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Spinal Elements' Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. It is intended for single level 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), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. Spinal Elements' Spinous Process Plate System is not intended for stand-alone use.

Spinal Elements' Spinous Process Plate System is comprised of a static plate and a translating plate for posterior fixation of the spine in order to achieve fusion. The plates are available in multiple sizes to accommodate various patient anatomies. Both the static plate and the translating plate present spikes to interface with the bone of the spinous processes. The barrel of the static plate passes through the insert of the translating plate such that, in their final position, the plates surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes. The spinous process plates are made from titanium alloy (Ti-6A1-4V) conforming to ASTM F136 with a nitinol spring conforming to ASTM F2063 and a coating of commercially pure titanium conforming to ASTM F1580. Additionally, the plates feature a titanium coating on their medial surfaces as well as the initial portion of the barrel.

This document is a 510(k) premarket notification decision letter and summary from the FDA for a medical device called "Spinal Elements' Spinous Process Plate System." It does not contain information about the acceptance criteria and study proving device performance as requested, because it is for a physical orthopedic implant, not an AI/software device.

The information provided (e.g., performance data, sample sizes, ground truth establishment) is specific to the evaluation of AI/software devices for regulatory purposes. This document details the regulatory review for a spinal implant, which relies on different types of testing.

Therefore, I cannot fulfill your request for acceptance criteria and study details for an AI/software device based on the provided text.

The document states:

• "No clinical testing was found to be necessary." This indicates that a study demonstrating device performance in a clinical setting (which is where metrics like sensitivity, specificity, or reader improvement would be measured) was not required for the clearance of this specific physical implant.
• Non-clinical performance testing included: Static Compression and Torsion testing per ASTM F 1717, Dynamic Compression Testing per ASTM F 1717, Plate Dissociation per ASTM F1798, Pullout Testing, Particulate Analysis per ASTM F1877, Corrosion testing per ASTM F2129, and Austenitic finish (Af) functional testing. These are engineering and material science tests relevant to a physical implant.

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The Affix IIS Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the lumbosacral spine (L1 - S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions:

· 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)

• Tumor

The Affix IIS Spinous Process Plate System is not intended for stand-alone use.

The Affix IIS Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the lumbosacral spine (L1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion, and is not intended for stand-alone use.

This document is a 510(k) summary for the NuVasive® Affix IIS® Spinous Process Plate System, a medical device. It does not describe an AI/ML powered device, nor does it contain information about acceptance criteria, efficacy studies, or performance metrics in the way a diagnostic or prognostic AI algorithm would.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

• Indications for Use: The Affix IIS Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device for use at a single level in the lumbosacral spine (L1-S1) to achieve supplemental fusion in conditions like Degenerative Disc Disease (DDD), Spondylolisthesis, Trauma, and Tumor. It is not for stand-alone use.
• Technological Characteristics: Comparison of design, labeling/intended use, material composition, and function to predicate devices.
• Performance Data: Nonclinical (bench) testing, including static and dynamic axial compression and static torsion, to demonstrate mechanical equivalence to predicates.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria, as it pertains to AI/ML device performance. This document is a regulatory submission for a physical medical implant, not a software-driven diagnostic or treatment planning system.

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The Affix Next Gen Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions:
· 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)
• · Tumor
  The Affix Next Gen Spinous Process Plate System is not intended for stand-alone use.

The Affix Next Gen Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion, and is not intended for stand-alone use. When the Affix II Plate is used as supplemental fixation in interbody fusion procedures, its use is limited to the treatment of degenerative disc disease (DDD) of the lumbosacral spine (L2-S1).

The acceptance criteria and study proving the device meets them are described below:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes nonclinical testing, specifically mechanical testing, to demonstrate substantial equivalence. It does not mention a "test set" in the context of human data or a sample size for such a set. The data provenance is from laboratory testing.

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

Not applicable. The ground truth for this device's performance was established through engineering and mechanical testing, not expert consensus on clinical data.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication is mentioned.

