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510(k) Data Aggregation
(88 days)
The TELIGEN System is indicated to provide minimally invasive access, visualization, illumination, magnification and discectomy of the surgical area of the spine.
The TELIGEN Access Probe and TELIGEN Clear are Navigation Ready Instruments and when used with the compatible Universal Navigation Adaptor Set (UNAS) are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. The navigation feature is used in surgical spinal procedures, in which:
· the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as the pelvis or a vertebrac 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 using a navigation system and associated tracking arrays.
These procedures include but are not limited to spinal fusion. TELIGEN Clear, when used with UNAS, can be precalibrated with the Brainlab Navigation System. TELIGEN Access Probe, when used with UNAS, can be pre-calibrated with the Brainlab Navigation System, where other navgation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.
The TELIGEN Access Probe is indicated for stimulation of peripheral motor nerves, including spinal nerve roots, for location and identification during surgery.
The TELIGEN Procedure Kit Pro is a sterile, single use kit intended for use in surgical spinal procedures allowing for access, visualization, discectomy, graft delivery, navigation and peripheral motor nerve stimulation.
The TELIGEN Procedure Kit Pro includes a camera, ports and port holder, TELIGEN Clear, an Access Probe, a soft tissue retractor, a port cutter cartridge and bone graft delivery instruments.
The TELIGEN Access Probe is part of the DePuy Synthes Navigation Ready Instruments Portfolio and is designed for navigated and non-navigated use. Navigation of this instrument is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling.
The TELIGEN Access Probe is intended to stimulate peripheral motor nerves, including spinal nerve roots, for location and identification during surgery. It contains an insulated probe compatible with the SENTIO MMG System. The SENTIO MMG sensors serve to measure a mechanomyographic (MMG) response and the SENTIO MMG System's detection of this response alerts the surgeon of nerve location in the proximity of the TELIGEN Access Probe's distal tip.
The provided FDA 510(k) summary describes the TELIGEN System's "Peripheral Motor Nerve Stimulation Indications." This section details the acceptance criteria and the studies performed to demonstrate equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety Evaluation | In accordance with IEC 60601-1: 2005(R)2012 | All evaluations passed acceptance criteria. |
| Functional Performance Testing and Verification Analysis | Pass criteria for: Connector Compatibility, Insulation Effectiveness, SENTIO MMG System Compatibility, Electrical Stimulation Density | All samples and evaluations passed acceptance criteria. |
| Sterility | Ethylene Oxide sterilization validated per ISO 11135 | All samples passed acceptance criteria. |
| Biocompatibility (endpoints per ISO 10993-1) | Satisfactory results for: Physical/chemical information, Cytotoxicity, Acute Systemic Toxicity, Irritation or Intracutaneous Reactivity, Sensitization, Material mediated pyrogenicity | Leveraged existing data, testing, and assessments; all endpoints covered. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test listed (Electrical Safety, Functional Performance, Sterility). It refers to "All samples and evaluations passed acceptance criteria." The data provenance (country of origin, retrospective or prospective) is not specified, but these are typically in-house engineering and lab tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a surgical instrument for nerve stimulation, and the performance evaluations are based on engineering and laboratory testing against established standards (e.g., IEC 60601-1, ISO 11135) and internal design specifications, not on clinical interpretation or expert consensus on a "ground truth" derived from patient data.
4. Adjudication Method for the Test Set
This is not applicable. The evaluations are objective measurements and assessments against predefined technical standards and specifications, not subjective interpretations requiring adjudication.
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, as this device is a surgical instrument and not an AI-powered diagnostic imaging tool or a system involving human "readers."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical surgical instrument for nerve stimulation and does not have an "algorithm-only" performance component as understood in the context of AI/software as a medical device. Its performance is related to its physical and electrical characteristics.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance claims of the TELIGEN Access Probe as a nerve stimulator is based on established engineering and electrical standards, and the known physiological response of peripheral motor nerves to electrical stimulation. For biocompatibility, it's based on ISO 10993-1.
8. The Sample Size for the Training Set
This is not applicable. This device is a physical instrument, not an algorithm, and therefore does not have a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this device.
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(111 days)
The TELIGEN System is indicated to provide minimally invasive access, visualization, illumination, magnification and discectomy of the surgical area of the spine.
The TELIGEN Access Probe and TELIGEN Clear are Navigation Ready Instruments and when used with the compatible Universal Navigation Adaptor Set (UNAS) are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. The navigation feature is used in surgical spinal procedures, in which:
· the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as the pelvis or a vertebrae 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 using a navigation system and associated tracking arrays.
These procedures include but are not limited to spinal fusion. TELIGEN Clear, when used with UNAS, can be precalibrated with the Brainlab Navigation System. TELIGEN Access Probe, when used with UNAS, can be pre-calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.
The TELIGEN Procedure Kit and the TELIGEN Procedure Kit Pro are sterile, single use kits intended for use in surgical spinal procedures allowing for access, visualization, discectomy, graft delivery and navigation.
The TELIGEN Procedure Kit and the TELIGEN Procedure Kit Pro include a camera, ports and port holder, TELIGEN Clear, a soft tissue retractor, a port cutter cartridge and bone graft delivery instruments. Additionally, the TELIGEN Procedure Kit Pro includes an Access Probe as well as the instruments included in the TELIGEN Procedure Kit.
TELIGEN Access Probe and TELIGEN Clear are part of the DePuy Synthes Navigation Ready Instruments Portfolio and are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling.
