Search Results

The Apollo Spine Venus Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 4.5mm and 5.5 mm screws. For transfacet fixation the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The Apollo Venus Facet System is indicated for treatment of any or all of the following:

• Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity
• Spondylolisthesis
• Spondylolysis
• Degenerative disk disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies
• Degeneration of the facets with instability
• Trauma including spinal fractures and/or dislocations

The Venus Facet Screw System consists of two separate diameter screws and is provided in variable lengths for cervical and lumbar use. The screws have small fenestration in the threaded portion. The system includes a cervical and lumbar facet screws. The system screws provide fixation and are designed to connect vertebral facets, resulting from such causes as degenerative disease and/or trauma. These screw kits are considered a 'family' product line with sizes based on the anatomical variations of the patient's facets. The materials contained in the device include implant grade titanium alloy, Ti-6AI-4V (ELI) per ASTM F-136. The device is sold non-sterile and is to be sterilized at the end use facility by steam sterilization. The Venus Facet Screw System is a single use device.

The provided text is a 510(k) Premarket Notification for the Apollo Spine Venus Facet Screw System. It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving device performance against such criteria in the context of a software or AI device.

The document details the mechanical properties and materials of the Venus Facet Screw System through performance testing, which is standard for implantable medical devices. However, it does not involve any AI, software, or imaging analysis that would require the typical components of device performance studies (like sample size for test/training sets, expert ground truth, adjudication methods, or MRMC studies) that you've listed.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to AI/software.
• Sample sizes for test sets or data provenance for AI/software.
• Number/qualifications of experts for AI/software ground truth.
• Adjudication method for AI/software test sets.
• Multi-reader multi-case (MRMC) comparative effectiveness study information.
• Standalone (algorithm only) performance information.
• Type of ground truth used for AI/software.
• Sample size or ground truth establishment for a training set (AI/software).

The study mentioned in the document focuses on mechanical performance standards for the physical screw system:

• Performance Standards: Performance testing and engineering analysis were conducted to characterize the performance of the Apollo Spine Venus Facet Screw System.
• Testing Performed: Dynamic and static three-point bend per ASTM F1264-03, cantilever bend per ASTM F2193, torsion and axial pull-out testing per ASTM F543.
• Device Performance: "The device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate devices."
• Conclusion: "Mechanical testing and engineering analysis demonstrated comparable mechanical properties to the predicate devices. Equivalency of this device to the predicate devices is based on similarities in intended use, materials and design in combination with acceptable mechanical performance properties."

This information speaks to the physical integrity and strength of the implant, not the diagnostic or analytical performance of an AI or software device.

Ask a specific question about this device

The Zenith Pedicle System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, trauma (i.e., fracture or dislocation), deformities or curvatures ( i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3-S1) with removal of implants after the attainment of a solid fusion.

The Apollo Spine Zenith Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Multi axial implant screws are supplied in 5.5mm, 6.5mm, 7.5mm and 8.5mm diameter sizes. All sizes are able to receive 5.5 mm connecting rods only. All implant components are fabricated from medical grade titanium alloy (TI-6AI-4V ELI) conforming to ASTM F136 or equivalent.

The Apollo Spine Zenith Pedicle Screw System is a temporary implant system, intended to be removed after solid fusion has occurred. Implant components should not be used with components from any other system or manufacturer. As with all orthopedic implants, components should not be reused.

The provided text describes the Apollo Spine Zenith Pedicle System, a spinal implant system. The regulatory submission primarily focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than an AI/ML-driven device with performance criteria based on clinical or diagnostic accuracy.

Therefore, many of the requested criteria related to AI/ML device performance, such as sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a separate "test set" for performance evaluation in the context of AI/ML. The "samples" referred to are test articles (medical device components) used in mechanical testing. The dynamic compression testing included "2 runout samples to 5 million cycles," indicating at least two physical samples for that specific test.
• Data Provenance: Not applicable in the AI/ML sense. The data is generated from laboratory mechanical testing of the device components.

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

• Not applicable. This submission is for a physical medical device and relies on engineering standards (ASTM F 1717-04) for performance validation, not expert-derived ground truth for diagnostic accuracy.

4. Adjudication method for the test set

• Not applicable. This relates to concordance among expert readers, which is irrelevant 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 not an AI-assisted diagnostic device.

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

• Not applicable. This is not an algorithmic device.

7. The type of ground truth used

• The "ground truth" for this device's performance is adherence to the ASTM F 1717-04 standard for spinal implant mechanical testing and the demonstration of substantial equivalence to predicate devices based on the results of these tests and their known performance.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device and does not involve a training set.

