When used for anterior/anterolateral and posterior, non-cervical pedicle fixation system, the SAGICO OSI SPINAL SYSTEM by Osimplant is intended to provide additional support during fusion using autograft or allograft in Skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

· Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
· Spondylolisthesis;
· Trauma (i.e. fracture or dislocation);
· Spinal stenosis;
· Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
· Tumor:
· Pseudoarthrosis; and
Failed previous fusion

The SAGICO OSI SPINAL SYSTEM by Osimplant for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The SAGICO OSI SPINAL SYSTEM by Osimplant constructs of monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking cap set screws, rods, hooks, monoaxial and muttiaxial transverse connectors and associated surgical instruments. The SACICO OSI SPINAL SYSTEM by Osimplants are available in a variety of sizes to accommodate individual patient anatomy and pathology conditions. SAGICO OSI SPINAL SYSTEM by Osimplant implants are designed to adapt 5.5mm diameter rods; the implants are manufactured from Ti6A14V alloy and offered in a sterile package option.

AI/ML Overview

The provided text is a 510(k) summary for the SAGICO OSI SPINAL SYSTEM by Osimplant, a medical device for spinal fixation. It details the device's indications for use, technological characteristics, and performance data used to establish substantial equivalence to predicate devices. However, this document does not describe an AI/ML device or algorithm. It is a clearance for a traditional physical medical implant system consisting of screws, rods, and associated instruments.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies for an AI device cannot be extracted from this document, as it pertains to a mechanical spinal implant system.

The information below is a general template for response if the input data would contain information for an AI/ML powered device, as the prompt is not expecting the type of the device to be considered.

This document does not describe an AI/ML powered medical device. It describes a traditional, mechanical spinal implant system (SAGICO OSI SPINAL SYSTEM by Osimplant). Therefore, the specific details requested regarding AI/ML device performance, acceptance criteria, sample sizes for AI/ML models, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance are not available in this document.

The document focuses on demonstrating substantial equivalence of the mechanical implant system to predicate devices based on:

Indications for Use: The SAGICO OSI SPINAL SYSTEM is intended for use in the non-cervical spine for various conditions like degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients. For pediatric patients, it's indicated for adolescent idiopathic scoliosis (posterior approach only).
Technological Characteristics: The device consists of monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking cap setscrews, rods, hooks, monoaxial and multiaxial transverse connectors, and associated surgical instruments. Implants are made from Ti6Al4V alloy and designed for 5.5mm diameter rods.
Performance Data (Non-clinical):
- ASTM F1717-04: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model (Static Compression Bending Test, Dynamic Compression Bending Test).
- ASTM F1798-13: Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants (Axial Gripping Test, Axial Torsion Gripping Test, Flexion Extension Static Test).
Basis of Substantial Equivalence: Comparable data drawn from design, labeling, indications for use, function, and implant materials compared to predicate devices (XIA® 3 Spinal System, USS Small Stature System, CD HORIZON Spinal System, TSRH Spinal System).

If this were an AI/ML device, the requested information would typically be presented as follows (this is a hypothetical example for illustrative purposes, not based on the provided document):

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical for an AI/ML device)

Performance Metric	Acceptance Criteria (e.g., for detecting spinal fractures)	Reported Device Performance (e.g., from a clinical study)
Sensitivity	≥ 90%	92.5% (95% CI: 90.1% - 94.4%)
Specificity	≥ 80%	85.3% (95% CI: 83.0% - 87.3%)
AUC	≥ 0.90	0.93

2. Sample Size and Data Provenance for Test Set (Hypothetical)

Sample Size: 500 spinal imaging studies (e.g., X-rays, CT scans)
Data Provenance: Retrospective data collected from 3 hospitals in the United States and 2 hospitals in Germany.

3. Number and Qualifications of Experts for Ground Truth (Hypothetical)

Number of Experts: 3 independent radiologists
Qualifications: All board-certified radiologists with subspecialty training in musculoskeletal radiology and at least 10 years of experience interpreting spinal imaging.

4. Adjudication Method for Test Set (Hypothetical)

Adjudication Method: 2+1. Initial assessment by two radiologists. Discrepancies were resolved by a third, senior radiologist.

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

Was an MRMC study done? Yes.
Effect Size: In the MRMC study, human readers (radiologists) demonstrated a statistically significant improvement in fracture detection accuracy (AUC increased by an average of 0.05, p < 0.001) when assisted by the AI device compared to reading without AI assistance. This translated to a 15% reduction in missed fractures among the assisted group.

6. Standalone Algorithm Performance (Hypothetical)

Was a standalone study done? Yes. The performance metrics in the table above reflect the standalone performance of the algorithm on the test set.

7. Type of Ground Truth Used for Test Set (Hypothetical)

Type of Ground Truth: Expert consensus (as established by the 2+1 adjudication method based on expert review of the imaging studies). In cases where available, pathology reports and follow-up clinical outcomes were used to corroborate expert diagnoses.

8. Sample Size for Training Set (Hypothetical)

Sample Size: 5,000 spinal imaging studies (e.g., X-rays, CT scans).

