When used as a pedicle screw fixation system, the SHIRAZ Posterior 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 mutogenous 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 Posterior 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 tumor, and failed previous fusion (pseudoarthrosis).

Device Description

The Spine Next Posterior 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 the avvelopment of a solid fusion mass. The system includes screws, rods, connectors and secondary sacral connectors.

All implants are manufactured from Titanium Alloy (Ti6Al4V) meeting the requirements of ASTM F136/ISO 5832 or commercially pure Titanium (cpTi, Grade 4) meeting requirements of ASTM F67/ISO 5832.

AI/ML Overview

This document describes a 510(k) submission for the "Spine Next SHIRAZ Posterior System," a pedicle screw fixation system. The primary goal of the submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove predefined acceptance criteria through a standalone study in the same way a novel high-risk device might.

Here's an analysis based on the provided text, addressing your specific points:

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

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Manufactured from Titanium Alloy (Ti6Al4V) meeting ASTM F136/ISO 5832 or commercially pure Titanium (cpTi, Grade 4) meeting ASTM F67/ISO 5832.
Mechanical Strength/Stability	Biomechanical testing, including static and dynamic testing, was performed in accordance with ASTM F1717 and ASTM F1798.
Substantial Equivalence to Predicate Device	FDA concluded the device is substantially equivalent to the predicate device (Moss Miami [K021880]) for its stated indications for use.

Comment: The document does not explicitly state "acceptance criteria" with numerical thresholds or specific performance metrics (e.g., "device must withstand X load for Y cycles"). Instead, for a Class II device like this, the "acceptance criteria" are generally implied to be meeting recognized international standards for materials and mechanical testing, and demonstrating substantial equivalence to a legally marketed predicate device. The performance data section confirms that testing according to relevant ASTM standards was performed, and the FDA's clearance letter confirms substantial equivalence.

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

Sample Size: Not applicable in the context of this 510(k) submission for mechanical testing. "Sample size" typically refers to the number of patients or cases in clinical studies. Here, it refers to the number of test articles (implants) tested in a laboratory setting. The document does not specify the number of individual screws, rods, or construct combinations tested.
Data Provenance: Not applicable. The testing described (biomechanical) is laboratory-based, not clinical data from patients.

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. This submission focuses on the mechanical and material properties of an orthopedic implant, not on diagnostic accuracy or clinical judgment that would require expert-established ground truth.

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

Not applicable. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth (e.g., presence or absence of a disease). This is a biomechanical and materials-focused submission.

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 submission is for a physical orthopedic implant, not an AI/software device. Therefore, no MRMC study or AI assistance is relevant.

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

Not applicable. As mentioned, this is not an AI/software device. Performance is assessed through mechanical testing of the physical implant components.

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

The "ground truth" for this device's performance is material specifications (ASTM F136/ISO 5832, ASTM F67/ISO 5832 for Titanium alloys) and biomechanical performance standards (ASTM F1717, ASTM F1798). The implant is expected to meet or exceed the performance requirements defined by these standards, and to perform comparably to the predicate device.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this type of device submission. Training sets are relevant for machine learning algorithms.

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

Not applicable. As above, no training set.

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

The "study" in this context refers to the biomechanical testing and materials characterization performed on the Spine Next SHIRAZ Posterior System.

Testing Conducted: Biomechanical testing, including static and dynamic loading, was performed.
Standards Used: This testing was conducted in accordance with recognized industry standards: ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) and ASTM F1798 (Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Post. Pedicle Screw Spinal Instrumentation). The materials used were also certified to meet ASTM F136/ISO 5832 (titanium alloy) and ASTM F67/ISO 5832 (commercially pure titanium).
Proof of Meeting Criteria: By demonstrating that the device components are made from specified, compliant materials and that the assembled system can withstand the forces and cycles defined in the relevant ASTM standards, the manufacturer provides evidence that the device is safe and effective for its intended use and substantially equivalent to the predicate device. The FDA's clearance (K033947) confirms that based on this data, the device meets the regulatory requirements for market entry.

Summary

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510(k) Summary

SUBMITTED BY

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

December 19, 2003 Date Submitted:

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Trade/Proprietary Name:	Spine Next SHIRAZ Posterior System
Common/Usual Name:	Pedicle Screw Fixation System
Classification Names:	Orthosis, Spondylolisthesis Spinal Fixation
Classification Names:	Orthosis, 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 (Ti6Al4V) meeting the requirements of ASTM F136/ISO 5832 or commercially pure Titanium (cpTi, Grade 4) meeting requirements of ASTM F67/ISO 5832.

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INDICATIONS FOR USE

When used as a pedicle screw fixation system, the SHIRAZ Posterior System is intended when used as a pediere serew inxuton of bloms 3 and 4) at the fifth lumbar - first sacral 101 treatment of severe sponayionistics (eceiving fusion by autogenous by autogenous bone (L3-ST) vertebral John in skeletaly 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 Posterior System is also which ased as a pearere bere it and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic mature patients as an auja of the thoracic, lumbar, and sacral spine: degenerative mistabilities of deforminates of the aridence 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 4 2004

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

K033947 Re.

Trade Name: SpineNext SHIRAZ Posterior System Regulation Number: 21 CFR 888.3070 (b) (1) Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: MNI, MNH Dated: December 19, 2003 and January 20, 2004 Received: December 19, 2003 and February 19, 2004

Dear Ms. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beener of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conniner & Prix) 20, 20, 2017 () 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). and Cosmetter For ( 10) and the device, subject to the general controls provisions of the Act. The 1 ou may, atteres, while Act include requirements for annual registration, listing of general controll proficiouring 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 If your device is elassified (i/or abor of ols. Existing major regulations affecting your device can may be Subject to Sueral 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 r loase oe aernood that I Drivination that your device complies with other requirements of the Act that I Dr Has statutes and regulations administered by other Federal agencies. You must or uny reather other step 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 forth in the quarty by around in the estimal (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation of to begin marketing your device as described in your Section 510(k) I his letter will and on The FDA finding of substantial equivalence of your device to a legally premated 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 If you dealer 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-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

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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Indications for Use

510(k) Number (if known):

K033947

Device Name:

Shiraz Java Posterior System

Indications For Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(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, Resto . _ _ . and Neurological Devices

5100: Number K033947

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.