(34 days)
The Jemo Spine, LLC, DELTA™, Spinal Fusion System, a posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the Jemo Spine, LLC, DELTA™, Spinal Fusion System is 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
When used as an posterior screw fixation system such as a sacral/iliac screw fixation system, the Jemo Spine, LLC, DELTA™, Spinal Fusion System is indicated for patients with severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.
The Jemo Spine, LLC, DELTA™, Spinal Fusion System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, cap/set screws, and a transverse (cross) linking mechanism. The Jemo Spine, LLC, DELTA™, Spinal Fusion System implant components are fabricated from titanium allov (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.
The Jemo Spine, LLC, DELTA™, Spinal Fusion System can be used in the posterior plane providing unilateral and bilateral modes of fixation.
The Jemo Spine, LLC, DELTA™, Spinal Fusion 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 preassembled bi-polar cup and internal saddle in the housing component between the screw and the rod which tightens against the head of the pedicle screw upon interface of the cap/set screw assembly with the rod.
Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Jemo Spine, LLC, DELTA™, Spinal Fusion System implants.
Here's an analysis of the provided 510(k) summary regarding the Jemo Spine, LLC, DELTA™ Spinal Fusion System, focusing on acceptance criteria and the study conducted to prove device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Type |
|---|---|---|
| Mechanical Performance: | ||
| (Static and Fatigue Testing per ASTM F 1717-04) | The subject device was "evaluated/tested per established requirements." | Mechanical Testing |
| Material Conformance: | ||
| (Implant components made from titanium alloy (Ti-6Al-4V ELI) conform to ASTM F 136) | Implant components are "fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136." | Material Specification / Manufacturing Compliance |
| Dimensional Equivalence to Predicate Device: | ||
| (Within acceptable limits of the predicate device, OPTIMA™ Spinal System) | Universal Housing Height: DELTA™: 0.670", OPTIMA™: 0.680" | |
| Universal Housing O.D. / Implant Width: DELTA™: 0.540", OPTIMA™: 0.550" | ||
| Pedicle Screw / Housing / Rod / Set Screw Implant Height / Prominence: DELTA™: 0.690", OPTIMA™: 0.690" | ||
| Conclusion: Height and width in Optima™ is ~0.010" larger, Overall prominence height is equal. | Dimensional Comparison | |
| Safety & Effectiveness Equivalence to Predicate Device: | ||
| (As safe and effective as the predicate device for stated indications, with similar indications for use, contraindications, warnings, and precautions) | "The subject Jemo Spine, LLC, DELTA™ Spinal Fusion System device is as safe and effective as named predicate and currently marketed competitive devices for the stated indications." | |
| "The principles of operation... and the cited predicate technologies are similar... each of these products employs similar indications for use, contraindications for use, warnings and precautions within labeling." | Substantial Equivalence Determination (based on design, indications, materials, and mechanical testing) | |
| Quality Systems Compliance: | ||
| (Conforms to 21 CFR Part 820, ISO 9001, and ISO 13485) | "The design and development process of the manufacturer of subject system and Predicate system conforms to 21 CFR part 820, ISO 9001 and ISO 13485 quality systems." | Quality System Audit/Compliance |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any particular "test set." The mechanical testing refers to "established requirements," implying a standardized testing protocol that would define the number of samples. For the dimensional comparison, it's a comparison of specifications rather than a statistical sample size from production.
- Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." The testing described is pre-market non-clinical (mechanical and dimensional comparison).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This submission is for a spinal implant, which is a physical device, not an AI or diagnostic device that requires expert ground truth for interpretation of images or patient data. The "ground truth" for this device relates to manufacturing specifications, material properties, and mechanical performance under standardized tests.
4. Adjudication Method for the Test Set
- Not Applicable. As noted above, this type of device does not involve human interpretation or subjective assessments that would require an adjudication method. Performance is measured against objective standards (e.g., ASTM standards, dimensional comparisons).
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
- No, an MRMC study was NOT done. This is a hardware medical device (spinal implant), not an AI-assisted diagnostic or interpretation system. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a physical spinal implant, not an algorithm.
7. The Type of Ground Truth Used
- For mechanical testing, the "ground truth" is defined by the ASTM F 1717-04 standard specifications for spinal implant constructs.
- For material composition, the "ground truth" is adherence to the ASTM F 136 standard for titanium alloys.
- For dimensional characteristics, the "ground truth" is the design specifications of the device itself and its comparison to the predicate device.
- For safety and effectiveness, the "ground truth" is demonstrated through substantial equivalence to a predicate device that has already been deemed safe and effective by the FDA, based on similar design, materials, indications, and non-clinical performance data.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI or machine learning device that requires a training set. The "training" for such devices involves adherence to design controls, manufacturing processes, and testing protocols.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As per point 8, there is no training set for this type of device.
§ 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.