The provided document, K223108 for the TELIGEN System, primarily focuses on the substantial equivalence of physical medical devices (TELIGEN Access Probe and TELIGEN Clear) which are "Navigation Ready Instruments" used in spinal procedures. It does not describe a study involving an AI/Machine Learning device or software, nor does it provide the detailed performance data, acceptance criteria, ground truth establishment, or study methodologies typically associated with such systems.
Therefore, I cannot extract the information required to populate the fields related to an AI/ML device study, such as acceptance criteria, sample sizes for test/training sets, expert qualifications, or MRMC studies.
The document discusses performance data related to the physical instruments:
- Accuracy Verification: Fulfillment of navigation systems instrument accuracy requirements, Instrument Length Comparison to Predicate Device, Array Characteristics Comparison to Predicate Device.
- Rigidity of Connections and Instrument during Use
- CAD Model Evaluation
- Simulated Use Evaluation
These are engineering and mechanical performance tests for physical instruments, not an AI/ML algorithm's diagnostic or assistive performance.
In summary, the provided text does not contain the information requested in the prompt regarding acceptance criteria and study details for an AI/ML device.
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(302 days)
The TELIGEN System is indicated to provide minimally invasive access, visualization, magnification and discectomy of the surgical area of the spine.
The TELIGEN Procedure Kit is part of the TELIGEN System. It is a sterile, single use kit intended for use in surgical spinal procedures to allow for access, visualization, discectomy and graft delivery.
The TELIGEN Procedure Kit includes a camera, ports and port holder, TELIGEN Clear, a soft tissue retractor, a port cutter cartridge and bone graft delivery instruments.
The TELIGEN HD Camera Control System (CCS) is part of the TELIGEN System. It operates the TELIGEN Camera which is used for illumination and visualization of the surgical site. The image collected at the camera head, is transferred to the CCS and subsequently displayed on the monitor.
I am sorry, but the provided text does not contain any information about acceptance criteria or specific study results to prove device performance. The document is an FDA 510(k) premarket notification letter and a 510(k) Summary for the TELIGEN System. This type of document declares substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and performance data, but it does not typically include detailed clinical study results with specific acceptance criteria and outcome metrics in the way your request describes.
The "Performance Data" section (Section I) only lists the types of evaluations conducted (e.g., Design Verification and Validation Testing, Human Factor/Usability, Electrical Safety, Thermal Safety & EMC Testing, Software and Systems Testing), but it does not provide the results, acceptance criteria, or study details such as sample size, provenance, expert qualifications, or ground truth methodology.
Therefore, I cannot provide the requested table or information regarding the study that proves the device meets acceptance criteria based on the provided text.
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(111 days)
When used with or without the CONDUIT™ Lateral Switch Plate, the EIT Cellular Titanium® LLIF Cage is indicated for use with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.
The EIT Cellular Titanium® LLIF Cage with a microscopic roughened surface and micro and nano-scale features is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneve bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
The CONDUIT™ Lateral Switch Plate ("Plate") is an optional device that connects to the EIT Cellular Titanium® LLIF Cage ("Cage") and adjacent vertebral body(s) to provide additional migration resistance and stability via DePuy Synthes AEGIS Screws ("Screws"). The subject device is not considered to be supplemental fixation. Both the Plate and Screws are manufactured from ASTM F136 titanium alloy (Ti-6A1-4V ELI). The Plate is supplied sterile in one- and two-hole configurations in a variety of sizes to attach to one or both adjacent vertebral bodies.
This document is a 510(k) premarket notification for a medical device called the CONDUIT™ Lateral Switch Plate. It describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to legally marketed predicate devices.
Here's the information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:
Important Note: The provided document is a 510(k) summary for a mechanical orthopedic implant (CONDUIT™ Lateral Switch Plate) for spinal fusion, not an AI/software as a medical device (SaMD) or a device that typically involves human readers interpreting images, ground truth establishment through expert consensus (radiologists), or MRMC studies. Therefore, many of the requested points related to AI/imaging device validation (e.g., sample size for test/training set in an AI context, expert qualifications, adjudication methods, MRMC studies, effect size of human readers with/without AI, standalone AI performance) are not applicable to this type of device and its non-clinical testing methodology.
The acceptance criteria described here are for demonstrating substantial equivalence based on mechanical, material, and biological safety standards, not diagnostic accuracy or clinical effectiveness in the way an AI medical device would be evaluated.
Acceptance Criteria and Device Performance Study (Non-Clinical)
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a mechanical device, the "acceptance criteria" are based on meeting established industry standards for mechanical performance, biocompatibility, and MRI safety, demonstrating similar performance to predicate devices. The document does not provide specific numerical acceptance thresholds within the text itself, but rather states that tests were performed in accordance with the standards and that results demonstrate compliance or substantial equivalence.
