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The FlareHawk Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

FlareHawk Interbody Fusion System is an expandable lumbar intervertebral body fusion device intended for use in the lumbosacral spine from L2 to S1. The FlareHawk interbody fusion device consists of a shell and a shim component that are offered in various lengths, heights, and lordotic angles to accommodate variations in patient anatomy. When the FlareHawk device is deployed within the intervertebral disc space, the shell and shim components lock together to create a complete implant construct to provide structural stability for interbody fusion. The final dimensions of the deployed device construct are determined by the dimensions of the selected shell and shim. Once implanted, the FlareHawk interbody fusion device is designed to restore intervertebral disc height, provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion.

The FlareHawk interbody fusion device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone, and with supplemental fixation instrumentation that has been cleared for use in the lumbar spine.

The FlareHawk Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation.

The provided FDA 510(k) clearance letter for the FlareHawk Interbody Fusion System does not contain any information about acceptance criteria or a study proving that the device meets specific performance criteria related to AI or diagnostic accuracy.

This document is for an Intervertebral Body Fusion Device (a spinal implant), which is a physical medical device, not a software-based diagnostic AI device. Therefore, the questions posed in the prompt related to AI performance, ground truth establishment, expert consensus, MRMC studies, and training/test set sizes are not applicable to the information provided in this 510(k) summary.

The "studies" mentioned in the document are non-clinical bench performance tests primarily related to MRI compatibility of the implant, such as:

• Measurement of magnetically induced displacement force
• Measurement of magnetically induced torque
• Evaluation of MR image artifacts
• Measurement of radio frequency induced heating

These tests confirm the physical properties and safety of the implant in an MRI environment, not the diagnostic or analytical performance of an AI algorithm.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and a study proving device performance in the context of an AI device, as the provided text pertains to a physical orthopedic implant.

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The FlareHawk Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

The Integrity Implants FlareHawk Interbody Fusion System is an expandable lumbar intervertebral body fusion device intended for use in the lumbosacral spine from L2 to S1. The FlareHawk interbody fusion device consists of a shell and a shim component that are offered in various lengths, heights, and lordotic angles to accommodate variations in patient anatomy. When the FlareHawk device is deployed within the intervertebral disc space, the shell and shim components lock together to create a complete implant construct to provide structural stability for interbody fusion. The final dimensions of the deployed device construct are determined by the dimensions of the selected shell and shim. Once implanted, the FlareHawk interbody fusion device is designed to restore intervertebral disc height, provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion. The FlareHawk interbody fusion device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone, and with supplemental fixation instrumentation that has been cleared for use in the lumbar spine. The FlareHawk Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation.

This looks like a 510(k) summary for a medical device called the FlareHawk Interbody Fusion System, which is an expandable lumbar intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria and a study proving those criteria are met for a new AI/ML-driven device.

Therefore, many of the requested categories (e.g., sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for training data, how ground truth for training data was established) are not applicable to this document because it is not about an AI/ML device that generates diagnostic or prognostic outputs requiring such evaluations.

However, I can extract the closest analogous information regarding acceptance criteria and the study performed, focusing on the bench performance testing mentioned.

Here's a breakdown of the information that can be extracted or noted as not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in precise numerical terms with corresponding reported performance for comparison in a table format as might be expected for AI/ML device metrics (e.g., sensitivity, specificity, AUC). Instead, it refers to industry standards for mechanical testing.

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

• Sample Size for Test Set: Not explicitly stated as this is mechanical testing of physical implants, not a data-driven AI/based test. The "test set" would be the number of physical devices subjected to the bench tests.
• Data Provenance: Not applicable in the context of digital data; this refers to results from physical bench testing performed by Integrity Implants Inc.

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 testing is typically established by physical measurement against engineering specifications and industry standards, not expert consensus on interpretations.

4. Adjudication method for the test set

• Not applicable. This is mechanical testing against 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

• Not applicable. This device is an interbody fusion system, not an AI/ML diagnostic or assistive device that would involve human readers.

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

• Not applicable. This device is a physical implant.

7. The type of ground truth used

• Ground Truth: Engineering specifications and compliance with established ASTM standards (specifically ASTM F2077) for mechanical properties (Static Axial Compression, Dynamic Axial Compression, Static Compression Shear, Dynamic Compression Shear).

8. The sample size for the training set

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

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

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

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

The document describes confirmatory bench performance testing as the study method. This testing was conducted in support of the premarket notification submission to demonstrate that the modified FlareHawk Interbody Fusion System maintains performance characteristics comparable to its predicate devices and adheres to relevant industry standards.

The specific tests performed were:

• Static Axial Compression in accordance with ASTM F2077
• Dynamic Axial Compression in accordance with ASTM F2077
• Static Compression Shear in accordance with ASTM F2077
• Dynamic Compression Shear in accordance with ASTM F2077

Additionally, a risk analysis was completed, demonstrating that no new risks were introduced and that the device modifications did not create a new worst-case scenario.

The conclusion stated is that, based on engineering rationales, confirmatory bench performance testing, and other supporting documentation, the subject FlareHawk® Interbody Fusion System demonstrates substantial equivalence to legally marketed predicate devices. This indicates that the device's performance met the implicit acceptance criteria of conforming to the established mechanical standards and not introducing new risks compared to its predicates.

