(94 days)
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
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static Compression | Met via testing in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device," ASTM F2077, and ASTM F2267. |
| Dynamic Compression | Met via testing in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device," ASTM F2077, and ASTM F2267. | |
| Static Compression-Shear | Met via testing in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device," ASTM F2077, and ASTM F2267. | |
| Dynamic Compression-Shear | Met via testing in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device," ASTM F2077, and ASTM F2267. | |
| Subsidence | Met via testing in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device," ASTM F2077, and ASTM F2267. | |
| Substantial Equivalence | Similarity in Design, Dimensions, Intended Use, Materials, and Performance Characteristics to Predicate Devices | "The technological characteristics of the additional CALIBER® Spacers are similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics." "The additional CALIBER® Spacers are similar to the predicate systems with respect to technical characteristics, performance and intended use." |
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.