Search Results

The Medyssey Co, Ltd. Zenius™ Spinal System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and /or allograft for the following indications: 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; and failed previous fusion.

The Zenius™ System, Internal Fixation Device for Spinal Surgery is comprised of: rods, pedicle screw assemblies, compression retaining assemblies, set screws and transverse-link assemblies. Various forms and sizes of these implants are available so that adaptations can be utilized to account for the unique pathology of individual patients. Subject screws are manufactured from Ti6Al4V ELI per ASTM F136.

This document is a 510(k) premarket notification for a medical device called the "Zenius™ Spinal System." It is not a study of an AI/ML powered device. Instead, it details the substantial equivalence of an updated version of a pedicle screw system to existing predicate devices.

Therefore, the requested information about acceptance criteria, study design, expert involvement, ground truth, and AI/ML specific performance metrics cannot be extracted from this document. The document focuses on demonstrating that the modified hardware (the pedicle screw with fenestration) performs at least as well as its predicate devices through mechanical testing.

Here's why the specific questions can't be answered for this document:

• No AI/ML Component: The "Zenius™ Spinal System" is a physical implant (pedicle screws, rods). There is no mention or implication of any artificial intelligence or machine learning component in its design, function, or evaluation.
• Mechanical Testing, Not Clinical or Diagnostic Study: The "study" mentioned is "Mechanical Testing" (per ASTM F1717) to evaluate "static compression bending, static torsion, static tension, and dynamic compression bending." This is a laboratory test of the device's physical properties, not a clinical trial or a diagnostic performance study.
• Substantial Equivalence, Not Performance Acceptance Criteria for an AI: The FDA 510(k) process for this type of device focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This involves showing that the new device is as safe and effective as the predicate. It does not involve establishing clinical performance acceptance criteria for an AI algorithm.

In summary, this document is irrelevant to the prompt. The prompt asks for details about the acceptance criteria and the study proving an AI/ML device meets those criteria, which is not what this document describes.

Ask a specific question about this device

The Athena III Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of a solid spinal fusion in patients with 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 (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. The Athena III Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

The Athena III Cervical Plate System is an anterior cervical plating system offered pre-lordosed with large graft visibility windows intended for anterior screw fixation to the cervical spine. The components of the Athena III Cervical Plate System are manufactured from titanium alloy (Ti-6AI-V), as per ASTM F136. The system consists of a variety of shapes and sizes of bone plates and screws. Implant components are anodized per AMS 2487A.

This document is a 510(k) premarket notification for the Athena III Cervical Plate System. It describes a medical device, specifically a spinal implant, and seeks to demonstrate its substantial equivalence to a previously cleared predicate device (Athena II Cervical Plate System).

The information provided does not describe an AI/ML medical device, nor does it detail acceptance criteria related to software performance, or a study involving human readers or ground truth determination as typically found in AI/ML performance evaluations. Instead, it focuses on the mechanical performance of a physical implant.

Therefore, I cannot extract the requested information using the prompt's categories, as they are tailored for AI/ML device evaluations.

Here's a breakdown of what is provided regarding acceptance criteria and the study, adapted to the context of this physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "a full suite of mechanical testing" but does not specify the sample size for the test articles (cervical plates and screws). The "data provenance" in this context would refer to the testing facility and conditions, which are not detailed here.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
This is not applicable as the evaluation is for mechanical performance of a physical device, not an AI/ML algorithm requiring expert-established ground truth.

4. Adjudication Method:
This is not applicable as the evaluation is for mechanical performance of a physical device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This is not applicable as the device is a physical spinal implant, not an AI/ML system evaluated with human readers.

6. Standalone Performance Study:
Yes, a standalone performance study was done in the sense that the mechanical properties of the Athena III Cervical Plate System were tested independently. The study involved:

• Static compression bending
• Static torsion
• Static tension
• Dynamic compression bending
  These tests were performed "as per ASTM F1717," which is a standard specification for spinal plate mechanical testing.

