(259 days)
MySpine is intended as a thoracic and lumbar posterior pedicle targeting quide for patients requiring spinal fusion between the levels of T1 to L5.
MySpine Screw Placement Guides are intended to be used as anatomical perforating guides specific for a single patient anatomy to assist intraoperatively in the positioning of Pedicle screws in the vertebral body. MySpine is intended for use with M.U.S.T Pedicle Screw System and its cleared indications for use. Use of the quides involves 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 surqiçal 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 Screw Placement Guides are intended for single use only.
The MySpine Pedicle Screw Placement Guides are patient specific surgical instruments that allow for guided pedicle screw placement of the M.U.S.T pedicle screws (K121115). The M.U.S.T pedicle screws are guided through the patient's anatomically matched MySpine Pedicle Screw Placement Guides in order to provide optimal positioning according to the surgeon's preoperative planning. The MySpine software platform allows the surgeon to complete the preoperative planning in 3D based on the patient's spinal CT scans.
The components of the MySpine Pedicle Screw Placement Guides include a Drill Guide (Polyamide PA 2200), Sleeves for Awls, Probes and Screw Drivers (Polyamide PA 2200). Sleeves for taps and drills (Wrought stainless steel AISI 630. ASTM F 899), and Vertebral Bone Models (Polyamide PA 2200). The MySpine Pedicle Screw Placement Guides are single use, external communicating devices with limited (
The provided document describes the MySpine Pedicle Screw Placement Guides, a patient-specific surgical instrument. It details performance testing and establishes substantial equivalence to a predicate device, but it does not include a typical AI/ML medical device study with acceptance criteria, sample sizes, and expert validation for an algorithm's performance.
Instead, the performance testing focuses on traditional medical device validation, such as biocompatibility, dimensional accuracy, mechanical testing, and process reproducibility. The document mentions "software tools used to manufacture the MySpine Pedicle Screw Placement Guides were validated for their intended use," but this refers to the software used for design and fabrication, not an AI algorithm performing diagnostic or predictive tasks.
Therefore, the requested information elements related to AI/ML device studies cannot be extracted from this 510(k) summary.
However, I can extract information regarding the general performance testing and a design validation cadaver study.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Met ISO 10993 applicable to external communicating devices with limited ( |
§ 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.