The Sintea Posterior Lumbar System is a posterior, nonpedicle screw system of the noncervical spine indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, tumor, pseudarthrosis, and failed previous fusion.

The Sintea Biotech Posterior Lumbar 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Sintea Biotech Posterior Lumbar System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Device Description

PLS recovery screws and screws for ring are available with the same material, shape, fillet, diameters and length of PLS standard screws. They have the same characteristics as PLS standard screws with the exception of a locking ring adopted in place of a locking cap.

The PLS Multi-axial screws are made of the same material as the PLS standard (monoaxial) screws. The somatic thread is the same as the thread of the PLS standard screws. The lengths and diameters of the multi-axial screws are the lengths and diameters of the PLS standard screws. The design of this screw allows for up to 25 degrees of angulation in any direction to accommodate different anatomic conditions.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Sintea Biotech Posterior Lumbar System Multi-axial Screw and Recovery Screw with Ring). It focuses on demonstrating substantial equivalence to a predicate device through mechanical testing and comparison of design, materials, and intended use.

Therefore, it does not describe a clinical study in the traditional sense that would involve patient data, ground truth established by experts, or human reader performance. The "acceptance criteria" here refer to the performance of the device in biomechanical tests compared to a predicate device, as required for 510(k) clearance rather than clinical efficacy/diagnostic accuracy.

However, based on the information provided, I can infer and extrapolate the relevant parts that would correspond to your requested sections, focusing on the device performance within a biomechanical study context.

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance	Study that Proves Device Meets Criteria
Biomechanical Properties	Comparable mechanical properties to predicate devices.	"Mechanical testing demonstrated comparable mechanical properties to the predicate devices."	Biomechanical studies conducted on the Sintea Biotech Posterior Lumbar System multi-axial screw, recovery screw, screw for ring and ring implant constructs.
Safety and Effectiveness	Safe, effective, and suitable for use as a spinal fixation device system.	"demonstrate that the device system is safe, effective, and suitable for use as a spinal fixation device system."	Biomechanical studies conducted on the Sintea Biotech Posterior Lumbar System multi-axial screw, recovery screw, screw for ring and ring implant constructs.
Material Equivalence	Same implant alloy as predicate.	"The devices are made of the same implant alloy."	Comparison to predicate devices (Sintea Biotech Posterior Lumbar System K020085 and Xia Spinal System K031893).
Design & Function Equivalence	Similar form, function, components, instruments, dimensions, geometry and features as predicate.	"The subject components share the same materials of construction, intended use and basic design characteristics as the predicate devices.""The devices have similar form, function, components, instruments, dimensions, geometry and features."	Comparison to predicate devices (Sintea Biotech Posterior Lumbar System K020085 and Xia Spinal System K031893).

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

Sample Size (Test Set): Not explicitly stated, as this was a biomechanical (material/engineering) study, not a clinical study involving patients. "Test set" in this context would refer to the number of device constructs tested. This detail is typically found in the full biomechanical report, not the 510(k) summary.
Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective for a biomechanical study. The studies were "conducted on the Sintea Biotech Posterior Lumbar System multi-axial screw, recovery screw, screw for ring and ring implant constructs," implying testing in a lab setting.

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

This is not applicable to this type of submission. "Ground truth" established by experts (e.g., radiologists) is relevant for diagnostic devices or those involving interpretation of medical images/patient data. For a biomechanical study, the "ground truth" would be established by validated engineering test standards and measurements, interpreted by engineers or scientists.

4. Adjudication Method for the Test Set

Not applicable for this type of biomechanical study. Adjudication typically refers to resolving discrepancies between human readers or experts, which is not relevant here.

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, an MRMC study was not done. This is a submission for a spinal implant, not an AI/diagnostic device.

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

No, this is not applicable. This is a hardware device (spinal implant), not an algorithm or software.

7. The Type of Ground Truth Used

For the biomechanical studies, the "ground truth" would be the physical measurements and performance under established mechanical testing standards (e.g., ASTM, ISO standards mentioned, though specific test numbers are not listed in the summary). This would be based on empirically measured properties and engineering specifications.

8. The Sample Size for the Training Set

Not applicable. This submission describes a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device submission.