| Criteria Category | Specific Test | Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Dynamic Axial Compression (ASTM F2077-18) | Device withstands specified dynamic axial loads without failure, demonstrating sufficient strength and durability. | "performed on the subject device system to demonstrate that the CONDUIT™ Lateral Switch Plate is substantially equivalent to other predicate devices" |
| Dynamic Compression Shear (ASTM F2077-18) | Device withstands specified dynamic compression shear loads without failure. | "performed on the subject device system to demonstrate that the CONDUIT™ Lateral Switch Plate is substantially equivalent to other predicate devices" | |
| Static Axial Compression analysis (ASTM F2077-18) | Device withstands specified static axial loads without permanent deformation or failure. | "performed on the subject device system to demonstrate that the CONDUIT™ Lateral Switch Plate is substantially equivalent to other predicate devices" | |
| Static Compression Shear analysis (ASTM F2077-18) | Device withstands specified static compression shear loads without permanent deformation or failure. | "performed on the subject device system to demonstrate that the CONDUIT™ Lateral Switch Plate is substantially equivalent to other predicate devices" | |
| Subsidence analysis (ASTM F2267-04) | Device demonstrates acceptable resistance to subsidence into vertebral bodies under load. | "performed on the subject device system to demonstrate that the CONDUIT™ Lateral Switch Plate is substantially equivalent to other predicate devices" | |
| Expulsion analysis | Device demonstrates acceptable resistance to expulsion from the intervertebral space. | "performed on the subject device system to demonstrate that the CONDUIT™ Lateral Switch Plate is substantially equivalent to other predicate devices" | |
| Biocompatibility | Biological Evaluation (ISO 10993-1:2018) | Device materials are biocompatible and do not pose unacceptable biological risks (e.g., cytotoxicity, sensitization, irritation). | "The results demonstrate the subject devices comply with the applicable requirements of ISO 10993-1:2018" |
| MRI Safety | MRI Safety Testing (ASTM F2052-15, F2182-17, F2119-07, F2182-19e2) | Device exhibits acceptable MRI compatibility (e.g., minimal artifact, safe temperature rise, acceptable magnetic field interactions). | "evaluated and tested in accordance with... ASTM F2052-15, ASTM F2182-17, ASTM F2119-07 and ASTM F2182-19e2" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of test samples (e.g., number of plates tested) for each mechanical test. For devices cleared via 510(k), testing is typically performed on a sufficient number of samples (e.g., 3-6 or more) per configuration to demonstrate compliance with the chosen standard. These are non-clinical (
in vitro) tests, not tests on patient data. - Data Provenance: The data provenance is in-vitro laboratory testing. There is no patient-specific data or country of origin mentioned for the "test set" as this is not a study using clinical data. The tests are performed on the device prototypes themselves.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. For mechanical device testing for 510(k) clearance, "ground truth" is not established by medical experts like radiologists. Ground truth is defined by the objective measurements and pass/fail criteria of the ASTM/ISO standards for mechanical, material, and biological properties. The "experts" involved would be engineers and scientists performing and interpreting the laboratory tests according to the standards.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (like 2+1, 3+1) are used for "reading" studies involving human interpretation of medical images or data. For mechanical device testing, the results are quantitative measurements against predefined (standardized) physical acceptance criteria. There is no subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study is specifically for evaluating the effectiveness of a diagnostic or interpretive medical device, often AI-based, on reader performance using medical images. This device is a mechanical orthopedic implant, and such a study is not relevant to its clearance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI-based device. "Standalone performance" here would refer to the mechanical device's performance in isolation, which is precisely what the listed mechanical and material tests (e.g., axial compression, shear, subsidence) evaluate.
7. The Type of Ground Truth Used
- Engineering Standards and Specifications: The "ground truth" for this device's performance is defined by adherence to specific, published, and internationally recognized engineering standards (ASTM and ISO). These standards specify test methods, fixtures, loading conditions, and acceptance criteria (implied or explicit) for the mechanical and biological properties of implantable devices. The "truth" is whether the device meets these pre-defined, objectively measurable criteria.
8. The Sample Size for the Training Set
- Not Applicable. "Training set" refers to data used to train an AI algorithm. This device is a mechanical implant; there is no AI algorithm being trained. The "design and development" process would involve iterative prototyping and testing, but not a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI algorithm and thus no "training set," this question is not relevant. The design and validation of this mechanical device rely on engineering principles, materials science, and testing against established performance standards.
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(190 days)
The CEREPAK™ Uniform, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, and Freeform Mini Detachable Coil Systems are indication of intracranial aneurysms, neurovascular abnormalities such as arteriovenous malformations and arterial and arterial and venous embolizations in the peripheral vasculature.
The CEREPAK™ Freeform XtraSoft Detachable Coil System is indication of intracranial aneurysms.
CEREPAK™ is a platform delivery system that aids in the delivery of embolic coils (or "microcoils") using standard endovascular methods to treat hemorrhagic conditions. It consists of two main components, the CEREPAK™ Detachable Coils, and the CEREPAK™ Detacher. These components will be provided sterile and sold separately. The CEREPAK™ Detachable Coils are comprised of an embolic coil implant (microcoil) attached to a delivery system. The CEREPAK™ Detacher is a mechanical accessory that aids in the detachment of the CEREPAK™ Detachable Coils.
The delivery system of the CEREPAK™ Detachable Coils consists of a long, thin hypotube (delivery tube) shaft with an attachment interface to secure the microcoil at its distal end until deployment is required. Microcoil designs are based on the microcoils present in the predicate device. The delivery tube is advanced with the microcoil through a compatible microcatheter using standard endovascular techniques until the microcoil is placed at the target lesion.
The CEREPAK™ Detacher interacts with the delivery system to detach the microcoils. Upon finger actuation, the Detacher translates (slides) a component within the delivery tube that aided in securing the microcoil. This detaches the microcoil from the delivery tube. Once the microcoil is detached at the desired location, the delivery tube can be removed and discarded.
The provided document is a 510(k) Premarket Notification for a medical device (CEREPAK™ Detachable Coil Systems), not an AI/ML device. Therefore, the questions regarding acceptance criteria and study design for AI/ML performance (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this document.
The document describes non-clinical bench testing and an animal study to demonstrate substantial equivalence to a predicate device, focusing on the physical and functional performance of the embolization coils and their delivery system.
Here's an attempt to answer the applicable parts based on the document's content, focusing on what is provided:
1. A table of acceptance criteria and the reported device performance:
The document provides a "Performance Testing Summary" (Table 5) and "Biocompatibility Test Summary" (Table 6). For all tests listed, the acceptance criteria are generally implied by the "Objective" of the test, and the reported performance is consistently a categorical "PASS." Specific quantitative acceptance criteria or detailed numerical results are not provided in this summary.
