Search Results
Found 68 results
510(k) Data Aggregation
(60 days)
DePuy Spine, Inc.
The CONFIDENCE SPINAL CEMENT SYSTEM® is intended for percutaneous delivery of the CONFIDENCE™ High Viscosity Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).
When the CONFIDENCE™ High Viscosity Spinal Cement is used in conjunction with the VIPER® and EXPEDIUM® Fenestrated Screw Systems, the cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER® and EXPEDIUM® Fenestrated Screw Systems augmented with the CONFIDENCE™ High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
The VERTEBROPLASTIC Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
CONFIDENCE® Spinal Cement System: The CONFIDENCE cement is a self-curing, polymethylmethacrylate (PMMA) radiopaque bone cement. Its package includes two sterile components: a sachet containing powder polymer and an ampoule containing liquid monometer.
VERTEBROPLASTIC™ Radiopaque Bone Cement: The VERTEBROPLASTIC Radiopaque Bone Cement is a self-curing methyl methacrylate cement consisting of a powder polymer component and a liquid monomer component. The powder component is contained within a foil pouch and the liquid component in a sterile ampoule within a blister pack. The blister pack and the foil pouch are held securely on a card insert that is sealed into a peelable pouch.
The provided FDA 510(k) summary (K201831) focuses on obtaining clearance for magnetic resonance compatibility labeling for the CONFIDENCE® Spinal Cement System and the VERTEBROPLASTIC™ Radiopaque Bone Cement. The document primarily describes the non-clinical testing performed to establish MR compatibility, rather than clinical performance for their primary intended use (treatment of certain vertebral fractures).
Therefore, the requested information specifically regarding acceptance criteria and performance related to the therapeutic efficacy or diagnostic accuracy of the device is not present in this document. The study described is about the device's behavior in an MR environment.
Here's an analysis based on the provided document for the MR compatibility study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for MR Compatibility) | Reported Device Performance (Summary) |
|---|---|
| Safety in the Magnetic Resonance Environment | Demonstrated compatibility conditions in the MR environment. |
Note: The document refers to the standard ASTM F2503 for "Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment." This standard outlines methods for testing and labeling medical devices for safe use in MRI. Specific quantitative thresholds from ASTM F2503 (e.g., maximum temperature increase, displacement force, image artifact size) are not explicitly detailed in this summary, but the general acceptance criterion is "safety in the MR environment."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific tests within the summary. However, non-clinical bench testing typically involves multiple samples to ensure reproducibility and statistical confidence.
- Data Provenance: Not applicable as this was a non-clinical, bench-top study conducted in a controlled lab environment, not involving human or animal subjects or
data from a specific country or in a retrospective/prospective manner in the traditional sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
- Not applicable. This was a non-clinical engineering/physics study to measure device behavior in an MR environment, not a clinical study requiring expert diagnosis or
interpretation to establish ground truth.
4. Adjudication Method for the Test Set
- Not applicable. This was a non-clinical engineering/physics study. The "ground truth" (i.e., the device's behavior in an MR field) is determined by direct measurement
against the specifications of the ASTM F2503 standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for assessing human reader performance with medical
AI/imaging devices, which is not the subject of this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This submission is for physical medical devices and their MR compatibility, not an algorithm or AI system.
7. The Type of Ground Truth Used
- For the MR compatibility study, the "ground truth" is defined by the technical specifications and safety limits outlined in the ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. The device performance is measured against these established engineering and safety standards.
8. The Sample Size for the Training Set
- Not applicable. This was a non-clinical bench study, not an AI or machine learning model development where training sets are used.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there was no training set in this non-clinical submission.
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(103 days)
DEPUY SPINE, INC.
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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(419 days)
DEPUY SPINE, INC.
The EXPEDIUM and VIPER/VIPER2 Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM and VIPER/VIPER2 Spine System metallic components are 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 in a posterior percutaneous approach with MIS instrumentation, the VIPER/VIPER2 System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for fusion 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 and VIPER/VIPER2 System metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The EXPEDIUM and VIPER/VIPER2 PEEK rods are only indicated for fusion procedures for spinal stenosis with instability (no greater than Grade I spondylolisthesis) from LI-SI in skeletally mature patients.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER/VIPER2 System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The subject EXPEDIUM® Spine System and VIPER®/VIPER®2 Systems are pedicle screw scoliosis systems for the treatment of pediatric patients consisting of a wide range of components in a variety of geometries and sizes.
