, it mentions that "Mechanical testing was provided in order to provide data to support a substantial equivalence determination. These tests were performed to characterize the properties and functionality of the screw, as well as to allow comparison with established acceptance criteria." This implies that the device's performance in the mechanical tests met or exceeded the acceptance criteria, which were likely derived from the performance of the predicate devices or relevant industry standards.

The mechanical tests conducted were:

Torque to failure test
Cantilever bend test
Pull-out strength test
Insertion torque test

While the specific numerical results and acceptance thresholds are not detailed in this summary, the FDA's clearance (K132910) indicates that the device's performance was deemed acceptable for its intended use and substantially equivalent to the predicate devices.

Study Details

Detailed information regarding the specific studies (sample sizes, data provenance, ground truth establishment, etc.) directly related to this device's performance validation is not extensively provided in the summary. The provided submission is a 510(k) summary, which often provides a high-level overview rather than granular study details.

Based on the available text:

Sample size used for the test set and the data provenance: Not explicitly stated for each mechanical test. The data provenance is implied to be from internal lab testing conducted by Synthes Spine. No country of origin for the data is specified, but given the submitter is "Synthes Spine, West Chester, PA", it's reasonable to assume the testing occurred within the US or under their oversight. 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. The ground truth for this device's performance is established through objective mechanical testing against engineering specifications and predicate device performance, not expert consensus on medical images or clinical outcomes.
Adjudication method for the test set: Not applicable for mechanical testing.
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 (bone screw and instruments), not an AI-powered diagnostic or assistive tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
The type of ground truth used: The "ground truth" for the mechanical tests would be the established engineering specifications (e.g., maximum torque, bend strength, pull-out force) derived from industry standards (e.g., ASTM) and/or the performance characteristics of the predicate devices. The objective measurements from the tests are compared against these predetermined values.
The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning model.
How the ground truth for the training set was established: Not applicable.

Summary of Device Performance and Equivalence

The K132910 submission for the DePuy Synthes Spine Dens Access System demonstrates substantial equivalence to predicate devices (Synthes 4.0mm Cannulated Screw - K963192, HBS Headless Bone Screw - K020791, Headless Compression Screw - K112672) based on mechanical testing. The testing covered torque to failure, cantilever bend, pull-out strength, and insertion torque. While explicit numerical acceptance criteria and performance values are not detailed in this summary, the FDA's clearance indicates that the performed tests supported the claim of substantial equivalence in terms of design, materials, performance, intended use, and other relevant characteristics. No clinical studies were necessary for this determination.

Summary

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K132910

Page 1 of 2

510(k) Summary

Submitter:	Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380	DEC 16 2013
Contact Person:	Eugene BangRegulatory Affairs AssociateTelephone: (508) 977-3966Fax: (508) 828-3797
Date Prepared:	November 25, 2013
Trade Name:	DePuy Synthes Spine Dens Access System
Device Class:	Class II
Product Code(s):	HWC
Common Name:	Screw, Fixation, Bone
Classification Name:	Smooth or Threaded Metallic Bone Fixation Fastener
Regulation Number:	21 CFR 888.3040
Predicate Devices:	Synthes 4.0mm Cannulated Screw - K963192HBS Headless Bone Screw - K020791Headless Compression Screw - K112672
Device Description:	DePuy Synthes Spine Dens Access System is comprised of screws andinstruments. The screws are available in multiple lengths and will beoffered non-sterile. The screws feature self-drilling, self-tapping tips,reverse cutting flutes and cancellous threads.
Indications:	For fracture fixation of small bones and small bone fragments includingodontoid fractures.
Materials:	Manufactured from Titanium-6Aluminum-7Niobium Alloy conformingto ASTM F-1295

. .

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K132910

. . . . .

and the comments of the comments of the comments of

and the comments of the comments of

Comparison toPredicate Device:	The substantial equivalence of the subject device to the predicates indentifiedabove is based upon the equivalence of intended use, design (fundamentalscientific technology), materials, performance, sterility, and biocompatibility.
Non-clinical TestSummary:	Mechanical testing was provided in order to provide data to support asubstantial equivalence determination. These tests were performed tocharacterize the properties and functionality of the screw, as well as toallow comparison with established acceptance criteria.
	The following mechanical tests were conducted on the screw:
	Torque to failure test Cantilever bend test Pull-out strength test Insertion torque test
Clinical TestSummary:	No clinical data was necessary to demonstrate substantial equivalence, norsafety and effectiveness of this system.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002

December 16, 2013

Synthes (USA) Products, LLC Mr. Eugene Bang Regulatory Affairs Associate 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K132910

Trade/Device Name: DePuy Synthes Spine Dens Access System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 23, 2013 Received: September 24, 2013

Dear Mr. Bang:

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. Drue. 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 111 (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 manufacturing practice requirements as set

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Page 2 - Mr. Eugene Bang

ﺍﻟﻤﺎﻟﻴﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﻘﺎﺑﻠﺔ ﻭﺍﻟﻘﺎﺑﻠﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤ

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/Safetv/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance 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 yours.

Ronald院剑ean -S for

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

Enclosure

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1135-17 1944 1994 1994 1994 1999 1999 11

Indications for Use Statement

510(k) Number (if known): K132910

Device Name: DePuy Synthes Spine Dens Access System

Indications For Use:

For fracture fixation of small bones and small bone fragments including odontoid fractures.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L. Frank -S

Division of Orthopedic Devices

DePuy Synthes Spine Dens Access System

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.