Search Results
Found 123 results
510(k) Data Aggregation
(147 days)
OUR
The SImmetry+ System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The SImmetry+ System consists of sterile packaged fully threaded titanium Implants designed to transfix the sacrum and ilium, providing stability for bony fusion. The surgical implants are available in various sizes to accommodate patient anatomy. Implants have major diameters ranging from 9.5mm-14.5mm, in 1mm increments. Implant lengths in 5mm increments range from 30mm to 110mm. All devices are additively manufactured from Titanium Alloy (Ti-6Al4V ELI).
This 510(k) clearance letter pertains to the SImmetry+ System, a device for sacroiliac joint fusion (a metallic bone fixation fastener). Unlike a clearance for a software device or AI/ML system, this document focuses on the physical and mechanical performance of the implantable device.
Therefore, the requested information regarding acceptance criteria and study that proves the device meets the acceptance criteria specifically in the context of AI/ML performance metrics (like sensitivity, specificity, MRMC studies, expert consensus on images, etc.) is not applicable to this type of medical device clearance.
The provided document describes:
- Device Type: A physical, implantable device (fully threaded titanium implants for sacroiliac joint fusion).
- Acceptance Criteria (Implicitly): Demonstrated through non-clinical performance testing against specific ASTM standards. These standards define the expected mechanical properties (e.g., static and dynamic cantilever testing, axial pullout, torsional properties, driving torque).
- Study Proving Acceptance: "Non-clinical testing data" was submitted, including:
- Static and dynamic cantilever testing per ASTM F2193
- Axial pullout testing per ASTM F543
- Torsional properties testing per ASTM F543
- Driving torque testing per ASTM F543
- Additive manufacturing characterization
Summary of Requested Information based on the provided document:
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Mechanical performance standards defined by ASTM F2193 and ASTM F543, and additive manufacturing characterization. (Specific numerical thresholds are not provided in this public clearance letter, but would have been part of the confidential submission.)
- Reported Device Performance: The document states that SiVantage completed non-clinical testing and the data demonstrates substantial equivalence. This implies the device met the performance criteria outlined in the standards.
-
Sample sizes used for the test set and the data provenance: Not applicable. The "test set" here refers to physical implants subjected to mechanical testing, not a dataset of patient information for AI/ML evaluation.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant is established by engineering measurements against defined material and mechanical standards.
-
Adjudication method for the test set: Not applicable. Mechanical testing results are objective measurements.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human interpretation of medical images, often with AI assistance.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/ML algorithm performance.
-
The type of ground truth used:
- For the physical device: Engineering specifications, material properties, and mechanical performance standards (ASTM F2193, ASTM F543).
-
The sample size for the training set: Not applicable. The "training set" concept applies to AI/ML model development. For a physical device, manufacturing processes are refined, but there isn't a "training set" in the AI sense.
-
How the ground truth for the training set was established: Not applicable for a physical device.
In conclusion, this FDA 510(k) clearance is for a conventional mechanical implant, not an AI/ML powered device. Therefore, many of the questions asked, which are highly relevant for AI/ML device clearances, do not apply to the details provided in this document. The "proof" of meeting acceptance criteria for this device rests on its physical and mechanical characteristics meeting established engineering standards and showing substantial equivalence to existing predicate devices based on those characteristics.
Ask a specific question about this device
(163 days)
OUR
The panaSIa SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The panaSIa SI Fusion device is a threaded, expandable device, designed to stabilize the sacroiliac joint by piercing the adjacent cortical bone when expanded. The device has large fenestrations to allow for uninterrupted graft contact across the SI joint space. The panaSIa SI Fusion implant is a sterile, single patient use, long-term implantable device made of a titanium grade alloy.
The provided FDA 510(k) clearance letter for the "panaSIa SI Fusion System" describes a medical device, specifically a smooth or threaded metallic bone fixation fastener, intended for sacroiliac (SI) joint fusion.
Based on the provided document, the acceptance criteria and the study proving the device meets these criteria are limited in detail. This is typical for a 510(k) clearance for this type of device, which primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing rather than extensive clinical studies or AI algorithm performance validation.
Here's an analysis of the provided information, addressing your points where possible, and noting where information is not present in the document.