The provided document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in terms of diagnostic accuracy or algorithmic performance.
Instead, this is a 510(k) summary for the "EXPEDIUM® Spine System, VIPER® System, VIPER®2 System," which are pedicle screw spinal systems. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, an approval pathway primarily concerned with the safety and effectiveness of a new device compared to an existing one, rather than novel performance benchmarks.
Here's a breakdown of what the document does state regarding performance:
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A table of acceptance criteria and the reported device performance: This information is not present. The document does not define specific performance metrics or acceptance criteria for the device's function or a study comparing it to those criteria.
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Sample size used for the test set and the data provenance: Not applicable. No test set or data provenance for performance evaluation is mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described.
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Adjudication method for the test set: Not applicable. No test set adjudication is described.
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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: Not applicable. This device is a surgical implant (pedicle screw system), not an AI-assisted diagnostic tool, so an MRMC study is irrelevant in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic or AI device.
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The type of ground truth used: Not applicable. No ground truth is mentioned.
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The sample size for the training set: Not applicable. No training set is mentioned.
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How the ground truth for the training set was established: Not applicable. No training set ground truth is mentioned.
Key statements from the document regarding performance:
- "No new testing was performed. Published clinical results and engineering analysis supported the expansion of indications." (Page 2, section "Performance Data")
- "The substantial equivalence justification demonstrates that the device is as effective, and performs as well as the predicate device." (Page 3, Conclusion)
In summary, this 510(k) submission relies on demonstrating substantial equivalence to predicate devices, drawing on existing clinical results and engineering analyses, rather than presenting a performance study with defined acceptance criteria for the device itself.
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(29 days)
DEPUY SPINE, INC.
The VIPER systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of deformities of the thoracic, lumbar, and sacral spine.
The VIPER 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 in a percutaneous, posterior approach with MIS instrumentation, the VIPER Systems are 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.
The VIPER® System is a 5.5mm rod system offered in both stainless steels and titanium materials. The system consists of monoaxial screws. polyaxial screws. uni-planar screws, and extended tab implants. They are available in various geometries and sizes to accommodate patient anatomy.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Equivalence/Safety: The modified VIPER System components must perform mechanically as safely and effectively as the predicate device. | "Performance data in the form of an engineering rationale that included Finite Element Analysis was conducted to prove there was no new worst case component for the proposed VIPER System's components contained in this notification." |
| "Both the engineering rationale that included Finite Element Analysis and the Substantial Equivalence Justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device." | |
| Material Equivalence: The materials used in the modified device must be identical to the predicate device and suitable for implant. | "Manufactured from ASTM F 138 implant grade stainless steel, ASTM F 139 implant grade stainless steel, and ASTM F 136 implant grade titanium alloy." (Implicitly, these are the same as the predicate and acceptable.) |
| Design/Technology Equivalence: The design and technology of the modified components should be identical to the predicate systems, except for the specified changes. | "The proposed modifications to the DePuy Spine VIPER® Systems are identical to predicate devices (K111571) except for the addition of fully threaded and partially threaded favored angle polyaxial screws in various sizes to the systems, which are outside the range of the currently cleared screw offerings. The design, materials, and technology remain identical to the predicate systems." |
| Intended Use Equivalence: The modified device must have the same intended use and indications as the predicate device. | The "Indications For Use" statement is identical to the predicate device's intended use described in section H. The only change is the addition of new screw types within this existing intended use. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The performance data relied on Finite Element Analysis (FEA), which is a computational simulation method, not a test on physical samples in the traditional sense requiring a "test set" sample size or data provenance from a specific geographical region (country of origin). It's a predictive engineering analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable/not provided. FEA uses engineering principles and material properties as its "ground truth" for simulation, not expert human interpretation of test data in the way a clinical study would. The analysis is performed by engineering professionals.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. As FEA is a computational analysis, there is no "adjudication method" in the sense of reconciling human expert opinions on a test set. The results are derived directly from the simulation model.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically involves human readers interpreting medical images or data, which is not relevant to the engineering rationale and Finite Element Analysis performed for this device modification.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, in essence, a "standalone" performance evaluation was done, though not a standalone algorithm in the typical AI sense. The Finite Element Analysis (FEA) is a computational method that stands alone in evaluating the mechanical performance based on engineering models, without human intervention in the execution of the mechanical test itself. The FEA itself is the "algorithm" that provides the performance data without a human-in-the-loop for the mechanical assessment.