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

• Not applicable. This is not an AI/ML device and does not involve a training set.

Ask a specific question about this device

When used as an Intervertebral Body Fusion System:

The Eclipse Vertebral Spacer System-Lumbar is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine with accompanying radicular symptoms at one disc level from L2-S1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse Vertebral Spacer System-Lumbar implants are to be used with autogenous bone graft. Supplemental fixation is required.

When used as a Vertebral Body Replacement Device:

The Eclipse Vertebral Spacer System-Lumbar when used as a vertebral body replacement is intended for use for partial and total replacement of a vertebral body that has been resected or excised due to tumor and/or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine at a single level from TI-L5. These devices are intended to be used with autogenous bone graft. Supplemental fixation is required.

The Eclipse Vertebral Spacer-Lumbar acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Eclipse Vertebral Spacer is manufactured from PEEK, unalloyed titanium, and Ti6Al4V titanium alloy. The device contains serrations on the superior and inferior surfaces and includes positioning pins that are advanced during placement. Pins are used to aid in the positioning and to allow for radiographic confirmation during device placement.

This document describes a 510(k) premarket notification for the "Eclipse Vertebral Spacer-Lumbar," an intervertebral body fusion device and vertebral body replacement device. This summary focuses on the safety and effectiveness studies, which are primarily non-clinical bench tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of Acceptance Criteria: The document explicitly states that "Test results for each of the above studies confirm that the Eclipse Vertebral Spacer is substantially equivalent to the predicate devices." For a 510(k) submission, "substantial equivalence" means the new device is as safe and effective as a legally marketed predicate device. Therefore, the implied acceptance criteria for each test is that the Eclipse Vertebral Spacer's performance must not be significantly different from, and ideally match or exceed, the performance of the identified predicate devices in these specific mechanical and material tests. The guidance document "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" (FDA, June 12, 2007) would provide the specific test parameters and potentially quantitative acceptance ranges for such devices, against which the predicate and new device would be compared.

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

• Sample Size for Test Set: Not specified, as this refers to the number of physical device units tested in the non-clinical bench studies.
• Data Provenance: The studies are non-clinical bench tests. The document does not specify the location where these tests were conducted, nor if they were retrospective or prospective, as these terms are generally not applicable to bench testing.

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

• Not applicable. For non-clinical bench testing, "ground truth" is established by adherence to standardized testing protocols (e.g., ASTM standards) and objective physical measurements. Expert consensus in a medical context (like for image interpretation) is not relevant here.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert opinions, typically in clinical studies or when reviewing medical images. This document describes mechanical bench testing only.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance:

• No, an MRMC comparative effectiveness study was not done. This submission is for a physical medical device (intervertebral spacer), not an AI/software device that assists human readers.

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

• No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

• Mechanical and Material Properties: The ground truth for these non-clinical tests is based on the established mechanical and material properties of the predicate devices and the requirements outlined in the FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device." This involves objective measurements of static and dynamic compression, shear forces, subsidence, and wear debris analysis.

8. The Sample Size for the Training Set:

• Not applicable. This submission describes non-clinical bench testing for a physical implant. There is no "training set" in the context of machine learning or AI algorithm development.

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

• Not applicable. As there is no training set, there is no ground truth to establish for it.

Ask a specific question about this device

The Eclipse Vertebral Spacer System-Cervical is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2 to T1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse Vertebral Spacer System-Cervical implants are to be used with autogenous bone graft. Supplemental fixation is required.

The Eclipse Vertebral Spacer-Cervical acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Eclipse Vertebral Spacer is manufactured from PEEK, unalloyed titanium, and Ti6Al4V titanium alloy.

The provided text describes a 510(k) premarket notification for the Apollo Spine Eclipse Vertebral Spacer-Cervical, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices primarily through mechanical testing and does not involve a study related to AI or a device that uses algorithms/software for performance evaluation.

Therefore, many of the requested points regarding AI/algorithm performance and clinical study design are not applicable to this submission.

Here's an analysis of the available information:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The acceptance criteria for the Eclipse Vertebral Spacer-Cervical, as presented in this 510(k) submission, are based on demonstrating mechanical equivalence to legally marketed predicate devices by conforming to established ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices.

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

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

This document summarizes mechanical testing, not a clinical study involving human patients. Therefore, terms like "test set," "data provenance," "country of origin," "retrospective," or "prospective" are not applicable in their traditional sense for clinical data. The "samples" would refer to the Eclipse Vertebral Spacer devices manufactured for testing. The summary does not specify the number of devices tested for each mechanical test. The testing was performed in the context of a premarket notification in the USA.

