Search Results

The Lumbar Spine Truss System Plation (LSTS-PS) without integrated fixation is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The LSTS-PS is designed to provide temporary stability until fusion is achieved. It is intended for lateral or anterolateral lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) (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), deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The LSTS-PS with integrated fixation is intended to be attached to the Lateral Spine Truss System (LSTS) Interbody Fusion Device after implantation. In this configuration the LSTS-PS must only be used to treat patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The 1-hole 4WEB LSTS-PS with integrated fixation is intended to be used with supplemental fixation (e.g. posterior fixation).

The Lumbar Spine Truss System Plating Solution (LSTS-PS) is comprised of lumbar plates and screws. The lumbar plates have a rotating locking tab for each screw position to prevent back-out of the screw. The plates are available in 1-hole, and 4-hole integrated configurations and 2-hole and 4-hole non-integrated configurations. Each plate is available in multiple lengths for single level fusion. The screws are available in two diameters and various lengths to accommodate the patient's anatomy. All LSTS-PS plates and screws are made from Ti6Al4V alloy.

This is a medical device application for the Lumbar Spine Truss System Plating Solution (LSTS-PS). The provided text describes the device, its indications for use, and a summary of performance testing. However, it does not contain the kind of information typically found in an AI/Software as a Medical Device (SaMD) submission regarding acceptance criteria and a study proving those criteria were met for an AI algorithm.

The document discusses a physical medical device (plates and screws for spinal fixation), not an AI algorithm. Therefore, many of your requested points, such as sample size for test sets, ground truth establishment, expert qualifications, and MRMC studies, are not applicable to the content provided.

Here's an attempt to answer your questions based on the provided document, highlighting where the information is absent or not applicable:

Acceptance Criteria and Study Proving Device Meets Criteria for Lumbar Spine Truss System Plating Solution (LSTS-PS)

As per the provided 510(k) summary, the device under review is a physical medical implant (spinal plates and screws), not an AI/SaMD algorithm. Therefore, the "acceptance criteria" and "study" described in the document refer to the mechanical and material performance of the hardware, tested against established engineering standards, rather than diagnostic performance of an AI.

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

The document states that the device has been tested per various ASTM standards (F1717, F543, F2077). The acceptance criterion, implicitly, is that the device meets or surpasses the requirements of these standards to be considered "sufficient for its intended use and substantially equivalent to legally marketed predicate devices."

The document provides a general statement about the performance:

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

This information is not provided in the document. For mechanical testing, the sample size would refer to the number of physical devices or components tested. The term "data provenance" (country/retrospective/prospective) is typically for clinical data or imaging, which is not the focus of this particular submission.

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/provided. Since this is a physical device, the "ground truth" is established by the mechanical properties of the materials and the structural integrity of the design, measured by engineering tests, not by expert medical interpretation.

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

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from multiple human readers for diagnostic studies, which is not relevant here.

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

This information is not applicable/provided. This type of study applies to AI-assisted diagnostic devices. The LSTS-PS is a surgical implant.

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

This information is not applicable/provided. This question pertains to AI algorithm performance.

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

The "ground truth" for this device is based on engineering benchmarks and material specifications derived from the ASTM standards mentioned. This includes material properties, mechanical strength under various loads (static, dynamic, compression, torsion, shear), and resistance to fatigue.

8. The sample size for the training set

This information is not applicable/provided. "Training set" refers to data used to train an AI algorithm. In this context, there is no AI algorithm being developed or cleared. If interpreted very broadly, "training" for mechanical design might refer to iterative design processes, but typical sample sizes for training sets are not relevant here.

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

This information is not applicable/provided. As above, there is no "training set" in the context of an AI algorithm. The design and manufacturing of the physical device would follow engineering principles and material science, where performance targets are established based on industry standards and predicate device characteristics.

