(73 days)
The Response 5.5/6.0 Spine System is intended for immobilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Response 5.5/6.0 Spine System implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The Response 5.5/6.0 Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Response 5.5/6.0 Spine System consists of longitudinal members (rods), anchors (hooks and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety of sizes to accommodate differing anatomic requirements.
No accessories are offered with the system.
The provided document is a 510(k) Pre-Market Notification for a medical device called the "Response 5.5/6.0 Spine System." This document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing and a review of material biocompatibility. It is not a study proving the device meets acceptance criteria related to AI or algorithmic performance, as the device itself is a physical spinal implant system, not a software algorithm.
Therefore, the requested information about AI/algorithmic performance, sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types and establishment are not applicable to this document. These questions are designed for evaluating AI/software as a medical device (SaMD), which this spinal system is not.
However, I can extract information regarding the device's mechanical acceptance criteria and the study (testing) performed to meet them.
Here's the relevant information paraphrased from the document:
1. Table of Acceptance Criteria and Reported Device Performance (Mechanical Testing)
The document states that the acceptance criteria for all mechanical tests were pre-determined. While the specific numerical acceptance values are not provided in this summary, the document explicitly states:
| Acceptance Criteria Type | Reported Device Performance |
|---|---|
| Mechanical Performance | The subject devices met the pre-determined acceptance criteria for all tests, including Axial Grip, Axial Torsion, Flexion Extension Static Testing, Flexion Extension Fatigue, Construct Static Compression Bending, Construct Static Torsion, and Construct Compression Bending Fatigue. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in terms of number of implants tested, but testing was performed on "subject devices" as per ASTM F1717 and ASTM F1798.
- Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective clinical study) as this refers to mechanical performance testing of the device itself, not clinical data from patients. The testing was conducted by OrthoPediatrics Corp.
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 there is no "ground truth" established by human experts for mechanical testing of a physical medical device in the way it would be for an AI algorithm evaluating medical images. The "ground truth" for mechanical testing is defined by the standardized test methods (ASTM F1717 and ASTM F1798) and their associated performance specifications.
4. Adjudication method for the test set
- This question is not applicable for mechanical testing. Performance is evaluated against objective, pre-defined engineering standards established by ASTM.
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
- This question is not applicable. This is a physical spinal implant, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. This is a physical spinal implant, not an AI software.
7. The type of ground truth used
- For mechanical performance: The "ground truth" (or standard of performance) is defined by the requirements of the recognized industry standards: ASTM F1717 - "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" and ASTM F1798 - "Standard Guide to Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants."
8. The sample size for the training set
- This question is not applicable. There is no "training set" for a physical medical device. The design, materials, and manufacturing processes are developed based on engineering principles and prior knowledge, not machine learning training.
9. How the ground truth for the training set was established
- This question is not applicable for the same reasons as above.
§ 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.