7. The Type of Ground Truth Used
The ground truth used for the Finite Element Analysis (FEA) would be established engineering principles, material properties (e.g., strength, stiffness of ASTM F 138, F 139 stainless steel, and F 136 titanium alloy), and validated computational models (e.g., meshing, boundary conditions, load application matching physiological conditions). There is no expert consensus, pathology, or outcomes data used as ground truth for this type of mechanical equivalence study.
8. The Sample Size for the Training Set
This information is not applicable/not provided. FEA is a simulation method, not a machine learning algorithm that requires a "training set." The models are built based on design specifications and material properties.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided. As there is no training set in the machine learning sense, there's no ground truth established for it. The "ground truth" for the FEA itself (as explained in point 7) is based on established scientific and engineering principles.
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(59 days)
DEPUY SPINE, INC.
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic iunction (occiput - T3), the MOUNTAINEER Occipito-Cervical-Thoracic (OCT) Spinal Svstem is intended for:
- . DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- spondylolisthesis .
- . spinal stenosis
- fracture/dislocation .
- atlanto/axial fracture with instability ●
- . occipitocervical dislocation
- revision of previous cervical spine surgery .
- . tumors
The occipital bone screws are limited to occipital fixation only.
The use of the monoaxial and polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The Songer Cable System, to be used with the MOUNTAINEER OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.
The MOUNTAINEER OCT Spinal System can also be linked to the ISOLA®, TiMX®, MONARCH®, EXPEDIUM®, VIPER® and MOSS® MIAMI Systems using the dual wedding band and axial connectors, and via dual diameter rods.
The MOUNTAINEER OCT Spinal System consists of plates, nuts, bone screws, rods, transverse rod connectors, lateral offset connectors, head-to-head connectors, cable connectors, dual wedding band and axial connectors, set screws, minipolyaxial screws, monoaxial screws, hooks and SONGER® Cables.
The MOUNTAINEER OCT System Titanium Rods (Ti-6AL-4V) are offered in both Straight and Dual Diameter designs. The Straight Rod diameter is 3.5mm and has lengths ranging from 25mm-100mm in increments of 5mm and lengths ranging from 100mm-400mm in increments of 20mm. The Dual Diameter Rods consists of 3.5 - 4.5mm, 3.5 -4.75mm. 3.5 - 5.5mm. and 3.5 - 6.35mm diameters with Rod lengths of 420mm and 600mm.
The proposed MOUNTAINEER Cobalt Chromium (Co-Cr) Rods also consist of both Straight and Dual Diameter designs. The Straight Rod diameter is 3.5mm and available in lengths ranging from 25mm to 100mm (increments of 5mm) and 120, 200, 340 and 400mm. The Dual Diameter MOUNTAINEER Co-Cr Rods consist of 3.5 – 4.5mm, 3.5 – 4.75mm, 3.5 – 5.5mm and 3.5 – 6.35mm and available in lengths of 420 and 600mm.
Other than the modifications to the material from Ti-6Al-4V to Co-Cr, no other modifications have been made. The proposed Cobalt Chromium rods are not being made to address a known recall or adverse events. These proposed components have been developed as additions to the existing MOUNTAINEER OCT Spinal System.
The MOUNTAINEER OCT Spinal System is not an AI/ML powered medical device. The information provided describes a traditional medical device (Spinal System) and its 510(k) submission. Therefore, it does not have the acceptance criteria or study details typically associated with AI/ML device performance.
