(112 days)
The Calix-C™ Cervical Interbody Spacer is intended for spinal fusion procedures at one level (C2 - T1 inclusive) in skeletally mature patients with degenerative disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should receive at least six (6) weeks of non-operative treatment with the Calix-CTM Cervical Interbody Spacer.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e., posterior cervical screw and rod systems and anterior cervical plate systems).
The Calix-C™ Cervical Interbody Spacer is an intervertebral fusion device, generally box or oval-shaped, that has various holes throughout its geometry. The device body is made from Invibio PEEK-Optima™ (polyetheretherketone) per ASTM F2026, with radiographic markers made from tantalum per ASTM F560. Superior and inferior surfaces of the device have teeth to help prevent implant dislodgement or expulsion once placed in its desired location. The implants are available with or without titanium plasma coating on the superior and inferior surfaces of the device. The plasma coating is made from medicalgrade titanium per ASTM F1580. The hollow center of the implant allows the device to be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
The system does not contain software/firmware.
The given document is a 510(k) premarket notification for a medical device (Calix-C™ Cervical Interbody Spacer). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through clinical studies or detailed human-AI comparative effectiveness.
Therefore, the requested information regarding acceptance criteria, study design details like sample size for test sets and training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment cannot be found within this document.
The document specifically states under "X. PERFORMANCE DATA" that:
- "Mechanical testing is recommended in the FDA special controls guidance document, 'Class II Special Controls Guidance: Intervertebral Body Fusion Device'."
- "X-spine has previously submitted to the FDA results of performance testing for Calix cervical implants: K112036 and K083637, according to the following standards:" (lists ASTM standards for mechanical testing).
- "Therefore, no new nonclinical testing was performed for the purpose of this submission."
This indicates that the "performance data" for this device relates to mechanical (non-clinical) testing, not clinical performance data involving human readers or AI. The product is a physical implant, not a software or AI-driven diagnostic device.
To directly answer your request based solely on the provided text, without making assumptions:
Acceptance Criteria and Study for Calix-C™ Cervical Interbody Spacer
Based on the provided FDA 510(k) submission document for the Calix-C™ Cervical Interbody Spacer, the "study" conducted for this submission primarily involved demonstrating substantial equivalence to predicate devices and relying on previously conducted nonclinical (mechanical) performance testing. The device is an intervertebral body fusion device, not an AI or software-based diagnostic tool. Therefore, the types of acceptance criteria and study methodologies typically associated with AI/software performance (e.g., sensitivity, specificity, reader studies, ground truth establishment by experts) are not applicable or described in this document.
The "performance data" mentioned in the document refers to mechanical testing to ensure the structural integrity and functional performance of the physical implant.
Key points from the document regarding "performance":
- No new nonclinical testing was performed for the purpose of this submission (K171075).
- The manufacturer (X-spine) had previously submitted results of performance testing for earlier versions of Calix cervical implants (K112036 and K083637).
- These previous tests were conducted according to established ASTM standards for intervertebral body fusion devices, focusing on:
- Static and dynamic torsion testing
- Static and dynamic axial compression and compression shear testing
- Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- Expulsion testing
- Performance Qualification of Commercially Pure Titanium Plasma Spray (CP Ti)
Given that the device is a physical implant and this submission is an update to an existing device (adding sizes and expanding indications), the performance evaluation relies on the known biomechanical properties and the established equivalence to predicate devices, rather than a new human-reader or AI-driven study.
Therefore, the following information cannot be extracted or inferred from the provided text, as it pertains to methodologies not described or applicable to this type of device submission:
- Table of acceptance criteria and reported device performance (for AI/diagnostic): Not applicable for a physical implant. The "acceptance criteria" here relate to mechanical properties and substantial equivalence to predicates.
- Sample size for test set and data provenance: Not applicable for AI/diagnostic performance. Mechanical testing would have specific samples, but details not provided for this submission.
- Number of experts and qualifications for ground truth: Not applicable.
- Adjudication method for test set: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for 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.