(49 days)
The Accin™ Pedicle Screw System components are intended for noncervical and nonpedicle anterolateral fixation of: Degenerative disk disease (defined as back pain of discogenic origin with degeneration . of the disc confirmed by history and radiographic studies); Spondylolisthesis (grade 3 or 4); Trauma (i.e.: fracture or dislocation) ●; Spinal stenosis ●; Curvatures (i.e.: scoliosis, kyphosis, and/or lordosis) ●; Tumor; Pseudoarthrosis .; Failed previous fusion. ●. The Accin™ Pedicle Screw System components are intended for non-cervical pedicle fixation of: Spondylolisthesis (grade 3 or 4) .; Trauma (i.e .: fracture or dislocation) .; Spinal stenosis; Curvatures (i.e. scoliosis, kyphosis, and/or lordosis) .; Tumor ●; Pseudoarthrosis ; Failed previous fusion. . These components are single use only and are intended for use in skeletally mature patients.
The Accin™ Pedicle System consists of titanium alloy rods, cannulated, multi-axial and standard screws, locking caps, and cross-connector components. The surgeon uses the components to make a construct for spinal fixation.
Acceptance Criteria and Study for Accin™ Pedicle Screw System
This document outlines the acceptance criteria and the study conducted to demonstrate the safety and effectiveness of the Accin™ Pedicle Screw System.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a mechanical performance study rather than a study with specific performance metrics like sensitivity, specificity, or accuracy, which are typical for diagnostic or AI-driven devices. Therefore, the "acceptance criteria" here refer to meeting the requirements of a recognized standard for mechanical testing of spinal implants.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Conformance to ASTM F1717 | Device meets the requirements of ASTM F1717, Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectmny Model. |
Note: The FDA also determined substantial equivalence to predicate devices (Vertebron PSS System - K033352, K043152, K051716 and K071376) as a key "acceptance criterion" for market clearance. This implies that the device's design, materials, and intended use are similar enough to a device already deemed safe and effective.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact number of samples (e.g., screws, constructs) tested. It states, "Tests were performed on the pedicle screw system," implying that a sufficient number were tested to satisfy the requirements of ASTM F1717.
- Data Provenance: The data is generated from laboratory mechanical testing of the device components, not from clinical patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" studies are not applicable in this context.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This study is a mechanical engineering test on an orthopedic implant, not a clinical study involving human assessment or expert review for diagnostic ground truth. The "ground truth" is defined by the physical properties and performance characteristics measured against the ASTM standard.
4. Adjudication Method for the Test Set
- Not Applicable. As this is a mechanical test conducted against a defined standard, there is no need for expert adjudication of results in the way one would for clinical image interpretation or diagnosis. The pass/fail criteria are objectively defined by the ASTM F1717 standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This is a mechanical device performance study, not a study evaluating human reader performance with or without AI assistance.
6. Standalone Performance Study
- Yes, a standalone study was done. The study described is a standalone performance test of the Accin™ Pedicle Screw System itself, evaluating its mechanical properties (static and fatigue) against a standard (ASTM F1717). This is an "algorithm only" equivalent in the sense that the device's inherent physical performance is being assessed without human intervention in the 'reading' or 'interpretation' of the device's function in a clinical scenario.
7. Type of Ground Truth Used
- Mechanical Specifications/Standard Conformance: The "ground truth" for this study is defined by the objective, quantifiable requirements and test methodologies outlined in the ASTM F1717 standard for spinal implant constructs in a vertebrectomy model. The device's performance (e.g., strength, fatigue life) must meet the minimum thresholds or performance profiles specified by this standard.
8. Sample Size for the Training Set
- Not Applicable. This is not a machine learning or AI-driven device, so there is no training set in the conventional sense. The device's design and manufacturing processes are likely informed by engineering principles and prior knowledge from predicate devices, but not by a formal "training set" of data for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. Since there is no training set for an AI algorithm, there is no "ground truth" to establish for such a set. The design and manufacturing process would refer to established biomechanical principles and material science, along with the performance of predicate devices.
§ 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.