Search Results

Ask a specific question about this device

The DynaNail Mini Tapered Hybrid is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle.

The proposed DynaNail Mini Tapered Hybrid™ is part of the DynaNail Mini™ Fusion System. The proposed implant is sterile, single use titanium device with an internal Nitinol compressive element for use in midfoot and hindfoot reconstruction. A titanium outer body provides bending and torsional rigidity to the arthrodesis construct, while the internal Nitinol compressive element sustains compression across the joints post-operatively.

The proposed DynaNail Mini Tapered Hybrid™ is available in identical diameters and lengths to the predicate device, and to accommodate variations in patient anatomy. The proposed device differs from the predicate device only in the threaded component major diameter, which is tapered. The DynaNail Mini Tapered Hybrid™ is implanted with the same driver/ deployment frame and fixation screws as the predicate. The fixation screws are single use titanium headless screws. These are available in various lengths to accommodate the anatomical fixation required. The system includes instruments for implantation identical to the predicate.

This document is a 510(k) Summary for a medical device called the "DynaNail Mini Tapered Hybrid." It details the manufacturer's claim that this new device is substantially equivalent to a previously cleared predicate device.

Based on the provided document, there is NO study information available that proves the device meets acceptance criteria related to AI/software performance or human reader improvement.

The document discusses the substantial equivalence of a physical medical device (an orthopedic nail) to a predicate device. The acceptance criteria and "study" information provided refer to mechanical and material testing of the physical implant, not to the performance of a software or AI algorithm.

Therefore, I cannot fulfill your request for information regarding AI acceptance criteria, data provenance, expert ground truth adjudication, MRMC studies, standalone AI performance, or training set details because this document does not contain information about an AI/software device.

The "studies" conducted and described are non-clinical (mechanical) tests to demonstrate that the physical device performs equivalently to its predicate.

Here's what I can extract related to the physical device's "acceptance criteria" and "performance," as inferred from the mechanical testing, but please note this is not for an AI device:

Acceptance Criteria and Device Performance (for the physical medical device - Orthopedic Nail)

This section outlines the non-clinical (mechanical) testing performed to demonstrate the substantial equivalence of the DynaNail Mini Tapered Hybrid to its predicate device. The "acceptance criteria" are implicitly met if the proposed device's performance is "substantially equivalent" or "superior" to the predicate or relevant standards.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

Regarding the other points of your request as they apply to an AI device (since this document is not about AI):

• 2. Sample sized used for the test set and the data provenance: Not applicable. The "test set" consists of physical devices subjected to mechanical testing. No patient data or clinical imagery is involved.
• 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 mechanical tests is established by published test standards and engineering measurements, not by human experts.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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. No human readers or AI assistance involved.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the objective physical measurements obtained according to validated standard test methods (e.g., ASTM standards).
• 8. The sample size for the training set: Not applicable. This is not an AI/software device.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a physical orthopedic implant, demonstrating its substantial equivalence through mechanical and material testing, not through AI performance studies.

Ask a specific question about this device

-Fracture, osteotomy fixation and joint arthrodesis of the hand and foot.

-Fixation of proximal tibial metaphysis osteotomy.

-Fixation of small fragments of bone (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna, or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula, and sternum.

The proposed MedShape DynaClip® Bone Staple is a sterile, single use orthopedic implant designed to use the principles of interference fit to hold the implant body into a predrilled hole and across the target fracture site. The DynaClip® Bone Staple is intended to be used for fracture and osteotomy fixation, including joint arthrodesis, and fixation of small bone fragments, and is comprised of Nickel Titanium alloy commonly referred to as NiTiNOL (reference ASTM F2063, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical lmplants). The staple is provided pre-loaded on a disposable inserter.

The provided FDA 510(k) summary for the MedShape DynaClip® Bone Staple (K220812) does not contain information related to a study involving image analysis, AI, or human reader performance.

Instead, this document describes a bone staple, which is a physical medical device intended for fracture and osteotomy fixation. The acceptance criteria and the study proving the device meets these criteria are based on mechanical testing, material characterization, and biocompatibility assessments, not on performance in interpreting medical images or improving human interpretation.

Therefore, I cannot populate the requested table and answer the questions related to acceptance criteria and studies (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) as they pertain to image analysis or AI/human-in-the-loop performance, because this information is not present in the provided text.

