(33 days)
The Response 5.5 Spine System is intended for immobilization of the posterior, noncervical 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 pediatic patients, the Response 5.5 Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Response 5.5 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 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 purpose of this Pre-Market Notification is to expand the Indications of Use of the system per product codes NKB, OSH, MNH, MNI, KWP.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for OrthoPediatrics Corp. Response 5.5 Spine System
Device Name: Response 5.5 Spine System
Submission Type: 510(k) Premarket Notification (K160466)
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | ||
| Axial Grip (ASTM F1717) | Not explicitly detailed, but implied to be within acceptable ranges for spinal implant constructs. | The subject devices met the pre-determined acceptance criteria for all tests. |
| Axial Torsion (ASTM F1717) | Not explicitly detailed, but implied to be within acceptable ranges for spinal implant constructs. | The subject devices met the pre-determined acceptance criteria for all tests. |
| Flexion Extension Static Testing (ASTM F1717) | Not explicitly detailed, but implied to be within acceptable ranges for spinal implant constructs. | The subject devices met the pre-determined acceptance criteria for all tests. |
| Flexion Extension Fatigue (ASTM F1717) | Not explicitly detailed, but implied to be within acceptable ranges for spinal implant constructs. | The subject devices met the pre-determined acceptance criteria for all tests. |
| Construct Static Compression Bending (ASTM F1798) | Not explicitly detailed, but implied to be within acceptable ranges for interconnection mechanisms. | The subject devices met the pre-determined acceptance criteria for all tests. |
| Construct Static Torsion (ASTM F1798) | Not explicitly detailed, but implied to be within acceptable ranges for interconnection mechanisms. | The subject devices met the pre-determined acceptance criteria for all tests. |
| Construct Compression Bending Fatigue (ASTM F1798) | Not explicitly detailed, but implied to be within acceptable ranges for interconnection mechanisms. | The subject devices met the pre-determined acceptance criteria for all tests. |
| Biocompatibility | Adherence to "Flow Chart for the Selection of Toxicity Tests for 510(K)s per FDA Guidance #G95-1 'Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing', May 1, 1995" or demonstration of identical materials and processing to existing biocompatible predicates. | Biocompatibility testing was not required because the materials are identical to previously cleared predicate systems (Response 5.5/6.0 Spine System (K150600) and Response Spine System (K130655)) and have a well-characterized history of clinical use. |
Summary of Acceptance: The device met the pre-determined acceptance criteria for all mechanical tests and biocompatibility was deemed not required due to material equivalence to established predicates and FDA guidance.
Study Details
The provided document describes a 510(k) Premarket Notification, which primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than a clinical effectiveness study. Therefore, the "study" referred to here is the set of tests and comparisons conducted to support this substantial equivalence.
1. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a "sample size" in terms of patient data. For mechanical testing, the sample size would refer to the number of device components or constructs tested. This information is not explicitly provided in the excerpt.
- Data Provenance: The data is primarily from mechanical testing conducted in a lab environment. The document does not mention any human or animal studies, or data from specific countries of origin for test results. It's an engineering and material science assessment.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission relies on established international standards (ASTM) and FDA guidance for mechanical testing and biocompatibility rather than expert consensus on a test set's ground truth. The "ground truth" here is the adherence to these accepted scientific and regulatory standards.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where human reviewers assess ambiguous cases. In this context, the assessment is based on objective measurements against pre-defined engineering standards.
4. 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 performed. This type of study is relevant for AI-powered diagnostic or assistive devices, which is not what the Response 5.5 Spine System (a pedicle screw spinal system) is.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical implantable device, not a software algorithm or AI device. Therefore, the concept of "standalone performance" for an algorithm is not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Mechanical Testing: The "ground truth" is defined by the acceptance criteria within the international standards ASTM F1717 and ASTM F1798 and presumably internal specifications aligned with these standards. These standards prescribe methodologies and expected performance characteristics for spinal implants.
- For Biocompatibility: The "ground truth" is based on FDA guidance (FDA Guidance #G95-1 and ISO-10993) and the historical clinical safety record of the specific materials (Titanium Alloy and CoCr) that match those used in legally marketed predicate devices.
7. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set."
8. How the ground truth for the training set was established:
- Not applicable. As there is no training set for a machine learning model, this question is not relevant.
§ 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.