Table: Acceptance Criteria (Implied) and Reported Device Performance
| Test | Implied Acceptance Criteria (Objective) | Reported Device Performance |
|---|---|---|
| CEREPAK™ Detachable Coils - Design Verification | ||
| Manual Break Joint Integrity After Transit | Ensure that the manual break joint is not kinked or separated after transit. | PASS |
| Crimp Integrity After Transit | Ensure that the proximal inner tube does not accidentally translate prematurely after transit. | PASS |
| Track Force (Delivery) | Evaluate the force necessary to deliver the proposed device through a microcatheter in a simulated tortuous anatomy model. | PASS |
| Microcatheter Pullback | Measure the distance the microcatheter retracts comparing the tip position from prior to coil delivery to when the entire embolic coil is exposed out of the distal tip of the microcatheter. | PASS |
| Microcatheter Tip Deflection | Measure the deflection angle at the microcatheter tip as the device is advanced to the detachment position. | PASS |
| Overall Length | Measure the overall length of the delivery tube shaft of the CEREPAK™ delivery system. | PASS |
| Fluorosaver Location | Verify the location of the fluorosaver marker relative to the distal end of the microcoil. | PASS |
| Fluorosaver Marker Durability | Verify that the fluorosaver marker remains visible on the delivery system after 6 delivery and 5 withdrawal cycles. | PASS |
| Delivery System Outer Diameter | Measure the overall outer diameter of the CEREPAK™ delivery system. | PASS |
| Marker Band Location | Verify the location of the radiopaque marker relative to the distal end of the delivery tube. | PASS |
| Detachment Zone Strength | Measure the tensile strength of the detachment zone to prevent premature separation of the microcoil from the detachment system. | PASS |
| Delivery System Weld Strength | Measure the break load required to separate the overall delivery system. | PASS |
| Key to Coil Weld Strength | Measure the force required to separate the proximal key from the microcoil wire. | PASS |
| Durability (Pull Wire Position) | Verify the pull wire position relative to the proximal key shoulders after durability simulation (6 advancements and 5 withdrawals) to evaluate any movement. | PASS |
| Detachment Reliability with Detacher | Verify microcoil separation from the delivery tube and inner tube translation after using the Detacher to detach the microcoil. | PASS |
| Inner Tube/Pull Wire Joint Strength | Measure the strength of the joint between the pull wire and the proximal inner tube. | PASS |
| Inner Tube Outer Diameter | Measure the outer diameter of the proximal inner tube. | PASS |
| Inner Tube Length | Measure the overall length of the proximal inner tube and the length of the proximal inner tube that is exposed outside the main delivery tube. | PASS |
| Detachment Reliability with Manual Break | Verify microcoil separation from the delivery tube after using the manual break method to detach the microcoil. | PASS |
| Manual Break Feature Buckling | Measure the force required to buckle the delivery system using the manual break feature. | PASS |
| Particulate Evaluation | Measure particulates generated during simulated use with the CEREPAK™ Detachable Coils. | PASS |
| Manual Break Markers Location | Measure the spacing between the 2 manual break indicators, the distance between the manual break and each indicator, and the distance from the manual break to the proximal end of the main delivery tube. | PASS |
| Detachment Kickback | Measure the distance the delivery system retracts after detachment. | PASS |
| Microcoil Secondary Shape | Verify the secondary shape of the microcoil. | PASS |
| Microcoil Secondary Diameter | Measure the secondary shape diameter of the microcoil. | PASS |
| Microcoil Length | Measure the length of the microcoil. | PASS |
| Atraumatic 2 Terminal Ends | Verify that the two terminal ends of the microcoil have rounded edges and no sharp features. | PASS |
| Stretch Resistance of Suture | Evaluate the force at which the stretch resistant suture (SRS) fails to resist stretching. | PASS |
| Introducer Secured After Transit | Ensure that the introducer is within the packaging hoop in the correct location and the microcoil is not exposed out of the introducer after transit. | PASS |
| Introducer Dimensions | Verify the introducer length, outer diameter, taper angle and inner diameter. | PASS |
| Introducer Purge Holes Dimensions | Verify the introducer purge hole diameter and distance from the introducer tip to the purge hole. | PASS |
| Introducer Re-Sheathing | Confirm that the introducer can be re-sheathed successfully without damage to the microcoil or delivery system. | PASS |
| MRI Testing | Determine the safety in the magnetic resonance (MR) environment and the appropriate parameters for MR conditional labeling. | PASS |
| CEREPAK™ Detacher - Design Verification | ||
| Integrity after Transit | Ensure the nose cone and housing assembly of the Detacher are intact to maintain product performance. | PASS |
| Max User Input Force | Measure the maximum user input force required to actuate the slider on the detacher. | PASS |
| Slider Travel Distance and Min Input Force | Measure the distance of slider travel and user input force required to begin the detachment motion. Confirm that the spring returns the components to their initial position after use. | PASS |
| Multiple Cycle Durability | Measure the distance the Detacher translates the inner tube after 20 detachment cycles and to ensure the delivery system encounters a hard stop in the Detacher after 20 cycles. | PASS |
| Nose Cone Insert Hard Stop and Clearance | Measure the diameter of the nose cone insert proximal hole where the delivery tube will encounter a hard stop upon insertion into the Detacher. | PASS |
| Insertion Max Force | Measure the maximum force exerted on the Detacher during insertion of the proximal end of the delivery system. | PASS |
| Printed Logo and Name Verification | Ensure that the logo is printed on the CEREPAK™ Detacher. | PASS |
| CEREPAK™ Detachable Coils and Detacher - Design Validation | ||
| In-Vitro Usability Study | Evaluate various aspects of product performance under simulated use conditions utilizing a silicone arterial model which simulates clinically relevant anatomy. | PASS |
| Biocompatibility Testing | ||
| Cytotoxicity | Non-cytotoxic | PASS |
| Sensitization | Non-sensitizing | PASS |
| Irritation or Intracutaneous Reactivity | Non-irritating | PASS |
| (Acute) Systemic Toxicity | Negative | PASS |
| Genotoxicity | Non-genotoxic | PASS |
| Hemocompatibility (ASTM Hemolysis) | Non-hemolytic | PASS |
| Hemocompatibility (SC5b-9 Complement Activation Assay) | Not a potential activator of complement system (for coils), Not a potential activator of complement system (for delivery system) | PASS |
| In Vivo Thromboresistance Study (delivery system component) | Thromboresistant | PASS |
2. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: The document states that "All testing was conducted using sampling methods as required by internal procedure," but it does not specify the exact sample sizes for each bench test. For the "In-Vitro Usability Study," it mentions it was conducted with "skilled users" using a "silicone arterial model." For the "Animal Study," it mentions it was conducted "in a porcine model," again without specifying the number of animals.
