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Elite™ Expandable implants are intervertebral body fusion devices 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 1 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.

Elite™ Expandable implants are designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

The Elite™ Expandable Interbody Fusion System is designed for use as a lumbar intervertebral body fusion device and consists of medical grade titanium alloy (Ti-6AL-4V, ELI) cages and implantation instrumentation. The cages are available in various geometries and sizes to accommodate patient anatomy. The cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft. Components of the Elite™ IBF Expandable Lumbar Fusion System should not be used with components of any other system or manufacturer.

This document does not contain information about acceptance criteria, device performance metrics, or a study specifically designed to establish acceptance criteria for the Elite™ Expandable Interbody Fusion Device.

The document is an FDA 510(k) clearance letter and a 510(k) summary for the Elite™ Expandable Interbody Fusion Device. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on proving that the device meets specific performance acceptance criteria through a clinical study or detailed non-clinical performance report.

Here's what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The document lists mechanical tests performed (ASTM F2077, F2267) and bacterial endotoxin testing, but it does not specify quantitative acceptance criteria for these tests nor does it report specific numeric results against those criteria. It only states that these tests were "conducted in accordance with FDA's Class II Special Controls Guidance Document... and applicable American Society for Testing and Materials (ASTM) standards." This implies the tests were performed to demonstrate mechanical integrity and biocompatibility, but the specific performance values and acceptable ranges are not disclosed.

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

• Test Set Sample Size: Not applicable as no specific clinical or performance test set (in the context of real-world patient data or detailed device performance metrics) is described in terms of a sample size. The "test set" here refers to the physical devices subjected to mechanical testing.
• Data Provenance: The document refers to non-clinical mechanical testing and bacterial endotoxin testing. This is laboratory-based testing, not clinical data from patients.

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

Not applicable. The document describes mechanical and biocompatibility testing of the device, not a study evaluating human interpretation or diagnosis. Therefore, there's no "ground truth" established by experts in the context of diagnostic performance.

4. Adjudication Method:

Not applicable. There's no adjudication method mentioned as this document does not describe a study involving expert review or interpretation.

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

No. An MRMC comparative effectiveness study was not done. This type of study typically assesses the performance of human readers (e.g., radiologists) with and without AI assistance, which is not relevant to this mechanical device submission.

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

Not applicable. This is a physical intervertebral body fusion device, not an algorithm or AI software. Therefore, "standalone performance" in the context of an algorithm is not relevant.

7. Type of Ground Truth Used:

Not applicable in the context of diagnostic or interpretive performance. For the mechanical and biocompatibility testing, the "ground truth" would be established by the physical properties of the materials and the manufacturing process, verified by standardized laboratory tests.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable for the same reason as point 8.

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The Opticage™ Expandable Interbody Fusion Device is a lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Expandable Interbody Fusion Device can be implanted via posterior, transforaminal, or lateral approach.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had a six month course of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.

The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

The Opticage™ Expandable Interbody Fusion Devices, Model Series 9070 are designed for lumbar intervertebral body fusion via posterior, transforaminal or lateral approach. The devices are fabricated from titanium alloy (Ti-6AI-4V) as per ASTM Fl36. Each device consists of an upper and lower titanium plate, two titanium wedges and a central shaft. The two titanium wedges are connected by the central shaft. The shaft can be rotated to move the wedges toward the center of the device thereby increasing the distance (i.e. height) between the upper and lower titanium plates. Alternatively, the shaft can be rotated in the opposite direction to move the wedges away from the center of the device causing the distance (i.e. height) between the upper and lower plates to decrease. In this manner, the height of the construct can be continuously adjusted. The devices are available in a several footprint sizes. The top and bottom of the devices are fenestrated and each contain windows to enhance bony in growth. A cavity internal to each device is intended to hold autogenous bone graft.

The Opticage Expandable Interbody Fusion Devices in Model Series 9070 are provided in both sterile and non-sterile versions.

This document (K140716) is a 510(k) premarket notification for a medical device called the Opticage™ Expandable Interbody Fusion Device. As such, it focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing acceptance criteria and proving the device meets those criteria through a primary clinical study.

The FDA 510(k) pathway does not typically require clinical trials in the same way a PMA (Premarket Approval) does, especially for Class II devices like this one. Instead, it relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of typical AI/diagnostic device performance metrics (like sensitivity, specificity, etc., with associated sample sizes, ground truths, and reader studies) is not directly applicable or present in this 510(k) submission.

However, I can extract the information related to the performance data provided to support the claim of substantial equivalence. This "performance data" serves the purpose of demonstrating that the new device functions similarly and is as safe as the predicate devices.

Here's a breakdown based on the provided document, addressing the closest analogues to your request:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, there aren't "acceptance criteria" in the traditional sense of a diagnostic performance study (e.g., minimum sensitivity). Instead, the performance claims are based on meeting established standards for intervertebral body fusion devices, and demonstrating comparable performance to predicate devices.

• Static compression
• Dynamic compression
• Static compression shear
• Dynamic compression shear
• Static torsional
• Dynamic torsional |
  | ASTM F2267 | Subsidence testing completed for Opticage™ Model Series 9070. |
  | ISO 17853 | Evaluation of wear debris/particulates completed for Opticage™ Model Series 9070. |
  | ASTM F1877 | Evaluation of wear debris/particulates completed for Opticage™ Model Series 9070. |
  | Not explicitly listed, but implied | Expulsion testing completed for Opticage™ Model Series 9070. |
  | Not explicitly listed, but implied | Finite Element Analysis (FEA) conducted to confirm worst-case performance configuration. |
  | Overall Comparison to Predicates | "Test performance data demonstrated substantial equivalence to the predicate devices." (Specifically Caliber® Spacer (K123231), L-Varlock Lumbar Cages (K080537), Caliber™ Spacer (K102293), and referenced Opticage models (K113527, K132479, K133583)). The device has similar size, shape, and material composition (Ti-6AL-4V) to predicates, with similar operational characteristics. |

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

This document describes mechanical and material testing, not clinical or diagnostic performance testing with human subjects. Therefore, the concept of a "test set" in terms clinical data or patient images (as would be relevant for an AI device) does not apply. The "samples" would be the physical devices or components tested according to the ASTM and ISO standards. The document does not specify the number of devices or components tested, nor their manufacturing origin (country). This type of testing is generally performed in a lab setting by the manufacturer or contracted labs.

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

Not applicable.

• For mechanical and material testing, ground truth is established by the physical properties and performance characteristics of the materials and device components as measured against established engineering standards (ASTM, ISO). There are no "experts" establishing a "ground truth" in the clinical sense.

4. Adjudication Method for the Test Set

Not applicable.

• There is no "adjudication" in the context of mechanical device testing; the results are typically quantitative and objective measurements against predefined criteria in the standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

Not applicable.

• This is a mechanical implant device, not a diagnostic imaging device or an AI algorithm intended to assist human readers. Therefore, an MRMC study is outside the scope of this submission.

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

Not applicable.

• This device is a physical implant for spinal fusion, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established engineering and material science standards (e.g., ASTM F2077-03, ASTM F2267, ISO 17853, ASTM F1877) that dictate acceptable performance ranges for intervertebral body fusion devices. The device's performance against these standards, and its similarity to predicate devices, forms the basis for demonstrating safety and effectiveness.

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.

• No training set exists for this type of device submission.

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