Summary

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DEC 17 2004

510(k) SUMMARY

Sintea Biotech Posterior Lumbar System Multi-axial Screw and Recovery Screw with Ring Prepared November 23, 2004 Revised December 10, 2004

Sintea Biotech Posterior Lumbar System Multi-axial Screw and Recovery Trade Name: Screw with Ring Common Name: Spinal Interlaminal Fixation Orthosis Classification Name(s): Spinal Interlaminal Fixation Orthosis and Pedicle Screw Spinal System, Class II. Classification(s): § 888.3050 - Spinal Interlaminal Fixation Orthosis; 888.3070 -Pedicle Screw Spinal System, Class II. Device Class: Class II for all requested indications Classification Panel: Orthopedic Device Panel Product Code(s): KWP, MNH, MNI

Applicant Name & Address: Sintea Biotech, Inc. 407 Lincoln Road Suite 10L Miami Beach, FL 33139 (305) 673-6226 FAX (305) 673-3312

Company Contact: Mr. Guido Zorzoli Sintea Biotech Inc. 407 Lincoln Road Miami Beach, FL 33139 (305) 673-6226 FAX (305) 673-3312

Predicate Device:

As a special 510(k) submission, the predicate device to which we are claiming equivalence is our own product. Sintea Biotech's Posterior Lumbar System with standard screw (K020085, decision date 12/10/2002). This special 510(k) submission represents a modification to the predicate, in that the standard (monoaxial) screw has been modified to be a multi-axial screw and a recovery screw with ring.

Additionally, we are claiming substantial equivalence to the Xia Spinal System's Polyaxial Screw, manufactured by Howmedica Osteonics, K031893, decision date 7/17/2003.

Page 1 of 3

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Description of Device Modification:

This submission is intended to address a line extension to the Sintea Biotech Posterior Lumbar System. The extension consists of the addition of a multi-axial screw, a recovery screw, and a screw for ring.

Intended Use and Indications for Use:

Device Description:

Please refer to the body of this submission for an extensive description of the multi-axial screw, recovery screw, screw for ring, and ring.

Statement of Technological Comparison:

The subject components share the same materials of construction, intended use and basic design characteristics as the predicate devices. Mechanical testing demonstrated comparable mechanical properties to the predicate devices.

Summary Basis for Equivalence and Comparison Table:

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Biomechanical studies conducted on the Sintea Biotech Posterior Lumbar System multiaxial screw, recovery screw, screw for ring and ring implant constructs demonstrate that the device system is safe, effective, and suitable for use as a spinal fixation device system. Based on the available information concerning the referenced comparison devices (the Sintea Biotech Posterior Lumbar System, the Xia Spinal System), these devices are similar in that:

The devices have the same intended use and indications for use; .
The devices are made of the same implant alloy; and .
The devices have similar form, function, components, instruments, . dimensions, geometry and features.

Performance Standards:

Food and Drug Administration mandated Performance Standards for Spinal Interlaminal Fixation Orthosis, Spondylolisthesis Spinal Fixation Device System Class II, and Pedicle Screw Spinal System Class II devices are not in effect. Sintea Biotech, Inc. intends to comply with all voluntary Performance Standards applicable to the Sintea Biotech Posterior Lumbar System. At the present time, various performance standards such as ASTM, ISO, QSR/GMP and in-house SOP standards are used. Sintea Biotech, Inc. also complies with the general controls authorized under Sections 501, 502, 510, 516, 518, 519 and 520 of the Food, Drug and Cosmetic Act. In addition, Sintea Biotech, Srl., which is the location of the manufacturing facility for this device, has earned the CE Mark (number 0546) using the ISO 9001 quality system model, and is in good standing with IQNet, their international certification body.

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Image /page/3/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

Mr. Guido Zorzoli Chief Executive Officer Sintea Biotech, Inc. 407 Lincoln Road Suite 10L Miami Beach, Florida 33139

Re: K043355

Trade/Device Name: Sintea Biotech Posterior Lumbar System with multiaxial screw and recovery screw/ring Regulation Number: 21 CFR 888.3050, 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWP, MNH, MNI Dated: November 22, 2004 Received: December 6, 2004

Dear Mr. Zorzoli:

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 – Mr. Guido Zorzoli

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in yourse 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 11 you a the Office of Compliance at (240) 276-0120. 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 other general 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 A. Milliken

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): K043355

Device Name: Sintea Biotech Posterior Lumbar System with multiaxial screw and recovery screw/ring

Indications for Use:

The Sintea Posterior Lumbar System is a posterior, nonpedicle screw system of the The Olifical Footoner Lated for degenerative disc disease (defined as back pain of nonocrood opine malsate reration of the disc confirmed by history and radiographic discogence ongin finen degencreture, tumor, pseudoarthrosis, and failed previous fusion.

The Sintea Biotech Posterior Lumbar System is a pedicle screw system intended to The Online Dioton't Posterior of spinal segments in skeletally mature patients provide inimobilization and element of the following acute and chronic instabilities or as an adjariet to fablem ic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Sintea Biotech Posterior Lumbar System is a pedicle screw system indicated for the

treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-SI vertebra in skeletally

mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Prescription Use × (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)

Mark N. Mikess
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number K043355

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.