The submission focuses on demonstrating substantial equivalence to a predicate device based on material change (from Titanium to Cobalt Chromium) while maintaining identical design, indications for use, and technology.
Here's an analysis based on the provided text, focusing on the available "Performance Data" which is relevant to a non-AI device submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are tied to mechanical performance standards to ensure the new material (Cobalt Chromium) performs equivalently to the predicate Titanium device. The reported performance refers to the results of these tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Equivalence to Predicate Device: | |
| Static Compression-Bending strength (per ASTM F 1717) | (Not explicitly stated in numerical terms in the summary, but the conclusion states that performance testing demonstrates that the device is as safe, as effective, and performs as well as the predicate device. This implies the new material met or exceeded the predicate's performance in these tests.) |
| Dynamic Compression-Bending (Fatigue) strength (per ASTM F 1717) | (Not explicitly stated in numerical terms in the summary, but the conclusion states that performance testing demonstrates that the device is as safe, as effective, and performs as well as the predicate device. This implies the new material met or exceeded the predicate's performance in these tests.) |
| Static Torsion strength (per ASTM F 1717) | (Not explicitly stated in numerical terms in the summary, but the conclusion states that performance testing demonstrates that the device is as safe, as effective, and performs as well as the predicate device. This implies the new material met or exceeded the predicate's performance in these tests.) |
| Compliance with ASTM F 1717: | Performance data per ASTM F 1717 were submitted to characterize the subject MOUNTAINEER OCT Spinal System rods addressed in this notification. This indicates that the testing methodology aligned with the standard, and the results were deemed acceptable for regulatory clearance. |
| Overall Safety and Effectiveness Equivalence: | Both the Performance Testing and Substantial Equivalence Justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device. This is the ultimate acceptance criterion for this type of 510(k) submission, confirming that the new Cobalt Chromium rods meet the required performance standards. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in the provided text. Mechanical testing typically involves a sufficient number of samples to achieve statistical significance for each test (static, dynamic, torsion).
- Data Provenance: The data is from "Performance data per ASTM F 1717" submitted by the manufacturer, DePuy Spine, Inc. This is prospective testing of the device itself, not retrospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a mechanical device, performance is established through objective, standardized physical testing (e.g., ASTM F 1717), not through expert consensus on medical images or patient outcomes. The "ground truth" is the physical properties and performance of the device under specific load conditions.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical data, especially in studies involving AI/ML where ground truth needs to be established from subjective interpretations. This submission involves objective mechanical 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
Not applicable. This is not an AI/ML powered device, and no MRMC study was conducted or is relevant for this type of device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is derived from mechanical testing standards (ASTM F 1717). The measured physical properties and performance characteristics (e.g., strength, fatigue resistance) of the Cobalt Chromium rods, when compared against the established performance of the Titanium predicate device, serve as the ground truth for demonstrating substantial equivalence.
8. The sample size for the training set
Not applicable. This is not an AI/ML powered device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML powered device.
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(66 days)
DEPUY SPINE, INC.
The EXPEDIUM and VIPER Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM and VIPER Systems are 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; pseudarthrosis; and failed previous fusion in skeletally mature patients.
When used in a percutaneous approach with MIS Instrumentation, the VIPER Systems are 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The proposed cortical fix polyaxial screws for EXPEDIUM and VIPER System are available in various geometries and sizes.
The provided 510(k) summary (K110216) describes the DePuy Spine EXPEDIUM® and VIPER® Systems. This device is a spinal fixation system, and the submission focuses on new cortical fix polyaxial screws for these systems.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static cantilever beam testing (ASTM F 1798-97) | The specific acceptance criteria are not detailed (e.g., maximum deflection, yield strength, etc.), but the document states: "The acceptance criteria was/were met." | Met |
| Static axial slip testing (ASTM F 1798-97) | The specific acceptance criteria are not detailed (e.g., maximum slip allowed), but the document states: "The acceptance criteria was/were met." | Met |
| Dynamic cantilever beam testing (ASTM F 1798-97) | The specific acceptance criteria are not detailed (e.g., number of cycles to failure at a given load, fatigue limit), but the document states: "The acceptance criteria was/were met." | Met |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "No clinical tests were performed." Therefore, there is no information regarding a test set sample size or data provenance from a human study. The testing performed was mechanical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable, as no clinical tests were performed. The "ground truth" for the mechanical tests would be the established engineering standards (ASTM F 1798-97) and the physical measurements against those standards. These would be assessed by engineers/technicians performing the tests.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical tests were performed involving human readers or interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The submission states, "No clinical tests were performed."
