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When used as a cervical intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.

The Zavation IBF implants offers a variety of heights, widths and lengths. There are six main configurations: ALIF, LLIF, TLIF, T-PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone).

The Zavation IBF implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. This modification seeks clearance for the addition of PEEK devices coated with a plasma-spray Titanium coating. The Titanium coated implants will be provided non-sterile.

The provided text is a 510(k) summary for the Zavation IBF System, which is an intervertebral body fusion device.

Crucially, this document is a premarket notification for a medical device (an implant) and not for an AI/ML-based medical device. Therefore, the information requested in the prompt, such as acceptance criteria for AI model performance, sample sizes for test sets, ground truth establishment, MRMC studies, and training set details, is not applicable to this document.

The "Performance Data" section in the document refers to mechanical and material testing of the implant itself, specifically related to the addition of a titanium coating, and not to the performance of an AI algorithm.

To answer your request, if this were an AI device, here's what would be expected based on the prompt's structure:

Based on the provided document, it is not possible to answer the detailed questions regarding acceptance criteria for an AI/ML-based medical device, as this 510(k) pertains to a physical intervertebral body fusion implant, not an AI algorithm.

The "Performance Data" section in the document refers to the mechanical and material performance testing of the implant and its coating, not the performance of an AI algorithm.

If this document were for an AI/ML medical device, the information would typically include:

1. Table of Acceptance Criteria and Reported Device Performance:
This would typically list metrics like sensitivity, specificity, AUC, recall, precision, F1-score, etc., along with the pre-defined target values (acceptance criteria) and the actual achieved performance of the AI model. Since this is a physical device, these metrics are irrelevant.

2. Sample Size and Data Provenance:
For an AI device, this would detail the number of cases (e.g., images, patient records) in the test set, their country of origin, and whether the data was collected retrospectively or prospectively. The current document makes no mention of AI test data.

3. Number of Experts and Qualifications for Ground Truth:
For an AI device, this would specify how many experts (e.g., board-certified radiologists, pathologists) annotated the test data to establish the "ground truth" (the correct diagnosis or finding). It would also detail their experience level. This is not applicable to a physical implant.

4. Adjudication Method for the Test Set:
This would describe how disagreements among experts were resolved (e.g., 2+1 means two experts agree, or a third expert adjudicates if they disagree). This is for AI model validation, not implant testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
If performed for an AI device, this would assess if human performance (e.g., radiologists' accuracy) improved when assisted by the AI compared to working without it. The effect size would quantify this improvement. Not applicable here.

6. Standalone (Algorithm Only) Performance:
This would describe the performance of the AI algorithm operating independently without human intervention. Not applicable here.

7. Type of Ground Truth Used:
For an AI device, this would specify how the "truth" was determined for the test cases (e.g., consensus of multiple experts, pathological confirmation, long-term patient outcomes). For a physical implant, ground truth relates to mechanical properties validated by ASTM standards.

8. Sample Size for the Training Set:
For an AI device, this is the number of data points used to train the algorithm. This is not mentioned as no AI is involved.

9. How Ground Truth for the Training Set was Established:
For an AI device, this would explain the process for labeling the data used to train the model, often involving similar expert annotation or established medical records. This is not applicable to this physical device.

What the document does describe under "Performance Data" (relevant to the physical implant):

The performance data listed relates to biocompatibility and mechanical testing of the Zavation IBF System implants, particularly concerning the addition of a titanium coating. This includes:

• ASTM F2077, Test Methods for Intervertebral Body Fusion Devices:
  • Static Axial Compression
  • Dynamic Axial Compression
  • Static Torsion (cervical)
  • Dynamic Torsion (cervical)
• Coating properties evaluated using:
  • ASTM F1147 (Tensile Bond Strength)
  • ASTM F1044 (Shear Fatigue Strength)
  • ASTM F1160 (Static Shear Strength)
  • ASTM F1854 (Abrasion Test)
  • ASTM F1978 (Metallurgical Testing and Image Analysis)

The document states that "no additional testing was performed for the purpose of this submission" because the new titanium coating's specifications were identical to an already cleared predicate device (K150061 Lucent Ti-Bond®), and the original Zavation IBF System (K181246) had already undergone the listed ASTM tests. This implies that the acceptance criteria for this modification were met by demonstrating equivalence to previously cleared devices through adherence to established ASTM standards for intervertebral body fusion devices and their coatings.

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The AUDERE Lumbar Spacer 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) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the AUDERE Lumbar Spacer System.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the AUDERE Lumbar Spacer System.
The AUDERE Lumbar Spacer System is designed for use with autogenous bone graft. The system is also intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbar spine.

The AUDERE Lumbar Spacer System consists of implants and trials that are compatible with all previously cleared AUDERE instruments. The AUDERE Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transforaminal (TLIF) approach.

The provided text describes a medical device, the AUDERE Lumbar Spacer System, and its FDA 510(k) clearance (K193457). However, the document does not contain information about acceptance criteria for an AI/algorithm-based device, nor does it detail a study proving device performance in the context of AI.