Overview of Device and Clearance Type
The panaSIa SI Fusion System is a physical implant (a threaded, expandable device made of titanium grade alloy) used for sacroiliac joint fusion. The FDA clearance is a 510(k), which means the manufacturer demonstrated the device is substantially equivalent to legally marketed predicate devices. This type of clearance typically relies on non-clinical testing (e.g., mechanical performance) and comparison of design, materials, and indications for use, rather than extensive human clinical trials or complex AI performance metrics.
Acceptance Criteria and Study Details (Based on Provided Document)
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device and submission (510(k) for a physical implant), the "acceptance criteria" are not explicitly quantifiable metrics like sensitivity/specificity for an AI algorithm. Instead, they are typically the successful fulfillment of recognized standards and comparative performance to predicates.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Document) | Reported Device Performance (From Document) |
|---|---|---|
| Intended Use Equivalence | Same intended use as predicate devices. | "The panaSIa SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis." - Matches indications for predicate devices. |
| Principles of Operation Equivalence | Similar principles of operation as predicate devices. | "The subject device and the predicate devices have similar principles of operation..." |
| Design Equivalence | Similar design as predicate devices. | "...designs..." |
| Material Equivalence | Similar materials as predicate devices. | "...and use similar materials. The panaSIa SI Fusion implant is a sterile, single patient use, long-term implantable device made of a titanium grade alloy." |
| Performance (Mechanical) Equivalence | Meets or exceeds mechanical testing standards (ASTM F3574) and performs comparably to predicate in relevant tests (e.g., cadaver testing). | "The non-clinical testing data submitted and relied upon to demonstrate substantial equivalence included static and dynamic vertical shear testing per ASTM F3574 and cadaver testing with comparison to the additional predicate device." |
| Safety & Effectiveness | Demonstrates comparable safety and effectiveness to predicate devices. | "The panaSIa SI Fusion System is as safe, as effective, and performs as well as, or better, than the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "cadaver testing," which refers to ex vivo testing of the device. However, it does not specify the sample size (i.e., number of cadavers or test specimens from cadavers) used for this testing.
- Data Provenance: The document does not specify the country of origin of the cadaver data or whether the testing was retrospective or prospective. Given it's cadaver testing, it's inherently a controlled, ex vivo experimental setup rather than a patient-based retrospective/prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This information is not applicable/not provided in this type of 510(k) submission. The "ground truth" for a physical implant's mechanical performance is typically established by engineering standards (like ASTM F3574) and direct measurement, not by expert consensus on image interpretation or clinical outcomes.
4. Adjudication Method for the Test Set
- Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing ground truth in clinical imaging studies or clinical trials where human interpretation or consensus is required. This information is not applicable/not provided for a mechanical device performance test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- This type of study is relevant for AI-powered diagnostic devices where the AI assists human readers (e.g., radiologists interpreting images). This device is a physical implant; therefore, no MRMC study was done or is relevant for this submission.
6. Standalone (Algorithm Only) Performance Study
- This refers to the performance of an AI algorithm alone, without human intervention. Since this is a physical medical device and not an AI algorithm, a standalone algorithm performance study was not conducted or is not relevant.
7. Type of Ground Truth Used
- For the non-clinical performance testing:
- Mechanical Standards: Adherence to established engineering standards (ASTM F3574 for static and dynamic vertical shear testing).
- Comparative Performance: The performance of the device was directly compared against a predicate device in cadaver models. While not explicitly stated as "ground truth," the predicate device's known performance serves as the benchmark against which the new device is measured.
- No clinical outcomes or pathology ground truth was used for this 510(k) clearance, as it is based on substantial equivalence through non-clinical testing.
8. Sample Size for the Training Set
- This device is not an AI algorithm, so there is no "training set" in the context of machine learning. The design and manufacturing processes are likely informed by engineering principles, material science, and prior device designs, but not through a formalized data training set as seen in AI development.
9. How the Ground Truth for the Training Set Was Established
- As there is no AI "training set," this question is not applicable.
In summary, the provided FDA 510(k) clearance letter details a non-AI medical device (an SI joint fusion implant). The "acceptance criteria" and "study" proving these criteria are primarily based on:
- Substantial equivalence to legally marketed predicate devices in terms of intended use, principles of operation, design, and materials.
- Non-clinical performance testing, specifically:
- Adherence to ASTM F3574 for static and dynamic vertical shear testing.