Ask a specific question about this device

The Anterior Spine Truss System - Stand Alone (ASTS-SA) Interbody Fusion Device is a stand-alone interbody fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbosacral spine at one or two contiguous disc levels. Each interbody fusion device is intended to be used with three titanium alloy screws which accompany the implant. Hyperlordotic implants (>20° lordosis) are intended to be used with supplemental fixation (e.g. posterior fixation). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. ASTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the lumbosacral spine and are placed via an anterior approach at the L2 to S1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's anatomy. Screws are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation.

This document is a 510(k) Premarket Notification from the FDA regarding the "Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device." It confirms the substantial equivalence of the device to legally marketed predicate devices.

Based on the provided text, the document primarily addresses regulatory clearance through substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed device performance results (e.g., sensitivity, specificity, accuracy).

Therefore, I cannot extract the information required for a study proving the device meets acceptance criteria as the provided document does not contain such a study report. It focuses on the regulatory approval process based on comparison to existing devices.

The document states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
• "4WEB, Inc. has compared these devices to the previously cleared predicate devices in regards to indications for use, materials, function, sizes and mechanical test results. These comparisons demonstrate substantial equivalence to the predicate devices."
• "4WEB, Inc. concludes that the ASTS-SA devices are substantially equivalent to the predicate devices and raise no new questions of safety or effectiveness."

It lists "Performance Standards" (ASTM F2077, ASTM F2267-04, Expulsion testing, and MR Conditional testing standards) but does not provide the results of these tests or specific acceptance criteria with corresponding numerical performance metrics for the ASTS-SA device. It only states that "Performance testing has been completed per the following standards."

Therefore, I am unable to fill out the requested table and answer the specific questions about device performance against acceptance criteria, sample sizes, ground truth establishment, or human reader studies, as this information is not present in the provided FDA 510(k) clearance letter.

Ask a specific question about this device

The Cervical Spine Truss System – Stand Alone (CSTS-SA) Interbody Fusion Device is a standalone interbody fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels and is to be used with two titanium alloy screws which accompany the device. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. CSTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment with the devices.

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's anatomy. Screws are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation.

The provided text is a 510(k) summary from the FDA for a medical device called the Cervical Spinal Truss System-Stand Alone (CSTS-SA). It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study to prove performance against specific acceptance criteria for an AI/software device.

Therefore, many of the requested categories for AI/software device studies are not applicable or cannot be extracted from this document, as this is a hardware device submission.

Here's an analysis based on the information available:

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

The document does not specify "acceptance criteria" in the typical sense for an AI/software device (e.g., sensitivity, specificity, AUC thresholds). Instead, it refers to performance standards for a physical medical implant.

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

Not applicable for this type of device and submission. The "test set" would refer to the physical devices tested according to the ASTM standards. The document doesn't provide details on the number of devices or units tested for each standard. Data provenance is not relevant in the context of device mechanical testing.

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

Not applicable. Ground truth, in this context, would be the physical properties and structural integrity of the device, established through standardized engineering tests, not expert human review of data.

4. Adjudication method for the test set

Not applicable. Testing is based on objective measurements 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 a physical interbody fusion device, not an AI/software product that assists human readers.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used

The "ground truth" for the device's performance is established by the specified ASTM and industry standards for mechanical and MR conditional testing. Compliance with these standards indicates the device performs as expected for its intended physical function.

8. The sample size for the training set

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

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

Not applicable.

Ask a specific question about this device

The Hammertoe Truss System (HTS) is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the Hammertoe Truss System (HTS) can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

The 4WEB HTS implants consists of a series of titanium implants that are designed to provide stability and fixation of the lesser toes in the foot. The 4WEB HTS implants have proximal and distal fixation features to provide structural support and will be offered in multiple sizes to accommodate various patients' anatomy. The implants are manufactured from Ti6Al4V alloy. Each implant is available in a sterile/packaged form.

This document is a 510(k) summary for the Hammertoe Truss System (HTS), a medical device intended for fixation of osteotomies and reconstruction of lesser toes. It does not describe an AI/ML powered device, and therefore the requested information about acceptance criteria and studies proving the device meets them in the context of AI/ML are not applicable here.

