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The panaSIa SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The panaSIa SI Fusion device is a threaded, expandable device, designed to stabilize the sacroiliac joint by piercing the adjacent cortical bone when expanded. The device has large fenestrations to allow for uninterrupted graft contact across the SI joint space. The panaSIa SI Fusion implant is a sterile, single patient use, long-term implantable device made of a titanium grade alloy.

The provided FDA 510(k) clearance letter for the "panaSIa SI Fusion System" describes a medical device, specifically a smooth or threaded metallic bone fixation fastener, intended for sacroiliac (SI) joint fusion.

Based on the provided document, the acceptance criteria and the study proving the device meets these criteria are limited in detail. This is typical for a 510(k) clearance for this type of device, which primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing rather than extensive clinical studies or AI algorithm performance validation.

Here's an analysis of the provided information, addressing your points where possible, and noting where information is not present in the document.

Overview of Device and Clearance Type

The panaSIa SI Fusion System is a physical implant (a threaded, expandable device made of titanium grade alloy) used for sacroiliac joint fusion. The FDA clearance is a 510(k), which means the manufacturer demonstrated the device is substantially equivalent to legally marketed predicate devices. This type of clearance typically relies on non-clinical testing (e.g., mechanical performance) and comparison of design, materials, and indications for use, rather than extensive human clinical trials or complex AI performance metrics.

Acceptance Criteria and Study Details (Based on Provided Document)

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device and submission (510(k) for a physical implant), the "acceptance criteria" are not explicitly quantifiable metrics like sensitivity/specificity for an AI algorithm. Instead, they are typically the successful fulfillment of recognized standards and comparative performance to predicates.

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

• Sample Size: The document mentions "cadaver testing," which refers to ex vivo testing of the device. However, it does not specify the sample size (i.e., number of cadavers or test specimens from cadavers) used for this testing.
• Data Provenance: The document does not specify the country of origin of the cadaver data or whether the testing was retrospective or prospective. Given it's cadaver testing, it's inherently a controlled, ex vivo experimental setup rather than a patient-based retrospective/prospective study.

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

• This information is not applicable/not provided in this type of 510(k) submission. The "ground truth" for a physical implant's mechanical performance is typically established by engineering standards (like ASTM F3574) and direct measurement, not by expert consensus on image interpretation or clinical outcomes.

4. Adjudication Method for the Test Set

• Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing ground truth in clinical imaging studies or clinical trials where human interpretation or consensus is required. This information is not applicable/not provided for a mechanical device performance test.

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

• This type of study is relevant for AI-powered diagnostic devices where the AI assists human readers (e.g., radiologists interpreting images). This device is a physical implant; therefore, no MRMC study was done or is relevant for this submission.

6. Standalone (Algorithm Only) Performance Study

• This refers to the performance of an AI algorithm alone, without human intervention. Since this is a physical medical device and not an AI algorithm, a standalone algorithm performance study was not conducted or is not relevant.

7. Type of Ground Truth Used

• For the non-clinical performance testing:
  • Mechanical Standards: Adherence to established engineering standards (ASTM F3574 for static and dynamic vertical shear testing).
  • Comparative Performance: The performance of the device was directly compared against a predicate device in cadaver models. While not explicitly stated as "ground truth," the predicate device's known performance serves as the benchmark against which the new device is measured.
  • No clinical outcomes or pathology ground truth was used for this 510(k) clearance, as it is based on substantial equivalence through non-clinical testing.

8. Sample Size for the Training Set

• This device is not an AI algorithm, so there is no "training set" in the context of machine learning. The design and manufacturing processes are likely informed by engineering principles, material science, and prior device designs, but not through a formalized data training set as seen in AI development.

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

• As there is no AI "training set," this question is not applicable.

In summary, the provided FDA 510(k) clearance letter details a non-AI medical device (an SI joint fusion implant). The "acceptance criteria" and "study" proving these criteria are primarily based on:

• Substantial equivalence to legally marketed predicate devices in terms of intended use, principles of operation, design, and materials.
• Non-clinical performance testing, specifically:
  • Adherence to ASTM F3574 for static and dynamic vertical shear testing.
  • Comparative cadaver testing against an additional predicate device.

The document does not delve into the detailed quantitative results of these tests (e.g., exact maximum shear force sustained), sample sizes of cadavers, or the specific methods of ground truth establishment beyond relying on industry standards and direct comparison. This level of detail for non-clinical testing is typically found within the full 510(k) submission, not the public-facing clearance letter.

