(166 days)
The X-spine Calix Lumbar Spinal Implant System is intended for spinal fusion procedures at one or two contiguous levels (L2 - S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autogenous bone graft and implanted via an anterior, posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
The X-spine Calix Lumbar Spinal Implant System is a generally box or oval shaped device manufactured from Invibio PEEK-Optima LT1 per ASTM F2026 with an array of holes located throughout its geometry as well as teeth on the superior and inferior surfaces. The device is supplied in several widths and heights to accommodate variations in patient anatomy. The devices contain radiographic markers made from tantalum per ASTM F560.
The hollow center of the implant allows the device to be packed with bone graft.
The provided text describes a 510(k) summary for the Calix™ Lumbar Spinal Implant System. This document focuses on the administrative and technical details of a medical device submission, specifically detailing its equivalence to previously marketed products and the performance testing conducted.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, it describes a series of standardized tests performed to demonstrate the device's biomechanical equivalence to predicate devices. The "reported device performance" is implied by the successful completion of these tests, signifying that the device performs "at least as safely and effectively as the cited predicate devices."
| Acceptance Criteria Category | Specific Test Standard / Type | Reported Device Performance Statement |
|---|---|---|
| Biomechanical Strength | ASTM F2077 - Test Methods for Intervertebral Body Fusion Devices | Demonstrated substantial equivalence to predicate devices for static and dynamic axial compression and axial compression-shear. |
| - Static and dynamic axial compression | ||
| - Static and dynamic axial compression-shear | ||
| Subsidence Resistance | ASTM F2267 - Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression | Demonstrated substantial equivalence to predicate devices. |
| Expulsion Resistance | Expulsion testing as suggested by FDA Guidance | Demonstrated substantial equivalence to predicate devices. |
Note: The document states "biomechanical testing results indicate that the Calix Lumbar Spinal Implant System is substantially equivalent to predicate device performance and is as effective, and performs at least as safely and effectively as the cited predicate devices." This is the general statement of performance, rather than specific quantitative results against discrete acceptance values.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide a "test set" in the context you would typically find for an AI/software device (e.g., a set of medical images for diagnostic accuracy assessment). Instead, the "performance data" refers to biomechanical testing of the device itself.
- Sample Size for Test Set: Not specified in terms of number of devices or specific load cycles, but refers to "full device constructs" undergoing standardized tests. For biomechanical testing, sample size would typically refer to the number of physical devices tested under various conditions.
- Data Provenance: The tests are standard ASTM (American Society for Testing and Materials) and FDA guidance-driven tests, which implies an engineering/laboratory setting rather than clinical data from a specific country or retrospective/prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable to the provided document. The "ground truth" here is established by the specifications and pass/fail criteria of the ASTM and FDA-recommended biomechanical tests themselves, not by human expert assessment of device performance in a clinical or diagnostic setting.
4. Adjudication Method for the Test Set
This question is not applicable to the provided document as it does not involve expert review or consensus for establishing ground truth. The 'adjudication' in biomechanical testing is typically determined by whether the physical device meets the mechanical performance requirements defined by the test standard.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. The document describes biomechanical testing of a spinal implant, not a diagnostic or AI-powered medical imaging device that would involve human readers. Therefore, an MRMC study is not relevant to this content.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This question is relevant for AI/software devices. The provided document concerns a physical spinal implant and its mechanical performance testing.
7. The Type of Ground Truth Used
The "ground truth" for the performance data in this context is the established physical and mechanical properties of the predicate devices and the requirements set forth in the ASTM standards (F2077, F2267) and FDA guidance for intervertebral body fusion devices. The device's performance is compared against these engineering standards and the known performance characteristics of already cleared devices to establish "substantial equivalence."
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical implant, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for a physical implant.
In summary: The provided 510(k) summary for the Calix Lumbar Spinal Implant System focuses on demonstrating substantial equivalence to predicate devices through biomechanical performance testing. It does not contain information related to AI/software device performance, clinical studies with human readers, or image-based diagnostic accuracy. The "acceptance criteria" are implied by the successful completion of standardized engineering tests, and the "ground truth" is based on these objective engineering standards and predicate device performance.
§ 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.