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

No MRMC comparative effectiveness study was mentioned. The study performed was nonclinical (mechanical testing) for substantial equivalence.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. This device is a medical implant, not an algorithm, so the concept of "standalone performance" in this context is irrelevant.

7. Type of Ground Truth Used

The ground truth used was based on benchmarking against predicate devices through nonclinical (mechanical) testing. The "truth" was defined by the established performance characteristics and safety profile of the legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. The device is a physical medical implant, not a machine learning algorithm, so there is no "training set" in the conventional sense.

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

Not applicable, as there is no training set for this type of device. The performance characteristics were established through empirical mechanical testing and comparison to predicate devices, whose safety and efficacy were previously established.

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The Affix II Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions:

• 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)
• Tumor
  The Affix II Spinous Process Plate System is not intended for stand-alone use.

The Affix II Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion, and is not intended for stand-alone use. When the Affix II Plate is used as supplemental fixation in interbody fusion procedures, its use is limited to the treatment of degenerative disc disease (DDD) of the lumbosacral spine (L2-S1).

Here's an analysis of the provided text regarding the Affix® II Spinous Process Plate System.

Please Note: The provided document is a 510(k) summary for a medical device (an orthopedic implant), not an AI algorithm or diagnostic tool. Therefore, many of the requested points, especially those related to AI-specific studies (e.g., MRMC studies, training sets, ground truth establishment for AI), are not applicable to this type of submission. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Acceptance Criteria and Device Performance (Non-Clinical Testing)

The "acceptance criteria" for this device are implicitly demonstrating substantial equivalence to predicate devices through non-clinical biomechanical performance testing. The reported device performance indicates that these tests were successfully passed, showing equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for the non-clinical tests. These are typically bench tests conducted on a sufficient number of devices to ensure statistical validity, but the exact N is not disclosed in this summary.
• Data Provenance: Not applicable in the context of clinical data. This refers to non-clinical, benchtop mechanical testing performed in a lab setting.

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 the context of clinical studies or AI algorithm evaluation is not relevant here. The "truth" for these non-clinical tests is based on objective measurements against established engineering standards and comparison to a predicate device's known performance.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical data labeling. This document details non-clinical, objective biomechanical 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

Not applicable. This is a medical device (implant), not an AI system or diagnostic tool, so an MRMC study is irrelevant.

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

Not applicable. This is a medical device (implant), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance data is the performance characteristics of the predicate device (NuVasive Spinous Process Plate System K073278 and NuVasive Affix Spinous Process Plate System K131238) and general engineering standards for spinal fixation devices. The goal was to prove "substantial equivalence" to these established devices.

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is a physical medical device, not a machine learning model.

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

Not applicable. There is no training set for a physical medical device.

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The Affix® Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to the 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
  The Affix Spinous Process Plate System is not intended for stand-alone use.

The Affix® Spinous Process Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion, and is not intended for stand-alone use. When the Affix Plate is used as supplemental fixation in interbody fusion procedures, its use is limited to the treatment of degenerative disc disease (DDD) of the lumbosacral spine (L2-S1).

This document is a 510(k) summary for the Affix® Spinous Process Plate System, seeking to modify the Surgical Technique. As such, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through new data generation. Instead, it relies on substantial equivalence to predicate devices.

Therefore, most of the requested information cannot be extracted from this document, as the submission states:

• "No new performance data was generated for the purpose of this submission."

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

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

Explanation: This 510(k) submission focuses on a modification to the surgical technique and asserts substantial equivalence to predicate devices. It does not provide specific acceptance criteria or performance data for new testing.

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

• Sample Size: Not applicable. No test set was used for this specific submission as no new performance data was generated.
• Data Provenance: Not applicable.

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)

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

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

• Adjudication method: Not applicable.

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

• MRMC Study: No. This is a medical implant, not an AI-assisted diagnostic device.

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

• Standalone Performance: No. This is a medical implant, not an algorithm.

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

• Ground Truth Type: Not applicable. No new study requiring ground truth was conducted for this submission.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.

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

• Ground Truth Establishment: Not applicable.

