(161 days)
MySpine is intended for use with M.U.S.T Pedicle Screw System and its cleared indications for use. MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guide for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.
MySpine MC is intended as a lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1.
The device is provided with two options:
- Drill based
- K-wire based
MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.
MySpine MC k-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body.
Use of the guides involves a surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipment components. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan.
MySpine MC and Drill Pilot guides are intended for single use only.
The MySpine Pedicle Screw Placement Guides – MC (Midline Cortical) and Drill Pilot Instruments are a line extension to Medacta's MySpine Pedicle Screw Placement Guides. The MySpine Pedicle Screw Placement Guides – MC and S1 Guide Instruments are for use in spinal levels L5 to S1. The MySpine Pedicle Screw Placement Guides - Drill Pilot Guide Instruments are for use in spinal levels T1 to S1.
The MySpine product line is a patient matched, pedicle targeted, technology involving the production of patient specific guides for placement of the M.U.S.T. Pedicle Screw System based on the patient's anatomy. The MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments are intended to be used with Medacta's M.U.S.T. Pedicle Screw System (K121115, K132878, K141988, K153664, K162061, and K171170) for the following indications: degenerative disc disease (DDD), spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudo-arthrosis, and failed previous fusion.
The MySpine platform allows the surgeon to complete pre-operative planning in 3D, based on the patient's spinal CT scans. Medacta International SA uses these images in combination with SW Mimics® (Materialize®) and W Solidworks® (Dassault Systèmes®) to import DICOM images from a patient's CT scans and then process the scans into accurate 3D models. CT imaging is used to create a 3D model of the vertebrae according to the patient's anatomy. The subsequent vertebral model represents the template used to generate the corresponding MySpine Screw Placement Guides to fit the patient's vertebral anatomy.
The provided document is a 510(k) premarket notification for the MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices.
However, the document does not contain specific acceptance criteria or performance data for an AI-powered device. The MySpine system described is a patient-matched surgical guide system that uses pre-operative CT scans to create 3D models and fabricate patient-specific guides. It utilizes software for planning, but it is not an AI/ML-driven device as understood in the context of diagnostic or prognostic AI.
Therefore, I cannot extract the requested information about acceptance criteria and a study proving device performance for an AI/ML device from this document. The document primarily focuses on the physical design, manufacturing process, materials, and intended use of the surgical guides, along with non-clinical performance tests relevant to mechanical and design validation, and a statement that no clinical studies were conducted for this particular submission.
To answer your request, if this were an AI or ML-enabled device, the information would typically include:
- A table of acceptance criteria and the reported device performance: This would detail metrics like sensitivity, specificity, accuracy, precision, recall, F1-score, AUC, etc., along with the target thresholds (acceptance criteria) and the actual performance achieved.
- Sample size used for the test set and the data provenance: Number of cases/patients in the test set, and details like country of origin, whether it was retrospective or prospective data, etc.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For example, 3 radiologists with 5+ years of experience each.
- Adjudication method for the test set: How disagreements among experts establishing ground truth were resolved (e.g., 2+1 means 2 experts agree, if not, a 3rd expert adjudicates; 3+1 means 3 experts agree, if not, a 4th adjudicates).
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Details on the study design and the effect size (e.g., human readers improved AUC by X with AI assistance).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The results of the algorithm's performance without human intervention.
- The type of ground truth used: For instance, expert consensus, pathology reports, clinical outcomes data, follow-up imaging, etc.
- The sample size for the training set: Number of cases/patients used to train the AI model.
- How the ground truth for the training set was established: Similar to the test set, but often less stringent or by different methods depending on the training methodology.
Since the provided document does not pertain to an AI/ML device, I am unable to provide the specific details requested. The "Performance Data" section (page 7) lists only non-clinical studies related to design validation, stability, post-operative evaluation (accuracy of the physical guide), and wear tests for the physical instruments. It explicitly states "no clinical studies were conducted."
§ 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.