(68 days)
The HydraLok System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis)
In addition, when used as a pedicle screw fixation system, the HydraLok System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft only having the device attached to the lumbar and sacral spine (L3 and below), who are having the device removed after the development of a solid fusion.
The HydraLok System is a top-loading spinal fixation system including screws, rods, and connectors. The titanium alloy components are provided clean and non-sterile. Various sizes of the implants are provided.
This 510(k) premarket notification for the Altiva HydraLok™ System does not contain specific acceptance criteria or details of a comprehensive study proving the device meets acceptance criteria related to its performance characteristics (e.g., strength, durability, biomechanical stability).
The document states, "Performance data were submitted to characterize the HydraLok System." However, the actual performance data, acceptance criteria for that data, and the study design are not provided within this summary.
Based on the provided information, I cannot complete the requested tables and descriptions because the document primarily serves as a regulatory submission summary rather than a detailed performance study report.
Here's what can be inferred from the document regarding the type of data submitted, but not the specifics:
1. Table of Acceptance Criteria and Reported Device Performance
- Not available from the provided text. The document only states that "Performance data were submitted to characterize the HydraLok System." No specific criteria or reported performance values are given.
2. Sample size used for the test set and the data provenance
- Not available from the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This specific type of "ground truth" establishment is typically relevant for AI/diagnostic devices, not for a spinal fixation system, unless the performance data involved human assessment of biomechanical outcomes, which is not indicated here.
4. Adjudication method
- Not applicable. See point 3.
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 mechanical device, not an AI or diagnostic tool where human reader performance would be enhanced by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device.
7. The type of ground truth used
- Not applicable. For a mechanical device, performance is typically evaluated against engineering specifications, material properties, and biomechanical testing standards, rather than "ground truth" derived from expert consensus, pathology, or outcomes data in the way AI/diagnostic devices are.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not an AI system that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of available information:
The document is a 510(k) summary for a medical device called the "HydraLok™ System," a pedicle screw spinal fixation system. It outlines the company, contact, date, trade name, common name, classification, device description, intended use, and predicate device information. It explicitly states that "Performance data were submitted to characterize the HydraLok System," which is a mandatory part of a 510(k) submission to demonstrate substantial equivalence to a predicate device. However, the details of that performance data, including specific acceptance criteria, test results, study methodology, sample sizes, and how ground truth was established, are not contained within this summary document.
§ 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.