(165 days)
The ISS-JAZZ Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The ISS-JAZZ Screw System is intended for posterior, non-cervical pedicle and non-pedicle fixation for 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 deformities (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis, or revision of a failed fusion attempt.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ISS-JAZZ Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The JAZZ systems (including the JAZZ Claw Connector) are temporary implants to be used in orthopedic surgery. The JAZZ systems are intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
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- Spinal trauma surgery, used in sublaminar or facet wiring techniques;
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- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis:
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- Spinal degenerative surgery, as an adjunct to spinal fusions.
The JAZZ Systems may also be used in conjunction with other medical implants made of titanium alloy or Cobalt-chromium-molybdenum alloy whenever "wiring" may help secure the attachment of other implants.
The JAZZ CAP SP is composed of three components, the Cap SP, the Base SP, and the Insert Lock. The head shape ISS pedicle screws is modified from the current tulip shape to a cylindrical shape to match the Cap SP, resulting in the JAZZ Screw. The ISS-JAZZ Screw System is composed of monoaxial and polyaxial screws and straight and pre bent rods. The JAZZ CAP SP is added to the proximal end of the JAZZ Screw and provides for an alternate method to attach the JAZZ Band and JAZZ Passer Band to skeletal structures as compared to the current method of using a JAZZ Connector (K171881).
This document is a 510(k) summary for a medical device called the ISS-JAZZ Screw System and JAZZ CAP SP. It describes the device, its intended use, comparison to predicate devices, and performance data to demonstrate substantial equivalence.
Here's an analysis of the requested information based on the provided text, indicating when information is not provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative table format. Instead, it refers to performance testing conforming to a standard and demonstrating substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Dynamic Compression | Equivalence to predicate device per ASTM F1717 | Performed on worst-case construct, established equivalence to predicate. |
| Static Axial Load | Characterize maximum load by Band on JAZZ CAP SP to cause displacement on JAZZ Screw | Testing conducted to characterize this load. |
| Sterilization | Not constituting a new worst-case compared to predicate | Detailed rationales provided to demonstrate this. |
| Cleaning | Not constituting a new worst-case compared to predicate | Detailed rationales provided to demonstrate this. |
| Biocompatibility | Not constituting a new worst-case compared to predicate | Detailed rationales provided to demonstrate this. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "worst-case construct" for dynamic compression testing, implying a limited number of samples representative of the most challenging configuration. For static axial load, it states "Additional static axial load testing" without specifying the number of samples.
- Data Provenance: Not provided, but generally, such performance testing for medical devices is conducted in a controlled laboratory environment. The document is for submission to the U.S. FDA, so the data is intended for U.S. regulatory review. It is a premarket notification, so the data would be based on pre-clinical testing, not clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable to this type of submission. This document describes the performance testing of a spinal implant system. The "ground truth" here is based on engineering principles, standardized mechanical tests (ASTM F1717), and material science, not clinical expert consensus on diagnostic images or patient outcomes.
4. Adjudication Method for the Test Set
- This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters where there might be disagreement in interpretations. This document pertains to mechanical performance testing.
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 information is not applicable. This is not an AI/software as a medical device (SaMD) submission. It is a traditional medical device (implant) submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- This information is not applicable. This is not an AI/software as a medical device (SaMD) submission.
7. The Type of Ground Truth Used
- The "ground truth" in this context is defined by engineering specifications, material properties, and established mechanical testing standards (ASTM F1717). The goal is to demonstrate that the device meets predefined physical and mechanical performance characteristics, and is substantially equivalent to predicate devices based on these objective measures.
8. The Sample Size for the Training Set
- This information is not applicable. This is not an AI/machine learning device. There is no "training set" in the context of mechanical performance testing for an implant.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable. As there is no training set for an AI/ML model, there is no ground truth derivation process for such a set.
§ 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.