• 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, pseudoarthrosis, 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-S1 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

Not Found

AI/ML Overview

The provided document describes a medical device, the "Sintea Biotech Posterior Lumbar System," and its clearance process through a 510(k) premarket notification. This process assesses substantial equivalence to legally marketed predicate devices, rather than a clinical trial demonstrating new performance claims against acceptance criteria in the way a novel AI device might.

Therefore, many of the typical acceptance criteria and study elements you've requested (like AI performance, ground truth establishment for training sets, expert consensus, MRMC studies, etc.) are not applicable to this type of medical device submission.

However, I can extract information related to the device's design verification and validation, which serves as its "acceptance criteria" in this context, and the study (biomechanical testing) that proves it meets these criteria.

Here's a breakdown based on the provided text:

1. Table of "Acceptance Criteria" and the Reported Device Performance

For this device, the "acceptance criteria" are compliance with established standards and demonstrated equivalence to predicate devices, focusing on safety and mechanical performance.

Acceptance Criterion (Standard/Requirement)	Reported Device Performance (Summary of Biomechanical Testing)
Material Standards: Compliance with material standards (implied by "Special Controls")	The device is made of the "same implant alloy" as predicate devices.
Mechanical Testing Standard: Compliance with mechanical testing standards, specifically ASTM standards (implied by "Special Controls" and "Performance Standards")	"Fatigue testing of a 'worst case' system configuration using constructs made of titanium was conducted. The testing demonstrates that when subjected to repeated physiological loads, increased by suitable safety factors, the Posterior Lumbar System overcomes both static and fatigue tests, with occurrences of neither microscopic nor macroscopic failures after five million cycles of a repeated applied force, according to ASTM testing standards."
Biocompatibility Standard: Compliance with biocompatibility standard (implied by "Special Controls")	Not explicitly detailed in the summary, but typically part of the material and design evaluation for equivalence. Assumed to be met by using the "same implant alloy" and being substantially equivalent to predicate devices.
Labeling Requirements: Compliance with specific labeling statements (as per "Special Controls")	The document outlines specific indications for use and warnings that must be included in the labeling. This is a regulatory compliance criterion rather than a performance one derived from testing.
Substantial Equivalence: To legally marketed predicate devices (TSRH Spinal System and Synergy Spinal System) in terms of intended use, indications for use, material, form, function, components, instruments, dimensions, geometry, and features.	"Biomechanical studies conducted on the Sintea Biotech Posterior Lumbar System implant constructs demonstrate that the device system is safe, effective, and suitable for use as a spinal fixation device system." "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."

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

Sample Size for Test Set: Not explicitly stated as a number of devices/constructs, but the description refers to "constructs made of titanium." The testing was likely performed on a sufficient number of samples to meet ASTM testing requirements and provide statistically significant results for mechanical strength. For mechanical testing, samples are typically physical specimens of the device or its components.
Data Provenance: The testing was conducted by Sintea Biotech Inc. as part of their submission. It is internal testing performed by the manufacturer to demonstrate compliance with standards. It is prospective in the sense that the tests were designed and conducted specifically to support this regulatory submission. It is not patient data; it's laboratory testing data.

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

Not Applicable. This device submission does not involve clinical data or "ground truth" derived from expert interpretation of medical images or patient outcomes in the way an AI diagnostic device would. The "ground truth" here is adherence to engineering standards and comparison to established predicate devices. The "experts" involved would be mechanical engineers and regulatory specialists ensuring compliance with the testing protocols and standards.

4. Adjudication Method for the Test Set

Not Applicable. There is no "adjudication" in the clinical sense for this type of mechanical testing. The results are quantitative measurements against predefined ASTM standards (e.g., number of cycles survived, load at failure). The outcome is determined by whether the measurements meet the numerical thresholds set by the standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data, often with or without AI assistance. The Sintea Biotech Posterior Lumbar System is an implantable surgical device, not a diagnostic tool requiring human interpretation of medical images for its primary function.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Not Applicable. This device is a passive, implantable medical device, not an algorithm or AI system. Therefore, standalone performance in that context is irrelevant.

7. Type of Ground Truth Used

The "ground truth" for this device's performance validation is compliance with established mechanical testing standards (ASTM) and demonstrated similarity to legally marketed predicate devices in terms of material, design, and intended use. This is primarily engineering and regulatory compliance ground truth, not clinical or pathological ground truth in the patient sense.

8. Sample Size for the Training Set

Not Applicable. This device is not an AI algorithm; therefore, there is no "training set" in the context of machine learning.

