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The Stryker Spine AVS® PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS® PL PEEK Spacers are to be implanted via posterior approach.

The AVS® PL PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

The subject AVS PL PEEK Spacers and the predicates AVS PL PEEK Spacers and DePuy's Lumbar I/F Cage (i.e., Brantigan Cage) share similar design features:

• Hollow frame PEEK Implant
• Lateral fenestrations
• Serrations on the superior and inferior surfaces
• Comparable heights, widths, and angles
• Materials and mechanical testing results are similar between the subject device and the listed predicates.

The provided document is a 510(k) Premarket Notification for a medical device (AVS® PL PEEK Spacer System) and is primarily focused on demonstrating substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and detailed performance metrics for a novel AI/software device. As such, most of the information requested in your prompt (especially regarding AI/software performance, ground truth, sample sizes for training/test sets, expert adjudication, MRMC studies, and standalone performance) is not available in these documents.

However, I can provide the information that is present in the document which relates to the device's acceptable performance and the study (or rather, testing) that supports it, tailored to the context of a spinal implant.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance for AVS® PL PEEK Spacer System

The acceptance criteria for this device are not explicitly stated in a quantitative table within the provided text. Instead, the document emphasizes substantial equivalence to predicate devices by demonstrating similar design features, materials, and mechanical testing results. The "study" mentioned isn't a clinical trial in the traditional sense, but rather "testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device'." This compliance is the core of its "performance."

Therefore, the "acceptance criteria" can be inferred as successful demonstration of:

1. Equivalent Design Features: The device shares design characteristics with established predicate devices.
2. Equivalent Materials: Uses similar materials to predicate devices.
3. Equivalent Mechanical Performance: Achieves mechanical testing results comparable to predicate devices, in accordance with FDA guidance for intervertebral body fusion devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text. The "testing" likely refers to benchtop mechanical and material testing, not human subject data.
• Data Provenance: Not explicitly stated for specific test data beyond "Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed." This strongly implies lab-based, pre-clinical testing data rather than clinical patient data. There is no mention of country of origin or retrospective/prospective human data.

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

• Not applicable as this is a device modification for a spinal implant, not an AI/software device requiring expert interpretation of diagnostic images or patient outcomes. The "ground truth" for a mechanical device is its physical and material properties meeting specified engineering standards.

4. Adjudication method for the test set:

• Not applicable for the type of device and testing described. Adjudication typically applies to expert consensus in clinical data review.

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

• Not applicable. This is not an AI/software device.

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

• Not applicable. This is not an AI/software device.

7. The type of ground truth used:

• The "ground truth" for this device's performance would be established through engineering specifications, material science testing standards, and established mechanical testing protocols (e.g., fatigue testing, static compression, subsidence testing as outlined in relevant ASTM or ISO standards for spinal implants, which would be referenced by the FDA guidance document). The results of these tests are compared against performance criteria derived from the predicate devices and the FDA guidance.

8. The sample size for the training set:

• Not applicable. This is not an AI/software device that utilizes a "training set."

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

• Not applicable. This is not an AI/software device that utilizes a "training set."

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The Stryker Spine AVS PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS PL PEEK. Spacers are to be implanted via posterior approach.

The AVS PL PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

The subject AVST™ PL PEEK Spacers and the predicates AVST™ PL PEEK Spacers and DePuy's Lumbar I/F Cage (i.e., Brantigan Cage) share similar design features:
• Hollow frame PEEK Implant
• Lateral fenestrations
• Serrations on the superior and inferior surfaces
• Comparable heights, widths, and angles
• Materials and mechanical testing results are similar between the subject device and the listed predicates.

This Special 510(k) premarket notification is intended to introduce the following modifications to the AVSTM PL PEEK Spacers approved under K073470, K080758, and K082014:

A range of 0° and 4° AVSTM PL PEEK Spacers (6-13mm in height, 30 and 33mm lengths with an 11mm width) were found to be substantially equivalent to the Brantigan Cage in K073470. In K080758, minor design changes were introduced to the 0° degree spacers. K082014 added four (4) implants in a 14 mm height. The minor design modifications approved under K080858 had been incorporated in these 14 mm implants.

The AVSTM PL PEEK Spacers that are the subject of this application add the design modifications that were approved on the 0 ° implants under K080758, to the 4 ° implants previously approved under K073470 and K082014. The lengths, width, and angles are the same as the predicate AVS® PL PEEK Spacers previously approved. The modifications include replacing the ogival shaped nose of the implant with the wedge-shaped design to facilitate insertion of the spacer between adjacent vertebral endplates. The threaded hole on the front side was removed as it is not needed to retrieve the implant and field feedback has confirmed that it would likely not be used. In the smaller heights, the back side threaded hole has been adapted to the various heights of the spacers to remain consistent with the existing instruments (i.e., the two Inserters), and the back side of the spacer has been tapered in the frontal plane to match the geometry of the vertebral endplates and the size of the two flat surfaces has been increased to improve the connection with the Inserters.

Note that the AVS™ PL PEEK Spacers may also be referred to as AVS™M Plus or UniLIF.

