(63 days)
The Acme 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 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).
The Acme Spinal System consists of monoaxial and polyaxial pedicle screws, locking plugs, spinal rods and rod to rod connectors. Acme Spine System can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. The modification included in this submission is the addition of the Acme Talon Pedicle Screw.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study information:
Based on the provided document, the device in question is the "Acme Spinal System," and the submission focuses on the addition of the "Acme Talon Pedicle Screw." This is a medical device clearance (510(k)), which typically relies on demonstrating substantial equivalence to a predicate device rather than extensive clinical efficacy studies like those for drugs.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength per ASTM F1717 | "Testing was conducted according to ASTM F1717 with adequate strength." |
Note: The document only explicitly mentions mechanical testing according to ASTM F1717. It does not provide specific numerical acceptance criteria or detailed performance results (e.g., specific load capacities, fatigue cycles survived) in this summary. It only states that the testing demonstrated "adequate strength."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for the non-clinical testing. The document states "Testing was conducted according to ASTM F1717," which is a standard for static and fatigue testing of pedicle screw spinal systems. This typically involves a defined number of test samples (e.g., screws, constructs) as per the standard's methodology.
- Data Provenance: Not explicitly stated, but assumed to be laboratory-based mechanical testing, likely conducted by or for the manufacturer (Acme Spine, LLC) in the USA. It is retrospective in the sense that the testing was performed, and the results are being reported for the 510(k) submission, not as a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. The ground truth for this device (Acme Spinal System with Talon Pedicle Screw) is established through mechanical testing against industry standards (ASTM F1717), not through expert clinical consensus for diagnostic or prognostic purposes.
4. Adjudication Method for the Test Set
- Not applicable. As noted above, the "test set" here refers to physical components undergoing mechanical evaluation, not clinical data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is a 510(k) submission for a spinal implant, which relies on mechanical performance and substantial equivalence to a predicate device. MRMC studies are typically performed for medical imaging devices or diagnostic algorithms where human readers interpret data, often with and without AI assistance, to assess diagnostic performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- Mechanical Performance Standards: The ground truth for this device is based on its ability to meet the mechanical performance requirements specified in ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model), which ensures the device's structural integrity and durability.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for such devices involves design, prototyping, and manufacturing process refinement.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As mentioned, there is no "training set" in the context of an AI/ML algorithm. For physical medical devices like the Acme Spinal System, the "ground truth" for design and manufacturing is established through engineering principles, material science, and adherence to quality systems and relevant standards (e.g., ASTM F136 for titanium alloy, ISO standards for manufacturing processes) to ensure the device's safety and effectiveness.
§ 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.