degenerative disc disease (ddd) defined as back 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
failed previous fusion

Device Description

The Radix Cervical Plate is a one or two level plate that is secured to the anterior cervical vertebral bodies with unicortical bone screws. The plate is available in twelve lengths ranging from 38mm to 60mm in lengthe. It has six holes to receive the bone screws. The screw holes allow variable angulation of the screws.

Ease of intra-operative handling is enhanced by pre-contouring the plates in two directions to facilitate adaptation to the patient's anatomy and self-tapping uni-cortical screws, which shorten operating time. The acrews are 03.9mm and are available in five lengths, 10mm to 18mm. The self-tapping thread of the screws eliminates are ed or preliminary tapping.

AI/ML Overview

The provided text describes a 510(k) summary for the "Radix Cervical Plate," a medical device for spinal fixation. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study details, and AI-related aspects is not present in the document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as quantifiable metrics. The "acceptance criteria" for a 510(k) submission like this are generally demonstrating substantial equivalence to a previously legally marketed device (predicate device) in terms of intended use, technological characteristics, and safety/effectiveness. This is typically shown through non-clinical testing and comparison.
Reported Device Performance: The document states: "Testing was performed according to ASTM 1717 with results comparable to other cervical plates." This is a general statement about performance, but no specific numerical results or benchmarks are provided. Also, the "performance" here refers to mechanical integrity, not clinical outcomes related to the indications.

Acceptance Criteria (Implied for 510(k))	Reported Device Performance
Substantial equivalence to predicate devices (Synthes Anterior CLSP System (K030866) and EBI VueLock Cervical Plate (K010003)) in design, material, intended use, and technological characteristics.	"The Radix Cervical Plate is similar in material, plate lengths, ability to angulate and lock the bone screws, precontoured plates and indications."
Mechanical integrity and safety (e.g., strength, durability).	"Testing was performed according to ASTM 1717 with results comparable to other cervical plates."

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

Not applicable / Not provided. This document describes a non-clinical (mechanical) testing scenario, not a clinical trial with a "test set" of patient data. ASTM 1717 is a standard for mechanical testing of spinal implant constructs, which would involve physical samples of the device, not a population of patients.

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

Not applicable / Not provided. Ground truth definition by experts is relevant for clinical studies, especially those involving image analysis or diagnostic accuracy. This document details non-clinical mechanical testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable / Not provided. Adjudication methods are used in clinical trials to resolve discrepancies in expert opinions on patient outcomes or diagnoses. This is a non-clinical submission.

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 device is a physical spinal implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant or mentioned.

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

No. As above, this is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical testing (ASTM 1717), the "ground truth" would be established engineering principles and the mechanical properties/specifications defined by the ASTM standard. There's no biological "ground truth" in this context.

8. The sample size for the training set:

Not applicable / Not provided. "Training set" is a concept for machine learning models. This document describes a physical medical device and its non-clinical testing.

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

Not applicable / Not provided. See point 8.

Summary

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

510(k) Summarv

Date December 19, 2003

Submitter Pisharodi Surgicals, Inc. 942 Wildrose Lane Brownsville, TX 78520

Contact person J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681

512-388-0199

Common name Anterior vertebral body fixation system

Classification name

Spinal Intervertebral Body Fixation Orthosis per 21 CFR section 888.3060.

Equivalent Device

The Radix Cervical Plate is equivalent in design, material and indications as the Synthes Anterior CLSP System (K030866) and EBI VueLock Cervical Plate (K010003).

Device Description

Intended Use

Radix Cervical Plate is intended for anterior screw fixation of the cervical spine.

Indications for use include:

degenerative disc disease (ddd) defined as back pain of discogenic o rigin 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
. failed previous fusion

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

Summary of Technological Characteristics Compared to Predicate Device

The Radix Cervical Plate is similar in material, plate lengths, ability to angulate and lock the bone screws, precontoured plates and indications.

Summary Nonclinical Tests

Testing was performed according to ASTM 1717 with results comparable to other cervical plates.

JUL 0 1 2004

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a stacked formation.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 0 1 2004

Pisharodi Surgicals, Inc. C/o J.D. Webb The Orthomedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K033951

Trade/Device Name: Radix Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: April 19, 2004 Received: April 22, 2004

Dear Mr. Webb:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set 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.

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

Page 2 - J.D. Webb

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4692. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.html.

Sincerely vours.

Miriam C. Provost

Calia 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

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

510(k) number (if known): KO3399

Device Name: Radix Cervical Plate

Indications for Use:

Radix Cervical Plate Indications for Use

Radix Cervical Plate is intended for anterior screw fixation of the cervical spine.

Indications for use include:

· degenerative disc disease (ddd) defined as back 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
· failed previous fusion

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

Concurrence of CDRH, Office of Device Evaluation (ODE

Prescription Use V (per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional format 1-2-96)

)

Muriam C. Provost

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

510(k) Number K633951

Regulation Number and Section

N/A