This document describes a Special 510(k) Premarket Notification for modifications to the AVS™ PL PEEK Spacer System, an intervertebral body fusion device. The purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, not to establish new clinical efficacy or safety claims through a clinical study with acceptance criteria.

Therefore, many of the requested categories in your prompt are not applicable to this type of submission. This document primarily focuses on demonstrating that the modified device is still substantially equivalent to the original cleared device and previously cleared predicate devices based on design features, materials, and mechanical testing, rather than reporting on a study designed to establish performance against specific acceptance criteria for a novel device.

Here's an analysis based on the provided text, indicating where information is not available or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not applicable in the context of this 510(k) submission. This is a Special 510(k) for modifications to an already cleared device, demonstrating substantial equivalence rather than presenting performance against new clinical acceptance criteria through a clinical trial. The text states:

"Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed for the AVS PL PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems."

This indicates that mechanical and material testing was performed to show the modified device performs similarly to the predicate devices, not to meet specific clinical acceptance criteria.

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

This information is not provided in the document. As this is a submission for device modifications and substantial equivalence, detailed clinical study data with test sets and provenance are not typically required or included. The "test set" would primarily refer to physical devices subjected to mechanical testing.

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

This information is not applicable/not provided. There was no clinical "test set" in the sense of patient data requiring expert ground truth establishment for performance evaluation.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. No clinical test set requiring adjudication was used.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses the impact of AI assistance on human reader performance, which is not relevant for this medical device (spinal intervertebral body fusion device).

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

No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an AI algorithm.

7. The Type of Ground Truth Used:

This information is not applicable. For this device, "ground truth" would relate to the physical and mechanical properties of the device (e.g., strength, durability, biocompatibility), which are assessed through engineering and material testing, not through expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or therapeutic clinical study. The "ground truth" for showing substantial equivalence relies on comparing the modified device's characteristics to those of the predicate devices.

8. The Sample Size for the Training Set:

This information is not applicable. This submission does not involve an AI algorithm that requires a training set.

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

This information is not applicable. No AI algorithm with a training set requiring ground truth establishment was involved.

In summary, this 510(k) submission is for demonstrating substantial equivalence of a modified intervertebral body fusion device to existing predicate devices, primarily through engineering and material testing. It does not involve algorithms, clinical trials with specific acceptance criteria for performance, or human-in-the-loop studies as typically seen with diagnostic AI devices.

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The Stryker Spine AVS® PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy.

The AVS® PL PEEK Spacers are to be implanted via posterior approach.

The AVS® PL PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

The subject AVS PL PEEK Spacers and the predicates AVS PL PEEK Spacers and DePuy's Lumbar I/F Cage (i.e., Brantigan Cage) share similar design features:
• Hollow frame PEEK Implant
• Lateral fenestrations
• Serrations on the superior and inferior surfaces
• Comparable heights, widths, and angles
• Materials and mechanical testing results are similar between the subject device and the listed predicates.
This Special 510(k) premarket notification is intended to introduce the following line extensions to the AVS® PL PEEK Spacers approved under K073470: The addition of 20 and 25 mm lengths, 14, 15, 16 and 18 mm heights, 8 and 9 mm widths, and 8° angle. Additions to implants approved under K080758 include: Addition of a 14 mm length (4 implants).

All other attributes remain the same. Note that the AVS® PL PEEK Spacers may also be referred to as AVS Plus.

The provided text discusses a Special 510(k) Premarket Notification for a line extension to the AVS™ PL PEEK Spacer System. This document does not describe a study involving an artificial intelligence (AI) or machine learning device, nor does it involve the evaluation of a diagnostic or assistive technology where performance metrics like sensitivity, specificity, or reader improvement would be relevant.

Instead, this document is for a medical device (spinal implant) and focuses on demonstrating substantial equivalence to previously cleared predicate devices for regulatory approval. The "study" mentioned here refers to mechanical testing of the device, not a clinical study involving human readers or AI performance.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, and standalone performance for an AI device cannot be extracted from this document because it pertains to a different type of medical device and regulatory submission.

However, I can extract the information that is relevant to the document for the physical device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed for the AVS PL PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems."

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

• Sample Size: Not specified in the provided text. The "test set" here refers to the number of physical devices or models subjected to mechanical testing.
• Data Provenance: Not applicable in the context of a retrospective/prospective study with human or AI data. The "provenance" refers to the results of internal mechanical testing performed by Stryker Spine.

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

Not applicable. This document is about the physical testing of a medical device, not a diagnostic or AI performance study requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set:

Not applicable. This concept pertains to resolving discrepancies in expert interpretations in diagnostic studies, which is not relevant here.

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

No. This is a special 510(k) for a physical medical device, not an AI or diagnostic tool.

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

No. This is a physical medical device.

7. Type of Ground Truth Used:

Mechanical properties and performance characteristics, as defined by FDA guidance for intervertebral body fusion devices, established through engineering testing.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Ask a specific question about this device

The Stryker Spine AVS PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS PL PEEK Spacers are to be implanted via posterior approach.