- Comparative cadaver testing against an additional predicate device.
The document does not delve into the detailed quantitative results of these tests (e.g., exact maximum shear force sustained), sample sizes of cadavers, or the specific methods of ground truth establishment beyond relying on industry standards and direct comparison. This level of detail for non-clinical testing is typically found within the full 510(k) submission, not the public-facing clearance letter.
Ask a specific question about this device
(52 days)
OUR
The Rialto™ SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The subject RIALTO™ SI Fusion System consists of cannulated devices available in various lengths, used to provide stabilization when fusion of the sacroiliac joint is desired. Autograft and/or allograft may be placed in conjunction with the RIALTO™ SI Fusion System. The RIALTO Screws are made using Titanium Alloy and are 40mm- 60mm in length with a diameter of 12mm. This device may be implanted via a minimally invasive approach using fluoroscopy or navigated instruments compatible with Medtronic StealthStation® and IPC® POWEREASE®.
The provided FDA 510(k) clearance letter for the Rialto™ SI Fusion System does not contain information about the acceptance criteria and study proving a device meets those criteria in the context of an AI/Software as a Medical Device (SaMD).
The document describes a medical implant (Rialto™ SI Fusion System) and its mechanical and MRI safety performance, not an AI or software device. The studies mentioned (ASTM F2182-19e2, F2052-21, F2213-17, F2119-24, F2503-23) are for evaluating the safety and compatibility of passive implants in the Magnetic Resonance (MR) Environment, which are standard non-clinical tests for physical medical devices.
Therefore, I cannot provide the requested information for acceptance criteria and study details related to an AI/SaMD, as the provided input does not pertain to such a device.
If you have a document describing the clearance of an AI/SaMD, I would be happy to analyze it for the requested information.
Ask a specific question about this device
(18 days)
OUR
The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System consists of an X shaped implant designed to assist in the healing of sacroiliac (SI) joints for fusion by providing fixation of the sacroiliac joint. The implant is not intended to replace normal body structures. The implant is offered in five variations with one size per variation. The implant is manufactured from titanium alloy per ASTM F136.
The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System was designed as a less invasive alternative to traditional open posterior surgical SI joint fusion. The titanium implant consists of a sacrum engaging side and an ilium engaging side connected by a bridge. During the procedure, bone graft material is placed in the window of the implant to facilitate stabilization. The implant is intended for single-use only. Implants are provided clean and non-sterile and designed for routine steam sterilization prior to use.
The provided document is a 510(k) clearance letter for a medical device (SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System), not an AI/ML medical device. As such, it does not contain any information about acceptance criteria, device performance metrics, sample sizes for test or training sets, expert ground truth establishment, adjudication methods, or MRMC studies, which are typical requirements for AI/ML device submissions.
The document is for a mechanical implant system and focuses on demonstrating substantial equivalence to a predicate device through:
- Identical indications for use.
- Identical technological design principles.
- Justifications and adoptions of existing performance testing (e.g., steam sterilization, FEA, pushout testing) from the predicate device (K241813), rather than new performance studies on clinical data or AI model outputs.
Therefore, I cannot extract the requested information to fill in the table or answer the questions related to AI/ML device validation.
Summary of why the requested information cannot be provided from the input:
- No AI/ML Component: The device is a physical implant (sacroiliac joint fusion system), not a software or AI-driven diagnostic/therapeutic device.
- Substantial Equivalence: The clearance is based on demonstrating substantial equivalence to a predicate device, meaning it relies on already established safety and efficacy data for a previous version or similar device, not de novo clinical trials or performance studies specific to an AI algorithm.
- Focus on Physical Properties: The "Performance Testing" section mentions engineering analyses (FEA, pushout testing) and sterilization, which are relevant to the physical characteristics and safety of an implant, not the diagnostic or analytical performance of an AI system.
Ask a specific question about this device
(294 days)
OUR
The Omnia Medical PsiF DNA™ System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions. The PsiF DNA™ may be implanted via a transverse or inline approach. When PsiF DNA™ is implanted inline, it must be used with a PsiF DNA™ screw implanted transversely across the same sacroiliac joint.
