(159 days)
Devine Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization 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, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above TS.
The proposed devices of Devine Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization 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, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis.
It is made of Titanium Alloy (Ti-6AL-4V), which meet ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well known biocompatibility.
The proposed device includes three models, which are TL5.5, TL6.0 and TL6.35. All models use the same material, and same design principle. The only difference is the parts size which does not affect the design. There is no surface modified or coated.
The proposed device consists of the following components: FAS, Reduction FAS, Spine Hook, Rod and Crosslink Plate
The proposed devices are not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 100 by the hospital prior to surgery. The sterilization method is presented in the user manual, which was validated per 150 17665-1: 2006 Sterilization of health care products -- Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization. process for medical devices.
The provided text describes a medical device, the "Devine Spinal System," and its submission for 510(k) clearance. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical studies with acceptance criteria based on performance metrics like sensitivity or specificity.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be fully provided from the given document.
The document details a non-clinical bench test study to demonstrate that the device meets design specifications and is substantially equivalent to a predicate device, not a study to prove acceptance criteria based on clinical performance metrics.
Here is what can be extracted and inferred based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Test Standard) | Reported Device Performance |
|---|---|
| ASTM F1717-09 Static Axial Compression | Met all design specifications and was Substantially Equivalent (SE) to the predicate device. |
| ASTM F1717-09 Dynamic Axial Compression | Met all design specifications and was Substantially Equivalent (SE) to the predicate device. |
| ASTM F1717-09 Static Torsion | Met all design specifications and was Substantially Equivalent (SE) to the predicate device. |
- Note: The acceptance criteria here are based on meeting the requirements of the ASTM F1717-09 standard for spinal implant constructs in a vertebrectomy model, not clinical performance metrics. The reported performance is a statement of compliance and substantial equivalence to a predicate device, not specific quantitative results for each test.
2. Sample size used for the test set and the data provenance
- The document describes bench tests conducted to verify mechanical performance, not a test set for assessing clinical performance using patient data. Therefore, the concept of "test set" in the context of clinical data provenance (country of origin, retrospective/prospective) is not applicable here.
- The sample sizes for the mechanical tests (e.g., number of implant constructs tested) are not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the study described is a non-clinical bench test of mechanical properties, not an evaluation of a diagnostic or assistive device requiring expert consensus for ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable as the study described is a non-clinical bench test of mechanical properties. Adjudication methods are typically used for establishing ground truth from expert interpretations of clinical data.
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 comparative effectiveness study was not done. The device is an orthopedic implant (spinal system), not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone performance study in the context of an algorithm or AI was not done. The device is a physical spinal system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the bench tests, the "ground truth" would be the physical properties and performance characteristics defined by the ASTM F1717-09 standard. The device's components were also made from Titanium Alloy (Ti-6AL-4V) meeting ASTM F136-02a, which serves as a material "ground truth" for biocompatibility and material properties.
8. The sample size for the training set
- This question is not applicable. There is no "training set" as this is a physical medical device undergoing mechanical bench testing, not an AI or machine learning model.
9. How the ground truth for the training set was established
- This question is not applicable for the same reasons as point 8.
§ 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.