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The FIX-C PEEK ACIF SA System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The stand-alone interbody cages must be used with internal screw fixation. The FIX-C PEEK ACIF SA System is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The FIX-C PEEK ACIF SA System consists of a stand-alone interbody fusion device with internal screw fixation. The FIX-C PEEK ACIF SA System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc.

The FIX-C PEEK ACIF SA System is comprised of a PEEK interbody cage and screws. The PEEK interbody cage is made from medical-grade polyetheretherketone (PEEK) which is radiolucent and contains radiopaque titanium clips made from medical-grade titanium alloys. The titanium clip assembled in the PEEK cage includes a Zero-Step Mechanism designed to prevent the screw from disengaging or loosening from the cage. The PEEK materials conform to ASTM F2026, and the titanium alloys materials conform to ASTM F1136.

The FIX-C PEEK ACIF SA System is provided non-sterile. The devices must be sterilized prior to use per ISO 17665-1.

This FDA 510(k) clearance letter is for a medical device (an intervertebral body fusion device), not a software or AI-powered device. Therefore, the information provided does not include the details about acceptance criteria, study design (sample sizes, expert adjudication, MRMC studies, ground truth establishment, etc.) that would be relevant for an AI/software-based medical device.

The clearance letter focuses on establishing substantial equivalence to previously cleared predicate devices based on:

• Indications for Use: The FIX-C PEEK ACIF SA System is indicated for anterior cervical interbody fusion procedures, which is compared to the predicate device's indications.
• Technological Characteristics: The device materials (PEEK, titanium), design features (internal screw fixation, Zero-Step Mechanism), and sterilization methods are described and implicitly compared to predicates.
• Non-Clinical Testing (Bench Tests): This is the primary "study" mentioned. The device underwent mechanical bench tests to ensure its structural integrity and performance are comparable to established standards and the predicate device.

Here's a breakdown of the information that is and is not provided in the context of your request for AI/software device evaluation:

Information Provided in the Document (Relevant to a mechanical device):

1. Acceptance Criteria & Reported Device Performance:

   • Acceptance Criteria: "All test results were higher than the acceptance criteria from the reference literature." (Specific numeric criteria not detailed, but implied to be based on ASTM standards).
   • Reported Device Performance: "All test results were higher than the acceptance criteria... Therefore, substantially equivalent mechanical performance with the predicate device has been demonstrated." (No specific quantitative results are provided in the clearance letter itself, only the conclusion of meeting criteria.)

   Table (As much as can be constructed from the text):

   Acceptance Criteria	Reported Device Performance
   Performance higher than "reference literature" values for ASTM F2077 (Static axial compression, Static compression-shear, Static torsion, Dynamic axial compression, Dynamic compression-shear, Dynamic torsion) and ASTM F2267 (Subsidence)	All test results were reported as "higher than the acceptance criteria."
   Substantial equivalence to predicate device in mechanical performance	Substantial equivalence demonstrated.

2. Sample Sizes and Data Provenance:

   • Not applicable in the AI/software sense. This refers to physical bench testing of device units. The number of units tested is not specified.
   • Data provenance is "bench tests conducted for the subject device" (manufacturer).

3. Experts for Ground Truth, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth:

   • Not applicable: These concepts are entirely relevant to evaluation of diagnostic/AI software performance based on clinical image interpretation or patient data, not for the mechanical performance testing of an interbody fusion device.
   • The "ground truth" for this device's performance would be the physical measurements and results obtained from the bench tests, compared to engineering standards.

4. Training Set Sample Size and Ground Truth Establishment (Training Set):

   • Not applicable: There is no "training set" in the context of a mechanical device. These refer to the data used to train machine learning models.

Summary regarding your specific questions NOT answered by this document (because it's a mechanical device, not AI/software):

• Sample sized used for the test set and the data provenance: Not clinical data, but bench test data. Specific number of samples tested is not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No (not an algorithm).
• The type of ground truth used: Bench test measurements against engineering standards (not expert consensus, pathology, or outcomes data in the clinical sense).
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Conclusion:

This FDA 510(k) clearance letter details the regulatory approval of a physical medical implant based on its compliance with established mechanical safety and performance standards (ASTM F2077, ASTM F2267) and substantial equivalence to existing devices. It does not provide the type of performance metrics, study designs, or data provenance relevant to the validation of an AI/software medical device.