The Omnia Medical PsiF DNA™ System consists of screws and washers manufactured from Ti-6Al-4V ELI per ASTM F3001 and ASTM F136, respectively. The screws are available in one diameter and a variety of lengths to accommodate varying patient anatomy. The system includes instrumentation for implantation that is manufactured from surgical grade stainless steel or aluminum. During the procedure, the implant is inserted through the ilium to pierce its medial cortex, across the sacroiliac joint and into the sacrum to pierce its lateral cortex, and bone graft material is placed in the barrel of the implant to facilitate additional bone incorporation after surgery. The implants and instruments are provided in two surgical kit options. In one kit, the implants and instruments are provided non-sterile and sterilized by the end user. In the other kit, the implants and instruments are single-use and provided sterile.
Based on the provided FDA 510(k) clearance letter for the Omnia Medical PsiF DNA™ System, there is no information about specific acceptance criteria or a study that proves the device meets those criteria in the context of AI/Software performance.
The clearance letter focuses on the device being a physical medical device (a bone fixation fastener) and its substantial equivalence to predicate devices based on mechanical and cadaveric testing.
Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria for a device, a test set, expert ground truth, MRMC studies, or training sets, as these concepts are typically applied to the evaluation of software as a medical device (SaMD) or AI-enabled medical devices, not to a physical implant like the Omnia Medical PsiF DNA™ System.
The document explicitly states:
- "Clinical testing was not required to support a substantial equivalence determination for the PsiF DNA™ device." This confirms that there was no clinical study, let alone one focused on human-in-the-loop performance or AI assistance.
- The non-clinical testing listed consists entirely of mechanical and cadaveric tests, which are standard for orthopedic implants to assess their structural integrity, strength, and biomechanical compatibility.
In summary, none of the requested information (table of acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, ground truth types) is present in this 510(k) document because the cleared device is a physical implant, not an AI/software product requiring such performance evaluation.
Ask a specific question about this device
(152 days)
OUR
The Patriot SI Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The Patriot SI Implant System is a minimally invasive sacroiliac joint fusion implant that pierces the cortical bone of the ilium and sacrum and is intended for the purpose of stabilizing and fusing the sacroiliac joint with intrinsic fixation features. It is available in one size and may be implanted using the designated surgical instruments into the SI joint space. Bone graft materials may be used with the Patriot SI Implant System. The Patriot SI Implant System device is made from additively manufactured titanium alloy, Ti-6Al-4V-ELI per ASTM F3001 and is offered with or without a hydroxyapatite (HA) coating per ASTM F1185. The Patriot SI Implant System device is provided sterile and individually packed.
The provided FDA 510(k) clearance letter for the Patriot SI Implant System does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria for the purposes of an AI/software device.
The document is for a physical medical implant device (sacroiliac joint fusion implant). The information it provides is:
- Device Type: Patriot SI Implant System (a physical implantable device)
- Intended Use: Sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
- Materials: Additively manufactured titanium alloy, Ti-6Al-4V-ELI, with or without hydroxyapatite (HA) coating.
- Testing Information: "Non-clinical cadaveric biomechanical testing was performed to support substantial equivalence of the Patriot SI Implant system." This type of testing is relevant for mechanical implants, not AI/software.
- Predicate Device: Patriot-SI Posterior Implant System (K232259).
Therefore, I cannot provide details on acceptance criteria and study design for an AI/software device based on this document. The questions posed in your request (sample size, expert qualifications, MRMC studies, standalone performance, ground truth types) are universally applicable to AI/software performance studies, but the source document is entirely about a physical hardware device.
If you have a document describing an AI/software medical device, I would be happy to analyze it according to your criteria.
Ask a specific question about this device
(17 days)
OUR
The DYNAMIS™ Implant System is indicated for sacroiliac joint fusion for:
- Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.
- Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The DYNAMIS™ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.
The DYNAMIS™ Implant System consists of threaded, fenestrated, cannulated, 3D-printed implants and associated instruments. The implants are constructed from medical grade titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The implants are fully threaded with a lag design and a cannulated central threaded body. To accommodate varying patient anatomy, the DYNAMIS™ Implants are available in multiple diameters and length offerings. The implants allow for packing of autograft and allograft materials. Using the designated instrument system, two or more implants should be inserted across the SI Joint to apply a compressive force across the joint and to provide stabilization and fusion. The DYNAMIS™ implants are single use devices that are provided sterile. The DYNAMIS™ Implant System is comprised of DYNAMIS™ Screws and DYNAMIS™ TRU-NANO Screws.
