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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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LineSider® Spinal System, with or without MIS instrumentation, is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to the following indications: 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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor: pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pediction in pediatic patients, LineSider® Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, LineSider Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis; fracture caused by tumor and/or trauma. LineSider® Spinal System is intended to be used with autograft. Pediatric pediatic pediatic pedicle screw fixation is limited to a posterior approach.

The LineSider® Spinal System is a thoracolumbosacral pedicle screw system containing metallic implants intended to provide immobilization and stabilization of spinal segments. The system consists of a variety of screws, hooks, rods, set screws, crosslink connectors, rod-to-rod connectors, iliac connectors, and associated instruments. Components are offered in various shapes and sizes to meet the requirements of the individual patient anatomy.

This document describes the regulatory clearance for the LineSider® Spinal System, a thoracolumbosacral pedicle screw system. It is a 510(k) summary, which means the manufacturer is claiming substantial equivalence to previously cleared devices, not presenting novel clinical trial data for acceptance criteria. As such, the information you're requesting regarding acceptance criteria related to AI/algorithm performance, ground truth establishment, expert adjudication, MRMC studies, and sample sizes for training/test sets is not applicable to this type of medical device submission.

The document primarily focuses on bench performance testing to demonstrate the physical and mechanical equivalence of the new device to its predicates.

Here's a breakdown based on the provided text, highlighting what is available and what is not applicable:

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

The document lists the following bench performance tests and states that they were conducted in support of the submission. The acceptance criteria for these tests would typically be established by the relevant ASTM standards (e.g., meeting or exceeding certain load values, deflection limits, or fatigue cycles specified in the standard or observed in predicate devices). However, the specific quantitative acceptance criteria values and the reported device performance results are not detailed in this summary document. The summary only states that the tests were performed and conclude substantial equivalence.

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

• Sample Size: For bench performance testing, "sample size" refers to the number of physical device components or constructs tested. This information is not detailed in the provided 510(k) summary. These tests are typically conducted in a laboratory setting (e.g., in the US, given the company's location).
• Data Provenance: The data is from laboratory bench testing. Provenance (country of origin, retrospective/prospective) is not applicable in the same way it would be for clinical study data.

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)

This question is not applicable to this 510(k) submission. There is no AI or diagnostic algorithm involved that would require expert ground truth establishment for a test set. The "ground truth" for mechanical testing is based on engineered specifications and the ASTM standards.

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

This question is not applicable as there is no diagnostic or image-based ground truth requiring adjudication.

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

An MRMC study is not applicable and was not done. This device is a physical pedicle screw system, not an AI-powered diagnostic tool.

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

This question is not applicable. There is no algorithm for this device.

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

The "ground truth" for the performance claims relate to mechanical test standards (ASTM F1717 and ASTM F1798) and comparison to the performance of legally marketed predicate devices.

8. The sample size for the training set

This question is not applicable. There is no training set for an AI/algorithm as this is a physical medical device.

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

This question is not applicable.

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The Toro-L Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or cortical cancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle screw/rod systems) cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The Toro-L Interbody Fusion System is interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracy disc herniation (with myelopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Toro-L Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scollosis.

Integrity Implants' Toro-L Interbody Fusion System incorporates a bi-directional expandable interbody fusion device and a non-expandable monolithic interbody fusion device intended for use in the thoracolumbar spine from T1-S1. The Toro-L Interbody Fusion System implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136 and Ti-6Al-4V per ASTM F2924) and polyether ether ketone (PEEK) per ASTM F2026; and are offered in a range of sizes and lordotic options to accommodate variations in patient anatomy.

Once implanted via a lateral surgical approach, the Toro-L interbody fusion devices are designed to restore intervertebral disc height, provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion. The Toro-L interbody fusion devices interbody fusion device is intended to be used with autograft and/or allograft, and with supplemental fixation instrumentation that has been cleared for use in the thoracolumbar spine. The Toro-L interbody fusion devices are single use devices. The Toro-L Interbody Fusion System includes manual surgical instruments for delivery of the implant devices and for disc preparation. The Toro-L Interbody Fusion System implant and instrument devices are supplied non-sterile and are intended for steam sterilization by the user prior to use.