However, I can extract the relevant performance testing information for this physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of numerical thresholds for each test. Instead, it refers to performance testing completed "per the following standards," implying that compliance with these standards and their methodologies serves as the acceptance criteria. The "reported device performance" is implicitly that the device met these standards, leading to the conclusion of substantial equivalence.

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

This information is not provided in the document. The document refers to "Performance testing has been completed per the following standards," but does not detail the specific sample sizes used for each test or the provenance of any 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 is not applicable as this is not an AI/ML device requiring expert-established ground truth for a test set. The performance is based on physical and material testing standards.

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

Not applicable, as this is not an AI/ML device.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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

Not applicable. For this physical medical device, the "ground truth" or standard for performance is adherence to established ASTM mechanical and MR compatibility standards.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device and therefore does not have a training set.

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

Not applicable, as this is not an AI/ML device and therefore does not have a training set.

Ask a specific question about this device

The Osteotomy Truss System (OTS) is intended to be used for internal bone fractures or osteotomies in the foot, such as:

-Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus

-Opening wedge of Medial Cuneiform or Cotton osteotomies

-Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)

-Metatarsal Cuneiform osteotomies

• -Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies(TMT or Lapidus) -Hindfoot osteotomies
  These devices are intended to be used with supplemental fixation. The Osteotomy Truss System is not intended for use in the spine.

The Osteotomy Truss System is a titanium alloy implant used for correction of small bones in the foot. It is offered in three footprints and multiple sizes for each footprint with varying widths and thicknesses to accommodate a variety of small bone applications. Each device uses the 4WEB truss system of architecture. Implants are made from medical grade titanium allow (6Al4V-ELI) per ASTM F-136/ISO 5832-3.

The provided text is a 510(k) summary for a medical device (Osteotomy Truss System - OTS) and primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing. It does not contain information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of AI/algorithm performance.

Therefore, I cannot fulfill your request with the provided input text. The information requested (acceptance criteria, device performance, sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details, etc.) would be typical for a clinical study evaluating the performance of a diagnostic or AI-driven device, which is not what this 510(k) summary describes.

This document describes a submission for a metallic bone fixation appliance, and the "Non-clinical testing" section refers to mechanical and MRI compatibility tests (ASTM standards), not clinical performance or AI algorithm validation.

Ask a specific question about this device

The Cervical Spine Truss System (CSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device must be used with supplement fixation.

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's anatomy.

This document, a 510(k) Premarket Notification from the FDA, pertains to a medical device (Cervical Spinal Truss System) and does not describe acceptance criteria, performance data, or study designs for an AI/ML-based medical device. Therefore, I cannot provide the requested information.

The document discusses:

• Device Name: Cervical Spinal Truss System (CSTS) Interbody Fusion Device
• Regulation Number and Name: 21 CFR 888.3080, Intervertebral Body Fusion Device
• Regulatory Class: Class II
• Product Code: ODP
• Indications for Use: For skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one or two contiguous disc levels, used as an adjunct to fusion with autograft and/or allogenic bone graft.
• Device Description: Open architecture truss design made from Ti6Al4V alloy, manufactured via an additive process.
• Predicate Devices: Primarily 4WEB CSTS (K121741), with additional predicates K142112, K171496, and K11119.
• Performance Standards: References ASTM standards for mechanical and MR compatibility testing (e.g., ASTM F2077, F2267, F2119, F2052, F2213, F2182).
• Conclusion: The manufacturer concludes the device is substantially equivalent to the predicate devices based on comparisons of indications for use, materials, function, sizes, and mechanical test results.

There is no mention of any AI/ML components, acceptance criteria for an AI/ML model, or studies related to AI/ML performance. The document focuses on the substantial equivalence of a physical implantable device based on its design, materials, and mechanical properties compared to already cleared devices.

Ask a specific question about this device

The Lateral Spine Truss System (LSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes and lordotic angles to accommodate the patient's anatomy.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance" in the context of clinical outcomes or specific metrics for an AI/device performance study. Instead, it refers to performance testing standards that the device has met.

