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Atlas Spine Project X Expandable Posterior Lumbar Interbody Spacers are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

Atlas Spine Project X Expandable Posterior Lumbar Interbody Spacers are to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the Apelo™ Pedicle Screw System.

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The provided FDA 510(k) clearance letter for the "Atlas Spine Project X Expandable Posterior Lumbar Interbody System" does not contain information on acceptance criteria or a study that proves the device meets specific performance criteria.

The letter is a regulatory document confirming that the device has been reviewed and found substantially equivalent to legally marketed predicate devices. It focuses on regulatory compliance, classification, and applicable regulations (such as Quality System regulations, UDI rules, and adverse event reporting).

Therefore, I cannot provide the requested information from the given input because the document does not contain details about:

1. Acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, or adjudication methods for any test set.
3. MRMC comparative effectiveness study results.
4. Standalone performance studies.
5. Type of ground truth used.
6. Training set sample size or how its ground truth was established.

The letter mentions the "Indications for Use" for the device, detailing the patient population and conditions for which it is intended, but this is distinct from performance criteria and study results.

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The Atlas Spine Lateral Expandable Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiquous levels in the thoracolumbar spine.

Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectory for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).

Lumbar: L1-L2 to L5-S1. for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

The Atlas Spine Lateral Expandable Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Atlas Spine Lateral Expandable Interbody System spacers expanded greater than 20° must be used with the provided bone screws in addition to supplemental fixation.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Atlas Spine Lateral Expandable Interbody System), a generic "Indications for Use" form, and information about the Paperwork Reduction Act.

This document does not contain any information about acceptance criteria for a study, reported device performance metrics, or details of any studies conducted to prove the device meets acceptance criteria.

Therefore, I cannot provide the requested information, which would typically include:

• A table of acceptance criteria and reported device performance.
• Sample sizes and data provenance for test sets.
• Information about experts for ground truth establishment.
• Adjudication methods.
• Results of multi-reader multi-case studies.
• Results of standalone algorithm performance studies.
• Type of ground truth used.
• Training set sample size and ground truth establishment methods.

To answer your request, I would need a document describing the actual performance evaluation studies for a medical device, including the study design, results, and acceptance criteria.

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The Atlas Spine Rebar® (Ti) Spacer System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Atlas Spine Rebar® (Ti) Spacer System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1.

The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

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The provided text is an FDA 510(k) clearance letter for the Atlas Spine Rebar™ (Ti) Spacer System. It outlines the regulatory status and intended use of the device. However, this document does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria, as it is a clearance letter, not a study report or a summary of performance data.

Therefore, I cannot provide the requested information based on the given input text. The text does not describe any specific performance metrics, test methodologies, sample sizes for a test set or training set, ground truth establishment, expert qualifications, or MRMC studies.

To answer your request, I would need a document such as:

• A clinical study report
• A premarket submission summary (e.g., a 510(k) summary or an IDE report) that details the performance data.

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The Atlas Spine Expandable Cervical Standalone Interbody System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of nonoperative treatment prior to treatment with the device. The Atlas Spine Expandable Cervical Standalone Interbody System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous bone and implanted via an open, anterior approach. The Atlas Spine Expandable Cervical Standalone Interbody System is intended to be used with the bone screw fixation provided by the V3 Segmental Plating system and requires no additional fixation.

Atlas Spine Expandable Cervical Standalone Interbody System

I am sorry, but the provided text from the FDA 510(k) letter for the Atlas Spine Expandable Cervical Standalone Interbody System does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

This document is primarily a letter from the FDA to Atlas Spine, Inc. indicating that their device has been found substantially equivalent to legally marketed predicate devices. It covers:

• The FDA's decision regarding substantial equivalence.
• Regulatory information and requirements for the device (e.g., general controls, potential additional controls, reporting adverse events).
• Details about the device name, regulation number, product code, and regulatory class.
• The Indications for Use for the device.

