(127 days)
The Novel III Spinal System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S 1 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 Novel Spinal 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).
The Novel ///TM Spinal Fixation and Adjustable Bridge System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Novel /// ™ Spinal Fixation and Adjustable Bridge System implant components are fabricated from titanium allov (Ti-6Al-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.
Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Novel ////™ Spinal Fixation and Adjustable Bridge System implants.
This 510(k) summary does not contain information related to an AI/ML device. The submission is for a medical device (spinal fixation system) and its modified sterilization trays, not a software algorithm that performs diagnostic or prognostic functions.
Therefore, many of the requested items (e.g., acceptance criteria for AI performance, sample size for test/training sets, expert ground truth, MRMC studies) are not applicable to this document.
Here's an analysis based on the information provided in the 510(k) summary, focusing on the device modification mentioned:
Acceptance Criteria and Study for Novel III™ Spinal Fixation and Adjustable Bridge System (Modified Sterilization Trays)
This 510(k) submission primarily concerns a "Special 510(k): Device Modification" related to redesigning custom sterilization trays for the Novel III™ Spinal Fixation and Adjustable Bridge System. The core spinal fixation device itself has already been cleared (predicates K081153 and K103147).
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria and reported device performance are focused on the sterilization process for the redesigned trays, not on the clinical performance of the spinal system or an AI/ML algorithm.
| Acceptance Criteria Category | Specific Criterion | Reported Performance / Outcome |
|---|---|---|
| Sterilization Validation | Achieve a Sterility Assurance Level (SAL) equal to at least 1 x 10⁻⁶ | Validation satisfactorily performed on the redesigned sterilization trays. |
| Mechanical Testing (of the implant) | Conformance to ASTM F 1717-04 (Static Compression, Tension, Torsion Bending) | Performed on the subject/predicate device. (Note: Not for the new trays themselves, as trays are not worst-case and don't require this specific testing) |
| Material Conformance (of the implant) | Titanium alloy (Ti-6Al-4V ELI) conforms to ASTM F 136 | Stated that implant components conform to ASTM F 136. |
| Substantial Equivalence | Device is substantially equivalent to predicate devices | Determined by FDA (letter) and stated in submission. |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- For the sterilization validation, the sample size is not explicitly stated in the summary, but it would typically involve a statistically relevant number of sterilization cycles and biological indicator tests. The summary just states it was "satisfactorily performed."
- For mechanical testing of the implant, the sample size is not specified but would follow ASTM F 1717-04 guidelines.
- Data Provenance: The data provenance for the tests performed (sterilization validation, mechanical testing) is not specified beyond being generated by Medyssey Co. Ltd. There is no mention of country of origin or whether it was retrospective or prospective, as these terms are relevant for clinical studies, not typically for device performance testing like sterilization or mechanical strength.
3. Number of Experts and Qualifications for Ground Truth Establishment
This item is not applicable as the submission does not involve an AI/ML algorithm or a diagnostic/prognostic device that requires expert ground truth establishment from clinical images or data. The ground truth for sterilization is a defined SAL, established through validated laboratory procedures.
4. Adjudication Method for the Test Set
This item is not applicable. The type of testing performed (sterilization validation, mechanical testing) does not involve human readers or adjudication processes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This item is not applicable. No MRMC study was performed as this is not an AI/ML device, nor is it a diagnostic imaging device where human reader performance would be the primary endpoint. The submission explicitly states: "Clinical tests: No clinical tests conducted on either the subject system nor the predicate system."
6. Standalone Performance (Algorithm Only)
This item is not applicable as there is no algorithm or software component for standalone performance evaluation in this 510(k) submission.
7. Type of Ground Truth Used
- For Sterilization Validation: The ground truth is the Sterility Assurance Level (SAL), which is a quantitative measure (1 x 10⁻⁶), established through specific, validated laboratory methods involving biological indicators and physical parameters of the sterilization cycle.
- For Mechanical Testing: The ground truth is the performance specifications defined by the ASTM F 1717-04 standard.
- For Substantial Equivalence: The ground truth is the characteristics and performance of the predicate devices and the regulatory standard for equivalence.
8. Sample Size for the Training Set
This item is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
This item is not applicable as there is no training set.
§ 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.