The Emerge Medical Solid Bone Screws are intended to provide bone fixation in the management of osteotomies, fusions, and fractures of metaphysis and diaphysis of both small and large bones and the pelvis. The screws may be used alone or with washers.

Device Description

The Emerge Medical Bone Fixation screws consist of cancellous, cortical and shaft screws with washers, as needed, in a variety of sizes to accommodate differing anatomic requirements. The screws are provided non-sterile.

AI/ML Overview

This 510(k) submission (K122489) is for Emerge Medical Solid Bone Screws, which are bone fixation devices. The information provided heavily emphasizes the substantial equivalence of the device to its predicates rather than detailed performance metrics that would typically be associated with software or AI-driven devices. Therefore, the questions related to AI/software performance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, and stand-alone performance are not applicable in this context.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Goal)	Reported Device Performance
Device performs as well as or better than the predicate devices in static tests.	"Static tests performed according to ASTM 543 demonstrated that the device performs as well as or better than the predicate devices. Testing included screw variations in material, diameters, lengths, partial versus full threads, and drive types."
Material composition meets specified standards.	Titanium alloy (ASTM F136) and Stainless steel (ASTM F138). (This is an inherent characteristic that also serves as an acceptance criterion for material compliance).
Intended use, materials, general design, and sizes are equivalent to predicate devices.	"The fundamental scientific principles and technological characteristics, including the intended use, material, general design, and sizes of the device are the equivalent the predicate devices." (This is a statement of equivalence, which implies meeting the acceptance criteria for similarity to established devices).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a number of samples in the traditional sense for algorithm testing. The testing was physical, involving "screw variations in material, diameters, lengths, partial versus full threads, and drive types." The number of individual screws tested for each variation is not provided.
Data Provenance: Not applicable in the context of clinical data for this device. The testing was conducted in vitro (static tests) and not on patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not Applicable. This submission pertains to a physical bone fixation screw, not a device requiring expert interpretation of medical images or data to establish ground truth for a test set. The "ground truth" for this device's performance is derived from mechanical testing standards (ASTM 543).

4. Adjudication Method for the Test Set

Not Applicable. As the “ground truth” is based on objective mechanical testing against a standard (ASTM 543), there is no need for expert adjudication in the classic sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve With AI vs. Without AI Assistance

Not Applicable. This is a physical medical device (bone screw), not an AI/software device. No human readers or AI assistance are involved in its primary function or testing as described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used

Mechanical Testing Standards: The ground truth for performance relied on established engineering and material standards, specifically ASTM F543 ("Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications" or similar, applied to the performance of bone screws). The "ground truth" is that the device must meet or exceed the mechanical performance characteristics (e.g., torsion, bending, fatigue strength) demonstrated by the predicate devices or specified by the ASTM standard.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/software device. There is no concept of a "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable.

Summary of the Study Proving Acceptance Criteria:

The study involved static mechanical tests performed according to ASTM F543. These tests were conducted on various configurations of the Emerge Medical Solid Bone Screws, including variations in material (Titanium alloy ASTM F136; Stainless steel ASTM F138), diameters, lengths, partial versus full threads, and drive types. The results of these tests demonstrated that the device "performs as well as or better than the predicate devices" (Synthes K112583 and K061621) against the established mechanical performance standards.

The acceptance criteria centered on demonstrating substantial equivalence to predicate devices in:

Technological characteristics (intended use, material, general design, sizes).
Mechanical performance as measured by static tests.

The submission explicitly states, "Clinical data were not needed to demonstrate substantial equivalence for these devices," which is typical for Class II devices like bone screws when robust mechanical equivalence to established predicates can be shown through in vitro testing.

Summary

{0}------------------------------------------------

K122489(1)

DEC 1 0 2012

510(k) Summary
NAME OF FIRM:	Emerge Medical720 S. Colorado Blvd.Suite 550-SDenver, CO 80246
DATE PREPARED:	November 29, 2012
510(K) CONTACT:	Victoria TrafkaVice President of Engineering & QualityTel: (303) 225-7909
PROPOSED TRADE NAME:	Emerge Medical Solid Bone Screws
DEVICE CLASSIFICATION:	Class II; 21 CFR 888.3040
CLASSIFICATION NAME:	Smooth or threaded metallic bone fixation fastener
PRODUCT CODE:	HWC
DEVICE DESCRIPTION:	The Emerge Medical Bone Fixation screws consist of cancellous,cortical and shaft screws with washers, as needed, in a variety ofsizes to accommodate differing anatomic requirements.Thescrews are provided non-sterile.
INDICATIONS FOR USE:	The Emerge Medical Solid Bone Screws are intended to providebone fixation in the management of osteotomies, fusions, andfractures of metaphysis and diaphysis of both small and largebones and the pelvis. The screws may be used alone or withwashers.
MATERIALS:	Titanium alloy (ASTM F136)Stainless steel (ASTM F138)
PREDICATE DEVICES:	Synthes K112583 and K061621
TECHNOLOGICCHARACTERISTICS:	The fundamental scientific principles and technologicalcharacteristics, including the intended use, material, generaldesign, and sizes of the device are the equivalent the predicatedevices.
PERFORMANCE DATA:	Static tests performed according to ASTM 543 demonstrated thatthe device performs as well as or better than the predicatedevices. Testing included screw variations in material, diameters,lengths, partial versus full threads, and drive types. Clinical datawere not needed to demonstrate substantial equivalence for thesedevices.

Page 4 of 10-

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming the body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

· Letter dated: December 10, 2012

Emerge Medical % Ms. Victoria Trafka Vice President of Engineering & Quality 720 South Colorado Boulevard, Suite 550-S Denver, Colorado 80246

Re: K122489

Trade/Device Name: Emerge Medical Solid Bone Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: November 13, 2012 Received: November 14, 2012

Dear Ms. Trafka:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{2}------------------------------------------------

Page 2 - Ms. Victoria Trafka

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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,

Mark N. Melkerson

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

Enclosure

{3}------------------------------------------------

Indications for Use Statement

510(k) Number (if known):

Device Name: Emerge Medical Solid Bone Screws

Indications for Use:

The Emerge Solid Bone Screws are intended to provide bone fixation in the management of rile Emerge Oolle Bone Golows and finetaphysis and diaphysis of both small and large bones and the pelvis. The screws may be used alone or with washers.

Over-The-Counter Use __ × Prescription Use OL (21 CFR 807 Subpart C) (21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Krishna Asundi

for (Division Sign-Off) Division of Orthopedic Devices 2012.12.05 18:11:13 -05'00'

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.