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The Vega™ SPAN™ Spinous Process Plate System is a posterior non-pedicle supplemental fixation system intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture or dislocation), tumor, or degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies). The device is intended for use with bone graft material and is not intended for stand-alone use.

The Vega™ SPAN™ Spinous Process Plate System consists of plates of varying length and hub diameters, set screws, and instruments required for implantation. Spikes are present on the sides of the plate that interface with the spinous process to restrain the plate from rotating post-operatively. The device is offered with varying lengths and hub diameters to accommodate anatomical needs. Set screws are used to secure the two sides of the device into the final compressed and implanted construct. System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.

The provided text describes the regulatory clearance for the Vega™ SPAN™ Spinous Process Plate System, not an AI/ML powered medical device. Therefore, the information requested about acceptance criteria and studies related to AI/ML device performance (such as sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment) is not applicable or available in the given document.

The document focuses on demonstrating substantial equivalence to predicate devices through a 510(k) submission, primarily relying on mechanical testing and comparison of technological characteristics.

Here's the relevant information based on the provided text, aligned with the spirit of your request regarding device performance and acceptance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This device’s clearance was based on mechanical testing, not a test set of data with human subjects or images requiring "data provenance" in the context of an AI/ML device. The "test set" here refers to the physical devices undergoing mechanical tests. The specific number of devices tested is not detailed in this summary, but mechanical testing typically involves a statistically significant number of samples to demonstrate consistency.

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 the context of AI/ML, refers to clinically validated diagnoses or classifications. For this device, "ground truth" relates to the performance standards defined by ASTM F1717 for mechanical properties, which are established engineering standards, not expert clinical consensus.

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

• Not Applicable. Adjudication methods are used to establish ground truth in studies involving human interpretation or clinical outcomes. This study involved mechanical testing against established standards.

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 study was not conducted as this is a physical medical device, not an AI/ML diagnostic or assistive tool.

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

• Not Applicable. This is not an algorithm-only device. The "standalone" performance here refers to the device's mechanical integrity as tested in a laboratory setting. The results of these tests demonstrated the device meets mechanical performance criteria as defined by ASTM F1717.

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

• For the mechanical testing, the "ground truth" was established engineering standards, specifically ASTM F1717, which define acceptable static and dynamic compression and torsion performance for spinal implant devices.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" in the machine learning sense.

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

• Not Applicable. As above, no training set was used.

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The NuVasive® Spinous Process Plate 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); and/or tumor. It is not intended for stand-alone use.

The NuVasive® Spinous Process Plate System features plates with spikes under the plate to help resist plate rotation after implantation.

The NuVasive® Spinous Process Plate System is a medical device. As such, the acceptance criteria and study detailed here pertain to its mechanical performance and substantial equivalence to existing devices, rather than AI/algorithm performance.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document indicates that non-clinical mechanical testing was performed. However, it does not specify the sample size used for these tests. There is no information provided regarding data provenance (e.g., country of origin or whether it was retrospective/prospective), as this typically applies to clinical data, which was not the primary basis for this review.

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

The document does not indicate the use of experts to establish ground truth for a "test set" in the context of device performance in the same way an AI model might. The evaluation relies on mechanical testing data for device performance and comparison to predicate devices, which is typically assessed by engineers and regulatory reviewers, not medical experts defining a "ground truth" for diagnostic accuracy.

4. Adjudication Method for the Test Set

Since the evaluation primarily involved non-clinical mechanical testing and comparison to predicate devices, there was no adjudication method described similar to those used in clinical or AI studies (e.g., 2+1, 3+1). The "ground truth" for mechanical testing is typically based on established engineering standards and measurements.

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

No MRMC comparative effectiveness study was done. This type of study is relevant for evaluating the impact of AI assistance on human readers in diagnostic tasks, which is not applicable to a spinal implant system.

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

No standalone performance study was conducted because this device is a physical medical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance was:

• Mechanical Testing Results: Performance of the device against engineering specifications and relevant standards.
• Substantial Equivalence to Predicate Devices: This serves as a primary form of "ground truth" where the new device's characteristics (indications for use, design, material, and function) are directly compared to those of legally marketed, already accepted devices.

