(329 days)
The Valorem Surgical MAXIMIS™ Pedicle Screw Fixation System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: 1) trauma (i.e. fracture or dislocation), 2) curvatures (scoliosis, and/or lordosis) 3) spinal tumor, 4) failed previous fusion, 5) pseudoarthrosis, 6) spinal stenosis. It is not intended for pedicle screw fixation above T8. This device may be used with autograft of allograft.
The MAXIMIS ™ Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, and set screws. The MAXIMIS TM Spinal Fixation System implant components are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.
The MAXIMIS ™ Spinal Fixation System can be used in the posterior plane providing bilateral modes of fixation.
The MAXIMIS ™ Spinal Fixation System design allows adjustment in both the sagittal and coronal planes permitting screw placement according to the best possible anatomic (spinal) location and orientation.
This is accomplished by means of a mobile and non-mobile housing component which houses the screw and the rod which accepts a setscrew which tightens against the rod which tightens head of the pedicle screw upon secure tightening interface of the set screw assembly with the rod.
Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the MAXIMIS ™ Spinal Fixation System implants.
The provided text describes a 510(k) premarket notification for the MAXIMIS™ Spinal Fixation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel clinical effectiveness through extensive clinical trials. Therefore, the information regarding typical acceptance criteria and study designs for AI/medical imaging devices, such as those related to accuracy, sensitivity, specificity, human reader performance, or training set details, is not applicable in this context.
The document primarily discusses the device's technical specifications, materials, indications for use, and a comparison to a predicate device. The performance data is limited to mechanical testing for the predicate device, not clinical performance for human-in-the-loop or standalone AI performance.
Here's a breakdown of why many of your requested items are not present:
- No AI/Algorithm Component: The MAXIMIS™ Spinal Fixation System is a physical implant (pedicle screws, rods, set screws) made from titanium alloy. It is not an AI or software-as-a-medical-device (SaMD) product. Therefore, concepts like acceptance criteria for AI performance, sample sizes for test/training sets in an AI context, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are irrelevant to this device.
- Focus on Substantial Equivalence: The 510(k) process aims to show that a new device is "substantially equivalent" to a predicate device, meaning it's as safe and effective. This is often done by comparing technical characteristics and, in the case of implants, mechanical performance, rather than clinical outcomes or advanced analytical performance.
- Performance Data is Mechanical: The "Performance Data" section (Item 8 in the 510(k) Summary) explicitly states that the predicate device underwent mechanical testing according to ASTM standards for static and fatigue properties of spinal implants. This is about physical durability and strength, not diagnostic accuracy.
- No Clinical Tests: Item 9 clearly states: "No clinical tests were conducted on either the subject system or the predicate system." This confirms the absence of human subject trials to establish clinical performance metrics.
Therefore, I cannot populate the table or answer the specific questions related to AI/algorithm performance and clinical study details because the provided document does not pertain to such a device or study type.
The relevant information from the document is related to its mechanical testing and comparison to a predicate device for regulatory clearance.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not explicitly stated as "acceptance criteria" but implied by substantial equivalence) | Reported Device Performance (Mechanical Testing) |
|---|---|
| Mechanical Performance: (Implied: device should withstand stresses similar to predicate) | Predicate Device underwent mechanical testing per: |
| - ASTM F1798-97: Standard guide for evaluating static and fatigue properties of interconnection mechanisms and subassemblies used in spinal arthrodesis implants. | |
| - ASTM F1717-04: Standard test methods for spinal implant constructs in a vertebrectomy model. | |
| - ASTM F2193-02: Standard specifications and test methods for components used in the surgical fixation of the spinal skeletal system. | |
| Material Composition: (Implied: biocompatibility and strength) | Fabricated from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F 136. |
| Indication for Use: (Implied: similar scope as predicate) | Posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients for instabilities/deformities (trauma, curvatures, tumor, failed fusion, pseudoarthrosis, spinal stenosis). Not for pedicle screw fixation above T8. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical test set or human data was used. Mechanical testing involves material samples and device constructs, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No clinical test set requiring expert ground truth for diagnosis/assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. Ground truth for clinical assessment is not relevant here. The "truth" in mechanical testing is whether the device constructs meet the specified ASTM standard requirements for strength and durability.
8. The sample size for the training set
- Not applicable. This is a physical implant, not an AI or machine learning model.
9. How the ground truth for the training set was established
- Not applicable. This is a physical implant, not an AI or machine learning model.
§ 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.