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. The "ground truth" for mechanical testing is established by the specified ASTM standards and the measurements obtained during testing in a laboratory setting by qualified engineers/technicians, not by medical experts forming a consensus.

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

Not applicable. Adjudication methods like 2+1 (two readers, one adjudicator if there's a disagreement) are relevant for clinical studies involving reader interpretations, not for mechanical bench 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

Not applicable. This device is a passive implant (intervertebral spacer) and does not involve AI or software for interpretation, nor a human-in-the-loop scenario. The submission is for a physical medical device.

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

Not applicable. As noted above, this device does not incorporate an algorithm or AI component.

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

For the mechanical testing, the "ground truth" is defined by the objective performance requirements outlined in the referenced ASTM standards (e.g., maximum load, cycles to failure, displacement limits). The device's performance is measured against these engineering specifications, and against publicly available data for predicate devices.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/machine learning device.

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

Not applicable. There is no training set or AI model involved.

Ask a specific question about this device

The Comet Anterior Cervical Plate System is intended for anterior fixation. immobilization and stabilization of adjacent cervical vertebral bodies as an adjunct to intervertebral fusion by autogenous and/or allogenic bone graft.

The Comet Anterior Cervical Plate System is indicated for anterior cervical fixation (levels C2-C7) for the following indications: degenerative disc disease (defined as neck pain of disogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Multi-level anterior cervical plates and fixation screws are being added to the previously cleared single-level Comet Anterior Cervical Plate System. The multi-level device additions consist of duallevel plate lengths ranging from 24mm through 48mm and triple-level plate lengths ranging from 36mm through 72mm. Similarly to the single-level devices, the multi-level devices contain barbed plate fixation pins that are permanently affixed to the plate. Plate fixation screws are used to secure the plate to each vertebrae. An additional plate fixation screw diameter is being added in a 3.3mm diameter in 14mm, 16mm and 18mm lengths.

The provided text describes a medical device, the "Comet Anterior Cervical Plate System," and its performance testing in support of a 510(k) premarket notification. However, it does not contain information about a study involving AI, human readers, or image analysis.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes bench tests for the device, not clinical studies with patient data. Therefore, there is no "test set" in the context of human or imaging data, nor data provenance (country of origin, retrospective/prospective). The tests were performed in a standardized vertebral body model.

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

Not applicable. This was a mechanical engineering bench test, not an evaluation of diagnostic accuracy requiring expert consensus on images.

4. Adjudication Method for the Test Set

Not applicable. (See #3)

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. The provided text describes the mechanical testing of a medical implant, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or reported here.

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

No. This is not an AI algorithm.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" would be the established engineering standards and specifications against which the device's mechanical performance was measured (e.g., specific load endurance, displacement limits).

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable. (See #8)

Ask a specific question about this device

The Comet Anterior Cervical Plate System is indicated for anterior cervical fixation for the following indications: degenerative disc disease, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Comet Anterior Cervical Plate System consists of an anterior cervical plate offered in lengths ranging from 10mm through 22mm. Four (4) barbed plate fixation pins are permanently affixed to the plate. A set of two (2) plate fixation screws are used to secure the plate to the superior and inferior vertebrae. Plate fixation screws are offered in two (2) diameters, each in 14mm, 16mm lengths.

The provided text describes a medical device, the Comet Anterior Cervical Plate System, and its clearance through the 510(k) process. This process is for demonstrating substantial equivalence to a predicate device, not for proving independent efficacy or safety through clinical trials in the way an AI/ML device would. Therefore, many of the requested categories for AI/ML device studies are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the Comet Anterior Cervical Plate System were based on demonstrating substantial equivalence to a predicate device (Synthes Anterior Cervical Plate System) and meeting pre-determined criteria through bench testing.

The study that "proves" the device meets the acceptance criteria is the Performance Testing described, which consisted of bench tests.

Specific Information Requested - Not Applicable for this Device Type:

The following requested information is not applicable to this 510(k) submission for a physical medical implant device. These questions are typically relevant for AI/Machine Learning (AI/ML) powered devices or diagnostic tools that involve analyzing data sets with ground truth established by experts.

• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi reader multi case (MRMC) comparative effectiveness study was done
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

Explanation:

The Comet Anterior Cervical Plate System is a physical medical implant. Its clearance relies on demonstrating that its design, materials, and mechanical properties are comparable to an already legally marketed device (predicate device) and that it meets specific engineering performance standards via bench testing (laboratory tests, not clinical studies involving human patients or complex data analysis by AI). There is no "test set" of patient data, "ground truth" derived from expert consensus on images, or AI algorithms to train in this context.

Ask a specific question about this device