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) ●

Device Description

The UNI-T Uni-Threaad 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 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 acceptance criteria and study proving the device meets them are not provided in the input text. The document is a 510(k) summary for a spinal system, which primarily focuses on establishing substantial equivalence to a predicate device through design, material, and intended use comparison, along with mechanical testing.

Here's what can be extracted based on the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified	Mechanical testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal systems.

Missing Information: The specific acceptance criteria (e.g., specific load endurance, fatigue limits, pull-out strength, range of motion, etc.) for the mechanical testing are not detailed. The actual results of these tests are also not provided, only the statement that equivalence was demonstrated.

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

Missing Information: The sample size for the mechanical tests is not mentioned. The data provenance is also not specified (e.g., country of origin, retrospective/prospective). Mechanical testing in this context typically refers to laboratory bench testing rather than clinical data from human subjects.

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

Not Applicable: For mechanical testing of a spinal implant, "ground truth" as a clinical diagnosis established by experts is not relevant. The "ground truth" would be the engineering specifications and test standards.

4. Adjudication Method for the Test Set:

Not Applicable: As this is mechanical testing, there is no adjudication method in the sense of clinical interpretations. Results are typically analyzed against predefined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No: The document does not describe an MRMC study. The study presented here is focused on mechanical equivalence of the device, not comparative effectiveness with human readers or AI assistance.

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

No: This device is a mechanical spinal implant, not an algorithm or AI-driven system. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used:

Mechanical Testing Standards/Specifications: The "ground truth" for this type of test would be the predetermined engineering and biomechanical specifications and standards (e.g., ASTM standards for spinal implants) against which the device's performance is measured. These specific standards are not detailed in the summary.

8. The Sample Size for the Training Set:

Not Applicable: This is a physical medical device. There is no concept of a "training set" in the context of an algorithm or AI model development described in this document.

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

Not Applicable: As there is no training set mentioned, this question is not applicable.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The study referenced is mechanical testing performed to demonstrate that the UNI-T Uni-Thread Spinal System is equivalent in construct design to currently marketed spinal systems. The basis of substantial equivalence is stated as the components being "identical in design, material, and intended use to other spinal instrumentation system that have been cleared by FDA for posterior spinal use." The mechanical testing serves to support this claim of equivalence.

However, the 510(k) summary does not provide details on:

The specific types of mechanical tests conducted (e.g., static compression, cyclic fatigue, bending strength).
The actual quantitative results of these tests.
The acceptance criteria (e.g., "must meet or exceed predicate device performance for X, Y, Z parameters").
The number of samples tested.

The overall conclusion reached by the FDA is that the device is "substantially equivalent" based on the information provided, including the implicitly successful mechanical testing results.

Summary

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AUG 0 1 2002

Image /page/0/Picture/2 description: The image contains the logo for SpineVision. The logo consists of a stylized black symbol above the word "SpineVision" in a bold, sans-serif font, with a trademark symbol to the right. Below the company name is the tagline "Spine systems for specialists" in a smaller font.

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 Affairs574-269-3701
TRADE NAME:	UNI-T TM 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:	UNI-T Uni-Thread Spinal System, SpineVision, Inc.

DEVICE DESCRIPTION AND INTENDED USE:

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

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) ●

BASIS OF SUBSTANTIAL EQUIVALENCE:

The components of the UNI-T Uni-Thread Spinal System are identical in design, material, and intended use to other spinal instrumentation system 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.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 01 2002

Ms. Lynnette Whitaker Vice President, Regulatory Affairs SpineVision, Incorporated 3003 Summit Boulevard, Suite 1500 Atlanta, Georgia 30319

Re: K021510

Trade/Device Name: UNI-TTM Uni-Thread Spinal System Regulation Number: 888.3070 Regulation Name: Pedicle Screw Spinal System and Spondylolisthesis Spinal Fixation Device System Regulatory Class: II Product Code: MNI, MNH Dated: May 8, 2002 Received: May 9, 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.

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

Page 2 - Ms. Lynnette Whitaker

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- . 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 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,

Mark N. Millenson

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) _ ≤ ○ 乙 ↓ 5 ↓ Φ

UNI-T™ Uni-Thread Spinal System, Additional Components 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

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

(Division Sign-Off)

Division of General, Restorative

and Neurological Devices

510(k) Ni ....................................................................................................................................................................

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.