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 fordosis)
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."

Device Description

The SIMPLEX Cervical Fixation System consists of plates and is used to build a spinal construct. The purpose of the SIMPLEX Cervical Fixation System is to provide stabilization during the development of a solid spinal fusion. The system is available in a variety of sizes. 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 screws are available in five lengths. The self-tapping thread of the screws eliminates the need for preliminary tapping.

AI/ML Overview

This document describes the SIMPLEX Cervical Fixation System, a medical device used for spinal stabilization. The information provided is from a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with detailed performance metrics and acceptance criteria in the way you've outlined.

Therefore, many of the requested categories – particularly those related to a study proving performance against acceptance criteria for an AI or diagnostic device – are not applicable to this type of submission. This is a mechanical implant, and its "performance" is generally assessed through mechanical testing and comparison to similar devices, not through a clinical trial with human readers or AI algorithms.

Here's a breakdown based on the provided text, indicating where information is present and where it's not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as numerical criteria. For mechanical devices, acceptance criteria often relate to material properties, design specifications, and performance in standardized mechanical tests (e.g., fatigue strength, pull-out strength). The document states testing was performed according to ASTM 1717.	"results comparable to other cervical plates." (This implies it met the expectations for such devices without providing specific numerical results.)

Explanation: The 510(k) summary primarily focuses on demonstrating that the SIMPLEX system is "substantially equivalent" to the predicate device (Radix Cervical Plate - K033951). For mechanical implants, this often involves showing similar materials, design principles, indications for use, and performance in standardized mechanical tests. Specific numerical acceptance criteria and a detailed comparison against them are typically part of the engineering design file, not usually summarized in this public 510(k) document. The key performance statement is that its "results [are] comparable to other cervical plates."

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

Sample Size: Not specified in the provided summary. Mechanical testing usually involves a defined number of test specimens (e.g., N plates or N screws) per test type.
Data Provenance: Not specified, but generally, mechanical testing data comes from laboratory tests conducted by the manufacturer or a third-party testing facility. It's not clinical data (retrospective or prospective).

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

Not Applicable. This is a mechanical medical device, not an AI or diagnostic tool requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for mechanical performance is established by the physical properties of the materials and component designs, and validated through engineering tests.

4. Adjudication method for the test set

Not Applicable. See point 3. Testing is against engineering specifications and industry standards, not subjective expert adjudication.

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

Not Applicable. This device is a surgical implant, not an AI-powered diagnostic or assistive tool. No human reader or AI interaction is involved in its direct function.

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

Not Applicable. This device is a surgical implant, not an algorithm.

7. The type of ground truth used

Not Applicable in the traditional sense. For mechanical devices, "ground truth" is typically derived from:
- Engineering specifications: Material properties, dimensional tolerances.
- Standardized test methods (e.g., ASTM 1717): These methods define how to measure performance (e.g., fatigue, static strength) and provide benchmarks or comparative data.
- Benchmarking against predicate devices: Showing similar performance characteristics to already-approved devices.

8. The sample size for the training set

Not Applicable. This device does not use machine learning or AI, so there is no "training set."

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

Not Applicable. See point 8.

Summary regarding "Study that proves the device meets the acceptance criteria":

The document states: "Testing was performed according to ASTM 1717 with results comparable to other cervical plates."

This single sentence is the "study" summary for this 510(k) submission. It indicates that the device underwent mechanical testing adhering to the ASTM F1717 standard, which is "Standard Test Methods for Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants." The key "proof" is the statement that the "results comparable to other cervical plates." This suggests that the SIMPLEX system met the expected mechanical performance profiles (e.g., static strength, fatigue life) typical for devices of its kind, as defined by industry standards and comparison to its predicate device. This comparison of performance to similar, legally marketed devices is the core of a 510(k) submission for this type of implant.

Summary

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K070335

Page 1 of 1

510(k) Summary for the SIMPLEX Cervical Fixation System

APR 16 2007

This safety and effectiveness summary for the SIMPLEX Cervical Fixation System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.

Date Prepared: January 31, 2007

1.	Submitter:	Contact Person:
	Pisharodi Surgicals, Inc.	J.D. Webb
	942 Wildrose Lane	The OrthoMedix Group, Inc.
	Brownsville, TX 78520	1001 Oakwood Blvd
	Telephone: 956-541-6725	Round Rock, TX 78681
		Telephone: 512-388-0199

2. Trade name:	SIMPLEX Cervical Fixation System
Common Name:	Anterior vertebral body fixation system
Classification Name:	Spinal Intervertebral Body Fixation Orthosis per 21 CFR section 888.3060

ന് Predicate or legally marketed devices which are substantially equivalent: Radix Cervical Plate - K033951

4. Description of the device:

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 screws are available in five lengths. The self-tapping thread of the screws eliminates the need for preliminary tapping.

ഗ് Intended Use:

The SIMPLEX Cervical Fixation System 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 fordosis)
. 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."

Comparison of the technological characteristics of the device to predicate and legally marketed devices: ల్.
The SIMPLEX Cervical Fixation System is similar in material, plate lengths, ability to angulate and lock the bone screws, pre-contoured plates and indications.

7. Summary of Nonclincal Tests

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

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three wing-like shapes, positioned to the right of a circular border. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pisharodi Surgicals, Inc. % Mr. J.D. Webb Authorized Contact Person 1001 Oakwood Blvd. Round Rock, Texas 78681

APR 16 2007

K070335 Re:

Trade/Device Name: SIMPLEX Cervical Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 16, 2007 Received: March 19, 2007

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.

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Page 2 - Mr. J.D. Webb

This letter will allow you to begin marketing your device as described in your Section 510(k) r market 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 in you attime of Compliance at (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Karbar Bonchra

Mark N. Melkerson Director Division of Gencral, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K070335

Device Name: ___ SIMPLEX Cervical Fixation System

Indications for Use:

The SIMPLEX Cervical Fixation System 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

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

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Saubare Buchun

Division of General, Restorative, and Neurological Devices

510(k) Number Ko 70335

Regulation Number and Section

N/A