The Slimplicity Solo Anterior Cervical Plate System is intended for anterior cervical fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

Device Description

The Slimplicity Solo Anterior Cervical Plate System consists of an assortment of plates and screws. Each Slimplicity Solo plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). Slimplicity Solo implants are composed of titanium alloy, as specified in ASTM F136. The components will be provided non-sterile.

AI/ML Overview

The provided text describes the mechanical testing performed for the "Slimplicity Solo Anterior Cervical Plate System" to establish its substantial equivalence to predicate devices. However, it does not explicitly state "acceptance criteria" in a quantitative table format or detail a "study that proves the device meets the acceptance criteria" in the way one might expect for an AI/software device.

Instead, the document focuses on demonstrating substantial equivalence through mechanical testing and comparison to predicate devices. The "acceptance criteria" here are implied by the performance of the predicate devices and the requirements of the ASTM F1717 standard.

Here's an attempt to structure the information based on your request, interpreting the provided text and acknowledging its limitations regarding typical "acceptance criteria" for a software device:

Acceptance Criteria and Study for the Slimplicity Solo Anterior Cervical Plate System

Based on the provided text, the acceptance criteria and the study conducted are focused on demonstrating substantial equivalence to predicate devices through mechanical testing. No specific quantitative acceptance criteria or detailed study results are reported in the provided snippets, but the conclusion of meeting the criteria is stated.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (Conclusion)
Mechanical Strength (per ASTM F1717)
- Static Axial Compression Bending (load to failure)	Substantially equivalent to predicate devices. (Specific quantitative results are mentioned as being in section 18 of the 510(k) submittal, but not provided here.)
- Static Torsion (load to failure)	Substantially equivalent to predicate devices.
- Cyclical Axial Compression (max. run out load at 5,000,000 cycles)	Substantially equivalent to predicate devices.
Design Similarity	Similar to predicates in thickness, width, and length.
Bone Screw Similarity	Similar to predicates in type, size, and length.
Material Usage	Same as used in predicate systems (titanium alloy, ASTM F136).
Intended Use	Same as the predicates.
Indications for Use	Same as the predicates.

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

The document does not specify a "test set" in the context of data for an AI/software device. Instead, it refers to mechanical testing of the physical implant device.

Sample Size for Mechanical Testing: Not explicitly stated. Mechanical testing typically involves a certain number of samples of the physical device components (plates and screws) to ensure statistical validity of the results, but the exact number is not provided in this summary.
Data Provenance: Not applicable in the context of data origin (e.g., country) as this is mechanical testing of a manufactured medical device.

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

This information is not applicable. The "ground truth" for mechanical testing is established by the specified standards (ASTM F1717) and engineering principles, not by expert human graders.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical data reviews (e.g., medical imaging), not for mechanical testing of physical devices.

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

This is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This document describes the mechanical testing of a physical implantable device, not an AI system.

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

This is not applicable. Standalone performance refers to the performance of an algorithm without human intervention. This document relates to a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical testing is based on:

Established engineering standards and methodologies outlined in ASTM F1717.
The performance characteristics of legally marketed predicate devices to which the new device is compared for substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. A "training set" refers to data used to train a machine learning model. This document describes the testing of a physical medical device.

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

This information is not applicable for the same reason as above.

Summary

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Image /page/0/Picture/0 description: The image shows the text "K112748." above the logo for Spinal USA. The logo is a black rectangle with the words "SPINAL" and "USA" in white. A graphic of a spine is between the two words.