DYNAMIS™ TRU-NANO Screws: The surfaces of the DYNAMIS™ TRU-NANO Screws incorporate a micro- and nano-roughened surface that demonstrates the requirements for nanotechnology. The surface of the screws have been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. These screws are electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having a pore size diameter between 30-97 nanometers. Calcium and phosphate are incorporated into the nanotube surface.
This document describes the DYNAMIS™ Implant System, a medical device for sacroiliac joint fusion and pelvic fracture fixation. The FDA 510(k) clearance letter determines the device to be substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain acceptance criteria for device performance or a detailed study description proving that the device meets those criteria, as typically found in a clinical study report or a more comprehensive technical document.
Instead, the performance data section mentions:
- Testing per ASTM standards:
- Static cantilever bending and dynamic cantilever bending (ASTM F3574)
- Static axial pullout, static torsion, and driving torque (ASTM F543)
- In vitro evaluations for nanotechnology: Quantitated mineralization of extracellular matrix by osteoblasts (OB) and mesenchymal stem cells (MSC) on titanium alloy surfaces.
- Bacterial endotoxin testing: In accordance with AAMI ST72:2011.
The statement reads: "The results demonstrate that the DYNAMIS™ Implant System is substantially equivalent to the predicate devices." and "in vitro study results demonstrated that the DYNAMIS™ TRU-NANO Screw nanosurface develops statistically significantly greater mineralization in both osteoblast and mesenchymal stem cell cultures compared to other surfaces."
Without further information, I cannot provide the specific details requested in your prompt regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The provided document is a regulatory clearance letter, which summarizes the basis for clearance, but does not include the detailed technical study reports.
Thus, I can only provide the information that is present in your input.
Based on the provided FDA 510(k) clearance letter (K251075) for the DYNAMIS™ Implant System, the following information can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list specific numerical acceptance criteria for the mechanical tests. Instead, it states that the performance testing results "demonstrate that the DYNAMIS™ Implant System is substantially equivalent to the predicate devices." For the nanotechnology aspect, the acceptance criterion implicitly relates to superior mineralization.
| Test Category | Specific Test (Standard) | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Mechanical Testing | Static cantilever bending (ASTM F3574) | Performance comparable/equivalent to predicate devices. | "The results demonstrate that the DYNAMIS™ Implant System is substantially equivalent to the predicate devices." |
| Dynamic cantilever bending (ASTM F3574) | Performance comparable/equivalent to predicate devices. | "The results demonstrate that the DYNAMIS™ Implant System is substantially equivalent to the predicate devices." | |
| Static axial pullout (ASTM F543) | Performance comparable/equivalent to predicate devices. | "The results demonstrate that the DYNAMIS™ Implant System is substantially equivalent to the predicate devices." | |
| Static torsion (ASTM F543) | Performance comparable/equivalent to predicate devices. | "The results demonstrate that the DYNAMIS™ Implant System is substantially equivalent to the predicate devices." | |
| Driving torque (ASTM F543) | Performance comparable/equivalent to predicate devices. | "The results demonstrate that the DYNAMIS™ Implant System is substantially equivalent to the predicate devices." | |
| Biological Testing | Nanotechnology - Cell Mineralization (In vitro) | Statistically significantly greater mineralization. | "in vitro study results demonstrated that the DYNAMIS™ TRU-NANO Screw nanosurface develops statistically significantly greater mineralization in both osteoblast and mesenchymal stem cell cultures compared to other surfaces." (compared to "other surfaces" - likely meaning unsuffaced titanium or the non-nano predicate) |
| Sterility Testing | Bacterial endotoxin testing (AAMI ST72:2011) | Meet specified testing limit. | "Bacterial endotoxin testing was conducted in accordance with AAMI ST72:2011 and met the specified testing limit." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes for any of the tests (mechanical, in vitro, or endotoxin).
Regarding data provenance:
- The mechanical and biological testing appears to be laboratory-based performance testing on the device itself and its components.
- The document implies the tests were conducted by the manufacturer or a contracted lab for regulatory submission.
- There is no mention of patient data (e.g., country of origin, retrospective/prospective clinical data) as this device is not an AI/imaging device. The testing is for the physical device's performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable or not provided in the context of the described device testing.