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The Wenzel Spine VariLift-C Interbody Fusion System is indicated for use in skeletally mature patients with cervical disc degeneration (DDD) 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/C3 to C7/T1. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The Wenzel Spine VariLift-C Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach using autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used at one disc level, the Wenzel Spine VariLift-C interbody Fusion System may be used with or without supplemental fixation. When used at multiple contiguous levels, the Wenzel Spine VariLift-C Interbody Fusion System is intended to be used with supplemental fixation. Patients should have at least six (0) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.

The VariLift® Cervical Interbody Fusion device (VariLift-C) is a self-tapping, expandable device with an interior sliding wedge. VariLift-C is cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral endplates. The grooved and fluted fusion device has fenestrations (graft windows) positioned between each of its four quadrants to allow bony ingrowth and contact with the endplates. The device is manufactured from medical grade titanium alloy (Ti6Al4V) per ASTM F136.

I'm sorry, but the provided text describes the Wenzel Spine VariLift-C Interbody Fusion System, which is a medical implant (intervertebral body fusion device). The document discusses its FDA clearance (K231076) as substantially equivalent to predicate devices based on indications for use, design principles, performance, materials, and manufacturing processes.

This document does not describe an AI/ML powered device, nor does it contain information about acceptance criteria, study performance, sample sizes for test/training sets, expert ground truth establishment, or any of the other specific details regarding the validation of an AI/ML model that you are requesting.

Therefore, I cannot extract the information to fill out the table and answer your questions about acceptance criteria and study proving device performance in the context of an AI/ML powered device.

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The primaLOK™ SP Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (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), tumor, and/or lumbar spinal stenosis. The primaLOK™ SP Interspinous Fusion System is intended for use with bone graft material and not intended for stand-alone use.

The primaLOK™ SP Interspinous Fusion System is a bilateral locking plate system intended for fixation to the spinous process for the purpose of achieving supplemental fusion. It is available in various interspinous heights and can accommodate a variety of spinous process widths. The device, as a system, consists of longitudinal member/anchor components (base and polyaxial locking plates) and an interconnection component (connecting post).

This document (K231807 510(k) Summary) is a premarket notification for a medical device and, as such, does not contain the level of detail typically found in a clinical study report or a publication describing a study proving a device meets acceptance criteria. It primarily focuses on demonstrating "substantial equivalence" to predicate devices rather than proving specific performance metrics derived from a study with defined acceptance criteria.

Therefore, many of the requested details, such as a table of "acceptance criteria" and "reported device performance" in the context of a robust clinical study, sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment methods for training sets, are not present in this 510(k) summary.

The document mentions "A variety of clinical data and biomechanical evaluations have been conducted in order to support the substantial equivalence," but it does not present these data or evaluations with the specificity required to answer your questions.

Here's an attempt to answer your questions based only on the provided text, highlighting what is not available:

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

   • Not Available: This document does not present acceptance criteria for performance metrics in a table format, nor does it provide detailed reported device performance against such criteria. The "performance testing" mentioned is to support "substantial equivalence," not necessarily to meet specific, quantifiable acceptance criteria for a new clinical claim or feature.

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

   • Not Available: The document mentions "clinical data" but provides no details on sample size, study design (retrospective/prospective), or data provenance (country of origin).

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 Available: The document does not describe the establishment of a "ground truth" for a test set, nor does it mention experts or their qualifications in this context.

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

   • Not Available: There is no mention of an adjudication method for a test set.

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/Not Available: This device is a physical interspinous fusion system, not an AI-assisted diagnostic device. Therefore, an MRMC study related to human readers improving with AI assistance would not be relevant.

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

   • Not Applicable/Not Available: As a physical medical device (interspinous fusion system), the concept of "standalone algorithm performance" does not apply.

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

   • Not Available: The document informally refers to "clinical data" to support substantial equivalence but does not specify the type of ground truth used from any study data. For an orthopedic implant, "outcomes data" would be the most relevant, but no details are provided.

8. The sample size for the training set

   • Not Applicable/Not Available: This document is about a physical implant, not a machine learning model, so there is no "training set" in the context of AI/ML.

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

   • Not Applicable/Not Available: As above, this concept does not apply to this type of device.

Summary of Device Performance (as stated in the document, which is limited):

The document broadly states that "A variety of clinical data and biomechanical evaluations have been conducted in order to support the substantial equivalence of the primaLOK™ SP System to the predicate devices cited within this Traditional 510(k)." The "performance" in this context is the determination of substantial equivalence itself, based on comparing the new device's indications, intended use, technological characteristics, principles of operation, materials, biocompatibility, sterility, shelf-life, and packaging to the predicate devices.

Key takeaway: This 510(k) summary focuses on regulatory clearance via substantial equivalence, not detailed performance metrics from a rigorous clinical trial against pre-defined acceptance criteria. The "proof" is the FDA's determination of substantial equivalence based on the provided information, which includes unspecified "clinical data and biomechanical evaluations."

