A construct with screws attached to the pedicles of the lumbar and sacral spine (L3 to S1) and autogenous bone graft may be used only for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint (see warnings below). The device is intended to be implanted using a posterior surgical approach and removed after the development of a solid fusion mass.

When not used as a pedicle screw fixation system, various combinations of the Titanium Versalok Screw Assembly components are also indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1) during bony fusion healing secondary to:

Unstable spinal fractures (such as fracture dislocations) or instability secondary to spinal tumors;
Degenerative disk diseases of the spine (defined as back pain of diskogenic origin with degeneration of the disk confirmed by radiographic studies);
Spinal curvatures (such as idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity, and secondary to spinal fractures) which are:

Progressive, despite other forms of treatment,
Detrimental to cardiopulmonary function,
Interfering with spinal mechanics or causing severe back pain,
Cosmetically unacceptable, progressive, and painful.

The system is intended to provide temporary maintenance and support of the correction during the time normally needed for the fusion mass to mature. Use of spinal fixation instrumentation in children has been reported. Children should have adequate bony and soft tissue maturity to undergo implantation but need not have reached skeletal maturity.

Device Description

The Titanium Versalok Screw Assembly consists of straight rods, an outer ring, cap, and polyaxial screws, and the instruments necessary to implant this specific system. The Titanium Versalok Screw Assembly is intended to provide stabilization of the spine for various indications (see below). The device is intended to be removed after solid fusion has occurred.

AI/ML Overview

The device in question is the Titanium Versalok Screw Assembly, a spinal fixation device.

Based on the provided document, the device is being reviewed under a 510(k) Pre-market Notification for substantial equivalence to a predicate device, not as a novel device requiring extensive clinical trials for performance validation against acceptance criteria. Therefore, the information typically associated with establishing acceptance criteria and detailed study results for a new medical device, especially those involving AI or diagnostic accuracy, is not present.

The document indicates that "Mechanical test data was provided in the application" to demonstrate substantial equivalence. This suggests that the acceptance criteria and the "study" demonstrating compliance were likely related to engineering performance specifications (e.g., strength, fatigue, material compatibility) rather than clinical performance metrics in humans or AI algorithm accuracy.

Here's an attempt to address your request based on the limited information provided in a 510(k) summary for a spinal implant from 1999:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a spinal implant in 1999, the acceptance criteria would primarily be based on mechanical and material testing standards to demonstrate substantial equivalence to a predicate device. There would not be acceptance criteria related to "accuracy," "sensitivity," or "specificity" in the way one would describe an AI diagnostic device.

Acceptance Criteria Category (Hypothetical for a Spinal Implant)	Specific Criteria (Inferred)	Reported Device Performance (Inferred from "Mechanical test data was provided")
Mechanical Strength/Integrity	- Yield Strength & Ultimate Tensile Strength of components (e.g., screws, rods)- Torsional Strength of screws- Bending Strength of rods- Pull-out strength of pedicle screws from simulated bone- Fatigue life under cyclic loading (e.g., per ASTM F1717 for Spinal Implants or similar 1999 standards)	Met or Exceeded the mechanical performance characteristics of the predicate device (Versalok Screw Assembly) and relevant industry standards. The data provided demonstrated substantial equivalence in mechanical properties and performance. (Specific numerical results are not provided in this summary but would have been in the full submission).
Material Compatibility	- Biocompatibility of Titanium alloy (e.g., per ISO 10993 or equivalent 1999 standards)	Demonstrated Biocompatibility through material testing and/or established use of the specific titanium alloy in similar medical devices.
Functional Equivalence	- Compatibility of components (e.g., screw-rod interface)- Ease of implantation (as inferred from design)	Demonstrated Functional Equivalence to the predicate device in terms of design, assembly, and intended surgical use.

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of clinical "test sets" for diagnostic accuracy or AI performance. For mechanical testing, the "sample size" would refer to the number of components or constructs tested to meet statistical power requirements for mechanical properties. This information is not detailed in the summary but would have been part of the mechanical test report.
Data Provenance: Not applicable. The "data" here refers to mechanical test results, not clinical data from patients. The testing would have been conducted in a laboratory setting by the manufacturer or a contracted lab.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. Ground truth, in the context of an AI device or a diagnostic test, refers to a definitive diagnosis or outcome. For a spinal implant, "ground truth" relates to its physical and material properties, which are assessed through engineering tests, not expert consensus on medical images or patient outcomes for the device itself (though clinical outcomes for patients are certainly relevant post-market).
Qualifications of Experts: The "experts" would be engineers, material scientists, and biomechanics specialists responsible for designing, testing, and interpreting the mechanical and material data, ensuring compliance with relevant standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations of clinical data or images, which is not relevant to mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. This type of study is specific to evaluating human reader performance, often in diagnostic imaging, and is particularly relevant for AI-assisted workflows. This device is a passive spinal implant, not an imaging or diagnostic AI tool.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study was not done. This concept is exclusively for AI algorithms. The Titanium Versalok Screw Assembly is a physical medical device.