- Data Provenance (Country of Origin and Retrospective/Prospective): The document does not specify the country of origin for the data or whether the data was retrospective or prospective. Given these are non-clinical bench and animal studies to support a 510(k) submission, they would inherently be prospective studies conducted by the manufacturer (Medos International, SARL). The manufacturer is based in Switzerland.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable as there is no "ground truth" to be established by experts in the context of an AI/ML model for this type of device (embolization coil system). The performance tests are largely engineering and material science evaluations against predefined specifications. The "skilled users" mentioned in the usability/animal studies would be medical professionals (e.g., interventional neuroradiologists) demonstrating the use of the device, but not establishing a "ground truth" in the sense of diagnostic interpretation for an AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no diagnostic "test set" requiring adjudication by multiple experts.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML algorithm. The device's performance is inherently tied to its physical interaction with the human body and the user.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's acceptance is based on predefined engineering specifications, material properties, and functional performance requirements of the device, derived from established standards and comparison to a legally marketed predicate device. For biocompatibility, it's based on International Standard ISO 10993-1 and FDA Guidance. For physical performance, it's based on successful operation within simulated environments and animal models ("PASS" results on specific functional tests).
8. The sample size for the training set:
Not applicable. There is no AI/ML training set.
9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML training set.
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(56 days)
The CONDUIT™ Instruments are intended to be used with the EIT Cellular Titanium® Cages: EIT Cellular Titanium® Cervical Cage, EIT Cellular Titanium® ALIF Cage, EIT Cellular Titanium® TLIF Cage, EIT Cellular Titanium® LLIF Cage, EIT Cellular Titanium® T/PLIF Cage.
The CONDUIT™ Instruments are non-sterile, reusable instruments that may be used during placement of various EIT Cellular Titanium® Interbody Cages during spinal surgery. The CONDUIT™ Instruments are made from materials commonly used in orthopedic and neurological procedures which meet available national standards specifications. The purpose of this submission is to introduce a new set of instruments to be used with the EIT Cellular Titanium® Cervical and Lumbar Cages and there are no changes to the implant devices.
The provided text is a 510(k) Premarket Notification summary for the CONDUIT™ Instruments, which are non-sterile, reusable instruments used in spinal surgery. This document primarily focuses on demonstrating substantial equivalence to a predicate device (EIT Cellular Titanium® Interbody Cages, K201605) based on intended use, technological characteristics, and performance.
Crucially, this document does not describe the acceptance criteria or a study that proves the device meets specific performance metrics for an AI/algorithm-based medical device aiming to achieve clinical performance goals (e.g., sensitivity, specificity, accuracy).
Instead, the document references "Non-clinical testing conducted in accordance with Design Controls and Risk Management to confirm device performance for its intended use." This type of testing typically involves:
- Mechanical/functional testing: Ensuring the instruments function as intended (e.g., proper grip, secure attachment to implants, durability).
- Biocompatibility: Confirmation that materials are safe for patient contact (though these are instruments, not implants, so direct patient contact for prolonged periods is less relevant, but sterilization and handling are).
- Sterilization validation: Ensuring the instruments can be effectively sterilized for reuse.
- Material verification: Confirmation that the materials meet specified ASTM standards.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance of an AI/algorithm for this specific device from the given text.
The closest I can get to a "study" is the statement in section H:
"Non-clinical testing was conducted in accordance with Design Controls and Risk Management to confirm device performance for its intended use. The results demonstrate that the device performs as well as the predicate devices for the compared design inputs."
This implies a comparison against a predicate, likely in terms of functional equivalence and safety, rather than a clinical performance study with specific AI metrics.
In summary, none of the requested information (acceptance criteria for AI, sample sizes for AI test sets, expert ground truth establishment, MRMC studies, standalone AI performance, training set details) is present in the provided FDA 510(k) documentation for the CONDUIT™ Instruments because it is a submission for surgical instruments, not an AI/algorithm-driven device.
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(90 days)
SYMPHONY Navigation Ready Instruments:
The SYMPHONY Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:
· the use of SYMPHONY OCT System is indicated,
· the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as a vertebrae 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 using a navigation system and associated tracking arrays.
These procedures include but are not limited to spinal fusion. The SYMPHONY Navigation Ready Instruments can be pre-calibrated and/or manually calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.
The SYMPHONY Navigation Ready Instruments are intended to support indicated cervical and thoracic polyaxial sorew placement.