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FIX-L PEEK PLIF and T-PLIF System is an intervertebral body fusion devices intended for use to skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. FIX-L PEEK PLIF and T-PLIF System is indicated to be used with autologous bone graft to facilitate fusion and are intended to be used with supplemental fixation. The device is to be used in patients who have had six months of nonoperative treatment.

FIX-L PEEK PLIF and T-PLIF System intended for use as an interbody fusion cage device and must be used with supplemental fixation. The device is available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The configurations are designed pursuant to a specific surgical approach and consist of the following: 1) Posterior Lumbar Approach (PLIF) and 2) Transforaminal Posterior Lumbar Approach (T-PLIF). FIX-L PEEK PLIF and T-PLIF System is made of PEEK VESTAKEEP i4R body (ASTM F2026) and tantalum markers (ASTM F560) for ease of visualization on radiographs. FIX-L PEEK PLIF and T-PLIF System is a non-sterile device, and it is required to be sterilized via autoclave method by the hospital prior to surgery.

The provided document is an FDA 510(k) clearance letter for an intervertebral body fusion device (FIX-L PEEK PLIF and T-PLIF System), which is a physical implant used in spinal surgery. This type of device is cleared based on non-clinical testing (bench tests) demonstrating substantial equivalence to a predicate device, not on clinical studies involving AI or human-in-the-loop performance.

Therefore, many of the questions related to AI device performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, and stand-alone algorithm performance are not applicable to this specific medical device clearance. The document explicitly states: "No clinical studies were considered necessary and performed."

However, I can extract information relevant to the non-clinical acceptance criteria and the study that proves the device meets them based on the provided text.

Acceptance Criteria and Device Performance for FIX-L PEEK PLIF and T-PLIF System

This device is an intervertebral body fusion device (an implant). Acceptance criteria and performance are established through bench testing to demonstrate mechanical safety and substantial equivalence to a predicate device, not through clinical or AI performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

For non-clinical bench testing of an implantable device, the "test set" refers to the physical samples of the device undergoing mechanical testing. The document does not specify the exact number of device samples tested for each criterion (e.g., number of implants subjected to axial compression).

• Sample Size: Not explicitly stated (typically, a statistically representative number of physical samples are used for each bench test, as defined by the ASTM standards).
• Data Provenance: Not applicable in the context of clinical or image data. The "data" comes from controlled laboratory bench tests of the manufactured physical device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable: For this type of device (physical implant), "ground truth" is established by adherence to recognized ASTM mechanical testing standards and comparison to a predicate device's established performance, not by expert human interpretation of data like in AI/imaging studies.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are common in clinical trials or AI performance evaluations involving subjective human interpretation. For mechanical bench testing, the results are quantitative and objective, measured against the specified ASTM standard thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No: The document explicitly states: "No clinical studies were considered necessary and performed." MRMC studies are clinical studies typically used to evaluate the diagnostic performance of imaging systems or AI algorithms with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• No: This is a physical, implantable medical device, not an AI algorithm. Standalone performance studies are for AI systems.

7. The Type of Ground Truth Used

• Bench Test Standards and Predicate Device Equivalence: The "ground truth" for this device is based on its ability to meet the acceptance criteria outlined in recognized ASTM mechanical testing standards (e.g., ASTM F2077, ASTM F2267) and to demonstrate mechanical characteristics that are substantially equivalent to a legally marketed predicate device (K190563 - 4CIS® PEEK PLIF Cage). The physical and material properties (e.g., PEEK VESTAKEEP i4R body, tantalum markers) also contribute to the basis for "truth" in terms of biocompatibility and radiolucency.

8. The Sample Size for the Training Set

• Not Applicable: There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable: There is no "training set." The device design and manufacturing process are based on established engineering principles, material science, and the performance characteristics of the predicate device.

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ARIX Pectus Bar System is intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities.

ARIX Pectus Bar System is used in a minimally invasive surgical procedure to correct pectus excavatum, a type of deformity of the thoracic wall, characterized by a concave shaped chest.

This device consists of pectus bar and stabilizer to lift the sternum upwards to lessen the severity of the deformity.