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Not applicable, as this device is a physical medical implant (spinal fixation system), not a software algorithm.
7. The Type of Ground Truth Used:
For the mechanical tests performed, the "ground truth" is defined by the ASTM F 1798-97 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. The device's performance was compared against the requirements and specifications outlined in this standard.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical implant, not a machine learning or AI algorithm, so there is no training set in the conventional sense. The "development" or "design" process for such a device involves engineering principles, material science, and manufacturing processes, rather than data-driven algorithm training.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device.
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(85 days)
DEPUY SPINE, INC.
The EXPEDIUM and VIPER Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM and VIPER Systems are 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; pseudarthrosis; and failed previous fusion in skeletally mature patients.
When used in a percutaneous approach with MIS Instrumentation, the VIPER Systems are 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.
The proposed closed polyaxial screws for EXPEDIUM and VIPER Spine System are available in various geometries and sizes. Manufactured from ASTM F138 implant grade stainless steel and ASTM F136 implant grade titanium alloy.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Cantilever Beam Testing | In accordance with ASTM F 1798-97 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. | The acceptance criteria was/were met. |
| Static Axial Slip Testing | In accordance with ASTM F 1798-97 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. | The acceptance criteria was/were met. |
| Dynamic Cantilever Beam Testing | In accordance with ASTM F 1798-97 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. | The acceptance criteria was/were met. |
Study Information:
This submission focuses on non-clinical (mechanical) testing for "EXPEDIUM® and VIPER® Systems" for spinal fixation. There were no clinical studies performed in this submission.
2. Sample size used for the test set and data provenance:
The document does not explicitly state the sample sizes for each mechanical test. However, these tests are typically conducted on multiple samples of the device components to ensure consistency and reliability. The data provenance is from non-clinical laboratory testing conducted by the manufacturer, DePuy Spine, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth for mechanical testing is established by engineering standards (ASTM F 1798-97) and measured physical properties, not by human expert interpretation.
4. Adjudication method for the test set:
Not applicable. Mechanical tests involve objective measurements against predefined engineering standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No. This was a non-clinical submission for spinal implants, focusing on mechanical performance. MRMC studies are relevant for evaluating diagnostic or interpretive devices that involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No. This is a hardware device (spinal implants), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of an algorithm is not applicable. The performance evaluated here is the standalone mechanical integrity of the device itself.
7. The type of ground truth used:
The ground truth used was objective mechanical measurements against established ASTM standards (ASTM F 1798-97) for spinal arthrodesis implants.
8. The sample size for the training set:
Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as no training set was used.
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(145 days)
DEPUY SPINE, INC.
The EXPEDIUM and VIPER Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM and VIPER Systems are 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; pseudarthrosis; and failed previous fusion in skeletally mature patients.
When used in a percutaneous approach with MIS Instrumentation, the VIPER Systems are 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.
The subject EXPEDIUM and VIPER Spine System components consist of screws and are available in various geometries and sizes.
The provided document is a 510(k) Summary for the DePuy Spine EXPEDIUM® and VIPER® Systems, which are spinal fixation devices. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials and detailed acceptance criteria for an AI/algorithm.
Therefore, the specific information requested about acceptance criteria, study design for proving device performance against those criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies for AI/software-as-a-medical-device (SaMD) are not applicable to this submission.
