Search Results

Rampart O and Rampart P are intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.

These devices may be implanted singly or in pairs via an open or a minimally invasive posterior or transforaminal approach.

Rampart O and Rampart P are designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

The Spineology Rampart O and P Devices are designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The device is available in a range of lengths and heights. The device and associated instruments are provided non-sterile.

This document is a 510(k) summary for the Spineology Rampart O and P Devices, which are intervertebral body fusion devices. The purpose of this 510(k) is to add devices as small as 20 mm in length and to add products that include features allowing for rotation of the devices after insertion on implants with tantalum markers.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets the criteria:

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

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: The document does not specify a "test set" in the context of human data. The testing mentioned is preclinical. For preclinical mechanical testing, sample sizes would typically be several units per test condition to ensure statistical robustness, but the exact numbers are not provided in this summary.
• Data Provenance: The data is preclinical testing. The country of origin and whether it's retrospective or prospective are not applicable to the type of testing described (mechanical testing).

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 section is not applicable as the provided text describes preclinical mechanical testing of an intervertebral body fusion device, not an AI/software device that requires expert-established ground truth for a test set.

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

This section is not applicable for the same reason as point 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

This section is not applicable. The device is an intervertebral body fusion device, which is a physical implant, not a software or AI tool requiring MRMC studies for human reader performance.

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

This section is not applicable as the device is not an algorithm or AI.

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

For the preclinical testing, the "ground truth" would be established by engineering standards and physical measurements based on ASTM F2077. For instance, load cells and displacement sensors would provide objective data on static compression and shear forces, which are then compared against performance characteristics of predicate devices.

8. The sample size for the training set

This section is not applicable as the device is not an AI/machine learning model that requires a training set.

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

This section is not applicable for the same reason as point 8.

Ask a specific question about this device

The Spineology PEEK Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices may be implanted via an open or a minimally invasive transforaminal approach. The Spineology PEEK Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

The Spineology PEEK Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The device is available in a range of lengths and heights and is made of PEEK Optima LT1. The device and associated instruments are provided non-sterile.

The document provided is a 510(k) Pre-market Notification for a medical device, the Spineology PEEK Lumbar Interbody Fusion Device. It describes the device, its intended use, and its substantial equivalence to a predicate device.

Crucially, this document is for a medical implant (an intervertebral fusion device), not a diagnostic algorithm or AI software, and therefore the concepts of "device performance," "test set," "training set," "ground truth," "experts," "adjudication," and "human-in-the-loop performance" as typically applied to AI/ML devices are not relevant here.

The acceptance criteria and the study performed for this device are related to its physical and mechanical performance and its safety and effectiveness as a physical implant for spinal fusion.

Here's an interpretation based on the provided text, re-framing the requests where appropriate for a physical medical device:

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

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

• Sample Size: The document does not specify the precise number of devices tested for the static compression testing. It only states that "Static compression testing per ASTM 2077 was performed." For mechanical testing, the "sample size" refers to the number of physical devices subjected to the test. Clinical data (like country of origin, retrospective/prospective) is not relevant here as the study is a bench-top mechanical test, not a clinical trial.
• Data Provenance: The data originates from bench-top mechanical testing conducted to ASTM F2077 standards.

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

• This concept is not applicable. For physical device mechanical testing, "ground truth" is established by adherence to recognized engineering standards (like ASTM F2077) and the physical properties and behavior of the material/device under stress conditions. The evaluation of whether the test was performed correctly and the results interpreted accurately would fall under the purview of engineering and regulatory experts, but they are not establishing a "ground truth" in the diagnostic sense.

4. Adjudication method for the test set

• This concept is not applicable. Adjudication is relevant for subjective assessments or disagreements in diagnostic interpretation. Mechanical testing involves objective measurement and comparison to predefined 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

• This concept is not applicable. MRMC studies are used for evaluating the performance of diagnostic imaging devices or algorithms that involve human interpretation. This document is about a physical spinal implant.

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

• This concept is not applicable. "Standalone performance" refers to the performance of an AI algorithm independent of human input. This device is a physical implant, not an algorithm.

7. The type of ground truth used

• The "ground truth" for the performance of this physical device is based on established engineering standards (ASTM F2077) and a comparison to the mechanical performance of a legally marketed predicate device. In essence, the predicate device's accepted mechanical performance serves as the benchmark for "truth."

8. The sample size for the training set

• This concept is not applicable. "Training set" refers to data used to train an AI model. For a physical medical device, there is no "training set" in this context. The design of the device is based on engineering principles and knowledge, not machine learning.

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

• This concept is not applicable, as there is no training set for this type of device. The "ground truth" for the design and safety requirements of such implants is established through extensive biomedical engineering research, regulatory guidelines, and clinical experience with similar devices over many years.

Ask a specific question about this device

The Spineology PEEK Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

These devices may be implanted via an open or a minimally invasive transforaminal approach.

The Spineology PEEK Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

The Spineology PEEK Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The device is available in a range of lengths and heights. The device and associated instruments are provided non-sterile.

The provided text describes a 510(k) premarket notification for the Spineology PEEK Lumbar Interbody Fusion Device. It outlines the device's characteristics, intended use, and substantial equivalence to predicate devices, primarily through pre-clinical testing. However, it does not contain information about studies involving acceptance criteria related to AI/ML device performance, human reader studies, or the establishment of ground truth for such studies.

The "Testing" section explicitly states: "The Spineology PEEK Lumbar Interbody Fusion Device was tested in compliance with FDA's guidance document titled 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device'. Preclinical testing according to ASTM F2077 and ASTM F2267. including static compression, static compression shear, dynamic axial and shear compression, and subsidence. Expulsion was also conducted. This testing demonstrated substantially equivalent performance characteristics to the identified predicate devices."

This indicates that the acceptance criteria and study described are for a physical medical device (an intervertebral fusion device), focusing on biomechanical performance and material properties. It is not an AI/ML device.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device, as the provided document does not pertain to such a device.

Ask a specific question about this device