(100 days)
The Altus Spine Pedicle Screw System is a noncervical spinal fixation device intended to provide stabilization of the spinal segments. It is indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft only having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the Altus Spine Pedicle Screw System may be used 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:
- Degenerative Spondylolisthesis with objective evidence of neurologic impairment;
- Fracture;
- Dislocation;
- Scoliosis;
- Kyphosis;
- Spinal Tumor;
- Failed previous fusion (pseudoarthrosis).
When used as a non-posterior, non-pedicle anterolateral fixation system the specific indications are:
- Degenerative disc disease as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
- Spondylolisthesis;
- Fracture;
- Dislocation;
- Scoliosis;
- Kyphosis;
- Lordosis;
- Spinal stenosis;
- Spinal tumor;
- Failed previous fusion (pseudoarthrosis)
The Altus Spine Pedicle Screw System consists of a system of implantable screws to be used with implantable rods for the purpose of aiding in spinal fusion. The Altus Spine Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct with the intent to stabilize the spinal operative site during the fusion process of bone graft in the disc space. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136. The device is supplied non-sterile and is intended for sterilization by hospital personal.
The provided text describes a 510(k) summary for the "Altus Spine Pedicle Screw System," a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical (mechanical) testing. It does not involve a clinical study with human patients, AI performance, or ground truth establishment in the way typically associated with AI/software medical devices.
Therefore, many of the requested categories in your prompt are not applicable to this document. I will fill in the relevant information and explicitly state when a category is not applicable based on the provided text.
Acceptance Criteria and Device Performance Study for Altus Spine Pedicle Screw System
This document describes the 510(k) submission for a spinal implant system, not a software or AI-driven device. The evaluation is based on demonstrating substantial equivalence through non-clinical mechanical testing, rather than clinical performance or AI algorithm metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Standard: ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy model. | All mechanical testing met the predetermined acceptance criteria. |
| Specific Tests: Dynamic compression bending, Static compression bending, Static torsion testing. (The specific pass/fail thresholds for these tests are not detailed in this summary but are implied to be part of ASTM F1717 and predetermined internal specifications). | Comparable performance and function when compared to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as "sample size" in this context but refers to the number of device components or constructs tested for mechanical properties. The specific number of test articles for dynamic compression bending, static compression bending, and static torsion tests per ASTM F1717 is not detailed in the summary.
- Data Provenance: Not applicable in the context of clinical data. The data originates from mechanical laboratory testing of the device components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. "Ground truth" in this context refers to established mechanical standards and performance requirements for spinal implants, not expert human interpretation for AI/diagnostic purposes. The acceptance criteria are based on defined engineering standards (ASTM F1717).
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretation of clinical data, which is not relevant to mechanical testing. The met the predetermined acceptance criteria implies a clear pass/fail based on quantitative measurements against the ASTM F1717 standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is a clinical study design used to evaluate the diagnostic performance of a system (often AI-assisted) by comparing multiple readers' interpretations of multiple cases. This device is a physical spinal implant, and its evaluation did not involve such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not applicable. This device is a physical implant, not an algorithm, so "standalone performance" in the AI sense is not relevant. The mechanical tests evaluate the device's inherent physical performance.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the Altus Spine Pedicle Screw System's mechanical performance is defined by adherence to established engineering standards and specifications, specifically ASTM F1717. This standard outlines methodologies and acceptance criteria for spinal implant constructs. The device's performance is compared against these quantitative mechanical benchmarks, not against pathology, outcomes data, or expert consensus in a clinical diagnostic sense.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI algorithm. Therefore, there is no "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.