9. How Ground Truth for Training Set was Established (Hypothetical)

Ground Truth Establishment: Annotated by a team of trained radiology residents and fellows under the supervision of experienced attending radiologists. A subset of the annotations (10%) was independently reviewed by a senior radiologist for quality control, and discrepancies were resolved through discussion.

Summary

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May 21, 2018

Spinal Analytics & Geometrical Implant Co, LLC James J. Gibson Jr., CPA, Ph.D. SAGICO Project Manager 2189 West Busch Boulevard Tampa, Florida 33612

Re: K180220

Trade/Device Name: SAGICO OSI SPINAL SYSTEM by Osimplant Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWO Dated: February 8, 2018 Received: February 9, 2018

Dear Dr. Gibson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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K180220

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ronald P. Jean -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K180220

Device Name

SAGICO OSI SPINAL SYSTEM by Osimplant

Indications for Use (Describe)

The SAGICO OSI SPINAL SYSTEM by Osimplant is intended for use in the non-cervical spine.

· Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
· Spondylolisthesis;
· Trauma (i.e. fracture or dislocation);
· Spinal stenosis;
· Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
· Tumor:
· Pseudoarthrosis; and
Failed previous fusion

The SAGICO OSI SPINAL SYSTEM by Osimplant for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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SAGICO OSI SPINAL SYSTEM by Osimplant Traditional 510(k) Premarket Notification

510(k) Summary

Device Trade Name(s): SAGICO OSI SPINAL SYSTEM by Osimplant Classification Panel: Orthopedic Common Name: Pedicle Screw Spinal System Class and Reference: Class II Product Code(s): NKB, KWQ, KWP Thoracolumbosacral Pedicle Screw System (NKB) Classification Name(s): Class II per 21 CFR §888.3070 Appliance, Fixation, Spinal Intervertebral Body (KWQ) Class II per 21 CFR §888.3060 Appliance, Fixation, Spinal Interlaminal (KWP) Class II per 21 CFR §888.3050 Applicant/Official Contact Person: James J. Gibson, Jr., CPA, PhD SAGICO Project Manager Email: JG@Sagico.com Tel. (813) 830-3636 / Fax (813) 433-5586 Submitter /Manufacturer: Spinal Analytics & Geometrical Implant Co, LLC dba/ SAGICO 2189 West Busch Blvd Tampa, Florida 33612 Tel. (813) 830-3636 / Fax (813) 433-5586 Preparation Date: May 18th, 2018

Predicate Devices

The subject device is substantially equivalent to the primary predicate device XIA® 3 Spinal System - Stryker Spine (K113666) and additional predicate devices, USS Small Stature System - Synthes Spine Medtronic Spine (K071373), CD HORIZON - Spinal System - Sofamor Danek USA (K091445), TSRH Spinal System - Sofamor Danek USA (K994121), XIA 3 Spinal System - Stryker Spine (K111492)

Purpose:

The purpose of this submission is to request clearance for new system "SAGICO OSI SPINAL SYSTEM by Osimplant".

Device Description:

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SAGICO OSI SPINAL SYSTEM by Osimplant Traditional 510(k) Premarket Notification

Indications for use:

The SAGICO OSI SPINAL SYSTEM by Osimplant is intended for use in the non-cervical spine. When used for anterior/anterolateral and posterior, non-cervical pedicle fixation system, the SAGICO OSI SPINAL SYSTEM by Osimplant is intended to provide additional support during fusion using autograft or allograft in Skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc > confirmed by history and radiographic studies);
Spondylolisthesis:
Trauma (i.e. fracture or dislocation);
MMMMM Spinal stenosis;
Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
Tumor;
Pseudoarthrosis; and
Failed previous fusion

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the SAGICO OSI SPINAL SYSTEM by Osimplant implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The SAGICO OSI SPINAL SYSTEM by Osimplant for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Technological Characteristics:

Testing performed on SAGICO OSI SPINAL SYSTEM by Osimplant included in this submission demonstrates that the SAGICO OSI SPINAL SYSTEM by Osimplant is substantially equivalent to predicate devices cleared by FDA for commercial distribution in the United States market. The SAGICO OSI SPINAL SYSTEM by Osimplant substantial equivalence determination to the predicate systems is based on comparable data drawn from design, labeling, and indications for use, function and implant materials.

Performance data:

Non-clinical performance data testing conducted to support substantial equivalence for the SAGICO OSI SPINAL SYSTEM by Osimplant device included:

ASTM F1717-04

Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

Static Compression Bending Test
Dynamic Compression Bending Test

ASTM F1798-13

Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants

Σ Axial Gripping Test
Σ Axial Torsion Gripping Test
Flexion Extension Static Test

Basis of Substantial Equivalence:

The SAGICO OSI SPINAL SYSTEM by Osimplant has been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject and predicate devices.

Conclusion:

The SAGICO OSI SPINAL SYSTEM by Osimplant has been shown to be substantially equivalent to legally marketed predicate devices with respect to its indications for use, design, function, and materials.

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.