(60 days)
The RIPLEY SPINAL SCREW SYSTEM BY SAGICO is intended for use in the non-cervical spine. When used for anterior/anteral and posterior, non-cervical pedicle and non-pedicle fixation system, the RIPLEY SPINAL SCREW SYSTEM BY SAGICO is intended to provide additional support during fusion using autograft or allograft in Skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
- Degenerative disc disease (DDD) (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, kyphosis, and/or lordosis);
- Tumor;
- Pseudoarthrosis; and
- Failed previous fusion
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the RIPLEY SPINAL SCREW SYSTEM BY SAGICO implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis.
The RIPLEY SPINAL SCREW SYSTEM BY SAGICO for pediative use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The RIPLEY SPINAL SCREW SYSTEM BY SAGICO constructs of monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking cap set screws, rods, hooks, monoaxial and multiaxial transverse connectors and associated surgical instruments. The RIPLEY SPINAL SCREW SYSTEM BY SAGICO implants are available in a variety of sizes to accommodate individual patient anatomy and pathology conditions. RIPLEY SPINAL SCREW SYSTEM BY SAGICO is designed to adapt 5.5mm diameter rods; the implants are manufactured from Ti6A14V alloy and offered in a sterile package option.
This FDA 510(k) Premarket Notification document (K232561) for the Ripley Spinal Screw System by SAGICO describes a medical device, not an AI or software-driven diagnostic tool. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating diagnostic performance, is not applicable in this context.
The document primarily focuses on demonstrating the device's substantial equivalence to existing predicate devices based on:
- Indications for Use: The Ripley Spinal Screw System's intended uses are comparable to existing predicate devices.
- Design and Materials: The system's design (monoaxial, uniplanar, polyaxial screws, rods, hooks, connectors) and material (Ti6A14V alloy) are similar to predicate devices.
- Performance Data (Non-Clinical): Mechanical testing was performed to ensure the device's physical properties are equivalent or superior to predicate devices.
Here's a breakdown of the relevant information provided for this medical device, which differs significantly from the requested AI-specific information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of specific clinical acceptance criteria or human-in-the-loop diagnostic performance. Instead, it references performance data generated from mechanical testing standards:
| Performance Standard | Test Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| ASTM F1717 | Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model (Static & Dynamic Compression Bending Test) | Device must meet or exceed the mechanical performance (e.g., stiffness, strength, fatigue life) of the predicate devices under these conditions. | Implicitly met, as the conclusion states substantial equivalence was established. Specific values are not provided in this summary. |
| ASTM F1798 | Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants (Axial Gripping, Axial Torsion Gripping, Flexion Extension Static Tests) | Device must demonstrate comparable mechanical integrity and stability to predicate devices for its interconnection mechanisms. | Implicitly met, as the conclusion states substantial equivalence was established. Specific values are not provided in this summary. |
Explanation: For mechanical devices like spinal screws, "acceptance criteria" are typically defined by engineering specifications (e.g., maximum load, fatigue cycles without failure, deformation limits) derived from recognized standards like ASTM. The goal of the testing is to show that the new device performs at least as well as legally marketed predicate devices, thereby establishing substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): Not applicable in the context of human data or AI diagnostic test sets. The "test set" here refers to the number of physical device samples used for mechanical testing according to ASTM standards. The exact number of samples tested for each ASTM standard is not specified in the provided summary, but these are typically small numbers of physical prototypes designed to represent the final product.
- Data Provenance: The data is non-clinical, derived from laboratory mechanical testing of physical implants, not from patient data or clinical studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. As this is a mechanical device, there is no "ground truth" to be established by clinical experts in the diagnostic sense. The "truth" is determined by the physical properties and performance measured in a laboratory setting against engineering standards.
- Mechanical testing engineers and quality assurance personnel would be involved in performing and validating these tests, but they are not "experts" establishing clinical ground truth.
4. Adjudication Method:
- Not Applicable. There is no adjudication method described for clinical interpretation or data labeling, as this is non-clinical product testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is relevant for evaluating the diagnostic performance of software or AI with human readers. It is not applicable to the mechanical testing of a spinal implant system.
6. Standalone (Algorithm Only) Performance:
- Not Applicable. This device is a physical implant, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. Type of Ground Truth Used:
- Engineering Specifications and Performance Standards (e.g., ASTM F1717, F1798). The "ground truth" or reference for evaluating performance is adherence to established mechanical testing standards and demonstrating comparable performance to predicate devices in those tests.
8. Sample Size for the Training Set:
- Not Applicable. This is a physical device, not an AI model. There is no concept of a "training set" for physical product development in this context. Design and engineering principles guide the development, followed by verification and validation through mechanical testing.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. No training set exists 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.