ARIX Pectus Bar System includes appliance accessories used in surgical procedures to insert a fixation bar into the thoracic cavity and get it fixed to the coastal ribs for repairing pectus excavatum, a type of deformity of the thoracic wall.

Depending on the method of connection, Pectus Bars are used in combination of three types (Single Bar System, Double Bar System, Multi Bar System).

Especially, Single Bar System is used only for the Lower Bar, and the Upper Bar cannot be used alone.

I apologize, but the provided text is an FDA approval letter for a medical device called the "ARIX Pectus Bar System." This document primarily addresses the administrative aspects of the approval, including the regulatory classification, intended use, and comparison to predicate devices, to establish substantial equivalence.

It does not contain any information about acceptance criteria for a study, nor does it describe a study (clinical or non-clinical in detail) that proves the device meets specific performance criteria. The letter explicitly states:

• "No clinical studies were considered necessary and performed."
• It mentions "Bench tests were conducted to ensure the safety and effectiveness of the device as well as to demonstrate substantial equivalence to the predicate device" and lists some ASTM standards, but it does not provide any specific acceptance criteria or reported performance results from these tests.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The requested information regarding sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment for test/training sets, and training set sample size is not present in this document.

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ARIX Femur Nail System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).

ARIX Femur Nail System (Nail, Lag Screw, Interlocking Screw, Set Screw, and End Cap) is made of Titanium Alloy which meets ASTM F136. ARIX Femur Nail System is provided Sterile or Non-Sterile.

The provided text is an FDA 510(k) Clearance Letter for the ARIX Femur Nail System. This type of document is for a physical medical device (an intramedullary fixation rod), not a software or AI-powered device. Therefore, the questions regarding acceptance criteria, study details, expert involvement, and AI-specific metrics (like human improvement with AI assistance) are not applicable to the information given in this document.

For medical devices like the ARIX Femur Nail System, "acceptance criteria" are generally tied to meeting established industry standards for performance, material properties, and biocompatibility, rather than diagnostic accuracy or algorithmic performance. The "study that proves the device meets the acceptance criteria" refers to bench testing to demonstrate compliance with these standards and substantial equivalence to a predicate device.

Here's a breakdown of the information that is available based on your request, with an explanation of why other points are not applicable:

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):

This information is not provided in a 510(k) summary for bench testing. The "test set" in this context refers to the physical samples of the device components manufactured for the specified mechanical and material tests. The document does not specify the number of samples tested for each benchmark. There is no patient data involved, as no clinical studies were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. "Ground truth" in this context would refer to the established pass/fail criteria for mechanical and material tests, which are defined by the ASTM standards themselves. These are engineering specifications, not expert interpretations of clinical data.

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

Not applicable. This refers to methods for reconciling discordant expert opinions in clinical studies, which were not conducted.

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 device, and no MRMC studies or clinical studies were performed.

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

Not applicable. This is not an AI-powered device.

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

The "ground truth" for the device's performance is established by the specified ASTM (American Society for Testing and Materials) standards. These are internationally recognized engineering standards that define the methods and criteria for evaluating the mechanical properties and performance of medical implants.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable. This device does not involve machine learning or a training set.

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The FIX-C 3D Ti ACIF System is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at one or multiple contiguous levels from C2-T1.

The FIX-C 3D Ti ACIF System is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment. The FIX-C 3D Ti ACIF System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The FIX-C 3D Ti ACIF System comprises of 3D-printed porous titanium spinal cages intended to stabilize the spinal segment, restore intervertebral height, and facilitate interbody fusion in the cervical. The spinal cages are used in the anterior cervical interbody fusion (ACIF) procedures. The devices are intended to be used with supplemental spinal fixation (e.g., using anterior plate system).

The spinal cages are made from Ti-6Al-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures. The hollow geometry of the spinal cages allows them to be packed with autogenous bone graft comprised of cancellous and/or corticocancellous bone graft.

The FIX-C 3D Ti ACF System is manufactured in a pre-designated standard size, not patient-matched. The spinal cages are available in various sizes, footprints, heights, and angles.

The FIX-C 3D Ti ACIF System is provided non-sterile. The devices must be sterilized prior to use per ISO 17665-1.

