The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Description

The Asfora Anterior Cervical Plate System is composed of plates of varying lengths to accommodate surgical procedures from one to four levels. The plates are designed for application to the anterior aspect of the cervical spine and have three locking tabs to reduce the potential for screws to back out of the vertebral body. The screws are provided in diameters of 4.0mm (Variable Angle Implant Screw and Fixed Angle Implant Screw) and 4.4mm (Rescue Screw) and lengths of 12mm, 14mm and 16mm.

AI/ML Overview

This document is a 510(k) premarket notification for the Asfora Anterior Cervical Plate System. It describes a medical device, and the information requested pertains to the performance evaluation and regulatory approval of AI/ML-driven medical devices. Therefore, a direct extraction of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML device performance is not applicable to this document.

However, I can extract the relevant information about the non-AI device's performance testing as described in the document.

Acceptance Criteria and Device Performance for the Asfora Anterior Cervical Plate System (Non-AI device):

The document does not explicitly present acceptance criteria in a table format with corresponding performance results. Instead, it states that "Mechanical testing was conducted, in accordance with Guidance for Industry and FDA Staff: Spinal System 510(k)s and ASTM F 1717-14 to ensure the device performs according to specification, to verify that the device is able to withstand clinical loading and maintain mechanical integrity, and is suited for its intended purpose."

The types of tests performed indicate the areas where performance had to be satisfactory to meet the specified standards.

Table of Performance Testing (Interpreted from the document):

Performance Metric Area	Reported Device Performance (Implied)
Mechanical Integrity & Clinical Loading Endurance	"able to withstand clinical loading and maintain mechanical integrity": This is the overarching implied acceptance criteria. The specific tests performed to demonstrate this include:
Dynamic Compression Bending	Conformed to specifications of "Guidance for Industry and FDA Staff: Spinal System 510(k)s" and "ASTM F 1717-14". (Specific values are not provided in this summary document, but the implication is that the device met the required thresholds for dynamic compression under these standards.)
Static Compression Bending	Conformed to specifications of "Guidance for Industry and FDA Staff: Spinal System 510(k)s" and "ASTM F 1717-14". (Specific values are not provided).
Static Torsion	Conformed to specifications of "Guidance for Industry and FDA Staff: Spinal System 510(k)s" and "ASTM F 1717-14". (Specific values are not provided).
Screw Insertion Torque Evaluation	Conformed to specifications of "Guidance for Industry and FDA Staff: Spinal System 510(k)s" and "ASTM F 1717-14". (Specific values are not provided, but implies satisfactory torque characteristics for surgical use).
Screw Retention Force Evaluation	Conformed to specifications of "Guidance for Industry and FDA Staff: Spinal System 510(k)s" and "ASTM F 1717-14". (Specific values are not provided, but implies screws remained securely in place under tested conditions).
Device performs according to specification	"ensure the device performs according to specification": Overall device functionality and design specifications were met.
Suited for its intended purpose	"suited for its intended purpose": The accumulated mechanical testing demonstrated the device is appropriate for its stated indications for use.

Regarding the specific questions about AI/ML device studies:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document describes mechanical testing of a medical implant, not an AI/ML device analyzing data.
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): Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus on data interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is objective physical measurement against established engineering standards (ASTM F 1717-14) and FDA guidance for spinal systems.
The sample size for the training set: Not applicable. There is no AI/ML model for which to describe a training set.
How the ground truth for the training set was established: Not applicable.

Summary for this document:

The document K143688 is a 510(k) premarket notification for a physical medical device (Asfora Anterior Cervical Plate System), not an AI/ML device. Therefore, the specific questions related to AI/ML device performance evaluation (such as test set sample size, data provenance, expert ground truth, MRMC studies, training set details) are not applicable to the information provided in this regulatory submission.

The "study" proving the device meets acceptance criteria is described as "Mechanical testing was conducted, in accordance with Guidance for Industry and FDA Staff: Spinal System 510(k)s and ASTM F 1717-14". The acceptance criterion is implied that the device "performs according to specification, to verify that the device is able to withstand clinical loading and maintain mechanical integrity, and is suited for its intended purpose" as defined by those standards. Specific quantitative results are not included in this summary document.

