(82 days)
The SteriSpine™ PS system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. SteriSpine™ PS System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: 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; tumor; pseudoarthrosis; and failed previous fusion.
SteriSpine™PS system includes Pedicle Screw and Rod. Components of SteriSpine™PS system are made of Titanium Ta6V Eli grade conforming to ASTM F136. SteriSpine™PS components are supplied sterile with a single-use set of surgical instruments.
The provided text describes a medical device, the SteriSpine™PS, which is a pedicle screw spinal system. The document is a 510(k) summary submitted to the FDA for market clearance. It outlines the device's description, indications for use, and performance data to demonstrate substantial equivalence to a predicate device.
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 | Reported Device Performance |
|---|---|
| Mechanical Properties: Conformity to special controls and guidance for Spinal System 510(k)s (May 3, 2004) | "Results demonstrate comparable mechanical properties to the predicate device." |
| Static Compression (ASTM F1717) | Conducted, results comparable to predicate. |
| Static Torsion (ASTM F1717) | Conducted, results comparable to predicate. |
| Dynamic Compression (ASTM F1717) | Conducted, results comparable to predicate. |
| Static Slipping (ASTM F1798) | Conducted, results comparable to predicate. |
| Static Bending (ASTM F1798) | Conducted, results comparable to predicate. |
| Static Rotation (ASTM F1798) | Conducted, results comparable to predicate. |
| Instrumentation Validation: | "Cadaver testing performed to validate the instrumentation have been presented." |
| Clinical Performance: Safety and effectiveness for indicated uses (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, tumor, pseudoarthrosis, failed previous fusion). | "Clinical data from a review of the literature has been presented in the class III summary." "Non clinical performance testing according to special control demonstrate that SteriSpine™PS is as safe, as effective, and performs as safely and effectively as its predicate devices." |
2. Sample size used for the test set and the data provenance
The document only references mechanical testing and cadaver testing. It does not explicitly state sample sizes for these tests, nor does it specify the provenance (country of origin, retrospective/prospective) of the cadaver testing or the literature review for clinical data.
- Mechanical Testing: The sample sizes for the various mechanical tests (ASTM F1717 and ASTM F1798) are not specified.
- Cadaver Testing: The sample size for cadaver testing is not specified.
- Clinical Data (Literature Review): The sample size for the literature review is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The document discusses mechanical testing and a review of literature for clinical data, but not a process involving experts to establish ground truth for a test set in the context of device performance in humans or with expert interpretation.
4. Adjudication method for the test set
This information is not provided in the document. The type of studies described (mechanical testing, cadaver testing, literature review) do not typically involve adjudication methods for "test sets" in the way an AI/software device would.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a pedicle screw spinal system, not an AI/software diagnostic tool, so such a study would not be applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
There is no mention of a standalone (algorithm only) performance study. Again, this is a physical medical device, not an AI/software algorithm.
7. The type of ground truth used
- Mechanical Performance: The ground truth for mechanical performance is established through standardized ASTM test methods (ASTM F1717 and ASTM F1798), which define the criteria for evaluating the physical properties of spinal implants. The comparison is against a predicate device (Synergy VLS, K011437) that has already been deemed safe and effective.
- Instrumentation Validation: The ground truth for instrumentation validation was established through cadaver testing. The specific metrics or "ground truth" criteria for this validation are not detailed.
- Clinical Performance: The "ground truth" for clinical performance, as presented, relies on a review of existing literature (clinical data from other studies) and the established safety and effectiveness profile of the predicate device.
8. The sample size for the training set
This information is not applicable as this is a physical medical device, not an AI/software system that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above.
§ 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.