7. Type of Ground Truth Used:
In the context of a physical device, the "ground truth" is defined by established engineering standards and material properties. For this device, the relevant "ground truth" is adherence to:

• ASTM F136 (for titanium alloy material)
• ASTM F1717 (for mechanical testing methods and likely performance criteria thresholds)
• AMS 2487A (for anodization).

8. Sample Size for the Training Set:
This is not applicable as the device is a physical spinal implant and does not involve a training set for an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established:
This is not applicable as there is no training set for a physical device. The "ground truth" for developing and validating the device is based on mechanical engineering principles, material science, and established regulatory and industry standards for spinal implants.

Ask a specific question about this device

The Medussa-PL Cage is indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

The Medussa-PL Cage is an interbody fusion device utilized to facilitate the fusion process in the lumbar spine. The Medussa-PL Cage is additively manufactured from Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001 and is available in a range of sizes to accommodate different patient anatomies, and pathologies.

I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) clearance letter for a medical device (Medussa-PL Cage) and does not contain details about:

1. Acceptance criteria and reported device performance: The document mentions "engineering analysis and the performance testing result" but does not provide specific acceptance criteria or quantitative performance data.
2. Study design details: There is no mention of sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance.
3. Ground truth information: While it states the device is for Degenerative Disc Disease (DDD) confirmed by "patient history and radiographic studies," it doesn't elaborate on how ground truth was established for any assessment studies, nor does it specify training set details.

The document primarily focuses on establishing substantial equivalence to a predicate device based on general similarities in design, materials, function, and indications for use, rather than presenting a detailed clinical or performance study with quantified acceptance criteria.

Ask a specific question about this device

The Medussa-PL Cage is indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

The Medyssey, Medussa-PL Cage is an interbody fusion device utilized to facilitate the fusion process in the lumbar spine. The cage is additively manufactured from titanium alloy (ASTM F136 and ASTM F3001) and is available in a range of sizes to accommodate different patient anatomies and pathologies.

The provided document is a 510(k) summary for the Medussa-PL Cage, an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on performance studies with human readers or clinical outcomes.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding study design, sample sizes, expert involvement, multi-reader studies, and ground truth establishment cannot be answered from the provided text, as this information is not typically part of a 510(k) summary for a spinal implant device unless specific clinical or performance studies were required.

Here's the information that can be extracted or deduced from the document:

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

The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or inter-reader agreement, which are common for AI/diagnostic devices. Instead, for this type of implantable medical device, the "acceptance criteria" are implicitly related to demonstrating substantial equivalence to a previously cleared predicate device. This is primarily done through engineering analysis comparing design, materials, function, and performance.

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

Not applicable. This is not a study involving a "test set" of patient data for evaluating diagnostic performance. The evaluation is based on engineering analyses and comparison to a predicate device.

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. No ground truth for a test set was established in the context of a diagnostic performance study.

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

Not applicable. No test set requiring expert 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

Not applicable. The device is a spinal implant, not an AI-assisted diagnostic tool for human readers.

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

Not applicable. The device is a physical implant, not an algorithm.

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

Not applicable. The evaluation is based on engineering and material standards, and comparison to a predicate device, not on clinical efficacy measured against a ground truth from patient outcomes or pathology, which would typically be part of a PMA (Premarket Approval) submission rather than a 510(k). For a 510(k), the "truth" is established by demonstrating equivalence to a legally marketed device.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that "proves" the device meets the acceptance criteria (i.e., is substantially equivalent to a predicate) is described as Engineering CAD analyses and a comparison of device dimensions and materials. This analysis concluded that the subject device (Medussa-PL Cage) and the predicate device (Medussa-PL Cage K170341) have the "same dimensions, material, area and bone graft lumen capacity." This demonstration of equivalence across key design and material components, along with the same Indications for Use, is considered sufficient for 510(k) clearance for this type of implantable device.

Ask a specific question about this device

The Triton Cage is indicated for use with bone graft (autograft bone graft composed of cancellous and or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. Patients with previous non-fusion spinal surgery at the treated. These patients should be sketally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion and are intended to be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine.

