Search Results

CALIBER® Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

CALIBER® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE® or REVOLVE® Stabilization Systems.

CALIBER® Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. CALIBER® Spacers are provided in different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral] or lateral) and can expand to the desired height or the desired lordosis. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

CALIBER® Spacers are manufactured from radiolucent PEEK polymer and titanium alloy per ASTM F2026, F136 and F1295; non-expanding CALIBER® CALIBER® Spacers contain Spacers are manufactured from PEEK only. radiopaque titanium alloy or tantalum markers as specified in ASTM F136, F1295 and F560.

Here's an analysis of the provided text regarding the CALIBER® Spacers, focusing on acceptance criteria and the supporting study, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not contain information about a test set derived from patient data or any human clinical trials. The "performance data" section refers exclusively to mechanical testing.

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

This information is not applicable as the study did not involve a test set requiring expert ground truth establishment (e.g., image interpretation). The "ground truth" for the mechanical testing would be defined by the pre-established standards and methods outlined in the ASTM documents.

4. Adjudication Method for the Test Set

This information is not applicable as there was no test set requiring expert adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is entirely based on mechanical testing of the device itself, not on human interpretation or comparison of human readers with or without AI assistance.

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

No, a standalone (algorithm only) performance study was not done. The device itself is a physical medical implant, not an algorithm or software. The "performance" assessment was for its mechanical properties.

7. The Type of Ground Truth Used

The ground truth for the performance assessment was mechanical engineering standards and specifications as defined by:

• "Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007
• ASTM F2077 (Standard Specification for Intervertebral Body Fusion Devices)
• ASTM F2267 (Standard Test Method for Measuring Load-Displacement Properties of an Intervertebral Body Fusion Device, Including Measurement of Stiffness, Strength, and Subsidence)

These standards define the expected mechanical behavior and thresholds for device performance.

8. The Sample Size for the Training Set

This information is not applicable. There was no "training set" in the context of an AI/algorithm. If relating to the mechanical testing, the sample size would be the number of physical devices tested for each mechanical parameter, but this specific number is not provided in the document.

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

This information is not applicable as there was no training set in the context of an AI/algorithm.

Ask a specific question about this device

CALIBER™ Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

CALIBER™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE® or REVOLVE™ Stabilization Systems.

CALIBER™ Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. CALIBER™ Spacers are provided in different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral) or lateral) and can expand to the desired height. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

CALIBER™ Spacers are manufactured from radiolucent PEEK polymer and titanium alloy per ASTM F2026, F136 and F1295; non-expanding CALIBER™ Spacers are manufactured from PEEK only. CALIBER™ Spacers contain radiopaque titanium alloy or tantalum markers as specified in ASTM F136, F1295 and F560.

The CALIBER™ Spacer is a medical device and as such, the provided text does not describe acceptance criteria and studies in the context of an AI/ML device that would typically involve metrics such as sensitivity, specificity, or reader studies. Instead, it describes mechanical testing for a spinal implant to demonstrate substantial equivalence to predicate devices for regulatory clearance.

However, interpreting the request in the context of the provided information, I will extract relevant details regarding the device's performance evaluation and regulatory acceptance.

Acceptance Criteria and Reported Device Performance

Additional Information (Not applicable for this type of medical device submission):

The provided document is a 510(k) summary for a medical device (CALIBER™ Spacer), which is a physical implant, not an AI/ML software device. Therefore, many of the requested fields are not relevant to this type of regulatory submission. The submission focuses on demonstrating the device's mechanical integrity and substantial equivalence to existing, legally marketed predicate devices, not on the performance of a diagnostic algorithm or AI model.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for mechanical testing of a physical implant. The test set would consist of physical samples of the device undergoing stress. The document does not specify the number of samples used for each test.
2. 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 for mechanical testing is established by engineering standards and measurements, not expert consensus on medical images.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are for clinical or image-based evaluations.
4. 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 physical device, not an AI tool for human readers.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by established engineering standards (ASTM F2077) and regulatory guidance ("Class II Special Controls Guidance Document: Intervertebral Fusion Device"). The device's performance is measured against these established physical and mechanical benchmarks.
7. The sample size for the training set: Not applicable. This refers to the training of an AI model, not the development or testing of a physical implant.
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device