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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);
• · 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.

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.

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)

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

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