When used as a pedicle screw fixation system, the SHIRAZ JAVA Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used as a pedicle screw fixation system, the SHIRAZ JAVA Spinal Fixation System is also 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 turnor, and failed previous fusion (pseudarthrosis).

Device Description

The Spine Next SHIRAZ JAVA Top Loading Spinal Fixation System is designed to aid the surgical correction of several types of spinal conditions. This system is intended only to provide stabilization during the development of a solid fusion with the bone graft. These implanted are intended to be removed after development of a solid fusion mass. The system includes screws, rods, connectors and transverse connectors.

All implants are manufactured from Titanium Alloy (Ti6A4V) meeting the requirements of ASTM F136.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Spine Next SHIRAZ JAVA Spinal Fixation System. It details the device, its indications for use, and cites biomechanical testing according to specific ASTM standards. However, it does not provide information about acceptance criteria, reported device performance in a table, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of quantitative values. The acceptance criteria for a 510(k) submission generally revolve around demonstrating substantial equivalence to a legally marketed predicate device, often through meeting industry standards.
Reported Device Performance: Not reported in a table format. The document states that "Biomechanical testing, including static and dynamic testing, was performed in accordance with ASTM F1717 and ASTM 1798." These standards inherently define test methods and performance metrics (e.g., strength, durability, fatigue life), but the results of these tests (the actual performance data) and how they met specific acceptance thresholds are not provided in this summary.

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

Sample Size: Not mentioned. For biomechanical testing, this would typically refer to the number of test specimens (e.g., screws, rods, constructs) tested.
Data Provenance: Not mentioned. Biomechanical testing data would generally be generated in a lab setting, so "country of origin" is less relevant than for clinical data, but the specific lab or testing facility is not named. The studies are prospective in nature as they involve testing physical devices.

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 as this is biomechanical testing, not a study involving human interpretation or clinical data where expert ground truth would be established. The "ground truth" for biomechanical testing is typically defined by the physical loads applied and the measured deformation/failure, evaluated against engineering standards.

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

Not applicable for biomechanical testing.

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 MRMC study was mentioned. This type of study is relevant for imaging or diagnostic devices involving human interpretation, not for mechanical implants like spinal fixation systems.

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

Not applicable. This is not an algorithm-based device.

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

For biomechanical testing, the "ground truth" is defined by the objective physical measurements and engineering principles governed by the ASTM standards (F1717 and F1798). This involves applying defined loads and measuring mechanical responses (e.g., stiffness, yield strength, ultimate strength, fatigue cycles to failure).

8. The sample size for the training set

Not applicable. This is not a machine learning device, so there is no training set.

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

Not applicable.

Summary

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JAN 2 7 2004

K033772
PI=t2

510(k) Summary)

SUBMITTED BY

Diane Johnson On Behalf of Spine Next America Jackson Building, Suite 110 8381 Dix Ellis Trail Jacksonville, FL 32256

Date Submitted: December 1, 2003

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Trade/Proprietary Name:	Spine Next SHIRAZ JAVA Spinal FixationSystem
Common/Usual Name:	Pedicle Screw Fixation System
Classification Names:	Orthosis, Spondylolisthesis Spinal FixationOrthosis, Spinal Pedicle Fixation

PREDICATE DEVICE

Moss Miami [K021880, cleared June 26, 2002]. This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92

DEVICE DESCRIPTION AND MATERIALS OF CONSTRUCTION

All implants are manufactured from Titanium Alloy (Ti6A4V) meeting the requirements of ASTM F136.

INDICATIONS FOR USE

When used as a pedicle screw fixation system, the SHIRAZ JAVA Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine (1.3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used as a pedicle screw fixation system, the SHIRAZ JAVA Spinal Fixation System is also intended to provide immobilization and stabilization of spinal segments in

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14- (5) 3 3 2 2

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, and failed previous fusion (pseudoarthrosis).

PERFORMANCE DATA

Biomechanical testing, including static and dynamic testing, was performed in accordance with ASTM F1717 and ASTM 1798

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 7 2004

Ms. Diane Johnson Spine Next America Director, Regulatory Affairs 104 Greenwood Creek Road Queenstown, MD 21658

Re: K033772

Trade Name: Spine Next SHIRAZ JAVA Spinal Fixation System -- Addition of Transverse Connector Regulation Number: 21 CFR 888.3070 (b) (1), 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: MNI, MNH Dated: December 1, 2003 Received: December 3, 2003

Dear Ms. Johnson:

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 (Spccial 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.

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Page 2 - Ms. Diane Johnson

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. 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html.

Sincerely vours.

Mark A. Millhuser

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): _ 长 ○ 3 3 7 コ 1

Device Name: Spine Next SHIRAZ JAVA Spinal Fixation System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(PER 21 CFR 801.109)

Over-The-Counter Use

Optional Format 1-2-96

Mark A. Millman

K033772

Regulation Number and Section

N/A