Here's an explanation based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This submission is for mechanical spinal implants, not an AI/software device. The "performance" is assessed through a comparison to predicate devices and mechanical testing, not against specific diagnostic or treatment accuracy acceptance criteria as would be expected for a SaMD.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. There is no "test set" in the context of an AI/software device. The performance was evaluated via non-clinical mechanical testing of the physical implants. The document does not specify the number of units tested, but mechanical tests typically involve a pre-determined number of samples to ensure statistical validity for the specific test (e.g., fatigue or static load).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth, in the context of AI/SaMD, refers to the verified correct output (e.g., diagnosis, measurement) for comparison with the algorithm's output. For mechanical implants, "ground truth" is typically defined by engineering specifications and material properties, verified through testing procedures against established standards (e.g., ASTM F1798). Experts involved would be engineers and material scientists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert opinions when establishing ground truth for AI/SaMD. This is not pertinent to the mechanical testing of spinal implants.
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
- Not Applicable. MRMC studies are designed to evaluate the impact of an AI algorithm on human reader performance (e.g., radiologists, pathologists). This device is a physical implant, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This concept applies to AI algorithms and not to physical medical devices like spinal implants.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For mechanical testing: The "ground truth" (or reference standard) for the nonclinical tests would be the established scientific and engineering principles outlined in the cited ASTM standards (F1798). Performance is measured against physical properties and failure points defined by these standards, not against biological or clinical outcomes or expert consensus on images.
8. The sample size for the training set
- Not Applicable. There is no training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. Since there is no training set, this question is not relevant.
Summary of what the document does provide regarding device performance:
The document states that "No clinical tests were performed."
Instead, the device's performance and safety were established through "Nonclinical Test Summary:"
- Static Cantilever Beam in accordance with ASTM F1798
- Dynamic Cantilever Beam in accordance with ASTM F1798
- Axial Slip in accordance with ASTM F1798
These tests are designed to evaluate the mechanical properties and stability of the spinal implants and their interconnection mechanisms, ensuring they meet the requirements for their intended use and are comparable to predicate devices. The "acceptance criteria" here are implied to be the successful completion of these tests in accordance with the ASTM standards, demonstrating structural integrity and mechanical equivalence to the already cleared predicate devices. The specific results of these tests (e.g., actual load values, cycles to failure) are not detailed in this 510(k) summary but would have been submitted to the FDA in a more comprehensive report.
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(28 days)
DEPUY SPINE, INC.
The indications for use for the modified devices described in this submission are the same as those for the MOUNTAINEER OCT Spinal System. The indications are as follows:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput - T3), the MOUNTAINEER Occipito-Cervical-Thoracic (OCT) Spinal System is intended for:
- ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- spondylolisthesis
- spinal stenosis
- fracture/dislocation
- atlanto/axial fracture with instability
- occipitocervical dislocation
- revision of previous cervical spine surgery
- tumors
The occipital bone screws are limited to occipital fixation only.
The use of the monoaxial and polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The Songer Cable System, to be used with the MOUNTAINEER OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.
The MOUNTAINEER OCT Spinal System can also be linked to the ISOLA®, TiMX®, MONARCH®, EXPEDIUM®, VIPER® and MOSS® MIAMI® Systems using the dual wedding band and axial connectors, and via dual diameter rods.
Addition of the 3.5mm diameter monoaxial screw to the existing MOUNTAINEER® OCT Spinal System. This system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
The KIO3100 submission describes the addition of a 3.5mm diameter monoaxial screw to the existing MOUNTAINEER® OCT Spinal System. The device's performance is demonstrated through non-clinical mechanical testing, comparing it to predicate devices. This is a medical device, not an AI/ML device, so many of the requested categories are not applicable.
