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.

Device Description

The Reflex " ACP System consists of bone 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 non-sterile. The design modification involves changes to the cutting flute, thread design, and color of the 14 mm length screw. In addition, several longer length screws have been added to the system.

AI/ML Overview

Based on the provided text, the document describes a design modification to an existing medical device, the Reflex™ Anterior Cervical Plate System Screws, rather than a study proving the device meets new acceptance criteria. The purpose of this submission (a Special 510(k)) is to demonstrate substantial equivalence to the predicate device, not necessarily to set and meet new performance-based acceptance criteria through a clinical study.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable or not provided in this type of regulatory submission because it focuses on demonstrating equivalency through design and material comparisons, often supported by bench testing, rather than a clinical performance study.

Here's a breakdown of the available information:

Description of the Acceptance Criteria and Study:

The document describes a design modification to the Reflex™ Anterior Cervical Plate System Screws. The modifications involve changes to the cutting flute, thread design, and color of the 14mm length screw, and the addition of several longer length screws. The purpose of the submission is to demonstrate "substantial equivalence" to a predicate device.

The "study" conducted for this submission appears to be bench testing rather than a clinical performance study involving patient data or human readers. The statement "Testing has been conducted demonstrating substantial equivalence to the predicate device" refers to such bench testing, which would typically involve mechanical and material property tests to ensure the modified screws perform at least as well as the original design. However, the specific acceptance criteria and detailed results of this testing are not provided in the summary.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Material properties meet ASTM F-136, ISO 5832-3, and ASTM F-1813	Components fabricated from titanium alloy as described in these standards.
(Performance equivalent to predicate device)	"Testing has been conducted demonstrating substantial equivalence to the predicate device." (Specific performance metrics are not detailed in this summary.)

Explanation:
The document does not explicitly state numerical acceptance criteria for performance outcomes like strength, fatigue life, or screw pull-out force. Instead, it relies on the concept of "substantial equivalence" to an existing predicate device, primarily through material and design comparisons, and general "testing." For a device modification of this nature, acceptance criteria would typically involve demonstrating that the modified components meet or exceed the performance of the original components through mechanical bench testing (e.g., torsion, bending, withdrawal strength, fatigue). However, the details of these tests and their specific acceptance criteria are not included in this 510(k) summary.

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

Sample Size: Not specified in the provided summary. This type of regulatory submission typically relies on bench testing, where sample sizes are determined by engineering validation protocols (e.g., a certain number of screws per test type for statistical significance). The document does not refer to a "test set" in the context of clinical data.
Data Provenance: Not applicable in the context of clinical data. Any "testing" would be laboratory/bench testing, not data from a specific country or collected retrospectively/prospectively from patients.

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

Number of Experts: Not applicable. For a device modification focusing on mechanical properties, ground truth is established through engineering standards, test methods, and potentially comparison to predicate device specifications, rather than expert clinical consensus on patient data.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This concept is relevant for studies involving human interpretation or clinical outcomes, not for mechanical device testing for design modifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No. An MRMC study is relevant for evaluating the performance of diagnostic devices often using human readers. This document describes a modification to a spinal implant, which does not involve human readers in the assessment of its primary function.
Effect Size: Not applicable.

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

Standalone Performance: Not applicable. This concept relates to the performance of AI/algorithms. This document describes a physical medical device (spinal implant), not a software or AI-driven diagnostic.

7. The Type of Ground Truth Used

Type of Ground Truth: For a physical device design modification, ground truth is typically established through:
- Engineering Specifications and Standards: Adherence to material standards (ASTM F-136, ISO 5832-3, ASTM F-1813).
- Mechanical Test Results: Comparison of the modified device's mechanical performance (e.g., strength, fatigue) against the predicate device or established performance requirements.
- Predicate Device Specifications: The performance and safety profile of the legally marketed predicate device serve as the benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This concept is for machine learning models.

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

How Ground Truth Was Established: Not applicable. This concept is for machine learning models.

Summary based on the provided document:

The document is a 510(k) summary for a design modification to a spinal implant. It focuses on demonstrating "substantial equivalence" to a predicate device through material composition and implied mechanical performance testing. The detailed acceptance criteria for this testing, along with specific performance metrics and sample sizes for mechanical tests, are not included in this summary. The concepts of clinical studies, human readers, experts for ground truth, or AI algorithms are not relevant to this particular regulatory submission.

Summary

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Design Modification to the Reflex " Anterior Cervical Plate System Screws

MAR 2 9 2002 Special 510(k) Summary for the Design Modification to the Reflex™ Anterior Cervical Plate System Screws

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 §888.3060 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 February 27, 2002

Date Summary Prepared:

Predicate Device Identification

Device Description

The design modification involves changes to the cutting flute, thread design, and color of the 14 mm length screw. In addition, several longer length screws have been added to the system.

Intended Use:

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

Statement of Technological Comparison:

Equivalency of this device is based on similarities in intended use, materials, and design to the predicate device. Testing has been conducted demonstrating substantial equivalence to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

MAR 2 9 2002

Re: K020650

Trade Name: Reflex™ Anterior Cervical Plate System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: February 27, 2002 Received: February 28, 2002

Dear Ms. Ariemma:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your becalling in the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the encreasure) to devices manonents, or to devices that have been reclassified in enactifield date of the Medical Doviet Famentalities, Crug, and Cosmetic Act (Act). You may, accordance with the provisions of the reachers read controls provisions of the Act. The general therefore, market the device, subject to the genirements for annual registration, listing of devices, controls provisions of the receined requirentibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III II your device is classified (sec above) into this. Controls. Existing major regulations (Fremarket Apploval), it may of sacreer to advant Federal Regulations, Title 21, Parts 800 to 895. allecting your device our be found nation assumes compliance with the current Good A Substantially Cqurvalent doterimmaters assorth in the Quality System Regulation (QS) for Manufacturing Fractice requirements, as of CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspections, are rood and Drug Nammoutation (xxx ) (x) addition, FDA may publish Comply with the GMI Teganaton may rounder in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might Itsponse to your premanter notins and shown 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" (21 CFR 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Mark McMillan

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_(220450

Device Name: Reflex Anterior Cervical Plate System

The Reflex 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
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.

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

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

(Per 21 CFR 801.109)

(Optional. Format 1-2-96)

Mark N Millerson

(Division Sign-Off) Drision of General, Restorative and Neurological Devices

510(k) Number K02065

Regulation Number and Section

N/A