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510(k) Data Aggregation
(106 days)
The Streamline TL Spinal Fixation System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (T1-S2), posterior hook (T1-L5) or sacral/iliac screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudarthrosis, and failed previous fusion.
The Streamline TL Spinal System consists of a variety of rods, screws (poly-axial, fixed, and reduction), rod connectors, crosslinks, set screws, hooks and other connecting components used to build a spinal construct. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The Streamline TL Spinal System includes Class I manual instrumentation to facilitate implantation of the device components.
The provided document is a 510(k) premarket notification letter from the FDA regarding a spinal fixation system. It details the device's indications for use, its description, and a summary of performance testing.
However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device. The device in question is a physical spinal fixation system, not a software or AI/ML product.
Therefore, I cannot provide the requested information for the acceptance criteria and the study that proves the device meets them, as the provided text pertains to a mechanical medical device and not an AI/ML system.
To answer your request, I would need a document describing the validation activities for an AI/ML-enabled medical device.
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(35 days)
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/Ilium). Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft. The device is indicated for all of the following indications:
a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
b) spondylolisthesis,
c) trauma (i.e., fracture or dislocation),
d) spinal stenosis,
e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
f) tumor,
g) pseudoarthrosis, and
h) failed previous fusion
When used for fixation to the illum, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.
The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Firebird System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are temporary, multiple component systems comprised of a variety of non-sterile and sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow a surgeon to build a spinal implant construct. The systems are attached to the vertebral body and ilium by means of screw or hook fixation to the non-cervical spine. The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System consist of an assortment of rods, multi-axial and mono-axial pedicle screws, set screws, lateral offsets, bone screws, screw bodies, hooks, iliac connectors and STERILE packed HA Coated bone screws. A subset of the Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System components may be used in pediatric patients. These components consist of a variety of screws ranging in diameters from 4.0mm to 7.5mm and lengths ranging from 25mm to 60mm.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
This document is a 510(k) premarket notification for a medical device (Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System) and primarily focuses on proving substantial equivalence to a predicate device, not on presenting novel clinical study results for acceptance criteria in the typical sense of a new AI/diagnostic device.
The "acceptance criteria" here are mechanical performance standards for the spinal fixation system components and are met by demonstrating the new component (HA Coated Bone Screws) performs equivalently or better than the predicate device. The "study" is a series of non-clinical mechanical tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test / FDA Guidance) | Reported Device Performance |
|---|---|
| Mechanical Performance: | Substantially Equivalent Performance: |
| ASTM F1717-12 (Static Torsion Test) | "No change from the predicate device geometry." The addition of HA coating has "no effect on the mechanical testing previously conducted" and "will not generate a new worst case and will not impede the mechanical function of the bone screw." |
| ASTM F1717-12 (Static Axial Compression Bending Test) | "No change from the predicate device geometry." The addition of HA coating has "no effect on the mechanical testing previously conducted" and "will not generate a new worst case and will not impede the mechanical function of the bone screw." |
| ASTM F1717-12 (Dynamic Axial Compression Bending Test) | "No change from the predicate device geometry." The addition of HA coating has "no effect on the mechanical testing previously conducted" and "will not generate a new worst case and will not impede the mechanical function of the bone screw." |
| ASTM F1798-97(2008) (Implant Axial Rod Gripping Test) | "No change from the predicate device geometry." The addition of HA coating has "no effect on the mechanical testing previously conducted" and "will not generate a new worst case and will not impede the mechanical function of the bone screw." |
| Insertion Torque Testing – Test Method for Driving Torque of Medical Bone Screw (Proprietary Method) | "Test results demonstrated that the subject HA (Hydroxyapatite) Coated Bone Screws do not introduce any safety or efficacy concerns and is substantially equivalent to the predicate device Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System Self-tapping Cannulated Bone Screws (K130932)." Performance was specifically characterized for any difference in insertion torque, and the conclusion was that there were no safety or efficacy concerns. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a numerical sample size for the mechanical tests. It refers to "the subject Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System HA (Hydroxyapatite) Coated Bone Screws" and "predicate Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System Self-Tapping Cannulated Bone Screws." In mechanical testing, samples are typically specific numbers of manufactured devices.
- Data Provenance: The data comes from non-clinical performance testing conducted by the manufacturer, Orthofix, Incorporated. It is not patient or clinical data, so country of origin or retrospective/prospective does not apply in the typical sense. It's laboratory test data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable. For mechanical tests, the "ground truth" is defined by the physical properties and performance characteristics measured against industry standards (ASTM). The determination of "substantial equivalence" is made by the FDA based on the submitted test results and comparison to predicate devices, not by clinical experts establishing ground truth on a test set.
4. Adjudication method for the test set
- This is not applicable. Mechanical testing does not involve adjudication of expert opinions. The test results are quantitative measurements compared against predefined standards or predicate device performance.
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
- This is not applicable. This submission is for a spinal fixation system, not an AI or diagnostic imaging device. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
- The "ground truth" for the mechanical tests is defined by the industry standard specifications (ASTM F1717-12, ASTM F1798-97(2008)) for spinal implant systems and the measured performance characteristics of the predicate device (K130932). The goal was to show that the new HA-coated screws perform at least as well as the established, FDA-cleared predicate device against these objective mechanical benchmarks.
8. The sample size for the training set
- This is not applicable. No training set was used as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- This is not applicable. No training set was used.
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