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The FlareHawk Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

Integrity Implants' FlareHawk Interbody Fusion System is an expandable lumbar intervertebral body fusion device intended for use in the lumbosacral spine from L2 to S1. The FlareHawk interbody fusion device consists of a shell and a shim component that are offered in various lengths, heights, and lordotic angles to accommodate variations in patient anatomy. When the FlareHawk device is deployed within the intervertebral disc space, the shell and shim components lock together to create a complete implant construct to provide structural stability for interbody fusion. The final dimensions of the deployed device construct are determined by the dimensions of the selected shell and shim. Once implanted, the FlareHawk interbody fusion device is designed to restore intervertebral disc height, provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion. The FlareHawk interbody fusion device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone, and with supplemental fixation instrumentation that has been cleared for use in the lumbar spine. The FlareHawk Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation.

The provided text is a 510(k) summary for the FlareHawk Interbody Fusion System, an implantable medical device. It describes the device's indications for use, technological characteristics, and comparison to predicate devices, focusing on the mechanical and biocompatibility testing performed to demonstrate substantial equivalence.

This document does not contain information on the acceptance criteria or study details related to device performance as it would be relevant for a digital health/AI device. The provided text refers to an implantable medical device (Intervertebral body fusion device) which undergoes different types of testing to demonstrate safety and effectiveness. The questions in the prompt, such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "Multi-reader multi-case (MRMC) comparative effectiveness study," and "Standalone (algorithm only without human-in-the-loop performance) study," are specifically designed to evaluate AI/ML-based medical devices or diagnostic tools.

Therefore, I cannot extract the requested information from the provided document as it pertains to a different type of medical device and regulatory submission.

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FlareHawk™ Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/ or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk™ system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

Integrity Implants' FlareHawk™ Interbody Fusion System is an expandable lumbar intervertebral body fusion device intended for use in the lumbosacral spine from L2 to S1. The FlareHawk™ interbody fusion device consists of a shell and a shim component that are offered in various lengths, heights, and lordotic angles to accommodate variations in patient anatomy. When the FlareHawk™ device is deployed within the intervertebral disc space, the shell and shim components lock together to create a complete implant construct to provide structural stability for interbody fusion. The final dimensions of the deployed device construct are determined by the dimensions of the selected shell and shim. Once implanted, the FlareHawk™ interbody fusion device is designed to restore intervertebral disc height, provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion. The FlareHawk™ interbody fusion device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone, and with supplemental fixation instrumentation that has been cleared for use in the lumbar spine. The FlareHawk™ Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation. FlareHawk™ Interbody Fusion System implant and instrument devices are supplied non-sterile and are intended for steam sterilization by the user prior to use.

I apologize, but the provided text from the FDA 510(k) Premarket Notification document for the "FlareHawk™ Interbody Fusion System" 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 document describes a traditional medical device (an intervertebral body fusion system) and its mechanical testing for safety and performance (e.g., static and dynamic compression, subsidence testing). It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical strength.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them using the provided input, as the nature of the device and the testing described are not related to AI/ML performance.

If you have a document describing an AI/ML medical device, I would be happy to help analyze it according to the criteria you've outlined.

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FlareHawk™ Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/ or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk™ system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

Integrity Implants' FlareHawk™ Interbody Fusion System is an expandable lumbar intervertebral body fusion device intended for use in the lumbosacral spine from L2 to S1. The FlareHawk™ interbody fusion device consists of a shell and a shim component that are offered in various lengths, heights, and lordotic angles to accommodate variations in patient anatomy. When the FlareHawk™ device is deployed within the intervertebral disc space, the shell and shim components lock together to create a complete implant construct to provide structural stability for interbody fusion. The final dimensions of the deployed device construct are determined by the dimensions of the selected shell and shim. Once implanted via a transforaminal (TLIF) or posterior (PLIF) approach, the FlareHawk™ interbody fusion device is designed to restore intervertebral disc height, provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion. The FlareHawk™ interbody fusion device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone, and with supplemental fixation instrumentation that has been cleared for use in the lumbar spine. The FlareHawk™ Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation. FlareHawk™ Interbody Fusion System implant and instrument devices are supplied non-sterile and are intended for steam sterilization by the user prior to use.

The provided text is a 510(k) summary for a medical device called the "FlareHawk™ Interbody Fusion System." This documentation describes the device, its intended use, and its equivalence to legally marketed predicate devices based on non-clinical tests.

Crucially, the text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to a diagnostic or AI-driven medical device. This document is for an orthopedic implant and focuses on mechanical performance and substantial equivalence to previously cleared implants, not on the performance metrics typically associated with AI/diagnostic devices (e.g., sensitivity, specificity, AUC).

Therefore, I cannot provide the requested information. The document focuses on:

1. Device Description and Indications for Use: What the FlareHawk™ Interbody Fusion System is and what it's used for (spinal intervertebral body fusion).
2. Technological Characteristics: Materials, design, and function of the implant.
3. Predicate Devices: Identification of legally marketed devices to which the FlareHawk™ system is substantially equivalent.
4. Non-Clinical Testing: References to ASTM standards (F2077, F2267) for mechanical testing (static compression, dynamic compression, shear, subsidence) to demonstrate performance comparability to predicates.

There is no mention of an AI component, diagnostic function, human reader studies (MRMC), or any of the detailed performance metrics (sensitivity, specificity, etc.) typically required for acceptance criteria of an AI/diagnostic device.

To answer your request, the input text would need to be from an FDA submission related to a diagnostic device, particularly one employing AI.

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