Search Results

The SIros-X System is intended for sacroiliac joint fusion in skeletally mature patients for the following conditions:
• 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.
• To augment immobilization and stabilization of the sacroiliac joint in patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

When connected to the TiLock2 Spinal System, the SIros-X System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
• Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
• Spondylolisthesis
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Spinal tumor
• Pseudarthrosis
• Failed previous fusion

When connected to the TiLock2 Spinal System, the SIros-X System is intended to provide immobilization and stabilization of spinal segments in skeletally immature patients as an adjunct to thoracolumbar fusion for the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, as well as the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The SIros-X Navigation instruments are intended to be used with the SIros-X System to assist the surgeon in precisely locating anatomical structures in SIros-X System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data-based model of the anatomy. The SIros-X Navigation instruments are intended to be used with the Medtronic StealthStation System.

The SIros-X System is comprised of cannulated screws of various lengths, diameters, and configurations as well as system specific instruments. Instruments are offered to support open and minimally invasive placement of the SIros-X screws.

The SIros-X System is intended to provide fusion of the sacroiliac joint when multiple SIros-X screws traverse the SI joint. In addition, screws with tulips are intended to provide fixation to the pelvis when used with multi-level pedicle screw constructs that terminate in the lumbosacral spine.

The SIros-X System navigation instruments are offered to assist the surgeon in precisely locating anatomical structures in SIros-X System procedures in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data-based model of the anatomy.

N/A

Ask a specific question about this device

The iFuse Bedrock Granite Implant System is intended for sacroiliac joint fusion in skeletally mature patients for the following conditions:
• 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.
• To augment immobilization and stabilization of the sacroiliac joint in patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint

When connected to compatible pedicle screw systems with 5.5- or 6.0-mm posterior rods made from either titanium alloy or cobalt chrome alloys, the iFuse Bedrock Granite Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
• Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
• Spondylolisthesis
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Spinal tumor
• Pseudarthrosis
• Failed previous fusion

When connected to compatible pedicle screw systems with 5.5- or 6.0-mm posterior rods made from either titanium alloy or cobalt chrome alloys, the iFuse Bedrock Granite Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally immature patients as an adjunct to thoracolumbar fusion for the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, as well as the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Please refer to the additional information section in the Instructions for Use on compatible pedicle screw system rods.

The iFuse Bedrock Granite Navigation instruments are intended to be used with the iFuse Bedrock Granite Implant System and the Medtronic StealthStation System to assist the surgeon in precisely locating anatomical structures in iFuse Bedrock Granite Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data-based model of the anatomy.

The Granite iGPS instruments and iGPS Drill Bits are compatible with Globus ExcelsiusGPS® Instrument Trackers and intended to be used with the iFuse Bedrock Granite Implant System and the Globus ExcelsiusGPS® Robotic Navigation System (including the Globus Excelsius3D® Imaging System), which is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.

Use of the iGPS instruments is limited to use only with the 9.5 mm and 10.5 mm iFuse Bedrock Granite implants.

The iFuse Bedrock Granite® Implant System consists of implants of various lengths and diameters, and associated instruments sets. Instrument sets are provided for both open and minimally invasive approaches. The titanium (Ti-6Al-4V ELI) implant consists of a porous fusion sleeve with threaded length attached to a solid post that has connection and implant placement features of a typical pedicle fixation screw. It is intended to provide sacroiliac joint fusion in the sacral alar iliac (SAI) trajectory (when used with commercially available sacroiliac joint fusion promoting devices), and foundational stabilization when connected to pedicle screw fixation systems in both the SAI and the iliac trajectories. Additionally, iFuse Bedrock Granite can be placed into the S1 pedicle. The device is designed for connection to commercially available pedicle screw systems via Ø5.5 mm or Ø6.0 mm titanium alloy or cobalt chrome alloy spinal fixation rods.

The purpose of this submission is to add an alternative option for the set screw (referred to as the Granite Point Lock Set Screw) used with the iFuse Granite Implant System.

N/A

Ask a specific question about this device

The Eminent Spine Posterior SI System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions, to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. This includes those whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

The Eminent Spine Posterior SI System is inserted through an SI posterior approach and packed with autogenous bone graft to facilitate fusion. There are teeth on the superior and inferior surfaces of the device to inhibit movement of the device and to aid in expulsion resistance, while screws are inserted through the anterior face of the implant for bone fixation, adding compression and transfixation in the SI joint. The device is intended to provide mechanical support to the implanted level until fusion is achieved.

The cages are made from additively manufactured Ti-6Al-4V per ASTM F3001. The integrated fixation screws and screw anti-backout plate are manufactured from Ti-6Al-4V ELI per ASTM F136.

The SI posterior system cages are available in one footprint with a lordotic angle. The anterior face of the cage has one screw anti-backout plate that rotates to cover the screw heads and prevent the screws from backing out of the cage after insertion. The screws are available in two diameters (Ø3.50mm, Ø3.75mm), in lengths ranging from 10-18 mm. The screws are positioned to span and compress the cortices of the ilium and sacrum of the SI joint.

N/A

Ask a specific question about this device

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:

1. 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.

2. 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.

3. 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.

4. Adjudication method for the test set: Not applicable. Mechanical testing results are objective measurements.

5. 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.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/ML algorithm performance.

7. The type of ground truth used:

   • For the physical device: Engineering specifications, material properties, and mechanical performance standards (ASTM F2193, ASTM F543).

8. 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.

9. 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

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.

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

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

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

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

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

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.

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