Universal Navigation Adaptor Set:
The Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:
· the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as the pelvis or a vertebrac can be identified relative to the aquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.
These procedures include but are not limited to spinal fusion. The DePuy Synthes Navieation Ready Instrument, when used with UNAS, can be pre-calibrated and/or manually calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.
SYMPHONY Navigation Ready Instruments:
The SYMPHONY Navigation Ready Instruments are reusable instruments used for the preparation for and insertion of SYMPHONY OCT screws, in either open or percutaneous procedures. These instruments are designed for navigated and nonnavigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling.
Universal Navigation Adaptor Set:
The Universal Navigation Adaptor Set (UNAS) contains reusable spine surgical instruments used to aid in determining the correct location and trajectory of spinal instruments and implants. The UNAS has an interface between third-party navigation systems and the DePuy Synthes Navigation Ready Instruments. The UNAS can only be used with Brainlab and Medtronic StealthStation® navigation systems. The UNAS includes:
- Brainlab compatible UNAS Navigation Arrays, ●
- Brainlab compatible Navigation Ring and ●
- Medtronic compatible Navigation Ring ST. ●
The Navigation Ring and Navigation Ring ST mates with compatible DePuy Synthes Navigation Ready Instruments. These instruments include drill guides, probe, taps and screwdrivers. Drills and trocar are indirectly navigable through the drill guide.
When the Brainlab compatible Navigation Ring is attached to the Navigation Ready Instrument, a UNAS Navigation Array can be attached and the instrument can be used only with the Brainlab Navigation System as either a manually calibrated or pre-calibrated instrument.
When the Navigation Ring ST is attached to the Navigation Ready Instrument, a Medtronic SureTrak® II Universal Tracker Fighter array (SureTrak II array) can be attached, and the instrument can be manually calibrated only with the Medtronic StealthStation navigation system.
The provided text is a 510(k) summary for the SYMPHONY™ Navigation Ready Instruments and Universal Navigation Adaptor Set. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on demonstrating equivalence rather than establishing new acceptance criteria and conducting a primary study to prove them.
Therefore, the document does not contain information about:
- Acceptance Criteria in the sense of predefined performance thresholds for a novel device. Instead, it describes performance evaluations to show that the new device's performance aligns with that of predicate devices.
- A "study that proves the device meets the acceptance criteria" in the context of a clinical trial or a statistically powered study to demonstrate a new performance claim. The performance data presented are evaluations for substantial equivalence, not a standalone clinical validation study.
- Effect size of human readers improving with AI vs. without AI assistance, as this device is a surgical instrument and navigation accessory, not an AI-powered diagnostic or assistive tool for image interpretation.
- Standalone (algorithm only without human-in-the-loop performance), as this is not an algorithm-based device.
- Ground truth types (expert consensus, pathology, outcomes data, etc.), as this is not a diagnostic device requiring this type of ground truth establishment.
- Training set size and ground truth establishment for a training set, as this is not an AI/ML device.
However, it does provide information about the performance evaluations conducted to support substantial equivalence. Here's a breakdown of what is available:
1. Table of acceptance criteria and the reported device performance:
Since explicit acceptance criteria are not stated in a numerical or categorical format, and "reported device performance" refers to the results of assessments for substantial equivalence, I will list the evaluations performed and the implied objective (consistency with predicate devices).
| Acceptance Criteria (Implied Objective) | Reported Device Performance (Evaluations Performed) |
|---|---|
| Fulfilment of navigation systems instrument accuracy requirements (consistent with predicate) | Accuracy Verification (to fulfill navigation systems instrument accuracy requirements) |
| Instrument Length consistent with predicate device (for SYMPHONY Navigation Ready Instruments) | Instrument Length Comparison to Predicate Device |
| Array Characteristics consistent with predicate device (for Universal Navigation Adaptor Set) | Array Characteristics Comparison to Predicate Device |
| Array Recognition by Brainlab Navigation System (functional) | Confirmation of Array Recognition by Brainlab Navigation System |
| Proper Mating of Implants/Instruments (functional) | Implant/instrument mating conditions |
| Repeatable Navigation Connection for Pre-Calibrated Instruments (functional) | Navigation Connection Repeatability for Pre-Calibrated Instruments |
| CAD Model Accuracy/Suitability (design verification) | CAD Model Evaluation |
| Safe and Effective Use in Surgical Scenarios (functional) | Simulated Use Evaluation |
2. Sample size used for the test set and the data provenance:
The document does not detail specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for each of the performance evaluations. The evaluations appear to be bench testing and simulated use, not human subject studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The evaluations are primarily technical assessments against design specifications and functional requirements, not expert-based ground truth establishment as would be seen in diagnostic imaging studies.
4. Adjudication method for the test set:
Not applicable, as no expert-based ground truth or adjudication process is mentioned for these technical performance evaluations.
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-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a surgical instrument and navigation accessory, not an algorithm. The "Navigation Connection Repeatability for Pre-Calibrated Instruments" and "Confirmation of Array Recognition" could be considered "standalone" functional tests of the device's interaction with navigation systems, but these are not the same as algorithmic performance.
7. The type of ground truth used:
The "ground truth" for these evaluations would be the engineering specifications, design requirements, and known performance characteristics of the predicate devices and compatible navigation systems. For example:
- Accuracy Verification: Ground truth would be the defined accuracy requirements of the compatible navigation systems.
- Instrument Length Comparison: Ground truth would be the measurements of the predicate device's instruments.
- Array Characteristics Comparison: Ground truth would be the established specifications of the predicate device's arrays.
- Implant/instrument mating conditions: Ground truth would be the design specifications for proper fit and mechanical integrity.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
Not applicable.