The FDA Premarket Notification (510(k)) Summary for the Toro-L Interbody Fusion System (K213355) focuses entirely on non-clinical bench testing and biocompatibility assessment to demonstrate substantial equivalence to predicate devices. It does not present any clinical study data involving human patients or AI/algorithmic performance for medical image analysis.

Therefore, I cannot provide information on acceptance criteria and a study proving the device meets them in the context of an AI/human-in-the-loop setting. The document only describes a mechanical device (interbody fusion system) and its physical performance characteristics.

Based on the provided text, the following information is relevant to the device's acceptance, but NOT in the context of AI or diagnostic performance:

Acceptance Criteria and Device Performance (Mechanical/Biocompatibility)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test, but implied to be sufficient for the standard ASTM and ISO tests. These are bench tests, not patient data.
• Data Provenance: N/A for patient data. These are laboratory bench test results from Integrity Implants Inc.

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

• N/A. This device does not involve medical image analysis or human interpretation of such. The "ground truth" for mechanical testing is established by the specified ASTM and ISO standards themselves and the physical measurements taken. The "experts" would be the engineers and technicians performing and verifying the tests.

4. Adjudication Method for the Test Set

• N/A. Adjudication is not applicable to standardized mechanical and biocompatibility testing. The tests are designed to yield objective, measurable results.

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

• N/A. No MRMC study was done, as this is a mechanical implant device, not an AI diagnostic tool that assists human readers.

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

• N/A. As above, this is a mechanical implant. There is no algorithm or standalone performance being evaluated.

7. The Type of Ground Truth Used

• The "ground truth" for the device's performance is defined by established engineering standards (ASTM F2077) and biocompatibility standards (ISO 10993-1). Compliance with these standards indicates the device performs as expected mechanically and is biologically safe.

8. The Sample Size for the Training Set

• N/A. This applies to AI models. This device is not an AI/ML product.

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

• N/A. See point 8.

In summary, the provided document describes a premarket notification for a traditional medical device (an intervertebral body fusion system) that relies on bench testing and biocompatibility assessments to demonstrate substantial equivalence, not on clinical performance data or AI/ML algorithm evaluation.

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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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Integrity Implants Navigated Instruments are intended to be used during the preparation and placement of Integrity Implants spinal implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.

Integrity Implants Navigated Instruments are specifically designed for use with Medtronic's StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR-based model, finages, or digitized landmarks of the anatomy.

The Integrity Implants Navigated Instruments include non-sterile screw drivers, cannulated and solid taps (4.0 - 10.5 mm), probes, and awls designed to function with the Medtronic StealthStation® System and NavLock® Tracker. The subject devices are for use with the Integrity Implants LineSider® Spinal System (K190360 and K203367). The instruments are manufactured from stainless steel and Radel.

The provided text is a 510(k) summary for the Integrity Implants Navigated Instruments. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria for performance as an AI/ML-driven diagnostic or prognostic device.

However, I can extract information related to performance testing and acceptance criteria as much as possible from the provided text, while acknowledging that it's not a typical study report for acceptance criteria in the sense of accuracy, sensitivity, or specificity for AI/ML.

Here's a breakdown of the information based on your request, with limitations due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

Limitations: The document does not provide specific quantitative acceptance criteria (e.g., "positional accuracy must be within X mm") or specific quantitative results for each test. It states that tests were "completed to ensure" functionality and compatibility and that the devices are "as safe and effective" as the predicate, implying that acceptance criteria were met, but without detailing them.

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

The document does not specify a "test set sample size" or "data provenance" in the context of typical AI/ML performance studies (e.g., number of images, patient demographics). The performance data cited refers to:

• Accuracy testing: Performed in accordance with ASTM F2554-18. This standard likely dictates the setup and number of measurements, but the specific details (e.g., number of physical instruments tested, number of measurement points per instrument) are not provided.
• Registration testing: Details on the sample size (e.g., number of instruments registered, number of registration attempts) are not provided.
• Dimensional analysis: This likely involved comparing instrument dimensions, but the "sample size" here refers to the number of device types/models evaluated, which can be inferred from Section IV and the comparison table.
• Cleaning and sterilization validation data: Leveraged from a previous 510(k) (K190360). This implies prior validation studies were conducted, but their specific sample sizes are not detailed in this document.