7. Type of Ground Truth Used

The "ground truth" for this device, in the context of its 510(k) submission, would be based on:
- Engineering Specifications and Standards: The ultimate "truth" against which the device's mechanical performance is measured would be the established industry standards (e.g., ASTM standards for spinal implants) and the performance characteristics of the legally marketed predicate device.
- Material Characterization: Scientific data on the properties of the titanium alloy used.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of mechanical testing for a spinal implant. This term relates to machine learning models.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary of the 510(k) Context:

The K990708 510(k) Summary indicates that the Titanium Versalok Screw Assembly was found substantially equivalent to the predicate Versalok Screw Assembly. The core of this submission, related to demonstrating performance, was the provision of "Mechanical test data."

In 510(k) reviews for non-diagnostic devices like implants, the "acceptance criteria" are generally derived from:

Performance of the predicate device: The new device must perform as safely and effectively as the predicate, often demonstrated through comparable mechanical properties.
Recognized consensus standards: Adherence to national and international standards for material properties, mechanical integrity, and biocompatibility (e.g., ASTM, ISO).

The "study" to prove the device meets these criteria would be a series of benchtop mechanical tests (e.g., fatigue testing, static load testing, pull-out strength) and material characterization tests, comparing the results to the predicate device and relevant standards. The provided document heavily implies that this comparative mechanical testing was the basis for the substantial equivalence determination.

Summary

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3/30/99

Attachment 7

Summary

K990708 510(k) Summary

Company: Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 Date: March 3, 1999 Trade Name: Titanium Versalok Screw Assembly Common Name: Spondylolisthesis Spinal Fixation Device System Predicate Device: Versalok Screw Assembly

Description/Intended Use: The Titanium Versalok Screw Assembly consists of straight rods, an outer ring, cap, and polyaxial screws, and the instruments necessary to implant this specific system. The Titanium Versalok Screw Assembly is intended to provide stabilization of the spine for various indications (see below). The device is intended to be removed after solid fusion has occurred.

A construct with screws attached to the pedicles of the lumbar and sacral spine (L3 to S1) and autogenous bone graft may be used only for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the fifth lumbar - first sacral (LS-S1) vertebral joint (see warnings below). The device is intended to be implanted using a posterior surgical approach and removed after the development of a solid fusion mass.

Unstable spinal fractures (such as fracture dislocations) or instability 1. secondary to spinal tumors:
1. Degenerative disk diseases of the spine (defined as back pain of diskogenic origin with degeneration of the disk confirmed by radiographic studies):
Spinal curvatures (such as idiopathic scoliosis, neuromuscular 3. scoliosis/kyphoscoliosis with associated paralysis or spasticity, and secondary to spinal fractures) which are:
- · Progressive, despite other forms of treatment.
- · Detrimental to cardiopulmonary function,
- · Interfering with spinal mechanics or causing severe back pain,
- or
- · Cosmetically unacceptable, progressive, and painful.

The Titanium Versalok Screw Assembly was declared substantially equivalent to other predicate or preamendment devices. Mechanical test data was provided in the application.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 1999

Mr. Dan Regan Director, Clinical and Requlatory Affairs Wright Medical Technology, Inc. 5677 Airline Road 38002 Arlington, Tennessee

K990708 Re: Titanium Versalok Screw Assembly Trade Name: Requlatory Class: II Product Codes: KWP and MNH Dated: March 3, 1999 March 4, 1999 Received:

Dear Mr. Regan:

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 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 - Mr. Dan Regan

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 the regulation entification" (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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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Attachment 3

Indications for Use Statement

510(k) Number (if known)

Device Name	Titanium Versalok
Indications for Use	A construct with screws attached to the pedicles of the lumbar and sacral spine (L3 to S1) and autogenous bone graft may be used only for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint (see warnings below). The device is intended to be implanted using a posterior surgical approach and removed after the development of a solid fusion mass.
	When not used as a pedicle screw fixation system, various combinations of the Titanium Versalok Screw Assembly components are also indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1) during bony fusion healing secondary to:
	1. Unstable spinal fractures (such as fracture dislocations) or instability secondary to spinal tumors;
	2. Degenerative disk diseases of the spine (defined as back pain of diskogenic origin with degeneration of the disk confirmed by radiographic studies);
	3. Spinal curvatures (such as idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity, and secondary to spinal fractures) which are:
	Progressive, despite other forms of treatment,Detrimental to cardiopulmonary function,Interfering with spinal mechanics or causing severe back pain,Cosmetically unacceptable, progressive, and painful.
	The system is intended to provide temporary maintenance and support of the correction during the time normally needed for the fusion mass to mature. Use of spinal fixation instrumentation in children has been reported. Children should have adequate bony and soft tissue maturity to undergo implantation but need not have reached skeletal maturity.
	PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
	Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K990208

Prescription Use
X
(per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

00028

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.