The AVS PL PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

This Special 510(k) premarket notification is intended to introduce the following design changes to the 0° AVSTM PL PEEK Spacers: The ogival shaped nose of the implant has been changed to a tapered design to facilitate insertion. The threaded hole on the front side of the implant has been omitted as it is not needed to remove the implant and field feedback confirms it would likely not be used. In the smaller heights, the back sided threaded hole has been adapted to remain consistent with the existing instruments (i.e., the two Inserters), and the back side of the spacer has been tapered in the frontal plane to match the geometry of the vertebral endplates and the two flat surfaces have been increased to improve connection with the Inserters. Note that the AVS PL PEEK Spacers are also referred to as AVS Plus.

I'm sorry, but based on the provided text, I cannot describe the acceptance criteria or a study proving the device meets them. The document is primarily a "Special 510(k) Summary of Safety and Effectiveness" for modifications to an existing spinal implant system, not a detailed study report with specific performance metrics and acceptance criteria.

Here's why the requested information cannot be extracted:

• Acceptance Criteria and Reported Device Performance: The document states that "Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed for the AVS PL PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems." However, it does not provide a table of specific acceptance criteria (e.g., minimum compression strength, fatigue life) or the numerical 'reported device performance' values for these criteria. It only indicates that the device met the requirements for substantial equivalence.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): None of these details are present in the provided text. The document is a regulatory submission summary, not a scientific paper detailing the methodology and results of specific tests with a test set. It mentions "mechanical testing results" but does not elaborate on the specifics of these tests as would be required to answer your questions.
• Training Set Information: Similarly, there is no mention of a training set, how its ground truth was established, or its sample size. This type of information is relevant for AI/machine learning models, which are not described as being part of this device or its evaluation. This device is a physical intervertebral body fusion device.

In summary, the provided text confirms that certain tests were conducted to demonstrate substantial equivalence to a predicate device, but it lacks the granular detail about acceptance criteria, performance metrics, and study methodologies that you are requesting.

Ask a specific question about this device

The Stryker Spine AVS PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS PL PEEK Spacers are to be implanted via posterior approach.

The AVS PL PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

The AVS PL Peek Spacers are intervertebral body fusion devices intended for use as an aid in spinal fixation. The AVS PL PEEK Spacers are rectangular shaped, hollow frame implants with lateral fenestrations. The spacers incorporate two (2) Tantalum marker pins to aid in radiographic visualization.
The AVS PL PEEK Spacers are available in a variety of sizes, from 6 mm to 13 mm in height, two lengths: 30 mm and 33 mm and one width: 11 mm. There are also 0° and 4° wedge shaped options that allow the surgeon to best choose the size suited to the patient's anatomy and pathology.

The device described is the Stryker Spine AVS PL PEEK Spacers, an intervertebral body fusion device. The submission is a Traditional 510(k) Premarket Notification (K073470).

The provided text describes a medical device submission (510(k)) and its clearance. It focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing specific performance acceptance criteria for a new, innovative diagnostic device that requires rigorous clinical study with statistical endpoints.

Therefore, many of the requested elements (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or could not be extracted from the provided document. The document describes a device for spinal fusion, not a diagnostic AI device. The "study" mentioned is a set of bench tests to confirm mechanical and material properties, rather than a clinical trial to assess diagnostic accuracy or algorithm performance.

Here's an attempt to answer the questions based on the available information, noting the limitations:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in the format typically seen for diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" for a medical implant like this are related to its material properties, mechanical strength, and biocompatibility, ensuring it functions as intended and is safe. The performance is reported in terms of meeting the requirements of recognized standards.

Note: The document references compliance with a Class II Special Controls Guidance Document for Intervertebral Body Fusion Devices. This guidance document would outline the specific benchmarks and testing methodologies (e.g., static and dynamic compression, subsidence, expulsion, torsional testing) that the device must meet to demonstrate substantial equivalence to legally marketed predicates. The provided text confirms that such testing was performed and demonstrated substantial equivalent performance, but does not list the specific quantitative criteria or results.

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

• Sample Size for Test Set: Not applicable in the context of a diagnostic dataset. The "test set" for this device would refer to the physical prototypes subjected to bench testing. The document does not specify the number of individual spacers tested, but rather states that "Testing... was performed."
• Data Provenance: Not applicable in the context of diagnostic data. The "data" pertains to engineering and material testing results.

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

Not applicable. Ground truth for mechanical and material properties is established through standardized engineering tests and measurements, often conducted by engineers or technicians, rather than clinical experts or radiologists.

4. Adjudication method for the test set

Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert opinions for ground truth establishment. For device performance based on engineering tests, the results are objectively measured against predefined 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. This device is an intervertebral body fusion spacer, not an AI-powered diagnostic tool. Therefore, MRMC studies comparing human reader performance with and without AI assistance are not relevant.

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

No. This device is a physical medical implant, not an algorithm.

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

The "ground truth" for this device would be established engineering standards, material specifications, and biomechanical performance requirements as outlined in relevant ASTM/ISO standards and the FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device." It's based on objective measurements from bench testing to ensure mechanical integrity, biocompatibility, and functional equivalence to predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable.

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