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

This information is not applicable and not provided in the document. This device is a surgical instrument intended for use with a navigation system, not a diagnostic or prognostic AI/ML device that generates clinical findings requiring expert ground truth for a test set. The "ground truth" for its performance would be engineering measurements and physical tests.

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

Not applicable, as this is not an AI/ML diagnostic/prognostic device relying on human expert review for ground truth.

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-assisted diagnostic or prognostic device that involves human readers interpreting output. It's a navigated surgical instrument.

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

This concept is somewhat applicable in the sense that the navigational system's accuracy and the instrument's compatibility with it can be tested independently of a surgeon's clinical use. The "accuracy testing in accordance with ASTM F2554-18" and "registration testing" would fall under this category of standalone performance assessment of the instrument's interaction with the navigation system. The document does not, however, detail specific performance metrics or results from these standalone tests beyond stating they were performed.

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

For the type of device described, the "ground truth" would be established through:

• Physical measurements and engineering standards: For accuracy (e.g., comparing navigated position to physically measured position in a test setup per ASTM F2554-18).
• Functional tests: To confirm proper registration and compatibility with the StealthStation system.
• Dimensional specifications: For dimensional analysis.

It is not based on expert consensus, pathology, or outcomes data in the clinical diagnostic sense.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that undergoes a "training set" process.

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

Not applicable, as there is no "training set" for this type of device.

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The Toro-L Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or cortical cancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle screw/rod systems) cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The Toro-L Interbody Fusion System is intended for use in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracy disc herniation (with myelopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Toro-L Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scollosis.

Integrity Implants' Toro-L Interbody Fusion System incorporates a bi-directional expandable interbody fusion device and a monolithic interbody fusion device intended for use in the thoracolumbar spine.

Once implanted, the Toro-L 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 Toro-L 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 Toro-L Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation.

The Toro-L Interbody Fusion System implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136 and Ti-6Al-4V per ASTM F2924) and are offered in a range of sizes and lordotic options to accommodate variations in patient anatomy.

The Toro-L Interbody Fusion System expandable implant has integrated ramps and a threaded actuator that allow the implant to be inserted in a non-expanded form, and then subsequently expanded to full width and desired height through continuous expansion. When the desired height is achieved, the locking system is engaged to secure the construct in its final expanded configuration. The implant is then post-packed with bone graft.

The monolithic implant is a non-expanding conventional spacer with the interior space of the device divided into two compartments for bone graft containment.

Both the expandable and monolithic configurations have protrusions on the superior and inferior surfaces of the endplates of the implant to grip the adjacent vertebral endplates to resist expulsion.

The subject implant and instruments are offered non-sterile and are intended to be steam sterilized by the user prior to use.

This is a medical device 510(k) summary for the Toro-L Interbody Fusion System, which is a spinal implant. The document does not contain information related to AI/ML device performance, acceptance criteria for such, or studies involving human readers or ground truth as it pertains to AI/ML.

Therefore, I cannot fulfill your request for the specific information regarding AI/ML device performance, acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The provided text focuses on the mechanical and biological testing of the physical implant to demonstrate substantial equivalence to previously cleared devices.

Here's what the document does provide:

• Device Name: Toro-L Interbody Fusion System
• Regulatory Class: Class II (Product Codes MAX, PHM)
• Intended Use: Intervertebral body fusion of the spine in skeletally mature patients, with
  autogenous and/or allogeneic bone graft and supplemental internal spinal fixation systems. Intended for use in the thoracic spine (T1-T12) and thoracolumbar junction (T12-L1), and lumbar spine (L1-S1) for symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation. Can also be used as an adjunct to fusion in patients with multilevel degenerative scoliosis.
• Predicate Devices:
  • Amplify Surgical's DualX LLIF, K181397
  • Nuvasive's AP Expandable XLIF System, K173025
  • Globus Medical's Rise-L Spacers, K113447
  • Medtronic's Capstone-L Spinal System, K123978
  • Integrity Implants' FlareHawk7 Interbody Fusion System, K183184
• Non-Clinical Tests Conducted (Bench Performance Testing):
  • 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
  • Wear Debris and Particle Characterization in accordance with ASTM F1877
  • Subsidence in accordance with ASTM F2267
• Biocompatibility Assessment: In accordance with ISO 10993-1, including cytotoxicity testing in accordance with ISO 10993-5.

