(65 days)
The Prase MIS Spinal System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the Prase MIS Spinal System can be used in an open approach and a percutaneous approach. The Prase MIS Spinal System is intended 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 for lordosis)
- Tumor
- Pseudarthrosis
- · Failed previous fusion in skeletally mature patients.
Prase MIS Spinal System consists of cannulated poly screws, straight rods, curved rods and set screw components that can be used via percutaneous surqical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy. All products are made of titanium alloy (ASTM F136) and CoCrMo alloy (ASTM F1537) approved for medical use. The implants will be provided non-sterile.
This looks like a 510(k) summary for a medical device (Prase MIS Spinal System). This document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, nor does it describe a study involving human readers or AI.
The 510(k) summary focuses on demonstrating substantial equivalence to pre-existing devices through design, material, indications for use, and mechanical testing (ASTM F1717). It states:
- Mechanical Test Results: "The mechanical test results demonstrated that the Pathloc-L MIS Spinal System performs as well as the predicate device." This implies the acceptance criteria for mechanical performance were met, but the specific criteria (e.g., specific load values, deflection limits) and detailed results are not provided in this summary.
Therefore, based only on the provided text, I cannot complete the table or answer most of the questions.
Here's a breakdown of what could be inferred about the mechanical testing mentioned, and the information that is entirely missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from ASTM F1717) | Reported Device Performance | Comments |
|---|---|---|
| Static compression bending (per ASTM F1717) | (Not specified in summary) | Summary states "performed as well as the predicate device," implying it met or exceeded the predicate's performance. Specific quantitative criteria and results are missing. |
| Static tension (per ASTM F1717) | (Not specified in summary) | Summary states "performed as well as the predicate device." Specific quantitative criteria and results are missing. |
| Fatigue test (per ASTM F1717) | (Not specified in summary) | Summary states "performed as well as the predicate device." Specific quantitative criteria and results are missing. |
| Other Mechanical Tests (e.g., torsion, pull-out) | (Not specified in summary) | Only compression bending, tension, and fatigue are explicitly mentioned. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document only mentions "a worst-case, screw construct" for mechanical testing, but the number of constructs tested isn't stated.
- Data Provenance: Not specified, but generally, such bench testing is conducted in a controlled lab environment by the manufacturer or a contracted lab. Neither country of origin nor whether it's retrospective/prospective applies to this type of mechanical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This summary describes mechanical bench testing of implants, not a clinical study involving human patients or expert review for ground truth establishment.
4. Adjudication method for the test set
- Not applicable. This summary describes mechanical bench testing.
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
- No. This document describes a spinal implant system and its mechanical performance, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This document describes a spinal implant system, not an algorithm or software device.
7. The type of ground truth used
- For the mechanical testing, the "ground truth" would be the standards defined by ASTM F1717 and potentially the measured performance of the predicate device. There is no human expert "ground truth" in this context.
8. The sample size for the training set
- Not applicable. There is no mention of a training set as this is about a physical medical device, not an AI/ML model.
9. How the ground truth for the training set was established
- Not applicable. No training set is mentioned.
§ 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.