Search Results

The Omnia Medical VBR is a vertebral body replacement system indicated for use to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e. fracture). The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The device is intended for use with supplemental fixation cleared for use in the thoracolumbar spine and is to be used with autograft and/or allograft.

The Omnia Medical VBR is manufactured from PEEK-OPTIMA™ HA Enhanced conforming to ASTM F2026 and tantalum markers conforming to ASTM F560. This implant is available in two footprint sizes and offers spacers and endplates which allow for fine adjustments of the height and lordosis to accommodate various patient anatomy. The device features a hollow center and through holes for use with autograft or allograft to encourage formation of new bone. The device is intended to be used with supplemental fixation.

The FDA 510(k) K172323 submission for the Omnia Medical VBR (Vertebral Body Replacement) provides the following information regarding its acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes the type of mechanical testing performed, but does not explicitly state numerical acceptance criteria or specific reported performance values. The primary acceptance criterion appears to be demonstrating substantial equivalence to the predicate device (Vu Mesh VBR, K070381) through these mechanical tests.

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

The document mentions that mechanical testing was performed per ASTM F2077 and ASTM F2267. These standards typically specify the number of samples required for such tests. However, the exact sample sizes used in this specific study are not explicitly stated in the provided text.

Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given that it's mechanical testing of a device, the data would have been generated experimentally in a lab setting, likely in the US where Omnia Medical, LLC is located.

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

This information is not applicable as the study described is a mechanical performance test of a medical device, not a human or animal study requiring expert-established ground truth. The "ground truth" for mechanical testing is based on established engineering principles and ASTM standards.

4. Adjudication Method for the Test Set:

This information is not applicable for mechanical performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not conducted. This type of study is typically performed for diagnostic or AI-assisted interpretation devices involving human readers. The Omnia Medical VBR is a physical implant, and its evaluation focuses on mechanical integrity.

6. If a Standalone Performance Study Was Done:

Yes, a standalone performance study was done in the form of mechanical testing of the device itself (algorithm only without human-in-the loop performance, if we consider the device's inherent mechanical properties as its "algorithm"). The document states: "Substantial equivalence is supported by the results of mechanical testing including static and dynamic compression per ASTM F2077, static and dynamic torsion per ASTM F2077, subsidence per ASTM F2267, and expulsion testing." This indicates the device's performance was evaluated independently against established standards.

7. The Type of Ground Truth Used:

The "ground truth" for this study was based on established engineering standards and regulatory requirements (ASTM F2077, ASTM F2267) which define acceptable mechanical properties for spinal implants. The device's performance was compared to these standards and to the characteristics of a legally marketed predicate device.

8. The Sample Size for the Training Set:

This information is not applicable. Mechanical testing does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable.

Ask a specific question about this device

The ShurFit CpTi-HA Coated Anterior Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. ShurFit Anterior Cervical Interbody Fusion System implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have at least six weeks of non- operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.

The ShurFit Anterior Cervical Interbody Fusion (ACIF) System consists of implants with various widths, heights and lengths to accommodate individual patient anatomy and graft material size. It is implanted from the anterior approach and packed with autogenous bone graft to facilitate fusion. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved. All components are manufactured from medical grade polyetheretherketone as described by ASTM F2026, specifically PEEK Optima LT1. The cages are included without a coating (already cleared K083118) or with a CpTi-HA (Commercially Pure Titanium -Hydroxyapatite) coating (this submission).

I am sorry, but the provided text is a 510(k) summary for a medical device (ShurFit CpTi-HA ACIF Interbody Fusion System). It describes the device, its indications for use, and a comparison to predicate devices, including a brief summary of non-clinical tests performed.

However, this document does not contain information about:

• Acceptance criteria
• A study that proves the device meets acceptance criteria.
• Reported device performance values against specific criteria.
• Sample sizes used for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size and ground truth establishment for the training set.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and mechanical testing according to established ASTM standards for interbody fusion devices and coatings. It details what tests were performed on the device and its coating (e.g., Static Axial Compression, Static Tensile Bond Strength), but not the specific quantitative results or how those results compare to pre-defined acceptance criteria for a "study that proves the device meets the acceptance criteria."

Therefore, I cannot fulfill your request for the specific details you've asked for based on the provided text. This document is a regulatory submission for device marketing clearance, not a clinical study report or a detailed performance validation study report.

Ask a specific question about this device

The Latitude-C Interbody Spacer is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease. Degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The Latitude-C Interbody Spacer is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, eg. Hyper-C Anterior Cervical Plate System.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the Latitude-C Interbody Spacer in the cervical spine.

DeGen Medical Latitude-C Cervical Interbody Spacer is a cervical interbody fusion device for anterior cervical fusion procedures. The Latitude-C spacer has teeth on its superior and inferior surfaces to prevent migration. The Latitude-C spacer comes in 5 different size footprints, and different heights ranging from 5mm to 14mm.

This document describes the DeGen Medical Latitude-C Cervical Interbody Spacer System, a medical device, and its substantial equivalence to predicate devices, rather than a study on an AI/ML device. Therefore, the requested information regarding AI/ML device performance, ground truth, and expert adjudication cannot be extracted from this document.

However, I can provide information about the non-clinical performance testing conducted for the Latitude-C Cervical Interbody Spacer System, which demonstrates its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Testing):

The document states that non-clinical testing was performed in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s”, May 3, 2004 and Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 12, 2007. The results of these studies showed that the subject device meets or exceeds the performance of the predicate devices.

While specific numerical acceptance criteria and reported performance values are not detailed in this summary, the following tests were performed to demonstrate substantial equivalence:

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

• This document describes non-clinical performance testing of a physical medical device, not an AI/ML model. Therefore, the concepts of "test set" and "data provenance" in the context of AI/ML are not applicable here. The testing involved various mechanical tests on physical samples of the device. The specific number of samples for each test is not detailed in this summary.

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

• Not applicable as this is not an AI/ML device and does not involve ground truth established by experts for a test set. The "ground truth" for these tests would be the established engineering standards and predicate device performance.

4. Adjudication method 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:

• For the non-clinical performance testing, the "ground truth" implicitly refers to the established engineering specifications, performance standards outlined in ASTM and FDA guidance documents, and the performance characteristics of the legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device and therefore no training set was involved.

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

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

Ask a specific question about this device