(154 days)
The Calvary Spine Pedicle Screw System is 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 thoracic, lumbar, and sacral spine (T1 to S1/ilium); degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.
When used for posterior, non-cervical (T1 to S1/ilum), pedicte screw fixation in pediatric patients, the Calvary Spine Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Calvary Spine Pedicle Screw System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.
This system is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Calvary Spine Pedicle Screw System includes screws and connecting components in a wide variety of sizes and shapes, which can be locked in various configurations, each assembly being tailor-made. Calvary pedicular screws must be used with Ø 5.5mm straight and curved rods.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Calvary Spine Pedicle Screw System:
Based on the provided FDA 510(k) summary (K201568), there is no information about acceptance criteria or a study proving the device meets specific performance criteria in terms of an AI/algorithm-based medical device.
The document describes a traditional medical device, specifically a pedicle screw system, which is a hardware implant used in spinal fusion surgery. The "acceptance criteria" discussed in this document refer to the regulatory requirements for establishing substantial equivalence to previously cleared predicate devices, primarily based on design, materials, and mechanical performance through non-clinical testing.
Therefore, I cannot populate most of the requested fields because they are specifically tailored for studies validating AI/algorithm performance.
However, I can extract the relevant information regarding the type of study and the basis for substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a traditional medical device and not an AI/algorithm, there are no specific performance metrics like sensitivity, specificity, or AUC to list as acceptance criteria for automated diagnosis or analysis. The "acceptance criteria" for this device are broadly the demonstration of substantial equivalence to predicate devices based on:
| Acceptance Criteria (Broad Interpretation for Traditional Device) | Reported Device Performance (Summary) |
|---|---|
| Intended Use Equivalence | Equivalent to predicate devices. |
| Material Equivalence | Uses same materials (Ti-6Al-4V ELI, CP Titanium, CoCrMo). |
| Design Equivalence | Equivalent in shape, sizes, material, manufacturing process. |
| Strength Equivalence | Greater or equivalent strength values compared to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable (N/A) for an AI/algorithm test set.
- The "test set" in this context refers to the samples used in non-clinical mechanical testing, which are typically manufactured units of the device. No information on the specific number of units tested for each mechanical test is provided, but it would involve standard engineering sample sizes for material and mechanical property evaluations.
- Data Provenance: The data provenance for mechanical testing would be from internal laboratory testing of the manufactured devices. No country of origin for data in the AI sense is relevant here, nor is retrospective or prospective human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- N/A for an AI/algorithm test set.
- Ground truth for mechanical properties is established through standard engineering and materials testing protocols (e.g., ASTM standards), not by human experts adjudicating images or clinical data.
4. Adjudication Method for the Test Set
- N/A for an AI/algorithm test set.
- Mechanical test results are objective measurements against defined standards, not subject to human adjudication methods like 2+1 or 3+1.
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. An MRMC study was not done.
- This device is not an AI/algorithm, therefore, there is no human-in-the-loop performance improvement with AI assistance to measure.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. A standalone algorithm performance study was not done.
- This device is not an AI/algorithm.
7. The Type of Ground Truth Used
- Mechanical and Material Standards: The "ground truth" for this medical device's performance is compliance with established material specifications (e.g., ASTM F136, F67, F1582) and mechanical testing standards for spinal implants, demonstrating equivalent or superior strength to predicate devices.
8. The Sample Size for the Training Set
- N/A for an AI/algorithm training set.
- This device does not involve a training set as it's not an AI/algorithm.
9. How the Ground Truth for the Training Set Was Established
- N/A for an AI/algorithm training set.
- Not applicable as there is no training set.
Summary of what was done (based on the provided text):
The Calvary Spine Pedicle Screw System underwent non-clinical testing to demonstrate that it is substantially equivalent to legally marketed predicate devices. This equivalence was established based on:
- Similar materials (Ti-6Al-4V ELI, CP Titanium, CoCrMo).
- Similar intended use.
- Similar design (shape, sizes, manufacturing process).
- Comparable or superior strength values, presumably measured through mechanical testing (though specific tests and methodology are not detailed in this summary).
The document explicitly states: "No clinical studies were performed." This is common for 510(k) clearances where substantial equivalence can be demonstrated through non-clinical data.
§ 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.