have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; .
receive fusions using autogenous bone graft only; .
· have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
have the device removed after the development of a solid fusion. .

In addition, the UNI-T Uni-Thread Spinal System is a pedicle screw system intended to provide In addition, the UNF-1 Unl-Tiread Spinal System is a pkelers on on adjunct to fusion in fusion in fusion in immobilization and Sabilization of Spiralis in Skolouny Industry Industry of the thoracic, lumbar, and sacral spine:

Degenerative spondylolisthesis with objective evidence of neurologic impairment .
fracture ◆
. dislocation
scoliosis .
kyphosis .
spinal tumor .
failed previous fusion (pseudoarthrosis) .

Device Description

The UNI-T Uni-Thread Spinal System instrumentation consists of screws, rods and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The UNI-T System components are available in titanium alloy, manufactured according to ASTM F136.

AI/ML Overview

The provided text is a 510(k) summary for the UNI-T™ Uni-Thread Spinal System. This document describes a medical device (spinal instrumentation) and its indications for use, and it declares substantial equivalence to existing devices.

The information you are requesting, specifically acceptance criteria and a study proving a device meets acceptance criteria, is typically associated with performance studies for diagnostic devices or those with quantifiable performance metrics that are clinically assessed. For a spinal implant system like this, the "acceptance criteria" and "study" are primarily focused on mechanical testing to demonstrate equivalence and safety, rather than a clinical performance study with specific sensitivity, specificity, or similar metrics.

Based on the provided text, here's an attempt to extract relevant information according to your request, but please note that some of your requested categories are not directly applicable or explicitly detailed for this type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Equivalence in design, material, and indications to predicate devices for posterior spinal use.	Components are similar in design, material, and indications to other cleared spinal instrumentation systems.
Satisfactory mechanical performance to withstand stresses associated with spinal instrumentation.	"Mechanical testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal systems."

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

Test Set Sample Size: Not specified. "Mechanical testing" typically involves a specific number of constructs tested under various loading conditions, but the exact number of samples is not detailed in this summary.
Data Provenance: Not specified, but likely refers to laboratory testing data (in-vitro mechanical tests) rather than clinical patient data.

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

This category is not applicable for this type of device and submission. "Ground truth" established by experts in the context of diagnostic performance (e.g., radiologists interpreting images) is not relevant for a mechanical implant. For mechanical testing, the "ground truth" is defined by established engineering standards and test protocols.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used in clinical studies involving interpretation or outcome assessment by multiple experts, which is not described for this device.

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 is not an AI/diagnostic device.

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

Not applicable. This is not an algorithm/diagnostic device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this device, the "ground truth" for mechanical performance is established through adherence to recognized mechanical testing standards and protocols (e.g., ASTM standards for medical implants). This involves measuring properties like fatigue strength, pull-out strength, and bending stiffness according to predefined methods, and comparing these results to predicate devices or established minimum performance criteria. The text explicitly mentions "Mechanical testing was performed to demonstrate the equivalence."

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device that requires a training set.

Summary of the Study Discussed (Mechanical Testing):

The primary "study" mentioned to support the UNI-T™ Uni-Thread Spinal System's safety and effectiveness is mechanical testing.

Objective: To demonstrate the equivalence of the construct design to currently marketed spinal systems.
Methodology (implied): The mechanical testing would have involved subjecting samples of the UNI-T System components (screws, rods, connectors) and assembled constructs to various mechanical loads and conditions (e.g., static and dynamic loading, fatigue testing) as specified by relevant industry standards (e.g., ASTM F1717 for Spinal Implant Constructs, ASTM F1798 for fatigue testing of pedicle screw spinal systems).
Conclusion: The tests demonstrated the device's equivalence, implying that its mechanical performance characteristics are comparable to the predicate devices (SCS Claris Spinal System, Orthotec, Inc., and CD Horizon Sofamor Danek) which have already been cleared by the FDA. This equivalence in mechanical performance provides the scientific basis for demonstrating the device's safety and effectiveness for its intended use, as it suggests the device can withstand the physiological forces it will encounter in the body.

Summary

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FEB 1 3 2002

K013301

Image /page/0/Picture/2 description: The image shows the SpineVision logo. The logo consists of a stylized "S" shape above the word "SpineVision". The "S" shape is gray and black, and the word "SpineVision" is black. There is also a small "TM" symbol to the right of the word "SpineVision".

Spine systems for specialists

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	SpineVision, Inc.3003 Summit Blvd.Suite 1500Atlanta, GA 30319Phone: 404-460-5077
510(K) CONTACT:	Lynnette WhitakerVice President, Regulatory Affairs219-269-3701
TRADE NAME:	UNI-T™ Uni-Thread Spinal System
COMMON NAME:	Rod and Screw Spinal Instrumentation
CLASSIFICATION:	888.3070 Pedicle Screw Spinal System
DEVICE PRODUCT CODE:	Product code: 87 MNH, MNI
SUBSTANTIALLYEQUIVALENT DEVICES:	SCS Claris Spinal System, Orthotec, Inc.CD Horizon Sofamor Danek

DEVICE DESCRIPTION:

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K013301 2/2

INDICATIONS FOR USE:

The UNI-T Uni-Thread Spinal System is a pedicle screw system indicated for skeletally mature patients who:

have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; .
receive fusions using autogenous bone graft only; .
have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and ●
have the device removed after the development of a solid fusion. ●

In addition, the UNI-T Uni-Thread Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

Degenerative spondylolisthesis with objective evidence of neurologic impairment .
fracture .
dislocation ●
scoliosis
. kyphosis
spinal tumor .
failed previous fusion (pseudoarthrosis) .

BASIS OF SUBSTANTIAL EQUIVALENCE:

The components of the UNI-T Uni-Thread Spinal System are similar in design, material, and indications to other spinal instrumentation systems that have been cleared by FDA for posterior spinal use. Mechanical testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal systems.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized design featuring three parallel, curved lines that resemble a human figure. The lines are thicker at the top and taper towards the bottom, giving the impression of movement or flow.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2002

Ms. Lynnette Whitaker Vice President, Reģulatory Affairs SpineVision, Inc. 3003 Summit Blvd., Suite 1500 Atlanta, Georgia 30319

Re: K013301

UNI-TTM Uni-Thread Spinal System Regulation Number: 888.3070 Regulation Names: Pedicle Screw Spinal System and Spondylolisthesis Spinal Fixation Device System Regulatory Class: II Product Codes: MNI and MNH Dated: January 14, 2002 Received: January 15, 2002

Dear Ms. Whitaker:

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 - Ms. Lynnette Whitaker

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and w yourse of substantial equivalence of your device to a legally premated noticated. " 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 (301) 594-4659. Additionally, for questions on the promotion and advertising of Compliance at (301) 597 - the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Miriam C. Provost

for 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): __ K013301

UNI-T™ Uni-Thread Spinal System Device Name:

Indications for Use:

The UNI-T Uni-Thread Spinal System is a pedicle screw system indicated for skeletally mature patients who:

have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; .
receive fusions using autogenous bone graft only; .
· have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
have the device removed after the development of a solid fusion. .

Degenerative spondylolisthesis with objective evidence of neurologic impairment .
fracture ◆
. dislocation
scoliosis .
kyphosis .
spinal tumor .
failed previous fusion (pseudoarthrosis) .

Concurrence of CDRH, Office of Device Evaluation

1 Prescription Use

OR (Per 21 CFR 801.109) Over-The Counter Use _

Miriam C. Provost

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

510(k) Number K013301

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.