- For mechanical tests, the "ground truth" is derived from engineering standards (ASTM) and predicate device performance. No human experts are typically involved in establishing "ground truth" for these tests in the way they would for medical image interpretation or clinical outcomes.
- For in vitro biological tests, expert understanding of cell biology and statistical analysis is involved, but not in the sense of adjudicating a "ground truth" from a test set of patient cases.
4. Adjudication Method for the Test Set
This information is not applicable or not provided as there is no human interpretation or consensus process described for the test results. The tests are laboratory-based and yield objective measurements compared against standards or predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI-assisted interpretation devices to assess human reader performance with and without AI. The DYNAMIS™ Implant System is a physical orthopedic implant, not a diagnostic or AI software.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The DYNAMIS™ Implant System is a physical medical implant, not an algorithm or AI software, so the concept of "standalone performance" for an algorithm does not apply.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims appears to be:
- Engineering Standards: For mechanical tests, adherence to and performance relative to ASTM F3574 and ASTM F543 requirements.
- Predicate Device Performance: Comparative performance against the DYNAMIS™ SI Screw System (K243565) and Nanovis Nano FortiFix (K193211) for mechanical properties.
- Biological Activity (Quantitative Measurement): For the nanosurface, quantifiable measurements of secreted extracellular matrix mineralization by specific cell types (osteoblasts and mesenchymal stem cells) in an in vitro laboratory setting.
- Regulatory Standards: For bacterial endotoxin testing, compliance with AAMI ST72:2011.
8. The Sample Size for the Training Set
This information is not applicable or not provided. "Training set" refers to data used to train machine learning models. This device is a physical implant, not an AI or software device that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. As established above, there is no mention of an AI/ML component or a "training set" for this physical device.
Ask a specific question about this device
(37 days)
OUR
The Tenon Medical Catamaran SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including:
- Sacroiliac joint disruptions and degenerative sacroiliitis
- To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The Catamaran SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The Catamaran SI Joint Fusion System was developed as a less invasive alternative to traditional open posterior surgical SI Joint fusion. The system consists of the Catamaran SI Joint Fixation Implant (Ti6A1-4V ELI Titanium alloy / ASTM F136) included in a reusable System Tray containing: Access, Drill and Delivery, Bone Graft Packing, and Extraction Instruments. The Catamaran SI Joint Fixation Implants are designed in various widths and lengths, and allow autologous bone graft material placement in the barrels of the implant to support SI Joint fixation and fusion. The Instrument Set includes Class II single use and reusable surgical instruments designed to facilitate placement of the implant within the sacroiliac joint using an inferior-posterior surgical approach. The implants and associated instruments are provided clean and non-sterile and are designed for steam sterilization prior to use.
This document is a 510(k) Premarket Notification from the FDA regarding the Tenon Medical CATAMARAN™ SI Joint Fusion System. Based on the provided text, the submission does not include any study data relating to the performance of an AI/ML medical device.
The central point of this 510(k) submission is a change in the Indications for Use for an already cleared device. The text explicitly states:
- "The sole purpose of this submission is to modify the indications for use." ([Page 5])
- "No clinical or non-clinical performance testing was necessary to support the change in indications for use proposed." ([Page 5])
Therefore, I cannot extract the information required by your request about acceptance criteria and a study proving a device meets them, as this document concerns a change to an existing device's labeling and did not involve new performance testing.
If you have a document related to an AI/ML device approval that includes performance study data, please provide that.
Ask a specific question about this device
(91 days)
OUR
The NEXXT MATRIXX® SI System is indicated for sacroiliac joint fusion for:
· Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroillitis.
· Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients
undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The NEXXT MATRIXX® SI System is also indicated for fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures.
The NEXXT MATRIXX® SI System is a collection of additively manufactured implants intended to facilitate fusion of the sacroiliac joint. The NEXXT MATRIXX® SI System includes three different implants which are press-fit shafts or threaded screws including the IMPAXX SI Implant, HELIXX SI Fully Threaded Implant, and the HELIXX SI Lag Implant. The HELIXX SI Lag Implants may be used with optional HELIXX SI Modular Washers. All subject implants are manufactured from Ti-6A1-4V per ASTM F3001 or Ti-6A1-4V ELI titanium alloy per ASTM F136 and are offered in various sizes to accommodate patient anatomical needs.