This document is an FDA 510(k) clearance letter for a medical device called the "FIX-C 3D Ti ACIF System," an intervertebral body fusion device. The request asks for details about the acceptance criteria and the study that proves the device meets them. However, the provided text primarily describes the regulatory clearance process and device characteristics, and does not contain detailed information about specific performance acceptance criteria or a clinical study that proves the device meets those criteria.

Instead, it refers to bench testing as the primary method for demonstrating equivalence.

Here's what can be extracted and what information is missing:

Information Present in the Document:

• Device Name: FIX-C 3D Ti ACIF System
• Device Type: 3D-printed porous titanium spinal cages for anterior cervical interbody fusion (ACIF).
• Regulation Number: 21 CFR 888.3080 (Intervertebral Body Fusion Device)
• Regulatory Class: Class II
• Product Code: ODP
• Intended Use/Indications for Use: For anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, confirmed by imaging, resulting in radiculopathy, myelopathy, and/or pain at C2-T1 levels. To be used with supplemental fixation systems cleared for cervical spine, autogenous and/or allogeneic bone graft. Patients should have had at least six weeks of nonoperative treatment.
• Predicate Devices: K233839 (Peridot-PT Anterior Cervical Intervertebral body fusion System), K241738 (PYXIS 3D Titanium Cervical Cage System), K212266 (FIX-C PEEK Anterior Cervical Interbody System).
• Main Study Type: Bench tests, not clinical data.
• Standards Followed for Bench Tests:
  • ASTM F2077, Standard Test Methods for Intervertebral Body Fusion Devices (Static axial compression, Static compression-shear, Static torsion, Dynamic axial compression, Dynamic compression-shear, Dynamic torsion tests)
  • ASTM F2267, Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression (Subsidence test)
• Conclusion of Bench Tests: "All test results were higher than the acceptance criteria from the [text cut off] therefore, substantially equivalent mechanical performance with the predicate device has been demonstrated."

Missing Information (and why it's missing from this FDA letter):

The FDA 510(k) summary letter is an official decision document, not the detailed study report. It summarizes the basis for clearance, including the types of tests performed and the ultimate conclusion of substantial equivalence. It generally does not include the granular details of study protocols, raw data, or specific acceptance criteria values in the public summary.

Therefore, for the specific questions asked, most of the information is not available in the provided text.

Here's a breakdown of what can and cannot be answered:

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

• Acceptance Criteria: Not specified. The text only states "All test results were higher than the acceptance criteria". It doesn't list the numerical values of these criteria.
• Reported Device Performance: Not specified. The exact numerical results of the ASTM F2077 and ASTM F2267 tests are not provided. It only concludes that they met and exceeded the (unspecified) criteria.

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

• Sample Size for Test Set: Not specified. While bench tests were conducted, the number of devices or iterations tested is not mentioned.
• Data Provenance: The tests were "Bench tests" which means they are laboratory-based, not patient-derived. Therefore, there's no country of origin or retrospective/prospective distinction for the "data" in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This device clearance is based on bench testing for mechanical performance and substantial equivalence to legally marketed predicate devices, not on a clinical ground truth established by experts.

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

• Not Applicable. This is relevant for clinical studies, especially those involving human interpretation of data, not for mechanical bench testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC study was done. The document explicitly states "Clinical data is not applicable." This device is a physical implant, not an AI-assisted diagnostic or therapeutic tool.

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

• Not Applicable. This device is an implant, not an algorithm.

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

• For the bench testing, the "ground truth" is established by the specified ASTM standards and the mechanical properties they measure (e.g., load-bearing capacity, subsidence). It's a mechanical performance "ground truth" based on established engineering standards, not clinical ground truth.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. As there is no training set.

In summary, the provided FDA clearance letter focuses on establishing substantial equivalence for a physical medical device through engineering bench tests, rather than a clinical study with human readers or AI algorithms. Therefore, most of the requested information regarding clinical study methodologies, expert ground truth, and AI-specific details is not contained within this document. To obtain such granular detail on acceptance criteria and performance data, one would typically need to review the full 510(k) submission, which is generally proprietary.

