(150 days)
The subject components of the Osteonics® Spinal System Rod / Plate are single-use devices which are sold non-sterile, and are intended for use only with other components of the commercially available Osteonics® Spinal System. The components of the Osteonics® Spinal System, including the additional components described herein, are available in either ASTM F-136 Ti6AV ELI Alloy. Ti6Al4V ELI alloy components are intended for use only with other Ti6Al4V ELI alloy components.
The specific indications of the Osteonics® Spinal System, including the subject additional components, are as follows:
As a non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:
- . Long and short curve scoliosis
- . Vertebral fracture or dislocation
- . Spondylolisthesis
- . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- . Previously failed fusion
- . Spinal tumor
For Pedicular Use:
- When used as a pedicle screw fixation system of the non-cervical posterior spine in . skeletally mature patients, the Osteonics® Spinal System is indicated for one or more of the degenerative spondylolisthesis with objective evidence of neurological following: impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
- In addition, the Osteonics® Spinal System is indicated for pedicle screw fixation in . skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below)with removal of the implants after the development of a solid fusion mass.
The Osteonics® Spinal System Rod / Plate System (RPS) is designed for fixation of one or two levels of the lumbar and thoracic spine. The RPS offers options of both a low-profile plate and a stiff rod. The components which comprise the Osteonics® Spinal System Rod / Plate System are: The Rod / Plate, One-Level, Short, the Rod / Plate, One-Level, Long, the Rod / Plate, Two-Level, Long, the 5.0 mm Bone Screw (25mm to 60mm lengths) which are compatible with the rod / plate bone screw holes, the Threaded Cap (which tightens the 5.0mm bone screw to the Rod / Plate), and the Rod / Plate Ball Ring (pre-assembled to the Two-Level, Long Rod / Plate) in order to secure an Osteonics® Spinal System Bone Screw to the two-level rod / plate assembly.
The provided 510(k) Premarket Notification for the Osteonics® Spinal System - Rod / Plate System (K991055) primarily focuses on demonstrating substantial equivalence to predicate devices based on mechanical properties and intended use. It does not describe a study involving human or image-based performance for an AI/CAD/Software device, but rather a mechanical device.
Therefore, most of the requested information regarding acceptance criteria for device performance in a clinical/diagnostic context, sample sizes for test/training sets, expert qualifications, and ground truth establishment is not applicable to this submission.
However, I can extract the relevant information regarding the performance claims and the study type conducted.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Substantially equivalent mechanical and endurance properties to predicate devices. | "Fatigue and static testing demonstrates the comparable mechanical and endurance properties of these components." |
| Material | Same materials as predicate devices (ASTM F-136 Ti6AV ELI Alloy). | "The components... share the same materials," specifically ASTM F-136 Ti6AV ELI Alloy. |
| Intended Use | Same intended uses as predicate devices. | "The components... share the same... intended uses." |
| Basic Design Concepts | Similar basic design concepts as predicate devices. | "The components... share the same... basic design concepts." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The "test set" in this context refers to the samples of the device components (rods, plates, screws) that were subjected to mechanical testing. The specific number of physical components tested is not provided in this document.
- Data Provenance: Not applicable in the context of clinical data. The "data" refers to the results of the mechanical (fatigue and static) testing of the Osteonics® Spinal System Rod / Plate System components. This testing would have been conducted in a laboratory setting by Howmedica Osteonics Corp.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable. The "ground truth" for this device is established through engineering and materials science principles, verified by mechanical testing, not by expert clinical consensus.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods are typically used for disagreements in human expert interpretations of data (e.g., medical images). For mechanical testing, the "adjudication" is based on established engineering standards and whether the physical samples meet those standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the clinical performance of diagnostic or AI-assisted devices where human readers are involved. The K991055 submission is for a mechanical implantable device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical spinal implant system, not an algorithm or software. Its performance is evaluated through mechanical testing, not standalone algorithmic performance.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is based on engineering standards for mechanical strength, durability (fatigue), and material properties. The performance of the device components (rods, plates, screws) under static and dynamic loads is compared against established benchmarks and the performance of predicate devices.
8. The Sample Size for the Training Set
- Not applicable. As this is a physical medical device, not an AI/ML algorithm, there is no "training set" in the computational sense. The design and manufacturing processes are informed by established engineering principles and prior device experience, but not through a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Not applicable. See point 8. The "ground truth" for the device's design and manufacturing is derived from validated engineering specifications, material science, and regulatory requirements, not from a dataset with established ground truth labels for training.
§ 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.