(52 days)
The Hubble I System is indicated for use for noncervical pedicle fixation from the T1 to S1 vertebrae in skeletally mature patients as an adjunct to fusion 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 stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.
The Orbbo Hubble I System is an implant device made from a titanium alloy Ti 6Al-4V ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. The titanium alloy implants are provided sterile. The cobalt-chrome implants are provided non-sterile. It is to be implanted from the posterior approach. The screws are available as monobloc reduction (traction) screws and polyaxial and polyaxial reduction (traction) screws in diameters from 4.0 - 8.0 mm and in lengths from 25 - 55 mm and polyaxial illac screws of 7 and 8mm diameters with lengths from 55mm to 110mm. Rods are available in 5.5mm diameter in lengths from 40 - 500 mm. Hooks are available in various sizes to attach to the thoracic and lumbar spine. Transverse connectors are available in various sizes to attach to the two parallel rods. Associated instrumentation to complete the procedure is provided non-sterile.
The provided document is a 510(k) premarket notification for the Hubble I System, a thoracolumbosacral pedicle screw system. It declares substantial equivalence to a predicate device, the Mont Blanc Spinal System.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate) | Reported Device Performance (Hubble I System) |
|---|---|
| Mechanical performance and fatigue endurance for Static Compression Bend (per ASTM F1717-13) | Evaluated to demonstrate equivalence to predicate; no new performance testing required for design/material/manufacturing unchanged components. |
| Mechanical performance and fatigue endurance for Static Torsion (per ASTM F1717-13) | Evaluated to demonstrate equivalence to predicate; no new performance testing required for design/material/manufacturing unchanged components. |
| Mechanical performance and fatigue endurance for Dynamic Compression Bend (per ASTM F1717-13) | Evaluated to demonstrate equivalence to predicate; no new performance testing required for design/material/manufacturing unchanged components. |
Explanation: The document states that the Hubble I System was evaluated to demonstrate equivalence to the predicate devices. It explicitly mentions that mechanical testing was performed for the predicate devices, which characterized their mechanical performance and fatigue endurance (Static Compression Bend, Static Torsion, and Dynamic Compression Bend per ASTM F1717-13). For the Hubble I System itself, "As there are no changes in design or materials or manufacturing processes, no new performance testing was required." This implies that the Hubble I System is expected to have the same performance as the predicate device because it is considered equivalent in design, materials, and manufacturing, and thus no new tests were performed to establish new acceptance criteria or new performance data for the Hubble I System specifically. The acceptance criteria for the Hubble I System are essentially the demonstrated performance of the predicate device.
Regarding other requested information, the document does not provide the following details, as the submission relies on substantial equivalence and does not report a separate clinical or AI study:
- Sample size used for the test set and the data provenance: Not applicable, as no new clinical or AI study with a test set was performed for the Hubble I System.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is a surgical implant, not an AI diagnostic or assistive tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of what was done according to the document:
The Hubble I System's acceptance was primarily based on a declaration of substantial equivalence to existing predicate devices (Mont Blanc Spinal System, K150185 and K161387). The core of the "study that proves the device meets the acceptance criteria" is the assertion that the Hubble I System shares identical technological characteristics (indications for use, materials of manufacture, structural support mechanism) with its predicates.
Therefore, instead of new performance testing for the Hubble I System, the submission leveraged the existing mechanical performance and fatigue endurance data of the predicate devices, which were tested according to ASTM F1717-13 for Static Compression Bend, Static Torsion, and Dynamic Compression Bend. The rationale is that since there are no changes in design, materials, or manufacturing processes for the Hubble I System compared to the predicate, its performance is considered equivalent, and thus no new testing was deemed necessary.
The document explicitly states: "No clinical or animal studies were performed." This clarifies that no independent clinical validation or AI-specific performance study was conducted for the Hubble I System's 510(k) clearance process.
§ 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.