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Xpine Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

• · degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• · spondylolisthesis
• · trauma (i.e., fracture or dislocation)
• · spinal stenosis
• · curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• · tumor
• · pseudoarthrosis
• · failed previous fusion

The Xpine Spinal Fixation System, Internal Fixation Device for Spinal Surgery, is comprised of: Pedicle Screw, Set Screw. Rod. and Cross Link. Various forms and sizes of these implants are available to consider the unique pathology of individual patients for purposes of stabilization, or corrective action through the application of force. Components are made of Ti6Al4V ELI, a titanium-based alloy, which complies with ASTM F136.

I am sorry, but the provided text does not contain the information needed to answer your request. The document is a 510(k) premarket notification for a medical device called the "Xpine Spinal Fixation System," which is a Thoracolumbosacral Pedicle Screw System.

This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through:

• Indications for Use Comparison: Showing that the new device has similar intended uses.
• Technological Comparison: Demonstrating that the materials, design, and other technological characteristics are substantially similar and do not raise new questions of safety or effectiveness.
• Bench Testing: Performing mechanical tests to ensure the device meets relevant ASTM standards and performs comparably to the predicate device.

The document explicitly states: "Clinical data is not applicable." This means there was no clinical study, human-in-the-loop study, or a study involving human readers and AI assistance performed for this device as part of this 510(k) submission.

Therefore, I cannot provide details on:

1. Acceptance criteria and reported device performance (in the context of AI/diagnostic accuracy). The acceptance criteria mentioned refer to mechanical bench test results (e.g., meeting or exceeding values from reference literature for spinal implant constructs), not diagnostic performance metrics like sensitivity or specificity.
2. Sample size, data provenance, ground truth establishment, or expert involvement for a diagnostic test set.
3. Adjudication method.
4. MRMC study and effect size.
5. Standalone (algorithm-only) performance.
6. Type of ground truth (beyond mechanical test standards).
7. Training set sample size or ground truth establishment for a training set.

The document is about a mechanical spinal fixation system, not a diagnostic AI/software device.

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The FlexWing Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine(C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

The FlexWing Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The FlexWing Anterior Cervical Plate System is made of Titanium Alloy (Ti-6AL-4V) and Nickel-Titanium Alloy, which meet ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI(Extra Low Interstitial) Alloy for Surgical Implant Applications, and ASTM F2063, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. The Anterior Cervical Plates consist of 1 to 3 levels which have different lengths. The bone screws are 3.5 and 4.0mm in diameter with self-tapping and selfdrilling threads and provided in lengths from 10.0 to 26.0mm.

The provided text is a 510(k) summary for the Jeil Medical Corporation's FlexWing Anterior Cervical Plate System. It describes the device, its indications for use, technological characteristics, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic performance or AI model evaluation.

The document states: "No clinical studies were considered necessary and performed." This indicates that the regulatory clearance was based on non-clinical testing (mechanical and material tests) and substantial equivalence to existing predicate devices, rather than a study evaluating diagnostic performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies proving the device meets them because such information is not present in the provided text. The device described is a physical implant (Anterior Cervical Plate System), not a diagnostic or AI-powered medical device.

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The ARIX Cannulated Screw System is indicated for fracture fixation, fusions, osteotomies, and malunions of fragments of long bones of the pelvis, the femur, the humerus, and the foot. The system is not intended for use in the spine.

The ARIX Cannulated Screw System consists of cannulated screws and corresponding washer. The thread diameters of cannulated screws are 6.5 and 7.3 mm. They are either fully or partially threaded. Screws and a washer are made of Titanium Alloy (Ti-6Al-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. All devices in the system are provided non-sterile.

The provided document, K233912, is a 510(k) Premarket Notification for the ARIX Cannulated Screw System. This document outlines the premarket review by the FDA for a medical device, specifically a bone fixation fastener, and not an AI/ML-driven diagnostic or prognostic device.

Therefore, the information typically requested in your prompt regarding AI/ML device studies (such as acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone AI performance, etc.) is not applicable to this submission.

The document discusses bench tests for mechanical performance to demonstrate substantial equivalence to a predicate device. Here's what can be extracted from the document regarding its performance criteria and testing:

1. Acceptance Criteria and Reported Device Performance (Mechanical Testing):

• Torsion Test
• Driving Torque Test
• Axial Pull-out Test |

2. Sample Size and Data Provenance:

• Sample Size: The document does not specify the sample size (number of screws) used for the mechanical bench tests.
• Data Provenance: Not applicable in terms of patient data. The tests were bench tests conducted on the physical device. The manufacturer is Jeil Medical Corporation in South Korea.

