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510(k) Data Aggregation
(24 days)
The Release® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Release® Laminoplasty Fixation System is used to hold the graft material in place in order to prevent the graft material from expulsion, or impinging the spinal cord.
The Release Laminoplasty Fixation System consists of a variety of sizes of implantable plates and screws that are attached to the lamina after a laminoplasty or laminectomy procedure. The implantable components are manufactured from medical grade ASTM F 136 Titanium alloy. The system also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification.
The provided text describes a 510(k) premarket notification for a medical device called the "Release® Laminoplasty Fixation System." It includes information about the device's intended use, classification, and a summary of performance data. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI-powered device or diagnostic.
This document is a regulatory submission for a physical implantable device (plates and screws for spinal fixation), not an AI/ML-driven diagnostic or medical device. Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or ground truth establishment is not applicable to the content provided.
The "Non-Clinical Performance Data" section mentions:
- ASTM F543 (screw insertion torque, torque to failure, pull-out)
- ASTM F2193 cantilever bend testing
- Finite Element Analysis
These are standard mechanical and material performance tests for physical orthopedic implants, not software or AI-based diagnostics. The document explicitly states: "Clinical performance data was not provided in this submission for a determination of substantial equivalence." This further indicates that no clinical study (which would be relevant for establishing performance characteristics in the context of AI) was conducted or reported in this submission.
Therefore, I cannot fulfill the request as the provided text does not contain the pertinent information for an AI/ML device.
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(103 days)
The EXPEDIUM Verse System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine.
The EXPEDIUM Verse System is intended for noncervical pedicle fixation 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/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used in a posterior percutaneous approach with MIS instrumentation, the EXPEDIUM Verse System is intended for noncervical pedicle fixation and nonpedicle fixation 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/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM Verse System metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The EXPEDIUM Verse system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The EXPEDIUM® Verse System is designed to provide intraoperative polyaxial to monoaxial conversion. It facilitates easier rod capture and provides a powerful and precise reduction mechanism. Verse is a reduced profile thoracolumbar implant for use for with wide range of patient statures. EXPEDIUM Verse is a self-contained, efficient, and intuitive instrument system that is compatible with EXPEDIUM 5.5 rods, hooks and mono screws to enhance versatility.
The provided document is a 510(k) premarket notification for the DePuy Synthes Spine EXPEDIUM® Verse Spine System. It describes the device, its intended use, and comparability to predicate devices, but does not contain information related to software or AI algorithms, nor does it provide a study that directly assesses the performance of an AI device against specific acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for AI-related studies.
The document discusses mechanical testing for the physical medical device (spinal implant system), not an AI or software device. The "Non-clinical Test Summary" and "Conclusion" sections refer to these mechanical tests.
To answer your request, I would need a document detailing the performance of an AI-based device, including its acceptance criteria and a study demonstrating its performance.
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(140 days)
The CANOPY™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The CANOPY™ Laminoplasty Fixation System is used to hold bone allograft material in place in order to prevent the allograft from expulsion or impinging the spinal cord.
The CANOPY™ Laminoplasty Fixation System consists of spinal fixation plates and screws for use in laminoplasty procedures. CANOPY™ implants are inserted through a posterior cervical or thoracic approach, and are available in various sizes and geometric options to fit individual patient anatomy. Fixation plates may be used with bone graft material. Hinge plates may be used to stabilize a weakened or displaced lamina. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy.
CANOPY™ plates and screws are manufactured from titanium or titanium allov. as specified in ASTM F67, F136, F1295 and F1472. Optional graft chambers are manufactured from radiolucent polymer as specified in ASTM F2026 and contain tantalum or titanium alloy markers to permit radiographic visualization, per ASTM F67, F136, F560, F1295 or F1472.
The provided document is a 510(k) summary for a medical device called the CANOPY™ Laminoplasty Fixation System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance data.
However, the document does not contain information related to an AI/ML device study. Specifically, it lacks:
- A table of acceptance criteria and reported device performance for an AI/ML model.
- Sample sizes, data provenance, or details about test sets and training sets for an AI/ML model.
- Information about experts, ground truth adjudication, or multi-reader multi-case studies related to an AI/ML model.
- Any mention of standalone algorithm performance or human-in-the-loop performance with AI assistance.
Instead, the performance data cited refers to "Mechanical testing (static and dynamic compression, static compression bending and expulsion) was conducted in accordance with ASTM F543 and F2193 and, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004." This indicates physical testing of the implant's mechanical properties, not an AI/ML diagnostic or prognostic study.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies related to an AI/ML device based on the provided text. The document describes a physical medical implant device, not an AI/ML software device.
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(86 days)
The Pioneer Release Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Pioneer Release Laminoplasty Plating System is used to hold the graft material in place in order to prevent the graft material from expulsion, or impinging the spinal cord.
The Pioneer Release Laminoplasty Plating System consists of implantable plates and screws that will act as a buttress to maintain decompression after a laminoplasty procedure. The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
This document describes the acceptance criteria and the study that proves the Pioneer Release Laminoplasty Plating System meets those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Standard) | Reported Device Performance |
|---|---|
| Static Four-Point Bend per ASTM F2193 | Functioned as intended |
| Fatigue Four-Point Bend per ASTM F2193 | Functioned as intended |
| Axial Screw Pull-Out per ASTM F543 | Functioned as intended |
| Substantial Equivalence to Predicate System | Achieved |
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not explicitly stated in the provided document. The document mentions "standard testing" per ASTM F2193 and ASTM F543, implying that the number of samples would conform to the requirements of these standards.
- Data Provenance: The study appears to be a laboratory-based performance test conducted by the manufacturer, Pioneer Surgical Technology. There is no information regarding the country of origin of the data or whether it was retrospective or prospective in a clinical setting. The tests were performed on the device components themselves.
3. Number and Qualifications of Experts for Ground Truth (Test Set)
Not applicable. This device is a medical implant, and its performance was evaluated through mechanical testing, not by expert review of imaging or clinical data to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation was based on mechanical test results against established ASTM standards, not on expert adjudication of clinical or imaging data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not performed. This study focuses on the mechanical performance of a spinal implant system. MRMC studies are typically used for diagnostic or screening devices where human readers interpret data, often with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical medical implant, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this study was established by recognized ASTM standards (F2193 and F543) for the mechanical performance of spinal implants. The device's ability to maintain its structural integrity and mechanical properties under specified loads, as defined by these standards, constituted the success criteria.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not a machine learning model that requires a training set.
9. How Ground Truth for Training Set was Established
Not applicable, as no training set was used.
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