(116 days)
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)
| 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
§ 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.