The conclusions state that based on these bench tests and biocompatibility assessment, the device demonstrates substantial equivalence and that any differences do not impact safety and effectiveness. This entire document describes a physical medical device, not an AI/ML-driven one.

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LineSider™ Spinal System, with or without MIS instrumentation, is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: 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); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, LineSider™ Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis) including idiopathic scoliosis, neuromuscular scoliosis, and congental scoliosis. Additionally, LineSider™ is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis; fracture caused by tumor and/or trauma. LineSider™ Spinal System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The LineSider™ Spinal System is a thoracolumbosacral pedicle screw system containing metallic implants intended to provide immobilization of spinal segments. The system consists of a variety of screws, hooks, rods, set screws, crosslink connectors, rod-to-rod connectors, iliac connectors, and associated instruments. Components are offered in various shapes and sizes to meet the requirements of the individual patient anatomy. The LineSider™ Spinal System subject to this 510(k) adds non-modular screws to the line offered under K190360.

This document is a 510(k) summary for the LineSider™ Spinal System, which is a thoracolumbosacral pedicle screw system. It describes an expansion of an already cleared device to include non-modular screws.

Based on the provided text, the device itself is a spinal implant system, not an AI or imaging device with performance metrics like accuracy, sensitivity, or specificity. Therefore, many of the requested categories for AI/imaging device studies (like sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies) are not applicable.

The "acceptance criteria" and "device performance" instead refer to mechanical strength and substantial equivalence to predicate devices, rather than diagnostic accuracy.

Here's a breakdown of the applicable information:

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

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

• Test Set Sample Size: Not applicable. This refers to mechanical testing of physical parts, not a data-driven test set for an algorithm. The testing involves physical samples of the spinal system components.
• Data Provenance: Not applicable in the context of clinical or image data. The data provenance is from laboratory mechanical testing performed by Empirical Testing Corp. (Colorado Springs, Colorado).

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. Ground truth in this context refers to the physical properties of the spinal implants, which are assessed through standardized mechanical testing according to ASTM F1717. The "ground truth" is adherence to established engineering standards rather than expert clinical consensus.

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

• Not applicable. Adjudication methods are typically for reconciling discrepancies in human expert evaluations. Mechanical testing results are 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 medical device (spinal implant) clearance, not an AI diagnostic or assistance tool.

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

• Not applicable. This is for a physical medical device, not an algorithm.

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

• Type of Ground Truth: The "ground truth" for this device's performance is compliance with pre-defined mechanical performance standards (ASTM F1717), which ensure the device's structural integrity and equivalence to predicate devices under specified loads and conditions.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of mechanical testing for a spinal implant.

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

• Not applicable. There is no "training set" for this type of device submission.

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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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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 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.

Here's a breakdown of the acceptance criteria and study information for the FlareHawk Interbody Fusion System, based on the provided FDA 510(k) summary:

This device is an interbody fusion system, and the provided document is an FDA 510(k) summary. For this type of device, the "acceptance criteria" are typically related to mechanical performance and biocompatibility to demonstrate substantial equivalence to predicate devices, rather than a diagnostic performance metric (like sensitivity/specificity) seen in AI/imaging devices. The "study" refers to non-clinical bench testing. There is no mention of an AI component or clinical studies in this submission document.

1. Table of Acceptance Criteria and Reported Device Performance

Comment: The document states that integrity implants has conducted these tests "in support of this premarket notification submission" and concludes that the device "demonstrates substantial equivalence to legally marketed predicate devices, and any differences... do not impact the safety and effectiveness." This implicitly means the device met the acceptance criteria for these tests. Specific numerical performance results are not provided in this summary.