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(127 days)
Navigation Enabled Instruments are reusable instruments intended to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are intended; and with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:
• the use of EXPEDIUM® 4.5, EXPEDIUM® 5.5, EXPEDIUM® 6.35, VIPER® SAI, EXPEDIUM VERSE®. VIPER PRIME® (without stylet control) or SYMPHONYTM OCT system is indicated,
· the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as the pelvis or a vertebrae 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.
These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with Synthes Small Battery Drive II System and the Medtronic IPC® POWEREASE System.
The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT system are intended to support indicated cervical and thoracic polyaxial screw placement only.
Navigation Enabled Instruments are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUM® 4.5, EXPEDIUM® 5.5, EXPEDIUM® 6.35, VIPER® 2, VIPER® SAI, VIPER PRIME®, EXPEDIUM VERSE®, and SYMPHONYTM OCT screws, in either open or percutaneous procedures. The Navigation Enabled Instruments include drills, taps and screwdrivers and can be operated manually or under power. These instruments are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the Medtronic StealthStation navigation system and associated tracking arrays.
The provided FDA 510(k) summary for the "Navigation Enabled Instruments" (K200791) describes the device, its intended use, and a performance study. However, it does not contain the detailed acceptance criteria or the specific results in a format that would allow for a direct numerical comparison as requested in your prompt.
Specifically, the document states that "Simulated Use testing was performed" and lists what this testing aimed to demonstrate, but it does not provide:
- A table of quantitative acceptance criteria (e.g., specific accuracy thresholds)
- The reported device performance against those criteria (e.g., measured accuracy values)
- Sample sizes for test sets (it mentions "clinically relevant anatomical specimen / model" but not the number)
- Data provenance (country of origin, retrospective/prospective)
- Number/qualifications of experts for ground truth
- Adjudication method
- MRMC study information
- Standalone performance data
- Type of ground truth used (beyond "anatomical specimen / model")
- Sample size for training set
- How ground truth for the training set was established
Key information that can be extracted from the provided text, related to the performance study, is as follows:
1. Acceptance Criteria and Reported Device Performance:
The document describes the objectives of the simulated use evaluation, which implicitly define the areas for which performance must be acceptable. However, it does not state specific numerical acceptance criteria or the reported device performance against them.
| Acceptance Criteria (Implicit from study objectives) | Reported Device Performance (as stated in document) |
|---|---|
| Navigation Enabled Instruments can be rigidly connected to the NavLock tracker. | The Simulated Use Evaluation allows to show that: - Navigation Enabled Instruments can be rigidly connected to the NavLock tracker (rigidity). |
| Navigation Enabled Instruments can be adequately verified on the StealthStation Medtronic. | The Simulated Use Evaluation allows to show that: - Navigation Enabled Instruments can be adequately verified on the StealthStation Medtronic (instrument verification). |
| Navigation Enabled Instruments can be accurately navigated, and screws accurately placed. | The Simulated Use Evaluation allows to show that: - Navigation Enabled Instruments can be accurately navigated, and screws accurately placed (accuracy verification). |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document mentions "a clinically relevant anatomical specimen / model." It does not specify the number of specimens/models used or the number of trials/measurements performed.
- Data Provenance: The study was a "Simulated Use testing," implying it was conducted in a controlled environment, likely at the manufacturer's facility. No information on country of origin of data, or whether it's retrospective or prospective is provided, though based on "simulated use," it's prospective testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The ground truth would likely be established by the physical properties of the "anatomical specimen / model" and the known dimensions/placement attempts, but expert involvement for ground truth definition is not mentioned.
4. Adjudication method for the test set:
- This information is not provided in the document. Given it's a simulated use test on a model, formal adjudication as seen in clinical trials with human data is unlikely to be described here.
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:
- No MRMC comparative effectiveness study is mentioned. The device is a navigation system for surgical instruments, not an AI-assisted diagnostic or interpretive tool that would typically involve "human readers" in this context. The evaluation focuses on the instrument's performance, not human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device inherently involves human-in-the-loop, as they are "Navigation Enabled Instruments" intended to "assist the surgeon." Therefore, a "standalone algorithm only" performance study is not applicable or described for this type of device. The simulated use testing inherently includes the human (or simulated human interaction) with the system.
7. The type of ground truth used:
- "Clinically relevant anatomical specimen / model." This typically refers to cadaveric specimens or realistic physical models that mimic human anatomy. The ground truth for accuracy would be based on the known anatomical landmarks or pre-defined target locations within these models.
8. The sample size for the training set:
- This information is not provided. This device is largely mechanical and optical (for navigation) rather than a machine learning/AI device that typically requires a discrete "training set" in the conventional sense. Its "training" would be through engineering design, calibration, and predicate device experience.
9. How the ground truth for the training set was established:
- This information is not provided, and as noted above, a formal "training set" and its ground truth establishment, as understood in AI/ML contexts, is not explicitly documented for this type of medical device in this summary.
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(88 days)
SYMPHONY Navigation Ready Instruments:
The SYMPHONY Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:
· the use of SYMPHONY OCT System is indicated.
· the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as a vertebrae 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 using a navigation system which includes tracking arrays supplied by the navigation system manufacturer.
These procedures include but are not limited to spinal fusion. The SYMPHONY Navigation Ready Instruments require manual calibration with the Medtronic StealthStation navigation system.
The SYMPHONY Navigation Ready Instruments are intended to support cervical and thoracic polyaxial screw placement.
Universal Navigation Adaptor Set:
The Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:
· the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as the pelvis or a vertebrae 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 using a navigation system which includes tracking arrays supplied by the navigation system manufacturer. These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instrument, when used with UNAS, requires manual calibration with the Medtronic StealthStation navigation system.