8. The Sample Size for the Training Set

This concept is not applicable. The NuVasive® Spinous Process Plate System is a physical medical device, not an AI model that requires a training set.

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

This concept is not applicable. As mentioned, there is no training set for a physical medical device.

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The Spinous Process Plate is intended for fixation to adjacent spinous processes (L1-L5) as an adjunct to anterior interbody fusion and bone graft. The indications for the spinous process plate include spinal trauma, degenerative spondylolisthesis and degenerative disc disease. The spinous process plate should only be used in the presence of a vertebral body replacement device such as the Spinal Concepts, Inc. InFix® System.

The Tandem system consists of spinous process plates and interconnecting male and female grommets. The implants are used in combination with a vertebral body replacement device such as the Spinal Concepts, Inc. InFix System. The plates feature a slim profile, several rows of spikes, and holes on each end with a spherical seat for grommet attachment. The spikes around the plate holes resist plate rotation after implantation, while a row of spikes over the intraspinous ligament aids in fixation to any optional bone graft.

It appears there might be a misunderstanding regarding the nature of the provided document. The text is a 510(k) summary for a medical device (Spinal Concepts, Inc. Tandem Spinous Process Plate System), which is a premarket notification to the FDA.

This document describes a mechanical surgical implant and its regulatory approval process, not an AI or software-based device that would typically have "acceptance criteria" and be "proven to meet the acceptance criteria" through clinical studies in the way you've outlined with terms like "test set," "ground truth," "MRMC," or "standalone performance."

For this type of device, "acceptance criteria" are generally related to its physical and functional properties, and "proof" comes from mechanical testing and demonstrating substantial equivalence to a predicate device.

Given this context, I cannot provide the information in the format requested as it's not applicable to this document. However, I can extract the relevant information pertaining to the device's assessment from the provided text:

Summary of Device Assessment from K040096: Spinal Concepts, Inc. Tandem Spinous Process Plate System

1. Acceptance Criteria and Reported Device Performance (as inferred for a mechanical device):

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

• Not applicable in the way specified. For this mechanical device, the "test set" would refer to physical prototypes or samples subjected to mechanical stress tests. The document does not specify the number of samples used in these tests.
• Data Provenance: The mechanical test data would be generated in a lab setting, likely by the manufacturer (Spinal Concepts, Inc.). The exact country of origin for the testing is not specified, but the manufacturer is based in Austin, TX, USA. The testing would be prospective in the sense that the device was tested to demonstrate its capabilities before widespread use.

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. The "ground truth" for a mechanical device like this is established through engineering principles, material science, and biomechanical standards, not expert consensus on images or clinical outcomes in the same way an AI device would be evaluated. The mechanical performance itself (e.g., load-bearing capacity, fatigue resistance) is the "ground truth" being measured.

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

• Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant to mechanical testing results. Mechanical test results are typically quantitative and objective measurements.

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 a mechanical surgical implant, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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

• Not applicable. This concept is for AI algorithms, not mechanical implants. The device itself (the implant) is the "standalone" product that undergoes testing.

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

• For mechanical devices, the "ground truth" or standard of comparison is typically based on established engineering standards, biomechanical principles, and the performance of predicate devices. The document states:
  • "Mechanical testing demonstrated that the Tandem System exhibits the functional requirements to support its use as a spinous process plate system under normal physiologic loads in the spine." This suggests mechanical properties (strength, stability) as the core "ground truth."
  • The FDA determined "substantial equivalence" to a "legally marketed predicate device" (Meurig-Williams Plate). The performance characteristics of the predicate device serve as a benchmark for "ground truth."

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of a mechanical device undergoing mechanical testing or a 510(k) review for substantial equivalence. "Training set" refers to data used to train an AI algorithm.

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

• Not applicable. As there is no "training set" as defined for AI or statistical models, there is no ground truth established for it.

In summary, this document is for a traditional medical device, a surgical implant, and its regulatory clearance is based on mechanical performance and substantial equivalence, not the kind of AI/algorithm performance analysis detailed in your questions.

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