The Reflex Anterior Cervical Plate (ACP) System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), tumors, deformities or curvatures (including kyphosis, lordosis or scoliosis), pseudoarthrosis, failed previous fusion and decompression of the spinal cord following total or partial cervical vertebrectomy.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Description

The Reflex ACP System consists of a bone plates (an anti-migration mechanism is preassembled to plates) and screws. Both components are available in a variety of lengths in order to accommodate patient physiology. The components are fabricated from titanium alloy as described in ASTM F-136, ISO 5832-3 and ASTM F-1813. The implants will be provided nonsterile.

AI/ML Overview

The provided text (K010115) is a 510(k) Premarket Notification for the Reflex Anterior Cervical Plate System. This document is a regulatory submission for a medical device and describes its intended use, design, and claim of substantial equivalence to already marketed devices.

However, the 510(k) summary does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance or clinical effectiveness studies as typically found for AI/imaging devices. Instead, it focuses on demonstrating substantial equivalence through similarities in materials, design, and intended use, and indicates "Testing has been conducted demonstrating substantial equivalence to a currently marked device." Such testing for an implantable device like an anterior cervical plate system would typically involve non-clinical performance testing (e.g., mechanical strength, fatigue, biocompatibility) rather than a clinical study with human readers or AI algorithms.

Therefore, most of the requested information regarding clinical studies, ground truth, expert opinions, sample sizes for test/training sets, or MRMC studies is not applicable to this 510(k) document.

Here's a breakdown of the information that can be extracted or inferred, and what is not present in the document based on your questions:

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

Acceptance Criteria Type	Acceptance Criteria (Not Explicitly Stated for Clinical Performance)	Reported Device Performance (Inferred/Implied)
Substantial Equivalence	To a legally marketed predicate device (materials, design, intended use).	"Equivalency of this device is based on similarities in intended use, materials, and design to other currently marketed anterior cervical plate systems."
Mechanical/Biocompatibility Performance	(Not explicitly detailed, but implied through standard medical device testing for implants).	"Testing has been conducted demonstrating substantial equivalence to a currently marked device." (This would typically include bench testing for mechanical properties and biocompatibility).
Clinical Performance (e.g., accuracy, sensitivity, specificity, patient outcomes)	(Not applicable for this type of 510(k), as it's not a diagnostic or AI device and no clinical efficacy study is described).	Not reported in this document.

2. Sample size used for the test set and the data provenance

Not applicable for a clinical test set. The "testing" mentioned refers to non-clinical performance (bench testing) to demonstrate substantial equivalence, not a clinical study with a patient test set.
The document does not provide details on the specifics of this non-clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is an implant, not a diagnostic tool requiring expert interpretation or ground truth establishment in a clinical sense.

4. Adjudication method for the test set

Not applicable. See point 3.

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

No. This is not an AI or diagnostic imaging device.

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

No. This is not an AI or algorithm device.

7. The type of ground truth used

Not applicable in the context of clinical "ground truth." For substantial equivalence of an implant, the "ground truth" equates to the established performance characteristics of the predicate device, which would be based on its intended use, materials, design, and previously demonstrated safety and effectiveness (likely through non-clinical testing and clinical history).

8. The sample size for the training set

Not applicable. This device does not involve an AI algorithm or a training set.

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

Not applicable. See point 8.

Summary of what the 510(k) document states about "proving" the device meets criteria:

The document states:

"Equivalency of this device is based on similarities in intended use, materials, and design to other currently marketed anterior cervical plate systems."
"Testing has been conducted demonstrating substantial equivalence to a currently marked device."

This means the device's "acceptance criteria" revolve around demonstrating that it is substantially equivalent to a device already on the market (the predicate device) in terms of its intended use, design, materials, and performance (likely mechanical and biocompatibility). The study proving this involves comparing these aspects of the Reflex Anterior Cervical Plate System to a predicate device and conducting relevant non-clinical tests to show similar performance characteristics. The specific details of these non-clinical tests (e.g., fatigue testing, tensile strength, biocompatibility studies) are not disclosed in this 510(k) summary but would be part of the full 510(k) submission.

Summary

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K010115

510(k) Premarket Notification

APR 1 6 2001

510(k) Summary of Safety and Effectiveness for the Reflex Anterior Cervical Plate System

Proprietary Name: Common Name: Classification Name and Reference

Regulatory Class: Device Product Code: For Information contact:

Reflex Anterior Cervical Plate System Anterior Cervical Plate System Spinal Invertebral Body Fixation Orthosis 21 CFR 8888.3060 Class II 87 KWQ Karen Ariemma, Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 Phone: (201) 760-8187 Fax: (201) 760-8435 January 12, 2001

Date Summary Prepared:

Intended Üse:

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Description:

Substantial Equivalence:

Equivalency of this device is based on similarities in intended use, materials, and design to other currently marketed anterior cervical plate systems. Testing has been conducted demonstrating substantial equivalence to a currently marked device.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles an abstract eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 2001

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K010115

Trade/Device Name: Reflex Anterior Cervical Plate System Regulation Number: 888.3060 Regulatory Class: II Product Code: KWQ Dated: April 1, 2001 Received: April 16, 2001

Dear Ms. Ariemma:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls Connisions 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Karen Ariemma

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark N Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K_

Device Name: Reflex Anterior Cervical Plate System

The Reflex ACP System is intended for anterior intervertebral screw fixation of the cervical The North ACP 2556211 is indicated for temporary stabilization of the anterior spine Spine at levelopment of cervical spine fusions in patients with the following indications:

mg the development of very (as defined by neck pain of discogenic origin with degeneration of . the disc confirmed by history and radiographic studies)
Trauma (including fractures) .
. Tumors
Deformities or curvatures (including kyphosis, lordosis or scoliosis) .
Pseudoarthrosis .
Failed previous fusion .
I and provious rations .

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use OR Prescription Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Mark N. Millhurn

rision Division of General, Restorative and Neurological Devices

510(k) Number K010115

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.