There is no mention of:

• Specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity, or mechanical performance thresholds).
• Any in-vitro, in-vivo, or clinical studies conducted to demonstrate the device meets performance claims or specific acceptance criteria.
• Sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, or details about the study, as this information is not present in the provided text.

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The V3 Segmental Plating System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (i.e., fractures or dislocation), 3) tumors, 4) spinal stenosis, 5) spondylolisthesis, 6) deformity or curvatures (i.e., kyphosis and/or lordosis, or scoliosis), 7) pseudoarthrosis, and/or 8) failed previous fusions.

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I am sorry, but the provided text from the FDA 510(k) clearance letter for the "V3 Segmental Plating System" does not contain information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of an AI/ML-driven device.

The document discusses:

• The FDA's decision regarding substantial equivalence for the medical device.
• Regulatory information, general controls, and compliance requirements.
• The indications for use for the V3 Segmental Plating System, which is a spinal intervertebral body fixation orthosis.

It does not:

• Define specific performance acceptance criteria for an AI/ML product.
• Describe a study involving an AI algorithm, a test set, ground truth establishment, expert readers, or multi-reader multi-case (MRMC) studies.
• Provide details on training sets or their ground truth.

Therefore, I cannot fulfill your request for the table of acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods, as this information is not present in the provided text.

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The Atlas Spine Expandable Cervical Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Atlas Spine Expandable Cervical Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Atlas Spine Expandable Cervical 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. 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 post expansion.

The implants components are manufactured from implantable grade Ti6AI4V per ASTM F136 alloy and Peek Optima LT1 delivered in the pre-assembled, unexpanded state.

The provided documentation describes a medical device, the "Atlas Spine Expandable Cervical Interbody System," and its 510(k) premarket notification for substantial equivalence, not an AI/ML device. Therefore, the specific questions regarding acceptance criteria, study details, and performance metrics for AI/ML devices are not applicable.

However, I can extract the relevant information from the document concerning the device's evaluation and its deemed "acceptance criteria" for regulatory clearance based on substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, "acceptance criteria" are not reported as quantitative performance metrics for an AI/ML algorithm. Instead, they refer to the device meeting the requirements for substantial equivalence to predicate devices. The performance is demonstrated through non-clinical (bench) testing.

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

Not applicable for this type of medical device (physical implant). The "test set" refers to the specific implants tested during the non-clinical bench studies. The document does not specify the exact number of implants tested, only the types of tests performed. Data provenance is not mentioned beyond the tests being conducted according to ASTM standards.

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

Not applicable. Ground truth as typically defined for AI/ML studies by experts is not relevant here. The "ground truth" for a physical implant's mechanical properties is derived from the physical testing against established ASTM standards.

4. Adjudication method for the test set

Not applicable. Adjudication methods are typically used to resolve discrepancies in expert labeling or diagnoses for AI/ML 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/ML device that assists human readers.

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

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

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

The "ground truth" for this device's performance is established by physical mechanical testing against recognized industry standards (ASTM F2077 and ASTM F2267), demonstrating that the device meets or exceeds the performance criteria for intervertebral body fusion devices, and is comparable to predicate devices.

8. The 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.

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The Ortus™ Expandable Lumbar Interbody Fusion 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 Ortus™ Expandable Lumbar Interbody Fusion System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft; and supplemental fixation system (i.e. Apelo Pedicle Screw System).

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

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I'm sorry, but this document contains no information about the acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for the "Ortus™ Expandable Lumbar Interbody Fusion System," detailing its indications for use and regulatory compliance. It does not include performance data, study designs, or 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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The Apelo™ Pedicle Screw System is intended for noncervical pedicle 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, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

The subject of this submission is the design of Fixed Length Cross Connectors for the Apelo" Pedicle Screw System and additional smaller sizes, 20mm through and including 42mm. The Atlas Spine Fixed Length Cross Connectors will provide surgeons additional smaller sizes from which to choose based on the patients' anatomies. The Atlas Spine Fixed Length Cross Connectors will be manufactured from medical grade titanium alloy, Ti-6AI-4V (ELI), in accordance with ASTM F-136.