The Medyssey, Triton Cage is an interbody fusion device utilized to achieve fusion in the lumbar spine. The cage is manufactured from PEEK (ASTM F2026) and additively manufactured titanium alloy (ASTM F136) available in three variants (LLIF, ALIF, OLIF) and a range of sizes to accommodate different surgical approaches and anatomies.

The provided text describes the 510(k) premarket notification for the Triton Cage, an intervertebral body fusion device. While it details the device's indications for use, materials, and substantial equivalence to predicate devices, it does not contain any information about a study proving the device meets specific acceptance criteria based on its performance in a clinical or imaging-based assessment where AI or human performance is evaluated.

The "Performance Testing Summary" section only mentions mechanical testing (Static Compression, Dynamic Compression, etc.) performed on the device to demonstrate substantially equivalent performance to predicate devices in a benchtop setting, not a clinical study involving human or AI perceptual performance.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this device based on the given document. The document focuses on regulatory clearance based on substantial equivalence of the physical device's characteristics and mechanical properties to previously cleared devices.

Ask a specific question about this device

The Athena II Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of a solid spinal fusion in patients with 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 (defined as kyphosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. The Athena II Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

The Athena II Cervical Plate System is an anterior cervical plating system offered pre-lordosed with large graft visibility windows intended for anterior screw fixation to the cervical spine. The components of the Athena II Cervical Plate System are manufactured from titanium alloy (Ti-6Al-4V) as described in ASTM F136. The Athena II Cervical Plate System consists of a variety of shapes and sizes of bone plates and screws. Implant components are anodized per AMS 2487A.

The provided text is a 510(k) summary for the Athena II Cervical Plate System. It describes the device, its indications for use, and a comparison to predicate devices, including performance testing. However, this document does not describe a study involving an algorithm's performance, human reader studies, or the establishment of ground truth in a medical imaging context.

The information provided pertains to a mechanical medical device (a cervical plate system) and its structural performance, not an AI/ML-driven diagnostic or assistive device. Therefore, most of the requested information regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance cannot be extracted from this document.

The document discusses pre-clinical testing for the Athena II Cervical Plate System, which focuses on the mechanical integrity and performance of the physical implant itself.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that pre-clinical testing was performed per ASTM F1717-13. The reported performance is a comparison to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This is not a study of an AI/ML device using a test set of medical data. The testing involves mechanical bench testing of physical medical devices. The "test set" would refer to the number of physical samples tested, which is not specified but is typically much smaller than for an AI study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. Ground truth, in the context of expert review of medical images or clinical outcomes, is not relevant to the mechanical testing of a cervical plate.

4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like '2+1' or '3+1' are used for resolving discrepancies in expert interpretations of medical data, which is not what this document describes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This is not an MRMC study. It is mechanical testing of a physical medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used:
For the mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate devices and the physical properties determined through the tests (e.g., load-bearing capacity, fatigue resistance). This is established via standardized testing protocols (ASTM F1717-13).

8. The Sample Size for the Training Set:
Not applicable. There is no training set for an AI/ML algorithm in this document.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for an AI/ML algorithm in this document.

In summary: The provided document is a 510(k) clearance summary for a spinal implant, focusing on its mechanical pre-clinical performance testing against predicate devices. It does not contain the type of information requested about AI/ML device studies or human reader performance.

Ask a specific question about this device

The Medyssey Co, Ltd. Zenius™, Iliad™ and Kora™ Spinal Fixation Systems are intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft for the following indications: 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); tumor; pseudoarthrosis; and failed previous fusion.

The Zenius™ Spinal System, Internal Fixation Device for Spinal Surgery is comprised of: Rods, Pedicle Screw Assemblies, Compression Retaining Assemblies, and Transverse-Link Assemblies. Various forms and sizes of these implants are available so that adaptations can be utilized to account for the unique pathology of individual patients.

