(285 days)
The Pisces Spinal System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, sacrum and iliac spine (T1-Sacrum/Ilium) for the following indications:
- Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Degenerative Spondylolisthesis with objective evidence of neurologic impairment
- Trauma (fracture or dislocation)
- Spinal tumor
- Failed previous fusion (pseudarthrosis)
- Spinal stenosis
- Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis
The Pisces Spinal System is an implantable system intended to provide immobilization and stabilization of spine segments. The subject device is a modular pedicle screw assembly that consists of pedicle screws with solid and cannulated options, modular tulips in standard, reduction, and extended tab configurations, spinal rods, and set screws. All components are made of implantable-grade titanium.
The modular tulip is an assembly which consists of a tulip body, a saddle, and a locking ring. The top of the tulip body receives a locking set screw which secures the tulip body assembly to an ø5.5mm or ø6.0mm rod and pedicle screw when tightened.
The pedicle screw has a spherical head which the tulip assembly snaps onto either before or after surgical insertion. The 5.5mm or 6.0mm rod is inserted into the tulip assembly. After assembly of multiple pedicle screws, a set screw is inserted into the tulip and locked to a predetermined locking torque, immobilizing the construct. For the 20mm reduction and 90mm extended tab tulips, the guide tabs are removed from the construct following final lock. 20mm reduction tabs can be used to provide length for rod reduction while 90mm tab tulips facilitate minimally invasive surgeries (MIS). All implants are provided sterile for single use only.
This document describes the Pisces Spinal System and demonstrates its substantial equivalence to predicate devices, thus the acceptance criteria are based on mechanical and biological performance rather than diagnostic accuracy.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Sterility Assurance Level | Validated to 10⁻⁶ |
| Packaging Integrity | Complies with ISO 11607-1 and ISO 11607-2 |
| Biocompatibility | Complies with ISO 10993-1 and ANSI/AAMI ST72 |
| Mechanical Performance (Static Compression) | Performed per ASTM F1717 |
| Mechanical Performance (Dynamic Compression) | Performed per ASTM F1717 |
| Mechanical Performance (Static Torsion) | Performed per ASTM F1717 |
| Mechanical Performance (Flexion-Extension) | Performed per ASTM F1798 |
| Mechanical Performance (Static Anterior-Posterior Loading) | Performed per ASTM F1798 |
| Bacterial Endotoxin Level | Met predetermined acceptance criteria (≤ 20 EU/device) and routinely monitored |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for each specific test (e.g., number of devices tested for mechanical performance, number of samples for bacterial endotoxin testing). However, it mentions "Validation results" for sterilization, shelf life, and biocompatibility, and "Mechanical testing" was performed on the device. All these tests are inherently prospective, meaning the data was generated specifically for the validation of this device. The provenance is internal to Ortho Development Corporation, as they conducted or commissioned these validation tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The acceptance criteria for this device are based on objective, quantifiable engineering and biological tests (e.g., sterility, mechanical strength, material compatibility), not on subjective expert consensus for establishing ground truth like in a diagnostic device.
4. Adjudication Method for the Test Set
Not applicable, as the acceptance criteria are based on objective physical and chemical testing, not expert interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. This is a medical device for surgical implantation, not a diagnostic imaging device that would typically involve human readers or AI assistance in interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical implant, not an AI algorithm.
7. Type of Ground Truth Used
The ground truth is based on established engineering standards (ASTM and ISO), biological compatibility standards (ISO 10993-1, ANSI/AAMI ST72), and regulatory limits for sterility and endotoxins.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.