Here's the breakdown of the available information:
- A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Static cantilever beam in accordance with ASTM F1798 | Testing conducted and results supported substantial equivalence. The submission implies that the new components meet the same performance standards as the predicate devices under these conditions. Specific numerical results are not provided in the summary, but the conclusion states "Based on the predicate comparison and testing, the subject MOUNTAINEER® OCT Spinal System is device substantially equivalent to the predicate device." |
| Static axial slip in accordance with ASTM F1798 | Testing conducted and results supported substantial equivalence. The submission implies that the new components meet the same performance standards as the predicate devices under these conditions. |
| Dynamic cantilever beam in accordance with ASTM F1798 | Testing conducted and results supported substantial equivalence. The submission implies that the new components meet the same performance standards as the predicate devices under these conditions. |
| Intended Use, Design Characteristics, Materials, Performance, and Packaging (comparison to predicate devices) | The proposed components "have the same intended use, design characteristics, materials, performance, and packaging as the predicate devices." |
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided. The study involved non-clinical mechanical testing, not clinical human subject data. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is a mechanical device, and "ground truth" as it applies to AI/ML or diagnostic studies is not relevant here. The ground truth for mechanical testing is established by the ASTM standards themselves and the physical measurements obtained. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is a mechanical device. -
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
Not applicable. This is a mechanical device. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For mechanical testing, the "ground truth" is defined by the physical properties measured under standardized ASTM test methods (ASTM F1798 in this case) and the established performance characteristics of the predicate devices. -
The sample size for the training set
Not applicable. This is a mechanical device, not an AI/ML system requiring a training set. -
How the ground truth for the training set was established
Not applicable.
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(146 days)
DEPUY SPINE, INC.
The VIPER® F2 Facet Fixation System is intended to stabilize the spine as an aid to fusion by the transfacet fixation method only:
Transfacet fixation: - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle.
This system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.
The screws and washers that are the subject components of this submission are modified DISCOVERY® System screws and washers that are available in various geometries and sizes. Manufactured from ASTM F 136 implant grade titanium alloy.
The provided text describes the 510(k) summary for the VIPER® F2 Facet Fixation System. It focuses on demonstrating substantial equivalence to predicate devices through nonclinical mechanical testing, rather than device performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment cannot be extracted from this document in the typical sense of AI/medical device performance evaluation.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the way a diagnostic AI device summary would. Instead, the "device performance" is demonstrated through nonclinical mechanical testing and comparison to predicate devices, implying that if the device performs comparably to legally marketed devices, it meets the unstated "acceptance criteria" for safety and effectiveness.
Nonclinical Test Summary and Implied Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical integrity under static compression bending (similar to predicate) | Device underwent static compression bending in accordance with ASTM F1798. (Performance results not explicitly stated, but deemed substantially equivalent to predicates.) |
| Mechanical integrity under dynamic compression bending (similar to predicate) | Device underwent dynamic compression bending in accordance with ASTM F1798. (Performance results not explicitly stated, but deemed substantially equivalent to predicates.) |
| Mechanical integrity under static three-point bending (similar to predicate) | Device underwent static three-point bending in accordance with ASTM F1798. (Performance results not explicitly stated, but deemed substantially equivalent to predicates.) |
| Mechanical integrity under dynamic three-point bending (similar to predicate) | Device underwent dynamic three-point bending in accordance with ASTM F1798. (Performance results not explicitly stated, but deemed substantially equivalent to predicates.) |
| Equivalence in materials, manufacturing methods, sterility, biocompatibility, safety, and packaging design to predicate devices. | Stated as a basis for substantial equivalence comparison. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the study did not involve a test set of data points (e.g., medical images, patient records) for evaluation of the device's diagnostic or predictive performance. The "testing" involved mechanical benchmarks of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The device is an implantable medical device, not an AI or diagnostic tool requiring ground truth established by medical experts for performance evaluation. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1798).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There was no clinical test set or human interpretation involved that would require an adjudication method.
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 was no MRMC comparative effectiveness study done. This device is a surgical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the nonclinical mechanical testing was based on engineering standards (ASTM F1798) for evaluating spinal arthrodesis implants.
8. The sample size for the training set
This information is not applicable. There was no training set involved as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not applicable. There was no training set.
Summary of the Study:
The study proving the device meets acceptance criteria was a nonclinical mechanical testing program involving static and dynamic compression bending, and static and dynamic three-point bending, all conducted in accordance with ASTM F1798. The intent was to demonstrate that the modified components of the VIPER® F2 Facet Fixation System perform mechanically comparably to its predicate devices. No clinical tests were performed. The FDA's substantial equivalence determination was based on this nonclinical testing and comparison of intended use, design, materials, manufacturing methods, performance, sterility, biocompatibility, safety, and packaging design to legally marketed predicate devices.
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