The closest relevant information, regarding performance testing to support substantial equivalence, is listed as:

• Corrosion resistance testing per ASTM F2129
• Transformation temperature thermal analysis testing per ASTM F2004-17
• Bacterial endotoxin testing per ANSI/AAMI ST72:2011
• Mechanical comparison via Finite Element Analysis

The document explicitly states: "No clinical data was collected, as it was deemed unnecessary to support the assertion of safety." This further confirms that no studies involving human or AI interpretation of images were conducted or are described here.

Ask a specific question about this device

The MedShape DynaFuse Fixation System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

The proposed MedShape DynaFuse Fixation System is a sterile, single use orthopedic implant system consisting of a threaded bone fastener and washer. The DynaFuse Fixation System is designed to apply compression across a target fracture or fusion site and is intended to be used for fracture and osteotomy fixation, including joint arthrodesis. The devices provided sterile, intended for single use, and are comprised of titanium alloy and nickel-titanium.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy), or any clinical study details such as sample size, data provenance, expert ground truth, or adjudication methods in the context of an AI/algorithm-enabled medical device.

The provided document is a 510(k) premarket notification for the DynaFuse Fixation System, which is a physical orthopedic implant system (a threaded bone fastener and washer). The tests mentioned (Static Torsion Test, Static Strain Test, Fatigue Strain Test, Bacterial endotoxin testing) are engineering and biocompatibility tests for physical medical devices and are not related to the performance of an AI or software algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device meets them for an AI/algorithm-based device from this document.

Ask a specific question about this device

The DynaNail Mini™ Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle.

The proposed DynaNail Mini Hybrid™ is part of the DynaNail Mini™ Fusion System. The proposed implant is sterile, single use titanium device with an additional internal Nitinol compressive element for use in midfoot and hindfoot reconstruction. A titanium outer body provides bending and torsional rigidity to the arthrodesis construct, while the internal Nitinol compressive element sustains compression across the joints post-operatively. The DynaNail Mini Hybrid™ is available in multiple diameters and lengths to accommodate variations in patient anatomy. The DynaNail Mini Hybrid™ is implanted with a driver/ deployment frame and fixation screws. The fixation screws are single use titanium headless screws. These are available in various lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.

The provided text describes a medical device, the DynaNail Mini HybridTM, and its 510(k) premarket notification to the FDA. The information focuses on the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.

Based on the provided text, the device is a Smooth or threaded metallic bone fixation fastener / Orthopedic Nail. The acceptance criteria and the study that proves the device meets them are described in the context of establishing substantial equivalence to a predicate device, not in the typical sense of AI/algorithm performance.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   The document does not specify the sample sizes for the mechanical tests (Static Torsion, Static Axial Strain, Fatigue Strain, Pyrogenicity, BET). These tests are typically performed on a limited number of device samples, not patient data. The provenance of this data is from engineering analysis and laboratory testing, not patient-derived data from specific countries or study designs (retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
   Not applicable (N/A). The evaluation is based on engineering and material performance specifications of the device itself, not on expert interpretations of medical images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   N/A. This concept is for clinical trials or diagnostic performance studies involving human interpretation. The reported studies are mechanical and biocompatibility tests.

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
   N/A. This is a medical device (bone fixation fastener), not an AI diagnostic or assistance tool. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   N/A. This is a hardware medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
   The "ground truth" for the device's performance is established by validated engineering standards (ASTM F543, ASTM F2516, ASTM E606) and biocompatibility standards (ANSI/AAMI ST72). The ground truth for performance is the ability of the device to meet the specified performance criteria set by these standards, demonstrating substantial equivalence to the predicate device.

8. The sample size for the training set
   N/A. This medical device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established
   N/A. As there is no training set, this question is not applicable.

Ask a specific question about this device

The MedShape DynaClip Bone Staple is intended to be used for the following:

• Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
• Fixation of proximal tibial metaphysis osteotomy.
• Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.

The proposed MedShape DynaClip Bone Staple is a sterile, single use orthopedic implant designed to use the principles of interference fit to hold the implant body into a predrilled hole and across the target fracture site. The DynaClip Bone Staple is intended to be used for fracture and osteotomy fixation, including joint arthrodesis, and fixation of small bone fragments, and is comprised of Nickel Titanium alloy commonly referred to as NiTiNOL (reference ASTM F2063, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants). The staple is provided pre-loaded on a disposable inserter.