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

• Sample Size: Not specified in terms of number of devices or test repetitions. For bench testing, samples are typically representatives of the manufacturing process.
• Data Provenance: The tests were non-clinical bench performance tests, meaning they were conducted in a lab environment on the device itself, not on patient data or in a clinical setting. Therefore, "country of origin of the data" and "retrospective or prospective" do not apply in the usual sense.

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

• Not applicable. This is a medical device for implantation, and the "ground truth" for its performance is established through adherence to engineering standards (ASTM, ISO) and laboratory measurements, not through expert human interpretation of data for diagnostic purposes.

4. Adjudication method for the test set

• Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human experts interpreting data. This document describes bench testing against engineering 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 is not an AI-assisted diagnostic device, nor does the submission mention an AI component. It is an implantable intervertebral fusion system.

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

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

• For mechanical testing: Engineering standards (ASTM F2077, F1044, F1147, F1978, F1854, F1877) and laboratory measurements of physical properties.
• For biocompatibility: ISO standards (ISO 10993-1, ISO 10993-5) and laboratory biological assessments (e.g., cytotoxicity assays).

8. The sample size for the training set

• Not applicable. This refers to an implantable medical device, not a machine learning model. There is no "training set" in this context.

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

• Not applicable, as there is no training set mentioned or relevant to this device type.

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LineSider™ Spinal System, with or without MIS instrumentation, is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to following indications: 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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatic patients, LineSider™ Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, LineSider™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis; fracture caused by tumor and/or trauma. LineSider™ Spinal System is intended to be used with autograft and/or allograff. Pediatric pedicle screw fixation is limited to a posterior approach.

The LineSider™ Spinal System is a thoracolumbosacral pedicle screw system containing metallic implants intended to provide immobilization of spinal segments. The system consists of a variety of screws, hooks, rods, set screws, crosslink connectors, rod-to-rod connectors, iliac connectors, and associated instruments. Components are offered in various shapes and sizes to meet the requirements of the individual patient anatomy.

The provided text describes the LineSider™ Spinal System, a thoracolumbosacral pedicle screw system, and its FDA 510(k) clearance. However, it does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of AI/ML device performance.

The document is a traditional 510(k) clearance letter for a physical medical device (spinal system), which focuses on mechanical performance and substantial equivalence to predicate devices, rather than AI/ML algorithm performance.

Therefore, I cannot extract the requested information regarding AI/ML device performance, as it is not present in the provided text.

Here's why and what information is available:

• Acceptance Criteria & Reported Device Performance (AI/ML): Not applicable. The document discusses mechanical testing criteria for a physical spinal implant, such as static axial compression, static torsion, and dynamic axial compression bending fatigue. It states: "The results of this non-clinical testing show that the strength of the LineSider™ Spinal System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." No specific quantitative acceptance criteria or reported performance metrics for an AI/ML component are provided because there isn't one.
• Sample size and data provenance (AI/ML): Not applicable.
• Number of experts and qualifications (AI/ML): Not applicable.
• Adjudication method (AI/ML): Not applicable.
• MRMC comparative effectiveness study (AI/ML): Not applicable.
• Standalone (algorithm only) performance (AI/ML): Not applicable.
• Type of ground truth (AI/ML): Not applicable.
• Training set sample size (AI/ML): Not applicable.
• How ground truth for training set was established (AI/ML): Not applicable.

Summary of what is available in the document regarding traditional device testing:

• Device Name: LineSider™ Spinal System
• Regulatory Class: Class II
• Product Code: NKB, KWP
• Predicate Devices: K170126 (NuVasive® Reline® 4.5-5.0 System) and K041449 (Synergy VLS)
• Performance Tests Conducted:
  • Static axial compression bending per ASTM F1717-18
  • Static torsion per ASTM F1717-18
  • Dynamic axial compression bending fatigue per ASTM F1717-18
• Conclusion: "The overall technology characteristics and mechanical performance data lead to the conclusion that the LineSider™ Spinal System is substantially equivalent to the predicate devices."

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