SYMPHONY Navigation Ready Instruments:
The SYMPHONY Navigation Ready Instruments are reusable instruments used for the preparation for and insertion of SYMPHONY OCT screws, in either open or percutaneous procedures. These instruments are designed for navigated and nonnavigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling.
Universal Navigation Adaptor Set:
The Universal Navigation Adaptor Set contains the Navigation Ring ST used to aid in determining the correct location and trajectory of spinal instruments and implants. The Navigation Ring ST has an interface between the Medtronic StealthStation® navigation system and the DePuy Synthes Navigation Ready Instruments.
The Navigation Ready Instruments include drills, trocar, probe, taps and screwdriver. When the Navigation Ring ST is attached to the Navigation Ready Instrument, a Medtronic SureTrak® II Universal Tracker Passive Fighter array (SureTrak II array) can be attached, and the instrument can be manually calibrated with the Medtronic StealthStation navigation system.
This document describes the FDA's 510(k) clearance for the SYMPHONY Navigation Ready Instruments and Universal Navigation Adaptor Set. The key aspects regarding acceptance criteria and supporting studies are extracted below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Measure) | Reported Device Performance (Summary) |
|---|---|
| Accuracy Verification | |
| Toggle Analysis (Positional Deviation) | Not explicitly stated in quantitative terms but implied to meet performance for substantial equivalence. |
| Toggle Analysis (Angular Deviation) | Not explicitly stated in quantitative terms but implied to meet performance for substantial equivalence. |
| Length Comparison to Reference Device | Not explicitly stated in quantitative terms but implied to meet performance for substantial equivalence. |
| Implant/Instrument Mating Conditions | Found to be acceptable. |
| Simulated Use Evaluation | Successful preparation of holes and screw insertion in sawbones model; final screw position compared favorably with post-operative scan and sawbones model. |
Note: The document does not provide specific quantitative acceptance criteria or detailed numerical results for the performance tests. The conclusion of substantial equivalence implies that the device met the necessary performance standards to be considered safe and effective as its predicate.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (e.g., number of instruments, number of measurements) for the accuracy verification tests or the simulated use evaluation.
The data provenance for the test set (e.g., country of origin, retrospective/prospective) is not explicitly stated. However, given it's a pre-market notification for a medical device seeking FDA clearance, the testing would typically be conducted under controlled laboratory conditions rather than using patient data. The simulated use evaluation used "sawbones models," which are synthetic bone models, indicating a prospective, lab-based study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set. The accuracy verification likely relied on engineering measurements against known specifications, and the simulated use evaluation would have been assessed by engineering and potentially clinical staff involved in the study.
4. Adjudication Method for the Test Set
Not applicable, as expert adjudication for establishing ground truth is not mentioned as part of the performance data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not done. The document describes a technical and simulated use evaluation rather than a clinical study involving human readers or a comparison of human performance with and without AI assistance. The device is a surgical instrument set, not an AI-based diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "performance data" sections (Accuracy Verification, Implant/instrument mating, Simulated Use Evaluation) represent the standalone performance of the device (instruments and adaptor set) in conjunction with a navigation system. It's not an algorithm in the AI sense, but rather the functional performance of the hardware. The simulated use evaluation specifically describes the device, when manually calibrated with the Medtronic StealthStation navigation system, being used to prepare holes and insert screws, and the final screw position was compared to a post-operative scan and sawbones model. This assesses the system's ability to guide the surgeon accurately.
7. The Type of Ground Truth Used
- Accuracy Verification: The ground truth for accuracy (positional, angular, length) would likely be based on engineering specifications, calibrated measurement devices, or a statistically reliable "true" value derived from multiple precise measurements.
- Simulated Use Evaluation: The ground truth for the simulated use was based on:
- The "final screw position in the software" (from the Medtronic StealthStation navigation system).
- Comparison with a "post-operative scan" of the sawbones model.
- Comparison with the "sawbones model" itself.
This implies a comparison against the intended surgical plan or ideal placement within the physical model.
8. The Sample Size for the Training Set
Not applicable. This device is a set of physical surgical instruments and an adaptor, not an AI or machine learning model that requires a training set.
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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(217 days)
The CONCORDE LIFT Expandable Interbody Device is a lumbar intervertebral body fusion device, and is indicated for use with autogenous bone graft and/or allograft comprised of carcellous and/or corticocancellous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine, L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The CONCORDE LIFT Expandable Interbody Device can be implanted via posterior, transforaminal or lateral approach.
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. Candidates for surgery should be skeletally mature and have had a six-month course of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.
The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
The CONCORDE LIFT Expandable Interbody Devices are provided gamma sterilized and are for single use only. The devices are designed for lumbar intervertebral body fusion. They are fabricated from titanium alloy (Ti-6Al-4V) per ASTM F136. A cavity internal to each device is intended to hold autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The CONCORDE LIFT device is available in both a convex configuration and a lordotic configuration.
The purpose of this submission is to seek clearance for the CONCORDE LIFT devices with lower starting heights.
The provided document is a 510(k) summary for a medical device called the CONCORDE LIFT Expandable Interbody Device. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML powered device.
The document primarily focuses on demonstrating substantial equivalence to a predicate device based on material, design, performance, and indications for use, which is a standard regulatory pathway for Class II medical devices like intervertebral body fusion devices. The performance data listed (ASTM standards) relate to the physical and material properties of the implant itself, such as mechanical testing, MRI safety, and bacterial endotoxin testing, not the performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information for an AI/ML device based on the given document. The questions about sample sizes, data provenance, ground truth, experts, adjudication, MRMC studies, and standalone AI performance are not applicable to the content provided.
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