The Iliad™ Spinal Fixation and Adjustable Bridge System, Internal Fixation Device for Spinal Surgery is comprised of: Rods, Pedicle Screw Assemblies, Compression Retaining Assemblies, and Transverse-Link Assemblies. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients.

The Kora™ Spinal Fixation and Adjustable Bridge System, Internal Fixation Device for Spinal Surgery is comprised of: Rods, Pedicle Screw Assemblies, Compression Retaining Assemblies, and Transverse-Link Assemblies. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients.

The subject of this 510(k) is the addition of Z-Rods to the spinal systems.

The provided document describes the Medyssey USA, Inc. Zenius™, Iliad™ and Kora™ Spinal Fixation Systems, specifically focusing on the addition of "Z-Rods" to these systems. The document is a 510(k) premarket notification summary to the FDA, indicating a request for clearance based on substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that mechanical testing was performed according to ASTM F2193-14. The acceptance criteria would be the standards set forth by this ASTM standard for spinal implant constructs. The reported device performance is that the "Results demonstrated substantial equivalence compared to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size for the mechanical testing or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "Mechanical testing per ASTM F2193-14 was performed."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This is a mechanical performance study, not a clinical study involving experts or ground truth establishment in a diagnostic context. Therefore, this question is not applicable.

4. Adjudication Method for the Test Set:

Not applicable, as this is a mechanical performance study.

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

Not applicable, as this is a mechanical performance study.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study:

Not applicable, as this is a mechanical performance study of a physical spinal fixation system, not a software algorithm.

7. Type of Ground Truth Used:

For this mechanical performance study, the "ground truth" would be the established engineering and biomechanical properties and performance requirements outlined in the ASTM F2193-14 standard.

8. Sample Size for the Training Set:

Not applicable, as this is a mechanical performance study. There is no "training set" in the context of device mechanical testing.

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

Not applicable, as this is a mechanical performance study.

Ask a specific question about this device

The Athena Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of a solid spinal fusion in patients with 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 (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. The Athena Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

The Medyssey Athena Cervical Plate System is designed to provide mechanical support while biologic fusion takes place. The system consists of multiple plate sizes and screws to accommodate various patients' anatomy. The plates are available in fixed and variable forms to allow for fixed attachment or implantation at variable angles.

This document is a 510(k) Premarket Notification from the FDA regarding the "Athena Cervical Plate System." It confirms the device's substantial equivalence to previously marketed devices. However, it does not contain information related to an AI/ML medical device, nor does it discuss acceptance criteria and study results for such a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is for a mechanical spinal intervertebral body fixation orthosis and the performance metrics discussed are mechanical tests (e.g., bending, compression), not AI/ML performance metrics like accuracy, sensitivity, or specificity.

Ask a specific question about this device

The TAURUS PEEK Cages are indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

The TAURUS PEEK Cage System consists of four different models of interbody fusion devices - TAURUS-P™ Cage, TAURUS-AL (ALIF) Cage, and TAURUS-DL Cage. TAURUS PEEK Cage System is intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The devices consist of PEEK cages of various heights, widths, and lengths, which can be inserted across the disc space between two lumbar vertebral bodies to give support and correction during vertebral bod fusion surgeries. All models have serrations on the superior and inferior surfaces of the implants to aid in fixation. All models are designed with hollow regions in the center to house autograft bone graft material. The new bone formation through the implant is intended to provide long-term structural support and biologic fusion at the implanted disc space. Radiopaque tantalum markers have been embedded within the implants to allow for visualization in radiographic images. Associated instruments are available to facilitate the implantation of the devices.

The PEEK material used in the subject interbody cages conforms to ASTM F2026 "Standard Specification for polyetheretherketone (PEEK) Polymers for Surgical Implant Applications" and the tantalum material used conforms to ASTM F560 "Standard Specification for Unalloyed Tantalum for Surgical Implant Applications".