Note: The document refers to the successful completion of these tests as evidence of "substantial equivalence" to predicate devices, rather than a clinical performance study with specific metrics like sensitivity/specificity for disease detection.

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

This information is not provided in the document. The document describes a medical device (Lateral Spinal Truss System (LSTS) Interbody Fusion Device), not an AI algorithm or diagnostic tool that would typically involve a "test set" of patient data for performance evaluation in the context of AI. The performance testing mentioned relates to the device's physical and material properties.

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

This information is not provided as the document describes a physical medical device and its mechanical/material testing, not a diagnostic AI system requiring expert-established ground truth from a test set.

4. Adjudication Method for the Test Set

This information is not provided as it's not relevant to the type of device and testing described in the document.

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

This information is not provided. The document describes a physical interbody fusion device, not a diagnostic or assistive AI system that would typically undergo an MRMC study.

6. Standalone (Algorithm Only) Performance Study

This information is not provided. The document is about a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The concept of "ground truth" as typically understood in AI/diagnostic studies (e.g., pathology, expert consensus, outcomes data) is not applicable to the performance testing described. The "ground truth" for the device's performance would be the physical and mechanical properties measured against established engineering standards (ASTM).

8. Sample Size for the Training Set

This information is not provided as the document describes a physical medical device, not an AI system that requires a "training set" of data.

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

This information is not provided as it's not relevant to the device described.

Ask a specific question about this device

The Posterior Spine Truss System (PSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s)

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes and lordotic angles to accommodate the patient's anatomy.

The provided FDA 510(k) K171351 document describes a medical device, the Posterior Spine Truss System (PSTS) Interbody Fusion Device, but does not contain information about the acceptance criteria or a study proving that the device meets those criteria in the context of AI/ML or diagnostic performance.

This document is a marketing clearance notification for a physical medical implant, not a software device or an AI/ML diagnostic tool. Therefore, the questions related to sample size for test/training sets, experts, ground truth, MRMC studies, or standalone algorithm performance are not applicable to this submission.

The "Performance Standards" section refers to mechanical and material performance testing for the implant itself, not diagnostic accuracy or AI performance. The tests listed (ASTM F2077, F2267, F2119, F2052, F2213, F2182) are standard tests for intervertebral body fusion devices, assessing physical properties like static/dynamic compression, shear, torsion, subsidence, and MR compatibility. These are not related to diagnostic accuracy or AI performance metrics.

In summary, this document does not provide the information requested regarding acceptance criteria and studies for an AI/ML-driven device.

Ask a specific question about this device

The Anterior Spine Truss System (STS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the device must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes and lordotic angles to accommodate the patient's anatomy.

This document describes a 510(k) premarket notification for a medical device called the "Anterior Spine Truss System (STS) Interbody Fusion Device." This device is an intervertebral body fusion device made from Ti6Al4V alloy, designed with an open architecture truss to support bone growth and fusion. It's intended for skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1, and must be used with supplemental fixation and bone graft.

Based on the provided text, the document focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering performance testing (mechanical, MR compatibility). It does NOT describe a clinical study involving human patients, nor a study on an Artificial Intelligence (AI) device.

Therefore, I cannot provide information on acceptance criteria and study details related to an AI/Machine Learning device's performance against human readers or standalone performance, expert ground truth establishment, or sample sizes for training/test sets in the context of an AI study.

The acceptance criteria and "study" described in this document are related to the physical properties and mechanical performance of the implied medical device itself, not an AI component.

Here's what can be inferred about the "acceptance criteria" and "study" from the provided text, related to the physical device:

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

The document doesn't provide a direct table of specific acceptance limits alongside the exact numerical results for each test. Instead, it lists the performance standards that the device was tested against. The "reported device performance" is implicitly that the device met these standards, allowing for a finding of substantial equivalence.

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

• Sample size: Not applicable in the context of a clinical study or AI model test set. For mechanical and MR testing, "samples" would refer to the number of physical devices tested to statistically demonstrate compliance with the standards. This specific number is not provided in the document, but it's typically a small number of devices (e.g., 5-10 per test) as per the individual ASTM standards.
• Data provenance: Not applicable. These are engineering tests performed on the device itself, not on patient data.