I am sorry, but the provided text is a 510(k) premarket notification for a medical device (NEXXT MATRIXX® SI System), which is an orthopedic implant for sacroiliac joint fusion and fracture fixation.
This document describes the device, its intended use, technological characteristics, and references non-clinical performance testing. However, it does not contain information about studies related to AI/software performance, human reader studies (MRMC), or the evaluation of an algorithm against acceptance criteria for diagnostic or prognostic purposes.
Therefore, I cannot extract the information required to answer your questions regarding:
- A table of acceptance criteria and the reported device performance (in the context of AI/software).
- Sample sizes used for a test set or data provenance (related to AI/software performance).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set (for AI).
- How ground truth for the training set was established.
The document focuses on the mechanical and material performance of a physical implant and its substantial equivalence to predicate devices based on non-clinical (mechanical) testing, not on the performance of a software or AI component.
Ask a specific question about this device
(102 days)
OUR
The DYNAMIS™ SI Screw System is indicated for sacroiliac joint fusion for:
· Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroillitis.
· Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients
undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The DYNAMIS™ SI Screw System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.
The DYNAMIS™ SI Screw System consists of threaded, fenestrated, cannulated, 3D-printed implants and associated instruments. Implants are constructed from medical grade titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The implants are fully threaded with a lag design. To accommodate varying patient anatomy, the DYNAMIS™ SI Screw Implants are available in multiple diameters and length offerings. The DYNAMIS™ SI Screw Implants consist of a cannulated central threaded body. The implants allow for packing of autograft and allograft materials. Using the designated instrument system, two or more implants should be inserted across the SI Joint to apply a compressive force across the joint and to provide stabilization and fusion. The DYNAMIS™ SI Screw implants are single use devices that are provided sterile.
This FDA 510(k) summary for the DYNAMIS™ SI Screw System does not describe an AI/ML device or a study involving human readers. Therefore, much of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, adjudication methods, and MRMC studies is not applicable.
The document primarily focuses on establishing substantial equivalence for a physical medical device (a sacrioiliac joint screw system) through mechanical performance testing against established ASTM standards and comparison to predicate devices.
However, I can extract the following relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Study Type) | Reported Device Performance |
|---|---|
| Static Cantilever Bending (per ASTM F3574) | "demonstrate that the DYNAMIS™ SI Screw System is substantially equivalent to the predicate devices." |
| Dynamic Cantilever Bending (per ASTM F3574) | "demonstrate that the DYNAMIS™ SI Screw System is substantially equivalent to the predicate devices." |
| Static Axial Pullout (per ASTM F543) | "demonstrate that the DYNAMIS™ SI Screw System is substantially equivalent to the predicate devices." |
| Static Torsion (per ASTM F543) | "demonstrate that the DYNAMIS™ SI Screw System is substantially equivalent to the predicate devices." |
| Driving Torque (per ASTM F543) | "demonstrate that the DYNAMIS™ SI Screw System is substantially equivalent to the predicate devices." |
Note: The document states the device "demonstrate[s] that the DYNAMIS™ SI Screw System is substantially equivalent to the predicate devices" for all tests, implying its performance met or exceeded the performance of the predicate devices based on these mechanical tests. Specific numerical acceptance criteria and performance values are not provided in this summary.
The following numbered points are not applicable or cannot be extracted from the provided text as the document pertains to a physical medical device clearance, not an AI/ML software device performance study:
- Sample sizes used for the test set and the data provenance: Not applicable. This is not a study assessing AI/ML model performance on a dataset of patient data. The "test set" refers to the physical screws undergoing mechanical testing. While not specified, these would be a sample of the manufactured screws.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML validation (e.g., expert labels on medical images) is not relevant here. The ground truth for mechanical testing is established by the specified ASTM standards and the physical properties of the materials and design.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No human adjudication is involved in assessing mechanical test results against established ASTM standards.
- 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 document is not about an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of typical AI/ML ground truth. For this device, the "ground truth" for performance is defined by the objective mechanical testing standards (ASTM F3574, ASTM F543) and comparison to the predicate devices.
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device that requires a training set or associated ground truth.
Ask a specific question about this device
Page 1 of 13