Summary

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

July 1, 2015

Medical Designs, LLC Ms. Kristi Vondra Vice President of Operations 6709 South Minnesota Avenue, Suite 204 Sioux Falls, South Dakota 57108

Re: K143688

Trade/Device Name: Asfora 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: June 3, 2015 Received: June 4, 2015

Dear Ms. Vondra:

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

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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 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/Resourcesfor You/Industry/default.htm. 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 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 vours.

Lori A. Wiggins -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

K143688

Page 1 of 1

510(k) Number (if known) K143688

Device Name

Asfora Anterior Cervical Plate (AACP) System

Indications for Use (Describe)

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)
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CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Summary

1. Submission Sponsor

Medical Designs, LLC 6709 S. Minnesota Ave., Suite 204 Sioux Falls, South Dakota 57108

2. Submission Correspondent

Kristi Vondra, Vice President of Operations Tel: (605) 275-1032 FAX: (605) 335-3734

3. Date Prepared

June 3, 2015

4. Device Identification

Trade/Proprietary Name:	Asfora Anterior Cervical Plate System
Common/Usual Name:	Anterior Cervical Plate System
Classification Name:	Spinal intervertebral body fixation orthosis
Classification Regulation:	21 CFR §888.3060
Product Code:	KWQ
Device Class:	Class II
Classification Panel:	Orthopaedic and Rehabilitation Devices Panel

5. Predicate Devices

Primary: K122497	Asfora Anterior Cervical Plate System
Additional: K030866	Synthes Cervical Spine Locking Plate

6. Device Description

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7. Indication for Use

8. Comparison to Predicates

No changes have been made to the intended use. Indications for Use, principle of operation or device materials of the cleared primary predicate Asfora Anterior Cervical Plate System. The subject device is identical to the primary predicate device except for the following differences. The additional plate and screw dimensions are substantially equivalent to the additional predicate.

Characteristic	Difference in Subject Device to Primary Predicate
Plate lockingmechanism	Locking tabs instead of locking rings
Plate dimensions	maximum plate width decreased from 19 to 17.5mm (in range of reference predicate)additional plate lengths at all 4 levels (in range of reference predicate)lateral hole to hole distance decreased (from 9 to 8.5mm)
Plate pre-bent angle	All plates pre-lordosed with a radius of 190mm
Screw Drive Feature	Square instead of hexalobe
Variable AngleImplant Screws	Added 4.0 x 12mm screw (in range of reference predicate); spherical head to fit plate recess
Variable AngleRescue Screw	Diameter decreased (5.0 to 4.4mm) and added 4.4 x 12mm screw (in range of reference predicate)
Fixed Angle Screws	Added fixed angle screws (in range of reference predicate); spherical head to fit plate recess and shank to match plate exit hole
Temporary FixationScrews	Removed from system; Casper Pin Style recommended for ease of use and functionality, but not provided
Extractor Assembly	Square interface instead of hexalobe
Drill Guide	Change in tip geometry to interface with spherical cavity of plate; addition of fixed angle drill guide configuration
Plate Bender	Simplified, off the shelf French bender
Retention Assembly	Nemcomed design; one-piece square driver with thermoplastic insert.
Sterilization Tray	Minor modification to hold redesigned cervical plates, screws and instruments

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9. Functional and Safety Testing

Mechanical testing was conducted, in accordance with Guidance for Industry and FDA Staff: Spinal System 510(k)s and ASTM F 1717-14 to ensure the device performs according to specification, to verify that the device is able to withstand clinical loading and maintain mechanical integrity, and is suited for its intended purpose. Testing included dynamic compression bending, static compression bending, static torsion, screw insertion torque evaluation and screw retention force evaluation.

10. Conclusion

Medical Designs. LLC considers the Asfora Anterior Cervical Plate System to be equivalent to the predicate Asfora Anterior Cervical Plate System listed above. This conclusion is based upon the device similarities in intended use, Indications for Use, principle of operation, materials and performance testing.

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.