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When used as an interbody fusion device, the ProLift® Micro Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The ProLift® Micro Expandable System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the ProLift® Micro Expandable System components with components from any other system or manufacturer. The ProLift® Micro Expandable System components should never be reused under any circumstances.

The provided text describes a medical device, the ProLift® Micro Expandable Spacer System, and its clearance through a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical performance data to establish specific acceptance criteria for device performance in a clinical setting.

Therefore, the document does not contain information typically found in a study that proves a device meets acceptance criteria related to AI/algorithm performance, human reader improvement, or detailed clinical efficacy. It focuses on the mechanical and material equivalence of the new device to existing ones.

Based on the provided text, I can extract information relevant to the device's technical specifications and the basis for its substantial equivalence, but not the specific clinical performance criteria, study design, or AI-related metrics requested in the prompt.

Here's an analysis of the information not present in the provided text, related to your specific questions:

• Acceptance Criteria and Reported Device Performance (Table): The document does not describe clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) or report specific clinical performance metrics. It focuses on mechanical testing for substantial equivalence.
• Sample Size for Test Set and Data Provenance: No clinical test set or patient data is mentioned as part of a performance study.
• Number of Experts and Qualifications: No experts were used to establish ground truth for a clinical test set because no such study is described.
• Adjudication Method: Not applicable as no clinical test set with ground truth is discussed.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned. The document is about a physical medical implant, not an AI or diagnostic tool that would directly assist human readers.
• Standalone Performance (Algorithm Only): Not applicable, as this is a physical implant, not an algorithm.
• Type of Ground Truth Used: Not applicable for a performance study in the context of your questions. The "ground truth" for this device relates to its mechanical integrity and biocompatibility, which are verified through material specifications and mechanical testing rather than clinical outcomes established by experts or pathology.
• Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable as this is not an AI/machine learning device.

Information that is extractable from the document, though not directly answering your specific questions about AI/clinical performance studies:

The document describes the mechanical performance data used to demonstrate substantial equivalence, which is a different kind of "acceptance criterion" based on engineering standards:

• Acceptance Criteria/Performance (Mechanical):
  • Type of Testing: Static Axial Compression, Dynamic Axial Compression, Static Shear, and Dynamic Shear testing.
  • Standard: According to ASTM F2077.
  • Purpose: To demonstrate substantial equivalency to the predicate device (Life Spine ProLift Micro Expandable System K212520).
  • Reported Performance: The document states that this testing "was presented to demonstrate the substantial equivalency," implying the device met the requirements of the standard consistent with the predicate. Specific numerical results are not provided in this summary.

In summary, the provided FDA 510(k) document is for a physical medical device (an expandable spinal spacer) and therefore does not contain the type of information requested about AI/algorithm performance studies, human-in-the-loop studies, or clinical ground truth establishment.

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The Plateau-LO Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The Plateau-LO Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from PEEK (Polyetheretherketone) with tantalum markers. The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Plateau-LO Spacer System components with components from any other system or manufacturer. The Plateau-LO Spacer System components should never be reused under any circumstances.

This document describes the regulatory approval of "The Plateau-LO Spacer System," an intervertebral body fusion device. The information provided is for a 510(k) premarket notification and focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than a detailed clinical study demonstrating device performance against specific acceptance criteria in the way one might expect for a diagnostic AI device.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this type of regulatory submission and the information available. The document is primarily concerned with proving the new device is as safe and effective as existing, legally marketed devices.

Here's an attempt to address your request based on the provided text, highlighting what is (and isn't) present:

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

The document does not present specific quantitative acceptance criteria or reported device performance in the way a diagnostic AI device study would. Instead, it relies on demonstrating "substantial equivalence" to predicate devices based on design, materials, indications for use, and mechanical performance.

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

This document is a 510(k) summary, which typically relies on non-clinical performance data (bench testing, engineering analysis) and comparison to predicate devices, rather than a clinical "test set" from patient data.

• Sample Size for Test Set: Not applicable in the context of clinical patient data. The "test set" (if we consider it as the subject of the performance data) would be the physical devices used in the engineering rationale, finite element analysis, and expulsion testing. The specific number of devices tested is not mentioned.
• Data Provenance: The studies mentioned (engineering rationale, finite element analysis, expulsion testing) are typically conducted in a laboratory setting by the manufacturer (Life Spine Inc.). No "country of origin of data" for clinical patient data is relevant here. The studies would be considered prospective in terms of how the tests were designed and executed on the device prototypes/samples.

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 is not applicable. "Ground truth" in the sense of expert consensus on clinical findings is not established for this type of submission. The ground truth here is derived from engineering principles, material science, and established acceptable performance limits for intervertebral fusion devices, as demonstrated through bench testing.