3. Number of Experts and Qualifications (for Ground Truth):

• Not applicable. Ground truth for mechanical performance is established through standardized engineering test methods (ASTM F543) and physical measurements, not human expert consensus.

4. Adjudication Method:

• Not applicable for mechanical bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This is a physical medical device, not an AI/ML system requiring human reader performance evaluation. The document explicitly states: "No clinical studies were considered necessary and performed."

6. Standalone Performance:

• Not applicable. This refers to the performance of the physical device in bench tests, not an AI algorithm. The document states its performance was evaluated for each mechanical test according to ASTM F543.

7. Type of Ground Truth Used:

• Engineering Standards and Physical Measurements: For mechanical performance, the ground truth is based on the specifications and test methods outlined in ASTM F543. Measurements from the tests (e.g., torque, axial pull-out force) are compared against these established physical and material science standards.

8. Sample Size for Training Set:

• Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

9. How Ground Truth for Training Set was Established:

• Not applicable.

In summary, the provided document relates to the FDA clearance of a conventional medical device based on mechanical bench testing and substantial equivalence to a predicate device, rather than the evaluation of an AI-powered diagnostic or prognostic tool. Therefore, many of the requested details about AI/ML study methodologies are not present in this type of FDA submission.

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The ARIX Ankle Distal Tibia System(Ankle fusion) is indicated for facilitating arthrodesis of the ankle including tibiotalcaneal and tibiotalar joints.

The ARIX Ankle Distal Tibia System is rigid fixation consisting of plates and screws in various configurations, shapes, and sizes.

The ARIX Ankle Distal Tibia System is made of Titanium Alloy (Ti-6AI-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.

This document is a 510(k) Premarket Notification for the ARIX Ankle Distal Tibia System. It states that no clinical studies were considered necessary and performed. Therefore, a study demonstrating the device meets acceptance criteria, an MRMC comparative effectiveness study, or a standalone algorithm-only study were not conducted or reported in this document.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing.

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

1. Table of acceptance criteria and the reported device performance

Since no clinical study was performed, there are no reported acceptance criteria or device performance measurements in terms of clinical outcomes or diagnostic accuracy. The testing performed focused on compliance with material and mechanical standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable, as no clinical test set was used. The testing was non-clinical bench testing of the physical device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical test set or ground truth established by medical experts was used.

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

Not applicable, as no clinical test set requiring adjudication was used.

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 was done. The device is a physical bone fixation system, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance study was done. The device is a physical bone fixation system.

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

Not applicable, as no clinical ground truth was established for this device, which is a physical implant. The "ground truth" for the non-clinical testing was compliance with established ASTM standards for material properties and mechanical performance.

8. The sample size for the training set

Not applicable, as no training set was used. The device is a physical bone fixation system, not a machine learning model.

9. How the ground truth for the training set was established

Not applicable, as no training set or its ground truth was established.

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The ARIX Ankle System is intended for use in internal fixation of the distal fibula.

The ARIX Ankle System is rigid fixation consisting of plates and screws in various configurations, shapes, and sizes. The ARIX Ankle System is made of Unalloyed Titanium Alloy (Ti-6Al-4V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.

This document describes a 510(k) premarket notification for the "ARIX Ankle System," which is a device for internal fixation of the distal fibula. The submission claims substantial equivalence to existing predicate devices.

Crucially, the provided text explicitly states there was no clinical study performed for this device, and therefore no data regarding AI performance, acceptance criteria for AI, or human reader studies.

Therefore, I cannot provide the requested information about acceptance criteria for AI, study details (sample size, ground truth, experts, adjudication, MRMC, standalone performance), or training set information.

The relevant section from the document states:

"Clinical Test Summary
No clinical studies were considered necessary and performed."

This indicates that the FDA clearance for the ARIX Ankle System was based on non-clinical bench testing and a comparison of its technological characteristics and intended use to predicate devices, not on a study involving AI performance or human reader analysis.

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