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;
curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
tumor;
pseudoarthrosis;
and failed previous fusion.
This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Description

The USA Locking Plate System consists of a multiple sized plates and screws. All components are fabricated from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136 Fixation is provided by inserting screws through holes in the plate into the vertebral bodies of the thoraco-lumbar and lumbar spine. The bone plates offer slotted and round holes that allow the bone screws to be located and securely seated in various positions. There are two plate configurations available: the straight locking plate and the narrow locking plate. The screws include the universal locking screw, the self locking screw and the cancellous locking screw.

AI/ML Overview

The provided text describes a medical device, the "Universal Spinal Anterior Locking Plate System," and its 510(k) submission. However, the document does not contain information related to acceptance criteria, specific device performance numerical values, or details of a study that would prove the device meets such criteria.

The submission focuses on establishing substantial equivalence to a predicate device (Amset Locking Plate K905023) primarily based on design and indications, with the main difference being a change in material. It mentions "Engineering analyses show that the maximum allowable loads for the USA straight and narrow plates are greater than the predicate plate," but no specific loads, acceptance criteria, or a study report are provided.

Therefore, I cannot populate the table or answer most of the questions as the necessary information is not present in the provided text.

Here is what I can state based on the text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in the document	"Engineering analyses show that the maximum allowable loads for the USA straight and narrow plates are greater than the predicate plate." (Specific values and criteria not given)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not specified. The document mentions "Engineering analyses," which typically refers to mechanical testing or simulations, but no details on sample size or data provenance are provided.

3. 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/Not specified. This type of information is usually relevant for studies involving human interpretation (e.g., imaging studies or diagnostic devices). This document describes a surgical implant, and the assessment is based on engineering analyses.

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

Not applicable/Not specified. 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 a diagnostic device involving human readers or AI assistance.

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

No. This is not an algorithm-based device.

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

Not explicitly stated in terms of "ground truth" for a clinical study. For mechanical performance, the "ground truth" would be established physical material properties and mechanical testing standards. The document only mentions "Engineering analyses."

8. The sample size for the training set

Not applicable/Not specified. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable/Not specified. This device does not involve a "training set" or corresponding ground truth establishment in the context of machine learning or AI.

Summary

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1662686 C/ (

510(k) Summary Universal Spinal Anterior Locking Plate System

OCT = 5 2006

ﺪﻧﺴﺘﻤ ﻋﺪﺩ ﺳ

This safety and effectiveness summary for the Universal Spinal Anterior Locking Plate System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.

Date Prepared: September 4, 2006

1. Submitter: Contact Person: J.D. Webb Advanced Spine Technology, Inc. The OrthoMedix Group, Inc. 457 Mariposa St. 1001 Oakwood Blvd San Francisco, CA 94107 Round Rock. TX 78681 Telephone: 415-241-2400 Telephone: 512-388-0199
1. Trade name: Universal Spinal Anterior Locking Plate System Common Name: anterior spinal plate Classification Name: Spinal intervertebral body fixation orthosis per CRF 888.3060 KWQ

Predicate or legally marketed devices which are substantially equivalent: 3.

The Universal Spinal Anterior (USA) Locking Plate system is a modification to the Amset . Locking Plate (K905023).

4. Description of the device:

5. Intended Use:

The Universal Spinal Anterior Locking Plate System is intended for anterior/anterolateral fixation for the following indications:

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;
. curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
. tumor;
. pseudoarthrosis:
. and failed previous fusion.

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

6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:

The design and indications are similar. The main difference is the change of material from 316L stainless steel to Ti-6Al-4V titanium alloy.

7. Summary of Nonclincal Tests

Engineering analyses show that the maximum allowable loads for the USA straight and narrow plates are greater than the predicate plate.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT = 5 2006

Advanced Spine Technology, Inc % Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K062686

Trade/Device Name: Universal Spinal Anterior Locking Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 4, 2006 Received: September 8, 2006

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. Iisting 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, and 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) 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 (240) 276-0120. Also, please note the regulation on ); plan "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) 633-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Rabaue Buchur

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

Enclosure

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Indications for Use

19 //

1062686

510(k) Number (if known):

Device Name:

Indications for Use:

Spinal Anterior Locking Plate System is intended for Universal The anterior/anterolateral fixation for the following indications:

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; .
curvatures (i.e., scoliosis, kyphosis, and/or lordosis); ●
tumor; ●
pseudoarthrosis;
and failed previous fusion.

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Bishop

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

510(k) Number K062646

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.