JUL 1 1 2012

2050 Executive Drive Pearl, MS 39208

Ph: 601-420-4244 Fax: 601-420-5501

510(k) Summary

Date Summary Prepared:	July 18, 2011
Submitter Information:	Spinal USA
	2050 Executive Drive
	Pearl, MS 39208
Contact Name:	Frankie Cummins
Phone:	601-420-4244
Fax:	601-420-5501
E-mail:	fc@spinalusa.com
Device Trade Name:	Slimplicity Solo Anterior Cervical Plate System
Common Name:	Spinal Intervertebral Body Fixation Orthosis
Regulatory Number:	888.3060
Classification:	Class II
Product Code:	KWQ
INTENDED USE:

DEVICE DESCRIPTION:

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KII2748

MECHANICAL TESTING:

The Slimplicity Solo Anterior Cervical Plate System was mechanically tested per ASTM F1717. The objective of this test battery is to mechanically test the Slimplicity Solo Anterior Cervical Plate System using the following test methods:

Static Axial Compression Bending testing in a load to failure mode

Static Torsion testing in a load to failure mode

Cyclical axial compression testing to estimate the maximum run out load value at 5,000,000 cycles

Mechanical Test Conclusion:

The Slimplicity Solo Anterior Cervical Plate System is as safe as the predicates based on the following:

1. The design of the Slimplicity Solo Anterior Cervical Plate System is similar to the predicates in thickness, width, and length.
1. The Slimplicity Solo Anterior Cervical Plate System bone screw is similar to the predicates in type, size, and length,
1. The material used in the Slimplicity Solo Anterior Cervical Plate System is the same as used in the predicate systems.
1. The mechanical strength of the Slimplicity Solo Anterior Cervical Plate System is substantially equivalent to the predicate based on mechanical test results. The Slimplicity Solo Anterior Cervical Plate System test results are provided in section 18 of this 510(k) submittal. Mechanical strength substantial equivalence to predicates is shown in section 12.

The Slimplicity Solo Anterior Cervical Plate System is as effective as the predicate based on the following:

1. The intended use of the Slimplicity Solo Anterior Cervical Plate System is the same as the predicates.
1. The indication for use of the Slimplicity Solo Anterior Cervical Plate System is the same as the predicates.

The Slimplicity Solo Anterior Cervical Plate System is as safe and effective as its predicates.

EQUIVALENT DEVICE:

Documentation was provided which demonstrated the Slimplicity Solo Anterior Cervical Plate System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture.

The overall design of the Slimplicity Solo Anterior Cervical Plate System consists of plates and bone screws. The components are available in a variety of lengths in order to accommodate patient anatomy and are substantially equivalent to the predicate devices.

Components of the Slimplicity Solo Anterior Cervical Plate System are similar to the predicate systems. The size and shape of the Slimplicity Solo Anterior Cervical Plate System and predicate systems are similar. The Slimplicity Solo Anterior Cervical Plate System bone screw thread type, size and length are similar to the predicates. Material of both the plate and screws is the same as the predicates. Sterilization is the same as the predicates.

Predicate Devices:

Uniplate Anterior Cervical Plate System K042544 Synthes Anterior CSLP System K030866 Synthes Vectra-One System K071667

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, depicted with three thick, curved lines forming the body and wings. The eagle is facing towards the right side of the image.

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

Spinal USA, LLC % Mr. Frankie Cummins Engineering Manager 2050 Executive Drive Pearl, Mississippi 39208

JUL 1 1 2012

Re: K112748

Trade/Device Name: Slimplicity Solo Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 05, 2012 Received: July 05, 2012

Dear Mr. Cummins:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rollowed your your be 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 I ou may, therefore, mains 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 your device 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 1 toase be devised that I hat your device complies with other requirements of the Act than - Diederal statutes and regulations administered by other Federal agencies. You must or uny I vith all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 – Mr. Frankie Cummins

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI I all 007); doomig (21 OFF 803); good manufacturing practice requirements as set Gorth 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 rr you doo!!e bpv.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 note the 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 Tou may 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for
Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K112748

Indications for Use

510(k) Number (if known): __ Ku2748

Device Name: Slimplicity Solo Anterior Cervical Plate System

Indications for Use:

Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) . Division of Surgical. Orthopedic, and Restorative Devices

KII2748 510(k) Number

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.