This document is for a physical implantable medical device (intervertebral body fusion device), not a software or AI-driven diagnostic/treatment device. The performance data section refers to non-clinical mechanical testing (e.g., static axial compression, dynamic axial compression, expulsion, subsidence) demonstrating the physical strength and durability of the implant, not the diagnostic or analytical performance of an algorithm.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/algorithm device from the provided text. The questions about sample size, data provenance, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this document.

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The VIRTU Lumbar Spacer 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) with up to Grade 1 spondylolisthesis or retrolisthessis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the VIRTU Lumbar Spacer System.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the VIRTU PLIF/TLIF System.

The VIRTU Lumbar Spacer System is designed for use with autogenous bone graft to facilitate fusion. The system is also intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The VIRTU Posterior Lumbar Spacer System consists of implants, trials and instruments. The VIRTU Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transforaminal (TLIF) approach.

This document describes a 510(k) premarket notification for the "VIRTU Lumbar Spacer System", a medical device. As such, it does not present independent clinical studies or acceptance criteria for AI/ML device performance. Instead, it demonstrates substantial equivalence to predicate devices based on non-clinical performance data.

Therefore, many of the requested categories for AI/ML device performance (like sample size for test set, ground truth experts, MRMC studies, standalone performance, training set size, etc.) are not applicable to this submission.

However, I can extract information related to the device's non-clinical performance acceptance criteria and the study that proves it meets them.

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

Based on the document, the acceptance criteria are implicitly tied to demonstrating performance "sufficient for its intended use" and "substantially equivalent to legally marketed predicate devices." While specific numerical acceptance criteria are not explicitly stated in the provided text, the device was tested against recognized ASTM standards. The reported device performance is that it met these standards and was found to be substantially equivalent.

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

The document does not specify the sample size for the mechanical tests. The data provenance is "non-clinical testing" conducted by the submitter (Met 1 Technologies, LLC). This is laboratory testing, not human patient 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)

Not applicable. This is mechanical testing to established engineering standards, not human expert consensus. The "ground truth" is adherence to the specified ASTM testing methodologies and achieving results comparable to predicate devices.

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

Not applicable. This is mechanical testing, not a clinical trial with human disagreement.

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 spinal implant device, not an AI diagnostic tool.

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

Not applicable. This is a spinal implant device, not an AI algorithm.

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

For the non-clinical performance data, the "ground truth" is adherence to established mechanical testing standards (ASTM standards) and the resultant data demonstrating the device's mechanical properties. The benchmark for "sufficient" is implied to be comparable performance 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 Leva® Spacer System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The Leva® Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The Leva® Spacer System is a lumbar intervertebral body fusion device fabricated from unalloyed commercially pure (Class II) titanium per ASTM F67. The device is available in both expandable and fixed configurations. The expandable device is provided in a collapsed form and is expanded to a predefined height in-situ using the Leva® Inserter Instrument. Both the fixed and expandable implants are provided in different heights and shapes (convex or lordotic) to accommodate the anatomical needs for a range of patients. The implants are designed to accommodate autogenous bone graft material. The implants have curved endplates to conform to the bony endplates of the patient and ridges on the endplates to resist expulsion.

This document describes a 510(k) premarket notification for the Leva® Spacer System, specifically a line addition including new 10° lordotic implant sizes. It is a medical device, not an AI/ML product, and therefore the standard AI/ML acceptance criteria and study aspects you've asked for (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set sample size) are not applicable or described in this document.

The document discusses mechanical testing to demonstrate substantial equivalence to predicate devices, which is the relevant "performance data" for this type of medical device.

Here's an attempt to answer your questions based on the provided text, primarily focusing on what is present. Much of your requested information is for AI/ML devices and is not found in this document for a physical medical implant.

1. Table of acceptance criteria and the reported device performance

Since this is not an AI/ML device, the "acceptance criteria" discussed are primarily about mechanical performance and substantial equivalence to legally marketed predicate devices, rather than statistical performance metrics like sensitivity, specificity, or AUC.

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

• Sample Size for Test Set: This information is not provided in the document. The testing involved mechanical measurements on the device itself, not clinical data or data from a "test set" in the AI/ML sense.
• Data Provenance: Not applicable. The "data" refers to mechanical test results from the fabricated implants, not patient 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)

Not applicable. "Ground truth" in the context of this device refers to established mechanical engineering standards and the performance of predicate devices, not expert human assessment of images or clinical outcomes.

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

Not applicable. There's no "adjudication" in the AI/ML sense for mechanical testing.

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

No. This is a physical medical implant, not an AI-assisted diagnostic tool.

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

No. This is a physical medical implant.

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

The "ground truth" for demonstrating the safety and effectiveness of this device (a physical implant) is based on established mechanical engineering standards (ASTM F2077, ASTM F2267) and comparison to the performance of legally marketed predicate devices. These standards dictate acceptable performance parameters for intervertebral body fusion devices.

8. The sample size for the training set

Not applicable. There is no "training set" for physical implant device testing in the AI/ML sense.

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

Not applicable. There is no training set mentioned or implied in the context of this device's evaluation.