The provided text is a 510(k) Premarket Notification for the Atlas Spine Pedicle Screw System. This document is a regulatory submission for a medical device that demonstrates substantial equivalence to a legally marketed predicate device. The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is typically associated with studies evaluating the performance of AI/ML-driven diagnostic or prognostic devices, or software as a medical device (SaMD).

This 510(k) submission, however, is for a physical orthopedic implant (pedicle screw system), not a diagnostic or AI-enabled device. Therefore, the detailed performance metrics and study design elements requested in the prompt are not applicable to this type of submission.

Here's why the information cannot be provided from this document:

• Device Type: This is a physical orthopedic implant (pedicle screw system), not a diagnostic device or a software product requiring AI performance evaluation.
• Regulatory Pathway: A 510(k) for such devices primarily focuses on demonstrating "substantial equivalence" to a predicate device in terms of intended use, design, materials, and functional characteristics (e.g., mechanical testing, biocompatibility). It does not typically involve clinical performance studies in the way an AI/ML device would, especially not with "acceptance criteria" related to sensitivity, specificity, or other diagnostic performance metrics.
• Missing Information: The document does not contain any information regarding:
  • Acceptance criteria for diagnostic or prognostic performance.
  • Reported device performance in terms of diagnostic accuracy.
  • Sample sizes for test sets (as there isn't a "test set" in the context of AI performance).
  • Data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types (pathology, outcomes data, expert consensus).
  • Training set size or how ground truth for a training set would be established, as these terms are irrelevant to a physical implant's 510(k).

The document explicitly states the basis for substantial equivalence:

• Same indications for use
• Same operating principle
• Same raw materials
• Similar manufacturing environments
• Same packaging configurations
• Same sterilization process
• Implanted using the same surgical techniques and similar equipment types

The conclusion explicitly states "This conclusion is based on the devices' similarities in indications for use, design, function, materials and mechanical function." This indicates the focus is on engineering and material equivalence, not clinical diagnostic performance.

Therefore, I cannot provide the requested table and study details as they are not relevant to or present in the provided 510(k) document for the Atlas Spine Pedicle Screw System.

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The Apelo™ Pedicle Screw System is intended for noncervical pedicle 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, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

Being proposed in this Special 510(k) is the introduction of line extensions to the existing Apelo™ Pedicle Screw System. The proposed line extensions consist of new sizes of solid monoaxial and polyaxial pedicle screws and cannulated monoaxial and polyaxial pedicle screws without fenestrations. The new design and sizes of pedicle screws will be offered in order to provide surgeons a variety of screws from which to choose for open and minimally invasive procedures based on patients' anatomies.

The provided text describes a Special 510(k) Premarket Notification for the Apelo™ Pedicle Screw System, which is a medical device. This document does NOT contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/machine learning application.

Instead, this document describes a traditional medical device submission to the FDA, focusing on:

• Substantial Equivalence: The primary objective of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and either the same technological characteristics or different technological characteristics that do not raise new questions of safety and effectiveness.
• Device Modification (Line Extension): The specific purpose of this Special 510(k) is to introduce new sizes of solid and cannulated pedicle screws as line extensions to an existing system.
• Mechanical Testing: The document mentions "Dynamic compression bending testing according to ASTM F1717" was conducted to show that the proposed screws do not create a new worst-case construct. This is a standard engineering test for spinal fixation devices to assess their mechanical performance and safety, not a clinical study involving human or AI performance.

Therefore, I cannot extract the requested information (acceptance criteria, device performance tables, sample sizes for test/training sets, ground truth details, expert qualifications, MRMC studies, standalone studies, etc.) because this document pertains to a mechanical device submission, not an AI-powered device or software as a medical device (SaMD). The concepts of "acceptance criteria" and "study" in this context refer to engineering specifications and mechanical tests, not statistical performance metrics for an algorithm.

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