This document, a 510(k) Premarket Notification for the TAURUS PEEK Cage System, describes the device and its indications for use, and makes a claim of substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The provided text focuses on the regulatory clearance process for a physical medical implant (intervertebral body fusion device) and demonstrates substantial equivalence based on mechanical performance testing compared to predicate devices, rather than a study evaluating the performance of a software or AI/ML algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, as it pertains to AI/ML device performance. The type of study described in the document is mechanical performance testing for a physical implant, not a clinical or AI/ML performance study.

Here's a breakdown of why I cannot answer the specific AI/ML related questions:

• Acceptance Criteria & Reported Device Performance (Table): The document reports mechanical testing results for the implant (static axial compression bending, static shear compression bending, static torsion, dynamic axial compression fatigue, and subsidence) per ASTM F2077 and ASTM F2267. It states these results "have shown them to be substantially equivalent to the predicate interbody devices." It does not provide specific numerical acceptance criteria or detailed numerical results for AI/ML performance metrics like accuracy, sensitivity, specificity, AUC, etc.
• Sample size for test set and data provenance: Not applicable to this type of mechanical testing.
• Number of experts and qualifications for ground truth: Not applicable. Ground truth for mechanical testing is based on physical measurements and engineering standards.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: For mechanical testing, the ground truth is the physical properties and behavior of the device under specific loads, measured against established engineering standards (ASTM F2077, ASTM F2267).
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

In summary, the provided document details the regulatory pathway for a physical medical device (intervertebral cage) based on substantial equivalence and mechanical performance testing, not on the performance evaluation of an AI/ML algorithm.

Ask a specific question about this device

The Varian cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Varian cage is designed to be implanted bi-laterally via a posterior (PLIF) approach. The device is intended for use with supplemental fixation and is intended for use with autograft to facilitate fusion.

The Medyssey Varian cage is an interbody fusion device utilized to achieve fusion in the lumbosacral spine. The system is made of titanium alloy and includes seven sizes, ranging from 9 mm to 15 mm in height and 24 mm or 27mm in length with 8° or 10° lordotic angle versions.

The provided text describes a medical device, the "Varian cage," and its FDA 510(k) clearance, which attests to its substantial equivalence to previously marketed devices. However, the document does not describe a study that establishes acceptance criteria for performance metrics (such as sensitivity, specificity, or AUC) and then proves the device meets those criteria, as typically seen in AI/ML device submissions.

Instead, the "acceptance criteria" discussed are related to the mechanical and functional performance of the intervertebral body fusion device. The study described is a series of engineering tests designed to demonstrate the device's structural integrity and equivalence to predicate devices, not a study involving human readers or AI.

Therefore, many of the requested fields cannot be filled as they pertain to clinical or AI performance studies that are not present in this document.

Here's the breakdown of what can be extracted:

Acceptance Criteria and Device Performance (Mechanical/Functional)

1. A table of acceptance criteria and the reported device performance
(See table above)
The document states that testing was performed in accordance with ASTM F2077 and ASTM F2267, which are standards for intervertebral body fusion device testing. The acceptance criterion is implicitly meeting the requirements of these standards and demonstrating substantial equivalence to predicate devices in these mechanical performance aspects. The reported device performance is that these studies were designed to address risks and demonstrate substantial equivalent performance to predicate devices. Specific numerical results are not provided in this 510(k) summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document describes mechanical testing of a physical device, not a study with a "test set" of clinical data. The "samples" would be the physical devices tested according to the ASTM standards.

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. This document describes mechanical testing of a physical device. Ground truth is not established by experts in a clinical context for this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document describes mechanical testing of a physical device. Adjudication methods are not relevant 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, an MRMC comparative effectiveness study was not done. This device is a physical intervertebral cage, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This device is a physical intervertebral cage, not an AI/ML algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For mechanical testing, the "ground truth" relates to the physical properties and performance characteristics of the material and device design as per engineering standards, not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set
Not applicable. This document describes mechanical testing, not a machine learning study with a training set.

9. How the ground truth for the training set was established
Not applicable. This document describes mechanical testing, not a machine learning study.

Ask a specific question about this device