(18 days)
The Array Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use; degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.
The Array® Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. This premarket notification is being submitted to reflect the addition of a spinal system fabricated from stainless steel.
The provided text describes a medical device submission (K061563) for the EBI® Array® Spinal System. However, it does not contain the specific information requested regarding acceptance criteria, a study that proves the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about the training set.
The document primarily focuses on the substantial equivalence of the EBI® Array® Spinal System to existing predicate devices based on:
- Intended Use and Indications: The indications for use are clearly stated for various spinal conditions.
- Technological Characteristics: The submission highlights that the proposed system includes a new stainless steel version.
- Basic Principles of Operation: It asserts that the fundamental principles remain the same as predicate devices.
- Performance Testing (Mechanical): It states that mechanical testing was conducted and demonstrates conformity to design specifications, with requirements based on predicate devices. It explicitly mentions that the "worst case of the proposed system adequately meets the requirements established in design specifications for its mechanical performance."
Here's a breakdown of what can be extracted and what is missing based on your specific questions:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document implies that acceptance criteria were established through "design specifications" which were "based on those of the previously cleared predicate devices." However, the specific criteria themselves (e.g., specific load values, fatigue cycles, displacement limits) are NOT provided.
- Reported Device Performance: The document states that "The results of testing conducted demonstrate that the worst case of the proposed system adequately meets the requirements established in design specifications for its mechanical performance." However, the specific performance data (e.g., actual load to failure, number of cycles survived) are NOT provided.
Therefore, a table cannot be constructed with specific values from this document. The information is high-level and qualitative rather than quantitative.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions "mechanical testing" but does not specify the sample size (e.g., number of implants tested).
- Data Provenance: This is a mechanical engineering test, not a clinical data study. Therefore, concepts like country of origin or retrospective/prospective data are not applicable. The testing would have been conducted in a lab environment.
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)
- This is a mechanical engineering product. There are no "experts" in the clinical sense (like radiologists) establishing ground truth for the test set. Instead, there would be engineers designing the test protocols, conducting the tests, and analyzing the results against established engineering standards or internal specifications. No specific number or qualifications of such engineers are provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This concept is not applicable to mechanical testing of a medical device. Adjudication methods are typically used in clinical studies or image interpretation where human judgment, and potential discrepancies, need to be resolved.
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 MRMC study was done. This device is a physical spinal implant, not an AI or imaging diagnostic tool. Therefore, MRMC studies and concepts of human reader improvement with/without AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone (algorithm-only) performance was done. Again, this is a physical implant, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For mechanical testing, the "ground truth" would be established by engineering design specifications and recognized mechanical testing standards (e.g., ASTM, ISO standards applicable to spinal implants). The device's performance is tested against these predefined thresholds or comparison to predicate device performance. The document only states "design specifications were established based on those of the previously cleared predicate devices."
8. The sample size for the training set
- This is not applicable. There is no "training set" as this is not a machine learning or AI device. The submission refers to mechanical testing.
9. How the ground truth for the training set was established
- This is not applicable, as there is no training set for this type of device submission.
In summary: The provided document is a 510(k) premarket notification for a physical medical device (spinal implant). The information you're asking for (especially regarding AI/ML studies, ground truth, expert adjudication, etc.) is not relevant to this type of device and therefore is not present in the submission. The assessment of this device for substantial equivalence relies on comparing its mechanical properties and intended use to existing, legally marketed predicate devices through engineering testing.
§ 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.