(145 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 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
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static compression | Testing conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007, and ASTM F2077. Performance demonstrated substantial equivalence to predicate system(s). |
| Dynamic compression | Testing conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007, and ASTM F2077. Performance demonstrated substantial equivalence to predicate system(s). | |
| Static compression-shear | Testing conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007, and ASTM F2077. Performance demonstrated substantial equivalence to predicate system(s). | |
| Dynamic compression-shear | Testing conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007, and ASTM F2077. Performance demonstrated substantial equivalence to predicate system(s). | |
| Subsidence | Testing conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007, and ASTM F2077. Performance demonstrated substantial equivalence to predicate system(s). | |
| Substantial Equivalence | Comparison to predicate systems with respect to technical characteristics, performance, and intended use. | The device was found substantially equivalent to predicate devices (Globus PATRIOT® Spacers (K072970 & K093242) and Kiscomedica L-Varlock™ Lumbar Cages (K080537)) based on mechanical testing and similar technical characteristics, performance, and intended use. |
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.
- 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.
- 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.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are for clinical or image-based evaluations.
- 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.
- 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.
- 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.
- 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.
- How the ground truth for the training set was established: Not applicable.
§ 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.