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The Spine Wave Gen II Expandable Interbody System is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1 when implanted using a posterior surgical approach and levels L2-L5 when implanted using a lateral surgical approach. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The Gen II Expandable Interbody System is composed of wafers that are stacked into an expandable implant to adjust the height of the implants are manufactured of titanium alloy (Ti-6AI-4V, ASTM F136), PEEK-OPTIMA with 6% BaSO4, and commercially pure titanium (ASTM F1580). The Spine Wave Gen II Expandable Interbody System Implants are provided in various configurations to address the anatomical needs of a variety of patients and to accommodate various surgical approaches to the lumbar spine. The implants are to be used with autogenous bone graft material and supplemental fixation. The System also includes a delivery device that is used to both place and expand the implant. The implants are provided sterile.

The provided text does not contain information regarding software or AI device performance, acceptance criteria, or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification summary for a medical device called the "Spine Wave Gen II Expandable Interbody System," which is a physical implant for intervertebral body fusion procedures.

The information provided covers:

• Device Name: Spine Wave Gen II 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: Intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at specific levels (L2-S1 posterior surgical approach, L2-L5 lateral surgical approach), used with autogenous bone graft and supplemental fixation, after at least six months of non-operative treatment.
• Device Description: Composed of titanium alloy, PEEK-OPTIMA with BaSO4, and commercially pure titanium wafers stacked into an expandable implant. Includes a delivery device and is provided sterile.
• Predicate Devices: Multiple predicate devices from Spine Wave, Globus Medical Inc., LDR Spine USA, Ulrich GmbH & Co. KG, Biomet Spine, and Synthes Spine Co. LP.
• Non-Clinical Performance Data: Lists various ASTM standards for testing coating microstructure, shear testing, shear fatigue testing, tensile testing, abrasion testing, static and dynamic axial compression, static and dynamic compression shear, subsidence, and wear debris analysis. These are mechanical and material property tests for the physical implant, not software.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving a device meets acceptance criteria related to a software or AI device, as that information is not present in the provided document.

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The DePuy Synthes T-PAL Ti Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacers should be packed with autogenous bone graft (i.e. autograft).

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.

The T-PAL Spacers are intended to be used with DePuy Synthes supplemental fixation.

The DePuy Synthes T-PAL Ti Spacer is an interbody fusion device used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy. Previously, only T-PAL Spacers manufactured from PEEK (With TAN marker pins) material were available. The subject T-PAL Ti spacers will be manufactured entirely of TAN per ASTM F1295. The T-PAL Ti Spacer is available in two footprints and a range of heights and is angulated 5° to accommodate the lordotic curve (except for the smallest height of each footprint, which does not have a lordotic angle). Pyramidal teeth that assist in stabilization of the construct are located on the inferior and superior surfaces of the spacers. These teeth are oriented along a contour that follows the curve of the implant to assist in implantation. A bullet-nose design also facilitates self-distraction and ease of insertion. The open architecture of the devices allows them to be packed with autogenous bone graft material, i.e. autograft.

This document is a 510(k) premarket notification decision letter from the FDA regarding the DePuy Synthes T-PAL Ti Spacer. It is not a study demonstrating acceptance criteria or device performance in the context of an AI/algorithm-driven medical device.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and the reported device performance: This document does not contain performance metrics that would be applicable to an AI device. The "performance data" mentioned (Section H) refers to a Finite Element Analysis of the physical implant, not an AI algorithm's performance.
• Sample size for the test set and data provenance: No such data is presented.
• Number of experts and qualifications for ground truth: Not applicable to this type of device submission.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not conducted as this is a physical implant, not an AI device.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: No training data for an algorithm is mentioned.
• How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide:

The document concerns the regulatory clearance (510(k)) of a new version of an existing intervertebral body fusion device, the DePuy Synthes T-PAL Ti Spacer. The key aspects are:

• Device: DePuy Synthes T-PAL Ti Spacer (an intervertebral body fusion device).
• Changes from predicate: The main changes are a material change (from PEEK to Ti-6Al-7Nb (TAN) ASTM F-1295 titanium alloy), a sterilization modality change, and a minor design modification.
• Intended Use: For patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, requiring interbody fusion with supplemental fixation. The spacers must be packed with autogenous bone graft. DDD is defined by back pain of discogenic origin, confirmed by history and radiographic studies, in skeletally mature patients who have had six months of non-operative treatment.
• Predicate Device: Synthes T-PAL Spacer (K100089) and Patriot Signature® Ti Spacer (K122097).
• Demonstration of Equivalence: The submission asserts that the new device is substantially equivalent to the predicate devices because the intended use, performance, and technology remain "identical" despite the material and minor design changes.
• Performance Data (for the physical implant): A Finite Element Analysis (FEA) simulating static/dynamic axial compression and compression shear was performed to demonstrate that the proposed modifications do not introduce a "new worst case" regarding the physical implant's mechanical performance. This is not performance data for an AI algorithm.
• Conclusion: The FDA determined substantial equivalence based on the unchanged intended use and similar technological characteristics, with FEA and post-market data supporting that the changes do not raise new questions of safety and effectiveness.

In essence, this document is a regulatory approval letter for a medical implant, not a study of an AI device's performance against acceptance criteria.

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