(148 days)
As a pedicle screw system, it is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; © who are having the screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to S1/Ilium.
As a posterior, non-pedicle screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications are:
- Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- Idiopathic scoliosis.
- Kyphotic deformities of the spine.
- Paralytic scoliosis and/or pelvic obliquity.
- Lordotic deformities of the spine.
- Neuromuscular scoliosis associated with pelvic obliquity.
- Vertebral fracture or dislocation.
- Tumors.
- Spondylolisthesis.
- Stenosis.
- Pseudarthrosis.
- Unsuccessful previous attempts at spinal fusion.
For posterior, non-pedicle screw use, the levels of use are T1 to the Sacrum/Ilium. For anterior use, the levels of use are T10 to L3 for the double rod constructs, and T5 to L5 for the single rod constructs.
The SYNERGY™ Spinal System is intended to be used a part of a temporary construct that assists normal healing and is not intended to replace normal body structures. It is intended to help stabilize the spinal operative site during fusion procedures. It attaches to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods.
The posterior application components are grouped as follows:
- INTEGRALTM Open, Closed, Angled Closed and Reduction Screws, Variable Locking Screws with Variable Locking Seats, and Iliac Screws, with Hex Nuts and Set Screws. Only the INTEGRALTM Open, Closed, Reduction and Variable Locking Screws are intended for pedicle fixation (see INDICATIONS).
- Open and Closed Spinal Hooks with Sliders, C-Rings and Set Screws.
- Adjustable and Fixed Transverse connectors with Set Screws.
- Closed and Axial Rod Connectors with Set Screws.
- Lateral Connectors with Set Screws.
- Rods.
- Instruments.
- Sterilizer case(s).
The anterior application components are grouped as follows:
- INTEGRAL™ Open and Closed Screws and Variable Locking Screws with Variable Locking Seats, with Hex Nuts and Set Screws.
- Vertebral Washers.
- Fixed Transverse Connectors with Set Screws.
- Rods.
- Instruments.
- Sterilizer case(s).
Material: The implantable components may be made from either titanium or stainless steel. The titanium version consists of surgical implant grade titanium alloy as described by ASTM Standard F136 (Ti 6A1-4V ELI), and commercially pure titanium, grade 2 as described by ASTM Standard F67 (CP Ti, Gr. 2). The stainless steel version consists of surgical implant grade stainless steel as described by ASTM standard F1314 (22-13-5 Stainless Steel), and surgical implant grade stainless steel as described by ASTM standard F138, Grade 2 (316L Stainless Steel).
The provided document is a 510(k) Summary for a medical device (SYNERGY™ Spinal System-Additional Components), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission relies on demonstrating equivalence rather than proving performance against specific acceptance criteria through clinical studies. Therefore, the document does not describe, nor does it require, a standalone study to prove the device meets acceptance criteria in the way a clinical trial or performance study for a novel device would.
Instead, the "acceptance criteria" here are implied by the standards and regulations used to demonstrate substantial equivalence, and the "study" is the overall submission process that compares the new device to existing ones.
Here's a breakdown based on the provided document, addressing your questions with relevant information or stating when the information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, this document is a 510(k) summary, not a clinical trial report. Thus, there isn't a table of discrete acceptance criteria and direct device performance metrics from a study in the traditional sense. The "acceptance criteria" are compliance with regulatory requirements and demonstration of substantial equivalence. The "device performance" is established by showing it possesses similar characteristics and safety/effectiveness profiles to predicate devices, and through mechanical testing (mentioned but not detailed).
| Acceptance Criteria (Implied by 510(k) Process) | Reported Device Performance (Summary from Document) |
|---|---|
| Substantial Equivalence to Predicate Devices | The SYNERGY™ Spinal System-Additional Components are declared substantially equivalent to the SYNERGY™ Anterior and Posterior, Stainless Steel and Titanium Spinal System (cleared under K934429, K940631, K950099, and K950709). |
| Similar Indications for Use | Devices are used to treat "similar or the same conditions." |
| Equivalent Cautions and Contraindications | Devices have "essentially the same cautions and contraindications for use." |
| Equivalent Potential for Complications/Risk | Devices have "equivalent potential for complications for risk of use." |
| Basic Design Concept | The device represents "a long standing, basic design concept." |
| Material Standards Compliance | Implantable components comply with ASTM Standard F136 (Ti 6A1-4V ELI), ASTM Standard F67 (CP Ti, Gr. 2), ASTM standard F1314 (22-13-5 Stainless Steel), and ASTM standard F138, Grade 2 (316L Stainless Steel). Instruments comply with ASTM A276, ASTM A564/A564M, and ASTM F899 standards. |
| Sterilization Protocol Validation | High temperature steam sterilization cycle (Gravity, 250°F (121°C), 60 minutes) was "laboratory validated" based on HIMA/AORN protocols. |
| Mechanical Testing | "Mechanical testing" was performed (mentioned in conclusion, but no details provided). |
| Compliance with General Controls (GMP, Labeling, etc.) | Implied compliance with current Good Manufacturing Practice (GMP) requirements, annual registration, listing of devices, labeling, and prohibitions against misbranding and adulteration. This is a condition of market clearance. |
2. Sample Size Used for the Test Set and the Data Provenance
- Not Applicable. This document describes a 510(k) submission for mechanical spinal implants, not a study involving a "test set" of patient data or samples to evaluate AI/software performance. The "test set" in this context would refer to the device components undergoing various engineering and material tests, but specific sample sizes and data provenance for these are not detailed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. As above, this is a mechanical device submission, not a study requiring expert-established ground truth for a test set in the clinical or AI sense. The "experts" involved would be regulatory reviewers at the FDA and potentially engineers and scientists employed by Cross Medical Products, Inc. who perform the material and mechanical testing.
4. Adjudication Method for the Test Set
- Not Applicable. No test set or related adjudication method is described in this 510(k) summary. Decisions regarding the substantial equivalence are made by the FDA based on the provided evidence.
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
- Not Applicable. This is a physical spinal implant, not an AI or diagnostic imaging device that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical spinal implant, not an algorithm.
7. The Type of Ground Truth Used
- Not Applicable in the traditional sense of a clinical study. For this medical device, "ground truth" would relate to the accepted engineering standards for materials (e.g., ASTM standards: F136, F67, F1314, F138, A276, A564/A564M, F899) and the "laboratory validated" sterilization protocols (HIMA/AORN protocols). Additionally, the performance of the predicate devices serves as a "ground truth" for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
- Not Applicable. This document does not describe a machine learning algorithm or a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. No training set is involved.
§ 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.