The provided text is a 510(k) summary for the MedShape DynaClip Bone Staple. This document describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to predicate devices. It does not describe an AI/ML powered medical device, nor does it contain information typically found in studies related to AI/ML device acceptance criteria.

Specifically, the document focuses on bench testing for a physical orthopedic implant. Therefore, the questions regarding acceptance criteria and studies that prove an AI device meets acceptance criteria (such as sample sizes for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details, etc.) are not applicable to this document.

The document states: "No clinical data was collected, as it was deemed unnecessary to support the assertion of safety and effectiveness." This further reinforces that there was no study involving human readers or AI algorithms as would be expected for an AI/ML device.

Therefore, an answer based on the provided text cannot fulfill the user's request, as the request is predicated on the assumption of an AI-powered device, which the MedShape DynaClip Bone Staple is not.

Ask a specific question about this device

The DynaNail™ Mini Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle.

The proposed DynaNail™ Mini is a sterile, single use titanium device with an additional internal Nitinol compressive element for use in midfoot and hindfoot reconstruction. The DynaNail™ Mini's titanium outer body provides bending and torsional rigidity to the arthrodesis construct, while the internal Nitinol compressive element sustains compression across the joints post-operatively. The DynaNail™ Mini is available in multiple diameters and lengths to accommodate variations in patient anatomy. The DynaNail™ Mini is implanted with a deployment frame and fixation screws. The fixation screws are single use titanium headless screws. These are available in various lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.

This is a 510(k) premarket notification for a medical device (DynaNail Mini) and therefore does not include detailed information about clinical studies, acceptance criteria, or ground truth establishment for AI/ML device performance. This document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, materials, and mechanical performance testing, rather than reporting on a study demonstrating clinical performance against acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred from the document:

1. A table of acceptance criteria and the reported device performance:

The document mentions "Engineering analysis and mechanical performance testing (Pull-out per ASTM F543) was performed." and "The test results and analysis demonstrate substantial equivalent performance to the predicate devices." It also states "Pyrogenicity testing was conducted per ANSI/AAMI ST72 for the worst case largest DynaNail™ system, confirming the most loaded device scenario meets the limit of 20EU. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011."

However, the specific acceptance criteria (e.g., "pull-out strength X N or greater") and the exact reported performance values are not provided in the text. The only specific acceptance criterion mentioned is for pyrogenicity: "confirmi[ng] the most loaded device scenario meets the limit of 20EU."

2. Sample size used for the test set and the data provenance: Not applicable. This document describes a mechanical device, not an AI/ML system tested on a dataset of patient information.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be its mechanical properties and biological compatibility, which are assessed through engineering analysis and laboratory testing (e.g., ASTM F543, ANSI/AAMI ST72), not clinical data from patients.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The MedShape DynaClip™ Bone Staple is intended to be used for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.

The proposed MedShape DynaClip Bone Staple is a sterile, single use orthopedic implant designed to use the principles of interference fit to hold the implant body into a predrilled hole and across the target fracture site. The DynaClip Bone Staple is intended to be implanted in the bones of the hand or foot and is comprised of Nickel Titanium alloy commonly referred to as NiTiNOL (reference ASTM F2063, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants). The staple is provided pre-loaded on a disposable inserter.

The provided text describes a 510(k) premarket notification for the MedShape DynaClip™ Bone Staple, a medical device for bone fixation. It details the device's characteristics, indications for use, and a comparison to a predicate device, focusing on the rationale for substantial equivalence.

However, the document does not contain any information about an AI/algorithm-based device, human reader studies, or the establishment of ground truth by expert consensus or other methods. It describes a traditional medical device (bone staple) that undergoes mechanical and material testing, not a diagnostic or AI-driven system.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies that prove an AI/algorithm device meets those criteria based on the provided text. The questions you posed are relevant to AI-based medical devices, which this document does not cover.