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

Not Applicable. As there is no AI algorithm or training set, this question is not relevant.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

Sintea Biotech Posterior Lumbar System

DEC 1 0 2002

Trade Name: Sintea Biotech Posterior Lumbar System Common Name: Spinal Interlaminal Fixation Orthosis Classification Name(s): Spinal Interlaminal Fixation Orthosis: Spondylolisthesis Spinal Fixation Device System Class II; and Pedicle Screw Spinal System Class II. Classification(s): § 888.3050 - Spinal Interlaminal Fixation Orthosis; 888.3070 -Spondylolisthesis Spinal Fixation Device System class II; and 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 Miami Beach, FL 33139 (305) 673-6226 FAX (305) 673-3312

Company Contact: Ms. Marianne Grunwaldt Sintea Biotech Inc. 407 Lincoln Road Miami Beach, FL 33139 (305) 673-6226 FAX (305) 673-3312

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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Special Controls:

Posterior Lumbar Systems must comply with the following special controls:

(i) Compliance with material standards,
Compliance with mechanical testing standard, (ii)
Compliance with biocompatibility standard, and (iii)
(iv) Labeling which contains the following statements in addition to other appropriate labeling information:

Indications for Use:

• The Sintea Biotech Posterior Lumbar System is a pedicle screw system indicated for the treatment of severe spondvlolisthesis (Grades 3 and 4) of the L5-S1 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.

Labeling:

The Sintea Biotech Posterior Lumbar System discussed in this premarket notification will be manufactured by Sintea Biotech, Inc. and labeled as such. The system will be marketed exclusively to healthcare facilities and physicians. In addition, FDA requirements stipulate that the following additional labeling warnings be provided:

Warnings:

• When used as a pedicle screw system, this device system is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar-first sacral vertebral (L5-S1) vertebral joint.

· The screws of this device system are not intended for insertion into the pedicles to facilitate spinal fusions above the L5-S1 joint.

· Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines.

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K 0 20085
page 3 of 4

· Potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.

· 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 degenerative spondylolisthesis with objective evidence of neurological 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.

See Warnings and Precautions, and Other Potential Adverse Effects section of the package insert for a complete list of potential risks.

CAUTION: Federal law (USA) restricts these devices to sale by or on the order of a physician.

Surgical Technique:

The surgical approach of the Sintea Biotech Posterior Lumbar System is enclosed in Section 8 of this submission.

CAUTION: Mixing of dissimilar metals can accelerate the corrosion process. The components of this system must NOT be used with implants of other material in building a construct. Components of the Sintea Biotech Posterior Cervical Plates System should NOT be used with components from any other system or manufacturer.

Predicate Devices (legally marketed comparison devices):

Sintea Biotech Inc. believes that the Sintea Biotech Posterior Lumbar System is substantially equivalent to the TSRH Spinal System, K010720, manufactured by Medtronic Sofamor Danek, Inc., (decision date: 04/11/01), and the Synergy Spinal System, K010515, manufactured by Interpore Cross Intl., (decision date: 03/22/01). A basic feature comparison table for the Sintea Biotech Posterior Lumbar System and these predicate devices is located at the end of this document.

Summary of Biomechanical Testing:

Fatigue testing of a "worst case" system configuration using constructs made of titanium was conducted. The testing demonstrates that when subjected to repeated physiological loads, increased by suitable safety factors, the Posterior Lumbar System overcomes both static and fatigue tests, with occurrences of neither microscopic nor macroscopic failures,

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< 020085
page 4 of 4

after five million cycles of a repeated applied force, according to ASTM testing standards.

Summary Basis for Equivalence and Comparison Table:

Biomechanical studies conducted on the Sintea Biotech Posterior Lumbar System 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 Medtronic TSRH Spinal System and the Interpore Cross Synergy 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.

The use of QSR-based process controls, testing standards, materials standards, and the similarities to the predicate device establish that the Sintea Biotech Posterior Lumbar System is substantially equivalent to the Medtronic TSRH Spinal System and the Interpore Cross Synergy Spinal System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marianne Grunwaldt Regulatory Affairs Specialist Sintea Biotech Incorporated 407 Lincoln Road, Suite 10 L Miami Beach, Florida 33139

K020085 Re:

Trade Name: Sintea Biotech Posterior Lumbar System Regulation Number: 21 CFR 888.3070 and 888.3050 Regulation Name: Pedicle Screw Spinal System, and Spinal Interlaminal Fixation Orthosis

Regulatory Class: II

Product Code: MNH, MNI, KWP

Dated: September 17 and October 9, 2002 Received: September 23 and October 11, 2002

Dear Ms. Grunwaldt:

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);

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Page 2 - Ms. Marianne Grunwaldt

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4692 . 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 Milkman

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): K020085

Device Name: Sintea Biotech Posterior Lumbar System

Indications for Use:

· 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, pseudoarthrosis, and failed previous fusion.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark M. Millera

Division Sig Division of C and Neurolo; KO200 "10(k) Number

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.