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The Wenzel Spine VariLift® Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level.

The Wenzel Spine VariLift Cervical Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The Wenzel Spine VariLift Cervical Interbody Fusion System may be used with or without supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.

The Wenzel Spine VariLift® Interbody Fusion System (VariLift®-L/LX and VariLift®-A) 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.

VariLift®-L/LX is designed to be implanted bi-laterally via a posterior (PLF) approach or as a single device via a transverse (TLIF) approach. VariLift®-L/LX may be implanted with or without supplemental fixation and is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. VariLift®-A is designed to be implanted bi-laterally via an anterior (ALIF) approach. VariLift®-A may be implanted with or without supplemental fixation and is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

VariLift-LX Interbody Fusion Device: The VariLift-LX is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral endplates. The VariLift-LX devices are made of titanium alloy (Ti6AI4V ELI per ASTM F136) and are provided sterile. The VariLift-LX Interbody Fusion Device may be implanted bi-laterally via a posterior lumbar (PLIF) approach or as a single device via a transverse (TLIF) approach.

VariLift-C Interbody Fusion Device: The Wenzel Spine VariLift Cervical Interbody Fusion System is a self-tapping, expandable device with an interior sliding wedge. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral end plates. All components are composed of Titanium-6A1-4V ELI alloy that conforms to ASTM F136. The VariLift Cervical device is grooved and fluted with large fenestrations (graft windows) positioned between each of its four quadrants that provide bony contact with the endplates. The device is supplied sterile.

This document is a 510(k) summary for the VariLift®-LX Interbody Fusion System and the VariLift®-C Interbody Fusion System. It primarily establishes substantial equivalence to predicate devices and does not describe acceptance criteria or a specific study proving the device meets those criteria in the way a diagnostic AI device would.

However, I can extract the information provided about performance testing to infer how the device's mechanical performance was assessed.

Here's a breakdown of the available information regarding acceptance criteria and performance, as best as can be inferred from a device clearance document focused on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Strict acceptance criteria per se (e.g., sensitivity, specificity, or specific numerical thresholds for clinical outcomes) are not explicitly stated in this 510(k) summary, as it's for a physical implant device designed for mechanical stability and fusion, not a diagnostic AI system.

However, the "performance" described pertains to mechanical testing compared to predicate devices for substantial equivalence. The implicit "acceptance criteria" appear to be that the subject devices perform similarly or equivalently to the predicate devices in biomechanical tests.

• Static compression
• Compression shear
• Torsion testing
• Dynamic compression testing (per ASTM 2077-14)
• Subsidence testing (per ASTM F2267-04)
• Expulsion testing |

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

This document describes mechanical testing of physical device samples, not testing with a "test set" of data in the context of an AI/diagnostic device.

• Sample Size for Test Set: Not applicable in the context of a data-driven test set. For the VariLift-C, testing was conducted on "the smallest new size," implying a limited number of physical samples of that specific device configuration. The exact number of physical devices tested is not specified, but it would typically be a small, statistically justified sample for mechanical tests.
• Data Provenance: Not applicable in the context of data. The "provenance" here is the result of laboratory mechanical testing of physical implants.

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

Not applicable. This device is a physical implant, not a diagnostic AI device requiring expert ground truth for image or data interpretation.

4. Adjudication Method

Not applicable. This is not a study involving human interpretation or annotation that would require an adjudication method.

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

Not applicable. This is a medical device clearance for an implant, not an AI diagnostic tool that undergoes MRMC studies to assess improvement in human reader performance.

6. Standalone Performance (i.e., algorithm only without human-in-the-loop performance)

Not applicable. This is a physical interbody fusion device, not an algorithm.

7. Type of Ground Truth Used

• For the VariLift-C, the "ground truth" for mechanical performance was established by comparing its performance to established ASTM standards (ASTM 2077-14 and ASTM F2267-04) and to the mechanical performance of the legally marketed predicate device (VariLift-C Interbody Fusion Device, K120603). The implication is that if it performs comparably or better than the predicate device and meets relevant standard recommendations, it's considered safe and effective.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm requiring a training set of data.

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

Not applicable.

In summary: This document is a 510(k) summary for interbody fusion systems, emphasizing substantial equivalence to predicate devices through similar design, materials, and biomechanical performance. It does not contain the types of information typically found in a submission for an AI-powered diagnostic device, such as specific clinical outcome acceptance criteria, sample sizes for data sets, or ground truth established by experts. The "study" described is a series of non-clinical, mechanical tests designed to demonstrate that the new devices perform acceptably and comparably to existing, cleared devices.

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The Wenzel Spine VariLift® Interbody Fusion System (VariLift®-A) 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.