Ask a specific question about this device

The DynaNail™ TTC Fusion System is intended for tibio-talo-calcaneal fusions:

• Post-traumatic and degenerative arthritis.
• Post-traumatic or primary arthrosis involving both ankle and subtalar joints.
• Revision after failed ankle arthrodesis with subtalar involvement.
• Failed total ankle arthroplasty.
• Non-union ankle arthrodesis.
• Rheumatoid hindfoot.
• Absent Talus (requiring tibiocalcaneal arthrodesis).
• Avascular necrosis of the talus.
• Neuroarthropathy or neuropathic ankle deformity.
• Neuromuscular disease and severe deformity.
• Osteoarthritis.
• Charcot Foot.
• Previously infected arthrosis, second degree.

The proposed DynaNail™ is a sterile, single use titanium device with an additional internal Nitinol compressive element for use in tibiotalocalcaneal fusions. The DynaNail™'s titanium outer body provides bending and torsional rigidity to the arthrodesis construct, while the internal Nitinol compressive element sustains compression across the ankle and subtalar joints postoperatively.

The DynaNail™ is available in 10, 11, and 12mm diameters and lengths of 180mm, 220mm, 260mm, and 300mm. The DynaNail™ is implanted with a deployment frame and fixation screws. The fixation screws are single use 5mm titanium headed and headless screws. The screws are available in lengths that range from 20 to 110mm.

The provided text is a 510(k) Summary for the DynaNail TTC Fusion System, and it describes a medical device, not an AI/ML powered device. Therefore, the information requested in the prompt, which is primarily relevant to the evaluation and validation of AI/ML devices (e.g., acceptance criteria for algorithm performance, sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone performance), is not applicable and cannot be extracted from this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through design, function, intended use, and adherence to relevant standards like ASTM F 1264-03 for functional performance and ANSI/AAMI ST72 for pyrogenicity.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth, expert qualifications, adjudication methods, or AI/MRMC studies, as these concepts are not part of the described medical device evaluation in this 510(k) summary.

Ask a specific question about this device

The FastForward device is intended to assist in the correction of Hallux Valgus deformities by providing reduction of the 1st Intermetatarsal angle.

The FastForward device, consisting of Titanium (Ti-6AL-4V ELI), is a button designed to be implanted on the lateral aspect of the 200 metatarsal with suture or suture tape.

The provided text is a 510(k) summary for the MedShape FastForward device. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through comparative testing of mechanical properties, rather than clinical performance studies typically associated with AI/software-based devices. Therefore, much of the requested information regarding clinical acceptance criteria, human reader studies, and AI-specific ground truth will not be present.

Based on the provided text, here's the information that can be extracted:

Acceptance Criteria and Device Performance

The 510(k) summary indicates that the device's performance was evaluated through pullout/fracture strength testing, monotonic and cyclic tension, and shear testing. The overall acceptance criterion for these tests was substantial equivalence to the predicate device (Arthrex Mini Tightrope, K061925).

Study Details

Given the nature of a 510(k) for a metallic bone fixation appliance, the "study" referred to is primarily benchtop mechanical testing.

1. Sample size used for the test set and the data provenance:

   • The document does not specify the exact sample sizes (i.e., number of FastForward devices or predicate devices) used for the pullout, fracture, tension, and shear testing.
   • The data provenance is not explicitly stated as country of origin, but it is implied to be from MedShape's internal testing or a contract lab. The test data is retrospective in the sense that it was conducted as part of the device development and submission.

2. 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 the "ground truth" was established purely through objective mechanical testing measurements (e.g., force at failure, displacement under load) rather than expert interpretation of medical images or clinical outcomes.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • None. Adjudication methods are relevant for subjective assessments (e.g., reading medical images) where human agreement is required to establish ground truth. As this was mechanical testing, objective measurements were taken.

4. 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. An MRMC study is not mentioned. This type of study is relevant for AI-powered diagnostic or interpretive devices, not for a mechanical bone fixation device like the FastForward. There is no AI component mentioned for this device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • No. This device does not involve an algorithm or AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this device's performance evaluation was based on quantitative mechanical measurements (e.g., force, displacement) obtained during pullout/fracture strength, monotonic and cyclic tension, and shear testing. The performance was then compared to a predicate device's performance using these objective measurements.

7. The sample size for the training set:

   • This is not applicable. There is no "training set" as this device is a mechanical implant and does not involve machine learning or AI.

8. How the ground truth for the training set was established:

   • This is not applicable. There is no training set for a mechanical device.

Ask a specific question about this device