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

This is not applicable as there is no "ground truth" in the context of a clinical or AI study. The "ground truth" for the device's performance is established by the engineering standards themselves and the results of the physical tests.

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

This is not applicable as there are no expert readers or interpretations to adjudicate in these engineering and MR compatibility tests.

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:

This is not applicable. This document describes an interbody fusion device, not an AI or imaging diagnostic device that would involve human readers.

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

This is not applicable. This document describes a physical medical implant, not an algorithm.

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

The "ground truth" for this device's performance is compliance with established engineering and material standards (ASTM standards), demonstrated through physical testing of the device.

8. The sample size for the training set:

This is not applicable as there is no training set mentioned for an AI model.

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

This is not applicable as there is no training set mentioned for an AI model.

In summary, this document is a 510(k) submission for a physical medical device (an interbody fusion device) and does not involve AI or machine learning technology, nor does it describe a clinical study with human patients in the typical sense of evaluating diagnostic or treatment effectiveness through patient outcomes. The "study" refers to the engineering performance testing to demonstrate the device meets predefined physical and material requirements.

Ask a specific question about this device

The Lateral Spine Truss System (STS) is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft bone. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The device is available in a variety of sizes to accommodate the patient's anatomy. The implant is made from Ti6Al4V alloy (ASTM F-1108).

This document refers to a 510(k) premarket notification for a medical device called the "LATERAL Spine Truss System." It is a regulatory submission, not a study report, and therefore does not contain details about specific acceptance criteria or a study that "proves" the device meets acceptance criteria in the way a clinical trial or performance study would.

Instead, the document details the regulatory process by which the device was found substantially equivalent to existing devices. Substantial equivalence in the FDA 510(k) pathway means proving that a new device is as safe and effective as a legally marketed predicate device. This is often demonstrated through comparative analysis of technological characteristics, materials, indications for use, and sometimes non-clinical performance testing.

Here's an attempt to answer your questions based on the provided text, while also highlighting what information isn't present:

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

The document does not provide a table of acceptance criteria in the typical sense (e.g., target accuracy, sensitivity, specificity values) for a diagnostic AI device, nor does it present "reported device performance" in terms of clinical outcomes or diagnostic metrics. This is a spinal implant, and the "performance" discussed is in terms of mechanical testing and equivalence to predicates.

Here's what can be inferred for mechanical testing:

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

This information is not provided in the document. The document describes mechanical testing, not a clinical study involving a "test set" of patient data in the context of AI. The "test set" would typically refer to a dataset used to evaluate an AI model's performance on unseen 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 information is not provided. This document is for a spinal implant, and the assessment of its substantial equivalence relies on mechanical testing and comparison to predicate devices, not on expert ground truth labeling of medical images or diagnostic classification.

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

This information is not provided. This concept is relevant for studies involving human readers or AI in diagnostic tasks, where disagreements in labels or interpretations might need an adjudication process. It does not apply to the mechanical testing 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

This information is not provided. MRMC studies are used to evaluate diagnostic systems, especially AI-assisted ones, and compare them against human performance. This document is for a physical orthopedic implant and does not involve AI assistance for human readers.

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

This information is not provided. The device is a physical implant, not an algorithm. Therefore, "standalone" algorithm performance is not applicable.

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

For the mechanical testing, the "ground truth" implicitly refers to established engineering standards and measurements (e.g., ASTM F2267-04) and the performance characteristics of the predicate devices. The goal is to show the new device performs equivalently or acceptably according to these engineering benchmarks, rather than clinical ground truth like pathology or outcomes data in the context of an AI study.

8. The sample size for the training set

This information is not provided. The concept of a "training set" applies to machine learning algorithms. This document is for a physical medical device.

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

This information is not provided as it's not applicable. There is no "training set" in the context of this regulatory submission for an orthopedic implant.

Ask a specific question about this device