VariLift®-L is designed to be implanted bi-laterally via a posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift®-A is designed to be implanted bi-laterally via an anterior (ALIF) approach. VariLift®-L and VariLift®-A may be implanted with or without supplemental fixation and is intended for use with autograft to facilitate fusion.

The VariLift®-L Interbody Fusion Device may be implanted bi-laterally via a posterior lumbar (PLIF) approach or as a single device via a transverse (TLIF) approach. The VariLift®-L is a selftapping, expandable device with an interior sliding wedge and a posterior end cap. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral endplates. The VariLift®-L devices are made of titanium alloy (Ti6AI4V ELI per ASTM F136) and are provided sterile.

A design change was made on all sizes of the VariLift®-L devices to increase the surface in contact at the superior and inferior vertebrae. Additionally dimensional modification were made to the instrumentation to ensure all instruments work with all sizes of the modified devices.

This document describes the regulatory submission for the VariLift®-L Interbody Fusion Device (K151900). It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria in a table format. Instead, the acceptance criterion for the non-clinical tests is implicitly that the VariLift®-L Interbody Fusion Devices are "substantially equivalent" to the predicate devices in terms of mechanical performance.

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

• Sample Size: The document mentions that testing was conducted on "the smallest and longest of the new proposed sizes (10x28mm)" for additional device sizes and "the smallest and longest of the proposed new sizes (10x28mm)" for design modifications to existing sizes. It does not specify the exact number of devices tested for each type of test (e.g., how many 10x28mm devices were subjected to static compression).
• Data Provenance: The studies are non-clinical performance tests, usually conducted in a laboratory setting. There is no mention of country of origin of data or whether it's retrospective or prospective, as these terms typically apply to clinical studies with human subjects.

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

Not applicable. The tests are non-clinical mechanical performance studies, not clinical studies requiring expert interpretation of patient data or images to establish ground truth. The "ground truth" here is the physical measurement of mechanical properties according to established ASTM standards.

4. Adjudication Method for the Test Set:

Not applicable. This refers to the process of resolving discrepancies in expert opinions on ground truth in clinical or image-based studies. Mechanical testing relies on objective measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study is a clinical study involving multiple human readers interpreting medical cases. The provided document describes non-clinical mechanical testing for device equivalence, not a clinical effectiveness study. Therefore, there's no information on how much human readers improve with AI vs. without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is not an AI algorithm. It's an interbody fusion device, and the evaluation is mechanical performance.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical tests is established by adhering to widely accepted mechanical testing standards from ASTM (e.g., ASTM 2077, ASTM F2267, ASTM Draft Standard F-04.25.02.02). These standards define how to objectively measure properties like static compression, shear, dynamic axial testing, subsidence, and expulsion forces.

8. The Sample Size for the Training Set:

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

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

Not applicable, as there is no training set mentioned or implied for this device.

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The Wenzel Spine VariLift Interbody Fusion System (VariLift-L and VariLift-A) 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 decenerative 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.

VariLift-L is designed to be implanted bi-laterally via a posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-A is designed to be implanted bl-laterally via an anterior (ALIF) approach. VariLift-L and VariLift-A may be implanted with or without supplemental fixation and are intended for use with autograft to facilitate fusion.

The Wenzel Spine VariLift Interbody Fusion System is offered in two (2) configurations of various sizes that are designed based on surgical approach, and consist of:

• 1. VariLift-L®, which may be implanted bi-laterally via a posterior lumbar (PLIF) approach or as a single device via a transverse (TLIF) approach.
• 2. VariLift-A®, which may be implanted bi-laterally via an anterior (ALIF) approach.

A design change was made on all sizes of the VariLift-L® devices to eliminate the risk of orientation error when loading the implant on the insertion instruments. Additionally, dimensional and threadform modifications were made to the instrumentation to ensure all instruments work with the modified devices.

The VariLift-L® and VariLift-A® are self-tapping, expandable devices with an interior sliding wedge and a posterior end cap. They are grooved and fluted devices with large fenestrations (graft windows) positioned between each of the four quadrants that provide bony contact with the endplates. The devices are made of titanium alloy (per ASTM F136).

The provided text discusses the substantial equivalence of the Wenzel Spine VariLift-L Interbody Fusion Device to a predicate device based on non-clinical performance testing. It does not describe acceptance criteria, a study proving device meets acceptance criteria, or any information related to AI/algorithm performance.

Therefore, I cannot provide the requested information. The text focuses on the mechanical performance of the VariLift-L device and modifications, concluding that it is substantially equivalent to a previously cleared device. There is no mention of an algorithm, AI, human readers, ground truth, or any of the other specific study parameters you asked about.

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