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

Not applicable. There's no clinical "test set" requiring adjudication by clinical experts as this is not a diagnostic device and no clinical data review is described.

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 a surgical implant, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this submission is established by:

• Engineering principles and material science: For the design, materials, and mechanical properties.
• Regulatory standards and guidance: For what constitutes "substantial equivalence" for intervertebral body fusion devices.
• Performance of predicate devices: The established safety and effectiveness of the legally marketed predicate devices serve as the benchmark.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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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When used as an interbody fusion device, the ProLift® Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The ProLift® Expandable System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

All implants are provided sterile and intended for SINGLE USE ONL Y and should not be reused under any circumstances. Do not use any of the ProLift® Expandable System components with components from any other system or manufacturer. The ProLift® Expandable System components should never be reused under any circumstances.

The provided document is a 510(k) premarket notification for a medical device called the ProLift® Expandable System, an intervertebral body fusion device. This type of regulatory filing focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than proving efficacy or safety through clinical trials with defined acceptance criteria for a device's performance.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes for test/training sets, expert qualifications, adjudication methods, or ground truth establishment relevant to AI/algorithm performance.

Instead, the "Performance Data" section (page 4) refers to:

• Static compression, dynamic compression, static and dynamic shear testing according to ASTM F2077. This is mechanical testing to demonstrate the structural integrity and equivalence of the device to predicate devices, not performance related to clinical outcomes or diagnostic accuracy for an AI system.

The document explicitly states: "The ProLift® Expandable System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance." This underlines that the focus is on equivalence in physical and mechanical properties and intended use, not on a performance study comparing diagnostic accuracy or clinical effectiveness against specific acceptance criteria.

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The Atlas Spine Expandable Interbody System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).

The Atlas Spine Expandable Interbody System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft; and supplemental fixation system (i.e. Firebird® Spinal Fixation System).

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the Atlas Spine Expandable Interbody System.

The Atlas Spine Expandable Interbody System consists of various size and style options to address the clinical and anatomic needs of individual patients. The implant is rectangular in its general shape with the capability to expand in height infinitely within its design limitations. The implant incorporates bone graft cavities through the superior and inferior surfaces to allow fusion between adjacent vertebral bodies. The implants incorporate a textured bone contacting surface to resist migration/expulsion of the implant post operatively. Additionally, the implant incorporates an opening posteriorly to allow the addition of bone graft material post expansion.

The implants components are manufactured from implantable grade Ti6Al4V alloy and Peek Optima LT1 delivered in the pre-assembled, unexpanded state.

The provided text describes information about the Atlas Spine Expandable Interbody System, specifically regarding its 510(k) premarket notification to the FDA. However, it does not provide acceptance criteria for a device, nor does it detail a study proving a device meets specific acceptance criteria in the context of AI/ML performance.

The document discusses:

• Device Name: Atlas Spine Expandable Interbody System
• Regulation Number: 21 CFR 888.3080
• Regulation Name: Intervertebral Body Fusion Device
• Regulatory Class: Class II
• Product Code: MAX
• Indications for Use: Spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1), with or without Grade 1 spondylolisthesis, after at least six months of non-operative treatment. Intended for use with autograft/allograft and supplemental fixation.
• Predicate Devices: Caliber™ Spacer (Primary), ProLift® Expandable System, FORZA® PTC Spacer System, Spinal Jaxx Interbody Fusion Device, L-Varlock Lumbar Cage, Atlas Spine Verterbral Body Replacement, Bluefin™ Interbody System, Dorado™ Intervertebral Body Cage.
• Device Description: Rectangular, height-expandable implant with bone graft cavities and a textured bone-contacting surface, manufactured from implantable grade Ti6Al4V alloy and Peek Optima LT1.
• Non-Clinical Testing: Bench testing was performed as recommended by FDA guidance (Class II Special controls guidance document: Intervertebral body Fusion Device, June 12, 2007). This included:
  • Static testing in load to failure mode (axial compression, shear, expulsion, subsidence).
  • Dynamic axial compression testing to estimate maximum run-out load.
  • Dynamic compression shear testing to estimate maximum run-out load.
• Conclusion of Testing: Test results demonstrated that the Atlas Spine Expandable Interbody System is found to be substantially equivalent to the predicate devices.
• Clinical Performance Data: "No clinical testing was required."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets them, especially in the context of AI/ML, as this document pertains to a spinal implant and its mechanical substantial equivalence to predicate devices, with no mention of AI/ML components or performance metrics.

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